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The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no longer sought on genomic sequences is the U.S. Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which established that a sequence of naturally-occurring nucleotides is an unpatentable “product of nature” (Association for Molecular Pathology v. Myriad Genetics, 2013). Yet, in the midst of the COVID-19 crisis, patent advocates are calling on Congress to overturn the Myriad decision and once again allow patenting of genomic sequences. This Chapter argues that the COVID-19 pandemic illustrates why the “product of nature” exclusion under patent law, which prevents the patenting of genomic sequence data, should be preserved and strengthened under U.S. law. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.
Burris, S., de Guia, S., Gable, L., Levin, D.E., Parmet, W.E., Terry, N.P. (Eds.) (2021). COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future. Boston: Public Health Law Watch.