On appeal, Amgen wins protection for anemia drug
WASHINGTON -- Amgen Inc., the world's biggest biotechnology company, won an appeals court ruling that will help keep Shire Plc's Dynepo anemia drug out of the US market.
The federal patent appeals court in Washington said Dynepo infringes on two Amgen patents. The court reversed a finding that a third patent was violated and sent a fourth back for review. The nearly 10-year fight centers on a method of producing a human protein that Amgen uses to make its Epogen medicine. The protein fights anemia by spurring the growth of red blood cells.
The patents also are part of a separate Amgen legal battle to keep Roche Holding AG from introducing a medicine called Cera. Amgen is trying to prevent competition for Epogen and a second anemia drug, Aranesp, which together accounted for 46 percent of the company's revenue last year.
The ruling leaves Shire ``without recourse in launching in the US, but may ultimately aid Roche's case for Cera," said Steven Harr, a Morgan Stanley analyst, in a note to clients. ``Roche's case may have become modestly easier."
Roche has released limited information about Cera, making it difficult to judge the implications of yesterday's ruling, analysts including Mark Schoenebaum of Bear Stearns said. The ruling is ``net neutral" for the Cera case, he said.
In a dissent, Chief Judge Paul Michel agreed with the findings of infringement and chastised the other two judges for prolonging the case by siding against Amgen on the third patent.
``When will it end?" he wrote. ``Ironically, the patents in dispute may expire before this litigation concludes."
He said the district court is likely to issue a ruling that would preclude sales of Dynepo in the United States until the expiration of the two patents found to be infringed on, so ``prolonging this litigation seems futile."
The patent dispute hinges on the way that drug makers make copies of a protein called erythropoietin, or EPO, which triggers the production of red blood cells, which are depleted in patients with kidney disease and cancer, causing anemia. Amgen's Epogen is used to treat kidney patients, and the drug maker licensed the rights to use the medicine for cancer to Johnson & Johnson.
Amgen's Aranesp, which lasts longer in the body and is given to patients less often, is covered by additional patents. Aranesp was Amgen's best-selling drug last year, with $3.27 billion in sales. Epogen had $2.46 billion in sales, making it the company's third-best seller, behind Aranesp and an arthritis medicine called Enbrel.
