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The U.S. Court of Appeals for the Federal Circuit has refused to review en banc a ruling against the University of Rochester in its patent battle over rights to a multibillion-dollar painkiller. But the 7 to 5 decision — which sparked three written dissents — revealed a sharp divide that lawyers said requires action by the U.S. Supreme Court. At issue is whether a patent can be held invalid if it fails to provide a “written description” of the invention. The University of Rochester obtained a patent on a method to identify drugs that can block the so-called COX-2 enzyme that produces pain and inflammation without inhibiting the enzyme that coats the stomach lining. It then sued G.D. Searle & Co., Monsanto Co., Pharmacia Corp. and Pfizer Inc., alleging that Pfizer’s sale of the COX-2 inhibitor drugs Celebrex and Bextra infringed its patent. A three-judge panel of the Federal Circuit ruled in February that the university had failed to comply with the patent law’s written description requirement since the university did not identify a specific compound in its patent. “I don’t think there can be a more important issue for the biotech community” in terms of what can and can’t be patented, said Gerald Dodson, a partner at Morrison & Foerster in Palo Alto, Calif., who represents the University of Rochester. “There’s not a patent out there that can’t be attacked using this doctrine.” Dodson said his client has not decided whether to file a petition for certiorari with the Supreme Court but that he expects it will do so. Searle attorney Gerald Sobel, a partner at New York’s Kaye Scholer, could not be reached for comment. In dissenting from the court’s refusal to hear the case en banc, several judges said the court has issued conflicting opinions on the subject. “These uncertainties will remain unless resolved by this court en banc or by the Supreme Court,” Judge Richard Linn said. In his dissent, Judge Randall Rader cited criticism of the court’s 1997 decision Reagents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, which first addressed the scope of the written disclosure requirement. Rader attached to his opinion a list of 31 articles criticizing the ruling, seven defending it and 16 neutrally commenting on it. Linn and Rader disagreed with the court’s interpretation of the written description requirement in the University of Rochester case. Linn said the patent law’s enablement requirement — holding that an invention must enable any person skilled in the art to make it — is sufficient. While Judge Pauline Newman also dissented from the court’s refusal to take the case up en banc, she disagreed with “the exotic proposition that it is not necessary for the inventor to describe the patented invention.” Judge Timothy Dyk concurred with the court’s decision to defer reviewing the case, saying the University of Rochester “did not invent, much less describe, what was claimed [in its patent].” But Dyk said the court has not set forth clear standards on the question of written description standards and should do so when the appropriate case comes along. Citing the disparate views of the judges, Dodson said the outcome of a case depends on which judges serve on a given panel. “It’s pathetic that there’s this standard for determining if a patent is valid or not,” Dodson said. “Tell me the panel and I’ll tell you whether you have a valid patent.” Patent lawyers, as well as universities and the pharmaceutical and biotech industries, are closely following the case. The Regents of the University of California, the University of Texas and Eli Lilly filed amicus briefs with the Federal Circuit. “I think the consensus within the bar and among a number of Federal Circuit judges is that the standard for written descriptions is not clear to practitioners,” said Edward Reines, a partner at Weil, Gotshal & Manges in Redwood Shores, Calif. “This is probably an issue appropriate for Supreme Court review.”

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