Injunction Denied, Sandoz Clear to Launch

This morning, a divided Federal Circuit denied Amgen's motion for a temporary injunction preventing Sandoz from marketing ZARXIO, its biosimilar version of Amgen's NEUPOGEN filgrastim product.  With no explanation, the Court refused Amgen's request for a temporary injunction while the Federal Circuit considers both parties' requests for an en banc rehearing of its July 21, 2015 ruling regarding the Biologics Price Competition and Innovation Act (BPCIA). In this case of first impression, the Federal Circuit previously held (1) the "patent dance" provision of section (l)(2)(A) was not mandatory for subsection (k) applicants and (2) biosimilar applicants may only give effective notice of intent to commercially market after the FDA has licensed the biosimilar product. Amgen appealed the panel's decision that the patent dance is optional, whereas Sandoz appealed the ruling concerning the notice period.

Regarding Amgen's most recent request for a temporary injunction, Judge Lourie and Judge Chen joined in rejecting Amgen's request, while Judge Newman would have granted the injunction. Notably, this is the same majority that ruled against Amgen last month in holding that the patent dance provisions of the BPCIA are optional.

This decision, which comes as the injunction against Sandoz's marketing of ZARXIO is set to expire today, clears the way for Sandoz to begin marketing the first biosimilar approved under the BPCIA as early as tomorrow. It remains to be seen whether Sandoz will begin marketing and launch ZARXIO in light of the pending en banc petitions and Amgen's pending lawsuit alleging infringement of U.S. Patent No. 6,162,427, which claims a method of using filgrastim.

We will continue to monitor these events and provide updates.

Authors: Michael Amon, Tasha Francis