Roche Appeals Mircera Injunction
This article was originally published in The Pink Sheet Daily
Executive Summary
Company seeks to overturn move barring anemia launch in the U.S.
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In its continuing efforts to get anemia drug Mircera (epoetin beta) on the U.S. market, Roche has appealed a preliminary injunction barring the firm from launching the pegylated erythropoietin. Roche filed its notice of appeal in the Federal Court of Appeals April 9 and "plans to vigorously pursue" the action, the company said in a same-day statement. The preliminary injunction was issued Feb. 20 by a Massachusetts federal court judge to block the U.S. launch of Mircera. The injunction stems from a patent infringement suit brought by Amgen. In October, a jury found that Mircera infringed Amgen's EPO patent covering Epogen (epoetin) and Aranesp (darbepoetin alfa) (1 (Also see "Amgen EPO Patent Win Over Roche Could Derail Mircera Launch" - Pink Sheet, 23 Oct, 2007.)). Roche, however, "maintains its position that all of Amgen's patents for epoetin asserted against Roche are invalid and not infringed." While Roche likely appealed the injunction to "get the ball rolling," it may backfire, according to one analyst. "It is our understanding that by [Roche] appealing this decision, Judge Young no longer will have the opportunity to grant a modified preliminary injunction," Bear Stearns analyst Mark Schoenebaum wrote in an April 9 research note. "This is a positive decision for Amgen, as we believe the Appeals Court will be less likely to allow Roche to launch under a license agreement," Schoenebaum wrote. Judge William Young, of the U.S. District Court for the District of Massachusetts, said in February he would consider modifying the order to make the injunction permanent, unless Roche met certain requirements, including pricing restrictions. The judge suggested Roche offer Mircera to Medicare with an average selling price at or less than the average selling price of Epogen for the life of Amgen's patents. In a March 17 court filing, Roche indicated it would be able to satisfy the conditions laid out by the judge, who also said Roche would have to pay Amgen a 22.5 percent royalty, fund an independent agency to monitor Roche sales and account for royalty payments, and provide Mircera at or below the same price for which it was authorized to any patient requesting it as long as the patient required the therapy (2 (Also see "Roche Agrees To Court Conditions For Mircera Launch" - Pink Sheet, 19 Mar, 2008.)). -Brooke McManus ([email protected]) |