Should he or shouldn't he? The judge weighing the case of Amgen v. Roche is getting a lot of unsolicited advice on whether to allow Roche's anemia med Mircera onto the market. Last year, a jury ruled that Mircera stepped on Amgen's patents on Aranesp and Epogen; last month, the judge gave Amgen a preliminary injunction against Mircera, but said he might let Roche sell the med under five conditions.
Well, yesterday, Roche said OK to all those conditions. It would pay Amgen a 22.5 percent royalty, set prices at or below Epogen's until Amgen's patents expire, and so on. Amgen quickly countered in defense of its patents, saying that letting Roche sell the drug would set a precedent weakening patent protection--and weakening patent protection would squeeze R&D. Amgen wants the judge to block Mircera permanently. Or at least until its patents expire.
It's not clear when the judge will rule, but as In Vivo notes, he appears to be concerned about patients as much as patents. And Roche says that its anemia remedy could be administered only once every two weeks or even once every four weeks, so it's a good option that's not now available. Amgen disputes that, of course, saying that Mircera offers no additional benefits.
Meanwhile, the market for anemia drugs has already been shrinking on safety concerns. Dosing limits have been recommended or imposed by various regulators, and last week an FDA advisory panel said they should be further restricted in some cancer patients.