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U.S. Court of Appeals Today Hears Landmark Drug Patent Case Against Pfizer

University of Rochester’s Case Could Lead to Billions in Royalties on Celebrex and Other Cox-2 Inhibitor Drugs

Tuesday, November 04, 2003

The U.S. Court of Appeals for the Federal Circuit in Washington, D.C. will today consider a landmark patent case brought by the University of Rochester, which over the course of two decades conducted groundbreaking research on the origins of pain and inflammation and paved the way for the development of such blockbuster drugs as Pfizer’s Celebrex arthritis medication.

The original patent infringement case against Pfizer and other pharmaceutical companies was filed in April 2000, shortly after the United States Patent Office – after eight years of deliberation – awarded a patent entitling the university to collect what could be billions of dollars in royalties on a class of drugs known as “cox-2 inhibitors” over the 17-year life of the patent.

Cox-2 inhibitors have been heralded as “super aspirin” for their remarkable ability to ease pain and inflammation without causing such side effects as stomach pain, bleeding and ulcers. Many medical experts believe these drugs will eventually replace aspirin and ibuprofen in coming years.

The patent recognized the pioneering work of researchers at the University of Rochester Medical Center, who in 1990 discovered the gene that contains the chemical instructions for producing the enzyme called cox-2 and revealed the enzyme’s role in causing inflammation. The discovery set in motion a worldwide race among pharmaceutical companies to identify drugs that would inhibit the action of the enzyme and, in turn, reduce inflammation and pain associated with arthritis and other conditions.

“Universities play a critically important role in science and medicine by conducting intensive, time-consuming basic research that often creates the foundation for new drugs that make life better for millions of people around the world,” said University of Rochester President Thomas H. Jackson. “Our institutions set the stage for enormous benefits to the pharmaceutical industry and to society."

“The law entitles universities to collect royalties on their patents and requires us to invest those royalties right back into our educational and research programs. This additional funding allows universities to hire more researchers and provide them with the training and equipment they need to make the kind of breakthrough discoveries the University of Rochester made in unraveling the mystery of the cox-2 enzyme,” said Mr. Jackson.

Today pharmaceutical companies sell about $5 billion worth of cox-2 inhibitor drugs in the United States each year. Pfizer’s Celebrex, which was introduced in 1999 and is now the world’s best-selling arthritis treatment, accounted for more than $3 billion in worldwide sales in 2002.

Today’s appeal was brought by the University of Rochester after the U.S. District Court for the Western District of New York ruled invalid the university’s patent in March 2003.

In an amicus brief filed with the U.S. Court of Appeals in support of the University of Rochester, the University of California and the University of Texas said: “The patent law’s constitutional mandate of promoting the progress of science and the useful arts is best advanced by recognizing the contribution of researchers who make the pioneering inventions…Without basic research from the universities, the private sector will be unable to develop pharmaceutical compounds for the public.”

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