Amgen, Roche battle over Mircera still unsettled

In the long battle for Amgen to prevent generic drug company Roche Holdings from bringing its anemia drug Mircera into the US market, a federal appeals court has ruled that Roche could import its drug as long as it was not for sale, while also returning the case back to the International Trade Commission.

Amgen feels that since Roche applied for Mircera’s approval from the FDA, it was violating Amgen’s patents—for Epogen and Aranesp—because the application proved intent to sell. The FDA has already approved the drug but, according to published reports, it has not been marketed it in the US based on the legal matters involved.

As Drug Store News reported yesterday, Roche agreed to the U.S. District Court for Massachusetts’ conditions in an attempt to get Mircera on the market, including, according to published reports, paying Amgen a higher royalty fee. The court’s approval would give Amgen a new rival in the top selling Anemia market, which has made up more than 40 percent of Amgen’s revenue per year. Roche has agreed to set Mircera’s price at or below Epogen’s for the remainder of the patents that Amgen holds.

Amgen’s patents for its anemia drugs begin expiring in 2013, and, according to reports, Roche plans on waiting until then to sell its drug in the U.S. According to IMS Health, Aranesp had U.S. sales of $3.2 billion last year and Epogen had sales of $3.1 billion.