By Scott Graham, From The Recorder

The U.S. Court of Appeals for the Federal Circuit gave Sandoz Inc. the green light Wednesday to begin marketing its biosimilar version of Amgen Inc.’s Neupogen treatment for cancer patients.

By a 2-1 vote the Federal Circuit refused to extend a six-month injunction on sales of Zarxio while the full court weighs petitions from both sides to rehear the ground-breaking decision interpreting the Biologics Price Competition and Innovation Act. While the injunction expires today, it wasn’t clear that Zarxio, the first biosimiar to be approved by the U.S. Food and Drug Administration, will be hitting pharmacy shelves any time soon. Separate patent litigation still remains to be thrashed out before U.S. District Judge Richard Seeborg, and on Tuesday, Sandoz’s corporate parent, Novartis AG, announced a major collaboration with Amgen on a treatment for Alzheimer’s disease.

A Sandoz spokesman would say only that the company welcomes Wednesday’s decision and will keep the public apprised of launch plans.

“While they have the right to launch, there is still a pending patent litigation case going on in the Northern District of California,” said Finnegan, Henderson, Farabow, Garrett & Dunner partner Sanya Sukduang, who’s been closely following the case. “Sandoz has to balance out what we would call launching at risk versus being liable for damages” in the event Amgen ultimately can prove its infringement case.

Goodwin Procter partner Elaine Blais agreed. “I think the really interesting question is, ‘Are they going to launch their product tomorrow?’” she said. Sandoz has to weigh the risk of losing en banc or in the district court litigation, where lost profits for a branded drugmaker can far outstrip the actual profit earned by a biosimilar competitor.

Biologic medications, unlike chemical drugs, are made from biological material such as cells, blood or proteins. A biosimilar is an interchangeable medication, roughly comparable to a generic version of a conventional drug. The fight between Amgen and Sandoz has been seen as a test case in the new pharmaceutical market, which is expected to grow exponentially in the U.S.

The Federal Circuit’s July 21 decision in Amgen v. Sandoz held Sandoz was required to give Amgen 180 days’ notice of its plans to market Zarxio after first obtaining FDA approval of a compound modeled on Neupogen. Because that approval came in March, the Federal Circuit enjoined Sandoz only through today.

Last week Amgen filed an emergency motion seeking to extend the injunction until the full court has an opportunity to rehear the case. “Sandoz’s launch will fundamentally and permanently alter the market, causing irreparable harm to Amgen if the en banc court ultimately decides the issues in favor of Amgen,” states the motion, which was signed by Paul, Weiss, Rifkind, Wharton & Garrison partner Nicholas Groombridge.

Sandoz’s counsel, Morrison & Foerster partner Deanne Maynard, called it “a perfunctory motion” that doesn’t even try to demonstrate a likelihood of success, “i.e., that the court will both grant its petition and reverse.”

The Federal Circuit takes up only a small handful of cases en banc each year.

On Wednesday, Judges Alan Lourie and Raymond Chen voted to deny the motion, while Judge Pauline Newman indicated she would have granted it.

Goodwin Procter’s Blais said she wasn’t surprised given Lourie’s observation at oral argument that Amgen has enjoyed 20 years of exclusivity with Neupogen. “The court’s already been pretty generous with them” by extending the period another six months, she said.

In the meantime, Amgen v. Sandoz is reverberating around other courts. In Massachusetts, Janssen Biotech Inc. is wielding the decision as proof that Celltrion Inc. and Hospira Inc. acted prematurely in giving Janssen 180 days notice last February that it intends to market a biosimilar version of its autoimmune disease treatment Remicade.

Janssen argued in a motion filed last week that Amgen v. Sandoz makes clear Janssen must first obtain FDA approval before starting the six-month clock. But Celltrion is arguing that the Amgen decision makes clear it’s exempt from that requirement—because it engaged Janssen in the BPCIA “patent dance,” whereas Sandoz did not make disclosures outlined by the law. Janssen’s sole remedy is a declaratory judgment action, Celltrion contends.

IMAGE: Deanne Maynard, head of appellate practice at Morrison & Foerster. June 16, 2009. Photo by Diego M. Radzinschi/NATIONAL LAW JOURNAL.

For more on this story go to: http://www.therecorder.com/id=1202736324023/Circuit-Wont-Block-First-US-Biosimilar-Launch#ixzz3kgOHzY8G