Hospira to Court: Amgen v. Apotex does not address the specific question raised by Hospira’s Motion to Dismiss in Amgen v. Hospira – UPDATED: Amgen’s Response

Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Hospira (epoetin alfa)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions

 

Tuesday’s Federal Circuit opinion in Amgen v. Apotex  is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court for the District of Delaware (J. Andrews) in connection with its pending motion to dismiss Amgen’s action alleging violation of the BPCIA’s (8)(A) notice provision.   Hospira’s letter to the Court states that the Federal Circuit’s decision “addressed a similar but different question in Apotex,” noting: “Although the Federal Circuit found that Amgen was entitled to an injunction, it did so without ever considering whether there is a private right of action to enforce compliance with paragraph (8)(A).”

The Federal Circuit in Apotex stated on this point that “Apotex has not asserted that (8)(A) creates no privately enforceable right, even when asserted as part of an infringement action concerning patent rights whose fair and unhurried adjudication (8)(A) is designed to protect….Instead, Apotex suggests that the only remedy for an applicant’s unilateral denial to the reference product sponsor of the 180-day period for post-licensure litigation decision-making is a declaratory-judgment action on a patent” under (l)(9)(B).  (Fed. Cir. Op. p. 21.)

Hospira states that because the Federal Circuit did not otherwise address whether the BPCIA grants the reference product a private right of action to enforce the notice provision, “the specific issue of whether paragraph (8)(A) provides a private right of action as set forth in Hospira’s motion papers is still open for this Court to decide in this case.”

Stay tuned to the Big Molecule Watch for further developments.

UPDATED 7/7/2016: In response to Hospira’s letter to the Court, Amgen has submitted a letter of its own stating that “Hospira understates the significance of the Apotex decision” and that “the Court should deny Hospira’s Motion to Dismiss.”  Amgen writes: “[A]lthough the court [in Apotex] did not use the words ‘private right of action,’ its decision compels the conclusion that the BPCIA vests the reference product sponsor with a private right of action to obtain injunctive relief to enforce the commercial notice provision of paragraph 8(A).”

Amgen further states in the letter that the Federal Circuit “specifically rejected” Hospira’s other arguments in support of its Motion to Dismiss—namely, that because it engaged in the patent dance (though Amgen continues to dispute whether Hospira’s disclosure was sufficient under the first step of the dance) the notice requirement is not mandatory in this case, and that (l)(9)(B) provides the sole remedy to Amgen for a refusal to provide notice under (8)(A).

 

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