The Federal District Court in Boston has ruled that Roche’s new anemia drug, Mircera, infringes 11 of Amgen’s patent claims and that at least some of Amgen’s patents are valid. This means that Amgen will keep its monopoly on the drugs used to treat anemia in end-stage renal disease patients—Epogen and Aranesp—to the tune of more than US$6 billion annually.
Amgen, which has held the anemia treatment monopoly since 1989, said it would seek an injunction preventing Roche from releasing its competing drug in the United States. The same court will consider the injunction on November 15. The same court has upheld Amgen’s patents twice in the past.
Johnson & Johnson sells Procrit under license from Amgen.
In Europe, only one patent was granted and it expired in late 2004. Since then competition has begun to emerge. In the US, on the other hand, Amgen was granted seven patents, only one of which expired in late 2004. According to Andrew Pollack’s report in the New York Times, some of the Amgen patents weren’t immediately granted, extending patent protection to 2015, “longer than the 20 years contemplated by patent law.”
Roche argued that Amgen’s original patents should have expired. “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,” said Roche’s chief executive of its pharmaceuticals division, William M. Burns.
The drugs are all synthetic forms of erythopoietin, a protein made by the kidneys that stimulates the production of more red blood cells.
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