Pathogen Genomes as Global Public Goods (And Why They Should not Be Patented)
55 NYU J. Int'l L. & Policy 533 (2023)
47 Pages Posted: 6 Dec 2022 Last revised: 26 Oct 2023
Date Written: November 9, 2022
During past viral outbreaks, researchers rushed to patent genomic sequences of the viruses as they were discovered, leading to disputes and delays in research coordination. Yet similar disputes did not occur with respect to the genomic sequence of SARS-CoV-2, the virus responsible for COVID-19. With respect to COVID-19, global research collaboration occurred rapidly, leading to the identification of new variants, the ability to track the spread of the disease, and the development of vaccines and therapeutics in record time. The lack of patenting of SARS-CoV-2 is likely due the U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics, which established that naturally occurring genomic sequences are ineligible for patent protection, a decision that has had repercussions around the world. Recently, however, legislative proposals have been made in the U.S. to overturn this decision. Such legislation, if enacted, would enable researchers, likely based in countries where pathogenic outbreaks first occur, to obtain U.S. patents on pathogen genomes that are critical to disease response. Given that open, global research collaboration will be essential to address future disease outbreaks, and that ample opportunities exist for patenting of diagnostics, vaccines, therapeutics and other downstream biomedical innovations, I argue that steps should be taken to ensure that pathogenic sequence data cannot be appropriated by individual researchers, institutions, or states. Accordingly, proposed U.S. legislation seeking to reintroduce pathogen sequence patenting should be rejected and a new international agreement recognizing the genomic sequences of pathogenic agents as global public goods free from intellectual property protection should be enacted. In addition, WHO, public health agencies and research funders should adopt policy provisions that deter patenting of pathogen genomic sequences, either directly or through the imposition of rapid data release requirements. Individually or together, measures such as these will reduce the patenting of pathogenic genomic data in the service of global collaboration and innovation during future disease outbreaks
Funding Information: There is no funding for this paper.
Conflict of Interests: There are no conflicts.
Keywords: patent, eligibility, Myriad, genomics, sequence, DNA, 101, pathogen, COVID
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