Amgen v. Sandoz, No. 15-1499 (Fed. Cir. May 5, 2015)
In a per curium Order today, the Federal Circuit granted Amgen's Emergency Motion for an Injunction Pending Appeal, stalling, at least temporarily, Sandoz's commercial launch of Zarxio, a biosimilar version of Amgen's Neupogen (filgrastim). Zarxio is the first biosimilar product approved by FDA under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). FDA approved Zarxio on March 6, and Sandoz agreed not to commercially launch the product until May 11 or a Federal Circuit ruling in its favor.
The primary issue in the case is whether the pre-litigation information-exchange provisions of the BPCIA are mandatory, as Amgen argues, or optional, as Sandoz contends. The BPCIA states that a biosimilar applicant "shall provide" a copy of its FDA application and manufacturing information to the Reference Product Sponsor (RPS)--here, Amgen. The statute further states that in the event that a biosimilar applicant fails to provide its application and manufacturing information, the RPS may file a declaratory judgment action against the applicant. Sandoz argues that a biosimilar applicant therefore has a choice: either provide a copy of its application and manufacturing information to the RPS and proceed to the subsequent information-exchange provisions of the BPCIA (including the exchange of patent lists, invalidity and non-infringement contentions, etc.), or accept the consequence of a declaratory judgment action filed against it.
Amgen filed suit against Sandoz last October, alleging state-law claims of unfair competition and conversion based on Sandoz's alleged failure to comply with the BPCIA, as well as patent infringement. With Sandoz's biosimilar application proceeding quickly toward FDA approval, Amgen filed a motion for preliminary injunction against Sandoz in February. On March 19, the district court denied Amgen's motion, ruling that the information-exchange provisions of the BPCIA are optional and that Sandoz fully complied with the law.
Amgen immediately appealed to the Federal Circuit, and, two days after the district court denied Amgen's motion for injunction pending appeal, filed the emergency motion that the court granted today. Amgen's appeal attracted the support of three amicus filings, by BIO, AbbVie, and Janssen, while GPhA, Celltrion, and Hospira filed amicus briefs in support of Sandoz.
Amgen and Sandoz requested an expedited appeal schedule, which the Federal Circuit granted. Briefing is complete, and the court scheduled oral argument for June 3rd. The standard for granting a motion for injunction pending appeal is high--"whether the movant has made a strong showing of likelihood of success on the merits." It therefore appears likely that that Federal Circuit will ultimately reverse the district court and rule that the pre-litigation information-exchange provisions of the BPCIA are mandatory.