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The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court ruling dismissing a patent infringement suit initiated by the University of Rochester against pharmaceutical companies over a widely used painkiller. The court ruled that the university had been awarded an invalid patent by the U.S. Patent Office, and threw out the school’s lawsuit against Pfizer, G.D. Searle, Monsanto and Pharmacia for infringing on its patent with a line of drugs known as COX-2 inhibitors. Speaking for the court, Judge Alan Lourie confirmed the lower court decision to grant summary judgment against the upstate university. Both the lower court in the Western District of New York and the Circuit Court found that the university’s patent did not “comply with the written description requirement” of 35 U.S.C. � 112. Section 112 requires that the application “shall contain a written description of the invention.” It also requires an application to include an “enablement requirement” that explains the “manner and process of making and using” the invention. The final requirement, known as the “best mode requirement,” sets forth “the best mode contemplated by the inventor of carrying out his invention.” In 1992, scientists at the University of Rochester developed a screening mechanism that would determine whether a drug could help relieve arthritis pain without irritating the gastrointestinal track. Previously, anti-inflammatory drugs such as aspirin and ibuprofen inhibited COX-1 and COX-2 enzymes. As a result, they reduced arthritic pain but also caused upset stomachs and potentially dangerous side effects like ulcers. Rochester scientists found a method to determine whether a drug could inhibit the harmful COX-2 inflammatory enzymes without inhibiting the beneficial COX-1 enzymes. The same year, they filed for a patent and eventually received one — called the ’479 patent — that covered the process they had described. On April 11, 2000, they received a patent — called the ’850 patent — that tried to extend this process to individual compounds that prohibit the COX-2 enzyme. That same day, they sued for patent infringement for the COX-2 inhibitors, a lucrative group of drugs that grossed $5 billion in revenue last year, developed by the defendant drug companies. The district court dismissed the suit and the university appealed. The circuit court ruled that the ’850 patent covered a process — not the compounds used by defendants in their drugs. It required an applicant to “‘describe the claimed invention so that one skilled in the art [to which the application pertains] can recognize what is claimed.’” GENERALIZED LANGUAGE The circuit court said further: “Thus, generalized language may not suffice if it does not convey the detailed identity of an invention” in a patent application under � 112. “In this case,” it continued, “there is no language here, generalized or otherwise, that describes compounds that achieve the claimed effect.” In other words, the university failed to provide a significant written description of a compound that would effectively inhibit COX-2 enzymes without reducing COX-1 enzymes. Nor did the application provide any “guidance that would steer the skilled practitioner toward compounds that can be used to carry out” the claims made in the patent application. Instead, the ’850 patent “discloses nothing more than a hoped-for function for an as-yet-to-be-discovered compound, and a research plan for trying to find it. “The claimed methods thus cannot be practiced based on the patent’s specification, even considering the knowledge of one skilled in the art,” the circuit court said. The university also failed to list any compounds capable of performing this function and did not provide evidence that showed “that such a compound was known.” The court then tackled the public policy arguments proffered by the University of Rochester and by the University of California and University of Texas in amicus briefs. All three universities essentially argued that the lower court ruling would chill if not outright prohibit a university’s “ability to bring pioneering innovations to the public.” The circuit court rejected this argument, finding that the congressional desire to “enable universities to profit from their � research” did not “relax the statutory requirements for patentability.” James Kelley, an attorney at Eli Lilly, which filed an amicus brief, said he believed the University of Rochester would file a petition for a rehearing before the entire Federal Circuit.

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