Roche will be able to launch Mircera in mid-2014, ten months before the patents on Amgen's erythropoietin drugs expire, under a licensing agreement with Amgen.

The deal settles a patent suit Amgen brought against Roche in 2005. Roche also conceded that the five EPO patents at issue in the suit were valid, enforceable and infringed by Roche's pegylated erythropoietin product (Also see "Patent Power: Roche Concedes Case Over Amgen's EPO" - Pink Sheet, 22 December, 2009.). The U.S. District Court for the District of Massachusetts issued an order permanently enjoining Roche from selling Mircera (epoetin beta) until the latest of the five patents expired unless it obtained a license from Amgen. The latest patent, No. 5,756,349, expires on May 26, 2015.

Amgen issued a press release late on Dec. 22 announcing the limited license agreement with Roche. Amgen noted that the settlement terms do not include any financial payments between the two companies.

While Amgen had won a favorable ruling from the U.S. Court of Appeals for the Federal Circuit on the bulk of its claims, it apparently did not want to take the chance that Roche might eventually win after the case bounced back to the district court. The deal allows Roche to launch its product nearly a year before the patents on Epogen (epoetin) and Aranesp (darbepoetin alfa) expire and tap into the market for these products, which garnered $5.6 billion in sales in 2008.

-Brenda Sandburg (b.sandburg@elsevier.com)

Roche Can Launch Mircera 10 Months Before Amgen's EPO Patent Expires

More from Archive

More from Pink Sheet