Roche Could Start Selling Mircera in U.S. in mid-2014


THOUSAND OAKS, Calif.—Roche could be able to market its anemia drug Mircera in the United States in mid-2014 after it admitted that it infringed on rival Amgen’s patents, according to a Dec. 22 news release from Amgen.

Roche admitted that “the five Amgen EPO patents involved in the lawsuit are valid, enforceable and infringed by Roche's pegylated-erythropoietin (peg-EPO) product, Mircera,” according to Amgen.

As a result, the U.S. District Court in Boston entered a final judgment and issued a permanent injunction barring Roche from selling Mircera in the United States.

However, Roche will be allowed to sell Mircera in the United States in mid-2014 under terms of a limited license agreement, according to Amgen. The settlement terms do not include any financial payments between the parties.

Amgen filed a lawsuit in November 2005 in the U.S. District Court of Boston to stop Swiss drugmaker Roche from making or importing Mircera into the United States. Amgen said that Mircera violated EPO patents related to Amgen’s anemia drugs Epogen and Aranesp.

In October 2007, a jury ruled that Roche’s anemia drug infringes on Amgen’s existing patents. The U.S. Federal District Court in Boston issued a preliminary injunction barring Roche from selling Mircera in the United States. That ruling was upheld by a federal judge.

"We are very pleased with this agreement, a victory for Amgen that reaffirms the validity of our patents and brings to an end this long-standing legal dispute," said David Scott, senior vice president and general counsel for Amgen. "The settlement provides certainty to both companies and allows Amgen to focus intently on investing in innovative research and delivering medicines that treat grievous, unmet medical needs."

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