Federal Circuit Says Biosimilar Applicants Can Decline Patent Dance

On July 21, 2105, the Federal Circuit issued a split decision in Amgen v. Sandoz, affirming the dismissal of Amgen's state law claims of unfair competition and conversion, vacating the judgement on Sandoz's counter-claims, and remanding the case to district court. Some practitioners believe that the split decision means one or both parties are likely to appeal. Managing Intellectual Property contacted Finnegan attorney Sanya Sukduang for his thoughts on the decision.

Sukduang noted that the decision poses strategic questions for reference product sponsors (RPS). He said, "[RPSs are] going to have to start making some decisions on what to sue on without having the full complement of information that you might have thought you should receive when the BPCIA was enacted. [District courts] don't have to force biosimilar applicants to disclose before the case moves forward so motions to dismiss or motions such as Amgen's that said [Sandoz] violated the BPCIA are gone by the wayside, at least for the time being."