For more information, view the Duke Center for Public Genomics BRCA Gene Patenting Case archive.
At the American Society of Human Genetics meeting, geneticist Mary-Claire King announced her discovery of a genetic linkage to breast and ovarian cancer on chromosome 17. This sounded the start of what would be a four year race to sequence and clone the culprit gene.
In August of 1994, Dr. Mark Skolnick announced that his team at Myriad Genetics had discovered and sequenced the BRCA1 gene, a mutation in which causes hereditary breast and ovarian cancer. Myriad scientists subsequently patented and published this discovery.
Shortly after the discovery of BRCA1, UK scientist Michael Stratton announced that his team had tentatively identified a second gene correlated with hereditary breast and ovarian cancer: BRCA2. The BRCA2 sequence was published in Nature in December of 1995.
In March of 1992, scientists from Myriad’s team published a paper in Nature Genetics claiming that Stratton’s earlier publication was incomplete. Myriad’s scientists published the complete sequence in Nature Genetics in March of 1996. Both Stratton’s team and Skolnick’s team obtained patent protection on BRCA2.
The American Civil Liberties Union filed suit against Myriad Genetics, the US Patent and Trade Office, and the directors of the University of Utah Research Foundation. This case was first heard by Judge Robert Sweet in Federal District Court (Southern District of New York). Judge Sweet ruled that DNA constituted un-patentable subject matter.
Plaintiffs: ACLU, Public Patent Foundation, AMP, ACMG, ASCP, CAP, Breast Cancer Action, Boston Womens’ Health Collective
Defendants: USPTO, Myriad Genetics, University of Utah Research Foundation
After Judge Sweet’s ruling, the defendants appealed the case to the Court of Appeals for the Federal Circuit (CAFC). 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.)
Both plaintiffs and defendants petitioned for a panel rehearing on August 25 and August 29, respectively.
The Supreme Court conferred on whether or not to hear the BRCA case (Association for Molecular Pathology v. US Patent and Trademark Office, or AMP v USPTO). The petition for a Writ of Certiorari was submitted on December 7, 2011. The main issues of the case are 1) whether isolated DNA corresponding to sequences of human genes is patentable, and 2) whether the petitioners have standing to sue. Numerous amicus curiae briefs were written on behalf of the petitioners. All amicus briefs filed for this case can be seen on our BRCA Resources page.
The Supreme Court referred the case back down to the CAFC for further review in light of its recent decision on Prometheus v. Mayo, another biotechnology patent case.
As a result of the Supreme Court's decision to remand the case, the CAFC ordered for amicus briefs to be submitted by June 15, with oral arguments to take place on July 20, 2012. The court received many supplemental briefs, all of which can be viewed on Professor of Law Christopher Holman's Biotech IP blog and on Patent Docs. All amicus briefs filed for this case can be seen on our BRCA Resources page.
After hearing oral arguments on July 20, 2012, the CAFC issued a ruling that again upheld Myriad’s claims on isolated genes. This time, the decision questioned the validity of Myriad’s method claims directed at the comparison or analysis of gene sequences.
The American Civil Liberties Union and Public Patent Foundation filed a petition for a Writ of Certioriari on September 25, 2012. The petition asked the Supreme Court to reconsider the CAFC's ruling on specific issues, and broadly questioned a fundamental inquiry of this case: are human genes are, in fact, patentable substances?
The Supreme Court heard oral arguments on April 15, 2013. For more information, view the transcript of the oral arguments.
After granting certiorari on November 30, 2012 and hearing oral arguments on April 15, 2013, the Supreme Court of the United States ruled that claims on isolated genes, such as Myriad’s claims on the isolated genes BRCA1/2, were invalid. Aligning itself closely with the Solicitor General’s amicus brief, the court upheld patentability on cDNA. For more information, view the complete decision.
This webpage developed by Jae Cheon, Lane Baldwin, Kathryn Maxson, Christopher Heaney, and Robert Cook-Deegan for the Duke University Institute for Genome Sciences & Policy and the Duke/Georgetown Center for Public Genomics, funded by the U.S. National Human Genome Research Institute (P50 HG 003391).