On Friday, attorneys representing UR’s patent infringement claim against Pfizer filed a petition for a writ of certiorari to the Supreme Court. This comes nearly three months after the U.S. Court of Appeals for the Federal Circuit invalidated UR’s patent describing tests to selectively inhibit cox-2. UR filed a lawsuit in 2000 against pharmaceutical giant Pfizer alleging that the company’s sales of its popular cox-2 inhibitor drugs Celebrex and Bextra infringed on the patent. In 2002, a district court ruled in favor of Pfizer, holding the patent invalid on the grounds that it did not contain the exact chemical formula of a compound that selectively inhibits cox-2. This spring, a panel of the Federal Circuit Court of Appeals affirmed the lower-court ruling in a 2-1 split opinion. The case turned on the justices’ interpretation of 35 United States Code 112, which requires that a patent must “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains.” UR argued that its patent enabled pharmaceuticals to find compounds suitable for the selective inhibition of cox-2. Pfizer acknowledged that UR’s patent described how to make selectively-inhibiting compounds and tests to identify such compounds.The appeals court held that the patent did not contain a written description of the actual compound. It also disagreed with UR’s assertion that there is no written description requirement independent of the enablement requirement. It is this issue that UR and its supporters, mostly other research universities, are now asking the Supreme Court to visit. “We think it is a very important case, not just for UR, but for all research universities,” Vice President and General Counsel Sue Stewart said. “The case is about whether you can have a patent for early stage research or whether you have to develop something further. We expect other amici briefs from other universities.”Of course, there is no guarantee that the nation’s highest tribunal will ever review the case. Each year, the court receives around 7,000 petitions for a writ of certiorari, but will typically submit full opinions in only 100 of them. Despite the long odds, Stewart remains optimistic about UR’s chances.”The appeals court was divided 7-5,” she said. “This is an area of unsettled law. At the very least, things are confused – whether there are two tests and what the standard used to judge [the test] is. This case frames the question very clearly.”Published law review journals and many judges seem to mirror that sentiment. UR would stand to gain much from a decision in its favor. Stewart, however, downplays the issue of financial gain whenever the question is posed.”It’s hard to tell how much we could potentially gain,” she said. “What we really want is for [Pfizer] to come to us to offer royalties or receive a license. Celebrex has helped a lot of people – we just want [the royalties] to support other research.” If four or more members of the court agree to hear UR’s case, UR has a strong chance of being victorious. As empirical judicial studies have shown, the court reverses more decisions than it affirms. This is most likely because it stands to reason that justices have more to gain from agreeing to hear cases they want to overrule than to take up cases that have already been decided favorably to their views.Stewart believes UR is fighting this case for the benefit of research universities and pharmaceutical companies alike. “I worry, frankly, if we lose,” she said. “Even drug companies need this kind of research. Big research labs aren’t so fundamental as university research. The incentive today is for [universities] to do this.”In a few months, universities and pharmaceutical companies will find out if the Supreme Court agrees.Tipton can be reached email@example.com.
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