The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning. The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A) is mandatory and enforceable by injunction, even where the biosimilar applicant has triggered the patent dance by providing its application and information to the reference product sponsor under paragraph (l)(2)(A).
Stay tuned to Big Molecule Watch for a detailed discussion of today’s decision.