Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA), contains a private right of action.  The letters come in the wake of the Federal Circuit’s Amgen v. Apotex decision, which held that the BPCIA’s 180-day notice of commercial marketing provision is mandatory and enforceable by an injunction.

Last fall, Amgen sued Hospira in the U.S. District Court for Delaware in an effort to prevent the sale of a biosimilar of Amgen’s blockbuster biologic, Epogen (epoetin alfa).  In the suit, Amgen asserted claims for patent infringement and for violations of the BPCIA.  Hospira moved to dismiss the BPCIA claims, arguing, among other things, that the BPCIA does not contain a private right of action allowing private companies such as Amgen to bring suit to enforce it.  At a hearing in May, Judge Andrews indicated that he would not rule on Hospira’s motion until after the Amgen v. Apotex appeal, which raised closely related issues, was decided by the Federal Circuit.

As noted, the Federal Circuit decided Amgen v. Apotex last week.  In the decision, the Federal Circuit upheld the district court’s grant of an injunction requiring Apotex to comply with the notice of commercial marketing requirement of 42 U.S.C. § 262(l)(8)(A) (referred to in the decision simply as “(8)(A)”), one of the BPCIA provisions Amgen is seeking to enforce against Hospira.  Amgen and Hospira now debate the implications of that ruling for Hospira’s pending motion to dismiss in the Epogen litigation.

Hospira fired the opening salvo in a letter to Judge Andrews on July 6, 2016.  In the letter, Hospira argues that though the Federal Circuit affirmed the injunction in Amgen v. Apotex, “it did so without ever considering whether there is a private right of action to enforce compliance with paragraph (8)(A),” the notice of commercial marketing provision.  Hospira further asserts that the Federal Circuit did not address “the significant body of law concerning whether a statute creates a private right of action.”  Therefore, according to Hospira, “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.”

Amgen shot back with a letter of its own on July 7, 2016, asserting that the “Federal Circuit’s holding ‘that the commercial-marketing provision is mandatory and enforceable by injunction’ … compels a finding here that the BPCIA provides a private right of action” to enforce the 180-day provision.  Amgen points to language in the Apotex decision suggesting that the availability of injunctive relief to enforce the notice provision furthers the legislative intent of the BPCIA, and noting that there was no government agency entrusted with the responsibility to enforce the provision.  Thus, Amgen contends that “although the court 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.

Amgen’s letter goes on to argue that the Federal Circuit rejected many of the arguments Hospira had made in support of its motion to dismiss.  Amgen notes that Hospira had argued that because it complied with the requirements of 42 U.S.C. § 262(l)(2)(A), which begins the “patent dance,” it was exempted from compliance with paragraph (8)(A), the notice of commercial marketing provision.  This argument was rejected in Amgen v. Apotex.  Additionally, Amgen asserts that the Federal Circuit “specifically rejected” Hospira’s position that the BPCIA provides an exclusive declaratory judgment remedy for failure to provide notice and that therefore no injunction is available.

Hospira responded on July 11 with another letter, contending that Amgen “mischaracterize[d]” Amgen v. Apotex by suggesting that it had already addressed the existence of a private right of action.  Hospira reiterated that the Federal Circuit had “avoided the private right of action issue” in Amgen v. Apotex and that Hospira’s motion therefore presents an unsettled question.

Notably, neither party has identified any material factual distinctions between the BPCIA claims in Amgen v. Hospira and Amgen v. Apotex.  Rather, Hospira’s contention is that its motion survives because it has presented a legal theory – lack of a private right of action – that Apotex could have presented in Amgen v. Apotex, but did not.  It remains to be seen whether Judge Andrews, or, eventually, a higher court, will want to distinguish the cases on this basis.