Washington Editor

Although a federal district judge ruled Tuesday that an anemia product developed by F. Hoffmann-La Roche Ltd. violates a composition patent held by Amgen Inc., the ongoing battle between the two firms is far from over.

The companies are set to go to trial next Tuesday in a case brought by Amgen in November 2005 over whether Roche's erythropoiesis-stimulating agent (ESA) Mircera infringes patents held by Amgen.

Thousand Oaks, Calif.-based Amgen markets darbepoetin alfa as Aranesp and epoetin alfa as Epogen in the U.S. Bridgewater, N.J.-based Ortho Biotech, a subsidiary of Johnson & Johnson, markets epoetin alfa as Procrit under an agreement with Amgen.

In a summary judgment, U.S. District Court Judge William G. Young in Massachusetts ruled Tuesday that Mircera infringed Amgen's composition patent. The court also granted a summary judgment in favor of Amgen on certain Roche defenses against the patents-in-suit.

Roche spokeswoman Linda Dyson said that regardless of the court's rulings on process patent '349 and pharmaceutical composition patent '422, the firm "remains confident in our position that all of the Amgen patents are invalid and not infringed."

The rulings this week, she said, are "only one step along the way, and the trial has yet to begin."

"While we disagree with the judge on the matter of infringement, the ruling does not determine the ultimate validity of any Amgen patents," Dyson said in an e-mail response to questions.

Mircera, which received approval from European drug regulators in July, is under review by the FDA as a treatment for anemia associated with chronic renal failure.

Roche announced in May that it had received an approvable letter from FDA for Mircera.

The firm said it expects to win marketing approval of the drug sometime after the FDA's Cardiovascular and Renal Drugs Advisory Committee meets Sept. 11 to discuss risks associated with ESAs.

Regulators in March asked makers of ESAs to include a black-box warning in labeling of cautioning that patients have an increased risk of serious adverse cardiovascular events and death when the products are administered to target a hemoglobin concentration of greater than 12 g/dL.

The boxed warning advises prescribers to use the lowest dosage of the products that gradually will increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red-blood-cell transfusion.

FDA's Oncologic Drugs Advisory Committee met May 10 to discuss whether the new safety warnings were sufficient. Panelists then voted 15-2 that warnings even stronger than those in the black box were needed on the products. The experts also voted 12-5 that ESA labeling should specify that the drugs should be avoided in patients with certain types of cancer.

Roche said the upcoming Sept. 11 meeting will provide the firm an opportunity to launch Mircera "into an environment where physicians and patients will have greater clarity on how to use these treatments."

Dyson said that Roche has not been invited by the FDA to make a formal presentation at the September advisory meeting and does not plan to present information during the public hearing portion. Regulators generally wait until two or three days before advisory meetings before releasing the agency's agenda outlining topics of discussion.

Dyson said that Roche has "always maintained" that it will launch Mircera in the U.S. after gaining FDA approval.

Analyst Christopher Raymond with Robert Baird & Co. in New York warned that despite the court's ruling Tuesday, broader issues remain for Amgen.

Private payers have yet to fully weigh in after the government's decision in July to restrict Medicare payments in oncology use of ESAs, he noted. (See BioWorld Today, Aug. 1, 2007).

"We fear any widespread restrictions may represent yet another threat to Aranesp's revenues," he wrote in a research report.

Any significant changes to Aranesp's label, treatment guidelines or reimbursement decisions could further impact Aranesp's revenue, Raymond added.

If Roche's strategy to prove Amgen's intellectual property estate for ESAs invalid, that scenario could open the door to additional challenges and competitors, he said.

Amgen also has numerous registration and market-enhancing trials that are ongoing, any number of which could fail, materially damaging the firm's commercial prospects, Raymond warned.

Amgen's shares (NASDAQ:AMGN) gained $1.18, or 2.4 percent, closing at $50.19.