Virginia IP Law > Troutman Sanders LLP

AMA Files Amicus Brief in Gene Patent Lawsuit

In May 2009, the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit arguing to invalidate a group of patents having claims directed to human genes and the generic testing of human genes to determine their risk of breast and ovarian cancer. The gene patents are owned or licensed by Myriad Genetics.  The inventors of the patents recognized that mutations along the BRCA1 and BRCA2 gene sequences are indicators of an increased risk of breast and ovarian cancer in women. (Details of the lawsuit are available here on the ACLU website.) At least in part, the patents claim methods of determining the risk of these cancers by comparing the BRCA1 and BRCA2 gene sequences of a patient with the normal sequence of the genes. The ACLU and AMA argue that such claims should be found to be invalid and unpatentable as unconstitutional and for reasons of public policy.

The ACLU filed the lawsuit in U.S. District Court for the Southern District of New York against the U.S. Patent and Trademark Office (PTO) and Myriad Genetics and the University of Utah Research Foundation on behalf of breast cancer and women’s health groups, individual women and scientific associations.

This week, the American Medical Association along with other medical and genetic organizations have filed a “Brief for Amici Curiae” backing the ACLU position. The brief (found here)argues that the Myriad claims are unpatentable “laws of nature,” do not claim patentable subject matter based upon the machine or transformation test as interpreted by the Court of Appeals of the Federal Circuit in Bilski, and provide compelling public policy arguments against the patentability of these claims and similar medical and biotechnology method claims.

This is an important case to the biotech industry and may change how patent applications are prepared for gene and diagnostic method inventions.

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