Litigation Update: Amgen v. Hospira (epoetin alfa)

A couple of updates on Amgen v. Hospira (epoetin alfa): Amgen has requested that the district court (D. Del., J. Andrews) grant it leave to file a second amended complaint “to add three additional defendants” who, Amgen alleges, “have directly or indirectly infringed Amgen’s patent-in-suit, United States Patent No. 5,756,349.”

Meanwhile, Hospira has filed its answer and counterclaims to Amgen’s first amended complaint.  As a reminder, Hospira had previously moved to dismiss Count I of Amgen’s amended complaint, which seeks both a declaratory judgment that Hospira’s alleged refusal to provide Amgen with 180-days’ post-licensure notice of commercial marketing violates the notice provision (l)(8)(A) of the BPCIA, as well as injunctive relief requiring Hospira to provide Amgen with a legally effective notice of commercial marketing under (l)(8)(A).  The Court denied that motion on August 5, 2016.

In its answer to the first amended complaint, Hospira “denies that the BPCIA provides for a private right of action to enforce [the BPCIA notice] provisions” and maintains that Hospira has complied with “all relevant provisions of the BPCIA,” including the disclosure and notice provisions, and the patent-dance negotiation provisions of (l)(4).  On the (l)(4) step, Hospira answers that is “has fully complied with all provisions of 42 U.S.C. § 262(l)(4), including by engaging in negotiations that concluded on August 19, 2015 when Hospira accepted the patents listed in Amgen’s § 262(l)(3)(A) disclosure as constituting the list of patents required to be litigated by § 262(l)(6),” and that “[t]he BPCIA specifically contemplates this type of situation where the parties are able to agree on the patents to litigate.”  In response to Amgen’s statements regarding Hospira’s alleged failure to comply with the (l)(2) disclosure provisions, Hospira also states: “Amgen was required to list any of its ‘extensive portfolio of patents relating to various aspects of the manufacture of biological products’ on its § 262(l)(3)(A) list, but unilaterally decided not to do so despite the comprehensive information concerning its manufacturing process and product provided by Hospira,” and “[p]ursuant to 35 U.S.C. § 271(e)(6)(C), Amgen is prohibited from asserting a claim of infringement against Hospira’s Product on any patent that is not included in a timely manner on Amgen’s list of patents provided pursuant to 42 U.S.C. § 262(l)(3)(A).”

Hospira’s affirmative defenses to Amgen’s BPCIA claims include the following:

  • “Hospira is not required to provide a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A).”
  • “The Court lacks jurisdiction over Count 1” (Amgen’s request for a declaratory judgment that “Hospira’s refusal to give legally effective notice of commercial marketing violates 42 U.S.C.  § 262(l)(8)(A)”) because “the BPCIA does not confer a private right of action to enforce allegations of non-compliance with the statutory provisions of 42 U.S.C. § 262(l)(8)(A).”
  • “Hospira has complied with the provisions of the BPCIA, including specifically 42 U.S.C. § 262(l)(2)(A).”

Stay tuned to the Big Molecule Watch for further updates.