Will Roche Win A Compulsory License For Mircera?

Make a comment

judgeThat seems to be the betting. A federal appeals court is likely to uphold a preliminary injunction barring the sale of Roche’s Mircera in the US, but the ruling will be closely watched to see if the court addresses the so-called “public interest” issue, according to The Financial Times.

Last year, a federal jury in Massachusetts found that Roche infringed Amgen patents, but damages weren’t awarded because Roche had not yet launched the product in the US. Roche did threaten to launch Mircera unless an injunction barring it from doing so was issued and so Roche is now appealing the preliminary injunction that was subsequently put in place, the paper writes.

The District Court is likely to wait for the Federal Circuit to decide on Roche’s appeal before addressing the issue of a permanent injunction, according to the report. But if the Federal Circuit chooses to address the issue of ”public interest” it could go a long ways toward settling one of the biggest open questions in the case at the moment. Roche has argued the public interest would be served by a reduced price that should result from competition with Amgen’s Epogen and Aranesp treatments.

US District Court Judge William Young initially declined to issue a permanent injunction, noting it may not be in the public interest to ban sales of Mircera, and said he instead might impose a licensing deal allowing Roche to launch its drug if certain conditions were met, the report notes. Those conditions included a 22.5 percent royalty payment to Amgen, a promise not to eventually raise prices, and the funding of an independent body to monitor the situation.

The ability to issue a compulsory licensing agreement stems partly from a 2006 US Supreme Court decision in eBay vs. MercExchange, according to Felicia Boyd, a patent litigator at Faegre & Benson. The case discouraged the automatic issuing of injunctions in patent litigation suits and laid out a more flexible reading of a four-part test to determine whether an injunction is necessary.

Young was satisfied on three of the four parts, but not about the fourth concerning the public interest, the report notes. The case is also unique, attorneys says, because pharma is one of the few areas where the public interest argument could be made persuasively.

”What you have that makes pharmaceutical or biotechnology cases with drugs or devices involved very different from anything else, including an eBay situation, is you’re talking about administering or using a product in relation to human health,” said Diane Romza-Kutz, chair of the life sciences practice ground at Neal Gerber Eisenberg. ”The court is going to deal with those differently.”

In a court filing, the BIO trade group argued against giving Roche a compulsory license, because patent holders would be denied exclusivity, creating uncertainty in the market, according to BNA Pharmaceutical Law & Industry. “If infringers are allowed to enter the marketplace during this period in order to compete on price, the innovator’s incentives to make the necessary R&D expenditures would be greatly diminished.”

Nonetheless, some believe Young will eventually issue a permanent injunction, which Roche is likely to appeal. ”I think it would be very surprising if they didn’t get a permanent injunction,” says Boyd said. “We’re talking about valid patents, they’re infringed, and you’re dealing with real market competitors. It would be a big change.”

Jump to comments

Share

Leave a Comment

Subscribe

RSS Feed

Comments feed for this post only.

Clear

Clear

© 2007- 2008 Newark Morning Ledger Co.  All Rights Reserved.

Thanks for trying out the new Pharmalot printing tools. If you're got any suggestions for how we can help you print better, please let us know by clicking on the contact link at http://www.pharmalot.com/