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The stakes in the Rochester, N.Y., courtroom were high. At issue: who owned the rights to Celebrex and Bextra, two best-selling painkillers, with U.S. sales exceeding $2.4 billion last year. And this was only the beginning of the suit’s ramifications. The decision seems likely to curtail sharply the use of a controversial type of patent — significantly affecting the research, sales and patent rights of many universities, biotechnology firms and drug companies. The case centered on a patent obtained by the University of Rochester. That patent covered the utilization of a specific biochemical pathway to decrease pain. The university claimed that this patent was infringed by drug giants Pfizer Inc., Pharmacia Corp., Monsanto Co. and G.D. Searle & Co. because these companies make and sell Celebrex and Bextra, which use the university’s patented pathway to reduce pain. However, U.S. District Court Judge David Larimer, deciding a summary judgment motion, ruled on March 5 that the university’s patent was invalid because it was too vague. By not indicating a specific drug compound that used the pathway to decrease pain, the claim failed to satisfy the patent law’s written description and enablement requirements. University of Rochester v. G.D. Searle & Co. Inc., No. 00-CV-6161L (W.D.N.Y. March 5, 2003). “Without such a compound,” Larimer wrote, “it is impossible to practice the claimed method of treatment. It means little to invent a method if one does not have possession of a substance that is essential to practicing that method.” The judge concluded that the patent could not be considered a fully realized invention, but was merely “a wish or plan or first step for obtaining a desired result.” The University of Rochester has indicated that the fight isn’t over. It will appeal the district court’s ruling. But if Larimer’s ruling is upheld, as many predict it will be, it would seem likely to force major changes in a controversial type of biotech patent that has been growing in popularity over the last few years. The patent at issue in the Celebrex case was a relatively new variant on a well-established type of patent — a patent on a method of providing medical treatment. “Method-of-treatment patents have been in existence since time immemorial,” said Bernard Rose, patent counsel in the San Francisco office of Boston’s Bingham McCutchen. But, he added, these patents traditionally claimed specific compounds for providing the treatment. CLAIMS FOR MOLECULAR TARGETS Then, about 15 years ago, scientific advances made possible a new type of method-of-treatment patent. When medical discoveries first started identifying molecular targets to be inhibited or promoted, patent attorneys began to develop method-of-treatment claims covering these molecular targets — but without specifically detailing which chemical compounds would be used to inhibit or promote the molecular target. The University of Rochester’s patent, for instance, claimed a method of stopping painful inflammation by inhibiting the action of the PGHS-2 enzyme, but did not identify any specific drugs which could be used to inhibit the enzyme. “Companies started writing these patents in the 1980s, but they started becoming popular in the mid-1990s, with the genetics boom,” said Richard Berman, a patent expert and a partner at Washington-based Arent Fox Kintner Plotkin & Kahn. These patents are “extremely controversial,” he said. “The major problems are their breadth and the vagueness with which they describe their invention.” Nevertheless, such patents have been obtained by a wide variety of organizations, from universities to small biotech firms to huge drug companies. “Universities and small biotech companies don’t have the resources to test big banks of compounds like Big Pharma does, so they focus on biological pathways,” said Berman. “This sort of patent is their way to get the big payoff without the rigors of testing actual compounds.” Large drug companies, he added, get these patents in order to forestall competition with drugs they have developed. The Celebrex suit was the first time a court ruled on the validity of one of these patents, according to Gerald Dodson, a partner in the Palo Alto, Calif., office of San Francisco’s Morrison & Foerster, who is representing the University of Rochester. He added, “this ruling will be a major precedent on method-of-treatment patents — some say it will be a landmark.” If the district court’s ruling is upheld, the new variant of the method-of-treatment patent “is dead,” said Dodson. “A patentee can’t rely on someone with ordinary skill in the art to develop a compound [to implement the method of treatment]; a patentee must develop the compound itself.” IMPACT ON UNIVERSITIES, BIOTECH Such a result would discriminate against universities, small inventors and startup biotech firms because they don’t have the resources to discover safe and effective drug compounds, according to Dodson. “They don’t have the resources to do lengthy clinical trials,” he said. He predicted that universities would be harmed. “It will discourage universities from doing basic research, if for no other reason than [that] they won’t have the money coming back to allow them to do this research,” he said. Biotech firms might be hit even harder. “This decision calls into question a lot of the patents which small biotech companies have — including all the biotech tool patents,” said Berman. “These [tool patents] are what a lot of the small companies are using to try and stay afloat until they find a big drug patent.” Without these patents, the companies’ future is put in doubt. These pessimistic views were disputed by Robert Baechtold, a partner at New York’s Fitzpatrick, Cella, Harper & Scinto and the lead counsel for the four defendants in the Celebrex case. He said that universities and biotech firms will need only to alter the way they get funding. “This [ruling] will encourage both universities and biotech companies to partner with pharmaceutical companies who can identify compounds and develop them,” he said. In any case, big drug companies seem likely to benefit by Larimer’s ruling. “Only Big Pharma will be able to assert these [method-of-treatment] patents in the future because they are the only ones to have the resources to discover compounds,” said Berman. So, in addition to obtaining a patent on a compound, a large drug company could get extra protection against competitors by obtaining a method-of-treatment patent on the molecular pathway used by the compound. And that’s exactly what Pfizer is now trying to get in a lawsuit against Lilly Icos, Bayer and GlaxoSmithKline. These latter three companies want to market two drugs that will compete with Pfizer’s high-selling drug Viagra. But Pfizer has sued in Delaware federal court to prevent these drugs from coming onto the market in the United States, claiming that although they do not violate Pfizer’s patent on Viagra, they violate Pfizer’s method-of-treatment patent on inhibiting an enzyme that is blocked by Viagra. Can a company successfully claim a whole method of treatment if it has found only one compound to implement that treatment? The answer is unclear, according to Dodson. The court might uphold the patent in its entirety, or limit the method-of-treatment patent to the specific compounds identified by the patentee, or strike down the patent, finding that the invention is not sufficiently developed to cover the entire method of treatment. But whether or not any large drug company eventually succeeds on its method-of-treatment claims, it seems likely the company will be able to use such patents to tie up potential competitors in court. The result may be to forestall competition for years.

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