Aff - Judicial Exceptions - MSDI 2024

AFF – Judicial Exceptions
1AC – Judicial Exceptions (Core)
1AC – Inherency
Alice-Mayo explained – it is gutting innovation
Adam Mossof January 8, 2020 GMU Law Prof, Visiting Intellectual Property Fellow Heritage Foundation, and a Senior Fellow at the Hudson Institute LEGAL MEMORANDUM No. 257 | EDWIN MEESE III CENTER FOR LEGAL & JUDICIAL STUDIES Congress Should Reform Patent Eligibility Doctrine to Preserve the U.S. Innovation Economy https://www.heritage.org/sites/default/files/2020-01/LM257.pdf (ermo/sms, Acc:7-5-2024) [MSDI-JE-wk1]
Among the many changes in the patent system wrought by the Supreme Court in the past decade were four decisions between 2010 and 2014 on patent eligibility doctrine under § 101.13 These four decisions culminated in the “Alice-Mayo framework”—a new two-factor inquiry that courts and the U.S. Patent & Trademark Office (USPTO) have applied since 2014 in assessing whether an invention or discovery qualifies under § 101 as an invention or discovery that is patentable under the Patent Act even if it is new, useful, and fully disclosed in the patent.14
The Alice-Mayo framework does not apply the statutory text of § 101, but rather the judicially created exclusionary rule prohibiting patents issuing on abstract ideas, laws of nature, or physical phenomena. The two-factor inquiry is: (1) determine whether the patent claims an abstract idea, natural phenomenon, or law of nature that are ineligible for patent protection, and, if so, (2) determine if the patent claims something more that transforms it into a patent-eligible application (an “inventive concept”) of one of these ineligible categories or is this additional activity in the claim merely well-understood, routine, and conventional activity in the art.
As a new framework for applying patent eligibility doctrine in § 101, the Alice-Mayo framework has severely restricted the inventions and discoveries that have long been considered patentable for over two centuries in the U.S. patent system. All of the legal requirements for a valid patent, including that the invention or discovery be eligible for patent protection, are applied by examiners who review patent applications filed at the USPTO. The job of an examiner is to make sure that the applicant is seeking the protection for the fruits of his or her truly inventive labors in creating a new machine or process or in discovering a new composition of matter (such as a molecule that works as a drug treatment for cancer).
1AC – Plan
The United States federal government should substantially strengthen its protection of domestic intellectual property rights in patents by eliminating the judicial exceptions in 35 U.S. Code Sec. 101.
1AC – Solvency
Congress should abrogate Alice-Mayo, treating the claimed invention as a whole
Adam Mossof January 8, 2020 GMU Law Prof, Visiting Intellectual Property Fellow Heritage Foundation, and a Senior Fellow at the Hudson Institute LEGAL MEMORANDUM No. 257 | EDWIN MEESE III CENTER FOR LEGAL & JUDICIAL STUDIES Congress Should Reform Patent Eligibility Doctrine to Preserve the U.S. Innovation Economy https://www.heritage.org/sites/default/files/2020-01/LM257.pdf (ermo/sms, Acc:7-5-2024) [MSDI-JE-wk1]
The evidence that this contradicts long-standing U.S. patent doctrine is made clear by explaining how the courts’ application of the Alice-Mayo framework today would result in the invalidation of the very first patent that was issued in the U.S. under the first Patent Act of 1790. The first U.S. patent issued was to Samuel Hopkins in 1790 for his discovery of a new method of making potash.62 His novel method comprised well-known steps at the time, such as burning and dissolving ash. Hopkins’ claimed discovery was in the timing and order of the steps in the process.63
If Hopkins’ patent were challenged today and the courts applied their now-established methodology in construing it under the Alice-Mayo framework, they would first find that the elements of timing one’s steps in a process and using heat are abstract ideas, laws of nature, or natural phenomena—and thus ineligible for patent protection. Under the second step of the Alice-Mayo framework, a court would find that Hopkins did not add anything “inventive” to the steps beyond timing and heating contributions, all of which were well-known and conventional at his time. Thus, it is an entirely logical application of the Alice-Mayo framework today to find the first U.S. patent for a process of making potash to be ineligible for patent protection.
This is significant because Hopkins’s patent application was reviewed, approved, and signed by Thomas Jefferson as Secretary of State, who was a member of the three-person committee created under the 1790 Patent Act to review patent applications. Jefferson was both a drafter of some of the early patent laws and is known today for his belief that patents should be granted rarely and for only truly innovative inventions.64 Moreover, Hopkins’s patent was issued under the 1790 Patent Act, which was drafted and enacted into law by the original Framers of the Constitution, who were then serving in the First Congress.65 In fact, the other two members of the committee that reviewed Hopkins’ application and approved his patent were President George Washington and Attorney General Edmund Randolph, both of whom were members of the Constitutional Convention of 1787.
When a set of Supreme Court decisions between 2010 and 2014 claiming to apply a statutory provision that has been in existence since 1790 would, if applied to the first U.S. patent, call into question its validity, this is cause to question if the Supreme Court has rightly followed the law that has existed since the first Patent Act of 1790. It is especially concerning when this first patent was reviewed and signed by two prominent members of the Constitutional Convention (Washington and Randolph) and a prominent Founder (Jefferson) who is largely known today for his skepticism about patents.
Thus, Congress should return the patent system back to promoting and securing innovation, especially for the key biopharmaceutical and high-tech sectors of the U.S. innovation economy in the 21st century that have been hardest hit by the Alice-Mayo framework. It should abrogate the Alice-Mayo framework, reestablish the role of the courts to apply the statutory language it has enacted in § 101, and mandate that courts follow basic legal rules applied historically and in other patentability doctrines, such as that courts must always assess the claimed invention as a whole.
US patent protections critical to start ups
Christopher Borges, 12-11-2023, is a program manager and associate fellow with the Geoeconomics Center at the Center for Strategic and International Studies (CSIS) in Washington, D.C. Alexander Kersten is deputy director and a fellow of the Renewing American Innovation Project at CSIS. https://www.csis.org/analysis/new-efforts-promote-us-innovation-pera-and-prevail-act-context, "New Efforts to Promote U.S. Innovation: The PERA and PREVAIL Act in Context," No Publication (ermo/sms, Acc:6-28-2024)
The United States has a long tradition of technological innovation, and U.S. inventors and innovators continue to drive the creation of new companies, jobs, and economic growth. Secure intellectual property (IP) rights are essential to spur this innovation. Critically, patents transform ideas into property that can be assigned and protected, allowing small businesses to attract investment and collaborate with other firms with the assurance that their ideas will not be stolen. For this reason, the community of inventors, entrepreneurs, and start-ups repeatedly emphasize the importance of secure IP rights in providing them a path to market entry, growth, and fair participation.
However, there are actors who abuse the patent system to eliminate and extort competitors, stifling innovation by preying on start-ups, small businesses, and inventors that often do not have the resources to pursue expensive and time-consuming litigation. Some of the so-called Big Tech firms are known to infringe on patents and rely on large and well-compensated legal teams to drag out litigation and avoid penalties, or simply swallow fines as a cost of doing business. Other observers of the patent system decry “patent trolls,” who purportedly weaponize overly broad patents to extort legitimate businesses by initiating questionable lawsuits.
Start ups key to innovation
Christopher Borges, 12-11-2023, is a program manager and associate fellow with the Geoeconomics Center at the Center for Strategic and International Studies (CSIS) in Washington, D.C. Alexander Kersten is deputy director and a fellow of the Renewing American Innovation Project at CSIS. https://www.csis.org/analysis/new-efforts-promote-us-innovation-pera-and-prevail-act-context, "New Efforts to Promote U.S. Innovation: The PERA and PREVAIL Act in Context," No Publication (ermo/sms, Acc:6-28-2024)
A Balancing Act
Start-ups, small businesses, and independent inventors are essential to a robust economy and innovation ecosystem. They account for over 40 percent of U.S. economic activity and create two-thirds of new jobs. They take risks that established companies often do not, driving innovation, technological change, and economic growth. Many of the most impactful companies today were once start-ups. It is imperative to maintain a system of IP rights that encourages start-ups and protects the small actors in the economy.
1AC – Advantage Options
1AC – Biotech
SCOTUS exceptions crush biotech investment
Josh Saul, 5-1-2024, JD-2025, Fordham U, https://fordhamlawreview.org/issues/gene-patents-striking-the-right-balance-between-incentive-and-innovation/, "Gene Patents: Striking the Right Balance Between Incentive and Innovation – Fordham Law Review," No Publication (ermo/sms, Acc:6-28-2024)
1. Myriad Discourages Investment in Biotechs
One of the main disputes following Myriad was over what effect the decision would have on investments within the biotech industry. Although some argued that Myriad would open up the industry to greater collaboration,190 others saw Myriad as a harbinger of the downfall of American biotechs.191
Several studies have tried to get a handle on what impact Myriad actually had on the biotech industry. In “Patent Eligibility and Investment,” Professor David O. Taylor surveyed 475 venture capital and investment firms to find out.192 Taylor found that investors were generally less willing to invest in biotechs that did not have patent protection covering their most important products.193 He further found that almost 40 percent of investors who were aware of the Supreme Court’s decisions in Myriad, Mayo, and Alice believed that the decisions had negative effects on the firm’s existing investments; additionally, approximately 33 percent of firms indicated that these decisions caused them to shift investments away from impacted industries—especially biotechs and pharmaceutical companies.194 As a whole, the study indicated a general hesitancy of investment firms to back biotechs following Myriad. 195
In similar studies, others have found that, although investment in the biotech field continues to grow, it has done so at a slower rate after Myriad. Looking at venture capital investment data, A. Sasha Hoyt found that although investments in the biotech industry were higher than before Myriad, they were growing at a slower rate compared to other industries.196 Hoyt concluded that, had the Court not upended subject matter eligibility in Myriad, Mayo, and Alice, investments in disease diagnostic technologies would be $9.3 billion greater than their current level.197 Likewise, from analyzing venture capital data from 2004 to 2017, Professor Mark F. Schultz found that although venture capital investments have expanded in recent years, biotech’s share of those investments dropped significantly following Myriad. 198 Although biotechs and pharmaceutical companies constituted over 50 percent of the market share of startup investment in 2004, by 2017 their share had fallen to about 28 percent.199 Schultz determined that, absent some change in patent policy, a shift in investments away from biotechs would have a profound impact on the industry.200
Attempting to view the issue from a different angle, Professors Jay Kesan and Runhua Wang examined the impact of Myriad from the USPTO’s perspective.201 They found that, following Myriad, Mayo, and Alice, the USPTO experienced both a lower rate of patent applications and a higher rate of rejection of those applications than before these decisions.202 This effect was disproportionately felt in the fields most affected by the Supreme Court’s decisions, such as the biotech industry.203 Kesan and Wang concluded that both the greater uncertainty around patent approval and the increase in time and resources necessary to get a patent approved led to a reduction in the number of patent applications from biotechs.204
Collectively, these studies indicate that the Supreme Court’s decisions in Myriad, Mayo, and Alice have had a general chilling effect on investments in the biotech industry. They suggest that increased difficulties and uncertainties in the ability of biotechs to obtain patents has led to fewer biotechs patenting their inventions which in turn has led to less investment from venture capital firms.
Strong patent protections are vital to small research startups in biotechnology in getting products to market
Brenda Simon, (professor, California Western School of Law), 2020, Patents, Information, and Innovation, 85 Brook. L. Rev. (). Available at: https://brooklynworks.brooklaw.edu/blr/vol85/iss3/4
Intellectual property rights can encourage small and large companies in the biotech industry to enter into partnerships, facilitating the exchange of information. Smaller research startups typically lack the resources to meet the regulatory requirements associated with bringing a product to market, let alone cover the often extensive costs of manufacturing, marketing, and distributing a new product. Without intellectual property protection, other restrictions, or alternative mechanisms to reduce the risks of expropriation, many of these products would be less likely to make it to market. Even when alternative mechanisms or restrictions can function to mitigate expropriation risks at certain stages of the transaction, awareness of intellectual property rights may act as a further deterrence to would-be expropriators.
Biotech innovation key to disease mitigation.
Tulstrup 24 - Søren Tulstrup 05-02-2024 (President and CEO, Hansa Biopharma, . "Fueling the future: the role of biotech in advancing innovative science and delivering new medicines", No Publication, https://www.hansabiopharma.com/media/news-and-insights/fuelling-the-future-biotech-role/. accessed 5-28-2024) //MSUCB
Biotech companies are crucial to and at the forefront of the development of transformative and innovative new treatments that result in better patient outcomes. In fact, according to an industry report by Ernst and Young from 2022, small to midcap biotech companies are responsible for a growing number and share of FDA approvals.(1) To thrive, biotech companies must be able to navigate complex and high-risk, high-reward situations.
Advancements in the exciting field of gene therapy, as an example, are largely driven by the biotech industry, and thanks to the innovative new medicines being discovered and developed by biotech companies, patients with genetic disorders now have more and better treatment options.2-4 Biotech companies are helping to uncover underlying causes of diseases, better understand how to slow disease progression, and maybe even find cures for certain conditions. But with high reward comes high risk.
The risk comes not least in funding the complex, unpredictable, expensive, and time-consuming business of biotech. Research and development take time and require substantial investments – on average it takes more than a decade to bring a drug to market and costs close to USD 2 billion.5,6 This is an expensive waiting game for many shareholders who would like to see a faster return on their investment.
Disease risks extinction.
Kiseong Kim et al. 21. Department of Bio and Brain Engineering, KAIST; R&D Center, BioBrain Inc.; Department of ICT Convergence System Engineering, Chonnam National University; Bio-Synergy Research Center; Moon Soul Graduate School of Future Strategy. “Network Analysis to Identify the Risk of Epidemic Spreading.” Applied Sciences, vol. 11, no. 7, 7, Multidisciplinary Digital Publishing Institute, 01/2021, p. 2997
Several epidemics, such as the Black Death and the Spanish flu, have threatened human life throughout history; however, it is unclear if humans will remain safe from the sudden and fast spread of epidemic diseases. Moreover, the transmission characteristics of epidemics remain undiscovered. In this study, we present the results of an epidemic simulation experiment revealing the relationship between epidemic parameters and pandemic risk. To analyze the time-dependent risk and impact of epidemics, we considered two parameters for infectious diseases: the recovery time from infection and the transmission rate of the disease. Based on the epidemic simulation, we identified two important aspects of human safety with regard to the threat of a pandemic. First, humans should be safe if the fatality rate is below 100%. Second, even when the fatality rate is 100%, humans would be safe if the average degree of human social networks is below a threshold value. Nevertheless, certain diseases can potentially infect all nodes in the human social networks, and these diseases cause a pandemic when the average degree is larger than the threshold value. These results indicated that certain infectious diseases lead to human extinction and can be prevented by minimizing human contact. 1. Introduction The emergence of a pandemic is one of the various scenarios frequently discussed as a human extinction event, and it is listed as one of the global catastrophic risks in studies regarding the future [1,2,3]. In particular, several pandemics, such as the Black Death [4,5], Spanish flu [6], and those caused by smallpox [7], severe acute respiratory syndrome (SARS) [8], and Ebola [9], have affected a large population throughout history. The risk of pandemics increases with an increase in population mobility between cities, nations, and continents, thereby threatening humankind [10,11,12]. It is essential to analyze the epidemic spread in society to minimize the damage from epidemic disasters; however, extinctive epidemic spreading experiments have limitations in real-world situations, as they predict stochastic effects on the spread without considering the structure of human society. Network-based approaches have been proposed to overcome these limitations and perform epidemic spreading simulations by considering the network structure of numerous real-world connections [13,14,15]. These methods use various models of epidemic spreading, such as the susceptible–infectious–susceptible (SIS) [16,17,18], susceptible–infectious–recovered (SIR) [19,20,21], and Watts threshold models [22]. While these methods are mathematically convenient, they are epidemiologically unrealistic for various infections because they require exponentially distributed incubation and infectious periods [23,24,25]. Moreover, previous epidemic studies did not perform quantitative assessment of the pandemic risk depending on the network connectivity in individuals and fatality rate of various diseases [26]. In the present study, we applied an SIR epidemic model to a scale-free network with Monte Carlo simulation to identify the quantitative relationship between infectious diseases and human existence. Our fundamental hypothesis states that when the epidemic spreads to all nodes of the network and the fatality rate i

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