The Federal Circuit's July 5, 2016 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.
