Last week, Judge Richard Andrews in the District of Delaware heard argument in Amgen v. Hospira on Hospira’s motion to dismiss Amgen’s action over notice provisions in the Biologics Price Competition and Innovation Act (“BPCIA”). Hospira, now owned by Pfizer Inc., argued that Amgen cannot seek an injunction to enforce provisions of the BPCIA.
The dispute questions whether Congress intended to create a private right of action for a reference product sponsor like Amgen to enforce Section 262(l)(8)(A). If so, courts could require a biosimilar applicant to provide notice of commercial marketing, which would trigger a 180-day exclusivity for the reference product.
According to Hospira, the statute must indicate unambiguously that Congress intended to create a private right of action, which must especially benefit the reference product sponsor (as opposed to, e.g., the biosimilar sponsor, both sponsors, or neither sponsor). Also, the statute provides a particular remedy when the biosimilar sponsor does not provide notice of commercial marketing. Absent notice, the reference product sponsor can bring patent actions, and the biosimilar sponsor cannot file a declaratory judgment action. This remedy, Hospira said, indicates that Congress did not intend to create a private right of action to enforce the notice of commercial marketing provision.
Hospira separately argued that the notice of commercial marketing is optional for biosimilar sponsors that “opt in” and comply with paragraph (2)(A) by providing the reference sponsor with the technical information in the biosimilar application.
Amgen argued that Congress implied a right to action by imposing a duty on biosimilar applicants to provide notice, and that the notice requirement does particularly benefit the reference product sponsors. Relying on the Federal Circuit’s decision in Amgen v. Sandoz, Amgen also argued that the notice of commercial marketing is mandatory, regardless of whether the biosimilar applicant opts in by providing its technical materials under paragraph (2)(A).
Judge Andrews questioned the effect of a decision on the motion to dismiss in light of the appeal in Amgen v. Apotex. Both sides noted that the question of an implied right of action was not directly at issue in the other litigation, and whether the Federal Circuit would address it is unclear.
Big Molecule Watch will continue to track this case and other litigation involving the BPCIA, so check back for the latest news and analysis.