ITC RULES FOR ROCHE IN ERYTHROPOIETIN DISPUTE

The U.S. International Trade Commission (ITC) has decided not to review a decision made earlier this year that Roche's importation and use of its experimental anemia drug Mircera in the U.S. did not violate Amgen's patents on its anemia drug Epogen. Roche will continue to focus on obtaining FDA approval for Mircera, it said in a Sept. 1 statement.

Earlier this year, the ITC determined that Roche was eligible for a "clinical trial exemption," from patent infringement liability because Roche was studying the product only to get FDA approval for its drug. Federal law exempts a company from patent infringement liability if the company makes use of the patented product "solely for uses reasonably related to" obtaining and submitting information to get FDA approval for another product.

Amgen had filed the complaint asking the ITC to permanently block importation of Roche's erythropoietin product, claiming that Mircera, a continuous erythropoietin receptor activator, violates six patents on Epogen and its manufacturing method.

Epogen (epoetin alfa) is a form of erythropoietin, a biologic product that treats anemia by encouraging red blood cell production. Epogen contains pegylated recombinant human erythropoietin, or peg-EPO. Amgen said that ruling only applied to Roche's past importation and use of peg-EPO in the U.S., and did not address whether Roche's future importation or use would constitute a violation.