To modify or delete round reports, edit the associated round.
Cites
Entry
Date
0 - contact info
Tournament: All | Round: Doubles | Opponent: you | Judge: All hi, i'm maya. email: mayajen24@marlborough.org
10/23/21
SO - CRISPR CP
Tournament: Meadows | Round: 6 | Opponent: Immaculate Heart AW | Judge: Donald Fagan Counter plan text: The World Health Organization should harmonize its approach to CRISPR patents and the member nations of the World Trade Organization should follow these guidelines. Marlborough reading yellow. 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 and means that there’s no foreign governments interfering which solves the patent disputes in the first advantage
11/2/21
SO - Funding CP
Tournament: St Marks | Round: 5 | Opponent: Harvard-Westlake NL | Judge: Rodrigo Paramo 1 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.
10/18/21
SO - HIF CP
Tournament: St Marks | Round: 1 | Opponent: Harker KB | Judge: Ari Davidson Counterplan text: the member nations of the World Trade Organization should implement and fund a Health Impact Fund for COVID medicines 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.
10/18/21
SO - Indigenous da
Tournament: Meadows | Round: 2 | Opponent: Westwood PM | Judge: gordon krauss Indigenous people need strong intellectual property rights to traditional medicines – their unique medicinal knowledge is open to appropriation and theft from larger Western pharmaceutical companies without it – Sinela and Ramcharan ‘05 SINJELA, MPAZI, and ROBIN RAMCHARAN. “Protecting Traditional Knowledge and Traditional Medicines of Indigenous Peoples through Intellectual Property Rights: Issues, Challenges and Strategies.” International Journal on Minority and Group Rights, vol. 12, no. 1, 2005, pp. 1–24. LK At one stage a desire began to emerge in indigenous circles for a forum in the United Nations that dealt not only with human rights issues but with the broad range of environmental, developmental and cultural issues affecting indigenous populations. This led to calls for the establishment, as a subsidiary body of the ECOSOC, of a permanent forum on indigenous issues. This forum was finally established in 2000 and met for the first time at UN headquarters in New York in the summer of 2002.9 The Permanent Forum has thus far held three sessions. As of the time of writing there is a debate going on whether the buo Commission's Working Group on Indigenous Populations should be continued in the light of the establishment of the Permanent Forum. Some governments have apparently favored the discontinuance of the Working Group while indigenous peoples favor its continuation. At the Summer Session of the ECOSOC in 2004 the Secretary General of the United Nations submitted a report summarizing the views of States and indigenous organizations on this issue, and, as of the time of writing, the issue still remains open. The study by Mr. Martinez Cobo, the Working Group on Indigenous issues, the working group on a draft declaration and the Permanent Forum have thus been the main building blocks within the United Nations in the past four decades to advance the human rights of indigenous peoples. In the course of their work, they have, inter alia, highlighted the need for the protection of the intellectual property rights of indigenous peoples. Following on from the work of Mr. Martinez Cobo, cultural heritage and intellectual property have been issues of interest to the Working Group. In 1992, the Working Group and the World Intellectual Property Organization (WIPO) held a Technical Conference on Indigenous peoples at which participants recommended that the United Nations develop more effective measures to protect the intellectual and cultural property rights of indigenous peoples.10 A 1993 report by Erica Daes, Chairperson of the Working Group, on the protection of cultural and intellectual property, noted that the term "'indigenous' embraces the notion of a distinct and separate culture and way of life, based on long-held traditions and knowledge which are connected, fundamentally, to a specific territory. Indigenous peoples cannot survive, or exercise their fundamental human rights as distinct nations, societies and peoples, without the ability to conserve, revive, develop and teach the wisdom they have inherited from their ancestors."" The Chairperson was "compelled to the conclusion" that the distinction between cultural and intellectual property, from the indigenous viewpoint, was an artificial one. Indeed, "Industrialized societies tend to distinguish between art and science, or between creative inspiration and logical analysis. Indigenous peoples regard all products of the human mind and heart as interrelated, and as flowing from the same source: the relationship between the people and their land, their kinship with other living creatures that share the land, and with the spirit world. Since the ultimate source of knowledge and creativity is the land itself, all of the art and science of a specific people are manifestations of the same underlying relationship, and can be considered as manifestations of the people as a whole."12 It is not a coincidence that Article 8(j) of the 1992 Convention on Biological Diversity (CBD) adopted at the Rio Earth Summit, creates legal obligations for States party to respect, preserve and maintain knowledge, innovations and practices of indigenous people related to the conservation and sustainable use of bio diversity. The protection of cultural and intellectual property "is connected fundamentally with the realization of the territorial rights and self determination of indigenous peoples".13 The Chairpersons' report noted that the Working Group had received news from "indigenous representatives from every continent about the priority and urgency they attach to the protection of their spiritual and cultural life, arts and scientific and medical knowledge".14Consequently, the Draft Declaration prepared by the Sub-Commission, while recognizing in its preamble the "inherent rights and characteristics of indigenous peoples, especially their rights to their lands, territories and resources," provided for the right to fully participate, inter alia, in the cultural life of the State (Article 4), the right to revitalize and practice their cultural traditions (Article 11), the right to revitalize, use, develop and transmit to future generations their language, oral traditions, writing systems and literatures (Article 13) and, more importantly for present purposes, "the right to their traditional medicines and health practices, including the right to the protection of vital medicinal plants, animals and minerals" (Article 22). In this vein, the draft Article 27 provides that "indigenous peoples have the right to special measures to protect, as intellectual property, their sciences, technologies and cultural manifestations, including genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs and visual performing arts". Moreover, Article 28 provides that States should seek the free and informed consent of indigenous peoples "prior to commencement of any projects on their lands and territories, particularly in connection with natural resource development or exploitation of mineral or other sub-surface resources".15 In December 1995, to give impetus to the Decade for Indigenous People, the UN General Assembly adopted a Program of activities aimed at strengthening international cooperation for the solution of problems faced by indigenous people in such areas as human rights, the environment, development, health, culture and education. Among the specific actions to be taken were: "the promotion and protection of the rights of indigenous people and their empowerment to make choices which enable them to retain their cultural identity while participating in political, economic and social life, with full respect for their cultural values, languages, traditions and forms of social organization" and (ii) a request for specialized agencies of the UN system and other international and national agencies, as well as communities and private enterprises, "to devote special attention to development activities of benefit to indigenous peoples".16 WIPO has responded accordingly and the report by the Coordinator of the UN Decade for Indigenous Peoples has noted that WIPO's response "has been dramatic" as there is an entire division as part of the regular budget which is now responsible for traditional knowledge and related issues.17 The Permanent Forum has maintained a keen interest in traditional knowledge, soliciting information from all relevant parts of the UN system, notably WIPO.18 The last three sessions of WIPO have focused on its activities in the areas of intellectual property and genetic resources, traditional knowledge and traditional cultural expressions, and are described in greater detail below. Before proceeding to a consideration of the protection of the intellectual property rights of indigenous peoples, we shall in the next section, examine a major heritage of indigenous peoples - traditional medicine. TM, an important part of TK, refers to medicines used by local, tribal and indigenous communities. Such medicine is often herbal and sometimes combined with spiritual elements, such as those practiced by the shaman in tribal communities.19 TM has been refined over centuries of practice by communities who have inherited knowledge from their ancestors. For example, Felix, a member of the Arawak indigenous community of Guyana who works in the Shanklands resort on the banks of Essequibo River, conveyed his impressive knowledge of his community's medicinal uses of various plants and trees in the tropical rainforest. Using the native names of trees, he related the use of the 'yarula' tree for preventing and curing malaria, the use of the 'kakaballi' tree for treating diarrhea and the use of the 'capadulla' tree as a local viagra.20 While relying on textbooks for the Latin names, Felix's knowledge came from his father, the shaman in his community and from inherited knowledge among his people. Thus, often such knowledge is held communally and does not 'belong' to any single person or entity. Equally often, such knowledge cross-cuts communities as well as territorial boundaries. These aspects have implications for intellectual property protection, which we will consider below. The type of TM differs from community to community depending on the type of healing system that is historically prevalent. Until recently non-western healing systems and medicines were disregarded by western health systems, which insist on the development of medicines and healing techniques based on scientific proof and testing. Centuries-old healing systems of the world, such as Chinese traditional medicine and Indian Ayurveda, were given scant attention as the 'scientific' approach was allegedly missing. In Chinese medicine, for example, "disease is viewed as a disharmony of the various elements of the body and the personality of the patient. Chinese therapeutic thought concerns the entire organism's balance, rather than being devoted to clearly localizing and defining the nature of the illness" as in western medicine.21 The argument that non-western medicine is not based on scientific evidence may well ignore the centuries of trial and error, which has actually gone into making a particular medicine or remedy appropriate to a given community. Western science has grudgingly accepted alternative healing systems. However, they have readily sought after TK/IK, which could lead to the production of new drugs, "especially since the cost of putting new drugs on the market is becoming very high".22 Erica Daes noted in her 1993 report, cited above, that studies found that "using traditional knowledge increased the efficiency of screening plants for medical properties by more than 400 percent".23 Already by 1993, estimates of the total world sales of products derived from traditional medicines ran as high as USD 43 billion.24 However, only a tiny fraction of the profits are returned to the indigenous peoples and local communities. For example, it was estimated in the early 1990s, "that less than 0.001 per cent of profits from drugs developed from natural products and traditional knowledge accrue to the traditional people who provided technical leads for research".25 Attempts by Western governments and drug producing companies to harness such TK and TM for their own benefit have led to phenomena such as 'bio piracy' (theft of genetic resources by 'bioprospectors'). Concern has arisen for the preservation of biological diversity and genetic resources. The United States National Cancer Institute had already, by 1960, began a global program to collect and study naturally occurring substances and had tested some 35,000 plant species and a larger number of micro-organisms by 1981. This process intensified with the advent of research to combat AIDS. Pharmaceutical companies, necessarily driven by profit, have become increasingly aware of the potential economic rewards of TK/TM. Among the major US pharmaceutical companies engaged in screening plant species were Merck and Co., Smithkline Beecham, Monsanto, Sterling and Bristol Meyers. But this creates a conflict with the holders of TK/TM. The problem was stated thus by former Filipino President, Fidel Ramos at a ceremony for the signing of a Traditional and Alternative Health Care Law (R.A. 8423) in Manila on 9 December 1998: "We have looked forward to other nations for new technologies and cures, even for ordinary ailments. Indeed, many other nations have been exploiting the potentials of our own resources, claiming them as their own discoveries without giving due credit to us, and in addition to making tremendous profits at our own expense".26 The problem was recognized by Mrs. Daes in her report in 1993, namely that 'collectors' or bio-prospectors, "do not ordinarily have any formal contractual arrangements ... with the indigenous peoples upon whose knowledge of ecology they may rely. Indigenous people have also objected to alleged appropriation of their bodily substances which is taking place in the context of the Human Genome Diversity Project.28
11/2/21
SO - Innovation DA
Tournament: St Marks | Round: 1 | Opponent: Harker KB | Judge: Ari Davidson 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.” 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.
10/18/21
SO - Nebel T
Tournament: Meadows | Round: 6 | Opponent: Immaculate Heart AW | Judge: Donald Fagan Interpretation: medicines is a generic bare plural. The aff may not defend that member nations of the World Trade Organization reduce intellectual property protections for a subset of medicines. Nebel 19 Jake Nebel Jake Nebel is an assistant professor of philosophy at the University of Southern California and executive director of Victory Briefs. , 8-12-2019, "Genericity on the Standardized Tests Resolution," Briefly, https://www.vbriefly.com/2019/08/12/genericity-on-the-standardized-tests-resolution/ SM Both distinctions are important. Generic resolutions can’t be affirmed by specifying particular instances. But, since generics tolerate exceptions, plan-inclusive counterplans (PICs) do not negate generic resolutions. Bare plurals are typically used to express generic generalizations. But there are two important things to keep in mind. First, generic generalizations are also often expressed via other means (e.g., definite singulars, indefinite singulars, and bare singulars). Second, and more importantly for present purposes, bare plurals can also be used to express existential generalizations. For example, “Birds are singing outside my window” is true just in case there are some birds singing outside my window; it doesn’t require birds in general to be singing outside my window. So, what about “colleges and universities,” “standardized tests,” and “undergraduate admissions decisions”? Are they generic or existential bare plurals? On other topics I have taken great pains to point out that their bare plurals are generic—because, well, they are. On this topic, though, I think the answer is a bit more nuanced. Let’s see why. 1.1 “Colleges and Universities” “Colleges and universities” is a generic bare plural. I don’t think this claim should require any argument, when you think about it, but here are a few reasons. First, ask yourself, honestly, whether the following speech sounds good to you: “Eight colleges and universities—namely, those in the Ivy League—ought not consider standardized tests in undergraduate admissions decisions. Maybe other colleges and universities ought to consider them, but not the Ivies. Therefore, in the United States, colleges and universities ought not consider standardized tests in undergraduate admissions decisions.” That is obviously not a valid argument: the conclusion does not follow. Anyone who sincerely believes that it is valid argument is, to be charitable, deeply confused. But the inference above would be good if “colleges and universities” in the resolution were existential. By way of contrast: “Eight birds are singing outside my window. Maybe lots of birds aren’t singing outside my window, but eight birds are. Therefore, birds are singing outside my window.” Since the bare plural “birds” in the conclusion gets an existential reading, the conclusion follows from the premise that eight birds are singing outside my window: “eight” entails “some.” If the resolution were existential with respect to “colleges and universities,” then the Ivy League argument above would be a valid inference. Since it’s not a valid inference, “colleges and universities” must be a generic bare plural. Second, “colleges and universities” fails the upward-entailment test for existential uses of bare plurals. Consider the sentence, “Lima beans are on my plate.” This sentence expresses an existential statement that is true just in case there are some lima beans on my plate. One test of this is that it entails the more general sentence, “Beans are on my plate.” Now consider the sentence, “Colleges and universities ought not consider the SAT.” (To isolate “colleges and universities,” I’ve eliminated the other bare plurals in the resolution; it cannot plausibly be generic in the isolated case but existential in the resolution.) This sentence does not entail the more general statement that educational institutions ought not consider the SAT. This shows that “colleges and universities” is generic, because it fails the upward-entailment test for existential bare plurals. Third, “colleges and universities” fails the adverb of quantification test for existential bare plurals. Consider the sentence, “Dogs are barking outside my window.” This sentence expresses an existential statement that is true just in case there are some dogs barking outside my window. One test of this appeals to the drastic change of meaning caused by inserting any adverb of quantification (e.g., always, sometimes, generally, often, seldom, never, ever). You cannot add any such adverb into the sentence without drastically changing its meaning. To apply this test to the resolution, let’s again isolate the bare plural subject: “Colleges and universities ought not consider the SAT.” Adding generally (“Colleges and universities generally ought not consider the SAT”) or ever (“Colleges and universities ought not ever consider the SAT”) result in comparatively minor changes of meaning. (Note that this test doesn’t require there to be no change of meaning and doesn’t have to work for every adverb of quantification.) This strongly suggests what we already know: that “colleges and universities” is generic rather than existential in the resolution. Fourth, it is extremely unlikely that the topic committee would have written the resolution with the existential interpretation of “colleges and universities” in mind. If they intended the existential interpretation, they would have added explicit existential quantifiers like “some.” No such addition would be necessary or expected for the generic interpretation since generics lack explicit quantifiers by default. The topic committee’s likely intentions are not decisive, but they strongly suggest that the generic interpretation is correct, since it’s prima facie unlikely that a committee charged with writing a sentence to be debated would be so badly mistaken about what their sentence means (which they would be if they intended the existential interpretation). The committee, moreover, does not write resolutions for the 0.1 percent of debaters who debate on the national circuit; they write resolutions, at least in large part, to be debated by the vast majority of students on the vast majority of circuits, who would take the resolution to be (pretty obviously, I’d imagine) generic with respect to “colleges and universities,” given its face-value meaning and standard expectations about what LD resolutions tend to mean.
It applies to medicines:
Upward entailment test – spec fails the upward entailment test because saying that nations ought to reduce IPP for one medicine does not entail that those nations ought to reduce IPP for all medicines 2. Adverb test – adding “usually” to the res doesn’t substantially change its meaning because a reduction is permanent
Vote neg:
Semantics outweigh: a. T is a constitutive rule of the activity and a basic aff burden – they agreed to debate the topic when they came here b. Jurisdiction – you can’t vote aff if they haven’t affirmed the resolution c. It’s the only stasis point we know before the round so it controls the internal link to engagement – there’s no way to use ground if debaters aren’t prepared to defend it
2. Limits – there are countless affs accounting for thousands of medicines – unlimited topics incentivize obscure affs that negs won’t have prep on – limits are key to reciprocal prep burden – potential abuse doesn’t justify foregoing the topic and 1AR theory and functional limits checks PICs
There are over 20,000 affs FDA 11/18 (U.S. Food and Drug Administration, federal agency of the Department of Health and Human Service) “Fact Sheet: FDA at a Glance,” 11/18/2020 JL There are over 20,000 prescription drug products approved for marketing. FDA oversees over 6,500 different medical device product categories. There are over 1,600 FDA-approved animal drug products. There are about 300 FDA-licensed biologics products.
3. Ground – spec guts core generics like innovation that rely on reducing IP for all medicines because individual medicines don’t affect the pharmaceutical industry broadly – also means there is no universal DA to spec affs
4. TVA solves – read as an advantage to whole rez
Paradigm issues:
Drop the debater – their abusive advocacy skewed the debate from the start 2. Comes before 1AR theory – NC abuse is responsive to them not being topical 3. Competing interps – reasonability invites arbitrary judge intervention and a race to the bottom of questionable argumentation 4. No RVIs – fairness and education are a priori burdens – and encourages baiting – outweighs because if T is frivolous, they can beat it quickly 5. Fairness is a voter ¬– necessary to determine the better debater 6. Education is a voter – why schools fund debate
11/2/21
SO - Neolib K
Tournament: St Marks | Round: 1 | Opponent: Harker KB | Judge: Ari Davidson The Aff’s portrayal of a world with reduced IP protections as an “information commons” where inequality is solved by deregulation perpetuates the neoliberal myth of increased competition ensuring a perfect market Kapczynski 14 (Amy, a Professor of Law at Yale Law School, Faculty Co-Director of the Global Health Justice Partnership, and Faculty Co-Director of the Collaboration for Research Integrity and Transparency. She is also Faculty Co-Director of the Law and Political Economy Project and cofounder of the Law and Political Economy blog. Her areas of research include information policy, intellectual property law, international law, and global health.) “INTELLECTUAL PROPERTY’S LEVIATHAN” Duke Law, Law and Contemporary problems, 2014. https://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=4710andcontext=lcp BC Over the last decade or so, a powerful set of critiques has emerged to contest the dominant account just sketched out as well as the contemporary state of IP law.12 These arguments have come from many directions, some even arising from scholars who previously were champions of the dominant account.13 The most prominent and potent line of theoretical critique in the legal literature has come in the guise of arguments for free culture and the “information commons” and has been most influentially articulated by Lawrence Lessig and Yochai Benkler.14 Both have stressed the problems with expansive exclusive rights regimes in information and have also sketched a set of actually existing alternatives to market-based exclusionary forms of information and cultural production. Lessig has written a series of influential books that have made him a “rock star of the information age,”15 particularly for young Internet and free-culture activists. He has argued powerfully, for example, that existing copyright law is in deep conflict with the radical new possibilities for creativity in the digital age. As he points out, when a mother posting a video of her toddler dancing to a Prince song on YouTube is threatened with a $150,000 fine for copyright infringement, something has gone seriously awry.16 Lessig also contends that copyright law today is too long, too expansive, and instantiates a “permission culture” that is antithetical to free expression in the age of the remix.17 As he puts it, “the Internet has unleashed an extraordinary possibility for many to participate in the process of building and cultivating a culture that reaches far beyond local boundaries,” creating the possibility of markets that “include a much wider and more diverse range of creators,” if not stifled by incumbents who use IP law to “protect themselves against this competition.”18 Benkler’s work has also been extraordinarily formative in the field, particularly for his insights into the multiplicity of modes of information production. As he has stressed, the conventional justification for IP does not account for the many successful and longstanding modes of market nonexclusionary information production.19 For example, attorneys write articles to attract clients, software developers sell services customizing free and opensource software for individual clients, and bands give music away for free to increase revenues from touring or merchandise.20 More pathbreaking still is Benkler’s account of the importance of “commons-based peer production,” a form of socially motivated and cooperative production exemplified by the volunteer network that maintains Wikipedia or the groups of coders who create open-source software products such as the Linux operating system.21 In the digital networked age, as Benkler describes, the tools of information production are very broadly distributed, “creating new opportunities for how we make and exchange information, knowledge, and culture.”22 These changes have increased the relative role in our information economy of nonproprietary production and facilitate “new forms of production that are based neither in the state nor in the market.”23 Because commons-based peer production is not hierarchically organized and is motivated by social dynamics and concerns, it also offers new possibilities for human development, human freedom, a more critical approach to culture, and more democratic forms of political participation.24 This line of critique has been profoundly generative and has helped launch an important new conceptualization of the commons as a paradigm. That paradigm, as a recent book puts it, “helps us ‘get outside’ of the dominant discourse of the market economy and helps us represent different, more wholesome ways of being.”25 Proponents of the commons concept draw upon contemporary articulations of successful commons-based resource management by Elinor Ostrom and her followers.26 They do mobilize retellings of the political and economic history of the commons in land in Europe before enclosure,27 and recent evidence from psychology and behavioral economics that suggests that humans have deep tendencies toward cooperation and reciprocation.28 They argue that A key revelation of the commons way of thinking is that we humans are not in fact isolated, atomistic individuals. We are not amoebas with no human agency except hedonistic “utility preferences” expressed in the marketplace. No: We are commoners—creative, distinctive individuals inscribed within larger wholes. We may have unattractive human traits fueled by individual fears and ego, but we are also creatures entirely capable of self-organization and cooperation; with a concern for fairness and social justice; and willing to make sacrifices for the larger good and future generations.29 This stands, of course, as a powerful rebuke to the neoliberal imaginary, which “constructs and interpellates individuals as . . . rational, calculating creatures whose moral autonomy is measured by their capacity for ‘self-care’— the ability to provide for their own needs and service their own ambitions.”30 III Given this radical—and, in my view, critically important—attempt to rethink the subject at the core of neoliberal accounts, it is all the more striking that proponents of the commons often appear to adopt a neoliberal image of the state. For example, the introduction to a recently edited volume that gathers writings on the commons from seventy-three authors in thirty countries (entitled, tellingly, The Wealth of the Commons: A World Beyond Market and State) has this to say: The presumption that the state can and will intervene to represent the interests of citizens is no longer credible. Unable to govern for the long term, captured by commercial interests and hobbled by stodgy bureaucratic structures in an age of nimble electronic networks, the state is arguably incapable of meeting the needs of citizens as a whole.31 The commons, they suggest, is a concept that seeks not only to liberate us from predatory and dysfunctional markets, but also from predatory and dysfunctional states. Something immediately seems incongruous here. If people are inherently cooperative reciprocators, why are states irredeemably corrupt? After all, as Harold Demsetz famously wrote in his 1967 attack on Arrow’s optimism about state production of information, “government is a group of people.”32 Lessig, one of the progenitors of the language of the commons in the informational domain, often leads with a similar view of the state: If the twentieth century taught us one lesson, it is the dominance of private over state ordering. Markets work better than Tammany Hall in deciding who should get what, when. Or as Nobel Prize-winning economist Ronald Coase put it, whatever problems there are with the market, the problems with government are more profound.33 Lessig reveals his own sense of the power of this conception of the state when he seeks to tar IP law with the same brush; we should rebel against current IP law, he suggests, because we should “limit the government’s role in choosing the future of creativity.”34 Benkler is more measured but admits as well to viewing the state as “a relatively suspect actor.”35 We should worry, he suggests, that direct governmental intervention “leads to centralization in the hands of government agencies and powerful political lobbies,”36 a view that echoes the neoliberal account described above. It should perhaps not surprise us that leading critics of neoliberal information policy embrace a neoliberal conception of the state. After all, neoliberalism is not merely an ideology, but also a set of policy prescriptions that may have helped to call forth the state that it has described. As David Harvey puts it, “the neoliberal fear that special-interest groups would pervert and subvert the state is nowhere better realized than in Washington, where armies of corporate lobbyists . . . effectively dictate legislation to match their special interests.”37 There are, it must be said, few areas of law that better exemplify this problem than IP law. For example, Jessica Litman has documented the astonishing process through which the 1976 Copyright Act was drafted, in which Congress delegated most of the drafting to interest groups that were forced to negotiate with one another.38 Other scholars have offered similarly startling accounts of the genesis of the most important IP treaty today, the TradeRelated Aspects of Intellectual Property Rights (TRIPS) Agreement. TRIPS came into force in 1996, revolutionizing international IP law by both imposing new standards and by rendering them enforceable through the WTO’s disputeresolution system, which authorizes trade retaliation to enforce its judgments. Most countries in the world are members of TRIPS, and the Agreement introduced, for developing countries in particular, substantial new obligations, such as the obligation to grant patents on medicines and food-related inventions. Several excellent histories of the treaty have been written, documenting its beginnings as a brash idea proposed by “twelve chief executive officers (representing pharmaceutical, entertainment, and software industries).”39 As Susan Sell has described, the TRIPS Agreement was a triumph of industry organizing. Through TRIPS, Industry revealed its power to identify and define a trade problem, devise a solution, and reduce it to a concrete proposal that could be sold to governments. These private sector actors succeeded in getting most of what they wanted from a global IP agreement, which now has the status of public international law.
Neoliberalism rips apart communal bonds to maintain the illusion that structural inequalities are individual problems – the impact is systemic victim-blaming, poverty, and violence. Smith 12 (Candace, author for Societpages, cites Bruno Amable, Associate Professor of Economics at Paris School of Economics) “Neoliberalism and Individualism: Ego Leads to Interpersonal Violence?” Sociology Lens is the associated site for Sociology Compass, Wiley-Blackwell’s review journal on all fields sociological AT There appears to be a link between neoliberalism, individualism, and violence. In reference to the association between neoliberalism and individualism, consider neoliberalism’s insistence that we do not need society since we are all solely responsible for our personal well-being (Peters 2001; Brown 2003). From a criminological standpoint, it is not hard to understand how this focus on the individual can lead to violence. According to Hirschi’s (1969) social control theory, for instance, broken or weak social bonds free a person to engage in deviancy. Since, according to this theory, individuals are naturally self-interested, they can use the opportunity of individualization to overcome the restraining powers of society. Bearing in mind neoliberalism’s tendency to value the individual over society, it could be argued that this ideology is hazardous as it acts to tear apart important social bonds and to thereby contribute to the occurrence of ego-driven crimes, including violent interpersonal crimes. Such a thought suggests that as neoliberalism becomes more prominent in a country, it can be expected that individualism and, as a result, interpersonal violence within that country will increase. When it comes to individualization, this idea is one of the fundamental aspects of neoliberalism. In fact, Bauman (2000:34) argues that in neoliberal states “individualization is a fate, not a choice.” As Amable (2011) explains, neoliberals have realized that in order for their ideology to be successful, a state’s populace must internalize the belief that individuals are only to be rewarded based on their personal effort. With such an ego-driven focus, Scharff (2011) explains that the process of individualization engenders a climate where structural inequalities are converted into individual problems. The alt is to reject the aff in favor of a critique that cultivates educated hope - evaluate the aff and alt on the level of ideological commitments – these policies won’t happen which takes out consequentialism good offense – BUT until we unlearn the assumption that getting government out of the way will let markets flourish and solve all our problems, we'll never be able to engage in robust, communitarian policymaking that truly centers human need and our obligations to others. Wilson 17: Julie A. Wilson {Julie A. Wilson is Associate Professor, Allegheny College, Department of Communication Arts and Theatre. She has a Ph.D. from the University of Minnesota in Critical Media Studies and a M.A. in Comparative Studies in Discourse and Society. Her B.A. came from Macalester College, where she graduated Summa Cum Laude, Phi Beta Kappa}, 17 - ("Neoliberalism (Key Ideas in Media andamp; Cultural Studies): 9781138654631: Media Studies Books @ Amazon.com," Routledge, 7-19-2017, https://books.google.com/books?id=5pouDwAAQBAJandpg=PT29andlpg=PT29anddq=22unlearn+neoliberalism22andsource=blandots=vIhe_sQ1Wkandsig=ACfU3U0i7yO8ittjco_PDzZGO7rxU89CYAandhl=enandsa=Xandved=2ahUKEwiN4631n_ryAhUdCTQIHWLNAzcQ6AF6BAgCEAM#v=onepageandqandf=false)//marlborough-wr/ New Stories for New Worlds As we will see in our mapping of the neoliberal conjuncture, competition's totalizing yet tenuous power over our everyday lives is rooted in what Keating calls “status quo stories”—those stories that get told in popular culture, and that we often tell ourselves, which cement our relationship to our present conjuncture and our investment in the world as we currently know it. She explains: Generally spoken with great certainty, these and similar comments (commands, really) reflect unthinking affirmation of the existing reality and a stubborn, equally unthinking resistance to change. Because we believe that our status-quo stories represent accurate factual statements about ourselves, other people, and the world, we view them as permanent, unchanging facts. This belief in the status-quo's permanence becomes self-fulfilling: We do not try to make change because change is impossible to make. “It's always been that way,” we tell ourselves, “so why waste our energy trying to change things?” “People are just like that-it's human nature, so plan accordingly and alter your expectations! There's no point in trying to change human nature!" Status-quo stories trap us in our current circumstances and conditions; they limit our imaginations because they prevent us from envisioning alternate possibilities.10 Status-quo stories double down on reality, making it seem like those socially constructed forces impinging on us are natural rather than historical, political, and subject to change. “Status-quo stories have a numbing effect,” Keating writes. “When we organize our lives around such stories or in other ways use them as ethical roadmaps or guides, they prevent us from extending our imaginations and exploring additional possibilities."11 One of my students aptly described neoliberal culture as a “status-quo storytelling machine.” To keep us living in competition, neoliberalism generates a host of status-quo stories about the naturalness and inevitability of self-enclosed individualism. Indeed, we might say that self-enclosed individualism operates as the foundational status quo story of neoliberal culture, where competition has become synonymous with all of life. Self-enclosed individualism keeps us not only divided from one another, but also actively pitted against each other. We are stuck in an oppositional consciousness that refuses to acknowledge our social interconnections, even though, as our shared anxieties suggest, we've never had more in common than right now! No matter where we are or what we're doing, neoliberal culture encourages us to see each other through a competitive lens that makes the transformation of our social world, and ourselves, impossible. We become incapable of acknowledging how our fortunes and fates are entwined with those of others who are living very different realities. We become callous and hardened to the suffering of others. We see suffering and death everywhere, and while this might register as bad or wrong or upsetting, we nonetheless stay stuck within the horizons of our own self-enclosed bubbles. The devastating powers of status-quo stories are clear in so many of the conversations we have on college campuses about power, privilege, and difference. In fact, I started teaching courses on neoliberal culture to help my students understand the broader histories and contexts that were impinging on these conversations and making them so fraught, and ultimately so unproductive. Time and time again, in open community forums and classroom discussions of systemic inequalities, I watched students voice painful personal experiences only to get nowhere. Indeed, when asked to consider various forms of privilege, many of my white, male students get defensive. The idea that they haven't earned their place through their own decisions and hard work, but rather benefited from inherited wealth and opportunity, means that they are not good people from the perspective of neoliberalism. Talking about issues of privilege threatens to diminish their sense of self and individual value, so they recoil from conversations that ask them to see their place within broader legacies of settler colonialism, patriarchy, and capitalism. Accordingly, they hold on tight to status-quo stories of self-enclosed individualism to protect themselves, doubling down on their privilege to secure their status in a competitive world. However, it is important to see that status-quo stories of self- enclosed individualism also inform my students from historically oppressed and marginalized groups. These students suffer daily: they live in an environment that professes to celebrate “diversity,” while, in the context of their own lives, they are reminded again and again just how much they don't belong or matter. Not surprisingly, they demand “safe spaces” and protection for themselves and their peers, and they often draw hard lines between allies and enemies. Here too though, we see neoliberal stories at work. What matters for my students, and rightly so, is the way that “microaggressions”—those daily, mundane experiences of discrimination that accumulate over time-diminish their own capacities for flourishing as self-enclosed individuals. My point here is not to suggest that privileged students and marginalized students are the same because they are both invested in a version of self-enclosed individualism. Rather, my point is they share a situation; despite their different and unequal social positions, they have similar feelings-of defensiveness and a fear of failure—and status-quo stories in common. These commonalities do not imply evenness or equality, but rather interconnection, that is, a shared conjuncture. It is the recognition of this conjunctural interconnection that can thread our lives together and open up possibilities for more egalitarian futures. However, living in competition and the oppositional consciousness it demands obscure these commonalities and the interconnections that could bring students into new relations with one another. As a result, we stay caught up in the world as we know it. We stay stuck in competition, even though we all are yearning for different worlds. We desperately need new stories, stories that offer us different pathways to each other. As Keating puts it, we need stories that help us move from “me” to “we” consciousness.12 However, this book is not going to write these new stories for you. Rather, the goal of this book is to provide you with the resources for writing these new stories in and through your own lives. The Work of Critique Ultimately, writing new stories will require a new sense of yourself and your world, as well as what is possible, and realizing this new sense will require, first and foremost, cultivating a deeply critical orientation toward the world as we currently know and experience it. This critical orientation dislodges the sense of inevitability of neoliberalism, self-enclosed individualism, and living in competition; it knows that things don't have to be this way and, thus, senses the possibilities for resistance and transformation that are everywhere. It is so crucial to understand that this critical orientation is not simply about saying that aspects of neoliberal culture are “bad” or "wrong.” Rather, the work of critique is about seeing the flows of power and ways of thinking that make the neoliberal conjuncture possible and hold it together. Critique is therefore a mode of knowing—a form of everyday intellectual work—that is aimed at exposing the myriad workings of power and its status-quo stories. As Michel Foucault explains, “A critique is not a matter of saying that things are not right as they are. It is a matter of pointing out on what kinds of assumptions, what kinds of familiar, unchallenged, unconsidered modes of thought the practices that we accept rest.”13 To clarify Foucault's idea, let's think back to the student discussions of power and privilege discussed above. The work of critique is not simply about pointing out privilege, although this is, of course, vital work. The work of critique goes beyond pointing out what's wrong and seeks to unravel the socially constructed conjuncture in which these problems emerge and get negotiated. For only then can we step outside of the competitive, oppositional consciousness of neoliberal culture and begin to imagine a radically different future built on equality and shared security. This work of dislodging the inevitability of our conjuncture and its status-quo stories is hard but vital intellectual work that requires not only critique of our social world, but also transformation of ourselves. Indeed, truly critical work is always profoundly disruptive of our own identities and knowledges. This work can be immensely painful, as it strips away the certainty and comfort provided by status-quo stories. This work can also be, and should be, immensely joyful and life-giving, as it enables us to free ourselves from the status-quo stories and devastating limitations they put on our lives, imaginations, and social relationships. This mix of pain and joy at the heart of critical work comes from the way that critique asks us to “lose confidence” in our world. As feminist theorist Sara Ahmed writes, Losing confidence: it can be a feeling of something gradually going away from you, being eroded. You sense the erosion. You might stumble, hesitate, falter; things might gradually unravel so you end up holding onto the barest of threads. It might be an experience in the present that throws things up, throws you off balance.... When you lose confidence it can feel like you are losing yourself: like you have gone into hiding from yourself.4 Losing confidence in your world is thus a form of existential crisis —you are disoriented; your world is shattered. At the same time, losing confidence in status-quo stories means gaining confidence for resistance and transformation. We become bolder, less anxious, more optimistic, capable of social interconnection, political intervention, and acting on and from a place of commonality. This is real freedom. Critique is ultimately about unlearning our world so that we might reconstruct it anew. Losing confidence in neoliberal culture means being able to say no to it in the conduct of our daily lives. In these capacities for resistance, we gain confidence that another world might actually be better, worth opening ourselves up to, worth fighting for. We begin to cultivate what Henry Giroux calls educated hope. Educated hope is not “a romanticized and empty” version of hope; rather, it is a form of hope enabled by critique that “taps into our deepest experiences and longing for a life of dignity with others, a life in which it becomes possible to imagine a future that does not mimic the present.” With educated hope, our sense of who we are and of what might be possible shifts in profound ways. This is when those new worlds we are longing for open up. What’s to Come Each of the chapters that follow offer a variety of intellectual tools for mapping the neoliberal conjuncture. Taken together, they are designed to produce a holistic and thick understanding of neoliberalism and its myriad powers to shape our identities, sensibilities, social worlds, and political horizons. Having a thick understanding of neoliberalism means that you feel in your bones that there is nothing natural or inevitable about neoliberalism and its status-quo stories. It means that you understand that neoliberalism is the outcome of a range of contingent historical processes that have consequences across social, political, economic, and cultural fields. In other words, by the end of our journey, you'll know how our neoliberal conjuncture has been, and continues to be, constructed. You'll also, therefore, be able to sense the other worlds on the horizon that are just waiting to be constructed, so long as, together, we can develop the resources, capacities, and stories of interconnection for bringing them into being. More specifically, the book is divided into two sections. The first section, titled “Critical Foundations,” focuses on cultivating a broad, critical orientation toward neoliberal culture. The first chapter charts the rise of neoliberal hegemony through four historical phases. The goal is to illustrate exactly how competition came to be the driving cultural force in our everyday lives. As we will see, there is nothing natural or inevitable about neoliberalism. It was a political and class-based project to remake capitalism and liberal democracy that was conceived, organized for, and eventually won. In the second chapter, we delve into the world of neoliberal theory and its critical consequences. Here we'll explore exactly what neoliberal thinkers believe about the state, markets, and human actors, and what distinguishes neoliberalism from earlier schools of liberal thought. We'll also interrogate what I call the four Ds—disposability, dispossession, disimagination, and de- democratization—which, taken together, enable us to clearly see and articulate what is so devastating about the rise of neoliberalism. The third chapter examines the cultural powers specific to neoliberalism. Neoliberalism advances through culture, specifically through the promotion of an enterprise culture that works to impose competition as a norm across all arenas of social life. In order to see and specify how neoliberalism works through culture, we take contemporary education as a case study and unpack the entangled cultural powers of neoliberal governmentality, affect, and ideology. The second section is titled “Neoliberal Culture.” In these chapters, we explore the worlds of neoliberal labor, affect, and politics respectively, tracing what happens when our everyday lives as workers, individuals, and citizens become organized around living in competition. The fourth chapter examines how neoliberalism turns everyday life into a “hustle,” where all the contexts of daily life become animated by the demands of neoliberal labor. At stake here are the ways in which we are all hustling to get by, yet we stay radically divided from one another along lines of gender, race, and class thanks to the norm of self- enterprise. The next chapter hones in on what it feels like to inhabit enterprise culture by exploring neoliberal affect and the care of the self. As we already know, living in competition breeds widespread anxiety, not to mention depression and illness, making self-care an ongoing, pressing problem of everyday life. While neoliberal culture offers us plenty of tools for self-care that ultimately keep us stuck in our self-enclosed individualism, this chapter also considers how self-care might be a site for resistance and political intervention. The final chapter focuses on neoliberal politics, tracing what happens to citizenship and social action in our contemporary conjuncture. As we'll see, neoliberalism privatizes our political horizons by remaking democracy into a market competition for visibility and equality. Throughout this mapping of the neoliberal conjuncture, we will engage in a mode of critical work that will, hopefully, enable you to unlearn neoliberalism and thus begin to write new stories about our conjuncture—including both our commonalities and differences—and the alternative worlds we are yearning for. Indeed, our critical work will only matter to the extent that it opens up our individual and collective horizons to a future beyond living in competition.
10/18/21
SO - Regulation CP
Tournament: Meadows | Round: 4 | Opponent: Catonsville AT | Judge: Delanie Ness The member nations of the World Trade Organization ought to reform intellectual property protections for bioterror medicines using the mechanisms described by MSF ’17.
We allow secondary patents, but only under stricter patentability requirements, which solves innovation and high drug prices. MSF 17: MSF ’17 – Médecins Sans Frontières Doctors Without Borders - Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural or man-made disasters., “A Fair Shot for Vaccine Affordability: Understanding and addressing the effects of patents on access to newer vaccines,” September, 2017. Accessed Aug. 12, 2021. https://msfaccess.org/sites/default/files/2018-06/VAC_report_A20Fair20Shot20for20Vaccine20Affordability_ENG_2017.pdf AT Countries can take a variety of steps to promote competition in vaccine manufacturing and help mitigate the complex patent thickets that could block, delay or increase uncertainties around access to multiple sources of vaccines. Governments should adopt public health-oriented IP policies, making full use of TRIPS flexibilities in both substantive and procedural aspects of national patent laws. Countries should: • Encourage and accelerate follow-on development and competition of vaccines and vaccine technologies through the introduction and use of broad Bolar exemptions. This will support an early start for research and clinical studies by follow-on manufacturers, and support independent follow-on research and development. • Apply strict patentability criteria for vaccine and vaccine technologies in patent examination and judicial proceedings. Countries should closely scrutinise patent applications concerning common methods of treatment, dosage forms and claims concerning specific age groups. Countries should reject trivial changes to known vaccine technologies, or composition patent applications that merely present the assembly of more ingredients using a known technology. • Implement robust pre- and post-grant opposition procedures in national patent law systems that allow greater public scrutiny and opportunities to challenge unmerited patent applications from an early stage. Procedures that allow third-party observation but lack a mandatory hearing requirement could be improved to provide better transparency and accountability to the public. • Improve use of compulsory licencing. Governments should strengthen the mechanisms of issuing compulsory licences to facilitate the most expedited access to multiple sources of vaccines and to safeguard public health. • Strengthen technical capacity to ensure patent examiners apply strict patentability criteria and screen out unmerited applications in a timely manner. This will provide clarity on the patent landscape concerning important vaccines and technologies. • Increase transparency of patent office filings to enable third parties to better understand the IP landscape, especially through procedures to promote disclosure of non-proprietary biological qualifier names74 of vaccines. Prospective manufacturers will be able to make decisions more efficiently if they understand the IP landscape clearly. Government procurement decision making will also be improved by addressing the current information asymmetry. • Make full use of LDCs’ exemption from mandatory patent protection to accelerate access to quality assured follow-on new vaccines and encourage competition to improve affordability of vaccines. • Demand that international organisations like WHO, Gavi, the Pan American Health Organization (PAHO) and the United Nations Children’s Fund (UNICEF) improve technical support for countries to: identify legal barriers, use flexibilities under IP laws and improve transparency of patent information to facilitate follow-on development and foster robust competition for new vaccines.75