Washington Editor

A jury in the U.S. District Court in Massachusetts Tuesday ruled in favor of Amgen Inc. in a patent infringement dispute against F. Hoffmann-La Roche Ltd. about its erythropoiesis-stimulating agent (ESA) Mircera.

The FDA is expected to make a decision by Nov. 14 about Roche's approval application for Mircera to treat anemia associated with chronic renal failure. The ESA received approval from regulators in the European Union in July and Switzerland and Norway in September.

Thousand Oaks, Calif.-based Amgen, which markets darbepoetin alfa as Aranesp and epoetin alfa as Epogen, said it would seek an injunction to stop Basel, Switzerland-based Roche from marketing Mircera in the U.S. "in violation of Amgen's affirmed patent rights."

A hearing on the injunction is scheduled for Nov. 15, Amgen said in a statement.

Weeks before the jury verdict, a Roche official, William M. Burns, reportedly had said his firm would not launch Mircera in the U.S. if Amgen won the suit.

Roche spokeswoman Linda Dyson told BioWorld Today that the firm could not comment on Burns' remarks or whether he meant his statement to pertain to a final appeal judgment or the verdict this week by the trial jury.

Roche said it would evaluate its legal options and possibly appeal the jury's decision. "Roche maintains its position that all of Amgen's patents for epoetin asserted against Roche are invalid and not infringed, and believes the facts and the law support that position," the firm, which has U.S. headquarters in Nutley, N.J., said in a statement.

Amgen claimed that Mircera "provides no clinical or patient benefit" over its ESA products.

Roche has argued that Mircera has a "longer half-life than any commercially available" ESA.

George Abercrombie, Roche's U.S. CEO, called the jury's decision a disappointing loss for U.S. patients with chronic kidney disease. "We believe it is important for there to be competition and choice in this country," he said in a statement. "Amgen has had an extended monopoly for the last 20 years not allowing for new therapeutic options to treat anemia to be introduced to patients in this country."

An earlier ruling by a U.S. district judge found that Mircera infringed Amgen's composition patent. The court in August also granted a summary judgment in favor of Amgen on certain Roche defenses against the patents-in-suit. (See BioWorld Today, Aug. 30, 2007.)

Given the August ruling from the bench by U.S. District Court Judge William G. Young that Mircera infringed at least one Amgen patent - U.S. patent 5,955,422 covering pharmaceutical compositions of erythropoietin purified from mammalian cells - the jury's verdict was "not surprising," analyst Eric Schmidt of Cowan and Co. in New York said in an investor note. Nonetheless, he said, the jury's decision "removes another overhang" on Amgen's shares, which have taken a beating since March after the FDA called for a black-box warning on all ESAs and a July decision by the Centers for Medicare & Medicaid Services' to restrict payments of the drugs in cancer patients.

While Roche is likely to appeal the jury's verdict, Schmidt said, "the fact that Amgen prevailed on 11 claims makes the prospect of any near-term Mircera launch remote." Over the next six months, he surmised, Amgen's stock could benefit from "better visibility that earnings and cash flows will emerge relatively unscathed from the ESA safety debate" and "a potential reversal in CMS's restrictive ESA reimbursement policy."

CMS last month told two physician groups that more evidence was needed before the agency could reconsider its July decision that limits payments for ESA use in cancer patients to those whose hemoglobin levels decrease to less than 10 g/dL. (See BioWorld Today, Sept. 26, 2007.)

Two advisory panels recently recommended new warnings on ESAs and more data about the drugs. (See BioWorld Today, May 11, 2007, and Sept. 13, 2007.)

Although John Jenkins, director of the FDA's Office of New Drugs, said on Sept. 11 that the agency would make a decision on those recommendations "within weeks," the agency has yet to act.

An FDA spokesperson Wednesday declined to say when regulators would make public a decision about labeling changes for ESAs.