On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more hurdle for market entry of the fi rst biosimilar in the United States. This current dispute hinges on the interpretation of two portions of subsection 42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act.

Amgen initiated the current action on October 24, 2014, when it asserted that Sandoz acted unlawfully because it (1) failed to comply with subsection (l)’s patent disclosure and negotiation procedures (i.e., the “patent dance”); and (2) intends to market its biosimilar immediately upon receiving FDA approval, rather than waiting until at least 180 days thereafter. These actions, Amgen asserted, constitute the predicate wrongful behavior to sustain a claim under California’s Unfair Competition Law. Amgen also asserted that Sandoz committed conversion by relying on Amgen’s FDA license for Neupogen in its biosimilar application while failing to engage in the patent dance. For its part, Sandoz asserted that (1) biosimilar applicants may elect not to provide their applications to the reference product sponsor; (2) the BPCIA does not provide for injunctive relief, restitution, or damages for failure of a subsection (k) applicant to share its BLA; (3) the BPCIA sets forth exclusive consequences for failure to comply with 42 U.S.C. § 262(l)’s disclosure, negotiation, and notifi cation provisions; (4) the BPCIA renders remedies under California’s Unfair Competition Law and conversion claims unlawful and/or preempted; (5) a reference product sponsor does not maintain exclusive possession or control over its biologic product license; (6) noninfringement of Amgen’s U.S. Pat. No. 6,162,427 patent; and (7) invalidity of the ’427 patent. As outlined below, the court decided the issues regarding interpretation of the BPCIA sections in Sandoz’s favor.