No link and turn – patent eligibility boosts research and innovation – and foreign patents make the link inevitable

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)).

A different narrative – and one that better reflects both technological and economic reality – is that including purified and isolated materials as eligible subject matter under 35 U.S.C. § 101 can benefit patients, researchers, and innovation. Legislatively overruling the Supreme Court’s 2013 decision in AMP v. Myriad Genetics could boost investment in biotechnology R&D. Identifying the existence, location, and sequence of the BRCA1 and BRCA2 gene variants at issue in Myriad, for example, took decades. New biologic therapeutics can require over $1 billion to develop. Without patents these innovations might never see the light of day.

Although genetic and other biotechnological research often begins in universities under federal funding, patents were clearly the focus of the university scientists racing to identify BRCA1 and BRCA2, as well as a gene relevant to Alzheimer’s. Biotechnological innovations also face resource-intensive and risky development cycles. Patent protections even for early-stage research by universities have become important in attracting private funding for both research and later commercialization.

This is why the U.S. passed the Bayh-Dole Act: so that federal funding recipients can patent and commercialize research that would otherwise be underutilized. Indeed, a study by David Taylor has shown that Supreme Court limitations on patentable subject matter, including Myriad, have decreased investment in R&D, particularly in biotechnology.

And there is concern that, if the U.S. does not broaden eligible subject matter, many innovators will ship their work abroad. The European Union, Australia, and Japan hold purified genomic DNA and proteins to be eligible subject matter (albeit with possible differences in their utility and inventive step requirements, as well as experimental-use exceptions). The European Union’s Biotechnology Directive, for example, specifies that “[b]iological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.” In this light, Senator Tillis’ bill should be seen as an effort to support the U.S.’s role as a leading biotech innovator.