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.
I thank Professor Emily Michiko Morris for her thoughtful response to my August 4 post “Another Legislative Attempt to Revive Gene Patenting”. The debate over U.S. patent eligibility is a complex and multifaceted one, making it tempting to draw on arguments pertinent to one issue when addressing another. My August 4 post was narrowly focused on proposed U.S. legislation that would reverse the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics (569 U.S. 576) to make naturally-occurring genomic sequences patentable when “isolated and purified”. In her response, which supports the proposed legislation, Professor Morris cites examples such as biologic therapeutics, patent evergreening, the drug Lipitor and others, all of which are unrelated to my principal thesis: that naturally occurring genomic sequences, whether human or non-human, are not, and should not become, patentable subject matter. A lengthy discussion of other issues relating to biotech patenting only serves to muddy the water and distract from the particular issue of genetic sequences.
For example, Professor Morris argues that “[n]ew biologic therapeutics can require over $1 billion to develop. Without patents these innovations might never see the light of day.” This may, in fact, be true. But my August 4 post, and the Myriad decision, are about naturally occurring genetic sequences, which are used primarily in the genetic diagnostics market (and now in pathogen monitoring). The cost of developing and bringing to market a new laboratory-developed genetic test is a small fraction of that of a new drug. This fact is easily demonstrated by the number of university clinics and non-profit organizations that developed and offered genetic screening assays for a range of conditions tied to genes discovered by academic labs, many of which were then shut down once patents began to issue on those genes. I discuss this history in my book, The Genome Defense: Inside the Epic Legal Battle Over Who Owns Your DNA (New York: Algonquin, 2021) (pp. 79-81, 121). And while biologic drugs and vaccines may make use of existing genetic sequences, there are typically many other aspects of these technologies that can be, and are, patented, leaving ample financial incentives for their developers.
Professor Morris also writes that “[i]dentifying the existence, location, and sequence of the BRCA1 and BRCA2 gene variants at issue in Myriad … took decades” (emphasis added). This statement is somewhat misleading. Mary Claire King at UC Berkeley isolated the BRCA1 gene to the long arm of chromosome 17 in 1990. The gene was sequenced four years later, in 1994. King, working with the members of her lab, spent around seventeen years (off and on) interviewing families and conducting painstaking genetic epidemiology work to narrow down the approximate location of the gene, but she did so on a shoestring budget and (as she herself has stated) with no intention of obtaining patents. Thus, suggesting that the “decades” long (i.e., 21 year) search for the BRCA genes justifies the need for patents can’t really be supported by the historical record.
In the same vein, Professor Morris states that “patents were clearly the focus of the university scientists racing to identify BRCA1 and BRCA2.” The factual backing for this statement is also unclear. As to King, it is certainly not true. While patents were, indeed, the focus of Myriad’s scientific founder, who also held a position at the University of Utah, statements by other scientists, even at the University of Utah, suggest that their focus during the BRCA race was not on patents, but rather on professional achievement and prestige. And Professor Morris overlooks a dozen other academic groups in the U.S., Canada, Europe and Japan that were simultaneously searching for the BRCA1/2 genes. There is no indication, of which I am aware, that these groups were focused on patents as their primary motivation for finding the genes. Quite the contrary. In addition to King, Francis Collins, then at University of Michigan, was a leading contender in the race to find the BRCA genes. Collins had previously led the search for the CFTR gene associated with cystic fibrosis. Even though his university patented the gene, he ensured that it was licensed broadly to the research and clinical community at minimal cost (TGD, p.350). Other researchers made statements to the press that patents were not concerns of theirs.
Far from requiring the financial incentives offered by patents, the BRCA genes almost certainly would have been discovered by competing academic groups around the same time, even if patents had not been available (TGD, p.345). The same can be said of many areas of basic biomedical inquiry (see, e.g., Rachel E. Sachs, The Uneasy Case for Patent Law, 117 Mich. L. Rev. 489 (2018) (noting negligible role that patents have played in research relating to the human microbiome), Jonas Anderson, Nonexcludable Surgical Method Patents, 61 Wm. & Mary L. Rev. 637 (2020) (exploring non-financial motivations for developing new surgical methods).
While I am sympathetic to arguments regarding patent eligibility in areas such as biologics, antibodies, medical decisionmaking and the like, these fields do not require patents to be issued on naturally occurring genomic sequences. Rather, as I discuss in my August 4 post, a return to such patents has the potential to impede scientific research and harm public health. While Professor Morris questions my grasp of “technological and economic reality”, I submit that focusing on the specific point at issue and adhering to the historical record would improve the quality of the debate over these important issues.