Update in Amgen v. Apotex: Apotex’s Opening Brief at the Federal Circuit

Amgen v. Apotex (pegfilgrastim)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance

As we have covered here, and here, Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex.

On December 30, 2015, Apotex filed its opening appellate brief, in which it argues that because the parties completed the patent dance under 42 U.S.C. § 262(l)(2)–(l)(5) prior to initiation of the underlying lawsuit under (l)(6), a notice of commercial marketing under (l)(8)(A) is not required.  According to Apotex, this distinguishes the instant case from Amgen v. Sandoz, where Sandoz chose not to participate in the patent dance, and was required to provide 180-days’ notice of commercial marking.

Further, Apotex argues that making the 180-day notice period mandatory in all cases—as opposed to just cases where the biosimilar applicant chooses not to participate in the patent dance—would amount to a de facto extension of the 12-year exclusivity period granted under the BPCIA.

We will continue to monitor and report developments in this case.

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