Posts Tagged: "Neupogen"

CAFC sides with Sandoz, Amgen’s state claims preempted by BPCIA

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. State law claims are preempted by the BPCIA on both field and conflict grounds, which means only remedy available against biosimilar applicants refusing to engage in the patent dance is filing for a declaration of infringement, validity, or enforceability of a patent that claims the biological product or its use. Notably, this must be done before receiving manufacturing information from the biosimilar company. Patent lawsuits are notoriously costly so, in the short term, the decision will have the greatest impact on innovator start-ups with limited financial resources. In the long term, relying on costly litigations to keep biosimilar drugs off the market will likely increase the consumer price for any biologic drug.

Aubrey Haddach

December 26, 2017

Federal Circuit Review – Issue 61 – July 31, 2015

Amgen filed a biologics license application (“BLA”) and obtained FDA approval for its filgrastim product, Neupogen. Sandoz subsequently filed an abbreviated BLA (“aBLA”) under 42 U.S.C. § 262(k), seeking approval for a biosimilar (generic) version of Neupogen. Amgen sued Sandoz, asserting claims of (1) unfair competition under state law based on violations of the Biologics Price Competition and Innovation Act (“BPCIA”); (2) wrongful use of Amgen’s approved BLA; and (3) infringement of U.S. Patent No. 6,162,427, which claims a method of using filgrastim. Amgen alleged that Sandoz violated the BPCIA by failing to disclose its aBLA and manufacturing information as required by 42 U.S.C. § 262(l)(2)(A) and by prematurely giving a notice of commercial marketing under 42 U.S.C.§ 262(l)(8)(A), i.e. giving notice before the FDA approved its biosimilar product.

Robert Schaffer & Joseph Robinson

July 31, 2015