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Polsinelli Polsinelli - Hatch-Waxman Litigation and Opinion

September 2015


First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains


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The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch follows FDA approval of Zarxio™ on March 6, 2015 and a Federal Circuit panel decision in July preventing Sandoz from marketing Zarxio™ until 180 days after FDA licensure (i.e., until September 2, 2015). The launch of Zarxio™ does not quell the legal dispute between Sandoz and Amgen Inc., as both parties have asked the full Federal Circuit to review the panel decision.

Yesterday, the Federal Circuit issued a 2-1 decision denying Amgen Inc.'s request to extend the injunction that halted the marketing and sale of Zarxio™, a biosimilar of Amgen's Neupogen® product. Earlier in July, in a similarly divided 2-1 panel decision, the Federal Circuit interpreted the commercial marketing notice requirements of the Biologics Price Competition and Innovation Act (BPCIA) as requiring a biosimilar applicant to provide 180-day advance notice of commercial marketing to the reference product sponsor after grant of FDA licensure. In the present situation, this prevented Sandoz (the biosimilar applicant) from marketing Zarxio™ until September 2, 2015, i.e. 180 days after it received FDA approval on March 6, 2015.

Amgen Inc. (the reference product sponsor) sought to extend the injunction while the Federal Circuit considers Amgen's petition for an en banc rehearing of a separate aspect of the panel's July decision on the BPCIA. In addition to interpreting the commercial marketing notice requirements of the BPCIA, the panel also decided that certain information-sharing requirements of the BPCIA are optional – the BPCIA's so-called "patent dance". Arguing for the new injunction, Amgen Inc. contended that the full scope of its legal remedies would be limited if the panel's decision that the BPCIA's patent dance is optional was reversed but Sandoz had already launched its biosimilar product. The Federal Circuit gave no explanation for denying Amgen Inc.'s request for a new injunction.

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