RMMS Secures Favorable Claim Construction Ruling in NEULASTA® (pegfilgrastim) BPCIA Litigation
11/20/2018 In a decision issued today, Judge Mark Hornak of United States District Court for the Western District of Pennsylvania adopted several favorable claim constructions advocated by RMMS in connection with U.S. Patent Nos. 8,273,707 and 9,643,997. RMMS represents Mylan in its first ever litigation brought under the Biologics Price Competition and Innovation Act (BPCIA). The Court's decision follows a September 21, 2018Markmanhearing, wherein the Court heard argument from the parties on nine (9) disputed claim terms.
Plaintiffs Amgen Inc. and Amgen Manufacturing Limited brought the litigation in 2017, allegingthat Mylan's manufacture of its pegfilgratim biosimilar purportedly infringe the '707 and '997 patents, including as they relate to certainmethods of protein purification.