ABBVIE FILES AMICUS BRIEF IN SANDOZ V. AMGEN SUPREME COURT CASE

Amgen v. Sandoz (filgrastim)  •  Amgen v. Sandoz (pegfilgrastim)  •  U.S. Federal Circuit Decisions  •  U.S. Supreme Court Decisions

On February 17, 2016, we reported that Amgen and Sandoz had both petitioned the U.S. Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz, each seeking to advance their respective positions on whether the BPCIA patent dance is mandatory and whether/when notice of commercial launch must be given. On January 13, 2017 we reported that the Supreme Court had granted those petitions.

On March 17, 2017, AbbVie Inc. filed an amicus brief in support of Amgen’s position, asserting that the Federal Circuit’s decision should be affirmed as to its finding that the 180-day notice provision is mandatory and must be provided after licensure, and reversed and remanded as to its finding that the patent dance is optional.

AbbVie’s brief focuses on two issues: (1) what the BPCIA requires in terms of the notice-and-exchange process, and (2) what a reference product sponsor can do if a biosimilar applicant fails to comply with those requirements. In addressing issue (1), AbbVie asserts that Sandoz’s account of how the BPCIA should work is incomplete and inconsistent with the statute. Specifically, AbbVie asserts that Sandoz’s account is “inconsistent with the FDA approval process, contradicted by real-world events, and premised on potential exceptions to a generally applicable rule. In the end, a discretionary “notice” of commercial marketing that has no temporal nexus to actual commercial marketing is the functional equivalent of no notice at all.”
AbbVie next asserts that issue (2) is not properly presented and need not be decided by the Court. AbbVie asserts that, regardless of whether there is federal private right of action to enforce the statute, this is not ripe for review because Amgen only brought state-law claims. AbbVie further claims that Sandoz cannot argue Amgen’s state-law claims are preempted by the BPCIA because Sandoz previously waived that argument.

Stay tuned to Big Molecule Watch for updates on this case.

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