December 11, 2013

Making the Case Against Gene Patents

 Download a printable PDF of this article (membership required).

 Purchase a PDF of this article from the ABA Webstore.

On May 12, 2009, a lawsuit was filed in the Southern District of New York challenging the patenting of human genes. Filed by the American Civil Liberties Union and Public Patent Foundation on behalf of 20 plaintiffs, including national scientific organizations, geneticists, genetic counselors, women’s health groups, and patients, the lawsuit—Association for Molecular Pathology, et al. v. U.S. Patent & Trademark Office, et al.—seeks to invalidate patents on two genes, BRCA1 and BRCA2, which have been associated with hereditary forms of breast and ovarian cancer. Myriad Genetics, a private company based in Utah, holds the patents on these genes and, as a result, has exclusive rights over these genes, any mutations found along these genes, and any clinical diagnostic testing associated with these genes. Plaintiffs won at the district court, but that holding was reversed by a divided panel of the Court of Appeals for the Federal Circuit on the question of whether human genes are patentable subject matter. In March 2012, the US Supreme Court granted plaintiffs’ petition for writ of certiorari, vacated the lower court judgment, and remanded to the Federal Circuit for further proceedings in light of Mayo v. Prometheus.1 In Mayo, the Supreme Court unanimously invalidated method claims for assessing a patient’s reaction to a drug because they covered laws of nature. The Federal Circuit panel issued its post-Mayo ruling in August, reflecting similar reasoning and division as on the original appeal.2

Premium Content For:
  • Section of Science and Technology Law
Join - Now