Cox-2 patent case thrown out

A federal judge this week invalidated the University of Rochester's patent for cox-2 inhibitors in a ruling that handed the makers of Celebrex an early victory in a fight closely watched by academic researchers across the country.US District Judge for Western New York David G. Larimer dismissed UR's complaint, reasoning that the description of the discovery in the school's patent was too generic to support an infringement claim against makers of the class of drugs known as cox-2 inhibitors. Celebrex, the best seller in the crowd, pulled in $1.5 billion in 1999, its first year on the market, and is expected to generate billions more in coming years. Pharmacia Corp., maker of Celebrex, hailed the court decision, saying it confirmed the company's position that UR had nothing to do with the invention of the blockbuster arthritis medication and was not entitled to royalties from it.GD Searle and Co., the Pharmacia subsidiary that introduced Celebrex to the market, has long maintained it was not aware UR was pursuing a cox-2 patent when it developed the product.The description of UR's discovery may have looked too generic to Larimer, but it looks like basic science to schools across the country that count on royalty revenues from such patented discoveries, which are licensed to commercial entities that turn them into drugs. "Companies often dismiss the value of the basic research that enables the development of drugs like cox-2 inhibitors, which benefit millions of people," said Jay H. Stein, chief executive officer of the University of Rochester Medical Center, in a prepared statement released shortly after the ruling on March 5.Lawyers for the school huddled Thursday with trustees to discuss plans to appeal the decision to the US Court of Appeals for the Federal Circuit, preserving the patent they were awarded in April 2000.If left standing, Larimer's decision that basic cellular science is not enough to support a patent could endanger the royalty revenues of universities across the country, since they are typically in the business of basic research, not the business of manufacturing drugs, a university statement said. In the early 1990's, UR scientists led by biochemist David Young found the genetic instructions for producing cox-2, discovered how the enzyme causes inflammation, and developed a method of testing compounds for signs they selectively inhibit cox-2 in humans, all with an eye toward relieving pain and inflammation without side effects. That was only "a wish or a plan or a first step" toward a patentable invention, Larimer held in throwing out UR's patent infringement claims against drug makers including Pfizer Inc., which is acquiring Pharmacia. The school should have described the formulation of a cox-2 inhibitor with specificity, or deposited a sample in a public repository, if it wanted its patent to stand against finished products like Celebrex, Larimer's decision said. "The patent office considered the patent for eight years, and their examiners felt that this was worthy of patent protection," Christopher DiFrancesco, spokesman for the university, told The Scientist.Lawyers were keeping the UR scientists under wraps this week. In addition to Young, the patent's named inventors include Kerry O'Banion and Virginia Winn, who was a postdoc helping to study a protein connected to cyclooxygenase, or cox. The new protein was eventually named cox-2, and Young's team learned how to shut it off without interfering with the original cox enzyme, cox-1, a one-two combination that meant pain relief without gastrointestinal irritation.

Cox-2 patent case thrown out

Judge rules Rochester researchers' basic science doesn't earn them royalties on final drug.

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