January 2015

Spotlight Info

In In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, Nos. 14-1361,
-1366 (Fed. Cir. Dec. 17, 2014), the Federal Circuit held that claims directed to BRCA1 and BRCA2 primers and methods of comparison of BRCA1 and BRCA2 genes were patent ineligible under 35 U.S.C. § 101.  In finding the primer claims unpatentable, the Federal Circuit applied the framework set forth in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).  The Court determined that the claimed primers “are not distinguishable from the isolated DNA found patent-ineligible in Myriad” because they “necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind.”  Slip op. at 7.  The Court also held method claims for comparing gene sequences to be patent ineligible after applying the Supreme Court’s abstract idea test from Alice Corp. v. CLS Bank International, 134 S. Ct. 2347, 2355 (2014).  The Court explained that the method claims were “directed to the patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations,” which “require[s] merely comparing the patient’s gene with the wild-type [sequences] and identifying any differences that arise.”  Slip op. at 15.  See this month’s edition of Last Month at the Federal Circuit for a full summary of this decision.