Amgen Inc., the world’s biggest biotechnology company, said a U.S. judge last week ruled that Roche Holding AG’s new anemia drug, Mircera, infringes an Amgen patent.
U.S. District Judge William Young, in a separate ruling, limited some of Roche’s challenges to the validity of the patent and four others owned by Amgen that are the subject of a trial in Boston beginning Tuesday, Sept. 4. Roche said the decision is “only one step along the way.”
“Amgen is delivering a punch before the battle,” said Gene Mack, an analyst with HSBC Bank USA in New York. “They delivered a blow. Whether or not it’s enough is too early to tell.”
Amgen is using its patents to try to prevent Basel, Switzerland-based Roche from entering the U.S. market with Mircera, which would compete with Amgen’s Epogen and Aranesp. Those two drugs had combined sales of $6.63 billion last year, 46 percent of Thousand Oaks, Calif.-based Amgen’s total.
As it is, Amgen has been struggling with slowing sales of Aranesp, and last month the company announced a restructuring and staff reduction aimed at saving more than $1 billion companywide in 2008. The company, which has two plants in West Greenwich that employ a combined 1,600 people, has said it will close the older plant and cut a still-undetermined number of jobs there. Companywide, as many as 2,600 jobs are to be cut.
Speaking about the patent, Amgen spokesman told Bloomberg that “we feel confident in our ability to defend it, as we are with the other issues in the case.”
The dispute is over the protein erythropoietin, or EPO, a trigger for producing red blood cells depleted by kidney disease and cancer. Amgen’s patent that was found to be infringed is for human EPO produced from mammal cells in a way that has therapeutic uses.
“It’s a composition-of-matter patent, so it’s the strongest intellectual property you can have for a drug,” Mack said, referring to a patent for an invented substance. “Amgen’s burden is to prove that Roche infringed at least one valid and enforceable patent.”
“Roche remains confident in our position that all of the Amgen patents are invalid and not infringed,” Roche spokeswoman Linda Dyson said in an e-mailed statement. “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.”
The case is Amgen Inc. v. F. Hoffmann-LaRoche Ltd., 05- 12237, U.S. District Court, District of Massachusetts (Boston). •
