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2AC › Adv --- Pharma › AT: Blockbusters
Taurel 3-18-2003. [Sidney, CEO, Eli Lilly; “The Worldwide Campaign Against Pharmaceutical Innovation,” American Enterprise Institute, //cpsw-ay]
Major pharmaceutical companies are built upon and driven by blockbuster drugs. At this point, that’s defined as a product with sales of above a billion dollars a year. All the “Big Pharma” companies have some of these very big drugs anchoring their portfolios, and most have grown by developing or acquiring a series of them over the years.
Blockbusters tend to be highly innovative drugs, often breakthroughs. They are big because they represent the first or best treatment for a major medical need.
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2AC › Adv --- Pharma › 2AC---AT: Financialization
Liu 2-26-2024. [Shuangshuang, School of Civil Engineering and Architecture, Baise University; “The influence of financial asset allocation on the innovation and investment of high-tech enterprises,” Finance Research Letters, Vol. 62, , //cpsw-ay
Scholars define financial asset allocation as allocating funds in a portfolio to different classes of financial assets based on an investor's risk appetite, investment objectives, and market conditions. The aim is to achieve the optimal balance between risk and return (Zhao et al., 2023). Financial asset allocation is the core aspect of portfolio management activities. Investors allocate funds to different financial assets, such as stocks, bonds, and cash, to maximize return or minimize risk (Yousaf et al., 2023). With the continuous development of the digital economy and digital finance, physical enterprises are increasingly shifting to virtual operations, and financial assets have become a vital part of high-tech enterprises’ assets. Financialization can promote enterprise innovation (Liu & He, 2023). The behavior of high-tech enterprises in the effective allocation and rational use of financial assets profoundly impacts enterprise development. Reasonable allocation of financial assets can provide more effective financial support for high-tech enterprises (Zhang et al., 2021). Providing convenient and diversified financial services for innovative investment has become an essential driving force in promoting structural transformation, technological progress, and the development of industrial marketization (Xolmirzaev, 2020). Therefore, in an era when innovation plays a crucial role in promoting progress, it has become imperative to study how the allocation of financial assets affects the innovation investment of high-tech enterprises.
The supply and distribution of financial assets can provide firms with research and development (R&D) resources and support for technological progress (Guo & Xu, 2021). Funding is the key to enterprise innovation, and reasonable financial assets can encourage enterprises to increase R&D investment, grow their innovation teams, and acquire advanced research equipment and technology (Yang et al., 2019).
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2AC › Adv --- Pharma › ! --- ADDON --- SL
Elizabeth Southerlan and Fritz Heese, ND, Elizabeth Southerlan is a principal in Oliver Wyman’s Health and Life Sciences practice. Fritz is a Partner and one of the leaders of Oliver Wyman’s Health and Life Sciences Practice. He works in pharmaceutical, medical technology, wholesale, and retail pharmacy markets across Europe and the US. "Pharma’s Opportunity To Impact Health Equity", Oliver Wyman, || 苗
Among the issues confronting healthcare leaders perhaps none presents more challenges or opportunities than health equity. The complexity of the problem cuts across age, ethnicity, gender, and race. And it’s both an outcomes and access problem. The statistics tell the story:
Hispanic patients are 50% more likely to die from diabetes than white patients
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2AC › Adv --- Pharma › S --- Pharma Innovation Key
Ikeda ’21 [Naomi; February 4; Manager of Innovation Incentives at Ayming; Pharma Times, “Pharma R&D: 2021 and beyond,” ] ARL
As companies face pressure from consumers and governments, sustainability and ethical practices are now on top of the agenda for all industries. Not only is this an environmental imperative for pharma firms, but a business necessity.
The pharma sector faces growing demand to address environmental problems, such as reducing the amount of waste, limiting the use of single-use plastics or fossil fuels, as well as complying with new standards around chemical sourcing and waste from development.
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2AC › Adv --- Pharma › S --- Pharma Innovation Key
Marjanovic & Feijao 20 [Sonja Marjanovic, director of healthcare innovation at RAND Europe, providing decisionmakers with evidence and insights to support innovation and improvement in healthcare systems, and supporting the translation of innovation into societal benefits, Carolina Feijao, Senior Policy Advisor at the Royal Academy of Engineering, “Pharmaceutical Innovation For Infectious Disease Management,” RAND Perspective, May 2020, https://www.rand.org/content/dam/rand/pubs/perspectives/PEA400/PEA407-1/RAND_PEA407-1.pdf//Accessed July 11th 2024) cpsw-sns]
This perspective argues for the need to establish more sustainable and scalable ways of incentivising pharmaceutical innovation in response to infectious disease threats to public health. It considers both past and current examples of efforts to mobilise pharmaceutical innovation in high commercial risk areas, including in the context of current efforts to respond to the COVID-19 pandemic. In global pandemic crises like COVID-19, the urgency and scale of the crisis – as well as the spotlight placed on pharmaceutical companies – mean that contributing to the search for effective medicines, vaccines or diagnostics is essential for socially responsible companies in the sector. 2 It is therefore unsurprising that we are seeing industry-wide efforts unfold at unprecedented scale and pace. Whereas there is always scope for more activity, industry is currently contributing in a variety of ways. Examples include pharmaceutical companies donating existing compounds to assess their utility in the fight against COVID19; screening existing compound libraries in-house or with This perspective argues for the need to establish more sustainable and scalable ways of incentivising pharmaceutical innovation in response to infectious disease threats to public health. partners to see if they can be repurposed; accelerating trials for potentially effective medicine or vaccine candidates; and in some cases rapidly accelerating in-house research and development to discover new treatments or vaccine agents and develop diagnostics tests.3,4 Pharmaceutical companies are collaborating with each other in some of these efforts and participating in global R&D partnerships (such as the Innovative Medicines Initiative effort to accelerate the development of potential therapies for COVID-19) and supporting national efforts to expand diagnosis and testing capacity and ensure affordable and ready access to potential solutions.3,5,6 The primary purpose of such innovation is to benefit patients and wider population health. Although there are also reputational benefits from involvement that can be realised across the industry, there are likely to be relatively few companies that are ‘commercial’ winners. Those who might gain substantial revenues will be under pressure not to be seen as profiting from the pandemic. In the United Kingdom for example, GSK has stated that it does not expect to profit from its COVID-19 related activities and that any gains will be invested in supporting research and long-term pandemic preparedness, as well as in developing products that would be affordable in the world’s poorest countries.7 Similarly, in the United States AbbVie has waived intellectual property rights for an existing combination product that is being tested for therapeutic potential against COVID-19, which would support affordability and allow for a supply of generics.8,9 Johnson & Johnson has stated that its potential vaccine – which is expected to begin trials – will be available on a not-for-profit basis during the pandemic.10 Pharma is mobilising substantial efforts to rise to the COVID-19 challenge at hand. However, we need to consider how pharmaceutical innovation for responding to emerging infectious diseases can best be enabled beyond the current crisis. Many public health threats (including those associated with other infectious diseases, bioterrorism agents and antimicrobial resistance) are urgently in need of pharmaceutical innovation, even if their impacts are not as visible to society as COVID-19 is in the immediate term. The pharmaceutical industry has responded to previous public health emergencies associated with infectious disease in recent times – for example those associated with Ebola and Zika outbreaks.11 However, it has done so to a lesser scale than for COVID-19 and with contributions from fewer companies. Similarly, levels of activity in response to the threat of antimicrobial resistance are still low.12 There are important policy questions as to whether – and how – industry could engage with such public health threats to an even greater extent under improved innovation conditions. The COVID-19 pandemic is a game-changer among global public health threats. The risk to human life (both in terms of morbidity and quality of life), the economic risks, the epidemiology of the disease and speed of escalation have led to a crisis-response by many governments around the world. This has in turn influenced the immediate industry efforts. Many other infectious disease threats may not manifest as crises in the short term and in the same way as COVID-19, but they could nevertheless escalate. They are not considered to be crises from a short term perspective because they are contained to specific regions and affect fewer people at present – or are re-emerging (e.g. Ebola) – or their impacts have not yet materialised at a scale that would The emerging threats raise important policy questions about how government and the pharmaceutical industry can work together.
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2AC › Adv --- Pharma › S --- Drug Patents Key
Mossinghoff and Bombelles 96. [Gerald J, JD, former Commissioner of Patents and Trademarks, former president, Pharmaceutical Research and Manufacturers of America; Thomas, Director of International Government Relations, Merck & Co., Inc.; “Intellectual Property Protection And The Pharmaceutical Industry,” Oblon, //cpsw-ay]
Without adequate and effective patent protection, the research-based pharmaceutical industry would not exist. Fortunately, the standards for protection of intellectual property in the United States, Europe, and Japan are, for the most part, adequate. In these regions, there is a mechanism for extending pharmaceutical patent terms to compensate in some measure for the years of effective patent life lost during the lengthy regulatory approval process.
Regrettably, however, intellectual property in the pharmaceutical field is not respected worldwide. Beginning in the 1980s, PhRMA and its member companies began a sustained campaign to make the protection of Americal intellectual property a priority in trade policy. As U.S. comparative advantage has shifted away from basic industrial manufacturing to high technology industries, the protection of intellectual property has become a cornerstone of American economic foreign policy.
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2AC › Adv --- Pharma › AT: Declining Virulence
Orent 11-16-2020. [Wendy, Ph.D., science writer w/ focus on pandemics & infectious disease; “Will the Coronavirus Evolve to Be Less Deadly?,” Smithsonian Magazine, //cpsw-ay]
A second theory, developed by evolutionary epidemiologist Paul Ewald, which he calls the "theory of virulence,” suggests that, as a rule, the deadlier the germ, the less likely it is to spread. The reason: If victims are quickly immobilized (think of Ebola, for example), then they can’t readily spread the infection. By this thinking, if a germ requires a mobile host to spread, its virulence will, of necessity, decline. Like the older conventional wisdom, the theory of virulence recognizes that many germs will evolve less virulence as they circulate and adapt to the human population. But Ewald’s theory also proposes that germs all have their own strategies to spread, and some of those strategies allow the germ to maintain high virulence and transmissibility.
Durability, Ewald says, is one such strategy. Variola virus, which causes smallpox, is very durable in the external environment, and it can have a high death rate of 10 to 40 percent. Ewald calls it and other durable germs “sit-and-wait” pathogens. Some deadly infections are spread from very sick hosts by vectors: fleas, lice, mosquitos, or ticks. Others, such as cholera, are spread in water. Still others, such as hospital-acquired staph infections, are spread by people taking care of the sick or dying. This is what happened in the women’s hospitals of the 19th century, when doctors spread puerperal or “childbed” fever from one postpartum woman to another.
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2AC › Adv --- Pharma › AT: Declining Virulence
Alderson 6-21-2021.[Rosie, Ph.D., science writer, “No, Viruses Don’t Always Evolve to Become Less Deadly,” Medium, //cpsw-ay]
Does increased virulence always lead to a decrease in viral fitness? Perhaps not — the virus may still be able to transmit to many others even if its host is very ill, and, if like SARS-CoV 2, the time between infection and death is relatively long, the ultimate death of the host will ‘not matter’ to the virus, since it will have had sufficient time to replicate and transmit to many others in the interim. Australian scientists Anderson and May developed this line of thinking, called the ‘trade-off’ model in the 1970s, which was a direct rebuttal to the previously widely-held ‘law of declining virulence’.
The consequences of the ‘trade off’ model are important: if we follow May and Anderson’s logic, it cannot be assumed that increased virulence decreases the fitness of any given pathogen. Rather, a pathogen’s ‘fitness’ is determined by its individual relationship to the host — increased virulence may or may not, make a difference to viral replication and transmission. No broad-brush statements can be made about the trend of viral virulence over time, we must consider pathogen’s relationship to their host individually.
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2AC › Adv --- Pharma › ! --- Disease
Martin 19 [Sean Martin holds two graduate diplomas from the London Academy of Music and Dramatic Art in both Acting and Directing, as well as a Bachelor of Fine Arts degree in Theatre from Abilene Christian University, 9/2/2019, “Disease X could kill millions and 'we're not prepared' - Bill Gates' shock warning; NUCLEAR war is not the biggest threat to humanity, but rather Disease X which has the potential to wipe out tens of millions of people, according to Bill Gates who warned "we're not ready".”, Source – Database: LexisNexis through the University of Michigan, cpsw/bvn sp]
The Ebola outbreak from 2014 through to 2016 should be a stark warning to humanity that a disease could pop up seemingly out of nowhere. During the Ebola outbreak, almost 12,000 people died, according to the Centers for Disease Control and Prevention , with most of the fatalities coming in West Africa. Tech billionaire Bill Gates has warned that another fatal disease could emerge on a more global scale - and there is little being done to prevent it.
The Microsoft chief said "we're not ready" for the next epidemic at a 2015 Ted Talk, claims which have resurfaced thanks to journalist Brian Walsh's new book End Times, which examines the existential threats to humanity.
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2AC › Adv --- Pharma › ! --- Disease
CE Noticias Financieras English 21 [CE NoticiasFinancieras (formerly known as Noticias Financieras) is content in English, Portuguese and Spanish, that provides breaking business, financial, and economic news from across the entire Latin American region, and much more, 1/23/21, “"X-disease," the next threat to humanity that worries WHO”, Source – Database: LexisNexis through the University of Michigan, cpsw/bvn sp]
The Covid-19 pandemic, little by little and with some setbacks and many tragedies, will come to mind. This coronavirus may disappear and then reappear, continue endemic under the control of the vaccine or simply attenuate and disappear. The economy and health systems will return to a new normal, some parts more quickly than others.
Like the multiple plagues humanity has endured since our ancestors gathered in cities- an investigation published by the U.S. National Center for Biotechnological Information (NCBI) - this pandemic will generate recriminations for slow and misguided responses, speculation, and exaggerated or insufficient reactions to economic, social, and health events that , retrospectively, will be obvious.
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2AC › Adv --- Pharma › ! --- Disease
CE Noticias Financieras English 24 [CE NoticiasFinancieras (formerly known as Noticias Financieras) is content in English, Portuguese and Spanish, that provides breaking business, financial, and economic news from across the entire Latin American region, and much more, 1/16/24, “Where could "disease X", listed as more dangerous than Covid-19, emerge?, Source – Database: LexisNexis through the University of Michigan, cpsw/bvn sp]
Disease "X": WHO warns it will be 20 times more deadly than Covid-19
•WHO: What exactly is Disease X? It could be more lethal than Covid-19
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2AC › Adv --- Pharma › ! --- Disease
Michael Prasad 07-2023, Michael Prasad is a Partner and Head of PJT Park Hill’s Alternative Credit/Hedge Funds European and Middle East distribution group, based in London. " Global Pandemics are Extinction-level Events and Should not be Coordinated Solely through National or Jurisdictional Emergency Management", Homeland Security Affairs, || 苗
While COVID-19 may have started in the United States as a small outbreak in Washington state on January 20, 2020, it expanded exponentially across the entire country in a matter of weeks. And at the same time, the virus spread worldwide.[4] The size and scope moved the incident typing off the scale[5]; there were no additional resources available anywhere, nor was there proper planning in place for this level of incident. There are hazards and threats for which emergency management cannot plan, organize, equip, train, and exercise because they are too complex. One way to quantify them is to describe them as Type 0 – Extinction Level Events.[6]
When the phrase ‘Extinction-Level Event’[7] is mentioned, thoughts turn towards world-changing events – such as asteroid strikes, nuclear war, and even climate change/global warming. None of those tragedies have their response and recovery missions coordinated through their national emergency management process. There is a cap to the maximum of maximums of the capabilities and capacities for national and jurisdictional emergency management agencies and departments – as well as the concepts of the Incident Command System within the field of emergency management itself. When a disaster expands[8] beyond the capability of the internal sub-jurisdictions within a nation, that jurisdiction usually requests assistance upward, all the way to the national level for support. When the nation itself needs support beyond its own capabilities, it can choose to reach out to partner nations, intergovernmental organizations, or non-governmental organizations for additional support (i.e., NATO, the United Nations, the Red Cross/Red Crescent National Societies across the globe, etc.). When all the nations are impacted at the same time by the same incident – and there is no one unimpacted left to help – that constitutes a worldwide catastrophe. Can any such incident be managed within a single nation’s borders? Maybe, but not by or through emergency management, since the decisions about all aspects of the disaster phase cycle missions of Preparedness/Prevention/Protection, Response, Recovery, and Mitigation are a matter of national security and economic development.[9]
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2AC › Adv --- Pharma › AT: Economies bounce back
Rogoff 20 [Kenneth Rogoff is the Thomas D. Cabot Professor of Public Policy and professor of economics at Harvard University. Publishes articles on the international monetary fund’s website, March 2020, “THE LONG-LASTING ECONOMIC SHOCK OF WAR”, , cpsw/bvn sp]
Russia’s invasion of Ukraine is an unmitigated catastrophe for global peace and particularly for peace in Europe. But the war also greatly compounds a number of preexisting adverse global economic trends, including rising inflation, extreme poverty, increasing food insecurity, deglobalization, and worsening environmental degradation. In addition, with an apparent end to the peace dividend that has long helped finance higher social expenditures, rebalancing fiscal priorities could prove quite challenging even in advanced economies.
To begin by stating the obvious, war-torn Ukraine is in a state of severe economic distress. In addition to the destruction of physical capital, millions have fled the country, and countless thousands have been killed or maimed. This comes on top of a generalized rise in economic distress around the world as a result of the COVID-19 pandemic. According to the World Bank, the number of people living in extreme poverty rose by roughly 100 million to nearly 700 million; a significant share live in conflict regions.
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2AC › Adv --- Pharma › ! --- Econ
Walt 20 [Stephen M. Walt is a columnist at Foreign Policy and the Robert and Renée Belfer professor of international relations at Harvard University, 5/13/20, “Will a Global Depression Trigger Another World War?”, , cpsw/bvn sp]
By many measures, 2020 is looking to be the worst year that humankind has faced in many decades. We’re in the midst of a pandemic that has already claimed more than 280,000 lives, sickened millions of people, and is certain to afflict millions more before it ends. The world economy is in free fall, with unemployment rising dramatically, trade and output plummeting, and no hopeful end in sight. A plague of locusts is back for a second time in Africa, and last week we learned about murderous killer wasps threatening the bee population in the United States. Americans have a head-in-the-sand president who prescribes potentially lethal nostrums and ignores the advice of his scientific advisors. Even if all those things magically disappeared tomorrow—and they won’t—we still face the looming long-term danger from climate change.
Given all that, what could possibly make things worse? Here’s one possibility: war. It is therefore worth asking whether the combination of a pandemic and a major economic depression is making war more or less likely. What does history and theory tell us about that question?
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2AC › Adv --- Pharma › ! --- Econ
Namsuk Kim and Pedro Conceição, Spring-Summer 2010. Namsuk Kim works for the UN, and Pedro Conceição is Director of the Human Development Report Office, United Nations Development Programme (UNDP) since January 2019. " THE ECONOMIC CRISIS, VIOLENT CONFLICT, AND HUMAN DEVELOPMENT", International Journal of Peace Studies, Volume 15, Number 1.
An adverse economic shock can be dangerous because its impact may be longlived if countries are forced into a vicious cycle of low human development and conflict. While conflict might be caused by many factors, low levels of human development increase the risks of conflict outbreaks and recurrence. Conflict, in turn, destroys the accumulated physical, social and human capital. The linkage between conflict and human development may form a self reinforcing cycle. The possibility of countries entering low human development – conflict traps implies that policies that sustain human development will eventually contribute to reduction of the risk of conflict. It suggests that there exists an additional benefit of policies that enhances human development, to the extent that enhanced human development reduces risks of conflict. The consideration of these benefits may lead to a re-assessment of policies that appear very costly when these benefits are ignored.
It is important to pursue policies that mitigate the risks of conflict outbreak, especially when countries are facing, as in the context of the current crisis, sharp economic slowdowns. International efforts on peacekeeping can play a significant role in peace building. Doyle and Sambanis (2006) review the evidence on United Nations peacekeeping missions and find that they are associated with a higher likelihood of peace two years after the end of the war. Their multivariate regressions show that international capacity and hostility variables are very robust and local capacity variables less so due to their competitive interaction with other covariates. Fortna (2008) also demonstrates that peacekeeping is an extremely effective policy tool, dramatically reducing the risk that war will resume. Relatively small and militarily weak consent-based peacekeeping operations are often just as effective as larger, more robust enforcement missions. However, peacekeeping does not guarantee the expected result. The effectiveness of peacekeeping is still being studies, and the policy options should be carefully considered. Foreign aid and development support can also have an impact in reducing the risk of civil war. Collier and Hoeffler (2002) suggest that aid and policy do not have direct effects upon conflict risk, but both directly affect the growth rate and the extent of dependence upon primary commodity exports, and these, in turn, affect the risk of conflict. Simulating the effect of a package of policy reform and increased aid on the average aid recipient country, they find that after five years the risk of conflict is reduced by nearly 30%. De Ree and Nillesen (2006) propose GDP levels of donor countries as new and powerful instruments for foreign aid flows in the conflict regression for subSaharan Africa. They find a 10 percent increase in foreign aid decreases the risk of civil conflict by about six percent. The current economic crisis, in addition to the potential devastating economic and human development impacts that it may originate, increases the risk of pushing some developing countries into a low human development – conflict trap. And consequently, policy measures to sustain human development would also have an additional indirect impact in lowering the risk of conflict.
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2AC › Adv --- Pharma › AT: Vaccine Hesitancy
Motadel 4-29-2021. [David, Ph.D., Associate Professor, International History, London School of Economics and Political Science; “Vaccine Hesitancy Is as Old as Vaccines. I Take Comfort in That,” New York Times, //cpsw-ay]
Throughout history, critics of vaccines have argued that immunization is more dangerous than disease itself. They have claimed that there are malicious, nonmedical reasons behind vaccinations, such as the profiteering of Big Pharma and biological schemes intended to reduce the human population. And they have been driven by exquisitely complex and diverse reasons: uncertainty, fear, science skepticism, anti-intellectualism and anti-elitism; sometimes they are motivated by profit.
But although attempts to delegitimize vaccines have posed a serious threat to human health, anti-vaccination movements, at least in the long run, have never succeeded in stopping rollouts. The spread of medical information, which took away most people's fear of the unknown, as well as the actual experience of the successes of vaccinations, have made populations increasingly less receptive to anti-vaccination messaging -- even as communicating those messages has gotten easier.
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2AC › Adv --- Pharma › AT: Vaccine Hesitancy
Lim et al. 2024. [JungKyu Rhys, Ph.D., Behavioral Scientist, Mind, Behavior, and Development Unit, Development Impact, World Bank; “Using social media surveys and interventions to address vaccine hesitancy in Saudi Arabia,” EMHJ Vol. 30 No. 3, //cpsw-ay]
Our experiment revealed that all message framings (i.e. expert, dynamic social norms, safety, efficacy and pro-social messages) were equally effective and that unvaccinated participants overwhelmingly intended to get vaccinated. Regarding vaccination intentions, researchers have commonly used behavioural intentions to predict behaviours in experiments (33), and one meta-analysis examining 47 experiments found that a medium-to-large change in behavioural intention (d = 0.66) led to a small-to-medium change in behaviours (d = 0.36) (33).
Our experiment leveraged an online survey and employed cutting-edge risk communication techniques (25,26,34-38) to examine which messages could increase vaccination intention relatively early for vaccination roll-out in the Kingdom of Saudi Arabia. Most of the previous research in Saudi Arabia focused on identifying factors predicting vaccination intentions using cross-sectional surveys (18-21). In contrast, previous experimental research conducted in other regions had mixed findings (3437). For example, vaccine safety messages encouraged vaccination intentions (34) in Latin America (39), the United Kingdom (40), and USA (41), but not among unvaccinated adults in California (42) and adults in Poland (43). Social norms messages increased vaccination intentions among healthcare workers (44) and adults (41) in the USA but not in Poland (43) and the United Kingdom (45). Sharing expert opinions about the COVID-19 vaccine increased vaccine uptakes in the Czech Republic (32). Our framing experiment provides causal evidence to support communication campaign designs and adds evidence from non-Western societies (34-38,46).
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2AC › Adv --- Pharma › L --- PTAB hurts small innov
(nexis isn’t working on my computer---will finish this cite later!) [cpsw – qls ms]
The America Invents Act of 2011 and its effect on Small Business Inventors In October 2013, when the first reports of the effects of the America Invents Act (AIA) became available, Federal Circuit Chief Judge Rader described the AIA's Patent Trial and Appeal Board ("PTAB") as "death squads killing property rights". By March 2014, more numbers emerged showing the effectiveness of the PTAB post issuance procedures. n33 More than 80% of the patent claims challenged are instituted for trial. Once instituted for trial, the PTAB is canceling 95.2% of all claims. n34 This means the vast majority of asserted patents now face getting invalidated. In light of the March PTAB numbers, Rader noted that his "death squad" comments may be more accurate than originally thought. n35 So, for inventors, after having paid about $75,000 for a patent, they now are in the position of a homeowner who finds that their house title is worthless. After spending years inventing, testing, and obtaining their patent, the inventor is now told all of their efforts were in vain. Most significantly, these property rights are being extinguished by a non-Article III court. To invalidate a patent in a court requires a showing of clear and convincing evidence with the burden of proof on the challenger. n36, n37 The PTAB procedures require only the lowest evidentiary standards n38 to open the door to a PTAB procedure. Then the burden of proof is switched to the patent holder, and the procedure is structured to require validation of the patentability tests a second time, like re-applying as if the first grant was moot and in dramatic contrast to the settled judicial procedure previously required to invalidate the patent. Some argue that in the end it is still fair because the patent holder can appeal to the Federal Circuit. However, the Federal Circuit is not a trial court and therefore does not control evidence, witnesses or other submissions, it is not the finder of fact, and the burden of proof again is on the patent holder. The cost of a PTAB review to the patent holder can exceed $250,000 and burn a year and a half of the patents already limited term. In sum, the patent holder has little recourse as the fight is almost always over when the PTAB invalidates. Statutory law applies the settled, 200 year old precedent demanding the presumption of validity which was defined by the Supreme Court to require clear and convincing evidence with the burden of proof on the challenger in a process structured to invalidate the patent. This result was blocked in the back rooms of the United States Patent and Trademark Office by implementing the new PTAB procedures. The effects of the AIA are just now coming to light and those effects are proving themselves to be devastating to small patent-based businesses and independent inventors. It is not surprising that during the first two months of 2014 the number of new patent cases dropped 25% over 2013. n39 The number is likely to fall even further as more and more inventors realize the risk. The consequences will spread across our economy causing grave damage to investment in patents. In 2010, America's most IP-intensive industries accounted for $5.06 trillion in value, or 34.8 percent of U.S. gross domestic product and IP-intensive industries generated 27.7 percent of all jobs in the U.S. economy. n40 The AmiCOUR IP Group's brief of Amicus Curiae in the high profile case Microsoft v i4i heard by the United States Supreme Court analyzed similar effects of a proposed lowering of the bar to invalidate a patent. AmiCOUR wrote, "Publicly held corporations will have to report any material devaluation to shareholders and the Securities and Exchange Commission (SEC), resulting in a devastating impact on patent centric companies. Hardest hit will be the high tech and biotech firms, which contribute significantly to U.S. economic growth, particularly through job creation and whose innovations are primarily responsible for the United States' edge over global competitors." This drop in IP value is in large part due to the ease at which a patent can be invalidated, and in part due to current legislative efforts to further diminish the value of granted patents. As noted previously, 80% of patents are admitted into a PTAB procedure and 95% of those admitted are invalidated. Using simple math, a patent has a 76% chance of invalidation. This high likelihood of invalidation is substantially decreasing the values of patent assets across the board. Aside from the chilling effects on innovation as there is no certainty that capital invested can ever be recovered, Sarbanes-Oxley require that this substantial change in patent asset values be written down on the books of thousands of companies. In the United States, patent assets are valued at $5.06 trillion so this write down could conceivably be as large at $3.84 trillion. Also under Sarbanes-Oxley, failure to do so is criminal and could land the CEO and CFO in jail. A write down this large would no doubt cascade negatively across our economy and will likely cause severe disruption in capital markets. The simple economics of lower business valuation in response to the measurably diminished ability to exclude competition would, in fact, be very real. The patent system is dead for all except large corporations thanks to the AIA. While the write-down may be unavoidable at this point, if we pass the current patent reform legislation thus expanding PTAB procedures, we will bury the patent system altogether along with the economic future of our nation. Instead, we need to go the other direction and strengthen patent rights. We can still save what is left of the patent system and avert economic disaster. To do this, we must first reject the current round of patent reform altogether and assess the full degree of damage caused by the AIA. This is extremely important to SBIR firms as they have received about 100,000 patents. This devaluation of patents is hurting the small high-tech, job-creating SBIR businesses, and thus the economy.
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2AC › Adv --- Pharma › L --- PTAB hurts small innov
Morinville and Metz 24 [Paul Morinville is the Founder and former President of US Inventor, Inc., which is an inventor organization in Washington D.C. that advocates strong patent protection for inventors and startups. Molly Metz is the innovator of JumpNRope and was granted two patents for her innovations, and is an active writer for IPWatchDog. “Hopelessly inexperienced PTAB judges are destroying US innovation” Innovation Gadfly; February 19, 2024; ] ARL
In December 2023, the Senate IP Subcommittee held a hearing on the Promoting and Respecting Economically Vital American Innovation Leadership Act, S.2220 (PREVAIL), which affects the Patent Trial and Appeal Board (PTAB).
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2AC › Adv --- Pharma › L --- PTAB hurts small innov
Duff 2013. [Douglas, Registered Patent Attorney, “The Reexamination Power of Patent Infringers and the Forgotten Inventor,” 41 Cap. U.L. Rev. 693, , Available on L/N //cpsw-ay]
Not only does an infringer enjoy the limitless opportunities to attack a patent using reexamination, the infringer also benefits from the fact that the standard for patent validity is lower in reexamination than it is in federal court. 86 If a patent is challenged in district court, the patent is presumed valid. 87 In order for the accused infringer to invalidate the inventor's patent rights in district court, the infringer must show clear and convincing evidence that the patent was erroneously granted. 88 Presuming validity reflects the court's respect for research and expertise involved in a long and scrutinizing examination at the USPTO. 89
In contrast, during ex parte reexamination and inter partes review, the examiner determines validity of the previously allowed patent by a preponderance of the evidence. 90 Reexamination gives no deference to the initial patent examination. 91 Just as the patent was initially examined at the [*705] USPTO, the claim language is given its broadest reasonable interpretation consistent with the specification. 92 The examiner tasked with reexamination does not attack the validity of the previously-granted intellectual property right, but rather "conduct[s] a subjective examination of the claims in light of prior art." 93