AC-evergreening NC- Innovation DA V3 Heg DA HIF CP 1Ar-all NR-innovation DA 2Ar- Innovation DA Case
Greenhill
4
Opponent: Southlake Carroll AS | Judge: Eric He
AC-Cannabis NC- Innovation DA V4 HIF Cp T reduce 1ar-all NR- innovation DA 2AR- Innovation DA case
Greenhill
6
Opponent: West HS SLC | Judge: Daksh Kapoor
AC-whole rez NC- Innovation DA V3 HIF CP Heg DA 1ar-All Nr- Innovation DA V3 HIF CP 2AR- innovation DA V3 HIF CP case
Loyola
2
Opponent: Princeton DR | Judge: Gordon Krauss
AC- eliminate secondary patents NC- innovation DA (on case) HIF CP Heg DA 1ar-all condo bad NR-condo good innovation DA HIF CP 2AR-innovation a2 CP
Loyola
4
Opponent: Immaculate Heart RR | Judge: Lucas Hunter
Ac-CRISPR- innovation advantage and WTO advantage NC-CRISPR CP Innovation DA V2 case 1ar- all condo NR- CRISPR CP innovation DA case 2ar- WTO advantage A2 CP A2 Innovation DA
Loyola
5
Opponent: Academy of Higher Learning JM | Judge: Asher Towner
AC-whole rez NC-disclosure theory HIF CP Innovation DA V3 1ar-all Nr-HIF CP Innovation DA V3 2ar-all
St Marks
3
Opponent: Harvard Westlake AT | Judge: David Dosch
AC- covid (China advantage WTO advantage) NC- Innovation DA V5 Covid funding CP Infrastructure DA v2 1ar- advantage 1 all offs NR-Innovation DA case 2AR- Innovation DA case
St Marks
2
Opponent: Harvard Westlake AW | Judge: Danielle Dosch
AC-covid NC-innovation DA v5 covid funding cP Biden politics DA 1ar-all NR-innovation DA covid funding CP case 2ar-innovation DA covid funding CP case
To modify or delete round reports, edit the associated round.
Cites
Entry
Date
0-Contact Information
Tournament: NA | Round: 1 | Opponent: NA | Judge: Hi, I am Macy (she/her). You can contact me through email. Email: Macylerner22@marlborough.org
8/25/21
SO- Heg DA
Tournament: Loyola | Round: 2 | Opponent: Princeton DR | Judge: Gordon Krauss IPR is key for U.S Dollar Centrality – it allows US firms near if not complete monopolies pushing dollars into international markets and stabilizing US financial influence Schwartz ‘19 Schwartz, Herman Mark (2019). American hegemony: intellectual property rights, dollar centrality, and infrastructural power. Review of International Political Economy, (), 1–30. doi:10.1080/09692290.2019.1597754 Phoenix Mechanism one relates to Strange’s (1989) financial power: US current account deficits generate the dollar centrality that network analyses reveal through self-reinforcing dynamics prior to the network. US current account deficits result from deep seated domestic institutional arrangements in current account surplus economies that produce chronic domestic demand shortfalls. The more those export-led economies run surpluses with the United States, the more dollars they accumulate; the more dollars they accumulate, the more dollars flow through their banking systems back into dollar assets and liabilities; the more dollar assets and liabilities those banks hold on their balance sheets, the more those banks both rely on the Federal Reserve Bank (FED) as a lender of last resort or a supplier of outside money during (the inevitable) crises, and the more their staff develop habitus (Bourdieu, 1977) or the routinized behaviors at the heart of infrastructural power (Mann, 1986) that support continued use of the dollar in non-crisis times; the more those banks lend in dollars, the more counterparty debtor economies are drawn into use of the dollar; a parallel habitus emerges among export firms that reinforces use of the dollar in a Hirschman (1945)-like dynamic. If suppliers (or debtors) are borrowing those recycled dollars, they will demand payment in dollars to meet their liabilities. Contemporary late developers similarly need export markets to grow, and the United States constitutes both the biggest import market and biggest net importer in the global economy (netting intra-EU trade). This mechanism originates from institutional responses to the problem of late development and not, via lower transaction costs, the emergent network of dollar claims and liabilities itself. That said, surely dollar acceptability faces limits set by persistent US current account deficits? Prudent actors might well balk at accepting more assets denominated in a currency at risk of sustained depreciation (Bergsten and Williamson, 2004). Indeed, the 1960s Triffin dilemma pitted declining confidence about the dollar as a store of value given rising US inflation rates and a declining productivity gap between the United States and its main competitors against the need for global liquidity supplied by a US current account deficit. Today, as Eichengreen (2010) has argued, centrality for the dollar faces a similar collective action problem among holders of dollar-denominated assets – why do US current account deficits not motivate individual countries with relatively smaller dollar holdings to defect for fear of depreciation or capital losses? In today’s flexible exchange rate world, only above average US economic growth and/or profits for the firms constituting the bulk of equity market capitalization validates confidence in dollar assets. Because economic activity is organized through capitalist markets, the critical issue for differential growth (Nitzan, 1998) and asset validation is always: ‘who gets the profits and in what proportion’? Mechanism two is thus about profits, which corresponds to Strange’s (1989) productive power. US firms capture a disproportionate share of global profits, and within this firms with robust intellectual property rights (IPRs – patent, copyright brand and trademark) capture a disproportionate share of US and global profits. Here compliance with international trade treaties protecting IPRs is the focal point or center of gravity for this disproportionality. IPRs give some US firms monopoly or near monopoly power in the global (and local) commodity chains they construct. The extension of US IPR law through various trade treaties (Drahos and Braithwaite, 2003; Sell, 2003; Sell and Prakash, 2004) allows US IPR firms to capture a disproportionate share of global profits via that monopoly power. This shifts claims on value added towards those firms, concentrating profits into a small number of US firms. Though we explore this below in more depth, US firms account for a disproportionate 33.9 of cumulative profits generated by any firm appearing on the Forbes Global 2000 list from 2006 to 2018 and firms in sectors characterized by robust IPRs account for a disproportionate 26.6 of those profits. Profitability thus also rests on infrastructural power, via compliance with trade treaties and enmeshment in global value chains orchestrated by US firms. As with bank behavior, this compliance is not purely voluntary (Gruber, 2000), but rather reflects a gradient in which mutually beneficial cooperation shades into coercion as the proportion of local firms benefiting from those treaties declines. US firms are not the only ones that possess marketable intellectual property. Non-US firms that also benefit from robust global IPRs broaden the global political coalition for creating and expanding those IPRs. Yet US firms tend to control the commodity chains in which those foreign firms participate. These two mechanisms are connected: the first explains why non-US actors receive dollars (more precisely, dollar-denominated assets) and the second explains why they opt to hold those assets; put differently, the supply of and demand for dollars. The two mechanisms transform the exorbitant burden – current account deficits associated with use of the dollar as the international reserve currency – back into an exorbitant privilege. They represent a transfer of real resources back to the US economy in exchange for promises to pay back something in the future. Finally, though we will not explore this in depth, these two mechanisms are also linked to the military side of US power, where a similar logic of dominance over potential peer rivals has driven science policy and technological innovation. Put bluntly, a military-innovation complex (c.f. Eisenhower’s military-industrial complex (Hozic, 1999; Hurt, 2010; Mazzucato, 2015; Weiss, 2014)) is the research foundation for the high profit US IPR firms that in turn feed a substantial portion of cash back into the IMS. As with all such systems of power, these structural strengths contain endogenously generated weaknesses and face on-going challenges from the less powerful. Financialization and profit strategies built on IPRs endogenously produce income inequality among firms and people, which erodes compliance, potentially slows growth and destabilizes the global financial system. Domestically, the current account deficits necessary for a dollar-centric IMS (Germain and Schwartz, 2014) generated part of the anger motivating the populist voting bloc that elected Trump. In turn, the Trump Administration’s erratic trade policy, its assaults on parts of the military-innovation complex, and, most significantly, its efforts to eviscerate financial regulation simultaneously threaten the dollar’s role in the IMS and US firms’ ability to capture global profits.3 The Trump administration is one logical consequence of current account deficits that have hollowed out manufacturing employment and limited upward mobility to a narrow slice of the US population. The paper thus has four sections corresponding to the issues: Why does infrastructural power matter? Why the IMS? Why IPRs? The conclusion considers critical endogenous sources of decay. Collapse of dollar centrality decks the US economy, prevents stimulus, and undermines security spending which emboldens China aggression. Zoffer 12 - Josh Zoffer (Legal Intern at the IMF, Yale Law), "Future of Dollar Hegemony", Harvard International Review, July 7, 2012. http://hir.harvard.edu/article/?a=2951 DM Despite the dollar’s long history as the international reserve currency, the past few years have seen a growing number of calls for the end of dollar hegemony. Countries as diverse as France, Russia, and China have decried the dollar’s monopoly in foreign exchange markets, while in 2009 reports of a shift away from dollar-based oil trading surfaced in the Middle East. Reported plans to move away from the dollar reflected international frustration at a system fueling the United States’ “exorbitant privilege,” as the French have called it, one that rests its stability on the financial conditions of a country mired in debt and facing a financial meltdown. The implications of a true end to dollar hegemony, a shift away from the dollar as a reserve currency and pricing standard for oil transactions, could be catastrophic for the United States. In the worst case scenario, a drastic drop in demand for dollar-denominated assets would cause the interest rates on Treasury Securities to skyrocket, sending ripples through the US economy as the value of the dollar plummets. What is certain, however, is that whatever decrease in demand for US debt occurs will constrain the federal government’s ability to spend and the ability of the United States to defend itself. The United States has built its foreign policy around its vast military capability; a sudden budgetary shock and drop in military spending would leave the United States vulnerable as it scrambles to regroup in a new security environment. The ability of the United States to respond to threats across the globe would be diminished, and enemies would be incentivized to take aggressive action to take advantage of this new weakness. In particular, a rapidly militarizing China might be emboldened by its partial decoupling from US economic fortunes to adopt a bolder stance in the South China Sea, threatening US allies and heightening tensions with the United States. While war with China is all but off the table in the status quo, an international system devoid of both US military might and Chinese dependence on US debt as a place to park excess liquidity might lead to the conflict feared on both sides of the Pacific. Economic collapse leads to oppressive populism and great power war. Liu 11/13/18 - Qian Liu Economist; the first Chinese analyst to join The Economist Intelligence Unit, the research arm of the group. Before becoming the managing director, she was the director of the global economics unit and director of Access China for the EIU. She also served as the chairwoman for internal review at EIU with the European Securities and Markets Authority. Ms Liu adopted econometric models to analyse economic data and produce macroeconomic forecasts.; guest lecturer at New York University, Tsinghua University, the Chinese Academy of Social Sciences and Fudan University.; PhD in economics from Uppsala University, Sweden, and spent a year as a visiting researcher at the University of California, Berkeley., “The next economic crisis could cause a global conflict. Here's why,” World Economic Forum (Web). Nov. 13, 2018. Accessed Feb. 16, 2019. https://www.weforum.org/agenda/2018/11/the-next-economic-crisis-could-cause-a-global-conflict-heres-why/ AT As monetary tightening reveals the vulnerabilities in the real economy, the collapse of asset-price bubbles will trigger another economic crisis – one that could be even more severe than the last, because we have built up a tolerance to our strongest macroeconomic medications. A decade of regular adrenaline shots, in the form of ultra-low interest rates and unconventional monetary policies, has severely depleted their power to stabilize and stimulate the economy.¶ If history is any guide, the consequences of this mistake could extend far beyond the economy. According to Harvard’s Benjamin Friedman, prolonged periods of economic distress have been characterized also by public antipathy toward minority groups or foreign countries – attitudes that can help to fuel unrest, terrorism, or even war.¶ For example, during the Great Depression, US President Herbert Hoover signed the 1930 Smoot-Hawley Tariff Act, intended to protect American workers and farmers from foreign competition. In the subsequent five years, global trade shrank by two-thirds. Within a decade, World War II had begun.¶ To be sure, WWII, like World War I, was caused by a multitude of factors; there is no standard path to war. But there is reason to believe that high levels of inequality can play a significant role in stoking conflict.¶ According to research by the economist Thomas Piketty, a spike in income inequality is often followed by a great crisis. Income inequality then declines for a while, before rising again, until a new peak – and a new disaster. Though causality has yet to be proven, given the limited number of data points, this correlation should not be taken lightly, especially with wealth and income inequality at historically high levels.¶ This is all the more worrying in view of the numerous other factors stoking social unrest and diplomatic tension, including technological disruption, a record-breaking migration crisis, anxiety over globalization, political polarization, and rising nationalism. All are symptoms of failed policies that could turn out to be trigger points for a future crisis.¶ Voters have good reason to be frustrated, but the emotionally appealing populists to whom they are increasingly giving their support are offering ill-advised solutions that will only make matters worse. For example, despite the world’s unprecedented interconnectedness, multilateralism is increasingly being eschewed, as countries – most notably, Donald Trump’s US – pursue unilateral, isolationist policies. Meanwhile, proxy wars are raging in Syria and Yemen.¶ Against this background, we must take seriously the possibility that the next economic crisis could lead to a large-scale military confrontation. By the logic of the political scientist Samuel Huntington, considering such a scenario could help us avoid it, because it would force us to take action. In this case, the key will be for policymakers to pursue the structural reforms that they have long promised, while replacing finger-pointing and antagonism with a sensible and respectful global dialogue. The alternative may well be global conflagration.
9/4/21
SO-CRISPR advantage CP
Tournament: Loyola | Round: 4 | Opponent: Immaculate Heart RR | Judge: Lucas Hunter CP Counter plan text: The World Health Organization should harmonize its approach to CRIPSR patents and the member nations of the World Trade Organization should follow these guidelines. Marlborough reading yellow. Their own card--Wachowicz 19 (Jessica, a third-year student at the University of Washington School of Law whose primary area of study is emerging technologies and the legal issues associated therewith.) “The Patentability of Gene Editing Technologies such as CRISPR and the Harmonization of Laws Relating to Germline Editing, “ Intellectual Property Breif, 2019 https://digitalcommons.wcl.american.edu/ipbrief/vol10/iss1/2/ RR At present, countries take different approaches in applying the ordre public doctrine to cases involving germline editing. In Japan, the patent office examines scientific guidelines pertaining to stem cell research in rendering its decisions.8 1 Others simply look to the values held by that particular country in determining whether the invention would benefit society.82 Looking at the values held by a particular community will lead to varying results. Some countries may value the welfare of individuals over the progression of science.83 Others argue that because these inventions can dramatically improve healthcare, and because healthcare is a human right, this public interest should override any bans on germline editing. 84 A similar dispute arose under TRIPS with respect to pharmaceuticals. As stated previously, some countries, India in particular, argued that patenting pharmaceuticals was immoral because it raised the cost of healthcare. In 2016, the World Health Organization published the "Guidelines for the examination of patent applications relating to pharmaceuticals."86 The purpose of this guideline was to assist legislators in crafting laws that would allow for the patentability of pharmaceuticals generally, while imposing limitations that would prevent healthcare from becoming unaffordable. One plausible solution is for the World Health Organization to create a set of guidelines for determining the patentability of technologies such as CRISPR. The guideline can look to other international treaties that focus on the preservation of human rights and the improvement of healthcare.87 By encouraging countries to take these agreed upon policy objectives into consideration when examining these controversial patents, results among different patent offices may be slightly less varied. A guideline from the World Health Organization (WHO) or a similar organization may assist countries' legislatures in crafting laws that allow for progression in this field of science while protecting their communities from potential human rights violations, such as the destruction of viable embryos. Attempts at harmonization have been made in the past. There are currently numerous international instruments that prohibit inventions involving genomes, such as the UNESCO Universal Declaration on Bioethics and Human Rights and the Oviedo Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biotechnology and Medicine: Convention on Human Rights and Biomedicine. The former states that public welfare should be prioritized over the progress of science, and the latter states that genetic modification techniques should only be allowed if "serious hereditary sexrelated diseases are to be avoided."89 These agreements make clear that public welfare is of primary importance, and that germline editing techniques should only be applied where serious risks can be avoided. The Oviedo Convention limited the scope of the exception to the avoidance of sex-related diseases, but perhaps with the introduction of CRISPR, countries may need to consider the circumstances under which genome and germline editing may be permissible. CONCLUSION In summary, relying on the ordre public doctrine to determine the patentability of CRISPR technology will lead to dramatically varying results around the world. The need for a more harmonized approach is present. Despite countries' general avoidance of genome and germline editing, technology has developed in such a way that these practices may be highly beneficial to public welfare. Countries should reconsider their stances on such practices in light of the potential benefits CRISPR technology can offer and should attempt to reach a general consensus on the proper uses of CRISPR. Given recent events, the WHO should promptly issue guidelines to assist legislatures in crafting laws that promote progress in this area while maintaining consistency with concepts of morality. The counter plan entails that the European Union would comply with the same patent rules as the rest of the WTO which solves the second advantage
9/5/21
SO-Covid funding CP
Tournament: St Marks | Round: 2 | Opponent: Harvard Westlake AW | Judge: Danielle Dosch CP Counterplan: High-income country governments, backed by the United States, should provide all necessary funding to purchase COVID-19 vaccines developed by drug companies at any reasonable cost and distribute them as requested world-wide. Lindsay 6/11 - Brink Lindsay, Brookings, 6-11, 2021, Why intellectual property and pandemics don’t mix, https://www.brookings.edu/blog/up-front/2021/06/03/why-intellectual-property-and-pandemics-dont-mix/ Waiving patent protections is certainly no panacea. What is needed most urgently is a massive drive of technology transfer, capacity expansion, and supply line coordination to bring vaccine supply in line with global demand. Dispensing with patents in no way obviates the need for governments to fund and oversee this effort.¶ Although focusing on these immediate constraints is vital, we cannot confine our attention to the short term. First of all, the COVID-19 pandemic is far from over. Although Americans can now see the light at the end of the tunnel thanks to the rapid rollout of vaccines, most of the world isn’t so lucky. The virus is¶ currently raging in India and throughout South America, overwhelming health care systems and inflicting suffering and loss on a horrific scale. And consider the fact that Australia, which has been successful in suppressing the virus, recently announced it was sticking to plans to keep its borders closed until mid-2022. Criticisms of the TRIPS waiver that focus only on the next few months are therefore short-sighted: this pandemic could well drag on long enough for elimination of patent restrictions to enable new vaccine producers to make a positive difference.¶ Furthermore, and probably even more important, this is almost certainly not the last pandemic we will face. Urbanization, the spread of factory-farming methods, and globalization all combine to increase the odds that a new virus will make the jump from animals to humans and then spread rapidly around the world. Prior to the current pandemic, the 21st century already saw outbreaks of SARS, H1N1, MERS, and Ebola. Everything we do and learn in the current crisis should be viewed from the perspective of getting ready for next time.¶ The Nature of the Patent Bargain¶ When we take the longer view, we can see a fundamental mismatch between the policy design of intellectual property protection and the policy requirements of effective pandemic response. Although patent law, properly restrained, constitutes one important element of a well-designed national innovation system, the way it goes about encouraging technological progress is singularly ill-suited to the emergency conditions of a pandemic or other public health crisis. Securing a TRIPS waiver for COVID-19 vaccines and treatments would thus establish a salutary precedent that, in emergencies of this kind, governments should employ other, more direct means to incentivize the development of new drugs.¶ Here is the basic bargain offered by patent law: encourage the creation of useful new ideas for the long run by slowing the diffusion of useful new ideas in the short run. The second half of the bargain, the half that imposes costs on society, comes from the temporary exclusive rights, or monopoly privileges, that a patent holder enjoys. Under U.S. patent law, for a period of 20 years nobody else can manufacture or sell the patented product without the permission of the patent holder. This allows the patent holder to block competitors from the market, or extract licensing fees before allowing them to enter, and consequently charge above-market prices to its customers. Patent rights thus slow the diffusion of a new invention by restricting output and raising prices.¶ The imposition of these short-run costs, however, can bring net long-term benefits by sharpening the incentives to invent new products. In the absence of patent protection, the prospect of easy imitation by later market entrants can deter would-be innovators from incurring the up-front fixed costs of research and development. But with a guaranteed period of market exclusivity, inventors can proceed with greater confidence that they will be able to recoup their investment.¶ For the tradeoff between costs and benefits to come out positive on net, patent law must strike the right balance. Exclusive rights should be valuable enough to encourage greater innovation, but not so easily granted or extensive in scope or term that this encouragement is outweighed by output restrictions on the patented product and discouragement of downstream innovations dependent on access to the patented technology.¶ Unfortunately, the U.S. patent system at present is out of balance. Over the past few decades, the expansion of patentability to include software and business methods as well as a general relaxation of patenting requirements have led to wildly excessive growth in these temporary monopolies: the number of patents granted annually has¶ skyrocketed roughly fivefold since the early 1980s. One unfortunate result has been the rise of “non-practicing entities,” better known as patent trolls: firms that make nothing themselves but buy up patent portfolios and monetize them through aggressive litigation. As a result, a law that is supposed to encourage innovation has turned into a¶ legal minefield for many would-be innovators. In the pharmaceutical industry, firms have abused the law by piling up patents for trivial, therapeutically irrelevant “innovations” that allow them to¶ extend their monopolies and keep raising prices long beyond the statutorily contemplated 20 years.¶ Patent law is creating these unintended consequences because policymakers have been caught in an ideological fog that¶ conflates “intellectual property” with actual property rights over physical objects. Enveloped in that fog, they regard any attempts to put limits on patent monopolies as attacks on private property and view ongoing expansions of patent privileges as necessary to keep innovation from grinding to a halt. In fact, patent law is a tool of regulatory policy with the usual tradeoffs between costs and benefits; like all tools, it can be misused, and as with all tools there are some jobs for which other tools are better suited. A well-designed patent system, in which benefits are maximized and costs kept to a minimum, is just one of various policy options that governments can employ to stimulate technological advance—including tax credits for RandD, prizes for targeted inventions, and direct government support.¶ Public Health Emergencies and Direct Government Support¶ For pandemics and other public health emergencies, patents’ mix of costs and benefits is misaligned with what is needed for an effective policy response. The basic patent bargain, even when well struck, is to pay for more innovation down the road with slower diffusion of innovation today. In the context of a pandemic, that bargain is a bad one and should be rejected entirely. Here the imperative is to accelerate the diffusion of vaccines and other treatments, not slow it down. Giving drug companies the power to hold things up by blocking competitors and raising prices pushes in the completely wrong direction. What approach to encouraging innovation should we take instead? How do we incentivize drug makers to undertake the hefty RandD costs to develop new vaccines without giving them exclusive rights over their production and sale? The most effective approach during a public health crisis is direct government support: public funding of RandD, advance purchase commitments by the government to buy large numbers of doses at set prices, and other, related payouts. And when we pay drug makers, we should not hesitate to pay generously, even extravagantly: we want to offer drug companies big profits so that they prioritize this work above everything else, and so that they are ready and eager to come to the rescue again the next time there’s a crisis. It was direct support via Operation Warp Speed that made possible the astonishingly rapid development of COVID-19 vaccines and then facilitated a relatively rapid rollout of vaccine distribution (relative, that is, to most of the rest of the world). And it’s worth noting that a major reason for the faster rollout here and in the United Kingdom compared to the European Union was the latter’s misguided penny-pinching. The EU bargained hard with firms to keep vaccine prices low, and as a result their citizens ended up in the back of the queue as various supply line kinks were being ironed out. This is particularly ironic since the Pfizer-BioNTech vaccine was developed in Germany. As this fact underscores, the chief advantage of direct support isn’t to “get tough” with drug firms and keep a lid on their profits. Instead, it is to accelerate the end of the public health emergency by making sure drug makers profit handsomely from doing the right thing. Patent law and direct support should be seen not as either-or alternatives but as complements that apply different incentives to different circumstances and time horizons. Patent law provides a decentralized system for encouraging innovation. The government doesn’t presume to tell the industry which new drugs are needed; it simply incentivizes the development of whatever new drugs that pharmaceutical firms can come up with by offering them a temporary monopoly. It is important to note that patent law’s incentives offer no commercial guarantees. Yes, you can block other competitors for a number of years, but that still doesn’t ensure enough consumer demand for the new product to make it profitable. The situation is different in a pandemic. Here the government knows exactly what it wants to incentivize: the creation of vaccines to prevent the spread of a specific virus and other drugs to treat that virus. Under these circumstances, the decentralized approach isn’t good enough. There is no time to sit back and let drug makers take the initiative on their own timeline. Instead, the government needs to be more involved to incentivize specific innovations now. As recompense for letting it call the shots (pardon the pun), the government sweetens the deal for drug companies by insulating them from commercial risk. If pharmaceutical firms develop effective vaccines and therapies, the government will buy large, predetermined quantities at prices set high enough to guarantee a healthy return. For the pharmaceutical industry, it is useful to conceive of patent law as the default regime for innovation promotion. It improves pharmaceutical companies’ incentives to develop new drugs while leaving them free to decide which new drugs to pursue – and also leaving them to bear all commercial risk. In a pandemic or other emergency, however, it is appropriate to shift to the direct support regime, in which the government focuses efforts on one disease. In this regime, it is important to note, the government provides qualitatively superior incentives to those offered under patent law. Not only does it offer public funding to cover the up-front costs of drug development, but it also provides advance purchase commitments that guarantee a healthy return. It should therefore be clear that the pharmaceutical industry has no legitimate basis for objecting to a TRIPS waiver. Since, because of the public health crisis, drug makers now qualify for the superior benefits of direct government support, they no longer need the default benefits of patent support. Arguments that a TRIPS waiver would deprive drug makers of the incentives they need to keep developing new drugs, when they are presently receiving the most favorable incentives available, can be dismissed as the worst sort of special pleading. That said, it is a serious mistake to try to cast the current crisis as a morality play in which drug makers wear the black hats and the choice at hand is between private profits and public health. We would have no chance of beating this virus without the formidable organizational capabilities of the pharmaceutical industry, and providing the appropriate incentives is essential to ensure that the industry plays its necessary and vital role. It is misguided to lament that private companies are profiting in the current crisis: those profits are a drop in the bucket compared to the staggering cost of this pandemic in lives and economic damage. What matters isn’t the existence or size of the profits, but how they are earned. We have good reason to want drug makers to profit from vaccinating the world: the comparative price is minuscule, and the incentive effects are a vital safeguard of public health in the event of future crises. What we want to avoid at all costs is putting drug makers in the position where drug companies can profit from standing in the way of rapid global vaccination. That is why intellectual property rights need to be taken out of the equation. Vaccinating the world in any kind of reasonable time frame will require large-scale technology transfer to drug firms in other countries and rapid expansion of their production capacity. And looking beyond the current pandemic to the longer term, we need ample, redundant global vaccine production capacity that is widely distributed around the planet. To achieve these goals as rapidly as possible will require the active cooperation of the U.S. pharmaceutical industry, which is why the direct support model now needs to be extended. What is needed now is an Operation Warp Speed for the world, in which we make it worth current vaccine producers’ while to share their know-how broadly and ramp up global capacity. Here again, we must recognize that the choice isn’t between people on the one hand and profits on the other. Rather, the key to good pandemic response policy is ensuring that incentives are structured so that drug company profit-seeking and global public health are well aligned. That means opting out of the default, decentralized patent bargain in favor of generous but well-focused direct government support.
10/16/21
SO-HIF CP
Tournament: Loyola | Round: 2 | Opponent: Princeton DR | Judge: Gordon Krauss Counterplan text: the member nations of the World Trade Organization should implement and fund a Health Impact Fund as per the Hollis and Pogge 08 card The Health Impact Fund would guarantee patent rights and increase profits, while also equalizing the cost of medicines Hollis and Pogge ’08 - Aidan Hollis Associate Professor of Economics, the University of Calgary and Thomas Pogge Leitner Professor of Philosophy and International Affairs, Yale University, “The Health Impact Fund Making New Medicines Accessible for All,” Incentives for Global Health (2008) AT We propose the Health Impact Fund as the most sensible solution that comprehensively addresses the problems. Financed by governments, the HIF would offer patentees the option to forgo monopoly pricing in exchange for a reward based on the global health impact of their new medicine. By registering a patented medicine with the HIF, a company would agree to sell it globally at cost. In exchange, the company would receive, for a fixed time, payments based on the product’s assessed global health impact. The arrangement would be optional and it wouldn’t diminish patent rights.¶ The HIF has the potential to be an institution that benefits everyone: patients, rich and poor alike, along with their caregivers; pharmaceutical companies and their shareholders; and taxpayers.¶ HOW THE HEALTH IMPACT FUND WORKS FOR PATIENTS¶ The HIF increases the incentives to invest in developing medicines that have high health impact. It directs research toward the medicines that can do the most good. It can also reward the development of new products, and the discovery of new uses for existing products, which the patent system alone can’t stimulate because of inadequate protection from imitation. All patients, rich and poor, would benefit from refocusing the innovation and marketing priorities of pharmaceutical companies toward health impact.¶ Any new medicines and new uses of existing medicines registered for health impact rewards would be available everywhere at marginal cost from the start. Many patients – especially in poor countries, but increasingly in wealthy ones too – are unable to afford the best treatment because it is too expensive. Even if fully insured, patients oft en lack access to medicines because their insurer deems them too expensive to reimburse. The HIF simply and directly solves this problem for registered drugs by setting their prices at marginal cost.¶ HOW THE HEALTH IMPACT FUND WORKS FOR PHARMACEUTICAL COMPANIES¶ Most proposals for increasing access to medicines would reduce the profits of pharmaceutical companies and hence their ability to fund research. The HIF, however, leaves the existing options of pharmaceutical firms untouched. It merely gives them the opportunity to make additional profits by developing new high-impact medicines that would be unprofitable or less profitable under monopoly pricing. Selling such registered medicines at cost, firms won’t be forced to defend a policy of charging high prices to poor people and they won’t be pressured to make charitable donations. With HIF-registered medicines they can instead “do well by doing good”: bring real benefit to patients in a profitable way. Research scientists of these firms will be encouraged to focus on addressing the most important diseases, not merely those that can support high prices.¶ HOW THE HEALTH IMPACT FUND WORKS FOR TAXPAYERS¶ The HIF will be supported mainly by governments, which are supported by the taxes they collect. Taxpayers want value for their money, and the HIF provides exactly that. Because the HIF is a more efficient way of incentivizing the pharmaceutical RandD we all want, total expenditures on medicines need not increase. However, if they do, the reason is that new medicines that would not have existed without the HIF are being developed. The HIF mechanism is designed to ensure that taxpayers always obtain value for money in the sense that any product regis-tered with the HIF will have a lower cost for a given amount of health impact than products outside the HIF. Taxpayers may also benefit from a reduction in risks of pandemics and other health problems that easily cross national borders.
9/4/21
SO-Infrastructure DA V2
Tournament: St Marks | Round: 3 | Opponent: Harvard Westlake AT | Judge: David Dosch Politics DA Biden not pushing the waiver Ramachandran, 8-21, 21, Reshma Ramachandran is a family medicine physician and fellow at the National Clinician Scholars Program at Yale University. She sits on the board of the non-profit organization Universities Allied for Essential Medicines North America, and is a member of the People's Vaccine Alliance and co-host of the Free The Vaccine campaign. Asia Russell is the Executive Director of the non-profit Health GAP, a member of the People's Vaccine Alliance and partner organization of the Free The Vaccine campaign, CNN, Biden's failing global Covid-19 response, https://www.cnn.com/2021/08/21/opinions/biden-global-covid-response-ramachandran-russell/index.html Reallocating excess doses and relying on pharmaceutical companies looking to profit off the prolongation of the pandemic that has driven demand for additional booster doses will not be enough to end this crisis. Despite his promise to support an IP waiver for Covid-19 vaccines, Biden has done seemingly little to encourage his counterparts in other wealthy nations including the European Union and United Kingdom to do the same; instead, these nations have continued to obstruct the waiver at the World Trade Organization (WTO). Going beyond a single statement of support, President Biden should champion this proposal and leverage his strong personal connections with allies to ensure its prompt passage and enactment at the WTO. Biden going weak on IPR burns capital and trades-off with other agenda items. Arun 21: TK Arun, April 15, 2021, Economic times, View: With the US sitting on a pile of vaccines, Biden needs to change tack on policy that harms the world, https://economictimes.indiatimes.com/news/economy/foreign-trade/view-with-the-us-sitting-on-a-pile-of-vaccines-biden-needs-to-changes-tack-on-policy-that-harms-the-world/articleshow/82058647.cms?from=mdr So, what can Biden do, to scale up vaccine production? Remove export restrictions. Buy out the intellectual property rights (IPRs) of successful vaccine candidates, strip vaccine know-how of patents and royalties, and make it available as a global public good. This is tactically superior to waiving IPR at the World Trade Organisation (WTO) for Biden, as the Republicans have already started a campaign against such threats to capitalism and Biden needs all the political capital he has to push his American Jobs Plan through the Senate. The infrastructure and budget bills are on the knife’s edge to pass. Grandoni and Dennis 8/11 - Dino Grandoni and Brady Dennis Environment reporters, “Biden aims for sweeping climate action as infrastructure, budget bills advance,” Washington Post (Web). 8/11/21. Accessed 9/15/21. https://www.washingtonpost.com/climate-environment/2021/08/10/biden-climate-congress/ AT The Senate approved on Tuesday a sweeping bipartisan $1.2 trillion infrastructure bill with funding for many public works meant to cut climate-warning emissions. A day later, Democrats in the chamber took a major step to adopt an even bigger, $3.5 trillion budget bill supporting yet more programs for cleaning up power plants and cars.¶ Each, if passed, would invest billions of dollars in the sort of clean energy transition the United States must make to have any chance of hitting the goal set by President Biden to cut the nation’s emissions by at least 50 percent by the end of this decade.¶ “This was one of the most significant legislative days we’ve had in a long time here,” Senate Majority Leader Charles E. Schumer (D-N.Y.) told reporters Wednesday.¶ But both bills face a potentially bumpy road ahead. Democrats still need to draft in committees the details of their massive budget reconciliation package over the coming weeks, with not a single vote to spare in the 50-50 split Senate. The bipartisan public-works bill, meanwhile, still needs approval from the House, where progressive Democrats hold significant sway.¶ The moves on Capitol Hill come as hundreds of scientists detailed this week the intensifying fires, floods and other catastrophes that will continue to worsen until humans dramatically scale back greenhouse gas emissions.¶ Scientists assembled by the United Nations made clear in a landmark report Monday that time is running out for the world to make immediate and dramatic cuts to emissions produced by the burning of fossil fuels and other human activities. U.N. Secretary General António Guterres called the sobering, sprawling report from the Intergovernmental Panel on Climate Change a “code red for humanity.” Infrastructure solves the grid – it’s vulnerable now and requires investment Gozdziewski 3/22 - Charles J. Gozdziewski is the American Council of Engineering Companies' (ACEC) Board Chair. He is also the Chairman Emeritus of Hardesty and Hanover in New York where he oversees transportation planning, construction inspection and support services for highways; all types of movable, fixed and railroad bridges; as well as special structures. 2021 (“Our nation's critical infrastructure is dangerously vulnerable”, available online at https://thehill.com/changing-america/opinion/544330-our-nations-critical-infrastructure-is-dangerously-vulnerable?amp, Changing America is a subsidiary of the Hill) The recent historic snowfall in Texas and the ensuing failure of the state's power grid have laid bare what we in the engineering industry have known for a long time - our nation's critical infrastructure is dangerously vulnerable to a wide range of threats. We must act quickly and comprehensively to make our infrastructure more resilient because those threats will only become more severe in the future. While the focus right now is justifiably on the energy sector and the power grid, all of our nation's infrastructure systems - transportation, water, and power - are at risk from extreme weather. Climate change lies at the heart of this challenge, and to mitigate its effects, we must have robust investment to fund the design and construction of the resilient infrastructure our country needs. As engineers, infrastructure is who we are. It is critically entwined in everything we do - from embracing smart cities, to establishing safe protocols in buildings for a post-COVID world, to preparing for the much needed Fourth Industrial Revolution. The need for resilience, sustainability, reliability, and flexibility will become even more vital as we move into the future. As leaders in the engineering and design industry, we have both a stake in and a valuable perspective on the policy discussion on infrastructure. Moreover, we are a critical partner in the implementation of that policy and the repair and upgrading of all aspects of our physical infrastructure - including roads, bridges, freight rail, ports, electrical grids, and Internet provision. Each of these components is critical to the health of our physical and built environment. Yet our expertise is worth nothing if the public sector clients we serve lack certainty from the federal government that there will be consistent, predictive funding in place to finance the infrastructure improvements we need. No designs will be drawn up and no dirt will be moved. It is imperative that our federal lawmakers act on a transformative infrastructure plan before the current law expires in September. Investing now in a long-term infrastructure bill will pay dividends, not only to mitigate the effects of a changing climate, but to help our nation recover from the COVID-19 pandemic. Engineers play a substantial role in the health of the national economy. According to the ACEC Research Institute's Industry Impact Series of reports, the Engineering and Design Services sector currently employs 1.5 million Americans directly. Those employees and their companies collectively support another 3 million jobs in the various contracting and other firms with which they work. The Institute's latest study found that each new job created in the Engineering and Design Services industry indirectly creates two additional jobs in related sectors across the economy. The data shows that investments in infrastructure that support engineering jobs pave the way for economic opportunity. What's more, the designs our industry creates help improve the built environment, making it more resilient to climate change. This is a win-win for society, creating a more equitable, environmentally sound, and prosperous built environment resulting in job creation and economic mobility. We look forward to working with policyholders, members of Congress, and the Biden-Harris Administration to develop sustainable solutions that benefit the country as a whole in the weeks ahead. Loss of critical infrastructure causes extinction Friedemann 16 (Alice Friedemann, transportation expert, founder of EnergySkeptic.com and author of “When Trucks Stop Running, Energy and the Future of Transportation,” worked at American Presidential Lines for 22 years, where she developed computer systems to coordinate the transit of cargo between ships, rail, trucks, and consumers, citing Dr. Peter Vincent Pry. Pry is executive director of the Task Force on National and Homeland Security, a Congressional advisory board dedicated to achieving protection of the United States from electromagnetic pulse and other threats. Dr. Pry is also the director of the United States Nuclear Strategy Forum, an advisory body to Congress on policies to counter weapons of mass destruction. Dr. Pry has served on the staffs of the Congressional Commission on the Strategic Posture of the United States, the Commission to Assess the Threat to the U.S. from an EMP Attack, the House Armed Services Committee, as an intelligence officer with the CIA, and as a verification analyst at the U.S. Arms Control and Disarmament Agency. 1-24-16, accessed 1/1/19 “Electromagnetic pulse threat to infrastructure (U.S. House hearings)” http://energyskeptic.com/2016/the-scariest-u-s-house-session-ever-electromagnetic-pulse-and-the-fall-of-civilization/) Modern civilization cannot exist for a protracted period without electricity. Within days of a blackout across the U.S., a blackout that could encompass the entire planet, emergency generators would run out of fuel, telecommunications would cease as would transportation due to gridlock, and eventually no fuel. Cities would have no running water and soon, within a few days, exhaust their food supplies. Police, Fire, Emergency Services and hospitals cannot long operate in a blackout. Government and Industry also need electricity in order to operate. The EMP Commission warns that a natural or nuclear EMP event, given current unpreparedness, would likely result in societal collapse. Terrorists, criminals, and even lone individuals can build a non-nuclear EMP weapon without great trouble or expense, working from Unclassified designs publicly available on the internet, and using parts available at any electronics store. In 2000, the Terrorism Panel of the House Armed Services Committee sponsored an experiment, recruiting a small team of amateur electronics enthusiasts to attempt constructing a radiofrequency weapon, relying only on unclassified design information and parts purchased from Radio Shack. The team, in 1 year, built two radiofrequency weapons of radically different designs. One was designed to fit inside the shipping crate for a Xerox machine, so it could be delivered to the Pentagon mail room where (in those more unguarded days before 9/11) it could slowly fry the Pentagon’s computers. The other radiofrequency weapon was designed to fit inside a small Volkswagon bus, so it could be driven down Wall Street and disrupt computers— and perhaps the National economy. Both designs were demonstrated and tested successfully during a special Congressional hearing for this purpose at the U.S. Army’s Aberdeen Proving Ground. Radiofrequency weapons are not merely a hypothetical threat. Terrorists, criminals, and disgruntled individuals have used home-made radiofrequency weapons. The U.S. military and foreign militaries have a wide variety of such weaponry. Moreover, non-nuclear EMP devices that could be used as radiofrequency weapons are publicly marketed for sale to anyone, usually advertised as ‘‘EMP simulators.’’ For example, one such simulator is advertised for public sale as an ‘‘EMP Suitcase.’’ This EMP simulator is designed to look like a suitcase, can be carried and operated by one person, and is purpose-built with a high energy radiofrequency output to destroy electronics. However, it has only a short radius of effect. Nonetheless, a terrorist or deranged individual who knows what he is doing, who has studied the electric grid for a major metropolitan area, could—armed with the ‘‘EMP Suitcase’’— black out a major city. A CLEAR AND PRESENT DANGER. An EMP weapon can be used by state actors who wish to level the battlefield by neutralizing the great technological advantage enjoyed by U.S. military forces. EMP is also the ideal means, the only means, whereby rogue states or terrorists could use a single nuclear weapon to destroy the United States and prevail in the War on Terrorism or some other conflict with a single blow. The EMP Commission also warned that states or terrorists could exploit U.S. vulnerability to EMP attack for coercion or blackmail: ‘‘Therefore, terrorists or state actors that possess relatively unsophisticated missiles armed with nuclear weapons may well calculate that, instead of destroying a city or military base, they may obtain the greatest political-military utility from one or a few such weapons by using them—or threatening their use—in an EMP attack.’’ The EMP Commission found that states such as Russia, China, North Korea, and Iran have incorporated EMP attack into their military doctrines, and openly describe making EMP attacks against the United States. Indeed, the EMP Commission was established by Congress partly in response to a Russian nuclear EMP threat made to an official Congressional Delegation on May 2, 1999, in the midst of the Balkans crisis. Vladimir Lukin, head of the Russian delegation and a former Ambassador to the United States, warned: ‘‘Hypothetically, if Russia really wanted to hurt the United States in retaliation for NATO’s bombing of Yugoslavia, Russia could fire an SLBM and detonate a single nuclear warhead at high altitude over the United States. The resulting EMP would massively disrupt U.S. communications and computer systems, shutting down everything.’’ China’s military doctrine also openly describes EMP attack as the ultimate asymmetric weapon, as it strikes at the very technology that is the basis of U.S. power. Where EMP is concerned, ‘‘The United States is more vulnerable to attacks than any other country in the world’’: ‘‘Some people might think that things similar to the ‘Pearl Harbor Incident’ are unlikely to take place during the information age. Yet it could be regarded as the ‘Pearl Harbor Incident’ of the 21st Century if a surprise attack is conducted against the enemy’s crucial information systems of command, control, and communications by such means as… electromagnetic pulse weapons… Even a superpower like the United States, which possesses nuclear missiles and powerful armed forces, cannot guarantee its immunity…In their own words, a highly computerized open society like the United States is extremely vulnerable to electronic attacks from all sides. This is because the U.S. economy, from banks to telephone systems and from power plants to iron and steel works, relies entirely on computer networks… When a country grows increasingly powerful economically and technologically…it will become increasingly dependent on modern information systems… The United States is more vulnerable to attacks than any other country in the world.’’ Iran—the world’s leading sponsor of international terrorism—in military writings openly describes EMP as a terrorist weapon, and as the ultimate weapon for prevailing over the West: ‘‘If the world’s industrial countries fail to devise effective ways to defend themselves against dangerous electronic assaults, then they will disintegrate within a few years… American soldiers would not be able to find food to eat nor would they be able to fire a single shot.’’ The threats are not merely words. The EMP Commission assesses that Russia has, as it openly declares in military writings, probably developed what Russia describes as a ‘‘Super-EMP’’ nuclear weapon—specifically designed to generate extraordinarily high EMP fields in order to paralyze even the best protected U.S. strategic and military forces. China probably also has Super-EMP weapons. North Korea too may possess or be developing a Super-EMP nuclear weapon, as alleged by credible Russian sources to the EMP Commission, and by open-source reporting from South Korean military intelligence. But any nuclear weapon, even a low-yield first generation device, could suffice to make a catastrophic EMP attack on the United States. Iran, although it is assessed as not yet having the bomb, is actively testing missile delivery systems and has practiced launches of its best missile, the Shahab–III, fuzing for high- altitude detonations, in exercises that look suspiciously like training for making EMP attacks. As noted earlier, Iran has also practiced launching from a ship a Scud, the world’s most common missile—possessed by over 60 nations, terrorist groups, and private collectors. A Scud might be the ideal choice for a ship-launched EMP attack against the United States intended to be executed anonymously, to escape any last-gasp U.S. retaliation. Unlike a nuclear weapon detonated in a city, a high-altitude EMP attack leaves no bomb debris for forensic analysis, no perpetrator ‘‘fingerprints.’’ Under present levels of preparedness, communications would be severely limited, restricted mainly to those few military communications networks that are hardened against EMP. Today’s microelectronics are the foundation of our modern civilization, but are over 1 million times more vulnerable to EMP than the far more primitive and robust electronics of the 1960s, that proved vulnerable during nuclear EMP tests of that era. Tests conducted by the EMP Commission confirmed empirically the theory that, as modern microelectronics become ever smaller and more efficient, and operate ever faster on lower voltages, they also become ever more vulnerable, and can be destroyed or disrupted by much lower EMP field strengths. Microelectronics and electronic systems are everywhere, and run virtually everything in the modern world. All of the civilian critical infrastructures that sustain the economy of the United States, and the lives of 310 million Americans, depend, directly or indirectly, upon electricity and electronic systems. Of special concern is the vulnerability to EMP of the Extra-High-Voltage (EHV) transformers, that are indispensable to the operation of the electric grid. EHV transformers drive electric current over long distances, from the point of generation to consumers (from the Niagara Falls hydroelectric facility to New York City, for example). The electric grid cannot operate without EHV transformers—which could be destroyed by an EMP event. The United States no longer manufactures EHV transformers. They must be manufactured and imported from overseas, from Germany or South Korea, the only two nations in the world that manufacture such transformers for export. Each EHV transformer must be custom-made for its unique role in the grid. A single EHV transformer typically requires 18 months to manufacture. The loss of large numbers of EHV transformers to an EMP event would plunge the United States into a protracted blackout lasting years, with perhaps no hope of eventual recovery, as the society and population probably could not survive for even 1 year without electricity. Another key vulnerability to EMP are Supervisory Control And Data Acquisition systems (SCADAs). SCADAs essentially are small computers, numbering in the millions and ubiquitous everywhere in the critical infrastructures, that perform jobs previously performed by hundreds of thousands of human technicians during the 1960s and before, in the era prior to the microelectronics revolution. SCADAs do things like regulating the flow of electricity into a transformer, controlling the flow of gas through a pipeline, or running traffic control lights. SCADAs enable a few dozen people to run the critical infrastructures for an entire city, whereas previously hundreds or even thousands of technicians were necessary. Unfortunately, SCADAs are especially vulnerable to EMP. EHV transformers and SCADAs are the most important vulnerabilities to EMP, but are by no means the only vulnerabilities. Each of the critical infrastructures has their own unique vulnerabilities to EMP: The National electric grid, with its transformers and generators and electronic controls and thousands of miles of power lines, is a vast electronic machine—more vulnerable to EMP than any other critical infrastructure. Yet the electric grid is the most important of all critical infrastructures, and is in fact the keystone supporting modern civilization, as it powers all the other critical infrastructures. As of now it is our technological Achilles Heel. The EMP Commission found that, if the electric grid collapses, so too will collapse all the other critical infrastructures. But, if the electric grid can be protected and recovered, so too all the other critical infrastructures can also be restored. Transportation is a critical infrastructure because modern civilization cannot exist without the goods and services moved by road, rail, ship, and air. Cars, trucks, locomotives, ships, and aircraft all have electronic components, motors, and controls that are potentially vulnerable to EMP. Gas stations, fuel pipelines, and refineries that make petroleum products depend upon electronic components and cannot operate without electricity. Given our current state of unpreparedness, in the aftermath of a natural or nuclear EMP event, transportation systems would be paralyzed. Traffic control systems that avert traffic jams and collisions for road, rail, and air depend upon electronic systems, that the EMP Commission discovered are especially vulnerable to EMP. Communications is a critical infrastructure because modern economies and the cohesion and operation of modern societies depend to a degree unprecedented in history on the rapid movement of information—accomplished today mostly by electronic means. Telephones, cell phones, personal computers, television, and radio are all directly vulnerable to EMP, and cannot operate without electricity. Satellites that operate at Low-Earth-Orbit (LEO) for communications, weather, scientific, and military purposes are vulnerable to EMP and to collateral effects from an EMP attack. Within weeks of an EMP event, the LEO satellites, which comprise most satellites, would probably be inoperable. Banking and finance are the critical infrastructure that sustain modern economies. Whether it is the stock market, the financial records of a multinational corporation, or the ATM card of an individual—financial transactions and record keeping all depend now at the macro- and micro-level upon computers and electronic automated systems. Many of these are directly vulnerable to EMP, and none can operate without electricity. The EMP Commission found that an EMP event could transform the modern electronic economy into a feudal economy based on barter. Food has always been vital to every person and every civilization. The critical infrastructure for producing, delivering, and storing food depends upon a complex web of technology, including machines for planting and harvesting and packaging, refrigerated vehicles for long-haul transportation, and temperature-controlled warehouses. Modern technology enables over 98 percent of the U.S. National population to be fed by less than 2 percent of the population. Huge regional warehouses that resupply supermarkets constitute the National food reserves, enough food to feed the Nation for 30–60 days at normal consumption rates, the warehoused food preserved by refrigeration and temperature control systems that typically have enough emergency electrical power (diesel or gas generators) to last only about an average of 3 days. Experience with storm-induced blackouts proves that when these big regional food warehouses lose electrical power, most of the food supply will rapidly spoil. Farmers, less than 2 percent of the population as noted above, cannot feed 310 million Americans if deprived of the means that currently makes possible this technological miracle. Water too has always been a basic necessity to every person and civilization, even more crucial than food. The critical infrastructure for purifying and delivering potable water, and for disposing of and treating waste water, is a vast networked machine powered by electricity that uses electrical pumps, screens, filters, paddles, and sprayers to purify and deliver drinkable water, and to remove and treat waste water. Much of the machinery in the water infrastructure is directly vulnerable to EMP. The system cannot operate without vast amounts of electricity supplied by the power grid. A natural or nuclear EMP event would immediately deprive most of the U.S. National population of running water. Many natural sources of water—lakes, streams, and rivers—would be dangerously polluted by toxic wastes from sewage, industry, and hospitals that would backflow from or bypass wastewater treatment plants, that could no longer intake and treat pollutants without electric power. Many natural water sources that would normally be safe to drink, after an EMP event, would be polluted with human wastes including feces, industrial wastes including arsenic and heavy metals, and hospital wastes including pathogens. Emergency services such as police, fire, and hospitals are the critical infrastructure that upholds the most basic functions of government and society—preserving law and order, protecting property and life. Experience from protracted storm-induced blackouts has shown, for example in the aftermath of Hurricanes Andrew and Katrina, that when the lights go out and communications systems fail and there is no gas for squad cars, fire trucks, and ambulances, the worst elements of society and the worst human instincts rapidly takeover. The EMP Commission found that, given our current state of unpreparedness, a natural or nuclear EMP event could create anarchic conditions that would profoundly challenge the existence of social order.
10/16/21
SO-Innovation DA V1
Tournament: Loyola | Round: 2 | Opponent: Princeton DR | Judge: Gordon Krauss Innovation DA The pharma industry is strong now but patents are key for continued economic growth. Batell and PhRMA 14: Batell and PhRMA {Battelle is the world’s largest nonprofit independent research and development organization, providing innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management, National Security, Energy, Environment and Material Sciences, and Health and Life Sciences. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.}, 14 – “The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It,” http://phrma-docs.phrma.org/sites/default/files/pdf/2014-economic-futures-report.pdf//marlborough-wr// Compared to other capital-intensive, advanced manufacturing industries in the U.S., the biopharmaceutical industry is a leader in RandD investment, IP generation, venture capital investment, and RandD employment. Policies and infrastructure that helped foster these innovative activities have allowed the U.S. to seize global leadership in biopharmaceutical RandD over the past 30 years. However, as this report details, other countries are seeking to compete with the U.S. by borrowing and building upon some of these pro-innovation policies to improve their own operating environment and become more favorable to biopharmaceutical companies making decisions about where to locate their RandD and manufacturing activities. A unique contribution of this report was the inclusion of the perspective of senior-level strategic planning executives of biopharmaceutical companies regarding what policy areas they see as most likely to impact the favorability of the U.S. business operating environment. The executives cited the following factors as having the most impact on the favorability of the operating environment and hence, potential growth of the innovative biopharmaceutical industry in the U.S.: • Coverage and payment policies that support and encourage medical innovation • A well-functioning, science-based regulatory system • Strong IP protection and enforcement in the U.S. and abroad The top sub-attribute identified as driving future biopharmaceutical industry growth in the U.S. cited by executives was a domestic IP system that provides adequate patent rights and data protection. Collectively, these factors underscore the need to reduce uncertainties and ensure adequate incentives for the lengthy, costly, and risky RandD investments necessary to develop new treatments needed by patients and society to address our most costly and challenging diseases. With more than 300,000 jobs at stake between the two scenarios, the continued growth and leadership of the U.S. innovative biopharmaceutical industry cannot be taken for granted. Continued innovation is fundamental to U.S. economic well-being and the nation’s ability to compete effectively in a globalized economy and to take advantage of the expected growth in demand for new medicines around the world. Just as other countries have drawn lessons from the growth of the U.S. biopharmaceutical sector, the U.S. needs to assess how it can improve the environment for innovation and continue to boost job creation by increasing RandD investment, fostering a robust talent pool, enhancing economic growth and sustainability, and continuing to bring new medicines to patients. COVID has kept patents and innovation strong, but continued protection is key to innovation by incentivizing biomedical research – it’s also crucial to preventing counterfeit medicines, economic collapse, and fatal diseases, which turns case. Macdole and Ezell 4-29: Jaci Mcdole and Stephen Ezell {Jaci McDole is a senior policy analyst covering intellectual property (IP) and innovation policy at the Information Technology and Innovation Foundation (ITIF). She focuses on IP and its correlations to global innovation and trade. McDole holds a double BA in Music Business and Radio-Television with a minor in Marketing, an MS in Education, and a JD with a specialization in intellectual property (Southern Illinois University Carbondale). McDole comes to ITIF from the Institute for Intellectual Property Research, an organization she co-founded to study and further robust global IP policies. Stephen Ezell is vice president, global innovation policy, at the Information Technology and Innovation Foundation (ITIF). He comes to ITIF from Peer Insight, an innovation research and consulting firm he cofounded in 2003 to study the practice of innovation in service industries. At Peer Insight, Ezell led the Global Service Innovation Consortium, published multiple research papers on service innovation, and researched national service innovation policies being implemented by governments worldwide. Prior to forming Peer Insight, Ezell worked in the New Service Development group at the NASDAQ Stock Market, where he spearheaded the creation of the NASDAQ Market Intelligence Desk and the NASDAQ Corporate Services Network, services for NASDAQ-listed corporations. Previously, Ezell cofounded two successful innovation ventures, the high-tech services firm Brivo Systems and Lynx Capital, a boutique investment bank. Ezell holds a B.S. from the School of Foreign Service at Georgetown University, with an honors certificate from Georgetown’s Landegger International Business Diplomacy program.}, 21 - ("Ten Ways Ip Has Enabled Innovations That Have Helped Sustain The World Through The Pandemic," Information Technology and Innovation Foundation, 4-29-2021, https://itif.org/publications/2021/04/29/ten-ways-ip-has-enabled-innovations-have-helped-sustain-world-through)//marlborough-wr/ To better understand the role of IP in enabling solutions related to COVID-19 challenges, this report relies on 10 case studies drawn from a variety of nations, technical fields, and firm sizes. This is but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. From a paramedic in Mexico to a veteran vaccine manufacturing company in India and a tech start-up in Estonia to a U.S.-based company offering workplace Internet of Things (IoT) services, small and large organizations alike are working to combat the pandemic. Some have adapted existing innovations, while others have developed novel solutions. All are working to take the world out of the pandemic and into the future. The case studies are: Bharat Biotech: Covaxin Gilead: Remdesivir LumiraDX: SARS-COV-2 Antigen POC Test Teal Bio: Teal Bio Respirator XE Ingeniería Médica: CápsulaXE Surgical Theater: Precision VR Tombot: Jennie Starship Technologies: Autonomous Delivery Robots Triax Technologies: Proximity Trace Zoom: Video Conferencing As the case studies show, IP is critical to enabling innovation. Policymakers around the world need to ensure robust IP protections are—and remain—in place if they wish their citizens to have safe and innovative solutions to health care, workplace, and societal challenges in the future. THE ROLE OF INTELLECTUAL PROPERTY IN RandD-INTENSIVE INDUSTRIES Intangible assets, such as IP rights, comprised approximately 84 percent of the corporate value of SandP 500 companies in 2018.4 For start-ups, this means much of the capital needed to operate is directly related to IP (see Teal Bio case study for more on this). IP also plays an especially important role for RandD-intensive industries.5 To take the example of the biopharmaceutical industry, it is characterized by high-risk, time-consuming, and expensive processes including basic research, drug discovery, pre-clinical trials, three stages of human clinical trials, regulatory review, and post-approval research and safety monitoring. The drug development process spans an average of 11.5 to 15 years.6 For every 5,000 to 10,000 compounds screened on average during the basic research and drug discovery phases, approximately 250 molecular compounds, or 2.5 to 5 percent, make it to preclinical testing. Out of those 250 molecular compounds, approximately 5 make it to clinical testing. That is, 0.05 to 0.1 percent of drugs make it from basic research into clinical trials. Of those rare few which make it to clinical testing, less than 12 percent are ultimately approved for use by the U.S. Food and Drug Administration (FDA).7 In addition to high risks, drug development is costly, and the expenses associated with it are increasing. A 2019 report by the Deloitte Center for Health Solutions concluded that since 2010 the average cost of bringing a new drug to market increased by 67 percent.8 Numerous studies have examined the substantial cost of biopharmaceutical RandD, and most confirm investing in new drug development requires $1.7 billion to $3.2 billion up front on average.9 A 2018 study by the Coalition for Epidemic Preparedness found similar risks and figures for vaccines, stating, “In general, vaccine development from discovery to licensure can cost billions of dollars, can take over 10 years to complete, and has an average 94 percent chance of failure.”10 Yet, a 2010 study found that 80 percent of new drugs—that is, the less than 12 percent ultimately approved by the FDA—made less than their capitalized RandD costs.11 Another study found that only 1 percent (maybe three new drugs each year) of the most successful 10 percent of FDA approved drugs generate half of the profits of the entire drug industry.12 To say the least, biopharmaceutical RandD represents a high-stakes, long-term endeavor with precarious returns. Without IP protection, biopharmaceutical manufacturers have little incentive to take the risks necessary to engage in the RandD process because they would be unable to recoup even a fraction of the costs incurred. Diminished revenues also result in reduced investments in RandD which means less research into cancer drugs, Alzheimer cures, vaccines, and more. IP rights give life-sciences enterprises the confidence needed to undertake the difficult, risky, and expensive process of life-sciences innovation secure in the knowledge they can capture a share of the gains from their innovations, which is indispensable not only to recouping the up-front RandD costs of a given drug, but which can generate sufficient profits to enable investment in future generations of biomedical innovation and thus perpetuate the enterprises into the future.13 THE IMPORTANCE OF INTELLECTUAL PROPERTY TO INNOVATION Although anti-IP proponents have attacked biopharmaceutical manufacturers particularly hard, the reality is all IP-protected innovations are at risk if these rights are ignored, or vitiated. Certain arguments have shown a desire for the term “COVID-19 innovations” to include everything from vaccines, therapeutics, diagnostics, and PPE to biotechnology, AI-related data, and educational materials.14 This could potentially open the floodgates to invalidate IP protection on many of the innovations highlighted in this report. However, much of the current discussion concerning IP focuses almost entirely on litigation fears or RandD incentives. Although RandD is an important aspect of IP, as previously mentioned, these discussions ignore the fact that IP protection can be—and often is—used for other purposes, including generating initial capital to create a company and begin manufacturing and, more importantly, using licensing agreements and IP to track the supply chain and ensure quality control of products. This report highlights but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. In 2018, Forbes identified counterfeiting as the largest criminal enterprise in the world.15 The global struggle against counterfeit and non-regulated products, which has hit Latin America particularly hard during the pandemic, proves the need for safety and quality assurance in supply chains.16 Some communities already ravaged by COVID-19 are seeing higher mortality rates related to counterfeit vaccines, therapeutics, PPE, and cleaning and sanitizing products.17 Polish authorities discovered vials of antiwrinkle treatment labeled as COVID-19 vaccines. 18 In Mexico, fake vaccines sold for approximately $1,000 per dose.19 Chinese and South African police seized thousands of counterfeit vaccine doses from warehouses and manufacturing plants.20 Meanwhile, dozens of websites worldwide claiming to sell vaccines or be affiliated with vaccine manufacturers have been taken down.21 But the problem is not limited to biopharmaceuticals. The National Intellectual Property Rights Coordination Center has recovered $48 million worth of counterfeit PPE and other products.22 Collaborative efforts between law enforcement and manufacturers have kept numerous counterfeits from reaching the population. In countries with strong IP protection, the chances of counterfeit products reaching the market are significantly lower. This is largely because counterfeiting tends to be an IP-related issue, and these countries generally provide superior means of tracking the supply chain through trademarks, trade secrets, and licensing agreements. This enables greater quality control and helps manufacturers maintain a level of public confidence in their products. By controlling the flow of knowledge associated with IP, voluntary licensing agreements provide innovators with opportunities to collaborate, while ensuring their partners are properly equipped and capable of producing quality products. Throughout this difficult time, the world has seen unexpected collaborations, especially between biopharmaceutical companies worldwide such as Gilead and Eva Pharma or Bharat Biotech and Ocugen, Inc. Throughout history, and most significantly in the nineteenth century through the widespread development of patent systems and the ensuing Industrial Revolution, IP has contributed toward greater economic growth.23 This is promising news as the world struggles for economic recovery. A 2021 joint study by the EU Intellectual Property Office (EUIPO) and European Patent Office (EPO) shows a strong, positive correlation between IP rights and economic performance.24 It states that “IP-owning firms represent a significantly larger proportion of economic activity and employment across Europe,” with IP-intensive industries contributing to 45 percent of gross domestic product (GDP) (€6.6 trillion; US$7.9 trillion).25 The study also shows 38.9 percent of employment is directly or indirectly attributed to IP-intensive industries, and IP generates higher wages and greater revenue per employee, especially for small-to-medium-sized enterprises.26 That concords with the United States, where the Department of Commerce estimated that IP-intensive industries support at least 45 million jobs and contribute more than $6 trillion dollars to, or 38.2 percent of, GDP.27 In 2020, global patent filings through the World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) system reached a record 275,900 filings amidst the pandemic, growing 4 percent from 2019.28 The top-four nations, which accounted for 180,530 of the patent applications, were China, the United States, Japan, and Korea, respectively.29 While several countries saw an increase in patent filings, Saudi Arabia and Malaysia both saw significant increases in the number of annual applications, with the top two filing growths of 73 percent and 26 percent, respectively.30 The COVID-19 pandemic slowed a lot of things, but it certainly couldn’t stop innovation. There are at least five principal benefits strong IP rights can generate, for both developing and developed countries alike.31 First, stronger IP protection spurs the virtuous cycle of innovation by increasing the appropriability of returns, enabling economic gain and catalyzing economic growth. Second, through patents—which require innovators to disclose certain knowledge as a condition of protection—knowledge spillovers build a platform of knowledge that enables other innovators. For instance, studies have found that the rate of return to society from corporate RandD and innovation activities is at least twice the estimated returns that each company itself receives.32 Third, countries with robust IP can operate more efficiently and productively by using IP to determine product quality and reduce transaction costs. Fourth, trade and foreign direct investment enabled and encouraged by strong IP protection offered to enterprises from foreign countries facilitates an accumulation of knowledge capital within the destination economy. That matters when foreign sources of technology account for over 90 percent of productivity growth in most countries.33 There’s also evidence suggesting that developing nations with stronger IP protections enjoy the earlier introduction of innovative new medicines.34 And fifth, strong IP boosts exports, including in developing countries.35 Research shows a positive correlation between stronger IP protection and exports from developing countries as well as faster growth rates of certain industries.36 The following case studies illustrate these benefits of IP and how they’ve enabled innovative solutions to help global society navigate the COVID-19 pandemic.
9/4/21
SO-Innovation DA V2
Tournament: Loyola | Round: 4 | Opponent: Immaculate Heart RR | Judge: Lucas Hunter Innovation da The pharma industry is strong now but patents are key for continued economic growth. Batell and PhRMA 14: Batell and PhRMA {Battelle is the world’s largest nonprofit independent research and development organization, providing innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management, National Security, Energy, Environment and Material Sciences, and Health and Life Sciences. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.}, 14 – “The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It,” http://phrma-docs.phrma.org/sites/default/files/pdf/2014-economic-futures-report.pdf//marlborough-wr// Compared to other capital-intensive, advanced manufacturing industries in the U.S., the biopharmaceutical industry is a leader in RandD investment, IP generation, venture capital investment, and RandD employment. Policies and infrastructure that helped foster these innovative activities have allowed the U.S. to seize global leadership in biopharmaceutical RandD over the past 30 years. However, as this report details, other countries are seeking to compete with the U.S. by borrowing and building upon some of these pro-innovation policies to improve their own operating environment and become more favorable to biopharmaceutical companies making decisions about where to locate their RandD and manufacturing activities. A unique contribution of this report was the inclusion of the perspective of senior-level strategic planning executives of biopharmaceutical companies regarding what policy areas they see as most likely to impact the favorability of the U.S. business operating environment. The executives cited the following factors as having the most impact on the favorability of the operating environment and hence, potential growth of the innovative biopharmaceutical industry in the U.S.: • Coverage and payment policies that support and encourage medical innovation • A well-functioning, science-based regulatory system • Strong IP protection and enforcement in the U.S. and abroad The top sub-attribute identified as driving future biopharmaceutical industry growth in the U.S. cited by executives was a domestic IP system that provides adequate patent rights and data protection. Collectively, these factors underscore the need to reduce uncertainties and ensure adequate incentives for the lengthy, costly, and risky RandD investments necessary to develop new treatments needed by patients and society to address our most costly and challenging diseases. With more than 300,000 jobs at stake between the two scenarios, the continued growth and leadership of the U.S. innovative biopharmaceutical industry cannot be taken for granted. Continued innovation is fundamental to U.S. economic well-being and the nation’s ability to compete effectively in a globalized economy and to take advantage of the expected growth in demand for new medicines around the world. Just as other countries have drawn lessons from the growth of the U.S. biopharmaceutical sector, the U.S. needs to assess how it can improve the environment for innovation and continue to boost job creation by increasing RandD investment, fostering a robust talent pool, enhancing economic growth and sustainability, and continuing to bring new medicines to patients. COVID has kept patents and innovation strong, but continued protection is key to innovation by incentivizing biomedical research – it’s also crucial to preventing counterfeit medicines, economic collapse, and fatal diseases, which turns case. Macdole and Ezell 4-29: Jaci Mcdole and Stephen Ezell {Jaci McDole is a senior policy analyst covering intellectual property (IP) and innovation policy at the Information Technology and Innovation Foundation (ITIF). She focuses on IP and its correlations to global innovation and trade. McDole holds a double BA in Music Business and Radio-Television with a minor in Marketing, an MS in Education, and a JD with a specialization in intellectual property (Southern Illinois University Carbondale). McDole comes to ITIF from the Institute for Intellectual Property Research, an organization she co-founded to study and further robust global IP policies. Stephen Ezell is vice president, global innovation policy, at the Information Technology and Innovation Foundation (ITIF). He comes to ITIF from Peer Insight, an innovation research and consulting firm he cofounded in 2003 to study the practice of innovation in service industries. At Peer Insight, Ezell led the Global Service Innovation Consortium, published multiple research papers on service innovation, and researched national service innovation policies being implemented by governments worldwide. Prior to forming Peer Insight, Ezell worked in the New Service Development group at the NASDAQ Stock Market, where he spearheaded the creation of the NASDAQ Market Intelligence Desk and the NASDAQ Corporate Services Network, services for NASDAQ-listed corporations. Previously, Ezell cofounded two successful innovation ventures, the high-tech services firm Brivo Systems and Lynx Capital, a boutique investment bank. Ezell holds a B.S. from the School of Foreign Service at Georgetown University, with an honors certificate from Georgetown’s Landegger International Business Diplomacy program.}, 21 - ("Ten Ways Ip Has Enabled Innovations That Have Helped Sustain The World Through The Pandemic," Information Technology and Innovation Foundation, 4-29-2021, https://itif.org/publications/2021/04/29/ten-ways-ip-has-enabled-innovations-have-helped-sustain-world-through)//marlborough-wr/ To better understand the role of IP in enabling solutions related to COVID-19 challenges, this report relies on 10 case studies drawn from a variety of nations, technical fields, and firm sizes. This is but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. From a paramedic in Mexico to a veteran vaccine manufacturing company in India and a tech start-up in Estonia to a U.S.-based company offering workplace Internet of Things (IoT) services, small and large organizations alike are working to combat the pandemic. Some have adapted existing innovations, while others have developed novel solutions. All are working to take the world out of the pandemic and into the future. The case studies are: Bharat Biotech: Covaxin Gilead: Remdesivir LumiraDX: SARS-COV-2 Antigen POC Test Teal Bio: Teal Bio Respirator XE Ingeniería Médica: CápsulaXE Surgical Theater: Precision VR Tombot: Jennie Starship Technologies: Autonomous Delivery Robots Triax Technologies: Proximity Trace Zoom: Video Conferencing As the case studies show, IP is critical to enabling innovation. Policymakers around the world need to ensure robust IP protections are—and remain—in place if they wish their citizens to have safe and innovative solutions to health care, workplace, and societal challenges in the future. THE ROLE OF INTELLECTUAL PROPERTY IN RandD-INTENSIVE INDUSTRIES Intangible assets, such as IP rights, comprised approximately 84 percent of the corporate value of SandP 500 companies in 2018.4 For start-ups, this means much of the capital needed to operate is directly related to IP (see Teal Bio case study for more on this). IP also plays an especially important role for RandD-intensive industries.5 To take the example of the biopharmaceutical industry, it is characterized by high-risk, time-consuming, and expensive processes including basic research, drug discovery, pre-clinical trials, three stages of human clinical trials, regulatory review, and post-approval research and safety monitoring. The drug development process spans an average of 11.5 to 15 years.6 For every 5,000 to 10,000 compounds screened on average during the basic research and drug discovery phases, approximately 250 molecular compounds, or 2.5 to 5 percent, make it to preclinical testing. Out of those 250 molecular compounds, approximately 5 make it to clinical testing. That is, 0.05 to 0.1 percent of drugs make it from basic research into clinical trials. Of those rare few which make it to clinical testing, less than 12 percent are ultimately approved for use by the U.S. Food and Drug Administration (FDA).7 In addition to high risks, drug development is costly, and the expenses associated with it are increasing. A 2019 report by the Deloitte Center for Health Solutions concluded that since 2010 the average cost of bringing a new drug to market increased by 67 percent.8 Numerous studies have examined the substantial cost of biopharmaceutical RandD, and most confirm investing in new drug development requires $1.7 billion to $3.2 billion up front on average.9 A 2018 study by the Coalition for Epidemic Preparedness found similar risks and figures for vaccines, stating, “In general, vaccine development from discovery to licensure can cost billions of dollars, can take over 10 years to complete, and has an average 94 percent chance of failure.”10 Yet, a 2010 study found that 80 percent of new drugs—that is, the less than 12 percent ultimately approved by the FDA—made less than their capitalized RandD costs.11 Another study found that only 1 percent (maybe three new drugs each year) of the most successful 10 percent of FDA approved drugs generate half of the profits of the entire drug industry.12 To say the least, biopharmaceutical RandD represents a high-stakes, long-term endeavor with precarious returns. Without IP protection, biopharmaceutical manufacturers have little incentive to take the risks necessary to engage in the RandD process because they would be unable to recoup even a fraction of the costs incurred. Diminished revenues also result in reduced investments in RandD which means less research into cancer drugs, Alzheimer cures, vaccines, and more. IP rights give life-sciences enterprises the confidence needed to undertake the difficult, risky, and expensive process of life-sciences innovation secure in the knowledge they can capture a share of the gains from their innovations, which is indispensable not only to recouping the up-front RandD costs of a given drug, but which can generate sufficient profits to enable investment in future generations of biomedical innovation and thus perpetuate the enterprises into the future.13 THE IMPORTANCE OF INTELLECTUAL PROPERTY TO INNOVATION Although anti-IP proponents have attacked biopharmaceutical manufacturers particularly hard, the reality is all IP-protected innovations are at risk if these rights are ignored, or vitiated. Certain arguments have shown a desire for the term “COVID-19 innovations” to include everything from vaccines, therapeutics, diagnostics, and PPE to biotechnology, AI-related data, and educational materials.14 This could potentially open the floodgates to invalidate IP protection on many of the innovations highlighted in this report. However, much of the current discussion concerning IP focuses almost entirely on litigation fears or RandD incentives. Although RandD is an important aspect of IP, as previously mentioned, these discussions ignore the fact that IP protection can be—and often is—used for other purposes, including generating initial capital to create a company and begin manufacturing and, more importantly, using licensing agreements and IP to track the supply chain and ensure quality control of products. This report highlights but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. In 2018, Forbes identified counterfeiting as the largest criminal enterprise in the world.15 The global struggle against counterfeit and non-regulated products, which has hit Latin America particularly hard during the pandemic, proves the need for safety and quality assurance in supply chains.16 Some communities already ravaged by COVID-19 are seeing higher mortality rates related to counterfeit vaccines, therapeutics, PPE, and cleaning and sanitizing products.17 Polish authorities discovered vials of antiwrinkle treatment labeled as COVID-19 vaccines. 18 In Mexico, fake vaccines sold for approximately $1,000 per dose.19 Chinese and South African police seized thousands of counterfeit vaccine doses from warehouses and manufacturing plants.20 Meanwhile, dozens of websites worldwide claiming to sell vaccines or be affiliated with vaccine manufacturers have been taken down.21 But the problem is not limited to biopharmaceuticals. The National Intellectual Property Rights Coordination Center has recovered $48 million worth of counterfeit PPE and other products.22 Collaborative efforts between law enforcement and manufacturers have kept numerous counterfeits from reaching the population. In countries with strong IP protection, the chances of counterfeit products reaching the market are significantly lower. This is largely because counterfeiting tends to be an IP-related issue, and these countries generally provide superior means of tracking the supply chain through trademarks, trade secrets, and licensing agreements. This enables greater quality control and helps manufacturers maintain a level of public confidence in their products. By controlling the flow of knowledge associated with IP, voluntary licensing agreements provide innovators with opportunities to collaborate, while ensuring their partners are properly equipped and capable of producing quality products. Throughout this difficult time, the world has seen unexpected collaborations, especially between biopharmaceutical companies worldwide such as Gilead and Eva Pharma or Bharat Biotech and Ocugen, Inc. Throughout history, and most significantly in the nineteenth century through the widespread development of patent systems and the ensuing Industrial Revolution, IP has contributed toward greater economic growth.23 This is promising news as the world struggles for economic recovery. A 2021 joint study by the EU Intellectual Property Office (EUIPO) and European Patent Office (EPO) shows a strong, positive correlation between IP rights and economic performance.24 It states that “IP-owning firms represent a significantly larger proportion of economic activity and employment across Europe,” with IP-intensive industries contributing to 45 percent of gross domestic product (GDP) (€6.6 trillion; US$7.9 trillion).25 The study also shows 38.9 percent of employment is directly or indirectly attributed to IP-intensive industries, and IP generates higher wages and greater revenue per employee, especially for small-to-medium-sized enterprises.26 That concords with the United States, where the Department of Commerce estimated that IP-intensive industries support at least 45 million jobs and contribute more than $6 trillion dollars to, or 38.2 percent of, GDP.27 In 2020, global patent filings through the World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) system reached a record 275,900 filings amidst the pandemic, growing 4 percent from 2019.28 The top-four nations, which accounted for 180,530 of the patent applications, were China, the United States, Japan, and Korea, respectively.29 While several countries saw an increase in patent filings, Saudi Arabia and Malaysia both saw significant increases in the number of annual applications, with the top two filing growths of 73 percent and 26 percent, respectively.30 The COVID-19 pandemic slowed a lot of things, but it certainly couldn’t stop innovation. There are at least five principal benefits strong IP rights can generate, for both developing and developed countries alike.31 First, stronger IP protection spurs the virtuous cycle of innovation by increasing the appropriability of returns, enabling economic gain and catalyzing economic growth. Second, through patents—which require innovators to disclose certain knowledge as a condition of protection—knowledge spillovers build a platform of knowledge that enables other innovators. For instance, studies have found that the rate of return to society from corporate RandD and innovation activities is at least twice the estimated returns that each company itself receives.32 Third, countries with robust IP can operate more efficiently and productively by using IP to determine product quality and reduce transaction costs. Fourth, trade and foreign direct investment enabled and encouraged by strong IP protection offered to enterprises from foreign countries facilitates an accumulation of knowledge capital within the destination economy. That matters when foreign sources of technology account for over 90 percent of productivity growth in most countries.33 There’s also evidence suggesting that developing nations with stronger IP protections enjoy the earlier introduction of innovative new medicines.34 And fifth, strong IP boosts exports, including in developing countries.35 Research shows a positive correlation between stronger IP protection and exports from developing countries as well as faster growth rates of certain industries.36 The following case studies illustrate these benefits of IP and how they’ve enabled innovative solutions to help global society navigate the COVID-19 pandemic. CRISPR has especially high prices. Irvine 19 Alison Irvine science writer, 19 - ("Paying for CRISPR Cures: The Economics of Genetic Therapies," Innovative Genomics Institute (IGI), 12-16-2019, accessed 9-4-2021, https://innovativegenomics.org/blog/paying-for-crispr-cures/)//ML Developing a gene therapy can cost an estimated $5 billion. This is more than five times the average cost of developing traditional drugs. In addition to the costs of research, manufacturing and distribution, these biological therapeutics are subjected to multiple regulatory structures, which result in a long and expensive route to approval. When you factor in the limited number of eligible patients (customers), the motivation behind pricing becomes clear.¶ According to a base-case analysis conducted by the Institute for Clinical and Economic Review (ICER), Zolgensma’s subjective value to their patients has been estimated to be around $900,000 per treatment. Still, nothing is stopping Novartis from inflating the price. Zolgensma’s only other competition is Spinraza, which, in comparison, requires a procedure every few months and can cost a total of $30 million over a lifetime.
Pharmaceutical innovation is key to protecting against future pandemics, bioterrorism, and antibiotic resistance. Marjanovic and Fejiao ‘20 Marjanovic, Sonja, and Carolina Feijao. Sonja Marjanovic, Ph.D., Judge Business School, University of Cambridge. Carolina Feijao, Ph.D. in biochemistry, University of Cambridge; M.Sc. in quantitive biology, Imperial College London; B.Sc. in biology, University of Lisbon. "Pharmaceutical Innovation for Infectious Disease Management: From Troubleshooting to Sustainable Models of Engagement." (2020). Quality Control As key actors in the healthcare innovation landscape, pharmaceutical and life sci-ences companies have been called on to develop medicines, vaccines and diagnostics for pressing public health challenges. The COVID-19 crisis is one such challenge, but there are many others. For example, MERS, SARS, Ebola, Zika and avian and swine flu are also infectious diseases that represent public health threats. Infectious agents such as anthrax, smallpox and tularemia could present threats in a bioterrorism con-text.1 The general threat to public health that is posed by antimicrobial resistance is also well-recognised as an area in need of pharmaceutical innovation. Innovating in response to these challenges does not always align well with pharmaceutical industry commercial models, shareholder expectations and compe-tition within the industry. However, the expertise, networks and infrastructure that industry has within its reach, as well as public expectations and the moral imperative, make pharmaceutical companies and the wider life sciences sector an indispensable partner in the search for solutions that save lives. This perspective argues for the need to establish more sustainable and scalable ways of incentivising pharmaceu-tical innovation in response to infectious disease threats to public health. It considers both past and current examples of efforts to mobilise pharmaceutical innovation in high commercial risk areas, including in the context of current efforts to respond to the COVID-19 pandemic. In global pandemic crises like COVID-19, the urgency and scale of the crisis – as well as the spotlight placed on pharmaceutical companies – mean that contributing to the search for effective medicines, vaccines or diagnostics is essential for socially responsible companies in the sec-tor.2 It is therefore unsurprising that we are seeing indus-try-wide efforts unfold at unprecedented scale and pace. Whereas there is always scope for more activity, industry is currently contributing in a variety of ways. Examples include pharmaceutical companies donating existing com-pounds to assess their utility in the fight against COVID-19; screening existing compound libraries in-house or with partners to see if they can be repurposed; accelerating tri-als for potentially effective medicine or vaccine candidates; and in some cases rapidly accelerating in-house research and development to discover new treatments or vaccine agents and develop diagnostics tests.3,4 Pharmaceutical companies are collaborating with each other in some of these efforts and participating in global RandD partnerships (such as the Innovative Medicines Initiative effort to accel-erate the development of potential therapies for COVID-19) and supporting national efforts to expand diagnosis and testing capacity and ensure affordable and ready access to potential solutions.3,5,6 The primary purpose of such innovation is to benefit patients and wider population health. Although there are also reputational benefits from involvement that can be realised across the industry, there are likely to be rela-tively few companies that are ‘commercial’ winners. Those who might gain substantial revenues will be under pres-sure not to be seen as profiting from the pandemic. In the United Kingdom for example, GSK has stated that it does not expect to profit from its COVID-19 related activities and that any gains will be invested in supporting research and long-term pandemic preparedness, as well as in developing products that would be affordable in the world’s poorest countries.7 Similarly, in the United States AbbVie has waived intellectual property rights for an existing com-bination product that is being tested for therapeutic poten-tial against COVID-19, which would support affordability and allow for a supply of generics.8,9 Johnson and Johnson has stated that its potential vaccine – which is expected to begin trials – will be available on a not-for-profit basis during the pandemic.10 Pharma is mobilising substantial efforts to rise to the COVID-19 challenge at hand. However, we need to consider how pharmaceutical innovation for responding to emerging infectious diseases can best be enabled beyond the current crisis. Many public health threats (including those associated with other infectious diseases, bioterror-ism agents and antimicrobial resistance) are urgently in need of pharmaceutical innovation, even if their impacts are not as visible to society as COVID-19 is in the imme-diate term. The pharmaceutical industry has responded to previous public health emergencies associated with infec-tious disease in recent times – for example those associated with Ebola and Zika outbreaks.11 However, it has done so to a lesser scale than for COVID-19 and with contribu-tions from fewer companies. Similarly, levels of activity in response to the threat of antimicrobial resistance are still low.12 There are important policy questions as to whether – and how – industry could engage with such public health threats to an even greater extent under improved innova-tion conditions. Bioterror causes extinction---early response key Farmer 17 (“Bioterrorism could kill more people than nuclear war, Bill Gates to warn world leaders” http://www.telegraph.co.uk/news/2017/02/17/biological-terrorism-could-kill-people-nuclear-attacks-bill/) Bioterrorists could one day kill hundreds of millions of people in an attack more deadly than nuclear war, Bill Gates will warn world leaders. Rapid advances in genetic engineering have opened the door for small terrorism groups to tailor and easily turn biological viruses into weapons. A resulting disease pandemic is currently one of the most deadly threats faced by the world, he believes, yet governments are complacent about the scale of the risk. Speaking ahead of an address to the Munich Security Conference, the richest man in the world said that while governments are concerned with the proliferation of nuclear and chemical weapons, they are overlooking the threat of biological warfare. Mr Gates, whose charitable foundationis funding research into quickly spotting outbreaks and speeding up vaccine production, said the defence and security establishment “have not been following biology and I’m here to bring them a little bit of bad news”. Mr Gates will today (Saturday) tell an audience of international leaders and senior officers that the world’s next deadly pandemic “could originate on the computer screen of a terrorist”. He told the Telegraph: “Natural epidemics can be extremely large. Intentionally caused epidemics, bioterrorism, would be the largest of all. “With nuclear weapons, you’d think you would probably stop after killing 100million. Smallpox won’t stop. Because the population is naïve, and there are no real preparations. That, if it got out and spread, would be a larger number.” He said developments in genetic engineering were proceeding at a “mind-blowing rate”. Biological warfare ambitions once limited to a handful of nation states are now open to small groups with limited resources and skills. He said: “They make it much easier for a non-state person. It doesn’t take much biology expertise nowadays to assemble a smallpox virus. Biology is making it way easier to create these things.” The increasingly common use of gene editing technology would make it difficult to spot any potential terrorist conspiracy. Technologies which have made it easy to read DNA sequences and tinker with them to rewrite or tweak genes have many legitimate uses. He said: “It’s not like when someone says, ‘Hey I’d like some Plutonium’ and you start saying ‘Hmmm.. I wonder why he wants Plutonium?’” Mr Gates said the potential death toll from a disease outbreak could be higher than other threats such as climate change or nuclear war. He said: “This is like earthquakes, you should think in order of magnitudes. If you can kill 10 people that’s a one, 100 people that’s a two... Bioterrorism is the thing that can give you not just sixes, but sevens, eights and nines. “With nuclear war, once you have got a six, or a seven, or eight, you’d think it would probably stop. With bioterrorism it’s just unbounded if you are not there to stop the spread of it.” By tailoring the genes of a virus, it would be possible to manipulate its ability to spread and its ability to harm people. Mr Gates said one of the most potentially deadly outbreaks could involve the humble flu virus. It would be relatively easy to engineer a new flu strain combining qualities from varieties that spread like wildfire with varieties that were deadly. The last time that happened naturally was the 1918 Spanish Influenza pandemic, which went on to kill more than 50 million people – or nearly three times the death toll from the First World War. By comparison, the recent Ebola outbreak in West Africa which killed just over 11,000 was “a Richter Scale three, it’s a nothing,” he said. But despite the potential, the founder of Microsoft said that world leaders and their militaries could not see beyond the more recognised risks. He said: “Should the world be serious about this? It is somewhat serious about normal classic warfare and nuclear warfare, but today it is not very serious about bio-defence or natural epidemics.” He went on: “They do tend to say ‘How easy is it to get fissile material and how accurate are the plans out on the internet for dirty bombs, plutonium bombs and hydrogen bombs?’ “They have some people that do that. What I am suggesting is that the number of people that look at bio-defence is worth increasing.” Whether naturally occurring, or deliberately started, it is almost certain that a highly lethal global pandemic will occur within our lifetimes, he believes. But the good news for those contemplating the potential damage is that the same biotechnology can prevent epidemics spreading out of control. Mr Gates will say in his speech that most of the things needed to protect against a naturally occurring pandemic are the same things needed to prepare for an intentional biological attack. Nations must amass an arsenal of new weapons to fight such a disease outbreak, including vaccines, drugs and diagnostic techniques. Being able to develop a vaccine as soon as possible against a new outbreak is particularly important and could save huge numbers of lives, scientists working at his foundation believe.
9/5/21
SO-Innovation DA V4
Tournament: Greenhill | Round: 4 | Opponent: Southlake Carroll AS | Judge: Eric He Innovation DA The pharma industry is strong now but patents are key for continued economic growth. Batell and PhRMA 14: Batell and PhRMA {Battelle is the world’s largest nonprofit independent research and development organization, providing innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management, National Security, Energy, Environment and Material Sciences, and Health and Life Sciences. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.}, 14 – “The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It,” http://phrma-docs.phrma.org/sites/default/files/pdf/2014-economic-futures-report.pdf//marlborough-wr// Compared to other capital-intensive, advanced manufacturing industries in the U.S., the biopharmaceutical industry is a leader in RandD investment, IP generation, venture capital investment, and RandD employment. Policies and infrastructure that helped foster these innovative activities have allowed the U.S. to seize global leadership in biopharmaceutical RandD over the past 30 years. However, as this report details, other countries are seeking to compete with the U.S. by borrowing and building upon some of these pro-innovation policies to improve their own operating environment and become more favorable to biopharmaceutical companies making decisions about where to locate their RandD and manufacturing activities. A unique contribution of this report was the inclusion of the perspective of senior-level strategic planning executives of biopharmaceutical companies regarding what policy areas they see as most likely to impact the favorability of the U.S. business operating environment. The executives cited the following factors as having the most impact on the favorability of the operating environment and hence, potential growth of the innovative biopharmaceutical industry in the U.S.: • Coverage and payment policies that support and encourage medical innovation • A well-functioning, science-based regulatory system • Strong IP protection and enforcement in the U.S. and abroad The top sub-attribute identified as driving future biopharmaceutical industry growth in the U.S. cited by executives was a domestic IP system that provides adequate patent rights and data protection. Collectively, these factors underscore the need to reduce uncertainties and ensure adequate incentives for the lengthy, costly, and risky RandD investments necessary to develop new treatments needed by patients and society to address our most costly and challenging diseases. With more than 300,000 jobs at stake between the two scenarios, the continued growth and leadership of the U.S. innovative biopharmaceutical industry cannot be taken for granted. Continued innovation is fundamental to U.S. economic well-being and the nation’s ability to compete effectively in a globalized economy and to take advantage of the expected growth in demand for new medicines around the world. Just as other countries have drawn lessons from the growth of the U.S. biopharmaceutical sector, the U.S. needs to assess how it can improve the environment for innovation and continue to boost job creation by increasing RandD investment, fostering a robust talent pool, enhancing economic growth and sustainability, and continuing to bring new medicines to patients. COVID has kept patents and innovation strong, but continued protection is key to innovation by incentivizing biomedical research – it’s also crucial to preventing counterfeit medicines, economic collapse, and fatal diseases, which independently turns case. Macdole and Ezell 4-29: Jaci Mcdole and Stephen Ezell {Jaci McDole is a senior policy analyst covering intellectual property (IP) and innovation policy at the Information Technology and Innovation Foundation (ITIF). She focuses on IP and its correlations to global innovation and trade. McDole holds a double BA in Music Business and Radio-Television with a minor in Marketing, an MS in Education, and a JD with a specialization in intellectual property (Southern Illinois University Carbondale). McDole comes to ITIF from the Institute for Intellectual Property Research, an organization she co-founded to study and further robust global IP policies. Stephen Ezell is vice president, global innovation policy, at the Information Technology and Innovation Foundation (ITIF). He comes to ITIF from Peer Insight, an innovation research and consulting firm he cofounded in 2003 to study the practice of innovation in service industries. At Peer Insight, Ezell led the Global Service Innovation Consortium, published multiple research papers on service innovation, and researched national service innovation policies being implemented by governments worldwide. Prior to forming Peer Insight, Ezell worked in the New Service Development group at the NASDAQ Stock Market, where he spearheaded the creation of the NASDAQ Market Intelligence Desk and the NASDAQ Corporate Services Network, services for NASDAQ-listed corporations. Previously, Ezell cofounded two successful innovation ventures, the high-tech services firm Brivo Systems and Lynx Capital, a boutique investment bank. Ezell holds a B.S. from the School of Foreign Service at Georgetown University, with an honors certificate from Georgetown’s Landegger International Business Diplomacy program.}, 21 - ("Ten Ways Ip Has Enabled Innovations That Have Helped Sustain The World Through The Pandemic," Information Technology and Innovation Foundation, 4-29-2021, https://itif.org/publications/2021/04/29/ten-ways-ip-has-enabled-innovations-have-helped-sustain-world-through)//marlborough-wr/ To better understand the role of IP in enabling solutions related to COVID-19 challenges, this report relies on 10 case studies drawn from a variety of nations, technical fields, and firm sizes. This is but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. From a paramedic in Mexico to a veteran vaccine manufacturing company in India and a tech start-up in Estonia to a U.S.-based company offering workplace Internet of Things (IoT) services, small and large organizations alike are working to combat the pandemic. Some have adapted existing innovations, while others have developed novel solutions. All are working to take the world out of the pandemic and into the future. The case studies are: Bharat Biotech: Covaxin Gilead: Remdesivir LumiraDX: SARS-COV-2 Antigen POC Test Teal Bio: Teal Bio Respirator XE Ingeniería Médica: CápsulaXE Surgical Theater: Precision VR Tombot: Jennie Starship Technologies: Autonomous Delivery Robots Triax Technologies: Proximity Trace Zoom: Video Conferencing As the case studies show, IP is critical to enabling innovation. Policymakers around the world need to ensure robust IP protections are—and remain—in place if they wish their citizens to have safe and innovative solutions to health care, workplace, and societal challenges in the future. THE ROLE OF INTELLECTUAL PROPERTY IN RandD-INTENSIVE INDUSTRIES Intangible assets, such as IP rights, comprised approximately 84 percent of the corporate value of SandP 500 companies in 2018.4 For start-ups, this means much of the capital needed to operate is directly related to IP (see Teal Bio case study for more on this). IP also plays an especially important role for RandD-intensive industries.5 To take the example of the biopharmaceutical industry, it is characterized by high-risk, time-consuming, and expensive processes including basic research, drug discovery, pre-clinical trials, three stages of human clinical trials, regulatory review, and post-approval research and safety monitoring. The drug development process spans an average of 11.5 to 15 years.6 For every 5,000 to 10,000 compounds screened on average during the basic research and drug discovery phases, approximately 250 molecular compounds, or 2.5 to 5 percent, make it to preclinical testing. Out of those 250 molecular compounds, approximately 5 make it to clinical testing. That is, 0.05 to 0.1 percent of drugs make it from basic research into clinical trials. Of those rare few which make it to clinical testing, less than 12 percent are ultimately approved for use by the U.S. Food and Drug Administration (FDA).7 In addition to high risks, drug development is costly, and the expenses associated with it are increasing. A 2019 report by the Deloitte Center for Health Solutions concluded that since 2010 the average cost of bringing a new drug to market increased by 67 percent.8 Numerous studies have examined the substantial cost of biopharmaceutical RandD, and most confirm investing in new drug development requires $1.7 billion to $3.2 billion up front on average.9 A 2018 study by the Coalition for Epidemic Preparedness found similar risks and figures for vaccines, stating, “In general, vaccine development from discovery to licensure can cost billions of dollars, can take over 10 years to complete, and has an average 94 percent chance of failure.”10 Yet, a 2010 study found that 80 percent of new drugs—that is, the less than 12 percent ultimately approved by the FDA—made less than their capitalized RandD costs.11 Another study found that only 1 percent (maybe three new drugs each year) of the most successful 10 percent of FDA approved drugs generate half of the profits of the entire drug industry.12 To say the least, biopharmaceutical RandD represents a high-stakes, long-term endeavor with precarious returns. Without IP protection, biopharmaceutical manufacturers have little incentive to take the risks necessary to engage in the RandD process because they would be unable to recoup even a fraction of the costs incurred. Diminished revenues also result in reduced investments in RandD which means less research into cancer drugs, Alzheimer cures, vaccines, and more. IP rights give life-sciences enterprises the confidence needed to undertake the difficult, risky, and expensive process of life-sciences innovation secure in the knowledge they can capture a share of the gains from their innovations, which is indispensable not only to recouping the up-front RandD costs of a given drug, but which can generate sufficient profits to enable investment in future generations of biomedical innovation and thus perpetuate the enterprises into the future.13 THE IMPORTANCE OF INTELLECTUAL PROPERTY TO INNOVATION Although anti-IP proponents have attacked biopharmaceutical manufacturers particularly hard, the reality is all IP-protected innovations are at risk if these rights are ignored, or vitiated. Certain arguments have shown a desire for the term “COVID-19 innovations” to include everything from vaccines, therapeutics, diagnostics, and PPE to biotechnology, AI-related data, and educational materials.14 This could potentially open the floodgates to invalidate IP protection on many of the innovations highlighted in this report. However, much of the current discussion concerning IP focuses almost entirely on litigation fears or RandD incentives. Although RandD is an important aspect of IP, as previously mentioned, these discussions ignore the fact that IP protection can be—and often is—used for other purposes, including generating initial capital to create a company and begin manufacturing and, more importantly, using licensing agreements and IP to track the supply chain and ensure quality control of products. This report highlights but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. In 2018, Forbes identified counterfeiting as the largest criminal enterprise in the world.15 The global struggle against counterfeit and non-regulated products, which has hit Latin America particularly hard during the pandemic, proves the need for safety and quality assurance in supply chains.16 Some communities already ravaged by COVID-19 are seeing higher mortality rates related to counterfeit vaccines, therapeutics, PPE, and cleaning and sanitizing products.17 Polish authorities discovered vials of antiwrinkle treatment labeled as COVID-19 vaccines. 18 In Mexico, fake vaccines sold for approximately $1,000 per dose.19 Chinese and South African police seized thousands of counterfeit vaccine doses from warehouses and manufacturing plants.20 Meanwhile, dozens of websites worldwide claiming to sell vaccines or be affiliated with vaccine manufacturers have been taken down.21 But the problem is not limited to biopharmaceuticals. The National Intellectual Property Rights Coordination Center has recovered $48 million worth of counterfeit PPE and other products.22 Collaborative efforts between law enforcement and manufacturers have kept numerous counterfeits from reaching the population. In countries with strong IP protection, the chances of counterfeit products reaching the market are significantly lower. This is largely because counterfeiting tends to be an IP-related issue, and these countries generally provide superior means of tracking the supply chain through trademarks, trade secrets, and licensing agreements. This enables greater quality control and helps manufacturers maintain a level of public confidence in their products. By controlling the flow of knowledge associated with IP, voluntary licensing agreements provide innovators with opportunities to collaborate, while ensuring their partners are properly equipped and capable of producing quality products. Throughout this difficult time, the world has seen unexpected collaborations, especially between biopharmaceutical companies worldwide such as Gilead and Eva Pharma or Bharat Biotech and Ocugen, Inc. Throughout history, and most significantly in the nineteenth century through the widespread development of patent systems and the ensuing Industrial Revolution, IP has contributed toward greater economic growth.23 This is promising news as the world struggles for economic recovery. A 2021 joint study by the EU Intellectual Property Office (EUIPO) and European Patent Office (EPO) shows a strong, positive correlation between IP rights and economic performance.24 It states that “IP-owning firms represent a significantly larger proportion of economic activity and employment across Europe,” with IP-intensive industries contributing to 45 percent of gross domestic product (GDP) (€6.6 trillion; US$7.9 trillion).25 The study also shows 38.9 percent of employment is directly or indirectly attributed to IP-intensive industries, and IP generates higher wages and greater revenue per employee, especially for small-to-medium-sized enterprises.26 That concords with the United States, where the Department of Commerce estimated that IP-intensive industries support at least 45 million jobs and contribute more than $6 trillion dollars to, or 38.2 percent of, GDP.27 In 2020, global patent filings through the World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) system reached a record 275,900 filings amidst the pandemic, growing 4 percent from 2019.28 The top-four nations, which accounted for 180,530 of the patent applications, were China, the United States, Japan, and Korea, respectively.29 While several countries saw an increase in patent filings, Saudi Arabia and Malaysia both saw significant increases in the number of annual applications, with the top two filing growths of 73 percent and 26 percent, respectively.30 The COVID-19 pandemic slowed a lot of things, but it certainly couldn’t stop innovation. There are at least five principal benefits strong IP rights can generate, for both developing and developed countries alike.31 First, stronger IP protection spurs the virtuous cycle of innovation by increasing the appropriability of returns, enabling economic gain and catalyzing economic growth. Second, through patents—which require innovators to disclose certain knowledge as a condition of protection—knowledge spillovers build a platform of knowledge that enables other innovators. For instance, studies have found that the rate of return to society from corporate RandD and innovation activities is at least twice the estimated returns that each company itself receives.32 Third, countries with robust IP can operate more efficiently and productively by using IP to determine product quality and reduce transaction costs. Fourth, trade and foreign direct investment enabled and encouraged by strong IP protection offered to enterprises from foreign countries facilitates an accumulation of knowledge capital within the destination economy. That matters when foreign sources of technology account for over 90 percent of productivity growth in most countries.33 There’s also evidence suggesting that developing nations with stronger IP protections enjoy the earlier introduction of innovative new medicines.34 And fifth, strong IP boosts exports, including in developing countries.35 Research shows a positive correlation between stronger IP protection and exports from developing countries as well as faster growth rates of certain industries.36 The following case studies illustrate these benefits of IP and how they’ve enabled innovative solutions to help global society navigate the COVID-19 pandemic. Cannabis is an especially expensive industry to enter Kathryn Hardison {reporter}, 19 - ("With marijuana startups, a green thumb comes at a cost," Springfield Business Journal, 11-4-2019, https://sbj.net/stories/with-marijuana-startups-a-green-thumb-comes-at-a-cost,66297)marlborough-wr/ Vying for a spot in the medical marijuana industry comes with a large buy-in.¶ Before a state application can be considered, these entrepreneurs must secure a location, assemble investors – because they can’t get a business loan – develop a medical team, hire an architect to create renderings of their potential business, determine a security plan for the high-dollar products and complete the application paperwork – or hire someone else to do it. That alone could cost $60,000-$100,000 a pop.¶ Then, they pay the $6,000-$10,000 application fee, depending on the license sought: dispensary, cultivation or infused-product manufacturing.¶ And that’s just the beginning.¶ Though medical marijuana may be a lucrative business, those with their eyes on the Springfield market know the return on investment is slow and the profit margins of 10-20 is less than some expect.¶ Jamie Tillman, owner of CBD operator CannaBliss LLC, hopes to open three medical marijuana dispensaries in 2020. After her dispensary is built at 1109 E. Battlefield Road, Tillman will have invested $1 million along with her two silent partners in the application process.¶ Tillman says she expects her profit margin to be about 20 after the many factors she anticipates taking their piece of the pie.¶ So, what are the financials behind a medical marijuana business?¶ Operating costs¶ A medical marijuana business, like a dispensary, incurs similar operating costs as other companies – just on a larger scale, said Marshall Marquardt, chief operations officer of Colorado-based Apothecary Farms. The company applied for 11 licenses in Missouri, according to past Springfield Business Journal reporting.¶ Marquardt said labor for an Apothecary Farms dispensary costs over $250,000. That covers 10-15 employees, an assistant manager and manager, he said.¶ Tillman said the Missouri application required her to have a medical team in place outside of her planned employees.¶ “You have to have a pharmacist, a medical director, a security adviser, and then anything else you can round up is perks,” Tillman said. “Usually, to get these people on your team, you have to give them a percentage of your business, which is what a lot of people have done – or you pay them.”¶ Marquardt said another large portion of the company’s operating cost goes to the security systems, noting each dispensary has over 100 security cameras, running off Wi-Fi. He cited security costs of over $100,000 per site.¶ “There’s a lot of other industries that will be positively impacted by cannabis,” Marquardt said, citing security and power companies.¶ Wendy Coy, chief operations manager at Midwest Security Inc. in Springfield, expects the burgeoning industry to be good for business. She said at least a dozen applicants have asked for a quote from Midwest Security for a 24-hour security guard. Many of these entrepreneurs are hopeful to open multiple locations across the state, Coy said.¶ “Most of the applicants will need one guard at a time, depending on the alarm systems that they will have in place,” Coy said. “Figuring 24-hour shifts, it would be around $219,000 a year per location.”¶ Then, there’s the product.¶ If she receives a license, Tillman said she’s budgeted close to $400,000 in furnishings, like display cabinets, and expects the initial marijuana product to cost $350,000 per dispensary location. She said it’s likely that her budget will change once product is grown in the state.¶ “No one knows what the going rate will be, because no one knows what our surplus will be because cultivators aren’t here,” Tillman said. “This is just throwing a dart at the board.”¶ Cultivators also have to fund the laboratory setting required by the state. According to past SBJ reporting, it could cost organizers of Springfield-based The Wholesome Bud Co. LLC about $70 per square foot of a cultivation building to create the laboratory – including lights, tables and HVAC. They’ll also need video cameras with two views on every plant.¶ The Wholesome Bud team projects an investment of $3 million-$5 million by the end of 2020 with help from angel investors to meet their business plan.¶ Banking and marijuana¶ As to how and where the marijuana business income will be processed, Tillman has to laugh: “That’s to be decided.”¶ That’s because it’s technically illegal for a bank to do business with a company that sells a Schedule I drug, said Shaun Burke, president and CEO of Guaranty Federal Bancshares Inc. (Nasdaq: GFED). It signals money laundering, he said.¶ There could be regulatory relief soon, however. The U.S. House of Representatives recently passed the Secure and Fair Enforcement Act, which would help regulate relationships between banks and marijuana-related businesses. It’s now awaiting approval from the Senate.¶ Until then, most Federal Deposit Insurance Corp. insured banks won’t do business with marijuana companies, Burke said. The few that do, however, can name their price.¶ “The reality is that some banks are banking (marijuana-related businesses), and they’re just not saying it,” Burke said, drawing on his experience as past chairman of the Missouri Bankers Association. “There are banks choosing to do it because right now they can charge anything they want to.”¶ Marquardt said it can cost $5,000-$15,000 to open a checking account with a bank in Colorado. Burke said he’s heard of other banks charging upwards of $10,000.¶ On top of that, Marquardt said Apothecary Farms is charged $2,500 a month just to keep an account open.¶ The limited access to banking also means many state-legal marijuana businesses nationwide are having to operate as a cash-only enterprise. Marquardt said that requires businesses to hire armed car services to transport money, which could cost as much as $100,000 a year, based on frequency. Biotech collapse wrecks the economy Carlson 16, Robert Carlson is the managing Director at Bioeconomy Capital, “Estimating the biotech sector's contribution to the US economy”, Nature Biotechnology 34, 247–255 (2016), http://www.nature.com/nbt/journal/v34/n3/full/nbt.3491.html?WT.feed_name=subjects_businessandfoxtrotcallback=true#author-information Biotech is now a major contributor to the US economy. When considered as an industry in itself, biotech and its economic impact rivals mining, utilities, chemicals and computing and electronics. Internationally, at least 20 countries have articulated strategies that explicitly identify biotech as critical to their future economic and employment growth1. Given this focus on economic development, it is crucial to better define the current systemic role of biotech. Moreover, ongoing discussions of funding and investment, benefit and risk, and opportunity and threat all would benefit from a more detailed understanding of where biotech is and where it is headed. In this article, I use data collected from a variety of public and private sources to assemble an initial economic assessment of biotech in the United States as a test case for an analysis at the global level. What emerges is a picture of a sector already making a remarkable and accelerating transformation of the US economy. By my estimate, total domestic US revenues generated by biotech in 2012 reached at least $324 billion—the equivalent of 2 of gross domestic product (GDP; for comparison, see Supplementary Table 1 for a list of selected industries and their contributions to US GDP). The estimate is intended to be conservative; the actual total could be 10–20 higher. Total revenues comprise three biotech subsectors: biologics (drugs), at $91 billion; crops (and seeds), at $128 billion; and industrial products (biofuels, enzymes, biomaterials and biochemicals), at $105 billion. Over the past decade, aggregate revenues have grown on average at annual rates 10, much faster than the economy as a whole. Remarkably, biotech revenue growth was the equivalent of 5 of annual US GDP growth every year between 2007 and 2012. It is difficult to project exactly how large the biotech sector might ultimately become, but the trends indicate that biological technologies are likely to generate an increasing share of both GDP and annual GDP growth. What is biotech, and how can it be measured? Current understanding of the biotech sector is hampered by inconsistencies in usage and definition of 'biotechnology' and 'bioeconomy' in public discussion and in print. These words may be used in reference only to pharmaceuticals (or biopharmaceuticals or biologics, depending on one's definition), genetically modified (GM) crops, or public companies whose primary revenues rely on biological technologies, thereby muddling an integrated description of the industry (Box 1). Beyond linguistic imprecision, a lack of data resulting from inadequate characterization of the economy hampers any assessment of the economic size and scope of biotech. Even in the United States, the country with the largest biotech sector, there is no official mechanism to distinguish between products made through biology and products manufactured through other technologies. At present, for example, a chemical manufactured through biological technologies is treated identically to one derived from fossil petroleum. The biological product may displace the petroleum product from the market on the basis of price or preference, yet revenues now accrue to a category that includes petrochemicals. Under the current classification system, even revenues from novel biomolecules, including those that may outperform petroleum products, will be misattributed to fossil sources. The approach I take here differs from the frequently employed tactic of describing 'biotech industry' revenues on the basis only of financial reporting from public companies. For example, this journal's 'What's Fueling the Biotech Engine' series2 focuses exclusively on the metric of domestic US sales of drug products. Another annual Feature, 'Public Biotech by the Numbers'3, defines the biotech industry as including only the companies whose revenues are derived primarily from sales of biotech products, an approach similar to that of the annual 'Beyond Borders' reports by consultants Ernst and Young (New York). Defining the biotech sector on the basis of financial reporting of qualifying companies works only as long as those companies fit the scope of that definition. If a biotech company is acquired by a company outside the biotech sector (e.g., a big pharma or a chemical company), the relevant revenues from the biotech company's products 'disappear' from estimates based on companies in the industry—for example, in these analyses, product revenues from Genentech (S. San Francisco, CA, USA) are no longer counted toward the biotech industry because Genentech is now part of Roche (Basel, Switzerland), which is classified as a large pharmaceutical company. More broadly, the above industry analyses often focus predominantly on biotech enterprises engaged in biomedical markets; companies involved in crops (and seeds) or industrial bioproducts are often given comparatively scant attention. Quantifying biotech's economic contribution The economic impact of an industry is often based on its contribution to GDP (Supplementary Table 1). GDP is a national measure of economic output, which in the United States is calculated by the government using survey and census data. According to the US Census Bureau, “the North American Industrial Classification System (NAICS) is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the US business economy” (http://www.census.gov/eos/www/naics/index.html). The NAICS is used to segment the economy according to a list of six-digit codes that are reevaluated every five years. The resulting data serve as the basis for constructing GDP in one of three ways: the value added to the economy for each industry, total domestic income earned and final sales of domestic products to purchasers. The algorithms used to calculate GDP are adjusted over time, with refinements intended to sharpen understanding of how goods and services are exchanged to create value. In principle, then, biotech innovations can, like any other component of the US economy, be assessed through changes in the NAICS and GDP calculations. However, there is at present no means to calculate the contribution of biotech to GDP on the basis of the value added, total income or final sales methods. Despite the intention that “producing units that use the same or similar production processes are grouped together in NAICS,” the only NAICS code for biotech-related businesses is specifically meant to identify research and development entities, and it is associated with a very broad definition of biotech (Box 2 and http://www.census.gov/eos/www/naics/reference_files_tools/NAICS_Update_Process_Fact_Sheet.pdf). The only code associated with biological manufacturing of any kind is a subset of pharmaceutical production. Although biotech may nominally be used in various industries that do not obviously overlap (e.g., in the production of fuels or drugs), it comprises a coherent set of tools, skills and practices that together constitute similar production processes that are very different from synthetic chemistry or resource mining. At present, the vast majority of biotech product and service revenues are evidently collected into generic categories such as chemicals, agriculture and pharmaceuticals. Consequently, among other shortcomings, in the NAICS system, what is identified as 'biochemicals' (Fig. 1) conflates chemicals produced largely via fermentation with chemicals produced from petroleum or mining. This is but one example of misaggregation of biotech revenues with those generated from entirely unrelated production processes. n lieu of standardized data classified via the NAICS, how might one estimate the contribution of biotech to GDP? One starting point is industry revenue, corrected as is feasible to remove double counting (Box 1 and Supplementary Methods). For the present analysis, I relied largely on data from the following sources: corporate financial reporting, US Department of Agriculture (USDA) crop price and GM seed usage reporting, and private consulting firms. Because these data are of varying quality and quantity, I combined available hard data with trends and anecdotes to develop estimates. I argue here that the result is a reasonable approximation of the contribution of biotech to GDP. US biotech revenues The quantitative data used were derived primarily from financial reporting and market prices, and the estimates primarily from surveys, private consulting reports and numerical interpolation of sparse time series data (sources of uncertainty are detailed in Box 3). Because of differences in the regulatory structure and financing and, consequently, the pace of innovation across the industry, the biotech sector naturally breaks down into three subsectors: biologics (biotech drugs), GM crops or seeds and industrial biotech. Although biologics development is said to run faster than small-molecule pharmaceuticals, the cost for each is frequently estimated to be $1 billion per drug, spent over 10 years of development and clinical trials4. GM crops may cost between $500 million and $700 million to develop, with field trials running 3–5 years, depending on whether those trials are conducted simultaneously in the southern and northern hemispheres4. Finally, industrial products may cost anywhere from tens to hundreds of millions of dollars to develop—depending in part on whether the physical infrastructure (i.e., 'steel in the ground') is included in the costs—and US regulatory barriers may be so low that only a notification letter to relevant authorities is required, meaning products can be marketed as soon as they are produced4, 5. Biologics. For this analysis, I define biologics as drugs produced using GM organisms; I explicitly exclude drugs purified from nonmodified organisms. On the basis of reporting from publicly traded companies, global 2012 revenues from biologics reached at least $125 billion; McKinsey and Company (New York) estimated that 2012 global biopharmaceuticals revenues may have been as high $168 billion6 (http://www.mckinsey.com/insights/health_systems_and_services/rapid_growth_in_biopharma) (Supplementary Table 2). Of that total, domestic US revenues from biologics reached $91 billion. This figure includes $28 billion in revenues accruing to such companies as Genentech and Genzyme (Cambridge, MA, USA) that are now wholly owned by overseas entities—Roche and Sanofi (Paris), respectively. Domestic US clinical sales of biologics rose 18, reaching $63.6 billion in 2012 (ref. 2). Beyond drugs that are produced biologically, the contemporary development and testing of virtually all small-molecule prescription drugs is highly dependent on biotech. Of the $337 billion in total 2012 US pharmaceutical revenues, a large fraction of the small-molecule revenues relied heavily on biotechnologies used in discovery, validation and trials7. Further complicating this estimate is the challenge of accounting for the potential double-counting of 'biologics feedstocks' produced in the United States, as some fraction of those revenues is produced from exports, and 75 of pharmaceutical ingredients used in the United States are imported from China8. Consequently, in the interest of simplicity and of using data that are relatively easy to come by, I have chosen to include here only 'nameplate' biologics revenues that are directly attributable to biological production, even though this probably underestimates the total relevant revenues by a substantial amount. GM crops. Global planting of GM crops increased by 6 in 2012, reaching a total of 170 million hectares9. In the United States, where farmers planted 40 of the total global GM crop area, GM corn, cotton and soy continued to have 90 penetration, with GM sugar beets at 95. Using average crop revenue figures and the fractions of crops planted in GM seed as compiled by the USDA, I estimate that the sum of farm-scale domestic US revenues, seeds and licensing revenues reached $128 billion (Fig. 2 and Supplementary Table 3). On the basis of the global acreage of GM crops as reported by the International Service for the Acquisition of Agri-biotech Applications, and assuming approximately uniform global prices, I estimate that 2012 global farm-scale revenues for GM crops were at least $300 billion9. How should the biotechnological contribution to GM crop revenues be valued? Until 2009, revenues from GM seeds alone were widely misreported as total “revenues from GM crops”10. Seeds, however, grow into larger organisms with greater value. Some of that value would be realized without the GM component. The US National Research Council (NRC) estimates that by planting GM crops, US farmers receive an additional economic benefit that ranges between 6 and 20 of total crop revenues, depending on the crop, where it is planted and how closely farmers follow recommended practices11. Cumulative 2000–2012 GM crop and seed revenues (Fig. 3) amount to $802 billion, suggesting that US farmers received between $50 billion and $160 billion in additional economic benefit over those years. These figures substantially exceed the benefits estimated by Brookes and Barfoot12 for 1996–2011. This difference highlights the complexity of the analysis and the need to develop standards and consistency. For example, a fraction of the economic benefit estimated by the NRC is indirect, in that farmers who plant GM crops are able to spend less time tending to those crops. That time can be used in other pursuits, including earning additional income, a factor that Brooks and Barfoot intentionally exclude owing to the complexity of gathering and analyzing such data in a global context12. More recently, Klümper and Qaim found that “on average, GM technology adoption has reduced chemical pesticide use by 37, increased crop yields by 22, and increased farmer profits by 68”13. Beyond the direct benefits to farmers planting GM crops, there are benefits to conventional crops in proximity to GM crops. Multiple lines of evidence demonstrate that insect-resistant crops produce area-wide pest suppression—also known as the 'halo effect'—reducing losses in nearby conventional crops. This effect both reduces pesticide requirements for conventional crops and increases their yield; consequently, by one estimate, more than 70 of the cumulative benefits of Bt corn adoption over a period of 14 years accrued to nonadopters in the US Midwest14. The economic benefits of GM crops to nonadopting farmers are difficult to assess broadly, but they should be attributed in some way to the total economic contribution GM crops. I do not attempt to include this value in the present revenue estimate. Going forward, a more thorough accounting of what revenues are produced by which crops might provide a mechanism to include only the fraction of revenues attributable to GM traits. This metric should include the value provided by nearby GM crops to farmers of conventional crops and would thereby contribute to solidifying conversations about the utility and value of various integrated pest-management approaches. This accounting strategy could be the product of work in the public or private sector, but it should be adopted at the federal level to facilitate data gathering and analysis. For simplicity, here I use the total farm-scale revenues from GM crops and seeds. This may well constitute an overestimate of GM crop revenues, but its contribution to estimated total biotech revenues is arguably offset by my use of only 'nameplate' biologics revenues, described above. Industrial biotech. The industrial subsector appears to be the fastest-growing portion of the biotech sector (Fig. 3), and the lack of resolution of this component at the level of the NAICS masks a large and accelerating shift in the US economy. US revenues from industrial biotech reached at least $105 billion in 2012. The accuracy of the industrial revenue estimate continues to suffer in comparison to estimates for biologics and GM crops, owing to the quantity and quality of available data (Fig. 3). My previous efforts have required reverse engineering of reports from private consulting firms who rarely describe data sources and methods4. For the present set of estimates, I first excluded the value of corn from annual US ethanol revenues, which I then used as a lower bound for total US revenues. To these figures I added a conservatively scaled fraction of the international industrial biotech revenue figures reported by consulting firms (Box 1 and Supplementary Table 4). For the 2012 data, I relied on data provided by by Agilent Technologies (Santa Clara, CA, USA), of $125 billion15. Although it would be preferable to categorize industrial biotech products under biofuels, enzymes, biomaterials and biochemicals (biologically derived chemicals), the Agilent report categorizes revenues differently. Its internal breakdown of the $125 billion in business-to-business sales for 2012 was as follows: $66 billion in biochemicals, $30 billion in biofuels, $16 billion in biologics feedstocks (active pharmaceutical ingredients), $12 billion in food and agricultural applications (including enzymes) and $1 billion in new markets. Darlene Solomon, senior vice-president and CTO of Agilent, later clarified that the “industrial biotechnology market analysis was developed via analysis of corporate financial reports, equity analyst reports, private consulting firms reports, and third party market research reports” (personal communication).No further information is available at present. For the revenue estimate reported here, I have scaled the 2012 Agilent biofuels revenues to avoid double counting the substantial contribution of corn feedstocks (on average, 68 of the wholesale cost of ethanol) (Supplementary Table 4). This reduces the 2012 value added of biofuels production to no more than $10 billion. Notably, biochemicals have eclipsed fuels as the largest component of industrial biotech revenues. The magnitude of the disparity between biofuel and biochemical revenues is informative for understanding the state of the bioeconomy and may inform ongoing policy debates about the relative levels of federal support received by each type of product. The estimates presented here suggest that biochemicals may already generate the equivalent of 0.4 of the US GDP (compared with 3 for petrochemicals; see below and Supplementary Table 4). Last, the ultimate contribution of industrial biotech to GDP could be 10–15 larger than that quoted here, depending on the actual retail margin and value added for consumers by biotech beyond business-to-business transactions. The total 2012 impact on the US economy could therefore have been as much as $155 billion, which would bring the total 2012 biotech revenues to $374 billion. Contribution to US GDP To what extent is it sensible to refer to a 'biotech industry' and its contribution to GDP? Just as cell culture and fermentation are quite different from mining or petroleum refining, so are they different from agriculture. But biological production methods, and their underlying bioengineering techniques and tools, are similar in many ways, particularly when contrasted with mining and refining. These distinctions are likely to be of increasing importance in policy discussions around renewable biological manufacturing and its potential to replace processes and manufacturing based on fossil energy and materials. Moreover, aggregate revenues from GM organisms are now a large and rapidly growing contribution to the US economy (Fig. 3). How well does the sum of biotech revenues in Figure 3 approximate the contribution of biotech to GDP? The overall quality of the data available supports treating any aggregate as only an estimate. As argued above, 'nameplate' biologics revenues are probably a substantial underestimate of subsector revenues. Similarly, although use of total GM crop revenues overestimates the value added to these crops by genetic modification, the total impact is probably underestimated, owing to the direct benefits for conventional crops via the halo effect. Historically, industrial revenues are the least precise owing to the quantity and quality of data, although I eliminated obvious double counting where feasible. In all three cases I sought to produce conservative estimates whenever possible. Taken together, until better data are available, the resulting revenue figure is a reasonable proxy for a direct measure of 'GM domestic product' (GMDP). Therefore, it is arguably both useful and approximately correct to aggregate the revenues from GM organisms as the GMDP to assess the economic impact of biotech. With this approximation in hand, the interpolation in Figure 3 enables a direct historical comparison of biotech revenues to GDP and GDP growth in the United States over the past three decades. This comparison reveals that the US economy, and in particular annual US GDP growth, is becoming increasingly dependent on biotech. Biotech revenues have increased as a fraction of GDP gradually since 1980, reaching the equivalent of at least 2 in 2012. This development is driven by annual increases in biotech revenues that, by 2012, contributed the equivalent of at least 5.4 of annual GDP growth. The apparent peak between 2007 and 2011 is due to the poor overall performance of the US economy rather than any particular trend in biotech. This phenomenon, also visible in 1991 and 2001–2003, suggests that biotech as a sector is relatively robust in the face of general economic downturn. Now, as the broader economy recovers, the annual biotech revenue growth contribution appears to be realigning with the multidecadal trend; several more years may yet be required to resolve the actual annual rate. The model is sensitive to the size of the 2012 industrial biotech revenues; using a biotech revenue estimate of $350 billion would raise the contribution of biotech to GDP to 2.26 and the 2012 contribution to GDP growth to 8.6 (data not shown). The code used to generate historical estimates can also be used to project future revenues. However, because of both the uncertainty in the size of 2012 biotech revenues (between $324 billion and $374 billion) and the sensitivity of the revenue interpolation and growth rates to the size of 2012 industrial revenues, I will not speculate on the magnitude of more recent revenues or quantitatively predict future performance. The code used to generate Figures 3 and 4 is available is available from Biodesic (http://www.biodesic.com). Better tracking of the bio-based economy Box 2 summarizes how NAICS could be used to track biotech products and revenues. Looking forward, one necessary change to the NAICS would be to institute a 'nonpharmaceutical, cell-based manufacturing' code. This code would capture the majority of industrial biotech revenues, which even at the business-to-business 2012 total of $105 billion exceeded the $101 billion in direct contribution to GDP claimed by the mining industry (Supplementary Table 4 compares the contributions to GDP of biotech and selected manufacturing and extractive industries)16. An additional code could be used to specify cell-based manufacturing that relies on modified genomes. These updates for biotech would not constitute a departure from previous practices; indeed, there is precedent to fine grain the measurement of any industry, and there are multiple NAICS codes to characterize aspects of mining and mineral processing, as well as related services and equipment manufacturing. The US government should examine the bioeconomy at a similar resolution. The current NAICS codes either miss substantial biotech revenues and employment or misaggregate them with entirely dissimilar means of production. Of more general concern, the misattribution of sector revenues obscures the broader raw economic contribution of biotech. The resulting ignorance impedes quantitative assessment of key features of sector growth and health, such as the number of firms, the rate of firm creation and destruction, firm longevity, employment and returns on public and private sector investment. I hope that, by calling attention to these and other shortcomings, this analysis will encourage private and public sector efforts to gather and share data that support a more detailed understanding of the biotech sector and its contributions to innovation and physical and economic security. The NAICS is under review for an update in 2017. New codes specifically designed to elicit information about biological production would address serious shortcomings in the way the US government assesses its economy. The continued use of NAICS codes adopted in previous years will explicitly confuse chemicals directly produced through biological systems with those refined from fossil sources and ores. For example, a recent attempt by the Battelle Memorial Institute (Columbus, OH, USA) to use the NAICS to define 'bioscience-related' employment was hampered by antiquated industrial groupings that not only excluded many companies that derive revenue from biotech products (including GM seeds, nonagricultural industrial chemicals and industrial enzymes) but also included companies that manufacture farm equipment and irradiation instruments that are clearly not biotech related17. Consequently, using the current NAICS to estimate biotech employment is a difficult proposition, because the current codes do not map well onto existing and emerging bioproduction methods18. Modernizing the NAICS must be a priority of both the public and private sectors to enable accurate economic analyses, employment measurements and appropriate marshaling and allocation of resources. The mechanisms to better characterize the bioeconomy throughout North America appear to exist in the form of NAICS and the North American Product Classification System (NAPCS). Ongoing revisions to industrial coding and classification provide opportunities to untangle biotech revenues from other industries and to clarify the contribution of biological production to the economy. The broader bioeconomy The estimates of the economic contribution of the biotech sector provided here are relatively inaccurate compared with those describing other parts of the US economy. Not only are there whole areas of biotech activity for which no data are collected, there is also a lack of detail for biotech products where data are available. A critical question for any analysis of the 'biotech sector' is that of what falls within the scope of biotech. For example, in excess of the biologics estimate provided here, there are almost certainly additional billions of dollars in revenues attributable to the creation, maintenance and production of GM model animals, such as knockout microbes and rodents, which are increasingly sold as services to industry and academia. Similarly, companies produce many types of modified cells and antibodies for sale, and vaccines are increasingly produced via biotechnological techniques such as reverse genetics. Marketing reports for sale on the Internet suggest that sales of chemically synthesized peptides, oligonucleotides and genes generate between hundreds of millions and several billion dollars annually. Other reports (http://www.bccresearch.com/market-research/biotechnology/synthetic-biology-bio066c.html;http://www.transparencymarketresearch.com/synthetic-biology-market.html) define a new category of 'synthetic biology' that is putatively already worth several billion dollars a year and that will purportedly climb to tens of billions by 2020. In principle, all of these contributions could be tracked with appropriate NAICS codes, because the value provided by biotech tools should be reflected in their price and thus in the revenues of the vending companies. Properly accounting for these contributions could add tens of billions of dollars in additional revenue to the biotech tally provided here, but such a calculation is not obviously feasible with current data. Clearly defined metrics are critical for formulating policy and allocating resources for research, development and market incentives. For example, policy discussions about alternatives to fossil fuels and reducing carbon emissions should consider metrics not only on biofuels but also on the contribution of biochemicals to plastics and solvents, given that 15 of a barrel of petroleum is processed into such materials (http://www.eia.gov/energyexplained/index.cfm?page=oil_refining and http://www.eia.gov/dnav/pet/PET_PNP_PCT_DC_NUS_PCT_A.htm). In other words, although the energy content of petroleum might be replaced by many sources, more consideration should be given to replacing the atoms in petroleum, given their crucial role as materials in the existing economy. Addressing the shortcomings of present data through better measurement would benefit strategy development and policy-making across the public and private sectors. For example, adequate planning to educate an appropriate labor force requires understanding the current skill base and overall sector employment. More broadly, accurate and precise historical revenue estimates would facilitate efforts to understand the long-term return on public and private investments in the bioeconomy and would benefit conversations both practical and political. Beyond the United States, better data would help governments assess biotech's contributions to their own economies. Yet assessing the specific economic roles of modified DNA and biomanufacturing should be undertaken as part of a larger effort. It is often said that this is the century of biology and that biology is the technology of the twenty-first century. Private investments continue to flow into biotech, motivated by hopes of developing new medical treatments, crops, chemicals and production processes.Public investments seek the same returns, with additional expectations for education, employment and economic development. How can the returns from these investments be tallied, and how should this tally be used to assess the contribution of biology to the larger economy? It is well past time for governments around the world to collaborate in developing a standardized and comprehensive understanding of the role of biology in their economies. Standardized data would be invaluable in an assessment of the economic importance of biotech and would enable a direct comparison with GDP. In the long term, it would be ideal to have an industry-wide reference metric that is comparable to GDP. Some governments track—to varying degrees—healthcare, domestic agricultural productivity and biofuels production, but data collection and analytical standards are far from uniform (e.g., see the variable quality and quantity of data in the European Commission's Bioeconomy Observatory (http://biobs.jrc.ec.europa.eu/)). As a step toward clarity, nascent efforts are under way to assemble a unified picture of the value provided by biological goods and services in the form of the biobased economy. The definition of 'biobased economy' varies internationally. In the United States, it is typically defined as “economic activity and jobs generated by the use and conversion of agricultural feedstocks to higher value products; the use of microbes and industrial enzymes as transformation agents or for process changes; and the production of bio-based products and biofuels”19. Responding to a mandate from the US Congress, the USDA has elaborated a list of potential “biobased economy indicators” and also described the difficulties in fleshing out those metrics20. Yet even in the current data-poor environment, the biobased economy was recently valued at an estimated $1.25 trillion in the United States for 2012, the equivalent of about 7 of the GDP21. As impressive as these numbers are, they may still exclude a wide variety of economically important biological goods and services. The preceding definition of biobased economy, and the one used by the USDA, omit fisheries, forestry and agriculture20. Depending on who is counting, those industries generate between $300 billion and $800 billion in revenue annually, bringing even a conservative estimate of the total size of the broader US bioeconomy to nearly 10 of GDP4. For comparison, a recent estimate of the European Union's bioeconomy sectors that included all biobased activity put the total at $2 trillion and 9 of GDP22. Yet even if a more detailed and thorough accounting were to raise the total bioeconomy to 15 or 20 of GDP, that number would underestimate the larger importance of biological systems in supporting countries and their economies. Without biological production in the form of food, water, oxygen and raw materials, the rest of the economy would be worthless. Precisely because the biobased economy is intertwined with, and depends on, agriculture and natural resources, a thorough understanding of the relationship between biological systems and the economy requires a broader systematic accounting that extends across land and water resources, agriculture, food, textiles and paper, to cutting-edge products of metabolic engineering. Simply put, we should measure everything better. Economic decline causes nuclear war – collapses faith in deterrence Tønnesson, 15—Research Professor, Peace Research Institute Oslo; Leader of East Asia Peace program, Uppsala University (Stein, “Deterrence, interdependence and Sino–US peace,” International Area Studies Review, Vol. 18, No. 3, p. 297-311, dml) Several recent works on China and Sino–US relations have made substantial contributions to the current understanding of how and under what circumstances a combination of nuclear deterrence and economic interdependence may reduce the risk of war between major powers. At least four conclusions can be drawn from the review above: first, those who say that interdependence may both inhibit and drive conflict are right. Interdependence raises the cost of conflict for all sides but asymmetrical or unbalanced dependencies and negative trade expectations may generate tensions leading to trade wars among inter-dependent states that in turn increase the risk of military conflict (Copeland, 2015: 1, 14, 437; Roach, 2014). The risk may increase if one of the interdependent countries is governed by an inward-looking socio-economic coalition (Solingen, 2015); second, the risk of war between China and the US should not just be analysed bilaterally but include their allies and partners. Third party countries could drag China or the US into confrontation; third, in this context it is of some comfort that the three main economic powers in Northeast Asia (China, Japan and South Korea) are all deeply integrated economically through production networks within a global system of trade and finance (Ravenhill, 2014; Yoshimatsu, 2014: 576); and fourth, decisions for war and peace are taken by very few people, who act on the basis of their future expectations. International relations theory must be supplemented by foreign policy analysis in order to assess the value attributed by national decision-makers to economic development and their assessments of risks and opportunities. If leaders on either side of the Atlantic begin to seriously fear or anticipate their own nation’s decline then they may blame this on external dependence, appeal to anti-foreign sentiments, contemplate the use of force to gain respect or credibility, adopt protectionist policies, and ultimately refuse to be deterred by either nuclear arms or prospects of socioeconomic calamities. Such a dangerous shift could happen abruptly, i.e. under the instigation of actions by a third party – or against a third party.Yet as long as there is both nuclear deterrence and interdependence, the tensions in East Asia are unlikely to escalate to war. As Chan (2013) says, all states in the region are aware that they cannot count on support from either China or the US if they make provocative moves. The greatest risk is not that a territorial dispute leads to war under present circumstances but that changes in the world economy alter those circumstances in ways that render inter-state peace more precarious. If China and the US fail to rebalance their financial and trading relations (Roach, 2014) then a trade war could result, interrupting transnational production networks, provoking social distress, and exacerbating nationalist emotions. This could have unforeseen consequences in the field of security, with nuclear deterrence remaining the only factor to protect the world from Armageddon, and unreliably so. Deterrence could lose its credibility: one of the two great powers might gamble that the other yield in a cyber-war or conventional limited war, or third party countries might engage in conflict with each other, with a view to obliging Washington or Beijing to intervene. The best way to enhance global peace is no doubt to multiply the factors protecting it: build a Pacific security community by topping up economic interdependence with political rapprochement and trust, institutionalized cooperation, and shared international norms. Yet even without such accomplishments, the combination of deterrence and economic interdependence may be enough to prevent war among the major powers. Because the leaders of nuclear armed nations are fearful of getting into a situation where peace relies uniquely on nuclear deterrence, and because they know that their adversaries have the same fear, they may accept the risks entailed by depending economically on others. And then there will be neither trade wars nor shooting wars, just disputes and diplomacy.
9/18/21
SO-T Reduce
Tournament: Greenhill | Round: 4 | Opponent: Southlake Carroll AS | Judge: Eric He T -- Reduce Interpretation: Reduce means unconditional and permanent – the aff is a suspension. Reynolds 59 – Judge (In the Matter of Doris A. Montesani, Petitioner, v. Arthur Levitt, as Comptroller of the State of New York, et al., Respondents NO NUMBER IN ORIGINAL Supreme Court of New York, Appellate Division, Third Department 9 A.D.2d 51; 189 N.Y.S.2d 695; 1959 N.Y. App. Div. LEXIS 7391 August 13, 1959, lexis) Section 83's counterpart with regard to nondisability pensioners, section 84, prescribes a reduction only if the pensioner should again take a public job. The disability pensioner is penalized if he takes any type of employment. The reason for the difference, of course, is that in one case the only reason pension benefits are available is because the pensioner is considered incapable of gainful employment, while in the other he has fully completed his "tour" and is considered as having earned his reward with almost no strings attached. It would be manifestly unfair to the ordinary retiree to accord the disability retiree the benefits of the System to which they both belong when the latter is otherwise capable of earning a living and had not fulfilled his service obligation. If it were to be held that withholdings under section 83 were payable whenever the pensioner died or stopped his other employment the whole purpose of the provision would be defeated, i.e., the System might just as well have continued payments during the other employment since it must later pay it anyway. *13 The section says "reduced", does not say that monthly payments shall be temporarily suspended; it says that the pension itself shall be reduced. The plain dictionary meaning of the word is to diminish, lower or degrade. The word "reduce" seems adequately to indicate permanency. Violation – the plan advocates a delay in enforcement, their own sovelncy advocates prove they leverage offense from the fact that they still grant cannabis patents they just do it later Vote neg: 1 Precision – Our definition is most precise which is the biggest internal link to predictability - anything else justifies the aff arbitrarily jettisoning words in the resolution which is the only stasis point we know before the round. 2 Limits and ground– their model allows affs to defend anything from pandemics to Biden’s presidency— there's no universal DA since it’s impossible to know the timeframe when there won’t be IP— that explodes neg prep and leads to random timeframe of the week affs which makes cutting stable neg links impossible — limits key to reciprocal engagement since they create a caselist for neg prep (innovation, collaboration, econ, ptx: all core neg literature thrown away) – controls the internal link to iterative testing and argument refinement 3 TVA solves all of their offense – defend your advantage with a plan text of permanently reducing ip protections for cannabis. DTD on T bc it skewed the entire round – it’s a question of whether or not the aff should have been read in the first place. No RVIs – they’re illogical, you don’t win for being topical Competing interpretations – reasonability is arbitrary and causes judge intervention, leads to a race to the bottom where debaters push the boundaries of what is reasonable in order to justify infinite abuse HIF CP
9/18/21
SO-disclosure theory
Tournament: Loyola | Round: 5 | Opponent: Academy of Higher Learning JM | Judge: Asher Towner Disclosure theory Debaters must disclose all of the positions that they have read in past debates on the wiki. Violation-they have no page on the wiki. Inserted screenshot of the wiki
standards 1.Intellectual integrity—The aff should not be able to win because of surprise but should have to defend their aff against rigorous neg prep. This is bad for education because 2.Evidence ethics—No disclosure allows debaters to get away with evidence ethics abuses because it is impossible for me to read through all of their cards closely in 4 minutes of prep. Evidence ethics is bad for education because it incentives people to cheat instead of learn about the topic. 3.Equitable access to prep—I disclosed all of my past neg positions on the wiki so they can prep against all the positions they will read but I do not know what their past affs have been, which kills fairness and skews the debate towards the aff.
Drop the debater to deter future abuse. Dropping the arg would entail dtd because their whole aff was new No RVIs because they should not win for bring fair
9/5/21
SO-innovation DA V3
Tournament: Loyola | Round: 5 | Opponent: Academy of Higher Learning JM | Judge: Asher Towner Innovation DA The pharma industry is strong now but patents are key for continued economic growth. Batell and PhRMA 14: Batell and PhRMA {Battelle is the world’s largest nonprofit independent research and development organization, providing innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management, National Security, Energy, Environment and Material Sciences, and Health and Life Sciences. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.}, 14 – “The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It,” http://phrma-docs.phrma.org/sites/default/files/pdf/2014-economic-futures-report.pdf//marlborough-wr// Compared to other capital-intensive, advanced manufacturing industries in the U.S., the biopharmaceutical industry is a leader in RandD investment, IP generation, venture capital investment, and RandD employment. Policies and infrastructure that helped foster these innovative activities have allowed the U.S. to seize global leadership in biopharmaceutical RandD over the past 30 years. However, as this report details, other countries are seeking to compete with the U.S. by borrowing and building upon some of these pro-innovation policies to improve their own operating environment and become more favorable to biopharmaceutical companies making decisions about where to locate their RandD and manufacturing activities. A unique contribution of this report was the inclusion of the perspective of senior-level strategic planning executives of biopharmaceutical companies regarding what policy areas they see as most likely to impact the favorability of the U.S. business operating environment. The executives cited the following factors as having the most impact on the favorability of the operating environment and hence, potential growth of the innovative biopharmaceutical industry in the U.S.: • Coverage and payment policies that support and encourage medical innovation • A well-functioning, science-based regulatory system • Strong IP protection and enforcement in the U.S. and abroad The top sub-attribute identified as driving future biopharmaceutical industry growth in the U.S. cited by executives was a domestic IP system that provides adequate patent rights and data protection. Collectively, these factors underscore the need to reduce uncertainties and ensure adequate incentives for the lengthy, costly, and risky RandD investments necessary to develop new treatments needed by patients and society to address our most costly and challenging diseases. With more than 300,000 jobs at stake between the two scenarios, the continued growth and leadership of the U.S. innovative biopharmaceutical industry cannot be taken for granted. Continued innovation is fundamental to U.S. economic well-being and the nation’s ability to compete effectively in a globalized economy and to take advantage of the expected growth in demand for new medicines around the world. Just as other countries have drawn lessons from the growth of the U.S. biopharmaceutical sector, the U.S. needs to assess how it can improve the environment for innovation and continue to boost job creation by increasing RandD investment, fostering a robust talent pool, enhancing economic growth and sustainability, and continuing to bring new medicines to patients. COVID has kept patents and innovation strong, but continued protection is key to innovation by incentivizing biomedical research – it’s also crucial to preventing counterfeit medicines, economic collapse, and fatal diseases, which turns case. Macdole and Ezell 4-29: Jaci Mcdole and Stephen Ezell {Jaci McDole is a senior policy analyst covering intellectual property (IP) and innovation policy at the Information Technology and Innovation Foundation (ITIF). She focuses on IP and its correlations to global innovation and trade. McDole holds a double BA in Music Business and Radio-Television with a minor in Marketing, an MS in Education, and a JD with a specialization in intellectual property (Southern Illinois University Carbondale). McDole comes to ITIF from the Institute for Intellectual Property Research, an organization she co-founded to study and further robust global IP policies. Stephen Ezell is vice president, global innovation policy, at the Information Technology and Innovation Foundation (ITIF). He comes to ITIF from Peer Insight, an innovation research and consulting firm he cofounded in 2003 to study the practice of innovation in service industries. At Peer Insight, Ezell led the Global Service Innovation Consortium, published multiple research papers on service innovation, and researched national service innovation policies being implemented by governments worldwide. Prior to forming Peer Insight, Ezell worked in the New Service Development group at the NASDAQ Stock Market, where he spearheaded the creation of the NASDAQ Market Intelligence Desk and the NASDAQ Corporate Services Network, services for NASDAQ-listed corporations. Previously, Ezell cofounded two successful innovation ventures, the high-tech services firm Brivo Systems and Lynx Capital, a boutique investment bank. Ezell holds a B.S. from the School of Foreign Service at Georgetown University, with an honors certificate from Georgetown’s Landegger International Business Diplomacy program.}, 21 - ("Ten Ways Ip Has Enabled Innovations That Have Helped Sustain The World Through The Pandemic," Information Technology and Innovation Foundation, 4-29-2021, https://itif.org/publications/2021/04/29/ten-ways-ip-has-enabled-innovations-have-helped-sustain-world-through)//marlborough-wr/ To better understand the role of IP in enabling solutions related to COVID-19 challenges, this report relies on 10 case studies drawn from a variety of nations, technical fields, and firm sizes. This is but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. From a paramedic in Mexico to a veteran vaccine manufacturing company in India and a tech start-up in Estonia to a U.S.-based company offering workplace Internet of Things (IoT) services, small and large organizations alike are working to combat the pandemic. Some have adapted existing innovations, while others have developed novel solutions. All are working to take the world out of the pandemic and into the future. The case studies are: Bharat Biotech: Covaxin Gilead: Remdesivir LumiraDX: SARS-COV-2 Antigen POC Test Teal Bio: Teal Bio Respirator XE Ingeniería Médica: CápsulaXE Surgical Theater: Precision VR Tombot: Jennie Starship Technologies: Autonomous Delivery Robots Triax Technologies: Proximity Trace Zoom: Video Conferencing As the case studies show, IP is critical to enabling innovation. Policymakers around the world need to ensure robust IP protections are—and remain—in place if they wish their citizens to have safe and innovative solutions to health care, workplace, and societal challenges in the future. THE ROLE OF INTELLECTUAL PROPERTY IN RandD-INTENSIVE INDUSTRIES Intangible assets, such as IP rights, comprised approximately 84 percent of the corporate value of SandP 500 companies in 2018.4 For start-ups, this means much of the capital needed to operate is directly related to IP (see Teal Bio case study for more on this). IP also plays an especially important role for RandD-intensive industries.5 To take the example of the biopharmaceutical industry, it is characterized by high-risk, time-consuming, and expensive processes including basic research, drug discovery, pre-clinical trials, three stages of human clinical trials, regulatory review, and post-approval research and safety monitoring. The drug development process spans an average of 11.5 to 15 years.6 For every 5,000 to 10,000 compounds screened on average during the basic research and drug discovery phases, approximately 250 molecular compounds, or 2.5 to 5 percent, make it to preclinical testing. Out of those 250 molecular compounds, approximately 5 make it to clinical testing. That is, 0.05 to 0.1 percent of drugs make it from basic research into clinical trials. Of those rare few which make it to clinical testing, less than 12 percent are ultimately approved for use by the U.S. Food and Drug Administration (FDA).7 In addition to high risks, drug development is costly, and the expenses associated with it are increasing. A 2019 report by the Deloitte Center for Health Solutions concluded that since 2010 the average cost of bringing a new drug to market increased by 67 percent.8 Numerous studies have examined the substantial cost of biopharmaceutical RandD, and most confirm investing in new drug development requires $1.7 billion to $3.2 billion up front on average.9 A 2018 study by the Coalition for Epidemic Preparedness found similar risks and figures for vaccines, stating, “In general, vaccine development from discovery to licensure can cost billions of dollars, can take over 10 years to complete, and has an average 94 percent chance of failure.”10 Yet, a 2010 study found that 80 percent of new drugs—that is, the less than 12 percent ultimately approved by the FDA—made less than their capitalized RandD costs.11 Another study found that only 1 percent (maybe three new drugs each year) of the most successful 10 percent of FDA approved drugs generate half of the profits of the entire drug industry.12 To say the least, biopharmaceutical RandD represents a high-stakes, long-term endeavor with precarious returns. Without IP protection, biopharmaceutical manufacturers have little incentive to take the risks necessary to engage in the RandD process because they would be unable to recoup even a fraction of the costs incurred. Diminished revenues also result in reduced investments in RandD which means less research into cancer drugs, Alzheimer cures, vaccines, and more. IP rights give life-sciences enterprises the confidence needed to undertake the difficult, risky, and expensive process of life-sciences innovation secure in the knowledge they can capture a share of the gains from their innovations, which is indispensable not only to recouping the up-front RandD costs of a given drug, but which can generate sufficient profits to enable investment in future generations of biomedical innovation and thus perpetuate the enterprises into the future.13 THE IMPORTANCE OF INTELLECTUAL PROPERTY TO INNOVATION Although anti-IP proponents have attacked biopharmaceutical manufacturers particularly hard, the reality is all IP-protected innovations are at risk if these rights are ignored, or vitiated. Certain arguments have shown a desire for the term “COVID-19 innovations” to include everything from vaccines, therapeutics, diagnostics, and PPE to biotechnology, AI-related data, and educational materials.14 This could potentially open the floodgates to invalidate IP protection on many of the innovations highlighted in this report. However, much of the current discussion concerning IP focuses almost entirely on litigation fears or RandD incentives. Although RandD is an important aspect of IP, as previously mentioned, these discussions ignore the fact that IP protection can be—and often is—used for other purposes, including generating initial capital to create a company and begin manufacturing and, more importantly, using licensing agreements and IP to track the supply chain and ensure quality control of products. This report highlights but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. In 2018, Forbes identified counterfeiting as the largest criminal enterprise in the world.15 The global struggle against counterfeit and non-regulated products, which has hit Latin America particularly hard during the pandemic, proves the need for safety and quality assurance in supply chains.16 Some communities already ravaged by COVID-19 are seeing higher mortality rates related to counterfeit vaccines, therapeutics, PPE, and cleaning and sanitizing products.17 Polish authorities discovered vials of antiwrinkle treatment labeled as COVID-19 vaccines. 18 In Mexico, fake vaccines sold for approximately $1,000 per dose.19 Chinese and South African police seized thousands of counterfeit vaccine doses from warehouses and manufacturing plants.20 Meanwhile, dozens of websites worldwide claiming to sell vaccines or be affiliated with vaccine manufacturers have been taken down.21 But the problem is not limited to biopharmaceuticals. The National Intellectual Property Rights Coordination Center has recovered $48 million worth of counterfeit PPE and other products.22 Collaborative efforts between law enforcement and manufacturers have kept numerous counterfeits from reaching the population. In countries with strong IP protection, the chances of counterfeit products reaching the market are significantly lower. This is largely because counterfeiting tends to be an IP-related issue, and these countries generally provide superior means of tracking the supply chain through trademarks, trade secrets, and licensing agreements. This enables greater quality control and helps manufacturers maintain a level of public confidence in their products. By controlling the flow of knowledge associated with IP, voluntary licensing agreements provide innovators with opportunities to collaborate, while ensuring their partners are properly equipped and capable of producing quality products. Throughout this difficult time, the world has seen unexpected collaborations, especially between biopharmaceutical companies worldwide such as Gilead and Eva Pharma or Bharat Biotech and Ocugen, Inc. Throughout history, and most significantly in the nineteenth century through the widespread development of patent systems and the ensuing Industrial Revolution, IP has contributed toward greater economic growth.23 This is promising news as the world struggles for economic recovery. A 2021 joint study by the EU Intellectual Property Office (EUIPO) and European Patent Office (EPO) shows a strong, positive correlation between IP rights and economic performance.24 It states that “IP-owning firms represent a significantly larger proportion of economic activity and employment across Europe,” with IP-intensive industries contributing to 45 percent of gross domestic product (GDP) (€6.6 trillion; US$7.9 trillion).25 The study also shows 38.9 percent of employment is directly or indirectly attributed to IP-intensive industries, and IP generates higher wages and greater revenue per employee, especially for small-to-medium-sized enterprises.26 That concords with the United States, where the Department of Commerce estimated that IP-intensive industries support at least 45 million jobs and contribute more than $6 trillion dollars to, or 38.2 percent of, GDP.27 In 2020, global patent filings through the World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) system reached a record 275,900 filings amidst the pandemic, growing 4 percent from 2019.28 The top-four nations, which accounted for 180,530 of the patent applications, were China, the United States, Japan, and Korea, respectively.29 While several countries saw an increase in patent filings, Saudi Arabia and Malaysia both saw significant increases in the number of annual applications, with the top two filing growths of 73 percent and 26 percent, respectively.30 The COVID-19 pandemic slowed a lot of things, but it certainly couldn’t stop innovation. There are at least five principal benefits strong IP rights can generate, for both developing and developed countries alike.31 First, stronger IP protection spurs the virtuous cycle of innovation by increasing the appropriability of returns, enabling economic gain and catalyzing economic growth. Second, through patents—which require innovators to disclose certain knowledge as a condition of protection—knowledge spillovers build a platform of knowledge that enables other innovators. For instance, studies have found that the rate of return to society from corporate RandD and innovation activities is at least twice the estimated returns that each company itself receives.32 Third, countries with robust IP can operate more efficiently and productively by using IP to determine product quality and reduce transaction costs. Fourth, trade and foreign direct investment enabled and encouraged by strong IP protection offered to enterprises from foreign countries facilitates an accumulation of knowledge capital within the destination economy. That matters when foreign sources of technology account for over 90 percent of productivity growth in most countries.33 There’s also evidence suggesting that developing nations with stronger IP protections enjoy the earlier introduction of innovative new medicines.34 And fifth, strong IP boosts exports, including in developing countries.35 Research shows a positive correlation between stronger IP protection and exports from developing countries as well as faster growth rates of certain industries.36 The following case studies illustrate these benefits of IP and how they’ve enabled innovative solutions to help global society navigate the COVID-19 pandemic.
Pharmaceutical innovation is key to protecting against future pandemics, bioterrorism, and antibiotic resistance. Marjanovic and Fejiao ‘20 Marjanovic, Sonja, and Carolina Feijao. Sonja Marjanovic, Ph.D., Judge Business School, University of Cambridge. Carolina Feijao, Ph.D. in biochemistry, University of Cambridge; M.Sc. in quantitive biology, Imperial College London; B.Sc. in biology, University of Lisbon. "Pharmaceutical Innovation for Infectious Disease Management: From Troubleshooting to Sustainable Models of Engagement." (2020). Quality Control As key actors in the healthcare innovation landscape, pharmaceutical and life sci-ences companies have been called on to develop medicines, vaccines and diagnostics for pressing public health challenges. The COVID-19 crisis is one such challenge, but there are many others. For example, MERS, SARS, Ebola, Zika and avian and swine flu are also infectious diseases that represent public health threats. Infectious agents such as anthrax, smallpox and tularemia could present threats in a bioterrorism con-text.1 The general threat to public health that is posed by antimicrobial resistance is also well-recognised as an area in need of pharmaceutical innovation. Innovating in response to these challenges does not always align well with pharmaceutical industry commercial models, shareholder expectations and compe-tition within the industry. However, the expertise, networks and infrastructure that industry has within its reach, as well as public expectations and the moral imperative, make pharmaceutical companies and the wider life sciences sector an indispensable partner in the search for solutions that save lives. This perspective argues for the need to establish more sustainable and scalable ways of incentivising pharmaceu-tical innovation in response to infectious disease threats to public health. It considers both past and current examples of efforts to mobilise pharmaceutical innovation in high commercial risk areas, including in the context of current efforts to respond to the COVID-19 pandemic. In global pandemic crises like COVID-19, the urgency and scale of the crisis – as well as the spotlight placed on pharmaceutical companies – mean that contributing to the search for effective medicines, vaccines or diagnostics is essential for socially responsible companies in the sec-tor.2 It is therefore unsurprising that we are seeing indus-try-wide efforts unfold at unprecedented scale and pace. Whereas there is always scope for more activity, industry is currently contributing in a variety of ways. Examples include pharmaceutical companies donating existing com-pounds to assess their utility in the fight against COVID-19; screening existing compound libraries in-house or with partners to see if they can be repurposed; accelerating tri-als for potentially effective medicine or vaccine candidates; and in some cases rapidly accelerating in-house research and development to discover new treatments or vaccine agents and develop diagnostics tests.3,4 Pharmaceutical companies are collaborating with each other in some of these efforts and participating in global RandD partnerships (such as the Innovative Medicines Initiative effort to accel-erate the development of potential therapies for COVID-19) and supporting national efforts to expand diagnosis and testing capacity and ensure affordable and ready access to potential solutions.3,5,6 The primary purpose of such innovation is to benefit patients and wider population health. Although there are also reputational benefits from involvement that can be realised across the industry, there are likely to be rela-tively few companies that are ‘commercial’ winners. Those who might gain substantial revenues will be under pres-sure not to be seen as profiting from the pandemic. In the United Kingdom for example, GSK has stated that it does not expect to profit from its COVID-19 related activities and that any gains will be invested in supporting research and long-term pandemic preparedness, as well as in developing products that would be affordable in the world’s poorest countries.7 Similarly, in the United States AbbVie has waived intellectual property rights for an existing com-bination product that is being tested for therapeutic poten-tial against COVID-19, which would support affordability and allow for a supply of generics.8,9 Johnson and Johnson has stated that its potential vaccine – which is expected to begin trials – will be available on a not-for-profit basis during the pandemic.10 Pharma is mobilising substantial efforts to rise to the COVID-19 challenge at hand. However, we need to consider how pharmaceutical innovation for responding to emerging infectious diseases can best be enabled beyond the current crisis. Many public health threats (including those associated with other infectious diseases, bioterror-ism agents and antimicrobial resistance) are urgently in need of pharmaceutical innovation, even if their impacts are not as visible to society as COVID-19 is in the imme-diate term. The pharmaceutical industry has responded to previous public health emergencies associated with infec-tious disease in recent times – for example those associated with Ebola and Zika outbreaks.11 However, it has done so to a lesser scale than for COVID-19 and with contribu-tions from fewer companies. Similarly, levels of activity in response to the threat of antimicrobial resistance are still low.12 There are important policy questions as to whether – and how – industry could engage with such public health threats to an even greater extent under improved innova-tion conditions. Bioterror causes extinction---early response key Farmer 17 (“Bioterrorism could kill more people than nuclear war, Bill Gates to warn world leaders” http://www.telegraph.co.uk/news/2017/02/17/biological-terrorism-could-kill-people-nuclear-attacks-bill/) Bioterrorists could one day kill hundreds of millions of people in an attack more deadly than nuclear war, Bill Gates will warn world leaders. Rapid advances in genetic engineering have opened the door for small terrorism groups to tailor and easily turn biological viruses into weapons. A resulting disease pandemic is currently one of the most deadly threats faced by the world, he believes, yet governments are complacent about the scale of the risk. Speaking ahead of an address to the Munich Security Conference, the richest man in the world said that while governments are concerned with the proliferation of nuclear and chemical weapons, they are overlooking the threat of biological warfare. Mr Gates, whose charitable foundationis funding research into quickly spotting outbreaks and speeding up vaccine production, said the defence and security establishment “have not been following biology and I’m here to bring them a little bit of bad news”. Mr Gates will today (Saturday) tell an audience of international leaders and senior officers that the world’s next deadly pandemic “could originate on the computer screen of a terrorist”. He told the Telegraph: “Natural epidemics can be extremely large. Intentionally caused epidemics, bioterrorism, would be the largest of all. “With nuclear weapons, you’d think you would probably stop after killing 100million. Smallpox won’t stop. Because the population is naïve, and there are no real preparations. That, if it got out and spread, would be a larger number.” He said developments in genetic engineering were proceeding at a “mind-blowing rate”. Biological warfare ambitions once limited to a handful of nation states are now open to small groups with limited resources and skills. He said: “They make it much easier for a non-state person. It doesn’t take much biology expertise nowadays to assemble a smallpox virus. Biology is making it way easier to create these things.” The increasingly common use of gene editing technology would make it difficult to spot any potential terrorist conspiracy. Technologies which have made it easy to read DNA sequences and tinker with them to rewrite or tweak genes have many legitimate uses. He said: “It’s not like when someone says, ‘Hey I’d like some Plutonium’ and you start saying ‘Hmmm.. I wonder why he wants Plutonium?’” Mr Gates said the potential death toll from a disease outbreak could be higher than other threats such as climate change or nuclear war. He said: “This is like earthquakes, you should think in order of magnitudes. If you can kill 10 people that’s a one, 100 people that’s a two... Bioterrorism is the thing that can give you not just sixes, but sevens, eights and nines. “With nuclear war, once you have got a six, or a seven, or eight, you’d think it would probably stop. With bioterrorism it’s just unbounded if you are not there to stop the spread of it.” By tailoring the genes of a virus, it would be possible to manipulate its ability to spread and its ability to harm people. Mr Gates said one of the most potentially deadly outbreaks could involve the humble flu virus. It would be relatively easy to engineer a new flu strain combining qualities from varieties that spread like wildfire with varieties that were deadly. The last time that happened naturally was the 1918 Spanish Influenza pandemic, which went on to kill more than 50 million people – or nearly three times the death toll from the First World War. By comparison, the recent Ebola outbreak in West Africa which killed just over 11,000 was “a Richter Scale three, it’s a nothing,” he said. But despite the potential, the founder of Microsoft said that world leaders and their militaries could not see beyond the more recognised risks. He said: “Should the world be serious about this? It is somewhat serious about normal classic warfare and nuclear warfare, but today it is not very serious about bio-defence or natural epidemics.” He went on: “They do tend to say ‘How easy is it to get fissile material and how accurate are the plans out on the internet for dirty bombs, plutonium bombs and hydrogen bombs?’ “They have some people that do that. What I am suggesting is that the number of people that look at bio-defence is worth increasing.” Whether naturally occurring, or deliberately started, it is almost certain that a highly lethal global pandemic will occur within our lifetimes, he believes. But the good news for those contemplating the potential damage is that the same biotechnology can prevent epidemics spreading out of control. Mr Gates will say in his speech that most of the things needed to protect against a naturally occurring pandemic are the same things needed to prepare for an intentional biological attack. Nations must amass an arsenal of new weapons to fight such a disease outbreak, including vaccines, drugs and diagnostic techniques. Being able to develop a vaccine as soon as possible against a new outbreak is particularly important and could save huge numbers of lives, scientists working at his foundation believe.
9/5/21
SO-innovation DA V5
Tournament: St Marks | Round: 2 | Opponent: Harvard Westlake AW | Judge: Danielle Dosch Innovation DA The pharma industry is strong now but patents are key for continued economic growth. Batell and PhRMA 14: Batell and PhRMA {Battelle is the world’s largest nonprofit independent research and development organization, providing innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management, National Security, Energy, Environment and Material Sciences, and Health and Life Sciences. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.}, 14 – “The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It,” http://phrma-docs.phrma.org/sites/default/files/pdf/2014-economic-futures-report.pdf//marlborough-wr// Compared to other capital-intensive, advanced manufacturing industries in the U.S., the biopharmaceutical industry is a leader in RandD investment, IP generation, venture capital investment, and RandD employment. Policies and infrastructure that helped foster these innovative activities have allowed the U.S. to seize global leadership in biopharmaceutical RandD over the past 30 years. However, as this report details, other countries are seeking to compete with the U.S. by borrowing and building upon some of these pro-innovation policies to improve their own operating environment and become more favorable to biopharmaceutical companies making decisions about where to locate their RandD and manufacturing activities. A unique contribution of this report was the inclusion of the perspective of senior-level strategic planning executives of biopharmaceutical companies regarding what policy areas they see as most likely to impact the favorability of the U.S. business operating environment. The executives cited the following factors as having the most impact on the favorability of the operating environment and hence, potential growth of the innovative biopharmaceutical industry in the U.S.: • Coverage and payment policies that support and encourage medical innovation • A well-functioning, science-based regulatory system • Strong IP protection and enforcement in the U.S. and abroad The top sub-attribute identified as driving future biopharmaceutical industry growth in the U.S. cited by executives was a domestic IP system that provides adequate patent rights and data protection. Collectively, these factors underscore the need to reduce uncertainties and ensure adequate incentives for the lengthy, costly, and risky RandD investments necessary to develop new treatments needed by patients and society to address our most costly and challenging diseases. With more than 300,000 jobs at stake between the two scenarios, the continued growth and leadership of the U.S. innovative biopharmaceutical industry cannot be taken for granted. Continued innovation is fundamental to U.S. economic well-being and the nation’s ability to compete effectively in a globalized economy and to take advantage of the expected growth in demand for new medicines around the world. Just as other countries have drawn lessons from the growth of the U.S. biopharmaceutical sector, the U.S. needs to assess how it can improve the environment for innovation and continue to boost job creation by increasing RandD investment, fostering a robust talent pool, enhancing economic growth and sustainability, and continuing to bring new medicines to patients. COVID has kept patents and innovation strong, but continued protection is key to innovation by incentivizing biomedical research – it’s also crucial to preventing counterfeit medicines, economic collapse, and fatal diseases, which independently turns case. Macdole and Ezell 4-29: Jaci Mcdole and Stephen Ezell {Jaci McDole is a senior policy analyst covering intellectual property (IP) and innovation policy at the Information Technology and Innovation Foundation (ITIF). She focuses on IP and its correlations to global innovation and trade. McDole holds a double BA in Music Business and Radio-Television with a minor in Marketing, an MS in Education, and a JD with a specialization in intellectual property (Southern Illinois University Carbondale). McDole comes to ITIF from the Institute for Intellectual Property Research, an organization she co-founded to study and further robust global IP policies. Stephen Ezell is vice president, global innovation policy, at the Information Technology and Innovation Foundation (ITIF). He comes to ITIF from Peer Insight, an innovation research and consulting firm he cofounded in 2003 to study the practice of innovation in service industries. At Peer Insight, Ezell led the Global Service Innovation Consortium, published multiple research papers on service innovation, and researched national service innovation policies being implemented by governments worldwide. Prior to forming Peer Insight, Ezell worked in the New Service Development group at the NASDAQ Stock Market, where he spearheaded the creation of the NASDAQ Market Intelligence Desk and the NASDAQ Corporate Services Network, services for NASDAQ-listed corporations. Previously, Ezell cofounded two successful innovation ventures, the high-tech services firm Brivo Systems and Lynx Capital, a boutique investment bank. Ezell holds a B.S. from the School of Foreign Service at Georgetown University, with an honors certificate from Georgetown’s Landegger International Business Diplomacy program.}, 21 - ("Ten Ways Ip Has Enabled Innovations That Have Helped Sustain The World Through The Pandemic," Information Technology and Innovation Foundation, 4-29-2021, https://itif.org/publications/2021/04/29/ten-ways-ip-has-enabled-innovations-have-helped-sustain-world-through)//marlborough-wr/ To better understand the role of IP in enabling solutions related to COVID-19 challenges, this report relies on 10 case studies drawn from a variety of nations, technical fields, and firm sizes. This is but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. From a paramedic in Mexico to a veteran vaccine manufacturing company in India and a tech start-up in Estonia to a U.S.-based company offering workplace Internet of Things (IoT) services, small and large organizations alike are working to combat the pandemic. Some have adapted existing innovations, while others have developed novel solutions. All are working to take the world out of the pandemic and into the future. The case studies are: Bharat Biotech: Covaxin Gilead: Remdesivir LumiraDX: SARS-COV-2 Antigen POC Test Teal Bio: Teal Bio Respirator XE Ingeniería Médica: CápsulaXE Surgical Theater: Precision VR Tombot: Jennie Starship Technologies: Autonomous Delivery Robots Triax Technologies: Proximity Trace Zoom: Video Conferencing As the case studies show, IP is critical to enabling innovation. Policymakers around the world need to ensure robust IP protections are—and remain—in place if they wish their citizens to have safe and innovative solutions to health care, workplace, and societal challenges in the future. THE ROLE OF INTELLECTUAL PROPERTY IN RandD-INTENSIVE INDUSTRIES Intangible assets, such as IP rights, comprised approximately 84 percent of the corporate value of SandP 500 companies in 2018.4 For start-ups, this means much of the capital needed to operate is directly related to IP (see Teal Bio case study for more on this). IP also plays an especially important role for RandD-intensive industries.5 To take the example of the biopharmaceutical industry, it is characterized by high-risk, time-consuming, and expensive processes including basic research, drug discovery, pre-clinical trials, three stages of human clinical trials, regulatory review, and post-approval research and safety monitoring. The drug development process spans an average of 11.5 to 15 years.6 For every 5,000 to 10,000 compounds screened on average during the basic research and drug discovery phases, approximately 250 molecular compounds, or 2.5 to 5 percent, make it to preclinical testing. Out of those 250 molecular compounds, approximately 5 make it to clinical testing. That is, 0.05 to 0.1 percent of drugs make it from basic research into clinical trials. Of those rare few which make it to clinical testing, less than 12 percent are ultimately approved for use by the U.S. Food and Drug Administration (FDA).7 In addition to high risks, drug development is costly, and the expenses associated with it are increasing. A 2019 report by the Deloitte Center for Health Solutions concluded that since 2010 the average cost of bringing a new drug to market increased by 67 percent.8 Numerous studies have examined the substantial cost of biopharmaceutical RandD, and most confirm investing in new drug development requires $1.7 billion to $3.2 billion up front on average.9 A 2018 study by the Coalition for Epidemic Preparedness found similar risks and figures for vaccines, stating, “In general, vaccine development from discovery to licensure can cost billions of dollars, can take over 10 years to complete, and has an average 94 percent chance of failure.”10 Yet, a 2010 study found that 80 percent of new drugs—that is, the less than 12 percent ultimately approved by the FDA—made less than their capitalized RandD costs.11 Another study found that only 1 percent (maybe three new drugs each year) of the most successful 10 percent of FDA approved drugs generate half of the profits of the entire drug industry.12 To say the least, biopharmaceutical RandD represents a high-stakes, long-term endeavor with precarious returns. Without IP protection, biopharmaceutical manufacturers have little incentive to take the risks necessary to engage in the RandD process because they would be unable to recoup even a fraction of the costs incurred. Diminished revenues also result in reduced investments in RandD which means less research into cancer drugs, Alzheimer cures, vaccines, and more. IP rights give life-sciences enterprises the confidence needed to undertake the difficult, risky, and expensive process of life-sciences innovation secure in the knowledge they can capture a share of the gains from their innovations, which is indispensable not only to recouping the up-front RandD costs of a given drug, but which can generate sufficient profits to enable investment in future generations of biomedical innovation and thus perpetuate the enterprises into the future.13 THE IMPORTANCE OF INTELLECTUAL PROPERTY TO INNOVATION Although anti-IP proponents have attacked biopharmaceutical manufacturers particularly hard, the reality is all IP-protected innovations are at risk if these rights are ignored, or vitiated. Certain arguments have shown a desire for the term “COVID-19 innovations” to include everything from vaccines, therapeutics, diagnostics, and PPE to biotechnology, AI-related data, and educational materials.14 This could potentially open the floodgates to invalidate IP protection on many of the innovations highlighted in this report. However, much of the current discussion concerning IP focuses almost entirely on litigation fears or RandD incentives. Although RandD is an important aspect of IP, as previously mentioned, these discussions ignore the fact that IP protection can be—and often is—used for other purposes, including generating initial capital to create a company and begin manufacturing and, more importantly, using licensing agreements and IP to track the supply chain and ensure quality control of products. This report highlights but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. In 2018, Forbes identified counterfeiting as the largest criminal enterprise in the world.15 The global struggle against counterfeit and non-regulated products, which has hit Latin America particularly hard during the pandemic, proves the need for safety and quality assurance in supply chains.16 Some communities already ravaged by COVID-19 are seeing higher mortality rates related to counterfeit vaccines, therapeutics, PPE, and cleaning and sanitizing products.17 Polish authorities discovered vials of antiwrinkle treatment labeled as COVID-19 vaccines. 18 In Mexico, fake vaccines sold for approximately $1,000 per dose.19 Chinese and South African police seized thousands of counterfeit vaccine doses from warehouses and manufacturing plants.20 Meanwhile, dozens of websites worldwide claiming to sell vaccines or be affiliated with vaccine manufacturers have been taken down.21 But the problem is not limited to biopharmaceuticals. The National Intellectual Property Rights Coordination Center has recovered $48 million worth of counterfeit PPE and other products.22 Collaborative efforts between law enforcement and manufacturers have kept numerous counterfeits from reaching the population. In countries with strong IP protection, the chances of counterfeit products reaching the market are significantly lower. This is largely because counterfeiting tends to be an IP-related issue, and these countries generally provide superior means of tracking the supply chain through trademarks, trade secrets, and licensing agreements. This enables greater quality control and helps manufacturers maintain a level of public confidence in their products. By controlling the flow of knowledge associated with IP, voluntary licensing agreements provide innovators with opportunities to collaborate, while ensuring their partners are properly equipped and capable of producing quality products. Throughout this difficult time, the world has seen unexpected collaborations, especially between biopharmaceutical companies worldwide such as Gilead and Eva Pharma or Bharat Biotech and Ocugen, Inc. Throughout history, and most significantly in the nineteenth century through the widespread development of patent systems and the ensuing Industrial Revolution, IP has contributed toward greater economic growth.23 This is promising news as the world struggles for economic recovery. A 2021 joint study by the EU Intellectual Property Office (EUIPO) and European Patent Office (EPO) shows a strong, positive correlation between IP rights and economic performance.24 It states that “IP-owning firms represent a significantly larger proportion of economic activity and employment across Europe,” with IP-intensive industries contributing to 45 percent of gross domestic product (GDP) (€6.6 trillion; US$7.9 trillion).25 The study also shows 38.9 percent of employment is directly or indirectly attributed to IP-intensive industries, and IP generates higher wages and greater revenue per employee, especially for small-to-medium-sized enterprises.26 That concords with the United States, where the Department of Commerce estimated that IP-intensive industries support at least 45 million jobs and contribute more than $6 trillion dollars to, or 38.2 percent of, GDP.27 In 2020, global patent filings through the World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) system reached a record 275,900 filings amidst the pandemic, growing 4 percent from 2019.28 The top-four nations, which accounted for 180,530 of the patent applications, were China, the United States, Japan, and Korea, respectively.29 While several countries saw an increase in patent filings, Saudi Arabia and Malaysia both saw significant increases in the number of annual applications, with the top two filing growths of 73 percent and 26 percent, respectively.30 The COVID-19 pandemic slowed a lot of things, but it certainly couldn’t stop innovation. There are at least five principal benefits strong IP rights can generate, for both developing and developed countries alike.31 First, stronger IP protection spurs the virtuous cycle of innovation by increasing the appropriability of returns, enabling economic gain and catalyzing economic growth. Second, through patents—which require innovators to disclose certain knowledge as a condition of protection—knowledge spillovers build a platform of knowledge that enables other innovators. For instance, studies have found that the rate of return to society from corporate RandD and innovation activities is at least twice the estimated returns that each company itself receives.32 Third, countries with robust IP can operate more efficiently and productively by using IP to determine product quality and reduce transaction costs. Fourth, trade and foreign direct investment enabled and encouraged by strong IP protection offered to enterprises from foreign countries facilitates an accumulation of knowledge capital within the destination economy. That matters when foreign sources of technology account for over 90 percent of productivity growth in most countries.33 There’s also evidence suggesting that developing nations with stronger IP protections enjoy the earlier introduction of innovative new medicines.34 And fifth, strong IP boosts exports, including in developing countries.35 Research shows a positive correlation between stronger IP protection and exports from developing countries as well as faster growth rates of certain industries.36 The following case studies illustrate these benefits of IP and how they’ve enabled innovative solutions to help global society navigate the COVID-19 pandemic. This sets a precedent that spills over to all future diseases – Hopkins 21: Jared S. Hopkins {Jared S. Hopkins is a New York-based reporter for The Wall Street Journal covering the pharmaceutical industry, including companies such as Pfizer Inc. and Merck and Co. He previously was a health-care reporter at Bloomberg News and an investigative reporter at the Chicago Tribune. Jared started his career at The Times-News in Twin Falls, Idaho covering politics. In 2014, he was a finalist for the Livingston Award For Young Journalists for an investigation into charities founded by professional athletes. In 2011, he was a finalist for the Pulitzer Prize in Investigative Reporting for a series about neglect at a residential facility for disabled kids. Jared graduated from the Merrill College of Journalism at the University of Maryland-College Park with a bachelor's degree in journalism}, 21 - ("U.S. Support for Patent Waiver Unlikely to Cost Covid-19 Vaccine Makers in Short Term ," WSJ, 5-7-2021, https://www.wsj.com/articles/u-s-support-for-patent-waiver-unlikely-to-cost-covid-19-vaccine-makers-in-short-term-11620414260)//marlborough-wr/ The Biden administration’s unexpected support for temporarily waiving Covid-19 vaccine patents won’t have an immediate financial impact on the companies making the shots, industry officials and analysts said. Yet the decision could mark a shift in Washington’s longstanding support of the industry’s valuable intellectual property, patent-law experts said. A waiver, if it does go into effect, may pose long-term risks to the vaccine makers, analysts said. Moderna Inc., MRNA -4.12 Pfizer Inc. PFE -3.10 and other vaccine makers weren’t counting on sales from the developing countries that would gain access to the vaccine technology, analysts said. If patents and other crucial product information behind the technology is made available, it would take at least several months before shots were produced, industry officials said. Yet long-term Covid-19 sales could take a hit if other companies and countries gained access to the technologies and figured out how to use it. Western drugmakers could also confront competition sooner for other medicines they are hoping to make using the technologies. A World Trade Organization waiver could also set a precedent for waiving patents for other medicines, a long-sought goal of some developing countries, patient groups and others to try to reduce the costs of prescription drugs. “It sets a tremendous precedent of waiving IP rights that’s likely going to come up in future pandemics or in other serious diseases,” said David Silverstein, a patent lawyer at Axinn, Veltrop and Harkrider LLP who advises drugmakers. “Other than that, this is largely symbolic.” Pharmaceutical innovation is key to protecting against future pandemics, bioterrorism, and antibiotic resistance. Marjanovic and Fejiao ‘20 Marjanovic, Sonja, and Carolina Feijao. Sonja Marjanovic, Ph.D., Judge Business School, University of Cambridge. Carolina Feijao, Ph.D. in biochemistry, University of Cambridge; M.Sc. in quantitive biology, Imperial College London; B.Sc. in biology, University of Lisbon. "Pharmaceutical Innovation for Infectious Disease Management: From Troubleshooting to Sustainable Models of Engagement." (2020). Quality Control As key actors in the healthcare innovation landscape, pharmaceutical and life sci-ences companies have been called on to develop medicines, vaccines and diagnostics for pressing public health challenges. The COVID-19 crisis is one such challenge, but there are many others. For example, MERS, SARS, Ebola, Zika and avian and swine flu are also infectious diseases that represent public health threats. Infectious agents such as anthrax, smallpox and tularemia could present threats in a bioterrorism con-text.1 The general threat to public health that is posed by antimicrobial resistance is also well-recognised as an area in need of pharmaceutical innovation. Innovating in response to these challenges does not always align well with pharmaceutical industry commercial models, shareholder expectations and compe-tition within the industry. However, the expertise, networks and infrastructure that industry has within its reach, as well as public expectations and the moral imperative, make pharmaceutical companies and the wider life sciences sector an indispensable partner in the search for solutions that save lives. This perspective argues for the need to establish more sustainable and scalable ways of incentivising pharmaceu-tical innovation in response to infectious disease threats to public health. It considers both past and current examples of efforts to mobilise pharmaceutical innovation in high commercial risk areas, including in the context of current efforts to respond to the COVID-19 pandemic. In global pandemic crises like COVID-19, the urgency and scale of the crisis – as well as the spotlight placed on pharmaceutical companies – mean that contributing to the search for effective medicines, vaccines or diagnostics is essential for socially responsible companies in the sec-tor.2 It is therefore unsurprising that we are seeing indus-try-wide efforts unfold at unprecedented scale and pace. Whereas there is always scope for more activity, industry is currently contributing in a variety of ways. Examples include pharmaceutical companies donating existing com-pounds to assess their utility in the fight against COVID-19; screening existing compound libraries in-house or with partners to see if they can be repurposed; accelerating tri-als for potentially effective medicine or vaccine candidates; and in some cases rapidly accelerating in-house research and development to discover new treatments or vaccine agents and develop diagnostics tests.3,4 Pharmaceutical companies are collaborating with each other in some of these efforts and participating in global RandD partnerships (such as the Innovative Medicines Initiative effort to accel-erate the development of potential therapies for COVID-19) and supporting national efforts to expand diagnosis and testing capacity and ensure affordable and ready access to potential solutions.3,5,6 The primary purpose of such innovation is to benefit patients and wider population health. Although there are also reputational benefits from involvement that can be realised across the industry, there are likely to be rela-tively few companies that are ‘commercial’ winners. Those who might gain substantial revenues will be under pres-sure not to be seen as profiting from the pandemic. In the United Kingdom for example, GSK has stated that it does not expect to profit from its COVID-19 related activities and that any gains will be invested in supporting research and long-term pandemic preparedness, as well as in developing products that would be affordable in the world’s poorest countries.7 Similarly, in the United States AbbVie has waived intellectual property rights for an existing com-bination product that is being tested for therapeutic poten-tial against COVID-19, which would support affordability and allow for a supply of generics.8,9 Johnson and Johnson has stated that its potential vaccine – which is expected to begin trials – will be available on a not-for-profit basis during the pandemic.10 Pharma is mobilising substantial efforts to rise to the COVID-19 challenge at hand. However, we need to consider how pharmaceutical innovation for responding to emerging infectious diseases can best be enabled beyond the current crisis. Many public health threats (including those associated with other infectious diseases, bioterror-ism agents and antimicrobial resistance) are urgently in need of pharmaceutical innovation, even if their impacts are not as visible to society as COVID-19 is in the imme-diate term. The pharmaceutical industry has responded to previous public health emergencies associated with infec-tious disease in recent times – for example those associated with Ebola and Zika outbreaks.11 However, it has done so to a lesser scale than for COVID-19 and with contribu-tions from fewer companies. Similarly, levels of activity in response to the threat of antimicrobial resistance are still low.12 There are important policy questions as to whether – and how – industry could engage with such public health threats to an even greater extent under improved innova-tion conditions. Bioterror causes extinction-~--quick innovation key Farmer 17 (“Bioterrorism could kill more people than nuclear war, Bill Gates to warn world leaders” http://www.telegraph.co.uk/news/2017/02/17/biological-terrorism-could-kill-people-nuclear-attacks-bill/) Bioterrorists could one day kill hundreds of millions of people in an attack more deadly than nuclear war, Bill Gates will warn world leaders. Rapid advances in genetic engineering have opened the door for small terrorism groups to tailor and easily turn biological viruses into weapons. A resulting disease pandemic is currently one of the most deadly threats faced by the world, he believes, yet governments are complacent about the scale of the risk. Speaking ahead of an address to the Munich Security Conference, the richest man in the world said that while governments are concerned with the proliferation of nuclear and chemical weapons, they are overlooking the threat of biological warfare. Mr Gates, whose charitable foundationis funding research into quickly spotting outbreaks and speeding up vaccine production, said the defence and security establishment “have not been following biology and I’m here to bring them a little bit of bad news”. Mr Gates will today (Saturday) tell an audience of international leaders and senior officers that the world’s next deadly pandemic “could originate on the computer screen of a terrorist”. He told the Telegraph: “Natural epidemics can be extremely large. Intentionally caused epidemics, bioterrorism, would be the largest of all. “With nuclear weapons, you’d think you would probably stop after killing 100million. Smallpox won’t stop. Because the population is naïve, and there are no real preparations. That, if it got out and spread, would be a larger number.” He said developments in genetic engineering were proceeding at a “mind-blowing rate”. Biological warfare ambitions once limited to a handful of nation states are now open to small groups with limited resources and skills. He said: “They make it much easier for a non-state person. It doesn’t take much biology expertise nowadays to assemble a smallpox virus. Biology is making it way easier to create these things.” The increasingly common use of gene editing technology would make it difficult to spot any potential terrorist conspiracy. Technologies which have made it easy to read DNA sequences and tinker with them to rewrite or tweak genes have many legitimate uses. He said: “It’s not like when someone says, ‘Hey I’d like some Plutonium’ and you start saying ‘Hmmm.. I wonder why he wants Plutonium?’” Mr Gates said the potential death toll from a disease outbreak could be higher than other threats such as climate change or nuclear war. He said: “This is like earthquakes, you should think in order of magnitudes. If you can kill 10 people that’s a one, 100 people that’s a two... Bioterrorism is the thing that can give you not just sixes, but sevens, eights and nines. “With nuclear war, once you have got a six, or a seven, or eight, you’d think it would probably stop. With bioterrorism it’s just unbounded if you are not there to stop the spread of it.” By tailoring the genes of a virus, it would be possible to manipulate its ability to spread and its ability to harm people. Mr Gates said one of the most potentially deadly outbreaks could involve the humble flu virus. It would be relatively easy to engineer a new flu strain combining qualities from varieties that spread like wildfire with varieties that were deadly. The last time that happened naturally was the 1918 Spanish Influenza pandemic, which went on to kill more than 50 million people – or nearly three times the death toll from the First World War. By comparison, the recent Ebola outbreak in West Africa which killed just over 11,000 was “a Richter Scale three, it’s a nothing,” he said. But despite the potential, the founder of Microsoft said that world leaders and their militaries could not see beyond the more recognised risks. He said: “Should the world be serious about this? It is somewhat serious about normal classic warfare and nuclear warfare, but today it is not very serious about bio-defence or natural epidemics.” He went on: “They do tend to say ‘How easy is it to get fissile material and how accurate are the plans out on the internet for dirty bombs, plutonium bombs and hydrogen bombs?’ “They have some people that do that. What I am suggesting is that the number of people that look at bio-defence is worth increasing.” Whether naturally occurring, or deliberately started, it is almost certain that a highly lethal global pandemic will occur within our lifetimes, he believes. But the good news for those contemplating the potential damage is that the same biotechnology can prevent epidemics spreading out of control. Mr Gates will say in his speech that most of the things needed to protect against a naturally occurring pandemic are the same things needed to prepare for an intentional biological attack. Nations must amass an arsenal of new weapons to fight such a disease outbreak, including vaccines, drugs and diagnostic techniques. Being able to develop a vaccine as soon as possible against a new outbreak is particularly important and could save huge numbers of lives, scientists working at his foundation believe.