BRCA Gene Patenting Case

 

The lawsuit against Myriad Genetics was filed May 12, 2009 in Federal District Court (Southern District of New York, Judge Robert Sweet, presiding). This suit resulted in a turbulent five years, culminating in a June 2013 decision by the Supreme Court of the United States that isolated genetic material is an un-patentable substance.

Myriad Genetics holds patents on genes that affect women's (and more rarely, men's) inherited susceptibility to develop breast and ovarian cancers. The company made headlines when it raced to find the genes, now called BRCA1 and BRCA2 and, later, when it used its intellectual property to dominate the American genetic testing market for those genes. The company and its patent-based business model have attracted both praise and criticism in the United States and beyond.

The lawsuit against Myriad, the United States Patent and Trademark Office (USPTO), and Directors of the University of Utah Research Foundation was filed by a group of plaintiffs that included patients, professional medical organizations, and patient advocacy groups (most notably, the American Civil Liberties Union and Public Patent Foundation). The plaintiffs argued that the court should invalidate several claims in patents assigned to Myriad Genetics, which they believed were in violation of both 35 U.S. Code Section 101 and Article I, Section 8, Clause 8 of the United States Constitution. 35 U.S.C. 101 describes subject matter that patents can claim: "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title." Similarly, Article 1, Section 8, Clause 8, also known as the Patent and Copyright Clause, delineates the right to Congress "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries". In other words, this clause authorizes the U.S. patent system.

The plaintiffs in the Myriad case asserted that the claims in dispute gave Myriad an illegal monopoly over “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.” Following the judge's decision to deny the defendants' motion to dismiss (669 F. Supp. 2d 365 [S.D.N.Y. 2009]), both sides asked the judge to rule based on the documents already submitted to the court. On March 29, 2010, Judge Robert Sweet ruled that, “[b]ecause the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter...” Furthermore, in other sections of his ruling, he determined that the claimed methods for analyzing genetic samples were also invalid, ruled that an additional claim on a specific use of testing was invalid, and indicated that he did not have to address the constitutional questions raised against the US Patent and Trademark Office.

Myriad appealed the decision to the Court of Appeals for the Federal Circuit (CAFC), which was formed by federal statute in 1982 and hears appeals of patent cases from all U.S. District courts. Oral arguments were held on April 4, 2011. The Solicitor General of the United States presented the US government's position; this was the first time that the Solicitor General had appeared before the C.A.F.C. (the task of the Office of the Solicitor General is to supervise and conduct litigation in the United States Supreme Court). On July 29, 2011, the CAFC reversed Judge Sweet’s decision and upheld Myriad’s gene patents. On the merits of the arguments, the three judges agreed that: 1. Some kinds of DNA can be patented, such as cDNA molecules that are not found in nature and other clearly "engineered" DNA constructs; 2. Five of the broadest method claims in Myriad's patents are invalid because they claimed any way of comparing sequences to look for differences, a mental act that cannot be patented; and 3. The claim for an assay on cancer therapeutics is valid because it entailed several "transformative" steps (it is not entirely clear why this claim was in the case at all, and it received very little attention in the briefings or oral arguments).

In August of 2011, both plaintiffs and defendants petitioned for a panel rehearing. After a February 17, 2012 conference in response to both petitions, the Supreme Court referred the case back down to the CAFC for further review based on their recent decision in Prometheus v. Mayo, a prominent biotechnology patent case.

Oral arguments were held at the CAFC on July 20, 2012, and their August 16 ruling again upheld Myriad’s claims on isolated genes. However, this time the decision questioned the validity of Myriad’s method claims directed at the comparison or analysis of gene sequences.

On September 25, 2012, the plaintiffs appealed to the Supreme Court. Certiorari was granted on November 30, 2012, and oral arguments took place on April 15, 2013. On June 13, 2013, five years after the plaintiffs originally filed suit, the Supreme Court ruled that claims on isolated genes were invalid. Aligning itself closely with the Solicitor General’s amicus brief, the court upheld patentability on cDNA.

This case was historically relevant not only from an intellectual property standpoint, but because of its inherent grounding in public interest law and policy. The history of this case unearthed a significant aspect of patent law in the healthcare space, where litigation need not be limited to arguments about profit and royalties. Scientists, physicians, and public health advocates maintained a prominent, persistent voice in all proceedings, ultimately winning over the nation’s highest court with arguments advocating for public good over corporate interest. While the implications of this case will continue to unfold for years after this ruling, the Center for Public Genomics is privileged to share our archives to future generations of scholars who study to this landmark decision.

Research files provided here include significant court documents, patent documents, policy engagement tools and presentations generated by staff at the Center for Public Genomics, and archival documents and relevant manuscripts collected during the research process. All items in this subcommunity, 'BRCA Gene Patenting Case' are licensed under CC-BY licenses (see below). In all scholarly and other attributions, please use accepted bibliographic conventions and include URL links to all items and/or collections used.

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