Saturday, May 30, 2015

CAFC to hear arguments in Amgen v. Sandoz over Neupogen biosimilar

The CAFC will interpret parts of the Biologic Price Competition and Innovation Act (BPCIA) in the case Amgen v. Sandoz related to Neupogen / Zarxio.

From The Recorder

Specifically, the court will be asked to decide whether biosimilar-drug makers must disclose their product and manufacturing process to the brand-drug maker and exchange patent contentions before Food and Drug Administration approval and commercial launch. That eight-month-long procedure, outlined in the BPCIA, is already known as "the patent dance."

U.S. District Judge Richard Seeborg of San Francisco ruled in March that the law permits either side to opt out of the dance and proceed directly to litigation. Amgen and its amici curiae say that would let biosimilar makers profit off their research and development without providing the fair warning Congress provided to protect their patents and resolve cases in a quick and orderly manner.

"Just as Hatch-Waxman patent litigation has become ubiquitous over the past three decades, the same is likely to happen with biosimilars litigation," Latham & Watkins partner Melissa Arbus Sherry writes for amiĀ­cus AbbVie Inc. "If Sandoz were to prevail, the entire biosimilar litigation process would become a free-for-all" in which brand manufacturers "blindly guess as to which patents they should sue on and when." That would lead to "inefficient and protracted litigation for years to come."



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