Engineering News

Court issues mixed ruling on Amgen Epogen patents
Thu Aug 3, 2006 3:19pm ET

NEW YORK, Aug 3 (Reuters) - A U.S. Appeals court on Thursday issued a mixed ruling in Amgen Inc.'s long-standing patent battle to prevent two other drugmakers from selling a product that would compete with its widely used Epogen anemia treatment.

Amgen in 1997 sued the drugmakers, Hoechst Marion Roussel and Transkaryotic Therapies, in U.S. District Court for the District of Massachusetts, alleging their planned product infringed five Amgen patents. Hoechst, after a merger, is now part of Paris-based Sanofi-Aventis. Transkaryotic has since been acquired by Shire Pharmaceuticals Group Plc of Britain.

The U.S. Court of Appeals for the Federal Circuit on Thursday vacated an earlier judgment by the lower court that had been favorable to Amgen, though it affirmed the lower court's judgment on other patent claims.

"I don't think it means much at all," Robert W. Baird analyst Christopher Raymond said of Thursday's court ruling, noting that the rival drugmakers had abandoned earlier plans to sell their form of Epogen in the United States.

The lower court had ruled that a pertinent claim of Amgen's so-called '422 patent is not invalid. It remanded the issue to the district court for further consideration.

The patent claim involves a "therapeutically effective amount" of the active ingredient of Epogen, the human hormone erythropoietin.

The court also reversed the lower court's judgment that the rival drugmakers had infringed certain claims of Amgen's so-called '080 patent.

But the court affirmed the lower court's judgment that the two drugmakers had infringed claims of two other Amgen patents -- its '698 and '349 patent.

A spokesman for Sanofi was not immediately available for comment.

Amgen officials said today's ruling reaffirms Amgen's confidence in the strength of its intellectual property portfolio.

Shares of Amgen edged up 28 cents to $71.05 on Nasdaq early Thursday afternoon. Shares of Shire closed down 1.7 percent in London, while Sanofi's slipped slightly in Paris.

Amgen's shares have suffered lately amid concern that a rival anemia drug being developed by Roche Holding AG could enter the market and threaten Amgen's anemia drugs, which together generated sales in 2005 of $6 billion, almost half the company's total product revenue.

Amgen is trying to block Cera's entry into the United States, claiming Cera infringes Amgen's patents.

Roche has argued that its pegylated version of EPO does not infringe Amgen's patents because it is linked to a chemical that makes it last longer in the body than Epogen, which Amgen sells in the United States as a treatment for kidney dialysis patients.

Aranesp is a longer-lasting version of Epogen, and is marketed in the United States as a treatment for kidney dialysis patients as well as for anemia in cancer patients undergoing chemotherapy.

Roche said the latest court ruling does not affect its determination to bring Cera to the United States.

"Our committment remains the same," said Shelley Rosenstock, a Roche spokeswoman. (Additional reporting by Bill Berkrot, Deena Beasley, Toni Clarke)

Source: United Steelworkers

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