PUBPAT > AMP v. Myriad: Gene Patents

AMP v. Myriad: Gene Patents

On May 12, 2009, the Public Patent Foundation (PUBPAT) and the American Civil Liberties Union (ACLU) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers.

The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.

Since the PTO granted patents on the BRCA genes to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad’s monopoly on the BRCA genes makes it impossible for women to use other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.

The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed on May 12, 2009, in the United States District Court for the Southern District of New York in Manhattan against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. On March 29, 2010, Judge Robert Sweet issued his opinion holding all of the challenged patents invalid. Myriad has appealed Judge Sweet's decision to the Court of Appeals for the Federal Circuit, where PUBPAT and the ACLU are fighting to defend it. The U.S. Government has filed an amicus brief in the appeal siding with PUBPAT/ACLU.

In July 2011, the Appeals Court unanimously upheld the invalidation of the patents on human gene analysis, but divided of whether genes themselves may be patented, with two judges ruling they could, and one judge dissenting. In March 2012, the Supreme Court reversed the decision of the Court of Appeals regarding the patentability of human genes and remanded the matter back to the Court of Appeals for a new ruling. In August 2012, the Court of Appeals again upheld patents on human genes in a 2-1 split decision. PUBPAT and the ACLU petitioned for Supreme Court a second time and the Supreme Court granted that petition on November 30, 2012.

Support for this project comes from the Nathan Cummings Foundation.

Watch our video on why we're fighting to Liberate the Breast Cancer Genes

PUBPAT Executive Director, Dan Ravicher, Discusses the Case on PBS NewsHour