RMMS Secures Favorable Resolution in BPCIA Litigation Involving FULPHILA® (pegfilgrastim-jmdb)

November 1, 2019 | Biologics

11/01/2019 RMMS recently secured a favorable resolution on behalf of its client, Mylan, in connection with litigation brought under the Biologics Price Competition and Innovation Act (BPCIA) concerning Mylan’s pegfilgrastim biosimilar product, FULPHILA®.

More specifically, on August 21, 2019,Chief Judge Mark Hornak of the United States District Court for the Western District of Pennsylvania granted Mylan’s Renewed Motion for Judgment on the Pleadings concerning U.S. Patent No. 8,273,707, holding that Mylan’s FULPHILA® product does not infringe as a matter of law. Subsequently, Amgen agreed to dismiss its claims of infringement related to U.S. Patent No. 9,643,997, based on a favorable claim construction secured by RMMSin the litigation, as well as proceedings in a related third-party litigation.

Members of the RMMS team representing Mylan in its first-ever litigation brought pursuant to the BPCIA included William Rakoczy, Eric Hunt, Heinz Salmen and Natasha White.