Amgen v. Apotex, Petition for Certiorari

Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Sandoz (pegfilgrastim)  •  U.S. Federal Circuit Decisions

We have been closely following the Amgen v. Apotex case.  On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision.  In its petition, Apotex presents two questions for the Supreme Court:

  1. Whether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the BPCIA for the resolution of patent disputes (viz., 42 U.S.C. § 262(l)(2)(A)) must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A).
  2. Whether the Federal Circuit improperly extended the statutory 12-year exclusivity period to 12 1/2 years by holding that a biosimilar applicant cannot give effective notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) for its biosimilar product until it receives an FDA license and therefore may not commercially market its biosimilar product for 180 days after receiving its license.

Apotex argues that, by extending by 180 days the amount of time a biosimilar applicant must wait before marketing its product, even when the brand-name producer has all of the information it needs from the biosimilar applicant to determine whether to challenge the applicant’s product, the Federal Circuit upset the careful balance between biologic price competition and innovation negotiated by Congress.  Apotex contends that the Federal Circuit’s decisions in Amgen v. Apotex and in Sandoz v. Amgen have anticompetitive effects, prolong the collection of monopoly rents, and bolster already-troublesome barriers to entry for biosimilars.

One notable distinction between the Sandoz and Apotex petitions is that, whereas Sandoz opted not to engage Amgen in the patent dance, Apotex and Amgen completed the patent dance.

Amgen’s response is due on October 14, 2016.  Stay tuned to Big Molecule Watch for more on this case as it develops.

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