Personalized Medicine After The ACLU "Gene Patenting" Decision

p>The biotechnology industry, including those investing in personalized medicine, have been waiting for the Federal Circuit's decision that answers the questions whether isolated DNA and use of the isolated material are patent-eligible under 35 U.S.C. § 101. As reported in our August 16^th post, the same three judges (Lourie, Bryson and Moore) that isolated DNA and cells transformed are patent-eligible. Claims that broadly claim detecting alterations in a gene, in this case the BRCA1 gene, were held to be patent-ineligible. The Ass'n for Molecular Pathology et al. v. USPTO, et al., No. 2010-1406 (Fed. Cir. 2012). In addition, the court determined that the plaintiffs had standing to maintain the action. This decision validates that the tools (DNA and isolated naturally occurring materials) underlying personalized medicine are still patent-eligible. Moreover, the court's evaluation of the claimed methods are informative to those seeking to patent medical diagnostic tests