Mircera judge seeks expert guidance

The judge refereeing the turf battle between Roche and Amgen over anemia meds has taken a time-out to consult the experts. Judge William Young said he's grappling "with complex issues" in the patent fight and ordered the appointment of a special master to make recommendations on price and dosing.

Here's the action so far: A court ruled that Roche's anemia drug Mircera infringes on Amgen's patents on Epogen. But though Young granted Amgen's request for a temporary injunction against Roche's med, he also said that--because it's given to patients less often than Amgen's version--it might be in patients' best interests for the two companies to make a deal. He set out five conditions for Mircera sales, including a 22.5 percent royalty payment to Amgen and a stipulation that Mircera would sell for no more than Epogen did. Roche accepted those conditions; Amgen asked for a permanent injunction.

Now, Young is giving Amgen and Roche 15 days to suggest candidates for the special master job and allotted 60 days for that master to make his or her recommendations. At issue: pricing parity. Given the different dosing schedules for the drugs, how can Roche be sure to keep Mircera's price at a level no higher than Epogen's? We'll have to wait and see. And that might be a long wait: Amgen has now asked for a trial to determine compensation if Roche gets to sell Mircera in the U.S.

- read the item in the WSJ Health Blog
- check out Pharmalot's coverage
- see Amgen's new motion

Related Articles:
Court sends Mircera case to ITC. Report
Amgen: Mircera deal would set precedent. Report
Roche accepts judge's deal on Mircera. Report
Mircera gets FDA nod, but blocked by patent case. Report
Amgen wins patent fight with Roche. Report
Roche: Patent ruling won't stop Mircera. Report