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.