Did the Federal Circuit doom Amgen’s Enbrel® monopoly?

Zachary Silbersher

Markman Advisors

Amgen's Enbrel® monopoly is currently protected by two antibody patents that are not scheduled expire for another 10 years.  In a recent case involving Amgen, Amgen v. Sanofi, the Federal  Circuit vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned on a finding that the jury was improperly instructed on the criteria for invalidating a patent directed to an antibody for lack of written description.  Thus, will the precedent recently established in Amgen’s PCSK9 case doom the validity of its patents covering Enbrel®?  There are likely two ways that the decision in Amgen v. Sanofimade a validity challenge to Enbrel®’s patents easier.  See our recent publication in IPWatchdog.