In its unanimous 2013 decision in Association for Molecular Pathology v. Myriad Genetics (569 U.S. 576) the U.S. Supreme Court held that naturally occurring genomic sequences are not eligible for patent protection. Not surprisingly, some representatives of the biotechnology industry, and many patent lawyers, reacted negatively to the decision, and have steadily lobbied Congress to restore patent protection for isolated and purified genomic sequences. On August 2, 2022, Senator Thom Tillis (R-NC) accommodated them with the Patent Eligibility Restoration Act of 2022, a bill that, if enacted into law, would reverse the Myriad decision and a decade of subsequent legal developments. Such a reversal would have serious implications not only for access to healthcare, but also the ability to respond rapidly and effectively to new viral outbreaks.
Myriad and Gene Patenting
As I document in my book The Genome Defense: Inside the Epic Legal Battle Over Who Owns Your DNA (New York: Algonquin, 2021), the Myriad case was brought by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PubPat) in response to widespread complaints that individuals at high risk of having one or more deleterious BRCA mutations could not afford, or were otherwise ineligible to receive, the BRCA testing that Myriad controlled through its patents (and for which it charged in excess of $3,000). At the time the lawsuit was brought, the U.S. Patent and Trademark Office (USPTO) had been granting patents on human genes for more than two decades on the theory that the “isolated and purified” forms of the genes did not occur in nature, but were instead created in the laboratory like other new chemical compounds. Representing a coalition of medical and scientific associations, researchers, genetic counselors and patients, the ACLU and PubPat argued instead that human genes are “products of nature” that should not be patentable. The Supreme Court agreed, holding that naturally occurring genomic sequences are beyond the scope of patent protection, even if purified and isolated from the human body. In a controversial gesture toward compromise, the Court also held that because complementary DNA (cDNA) constructs made in the laboratory and consisting only of the coding regions of a gene do not occur in nature, and are thus eligible for patent protection.
The Impact of Myriad
The Supreme Court’s decision in Myriad had an immediate effect on the price and availably of BRCA testing, and today consumers, for about $100, can learn whether they carry the primary BRCA mutations from direct-to-consumer (DTC) genetic testing companies like 23andMe. The Myriad decision eliminated not just patents on the BRCA genes, but all gene patents in the United States, suddenly opening a major segment of the genetic testing market to free and open competition.
More recently, as I have written previously, the unavailability of patents on genomic sequences has enabled researchers around the world to study the SARS-CoV-2 viral genome without fear of patent infringement and without the need to negotiate complex patent licensing agreements and pay royalties to the first researchers to determine its sequence. This open and unencumbered environment enabled researchers to identify and trace the spread of multiple pathogenic variants around the world, to understand the biological mechanisms of the virus, and to develop vaccines, diagnostics and therapeutics in record time. As we witnessed with respect to prior viral outbreaks such as SARS, MERS and H5N1, all of this work would have been hindered by patent claims to the basic genomic sequence of SARS-CoV-2.
Prior Efforts to Reverse Myriad
Not surprisingly, efforts to reverse or limit the Myriad decision began before the ink was dry on the page. In late 2013, Myriad sued competing BRCAtest vendors under patents that it believed were not affected by the Court’s decision. The company proved to be wrong: both the federal district court in Utah (3 F. Supp. 3d 1213 (D. Utah 2014)) and the Court of Appeals for the Federal Circuit (774 F.3d 755 (Fed. Cir. 2014)) confirmed that Myriad’s patents covering naturally occurring DNA sequences, no matter how short, were ineligible for patent protection. That same year, the Federal Circuit held that, under the precedent established in Myriad, the cloned offspring of “Dolly”, the ewe made famous as the first successfully cloned mammal, were not themselves patentable (In re Roslin Inst. (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014)).
Given the courts’ unwillingness to contravene the holding of Myriad, opponents turned to Congress. In response to a 2016 USPTO request for public comments, in 2017 several organizations asked Congress to amend the patent lawsto overrule Myriadand other recent Supreme Court precedents relating to patent eligibility. In 2019, Senators Chris Coons (D-DE), Tillis and others released a draft bill that would have “abrogated” any judicial exceptions to patentable subject matter involving, among other things “laws of nature” and “natural phenomena”. The effect of these provisions would have been to permit, once again, the patenting of any previously undiscovered natural substance or genomic sequence. One hundred sixty civil rights, medical, scientific, patient advocacy, and women’s health organizations opposed the Coons-Tillis bill, arguing that if it were enacted, “Patients will again be at risk of lacking access to information about their genes, about their very selves. We likely will again see high prices for tests with no competition in the market, and harms to innovation and useful research with no guarantee that the law would eventually provide the same protections that it now offers.” The Senate Judiciary Committee held three sets of hearings on the bill in 2019, after which the draft legislation stalled.
In 2021, Senators Coons, Tillis and others requested that the USPTO conduct a study of public views on “how the current [patent eligibility] jurisprudence has adversely impacted investment and innovation in critical technologies like quantum computing, artificial intelligence, precision medicine, diagnostic methods, and pharmaceutical treatments.” A total of 145 comments were submitted in response to the PTO’s public request for information (RFI). The responses were mixed, with a majority of respondents in the life sciences sector generally disposed favorably to existing judicial tests for patent eligibility.
Nevertheless, on August 1, 2022, Senator Tillis introduced the Patent Eligibility Restoration Act of 2022, which would explicitly overturn the Supreme Court’s ruling in Myriad.
The Patent Eligibility Restoration Act
The draft Patent Eligibility Restoration Act released on August 2 would effect numerous changes to the law of patent eligibility under Section 101 of the Patent Act as interpreted over the years by the courts. At first, the draft Act appears to exempt genomic sequences from the sweeping changes that the it introduces in other technology areas. Thus, Section 101(b)(1)(C) of the bill states that “a person may not obtain a patent for … an unmodified human gene, as that exists in the human body.” Yet this “exclusion” is a sleight of hand. Despite the rhetoric on both sides of the argument, the USPTO never granted patents on human genes “in the human body”, as I explain in this article (p. 28). Instead, the patents obtained by Myriad and others always covered, among other things, “isolated and purified” genes. Which is why Section (b)(2)(B) of the proposed Act expressly allows patenting of “a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity” (i.e., by saying that these altered substances are not “unmodified”). The result of this clever drafting is a complete reversal of the Supreme Court’s conclusion in Myriad that “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material” (569 U.S. at 596).
What’s more, the Act would place non-human genomic sequences squarely back into the realm of patentable subject matter, returning us to the days of preemptive patenting of emergent viral strains when speed and global cooperation are critical to protect global health.
While the draft Patent Eligibility Restoration Act may represent a legitimate attempt to address uncertainty concerning patent eligibility in areas such as computer software, artificial intelligence and business methods (areas that are beyond the scope of this post), the impact of its “human gene” provisions on access to healthcare, genetic self-knowledge, genetic epidemiology and public health are potentially serious. As such, the Act should be amended to reaffirm that naturally occurring genetic sequence information across the board remains beyond the scope of patent protection.