Neg - Judicial Exceptions - MSDI 2024

MSDI Judicial Exceptions – Neg
Neg – DA Link Help
Prices
Myriad overturn would drive up health care costs and hurt quality of care
Jorge L. Contreras (Contact Author), 2-15-2021, University of Utah - S.J. Quinney College of Law https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3808319, "COVID-19 as an Example of Why Genomic Sequence Data Should Remain Patent Ineligible," No Publication (ermo/sms, Acc:6-28-2024)
Patents on Genomic Sequences Increase Costs and Reduce Access to Medical Innovations
Myriad Genetics priced its genetic tests at a level beyond the means of many individuals, leading to widespread criticism of the company and the patents that gave it a monopoly over testing the BRCA1/2 genes. Issues surrounding access to genetic testing thus lay at the heart of the Myriad litigation. The issue of access was central to the American Civil Liberties Union, which brought the case, and its recruitment of numerous patient advocacy groups, health care providers, and medical societies as plaintiffs and amici curiae (Contreras, 2020). The Supreme Court’s decision invalidating most of Myriad’s gene patents was widely heralded as a victory for health care access. A return to the days of genomic sequence patents would reverse this victory and again enable private firms to wield legal exclusivity to increase patient costs, burden the health care system, and exclude those most in need from critical medical innovations.
Overturning Myriad drives up health care costs
ACLU, 6-23-2023, American Civil Liberties Union https://www.aclu.org/press-releases/aclu-condemns-congressional-bill-to-patent-human-genes-nature-and-abstract-ideas, "ACLU Condemns Congressional Bill To Patent Human Genes, Nature, and Abstract Ideas," American Civil Liberties Union (ermo/sms, Acc:6-28-2024)
WASHINGTON — The American Civil Liberties Union today announced its opposition to legislation introduced by Sens. Thom Tillis and Chris Coons. The Patent Eligibility Restoration Act of 2023, which was announced today by the senators, would eliminate the long-standing prohibition on patenting laws of nature, natural phenomena, and abstract ideas from U.S. patent law.
Ten years after the Supreme Court invalidated the patents on two human genes in AMP v. Myriad, the Patent Eligibility Restoration Act of 2023 threatens to reverse that critical ruling, and the 150 years of legal precedent before it. If passed, the Act would allow corporations and other entities to patent laws of nature and products of nature, including naturally-occurring genes, giving them exclusive domain over research, development, and analysis. Such monopolies would result in higher health care costs, deny patients access to their health information, and create new hurdles for developing technologies to fight cancer, pandemics, and much more.
“The government should not be granting exclusive rights to control something as personal and basic to the human body as our genes. Patents on nature and abstract ideas limit research, learning, and the free flow of information that benefits all of us,” said Sandra Park, senior staff attorney at the ACLU’s Women’s Rights Project. “The ACLU is proud to defend the ability of researchers, scientists, and patients to use what should be in the public commons to create true inventions, and we oppose this bill accordingly.”
The ACLU opposes patenting that would authorize exclusive control over access to something as fundamental to humanity as our genes. For decades, the U.S. Patent and Trademark Office granted patents on DNA once it was discovered and “isolated,” authorizing patents that covered at least 20 percent of the human genome. Because isolating DNA is a preliminary step in any type of genetic analysis, Myriad Genetics was able to stop all other laboratories from offering clinical testing of BRCA1 and BRCA2, two genes connected with hereditary breast and ovarian cancer risk, even when they wanted to offer different, cheaper, or more comprehensive testing methods.
In AMP v. Myriad, the ACLU filed a lawsuit on behalf of 20 geneticists, genetic counselors, women patients, cancer survivors, breast cancer and women’s health groups, and scientific associations representing 150,000 geneticists, pathologists, and laboratory professionals. On June 13, 2013, the Supreme Court stopped the practice and unanimously held that human genes, including those that are “isolated,” cannot be patented because they are “products of nature.” Recently, the CEO of Myriad Genetics, the defendant in the AMP v. Myriad Genetics suit, said that the Supreme Court “ruled correctly.”
The bill sponsored by Sens. Tillis and Coons directly overturns this Supreme Court decision by permitting companies to once again patent genes and other natural materials once they are merely “isolated” or otherwise used in some way. The bill would also permit companies to patent the connection between genes and different diseases, blocking efforts in the scientific community to better understand and respond to health conditions. Legislation reversing the Supreme Court precedent was opposed by over 150 groups when Sen. Tillis and others offered draft legislation in 2019.
Court Clog
Current stable precedents keeps patent controversies out of the Supreme Court
Adam Houldsworth, 7-7-2018, https://www.iam-media.com/article/all-the-big-legal-market-and-deals-news-the-life-sciences-sector-in-june, "All the big legal, market and deals news from the life sciences sector in June," No Publication (ermo/sms, Acc:6-28-2024)
Supreme Court refuses to grant certiorari in Cleveland Clinic Section 101 dispute – The United States Supreme Court decided not to address the way lower courts are applying criteria for patent subject eligibility, denying certiorari in Cleveland Clinic Foundation v. True Health Diagnostics. The Cleveland Clinic’s petition asked the court to review the 2017 decision of the Court of Appeals for the Federal Circuit to invalidate three of its patents relating to methods for testing for arterial damage and methods for treating patients with cardiovascular disease. Having applied the two-step Alice/Mayo test for determining patent subject eligibility under Section 101 of the Patent Act, the CAFC deemed the patents’ claims to be directed towards laws of nature and therefore unpatentable. The Supreme Court was asked to consider whether its Mayo decision authorises a district court to invalidate patents on the pleadings when there are disputed questions of fact, a disputed question of claim construction or scope, and/or an undeveloped evidentiary record; and whether the Federal Circuit erred in ruling that that a method involving natural phenomena is ineligible for patent protection if it claims known techniques that have been adapted for a new use and purpose not previously known in the art. Life sciences innovators, hoping for more clarity around the eligibility of method-of-treatment claims, will be disappointed with the Supreme Court's decision not to hear the case.
Clog link – the plan re-opens all settled patent law – everything would be re-litigated in depth
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)
3. Broad Congressional Overhauls Would Introduce Too Much Economic Instability
Some have advocated for sweeping congressional legislation to overturn Myriad, such as Senator Tillis’s Patent Eligibility Restoration Act.339 The bill would effectively reverse Myriad and set gene patents back to pre-2013 status.340 However, gene patents were not perfect before Myriad. 341 The Myriad suit was brought over very real concerns about the effects that gene patents had on healthcare costs and access by researchers.342 The bill, if enacted, would likely reopen those issues and reignite a number of debates over gene patents that would once again require judicial interpretation. Given the Supreme Court’s stance that genes should not be patentable, it is unclear whether those debates would lead to a different result. Such a move would likely provoke even greater uncertainty within the biotech industry and might ultimately prove counterproductive to the goal of reinvigorating investment in the field.
PESM is stable in the SQ – same language for 200 years
CRS 1-3-2024, Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role https://crsreports.congress.gov/product/pdf/IF/IF12563, " Patent-Eligible Subject Matter Reform: An Overview" (ermo/sms, Acc:6-28-2024)
Section 101 of the Patent Act
Patent-eligible subject matter generally refers to the types of inventions that may be patented. Section 101 of the Patent Act (35 U.S.C. §101) sets out four categories of patentable inventions: “any new and useful [1] process, [2] machine, [3] manufacture, or [4] composition of matter.” Through Section 101, Congress sought to ensure the patentability of “anything under the sun made by man” that meets all of the other requirements for patentability found in the Patent Act, such as novelty, enablement, and nonobviousness.
The statutory definition of patent-eligible subject matter under Section 101 has remained essentially unchanged for more than two centuries. Nonetheless, the scope of patenteligible subject matter has waxed and waned over time, depending on the trends in judicial decisions.
Innovation Links (also case turns)
Plan trades off with open source HGP, harming research
Jorge L. Contreras (Contact Author), 2-15-2021, University of Utah - S.J. Quinney College of Law https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3808319, "COVID-19 as an Example of Why Genomic Sequence Data Should Remain Patent Ineligible," No Publication (ermo/sms, Acc:6-28-2024)
In early 2021, new legislative proposals to strengthen patents, including by Senators Tillis and Coons, began to percolate as the Biden administration prepared to take office. Yet despite unsubstantiated claims that increased patent protection would have facilitated the speedier development and deployment of COVID-related diagnostics, vaccines, and therapies, there is ample evidence to suggest that, at least in the case of genomic sequences, a return to the days of patenting would have been counterproductive.
The Value of Open Genomic Data
The Genomic Commons
Since the Human Genome Project (HGP) (1988-2003), the field of genomic research has been characterized by norms of international collaboration and data sharing. Explicit patent deterrence strategies were embodied in the data sharing policies adopted by the governmental and philanthropic funding agencies that supported this research, resulting in a vast aggregation of genomic data that is available to researchers around the world — the “Genomic Commons” (Contreras & Knoppers, 2018). Contributions to this public store of knowledge were made not only by governmental and academic laboratories, but by pharmaceutical and biotechnology companies (Contreras & Knoppers, 2018). Research has shown that the public availability of genomic data from the HGP has significantly enhanced scientific research as compared to data that is maintained as proprietary (Williams, 2013)
Plan dissuades researchers from cooperation
Jorge L. Contreras (Contact Author), 2-15-2021, University of Utah - S.J. Quinney College of Law https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3808319, "COVID-19 as an Example of Why Genomic Sequence Data Should Remain Patent Ineligible," No Publication (ermo/sms, Acc:6-28-2024)
Genomic Sequence Data is a Basic Research Tool that Should be Broadly Available
A vast array of basic scientific research is enabled by knowledge of an organism’s genomic sequence. This research can lead to a better understanding of biochemical mechanisms and to medical innovations such as vaccines and therapeutics. As such, genomic sequence data are a form of basic “research tool” — a resource that can be used by multiple researchers to address different research questions. There is a broad policy consensus that research tools should be made as broadly available as possible to the research community (National Institutes of Health, 1999). Allowing one or a handful of entities to own this basic scientific information can hinder research when speed and international collaboration are needed most. Studies have shown that researchers were reluctant to study the patented BRCA genes, thereby reducing overall knowledge and scientific advancement, something that cannot be afforded in the face of an emergent global pandemic.
Patenting creates research bottlenecks
Jorge L. Contreras (Contact Author), 2-15-2021, University of Utah - S.J. Quinney College of Law https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3808319, "COVID-19 as an Example of Why Genomic Sequence Data Should Remain Patent Ineligible," No Publication (ermo/sms, Acc:6-28-2024)
Composition of Matter Patents Preempt all Uses of a Sequence
Because patents can claim genomic sequences as new “compositions of matter” (like polymers or metallic alloys), they preempt all possible uses of the patented sequences, whether or not envisioned by the patent holder (Contreras, 2020). The Supreme Court correctly recognized in Myriad that genomic sequences of biological organisms are not new forms of matter, even if they are isolated and purified in the laboratory. Reversing this holding would again allow individual patent holders to control all uses of a particular genomic sequence, thereby creating significant bottlenecks to effective research and development and granting patent holders a windfall with respect to applications of a discovery that they did not actually make.
Patenting hurts innovation via Monopoly
Jorge L. Contreras (Contact Author), 2-15-2021, University of Utah - S.J. Quinney College of Law https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3808319, "COVID-19 as an Example of Why Genomic Sequence Data Should Remain Patent Ineligible," No Publication (ermo/sms, Acc:6-28-2024)
Composition of Matter Patents Discourage Improvements
Because broad composition of matter patents cover all uses of a patented gene or variant, any improvement to a diagnostic test that the patent holder makes will likely be covered by its own patents. And because competitors are not permitted to offer competing diagnostic tests, a patent holder has little incentive to improve its own diagnostic tests once a patent is issued. That is, its broad patent is likely to cover both the original and improved tests, and no competing tests are allowed, giving the patent holder little motivation to improve the tests over which it already has monopoly control.
Alice/Mayo protects innovation by stopping hDNA patents
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 Patent Eligibility Restoration Act
Between 2010 and 2014, a series of Supreme Court decisions decreased the scope of patent-eligible subject matter. These decisions established a two-step test for determining patent-eligible inventions known as the Alice/Mayo test, which restricts patents related to laws of nature, natural phenomena, and abstract ideas. Under the restrictions of Alice/Mayo, many once-patentable inventions became patent ineligible, resulting in the nullification of hundreds of patents. Through 2020, 60 percent of patents challenged under the Alice/Mayo framework were invalidated. PERA will overrule these Supreme Court decisions and codify many categories of currently ineligible subject matter as patent eligible.
Critics of PERA argue that Alice/Mayo is a key tool for eliminating overly broad and vague patents, which benefits legitimate businesses and, ultimately, innovation. The Electronic Frontier Foundation, a digital rights advocacy group and strong critic of PERA, compiles examples of businesses utilizing Alice/Mayo to defend themselves from NPEs asserting broad and highly abstract patents. Engine, an industry association for start-ups, opposed an earlier version of PERA, stating it would “open doors to the type of weak, overbroad patents that preempt innovation and harm competition.”
Critics of PERA also argue that the subject matter that the bill codifies as patent-eligible should remain unpatentable. For instance, the Association of Molecular Pathologists strongly supports Alice/Mayo as it prohibits the patenting of isolated segments of human DNA, which it argues could stifle medical research, innovation, and treatment. Although PERA expressly states that unmodified human genes are not patentable, the ethics of patenting modified genes remains a contentious topic.
Elections
Plan kicks the hornet’s nest – brings is a wide range of incompatible views
CRS 1-3-2024, Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role https://crsreports.congress.gov/product/pdf/IF/IF12563, " Patent-Eligible Subject Matter Reform: An Overview" (ermo/sms, Acc:6-28-2024)
Stakeholder Views on Patent-Eligible Subject Matter Jurisprudence
Stakeholder views vary on whether the Alice/Mayo framework has positively or negatively affected the patent system’s ability to encourage investment in technology and encourage innovation. In June 2022, the U.S. Patent and Trademark Office (USPTO) submitted a report to Congress that reviewed public comments on patent subject matter eligibility from stakeholders, including legal associations, industry organizations, advocacy groups, nonprofit entities, businesses, law firms, practitioners, academics, and inventors. The variability in stakeholder views underscores an important aspect of patent and innovation policy: changes to patent policy often affect innovation differently depending on many factors, including, among other things, the economic sector, industry, and firm size in question.
Link: Ag biotech is widely disliked by the public
Blancke 15, Stefaan Blancke, 8-18-2015, "Why People Oppose GMOs Even Though Science Says They Are Safe," Scientific American, https://www.scientificamerican.com/article/why-people-oppose-gmos-even-though-science-says-they-are-safe/ PatHansen [MSDI-JE-wk1]
Genetically modified organisms (GMOs) have met with enormous public opposition over the past two decades. Many people believe that GMOs are bad for their health – even poisonous – and that they damage the environment. This is in spite of overwhelming scientific evidence that proves that GMOs are safe to eat, and that they bring environmental benefits by making agriculture more sustainable. Why is there such a discrepancy between what the science tells us about GMOs, and what people think? To be sure, some concerns, such as herbicide resistance in weeds and the involvement of multinationals, are not without basis, but they are not specific to GMOs. Hence, another

Preview shortened. Download the file for the full document.