MOMENTA & MYRIAD: Patent Cases Head for Supreme Court
The Supreme Court in 2013 will hear one key patent case being closely watched in biopharma circles, and is expected to hear a second such case. Momenta Pharmaceuticals was stung in November when the United States Court of Appeals for the Federal Circuit (CAFC) rejected its request for an en banc rehearing of Momenta Pharmaceuticals vs. Amphastar Pharmaceuticals, where a three-judge CAFC panel held in August that Amphastar's use of Momenta's patented method for processing enoxaparin sodium injection was protected by the "safe harbor" from patent infringement under 35 U.S.C. sec. 271(e)(1). Momenta said it will ask the high court to review the case, which company president and CEO Craig Wheeler said in a statement “could have wide-ranging, negative effects on drug development” if CAFC’s decision were upheld. “It has potentially broader implications as to how far post-approval activities that are tied to record keeping requirements of the FDA that are necessary to maintain an approval, can be used as a shield for patent infringement under 271 (e)(1). That’s the basic issue,” William (Bill) Gaede, a partner in the law firm McDermott Will Emery’s Silicon Valley office, told GEN.
The court this year will also hear whether breast cancer susceptibility genes BRCA 1 and 2, if not all genes, are legally patentable. CAFC in August found Myriad Genetics’ gene composition-of-matter claims and methods of screening for cancer compounds patent-eligible—but not Myriad’s claims for its method of analyzing the genes for breast-cancer mutations. The decision reaffirmed the mixed ruling CAFC rendered a year earlier on Myriad’s seven BRCA-related patents—a partial win for Myriad and the U.S. Patent & Trademark Office, which are fighting a four-year-old patent challenge by 20 medical associations and individual doctors led by the Association for Molecular Pathology, and assisted by the American Civil Liberties Union and Public Patent Foundation.