concept illustration of genes in DNA.

A Response to ‘Another Legislative Attempt to Revive Gene Patenting’

By Emily Michiko Morris

Professor Jorge Contreras’ commentary on the Patent Eligibility Restoration Act of 2022 objects to Senator Thom Tillis’ recently introduced bill. Specifically, he argues that proposed inclusion of isolated and purified human genes and other naturally occurring substances as patent eligible subject matter is unnecessary and would both stymie research and obstruct access to medicine. But the truth is these criticisms rely mostly on narrative and anecdote rather than rigorous empirical evidence. (Professor Contreras has written an article acknowledging the many narratives behind the gene patenting debate: see Narratives of Gene Patenting, 43 Fla. St. U. L. Rev. 1133 (2016)).

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graphic of test tube with double helix inside it

Another Legislative Attempt to Revive Gene Patenting

By Jorge Contreras

In its unanimous 2013 decision in Association for Molecular Pathology v. Myriad Genetics (569 U.S. 576) the U.S. Supreme Court held that naturally occurring genomic sequences are not eligible for patent protection.  Not surprisingly, some representatives of the biotechnology industry, and many patent lawyers, reacted negatively to the decision, and have steadily lobbied Congress to restore patent protection for isolated and purified genomic sequences.  On August 2, 2022, Senator Thom Tillis (R-NC) accommodated them with the Patent Eligibility Restoration Act of 2022, a bill that, if enacted into law, would reverse the Myriad decision and a decade of subsequent legal developments. Such a reversal would have serious implications not only for access to healthcare, but also the ability to respond rapidly and effectively to new viral outbreaks.

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Gavel and stethoscope.

The Journal of Law and the Biosciences’ Growing Impact

The Journal of Law and Biosciences, a co-venture between Duke University, Harvard Law School, and Stanford University, offers high-quality, open-access scholarship at the intersection of the biosciences and law. The Journal, which is published by Oxford University Press, is the first fully open-access, peer-reviewed legal journal to focus on these issues.

Recently, the Journal of Law and the Biosciences received exciting news in the form of an updated impact factor score. The journal now has an impact factor of 6.066, a substantial increase from the year prior. It ranks third out of 56 ethics journals, second out of sixteen journals in the medical ethics category, second out of 154 law journals, and first out of seventeen journals in the legal medicine category.

The following excerpts highlight the cutting-edge scholarship published in the Journal‘s most recent issue, which closed in June 2022.

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Vaccines.

COVID-19, Patents, and Trade Secrets

By David Gindler & Jasper L. Tran

Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.

The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.

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Chicago, IL, USA - October 18 2021: BinaxNOW Covid-19 Antigen Self Test. Results in 15 minutes at home.

Lessons Learned from the COVID-19 Pandemic: The Future for Diagnostics

By Matthew Bauer and Nicole Welch

Diagnostic tests have changed in the eyes of many Americans across the COVID-19 pandemic.

The traditional site of diagnostic testing, the doctor’s office, has taken a back seat during the COVID-19 pandemic. We can now receive at-home antigen tests in the mail, drive through PCR tests at local sports stadiums, and our workplace cafeteria may serve as a de facto COVID-19 testing site.

The new paradigm of fast, easily accessible, and user-based diagnostics helps to reduce barriers for people to test for COVID-19.

However, nearly all these tests give binary results of yes or no for detecting a specific piece of the SARS-CoV-2 virus. As we look ahead, both the ongoing COVID-19 pandemic and future pandemics will require binary tests, but also tests that give us more granular information about the disease. These changes should be integrated into future diagnostic paradigms, empowering clinical diagnostics to meet both the needs of patients and the broader public health community.  Read More

Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Pig Hearts for Humans and the FDA

By Jacob Balamut

David Bennett, a man who recently underwent the world’s first successful xenotransplantation organ surgery, died last month after a sudden and as yet unexplained period of rapid deterioration.

Bennett, who was 57 years old, had been suffering from end-stage heart disease. With limited options for treatment, he underwent an experimental emergency procedure to replace his damaged heart with a genetically modified pig’s heart. The pig was genetically modified to limit the likelihood that Bennett’s immune system would reject the heart.

Many researchers and clinicians alike see the potential for genetically modified animal organs to serve as a solution to our organ transplant and supply issues. The Health Resources and Services Administration estimates that 17 people die per day on the candidate waiting list. These deaths are the result of a lack of supply of organs, which has been a longstanding issue within the United States.

However, currently, the U.S. Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use”). The lack of approved xenotransplantation products stems from a lack of safety data and concerns regarding the potential for cross-species infections to occur.

In 2016, the FDA updated previously existing guidance for xenotransplantation. The purpose of the guidance was to inform the industry of how the FDA would be handling xenotransplantation applications and to provide recommendations.  In order for xenotransplantation products to be approved, the following process must occur.

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Bill of Health - Globe and vaccine, covid vaccine

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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close up of hands signing contract.

Using Contracts to Lessen Inequities in Access to Medicines in Pandemics and Epidemics

By Sapna Kumar and Ana Santos Rutschman

Research funding contracts can help to safeguard against profound inequities in global allocation and distribution of lifesaving diagnostics, drugs, and vaccines.

During large transnational public health crises, global demand soars for diagnostics, drugs, and vaccines. Although some of these products can be developed within compressed timelines, global production capacity remains limited. Against a backdrop of product scarcity, wealthier countries can out-bid their lower-income counterparts and capture most of the supply during the early stages of pandemics and epidemics. This leaves the vulnerable low-income populations waiting months, or even years, for their turn.

This predictable, inequitable pattern can be held off before the next pandemic. At the research and development (R&D) stage, government funders can bind producers to equity goals through targeted contractual provisions, as we explain in a recently-published Nature Biotechnology article. We summarize our proposals in the following sections. Read More

Front view of light silver bank vault door, closed. 3D Render.

The Risk of Pervasive Trade Secret Practices Within the Life Sciences

By Matt Bauer

The changing landscape of the life sciences industry relies more and more on a form of intellectual property protection called trade secrets to safeguard mechanisms of manufacturing and process knowledge not always included within life science patents.

To the public, this means the methods of production for life saving therapeutics may be kept indefinitely in the hands a single company, never to enter the public domain.

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Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

Call for Submissions: Journal of Law and the Biosciences Special Issue on Abortion Law

American law on reproduction seems likely to change, perhaps radically, in 2022, as the U.S. Supreme Court considers challenges to state laws limiting abortion. In Dobbs v. Jackson Women’s Health Organization, the Court is considering a substantive Mississippi ban on almost all abortions after 15 weeks; in Whole Woman’s Health v. Jackson and United States v. Texas, the Court is considering the more procedural Texas “bounty hunter” statute for enforcing a ban on abortions after about five weeks.

In anticipation of the Court rulings on these cases, the Journal of Law and the Biosciences will publish a limited number of submissions as a two-part special issue on this general topic. The issue will focus on abortion law, but also include near-future issues for other human reproductive practices and technologies.

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