Tournament: Presentation | Round: 2 | Opponent: South Eugene KS | Judge: Ben Cortez
Innovation
Future Pandemics – Longer NC Shell
The pharma industry is strong now but patents are key for continued economic growth. Batell and PhRMA 14:
Batell and PhRMA {Battelle is the world’s largest nonprofit independent research and development organization, providing innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management, National Security, Energy, Environment and Material Sciences, and Health and Life Sciences. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.}, 14 – “The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It,” http://phrma-docs.phrma.org/sites/default/files/pdf/2014-economic-futures-report.pdf//marlborough-wr//
Compared to other capital-intensive, advanced manufacturing industries in the U.S., the biopharmaceutical industry is a leader in RandD investment, IP generation, venture capital investment, and RandD employment. Policies and infrastructure that helped foster these innovative activities have allowed the U.S. to seize global leadership in biopharmaceutical RandD over the past 30 years. However, as this report details, other countries are seeking to compete with the U.S. by borrowing and building upon some of these pro-innovation policies to improve their own operating environment and become more favorable to biopharmaceutical companies making decisions about where to locate their RandD and manufacturing activities. A unique contribution of this report was the inclusion of the perspective of senior-level strategic planning executives of biopharmaceutical companies regarding what policy areas they see as most likely to impact the favorability of the U.S. business operating environment. The executives cited the following factors as having the most impact on the favorability of the operating environment and hence, potential growth of the innovative biopharmaceutical industry in the U.S.: • Coverage and payment policies that support and encourage medical innovation • A well-functioning, science-based regulatory system • Strong IP protection and enforcement in the U.S. and abroad The top sub-attribute identified as driving future biopharmaceutical industry growth in the U.S. cited by executives was a domestic IP system that provides adequate patent rights and data protection. Collectively, these factors underscore the need to reduce uncertainties and ensure adequate incentives for the lengthy, costly, and risky RandD investments necessary to develop new treatments needed by patients and society to address our most costly and challenging diseases. With more than 300,000 jobs at stake between the two scenarios, the continued growth and leadership of the U.S. innovative biopharmaceutical industry cannot be taken for granted. Continued innovation is fundamental to U.S. economic well-being and the nation’s ability to compete effectively in a globalized economy and to take advantage of the expected growth in demand for new medicines around the world. Just as other countries have drawn lessons from the growth of the U.S. biopharmaceutical sector, the U.S. needs to assess how it can improve the environment for innovation and continue to boost job creation by increasing RandD investment, fostering a robust talent pool, enhancing economic growth and sustainability, and continuing to bring new medicines to patients.
COVID has kept patents and innovation strong, but continued protection is key to innovation by incentivizing biomedical research – it’s also crucial to preventing counterfeit medicines, economic collapse, and fatal diseases, which independently turns case. Macdole and Ezell 4-29:
Jaci Mcdole and Stephen Ezell {Jaci McDole is a senior policy analyst covering intellectual property (IP) and innovation policy at the Information Technology and Innovation Foundation (ITIF). She focuses on IP and its correlations to global innovation and trade. McDole holds a double BA in Music Business and Radio-Television with a minor in Marketing, an MS in Education, and a JD with a specialization in intellectual property (Southern Illinois University Carbondale). McDole comes to ITIF from the Institute for Intellectual Property Research, an organization she co-founded to study and further robust global IP policies. Stephen Ezell is vice president, global innovation policy, at the Information Technology and Innovation Foundation (ITIF). He comes to ITIF from Peer Insight, an innovation research and consulting firm he cofounded in 2003 to study the practice of innovation in service industries. At Peer Insight, Ezell led the Global Service Innovation Consortium, published multiple research papers on service innovation, and researched national service innovation policies being implemented by governments worldwide. Prior to forming Peer Insight, Ezell worked in the New Service Development group at the NASDAQ Stock Market, where he spearheaded the creation of the NASDAQ Market Intelligence Desk and the NASDAQ Corporate Services Network, services for NASDAQ-listed corporations. Previously, Ezell cofounded two successful innovation ventures, the high-tech services firm Brivo Systems and Lynx Capital, a boutique investment bank. Ezell holds a B.S. from the School of Foreign Service at Georgetown University, with an honors certificate from Georgetown’s Landegger International Business Diplomacy program.}, 21 - ("Ten Ways Ip Has Enabled Innovations That Have Helped Sustain The World Through The Pandemic," Information Technology and Innovation Foundation, 4-29-2021, https://itif.org/publications/2021/04/29/ten-ways-ip-has-enabled-innovations-have-helped-sustain-world-through)//marlborough-wr/
To better understand the role of IP in enabling solutions related to COVID-19 challenges, this report relies on 10 case studies drawn from a variety of nations, technical fields, and firm sizes. This is but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. From a paramedic in Mexico to a veteran vaccine manufacturing company in India and a tech start-up in Estonia to a U.S.-based company offering workplace Internet of Things (IoT) services, small and large organizations alike are working to combat the pandemic. Some have adapted existing innovations, while others have developed novel solutions. All are working to take the world out of the pandemic and into the future. The case studies are: Bharat Biotech: Covaxin Gilead: Remdesivir LumiraDX: SARS-COV-2 Antigen POC Test Teal Bio: Teal Bio Respirator XE Ingeniería Médica: CápsulaXE Surgical Theater: Precision VR Tombot: Jennie Starship Technologies: Autonomous Delivery Robots Triax Technologies: Proximity Trace Zoom: Video Conferencing As the case studies show, IP is critical to enabling innovation. Policymakers around the world need to ensure robust IP protections are—and remain—in place if they wish their citizens to have safe and innovative solutions to health care, workplace, and societal challenges in the future. THE ROLE OF INTELLECTUAL PROPERTY IN RandD-INTENSIVE INDUSTRIES Intangible assets, such as IP rights, comprised approximately 84 percent of the corporate value of SandP 500 companies in 2018.4 For start-ups, this means much of the capital needed to operate is directly related to IP (see Teal Bio case study for more on this). IP also plays an especially important role for RandD-intensive industries.5 To take the example of the biopharmaceutical industry, it is characterized by high-risk, time-consuming, and expensive processes including basic research, drug discovery, pre-clinical trials, three stages of human clinical trials, regulatory review, and post-approval research and safety monitoring. The drug development process spans an average of 11.5 to 15 years.6 For every 5,000 to 10,000 compounds screened on average during the basic research and drug discovery phases, approximately 250 molecular compounds, or 2.5 to 5 percent, make it to preclinical testing. Out of those 250 molecular compounds, approximately 5 make it to clinical testing. That is, 0.05 to 0.1 percent of drugs make it from basic research into clinical trials. Of those rare few which make it to clinical testing, less than 12 percent are ultimately approved for use by the U.S. Food and Drug Administration (FDA).7 In addition to high risks, drug development is costly, and the expenses associated with it are increasing. A 2019 report by the Deloitte Center for Health Solutions concluded that since 2010 the average cost of bringing a new drug to market increased by 67 percent.8 Numerous studies have examined the substantial cost of biopharmaceutical RandD, and most confirm investing in new drug development requires $1.7 billion to $3.2 billion up front on average.9 A 2018 study by the Coalition for Epidemic Preparedness found similar risks and figures for vaccines, stating, “In general, vaccine development from discovery to licensure can cost billions of dollars, can take over 10 years to complete, and has an average 94 percent chance of failure.”10 Yet, a 2010 study found that 80 percent of new drugs—that is, the less than 12 percent ultimately approved by the FDA—made less than their capitalized RandD costs.11 Another study found that only 1 percent (maybe three new drugs each year) of the most successful 10 percent of FDA approved drugs generate half of the profits of the entire drug industry.12 To say the least, biopharmaceutical RandD represents a high-stakes, long-term endeavor with precarious returns. Without IP protection, biopharmaceutical manufacturers have little incentive to take the risks necessary to engage in the RandD process because they would be unable to recoup even a fraction of the costs incurred. Diminished revenues also result in reduced investments in RandD which means less research into cancer drugs, Alzheimer cures, vaccines, and more. IP rights give life-sciences enterprises the confidence needed to undertake the difficult, risky, and expensive process of life-sciences innovation secure in the knowledge they can capture a share of the gains from their innovations, which is indispensable not only to recouping the up-front RandD costs of a given drug, but which can generate sufficient profits to enable investment in future generations of biomedical innovation and thus perpetuate the enterprises into the future.13 THE IMPORTANCE OF INTELLECTUAL PROPERTY TO INNOVATION Although anti-IP proponents have attacked biopharmaceutical manufacturers particularly hard, the reality is all IP-protected innovations are at risk if these rights are ignored, or vitiated. Certain arguments have shown a desire for the term “COVID-19 innovations” to include everything from vaccines, therapeutics, diagnostics, and PPE to biotechnology, AI-related data, and educational materials.14 This could potentially open the floodgates to invalidate IP protection on many of the innovations highlighted in this report. However, much of the current discussion concerning IP focuses almost entirely on litigation fears or RandD incentives. Although RandD is an important aspect of IP, as previously mentioned, these discussions ignore the fact that IP protection can be—and often is—used for other purposes, including generating initial capital to create a company and begin manufacturing and, more importantly, using licensing agreements and IP to track the supply chain and ensure quality control of products. This report highlights but a handful of the thousands of IP-enabled innovations that have sprung forth over the past year in an effort to meet the tremendous challenges brought on by COVID-19 globally. In 2018, Forbes identified counterfeiting as the largest criminal enterprise in the world.15 The global struggle against counterfeit and non-regulated products, which has hit Latin America particularly hard during the pandemic, proves the need for safety and quality assurance in supply chains.16 Some communities already ravaged by COVID-19 are seeing higher mortality rates related to counterfeit vaccines, therapeutics, PPE, and cleaning and sanitizing products.17 Polish authorities discovered vials of antiwrinkle treatment labeled as COVID-19 vaccines. 18 In Mexico, fake vaccines sold for approximately $1,000 per dose.19 Chinese and South African police seized thousands of counterfeit vaccine doses from warehouses and manufacturing plants.20 Meanwhile, dozens of websites worldwide claiming to sell vaccines or be affiliated with vaccine manufacturers have been taken down.21 But the problem is not limited to biopharmaceuticals. The National Intellectual Property Rights Coordination Center has recovered $48 million worth of counterfeit PPE and other products.22 Collaborative efforts between law enforcement and manufacturers have kept numerous counterfeits from reaching the population. In countries with strong IP protection, the chances of counterfeit products reaching the market are significantly lower. This is largely because counterfeiting tends to be an IP-related issue, and these countries generally provide superior means of tracking the supply chain through trademarks, trade secrets, and licensing agreements. This enables greater quality control and helps manufacturers maintain a level of public confidence in their products. By controlling the flow of knowledge associated with IP, voluntary licensing agreements provide innovators with opportunities to collaborate, while ensuring their partners are properly equipped and capable of producing quality products. Throughout this difficult time, the world has seen unexpected collaborations, especially between biopharmaceutical companies worldwide such as Gilead and Eva Pharma or Bharat Biotech and Ocugen, Inc. Throughout history, and most significantly in the nineteenth century through the widespread development of patent systems and the ensuing Industrial Revolution, IP has contributed toward greater economic growth.23 This is promising news as the world struggles for economic recovery. A 2021 joint study by the EU Intellectual Property Office (EUIPO) and European Patent Office (EPO) shows a strong, positive correlation between IP rights and economic performance.24 It states that “IP-owning firms represent a significantly larger proportion of economic activity and employment across Europe,” with IP-intensive industries contributing to 45 percent of gross domestic product (GDP) (€6.6 trillion; US$7.9 trillion).25 The study also shows 38.9 percent of employment is directly or indirectly attributed to IP-intensive industries, and IP generates higher wages and greater revenue per employee, especially for small-to-medium-sized enterprises.26 That concords with the United States, where the Department of Commerce estimated that IP-intensive industries support at least 45 million jobs and contribute more than $6 trillion dollars to, or 38.2 percent of, GDP.27 In 2020, global patent filings through the World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) system reached a record 275,900 filings amidst the pandemic, growing 4 percent from 2019.28 The top-four nations, which accounted for 180,530 of the patent applications, were China, the United States, Japan, and Korea, respectively.29 While several countries saw an increase in patent filings, Saudi Arabia and Malaysia both saw significant increases in the number of annual applications, with the top two filing growths of 73 percent and 26 percent, respectively.30 The COVID-19 pandemic slowed a lot of things, but it certainly couldn’t stop innovation. There are at least five principal benefits strong IP rights can generate, for both developing and developed countries alike.31 First, stronger IP protection spurs the virtuous cycle of innovation by increasing the appropriability of returns, enabling economic gain and catalyzing economic growth. Second, through patents—which require innovators to disclose certain knowledge as a condition of protection—knowledge spillovers build a platform of knowledge that enables other innovators. For instance, studies have found that the rate of return to society from corporate RandD and innovation activities is at least twice the estimated returns that each company itself receives.32 Third, countries with robust IP can operate more efficiently and productively by using IP to determine product quality and reduce transaction costs. Fourth, trade and foreign direct investment enabled and encouraged by strong IP protection offered to enterprises from foreign countries facilitates an accumulation of knowledge capital within the destination economy. That matters when foreign sources of technology account for over 90 percent of productivity growth in most countries.33 There’s also evidence suggesting that developing nations with stronger IP protections enjoy the earlier introduction of innovative new medicines.34 And fifth, strong IP boosts exports, including in developing countries.35 Research shows a positive correlation between stronger IP protection and exports from developing countries as well as faster growth rates of certain industries.36 The following case studies illustrate these benefits of IP and how they’ve enabled innovative solutions to help global society navigate the COVID-19 pandemic.
This sets a precedent that spills over to all future diseases – Hopkins 21:
Jared S. Hopkins {Jared S. Hopkins is a New York-based reporter for The Wall Street Journal covering the pharmaceutical industry, including companies such as Pfizer Inc. and Merck and Co. He previously was a health-care reporter at Bloomberg News and an investigative reporter at the Chicago Tribune. Jared started his career at The Times-News in Twin Falls, Idaho covering politics. In 2014, he was a finalist for the Livingston Award For Young Journalists for an investigation into charities founded by professional athletes. In 2011, he was a finalist for the Pulitzer Prize in Investigative Reporting for a series about neglect at a residential facility for disabled kids. Jared graduated from the Merrill College of Journalism at the University of Maryland-College Park with a bachelor's degree in journalism}, 21 - ("U.S. Support for Patent Waiver Unlikely to Cost Covid-19 Vaccine Makers in Short Term ," WSJ, 5-7-2021, https://www.wsj.com/articles/u-s-support-for-patent-waiver-unlikely-to-cost-covid-19-vaccine-makers-in-short-term-11620414260)//marlborough-wr/
The Biden administration’s unexpected support for temporarily waiving Covid-19 vaccine patents won’t have an immediate financial impact on the companies making the shots, industry officials and analysts said. Yet the decision could mark a shift in Washington’s longstanding support of the industry’s valuable intellectual property, patent-law experts said. A waiver, if it does go into effect, may pose long-term risks to the vaccine makers, analysts said. Moderna Inc., MRNA -4.12 Pfizer Inc. PFE -3.10 and other vaccine makers weren’t counting on sales from the developing countries that would gain access to the vaccine technology, analysts said. If patents and other crucial product information behind the technology is made available, it would take at least several months before shots were produced, industry officials said. Yet long-term Covid-19 sales could take a hit if other companies and countries gained access to the technologies and figured out how to use it. Western drugmakers could also confront competition sooner for other medicines they are hoping to make using the technologies. A World Trade Organization waiver could also set a precedent for waiving patents for other medicines, a long-sought goal of some developing countries, patient groups and others to try to reduce the costs of prescription drugs. “It sets a tremendous precedent of waiving IP rights that’s likely going to come up in future pandemics or in other serious diseases,” said David Silverstein, a patent lawyer at Axinn, Veltrop and Harkrider LLP who advises drugmakers. “Other than that, this is largely symbolic.”
The DA outweighs on time-frame and magnitude: Need to sustain effective research now to avoid future pandemics
Lander 8/4/21 Eric Lander, President Biden’s Science Advisory and Director of the White House Office of Science and Technology Policy) “Opinion: As bad as Covid-19 has been, a future pandemic could be even worse—unless we act now” 8/4/21, The Washington Post RM
Coronavirus vaccines can end the current pandemic if enough people choose to protect themselves and their loved ones by getting vaccinated. But in the years to come, we will still need to defend against a pandemic side effect: collective amnesia. As public health emergencies recede, societies often quickly forget their experiences — and fail to prepare for future challenges. For pandemics, such a course would be disastrous. New infectious diseases have been emerging at an accelerating pace, and they are spreading faster. Our federal government is responsible for defending the United States against future threats. That’s why President Biden has asked Congress to fund his plan to build on current scientific progress to keep new infectious-disease threats from turning into pandemics like covid-19. As the president’s science adviser, I know what’s becoming possible. For the first time in our history, we have an opportunity not just to refill our stockpiles but also to transform our capabilities. However, if we don’t start preparing now for future pandemics, the window for action will close. Covid-19 has been a catastrophe: The toll in the United States alone is more than 614,000 lives and has been estimated to exceed $16 trillion, with disproportionate impact on vulnerable and marginalized communities. But a future pandemic could be even worse — unless we take steps now. It’s important to remember that the virus behind covid-19 is far less deadly than the 1918 influenza. The virus also belongs to a well-understood family, coronaviruses. It was possible to design vaccines within days of knowing the virus’s genetic code because 20 years of basic scientific research had revealed which protein to target and how to stabilize it. And while the current virus spins off variants, its mutation rate is slower than that of most viruses. Unfortunately, most of the 26 families of viruses that infect humans are less well understood or harder to control. We have a great deal of work still ahead. The development of mRNA vaccine technology — thanks to more than a decade of foresighted basic research — was a game-changer. It shortened the time needed to design and test vaccines to less than a year — far faster than for any previous vaccine. And it’s been surprisingly effective against covid-19. Still, there’s much more to do. We don’t yet know how mRNA vaccines will perform against other viruses down the road. And when the next pandemic breaks out, we’ll want to be able to respond even faster. Fortunately, the scientific community has been developing a bold plan to keep future viruses from becoming pandemics. Here are a few of the goals we should shoot for: The capability to design, test and approve safe and effective vaccines within 100 days of detecting a pandemic threat (for covid-19, that would have meant May 2020); manufacture enough doses to supply the world within 200 days; and speed vaccination campaigns by replacing sterile injections with skin patches. Diagnostics simple and cheap enough for daily home testing to limit spread and target medical care. Early-warning systems to spot new biological threats anywhere in the world soon after they emerge and monitor them thereafter. We desperately need to strengthen our public health system — from expanding the workforce to modernizing labs and data systems — including to ensure that vulnerable populations are protected. And we need to coordinate actions with our international partners, because pandemics know no borders. These goals are ambitious, but they’re feasible — provided the work is managed with the seriousness, focus and accountability of NASA’s Apollo Program, which sent humans to the moon. Importantly, these capabilities won’t just prepare us for future pandemics; they’ll also improve public health and medical care for infectious diseases today. Preparing for threats is a core national responsibility. That’s why our government invests heavily in missile defense and counterterrorism. We need to similarly protect the nation against biological threats, which range from the ongoing risk of pandemics to the possibility of deliberate use of bioweapons. Pandemics cause massive death and disruption. From a financial standpoint, they’re also astronomically expensive. If, as might be expected from history and current trends, we suffered a pandemic of the current scale every two decades, the annualized cost would exceed $500 billion per year. Investing a much smaller amount to avert this toll is an economic and moral imperative. The White House will put forward a detailed plan this month to ensure that the United States can fully prepare before the next outbreak. It’s hard to imagine a higher economic or human return on national investment.
Ecosystem sensitivity from climate change means future pandemics will cause extinction—assumes COVID
Supriya 4/19 Lakshmi Supriya got her BSc in Industrial Chemistry from IIT Kharagpur (India) and a Ph.D. in Polymer Science and Engineering from Virginia Tech (USA). She has more than a decade of global industry experience working in the USA, Europe, and India. After her Ph.D., she worked as part of the RandD group in diverse industries starting with semiconductor packaging at Intel, Arizona, where she developed a new elastomeric thermal solution, which has now been commercialized and is used in the core i3 and i5 processors. From there she went on to work at two startups, one managing the microfluidics chip manufacturing lab at a biotechnology company and the other developing polymer formulations for oil extraction from oil sands. She also worked at Saint Gobain North America, developing various material solutions for photovoltaics and processing techniques and new applications for fluoropolymers. Most recently, she managed the Indian RandD team of Enthone (now part of MacDermid) developing electroplating technologies for precious metals.) “Humans versus viruses - Can we avoid extinction in near future?” News Medical Life Sciences, 4/19/21, https://www.news-medical.net/news/20210419/Humans-versus-viruses-Can-we-avoid-extinction-in-near-future.aspx RM
Expert argues that human-caused changes to the environment can lead to the emergence of pathogens, not only from outside but also from our own microbiome, which can pave the way for large-scale destruction of humans and even our extinction. Whenever there is a change in any system, it will cause other changes to reach a balance or equilibrium, generally at a point different from the original balance. Although this principle was originally posited by the French chemist Henry Le Chatelier for chemical reactions, this theory can be applied to almost anything else. In an essay published on the online server Preprints*, Eleftherios P. Diamandis of the University of Toronto and the Mount Sinai Hospital, Toronto, argues that changes caused by humans, to the climate, and everything around us will lead to changes that may have a dramatic impact on human life. Because our ecosystems are so complex, we don’t know how our actions will affect us in the long run, so humans generally disregard them. Changing our environment Everything around us is changing, from living organisms to the climate, water, and soil. Some estimates say about half the organisms that existed 50 years ago have already become extinct, and about 80 of the species may become extinct in the future. As the debate on global warming continues, according to data, the last six years have been the warmest on record. Global warming is melting ice, and sea levels have been increasing. The changing climate is causing more and more wildfires, which are leading to other related damage. At the same time, increased flooding is causing large-scale devastation. One question that arises is how much environmental damage have humans already done? A recent study compared the natural biomass on Earth to the mass produced by humans and found humans produce a mass equal to their weight every week. This human-made mass is mainly for buildings, roads, and plastic products. In the early 1900s, human-made mass was about 3 of the global biomass. Today both are about equal. Projections say by 2040, the human-made mass will be triple that of Earth’s biomass. But, slowing down human activity that causes such production may be difficult, given it is considered part of our growth as a civilization. Emerging pathogens Although we are made up of human cells, we have almost ten times that of bacteria just in our guts and more on our skin. These microbes not only affect locally but also affect the entire body. There is a balance between the good and bad bacteria, and any change in the environment may cause this balance to shift, especially on the skin, the consequences of which are unknown. Although most bacteria on and inside of us are harmless, gut bacteria can also have viruses. If viruses don’t kill the bacteria immediately, they can incorporate into the bacterial genome and stay latent for a long time until reactivation by environmental factors, when they can become pathogenic. They can also escape from the gut and enter other organs or the bloodstream. Bacteria can then use these viruses to kill other bacteria or help them evolve to more virulent strains. An example of the evolution of pathogens is the cause of the current pandemic, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Several mutations are now known that make the virus more infectious and resistant to immune responses, and strengthening its to enter cells via surface receptors. The brain There is evidence that the SARS-CoV-2 can also affect the brain. The virus may enter the brain via the olfactory tract or through the angiotensin-converting enzyme 2 (ACE2) pathway. Viruses can also affect our senses, such as a loss of smell and taste, and there could be other so far unkown neurological effects. The loss of smell seen in COVID-19 could be a new viral syndrome specific to this disease. Many books and movies have described pandemics caused by pathogens that wipe out large populations and cause severe diseases. In the essay, the author provides a hypothetical scenario where a gut bacteria suddenly starts producing viral proteins. Some virions spread through the body and get transmitted through the human population. After a few months, the virus started causing blindness, and within a year, large populations lost their vision. Pandemics can cause other diseases that can threaten humanity’s entire existence. The COVID-19 pandemic brought this possibility to the forefront. If we continue disturbing the equilibrium between us and the environment, we don’t know what the consequences may be and the next pandemic could lead us to extinction.