Amgen: Mircera deal would set precedent

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.

- read the Wall Street Journal story
- get the article from the Associated Press
- see the In Vivo piece
- check out the item at the WSJ Health Blog

Suggested Articles

Mobile has become universal, accessible, and multi-generational. It’s time for life science brands to revolutionize how they’re telling their story.

Former Retrophin CEO was hoping for a SCOTUS hail mary to escape his seven-year fraud sentences Turns out the court was interest in hearing his plea.

A new investigation shines light on how Purdue pushed back on negative coverage of opioids, placed opioid-friendly experts in think tanks and more.