The Patentability of Gene Sequences: Myriad Genetics’ Day in the United States Supreme Court

The Patentability of Gene Sequences: Myriad Genetics’ Day in the United States Supreme Court

In late March, The United States Supreme Court ordered the U.S Court of Appeal for the Federal Circuit to reconsider Myriad Genetics’ existing patent on two genes associated with a high risk of breast and ovarian cancer, in light of the judgement rendered in Mayo Collaborative Services v Prometheus Labs (Prometheus). A unanimous Supreme Court in Prometheus held that the patent sought by Prometheus for the personalized medicine dosing process was ineligible for patent protection since it was a law of nature.

In the present case, the Association for Molecular Pathology v Myriad Genetics (Myriad), Myriad Genetics alongside the University of Utah, isolated two genes, BRCA 1 and BRCA 2, which are associated with breast and ovarian cancers.  Furthermore, it developed a test that examines the DNA extracted from the genes  for mutations that signify risk of developing breast or ovarian cancer.  The patent of the two genes grants Myriad Genetics a monopoly on testing for mutations and thus prevents other laboratories from performing such tests.

An action brought by the American Civil Liberties Union and the Public Patent Foundation on behalf of various medical groups, patients and researchers contended that Prometheus’ patent on the human genes were invalid as they were products of nature, and the ensuing monopoly granted prevented women from garnering confirmatory tests. A United States District judge in New York conceded and invalidated the patents in 2010.  Nonetheless, this victory for the American Civil Liberties Union and association was short lived, as the Court of Appeal for the Federal Circuit reversed the ruling, holding that the DNA isolated from the body was patentable since it was “markedly different” in a chemical structure from the DNA within the body.  On appeal to the Supreme Court, the case was remanded to the Court of Appeal for the Federal Circuit for review.

On review, the Federal Court will be required to resolve whether isolating genes BRCA 1 and BRCA 2 merely describes a law of nature or whether it is “more than a drafting effort designed to monopolize the law of nature itself.” As mentioned earlier, and pursuant to Section 101 of the Patent Act, laws of nature, natural phenomena, and an abstract idea are not patentable.  This provision is one that is seemingly simple to grasp, however, upon further interpretation, becomes complicated and abstract.  Patents sought by individuals who are able to demonstrate that their particular invention involves a unique application of an abstract idea or law of nature are entitled to patent protection.  Therefore, Section 101 patent analysis is oriented towards what constitutes an application.  In Prometheus, patent protection for the diagnostic test that looked for chemicals formed when drugs used to treat gastrointestinal diseases were broken down in the body was not granted since the test merely recited and applied a law of nature. The future success or failure of Myriad Genetics’ patent may be foreshadowed utilizing the lesson learned from Prometheus, with greater accuracy depending on the degree of alignment between both cases. 

Perspectives on whether the fate of the Prometheus patent foretells a grim tale for  Myriad are rather varied and stratified. Various lawyers and patent experts believe that the ruling in Prometheus is not easily transferable to the present case since Myriad’s patents are compositions of matter while Prometheus’ were methods of testing. Dr. Robert Cook-Deegan, director of the program on genome ethics, law and policy at Duke University believes the logic to be different since the present case is about a thing, as opposed to a method.  Others believe that the ruling in Prometheus is opposed to the rationale used by the appellate court to uphold Myriad’s patents.  Daniel Ravicher of the Public Patent Foundation opined, “the isolation of DNA is a trivial, well-understood step…A unanimous Supreme Court has now undeniably declared that a trivial noninventive transformation” is not sufficient to obtain patent protection.

Irrespective of outcome, both Prometheus and Myriad have generated useful dialogue about the ethical and economic challenges facing the Unites States patent system in an age of biotechnology and the increasing monetization and exploitation of genetics.

Tracy Ayodele is a JD Candidate at Osgoode Hall Law School.