The University of Rochester's dream of reaping a billion-dollar windfall from a drug patent has suffered a serious setback. A federal judge last week ruled invalid the university's sweeping claim to some lucrative anti-inflammatory drugs, dismissing the patent as "little more than a research plan." The university will appeal the ruling, which legal experts say could rein in inventors making similarly broad claims based on basic research.
More than a decade ago, the university applied for a patent based on discoveries by cancer researcher Donald Young and two colleagues. Young's team found and cloned the gene that produces cyclooxygenase-2 (COX-2), an enzyme that promotes inflammation. In its 1992 patent filing, the university described a technique for identifying compounds that inhibit COX-2 and suggested that they could be used to treat pain without causing the side-effects, such as upset stomach and internal bleeding, that can accompany aspirin and other widely used painkillers. The university finally won a patent in April 2000--years after several drug companies had already developed COX-2 inhibitors and earned billions of dollars selling them.
University of Rochester officials then sued drug giants Pharmacia and Pfizer, the makers of the top-selling COX-2 drug Celebrex, claiming that the school was entitled to significant royalties (Science, 21 Apr 2000, p. 410). Some university officials predicted that the patent would become the most valuable intellectual property ever held by a U.S. university, generating $1 billion or more over the patent's 17-year lifetime.
But U.S. District Judge David Larimer didn't buy the university's claim that its scientists had paved the way for the drug companies. The Rochester, New York, jurist ruled that the university's patent doesn't describes a specific "invention," meaning a particular compound or drug. "It means little to 'invent' a method [of painkilling] if one does not have possession of a substance that is essential to practicing that method," he wrote.
"This was a big, but not surprising, decision," says patent attorney Rochelle Seide of Baker Botts in New York City. She notes that U.S. patent officials currently frown on similar "reach through" patents, which lay broad claims to biochemical pathways or mechanisms but not specific products. "We probably wouldn't even see this case today," she says, adding that she would be surprised if the university prevailed in its appeal.
University of Rochester v. G. D. Searle & Co., Inc.