ITC Refuses to Rule on Amgen Complaint

The International Trade Commission has dismissed a complaint filed by Amgen Inc. alleging that Japan’s Chugai Pharmaceutical violated an Amgen patent by importing for clinical trials a version of a promising anti-anemia drug commonly called EPO.

It was a setback in one of several legal battles being fought by Amgen in its effort to be the first company to sell EPO, which is expected to be one of biotechnology’s most lucrative products.

The ITC said it could not rule on the dispute because the patent held by Amgen, a Thousand Oaks-based biotechnology firm, does not extend to the actual process of making EPO, which is short for erythropoietin. Instead, the commission said, the patent only covers the “host cells” that Amgen creates using biotechnology techniques and that act like tiny factories to produce the drug.

Amgen Stocks Fell

The ruling Monday had been widely expected after an ITC administrative law judge ruled against Amgen in January. In that ruling, Judge Sidney Harris found that Amgen has a valid patent, but that no infringement occurred because Chugai is making the drug in Tokyo instead of in the U.S.

Amgen still is awaiting approval to sell the drug from the U.S. Food and Drug Administration. The company’s legal disputes are delaying Amgen’s efforts to bring to market the drug, a hormone that triggers production of red blood cells and has been shown to be successful in treating anemia suffered by kidney dialysis patients.

Monday’s ruling does not affect a separate complaint Amgen filed with the ITC alleging unfair trade practices by Chugai, nor does it affect a patent infringement lawsuit Amgen filed in federal court in Boston against the Japanese company and its American partner, Genetics Institute of Cambridge, Mass.