INTRODUCTION -

The Federal Circuit today issued its opinion in Assoc. for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. (“Myriad”), in which it re-affirmed its prior ruling, despite the Supreme Court’s instruction to revisit that ruling in light of its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., ___U.S.___ (March 20, 2012) (“Prometheus”).

MYRIAD BACKGROUND -

At issue in Myriad are both composition claims directed to isolated DNA sequences, specifically the BRCA-1 and BRCA-2 genes, and method claims directed to screening for the presence of mutations in those genes. By some estimates 5-10% of women who develop breast cancer are likely to have a mutation in their BRCA-1 or BRCA-2 genes, and it has been estimated that women with one of these mutations can have an approximately 40-85% lifetime risk of developing breast cancer. These inherited mutations can also be an indicator of an increased risk of ovarian cancer. Genetic tests are available to determine if a person carries one of these mutations. On May 12, 2009, a coalition of groups and individuals brought a declaratory judgment action against the U.S. Patent Office, Myriad Genetics, Inc., and the University of Utah Research Foundation over several U.S. patents with claims directed to the BRCA genes.

Please see full alert below for more information.