On Thursday, 31 January 2013, KEI filed an amicus brief to the Supreme Court of the United States in the case Association for Molecular Pathology, et. al. v. Myriad Genetics, Inc., et. al. Our full brief is available for download here.
This case involves disputes over the patents over the BRCA1 and BRCA2 genes. Mutations on these genes are associated with an individual’s susceptibility to breast and ovarian cancer. Myriad Genetics holds the exclusive rights over the DNA claims which were initially isolated and discovered by researchers at the University of Utah through federal funding by the National Institute of Environmental Health Sciences. The high monopoly price of the test and the fact that insurance companies do not cover BRCA testing mean that many women have either had to pay the full costs out of pocket or have had to forego testing. The exclusive rights over the patents also prevents patients from receiving secondary, confirmatory testing or improved testing despite the fact that Myriad’s initial test was known to have a significant error rate and also failed to identify all known mutations.
The case was first filed by the ACLU and PUBPAT on May 12, 2009. In March 2010, the District Court for the Southern District of New York found the patents to be invalid. Myriad Genetics appealed to the Court of Appeals for the Federal Circuit which reversed the lower court’s opinion, but in July 2011 the three-court panel split three ways on the reasoning; notably each of these opinions differed from the opinion rendered by the District Court Judge Robert Sweet. ACLU and PUBPAT petitioned the Supreme Court for a writ of certiorari (KEI’s brief supporting the petition for writ available here). After unanimously ruling in a different case, Mayo Collaborative Services v. Prometheus Laboratories, that the claimed diagnostic methods were patent ineligible as laws of nature, the Supreme Court granted the petition for certiorari, vacated the decision below, then remanded the case for the Federal Circuit to hear it again. Upon rehearing, the same three judge panel split three ways again, each essentially reaffirming his own opinion or dissent. The plaintiffs in the case again requested the Supreme Court to grant certiorari and in November 2012, the Supreme Court granted the cert petition and limited review to the following question: Are human genes patentable?
The table of contents from the argument portion of our amicus brief is reprinted below:
I. PATENTING OF GENES IMPEDES THE CONSTITUTIONAL RATIONALE OF THE PATENT SYSTEM TO PROMOTE THE PROGRESS OF SCIENCE AND ALSO HARMS PUBLIC HEALTH.
A. Products of Nature, Laws of Nature and Natural Phenomena, Such as Human Genes, Are Not Patent-Eligible Because They Impede Innovation Rather than Promote It.
B. Where Patent Protection Improperly Preempts All Other Uses, the Progress of Science is Hindered and the Constitutional Rationale for Patents is Impeded.
C. Patenting of Human Genes Harms Genetic Research, Medical Innovations and the Future of Public Health.
II. NON-PATENT MECHANISMS CAN AND SHOULD ENCOURAGE PROGRESS WHERE PATENTS ARE AN INAPPROPRIATE, UNNECESSARY, INSUFFICIENT, OR BURDENSOME REWARD.
In addition to the court proceedings, the issue of gene patents and diagnostic testing have come up in Congress which directed the USPTO to evaluate the lack of availability of secondary, confirmatory testing and come up with recommendations in relation to patenting and licensing practices in the context of genetic diagnostic testing, specifically with regard to secondary or confirmatory testing. Over the past year, USPTO has held two hearings and one roundtable to study the effects of patents and licenses on secondary, confirmatory diagnostic testing. KEI’s notes from the most recent hearing are available here. Last year, KEI submitted comments to USPTO on this issue, available here.
Additional information about this case and other amicus filings of KEI with regard to access to medical technologies are available at our Legal Issues page.