In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize biosimilars applicants who fail to disclose information about their abbreviated Biologics License Applications (“aBLAs”) or manufacturing processes as required by 42 U.S.C. § 262(l)(2)(A).

Amgen’s State Law Claims

This is the latest in a line of BPCIA decisions arising out of Sandoz’s application to market a biosimilar version of Amgen’s Neupogen (filgrastim) biologic. (For more complete coverage of the facts and prior proceedings, see our prior coverage, including the Supreme Court and Federal Circuit opinions.) In relevant part, after filing its aBLA, Sandoz refused to provide Amgen with a copy of its aBLA and manufacturing information as required by § 262(l)(2)(A). Amgen then filed suit, asserting both patent infringement under the BPCIA as well as state law claims under California law, including a claim for unfair competition. Sandoz asserted, among its many defenses, an affirmative defense that Amgen’s state law claims are preempted by the federal BPCIA. However, neither the district court nor the Federal Circuit addressed preemption on the merits. On June 12, 2017, the Supreme Court ruled that the BPCIA’s “patent dance” information exchange provisions are optional and that an aBLA applicant may refuse to provide a reference product sponsor with a copy of the aBLA and manufacturing information required by § 262(l)(2)(A). The Court, however, remanded to the Federal Circuit for a determination of whether the BPCIA preempts Amgen’s state law claims.

Continue Reading Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.

Continue Reading Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

LifeSciences_TestOn May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product. Amgen asserted that the biosimilar manufacturing process disclosed in the Coherus aBLA will infringe the ’707 patent’s claimed protein purification process.

Continue Reading Amgen Sues Coherus Under BPCIA After Completing Patent Dance