Posts Tagged: "Sandoz Inc."

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(l) has two notification requirements that are important to this case… The second question addressed by the Court was whether the applicant must provide notice after the FDA licenses its biosimilar, or if it may provide notice before the FDA licenses its biosimilar. The Court concluded that an applicant might, but does not have to, provide notice to the manufacturer of the biologic before obtaining a license from the FDA.

The issue on appeal was whether a mixture comprising at least 92% of the (6S) isomer of leucovorin would have been obvious when both the 50/50 mixture of isomers and the pure (6S) isomer were known in the art. Affirming the district court, the Federal Circuit agreed that “one of skill would have been motivated to modify the prior art 50/50 mixture to make the claimed mixture,” especially when it was known that the desired activity lies with the (6S) isomer. The Court found no evidence indicating that the claimed mixture “possess[ed] unexpected advantages over the prior art pure material” so as to overcome obviousness.

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.