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The Federal Circuit 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 ”public interest” issue, industry attorneys told Pharmawire.

And despite a federal judge’s initial reluctance to grant a permanent injunction against Mircera, attorneys interviewed by this news service expect one to eventually be put in place.

Last year, the District Court of Massachusetts found that Roche infringed upon Amgen’s patents, but no damages were awarded because Roche had not yet launched the product in the US. The company has threatened to launch Mircera unless the court issues an injunction barring it from doing so. Roche is now appealing the preliminary injunction that was subsequently put in place, and will likely appeal the infringement ruling after the injunction question is settled.

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, the attorneys interviewed said, pushing any ruling on the matter back until at least early fall. 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.

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. Those conditions included a 22.5% royalty payment to Amgen, a promise not to eventually raise prices, and the funding of an independent body to monitor the situation.

”I don’t know if they’re going to take that question on or not,” said Scott Rothenberger, a patent attorney at Dorsey & Whitney. ”I think the majority of people involved in this industry would like to see that addressed.”

The ability to issue a compulsory licensing agreement stems partly from a 2006 Supreme Court decision in eBay vs. MercExchange, said Felicia Boyd, a patent litigator at Faegre & Benson, a case that discouraged the automatic issuing of injunctions in patent litigation suits. The case laid out a more flexible reading of a four-part test to determine whether an injunction is necessary. Judge Young was satisfied on three of the four parts, but stalled on the fourth: ”that the public interest would be disserved by a permanent injunction.”

Young’s decision to at least take more time to consider the permanent injunction was a surprise, Boyd admitted, adding that the case was being closely followed because it was the first time the eBay decision was being applied to actual competitors. The previous cases, including eBay, involved a non-practicing entity, meaning the party involved was not using the patent.

The case is also unique, attorneys pointed out, because the pharmaceutical industry 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.”

Still, courts are very reluctant to take away patent protection, she said. Boyd agreed, and said she expects the case to eventually return to a more typical path.

”I think it would be very surprising if they didn’t get a permanent injunction,” 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.”

Attorneys interview for this piece agreed with Boyd’s assessment that a permanent injunction would likely be the end result, but most also admitted the willingness of Judge Young to further consider allowing Roche to launch Mircera was a significant shift in pharmaceutical patent law.

”I think Judge Young is going to back off from all of this; I don’t think he wants to fight that battle,” said James J. Foster, a patent litigator at Wolf Greenfield. ”It may well be he’s looking for some signal of encouragement from the Federal Circuit.”

Should Young grant a permanent injunction eventually, it is likely Roche would again appeal to the Federal Circuit, Foster said. The Federal Circuit is the only appellate court that reviews patent cases. An appeal on a permanent injunction could be heard by the court in 2009.

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