As we reported in August, the Federal Circuit denied Hospira’s motion to dismiss Amgen’s interlocutory appeal from the district court (D.Del., J. Andrews) regarding a discovery dispute. The court ordered the parties to brief the merits of the discovery dispute and the issue of whether the circuit court had jurisdiction to hear the appeal. Amgen filed its brief on September 12, with the following two issues presented:
- Whether, in a patent-infringement action pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”), the district court erred by holding that “information that describes the process or processes used to manufacture the biological product that is the subject of” the Applicant’s subsection (k) application, 42 U.S.C. § 262(l)(2)(A), may properly be shielded from discovery, in light of this Court’s holding in Amgen Inc. v. Sandoz Inc. that where a subsection (k) applicant (“Applicant”) does not provide that information during the information-exchange period of the BPCIA, the reference product sponsor (“RPS”) can bring an infringement suit against the Applicant and “can access the required information through discovery,” 794 F.3d 1347, 1356 (Fed. Cir. 2015).
- Whether this Court has jurisdiction under the collateral-order doctrine or the All Writs Act, 28 U.S.C. § 1651(a), to review the first post-Sandoz decision of a district court denying an RPS access, through discovery in an infringement suit, to the manufacturing information that the Applicant refused to disclose during the BPCIA information-exchange period as set forth in 42 U.S.C. § 262(l)(2)(A), thereby denying the RPS the sole remedy that this Court has held is available to it for the Applicant’s failed disclosure: a patent-infringement action before the Applicant commences commercial marketing of the biosimilar.
We will continue to report on updates to this and other BPCIA litigations at the Big Molecule Watch.