Biotechnology

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

Including purified and isolated materials as eligible subject matter under 35 U.S.C. § 101 can benefit patients, researchers, and innovation.

concept illustration of genes in DNA.

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)).

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.

Society understandably balks at propertization of human genes or other substances, but the draft bill clarifies that “unmodified” human genes and other materials as they exist in the human body are ineligible for patenting. Gene patents do not propertize living beings or individuality – far from it. The genes of most interest for patenting are not genes unique to particular individuals but those common to many.

To the extent genetic and other biotech patents raise safety, privacy, or even morality concerns, courts have consistently held that the patent system is ill-suited to address these interests, which are better addressed through other areas of law. And to the extent morality does apply, failure to incentivize application of genetic and other substances itself is arguably immoral and violative of human rights to health care.

Professor Contreras asserts that gene patents deter both access to and research into medical care. This does not distinguish gene patents – any patent can impact further research on its subject matter and allow supracompetitive pricing during its twenty-year term. Indeed, that is the point of the patent system – to provide a temporary pricing advantage to incentivize difficult, expensive innovation that otherwise would not attract investment.

Policy-makers and patients are understandably uncomfortable with patents that price patients out of health care, however. In Myriad, for example, numerous amici cited the $3,000 plus price for diagnostic testing for the patented BRCA1 and BRCA2 genes, which predict higher risks of cancer.

But the effect of patents on price depends on context. Robert Cook-Deegan and others at the Duke University Center for Genome Ethics (included in an oft-cited Health and Human Services report) found that the BRCA1 and BRCA2 patents had little consistent effect on diagnostic testing prices, which were affected more by insurance and available testing methods. Even after Myriad, genetic testing for BRCA1 and BRCA2 costs anywhere from $200 to $5,000, depending on how many of the more than 1000 variants are screened. Moreover, genetic patents or other allegedly “evergreening” pharmaceutical patents can often be avoided. Lipitor (atorvastatin) – cited to the Subcommittee on Intellectual Property during hearings to illustrate the dangers of evergreening – saw marked generic entry in 2011 despite several other Orange Book listed patents, expiring as late as 2017. Indeed, the patent system often accelerates invention of new technologies, such as nanopore genetic sequencing, that effectively design around existing patents.

The effects of patents on R&D are also context-dependent. A study by Bhavan Sampat and Heidi L. Williams, for example, suggests that gene patents had little effect on follow-on innovation and were preferable to trade secrecy. As Sampat and Williams note, underlying criticism of gene patenting “seems to be an assumption that if genes are not patented, they would be placed in the public domain.” Patents encourage disclosure and access: patents on genes make the information encoded in them free for all to use.

At their core, the proposed amendments to § 101 seek to create certainty. Judges, administration officials, and members of Congress have grumbled for over a decade about the uncertainty of patentable subject matter, which the decisions in Mayo v. Prometheus and Alice Corp. v. CLS Bank have only aggravated. Certainty is valuable to patent rights holders and the public alike and would be served by the bill’s efforts to draw clearer lines, even if one might disagree with where the bill draws those lines. As the Supreme Court noted in Mayo, “we must recognize the role of Congress in crafting more finely tailored rules where necessary.”

Emily Michiko Morris is David L. Brennan Endowed Chair, Associate Professor, and Associate Director of the Center for Intellectual Property Law & Technology at the University of Akron School of Law.