On September 18, 2015, Amgen sued Hospira in a fourth lawsuit under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The lawsuit concerns Hospira’s proposed biosimilar of Amgen’s Epogen (epoetin alfa). Amgen filed the case in Delaware and it has been assigned to Judge Andrews.
In addition to its claims for patent infringement, Amgen sued Hospira for failing to comply with the patent litigation provisions of the BPCIA. In particular, Amgen explains that Hospira 1) failed to provide the manufacturing information required under 42 U.S.C. § 262(l)(2)(A), making it impossible for Amgen to ascertain whether certain of its patents were infringed, and 2) refused to participate in the BPCIA’s procedures for determining which patents are to be litigated immediately. 42 U.S.C. § 262(l)(4)-(6). Although the majority in the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015), recently held that a biosimilar maker can choose not to provide its regulatory application and other manufacturing information to the innovator company, Amgen notes that it is seeking for the full court to review this question. Amgen’s complaint also states that Hospira refused to provide a 180-day notice of commercial marking after the approval of its product, i.e., the first time that Hospira can provide an effective notice of commercial marketing under Amgen v. Sandoz. Amgen seeks an injunction to restore “the benefits afforded to [innovators] in the BPCIA, e.g., the information and time provided by the statute for evaluating Hospira’s manufacturing information, exchanging patent lists and information, negotiating patent lists, receiving Hospira’s notice of commercial marketing, and bringing patent infringement actions and preliminary injunction motions.”
Hospira’s proposed biosimilar has not been licensed by FDA. FDA also has not announced plans for an advisory committee meeting for Hospira’s product.