UR defeated in landmark patent lawsuit

On Friday, a federal patent appeals court in Washington, D.C. upheld a 2003 district court ruling invalidating the UR’s patent covering cox-2 inhibitors. “We plan to ask that all 12 judges of the special patent court sit en banc to review the patent infringement case,” Susan Stewart, a lawyer representing the university, said. “That’s a rare move, usually only made on landmark cases,” she explained.UR researchers discovered a gene responsible for producing the cox-2 enzyme and delineated its role in causing inflammation and the methods of finding compounds useful for suppressing inflammation without causing undesirable side effects such as upset stomach, irritation, ulcers and bleeding. In 1992, the university filed a patent application to protect the discoveries. A patent was awarded in April of 2000. After receiving the patents, the university filed an infringement lawsuit against Pfizer, who was marketing Celebrex, a drug based on the cox-2 inhibitor compound celecoxib. Pfizer countered the infringement suit by claiming the university’s patent was invalid. To qualify for a patent, inventions must be useful, nonobvious and novel. The patent application must also contain a written description of the invention enabling “any person skilled in the art to which it pertains to make and use the invention.” Pfizer contended that the university’s patent, the ‘850 patent, was neither novel nor contained the requisite sufficient written requirement.The appeals court agreed with Pfizer, arguing that the school’s patent did not present the actual compound that could be used to inhibit cox-2, and hence failed the novelty requirement. The court also agreed with Pfizer’s “written description” claim. They asserted that the university’s patent “does not teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.'”UR counsel responded that the patent is novel and that the written description used by the court is flawed. “Patent law recognizes the novelty of unique designs, machines, compounds and processes,” Stewart said. “Therefore, university researchers’ assays for identifying compounds that selectively inhibit cox-2 are novel and patentable.”Furthermore, university lawyers hold that UR’s patent enabled anyone with ordinary skills in the art to find the selective inhibitor. Thus Pfizer was able to discover their celecoxib compound very soon after learning of the university’s discovery. UR also made another point in the appeal. University lawyers assert that the “written description” requirement is subsumed under the “enablement requirement,” and for that reason there is no written description requirement independent of enablement. They assert that the appeals court erred in applying a written description test distinct from the enablement requirement.The matter of whether there is a written description requirement outside of the enablement standard is the issue on which the outcome of the case was ultimately decided. While that debate remains a controvertible point of patent law that is not settled by statutes and case law, the court ultimately disagreed with the university’s position on the matter. The school is willing to litigate the matter as far as it has to, even if it means filing an appeal to the United States Supreme Court. The case is University of Rochester v. G.D. Searle. The patent in question is United States Patent number 6,048,850 and can be found at http://www.USPTO.govTipton can be reached @ rtipton@campustimes.org