Hospira’s motion to dismiss Count I of Amgen’s complaint has been denied, and Amgen will be able to seek declaratory judgment relief in the form of an injunction requiring Hospira to comply with the notice of commercial marketing provisions of the BPCIA.  Amgen sued Hospira for patent infringement under the BPCIA in relation to Hospira’s aBLA for a biosimilar of Epogen®, which has not yet been licensed by the FDA. (Amgen v. Hospira, Action No. 15-cv-839 (D. Del)).  Amgen alleged that Hospira’s biosimilar will infringe Amgen’s U.S. Patent No. 5,856,298 and that Hospira’s manufacturing process does infringe U.S. 5,756,349. Amgen’s amended complaint included Count I, which sought declaratory judgment that Hospira violated the BPCIA’s notice provisions under section (8)(A) and sought injunctive relief requiring Hospira to provide effective notice of commercial marketing.  According to Amgen’s complaint, Hospira had first given ineffective notice before FDA approval and then took the position that it would not obey the notice provisions at all. (D.I. 11 at ¶¶ 81-83.)  Hospira then moved to dismiss Count I on the grounds that the BPCIA did not give Amgen a private right of action to enforce the notice provisions.

Judge Andrews in the District of Delaware denied the motion to dismiss, but effectively side-stepped the issue of whether the BPCIA creates a private right of action.  Instead, Judge Andrews found authority for Amgen’s count under the Declaratory Judgment Act.  The court analyzed the Federal Circuit’s opinion in Amgen v. Apotex, which was decided while Hospira’s motion was pending, and held that its reasoning allowed a declaratory judgment seeking enforcement of the BPCIA notice provision.

In Apotex, the biosimilar applicant (Apotex) had effectively agreed that Amgen had a right to enforce violations of (8)(A). (See Apotex at 21, stating “Apotex has not asserted that (8)(A) creates no privately enforceable right.”) Thus, assuming Amgen had a right to enforce, the question was what options were available for enforcement.  Apotex argued that the remedies in (9)(B) were exclusive, therefore precluding Amgen from seeking an injunction or any other remedy.  The Federal Circuit said that the remedy of a patent infringement suit outlined in (9)(B) was not the exclusive remedy, and a party with a private right of action could seek other remedies for violations of (8)(A) — such as a preliminary injunction.

Judge Andrews latched onto the Federal Circuit’s reasoning in Apotex: “that the federal courts’ equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command.” (Dkt. 68 at 4 quoting Apotex at 8.)  According to the court, “[t]he Federal Circuit has already recognized the availability of injunctive relief for violations of (8)(A)” via the holding in Apotex. And, in the absence of the declaratory judgment option, Amgen would simply ask for an injunction if and when Hospira violated the (8)(A) notice provision. Thus, the court reasons, just as (9)(B) of the BPCIA did not deprive courts of their equitable jurisdiction to issue an injunction for a violation of the (8)(A) notice provisions, so too did the Declaratory Judgment Act not limit the court’s equitable powers. Rather, the Declaratory Judgment Act expanded the court’s options, and allowed the court “to provide a milder alternative to the injunction remedy.”  Because the Court could issue an injunction for a violation of (8)(A), the court found it should likewise be able to enjoin Hospira from violating (8)(A) in the first place in a declaratory judgment action.

The court’s ruling does not find a private right of action to enforce (8)(A) within the BPCIA.  Rather, the opinion relies narrowly on the Declaratory Judgment Act, which allows a party to determine legal rights in advance of a violation. A declaratory judgment action requires that there be a an “actual case or controversy” so that the court is not simply giving an advisory opinion on what the ruling would be if a dispute arose.  In this case, an actual case or controversy existed at least because of Hospira’s alleged statements that it would violate (8)(A)—e.g., that Hospira’s pre-licensure notice was effective and/or that it would not provide notice at all.  The legal landscape at the time encouraged Hospira to make such statements to preserve its rights, because the law was unsettled as to whether a biosimilar applicant that engaged in at least part of the “patent dance” provisions (like Hospira) was required to provide notice of commercial marketing after FDA licensure.

We will continue to monitor this case and provide further updates.