University Wins Patent for Top-Selling Drugs

A decade-long research effort at the University to develop pain relievers that have few side effects--so called "super-aspirin" --received a historic shot-in-the-arm from the U.S. Patent Office last spring.

The office ruled that Medical Center scientists Donald Young, Virginia Winn, and Kerry O'Banion had laid the groundwork for the entire class of pain relievers known as "cox-2 inhibitors" and awarded the University a patent on the breakthrough.

The class includes such blockbuster pain relievers as the arthritis medication Celebrex, which was prescribed to 6.4 million patients in 1999, its first year on the market. With first-year sales reaching $1.5 billion, Celebrex is the fastest-selling new drug in history.

Jay Stein, vice provost for health affairs and CEO of the Medical Center and Strong Health, says the patent award highlights the importance of research in the basic sciences, something the Medical Center has emphasized during his five-year tenure.

"The research team's extraordinary work is an example of the tremendous potential that basic science has to improve health," Stein says.

The patent entitles the University to royalties on the sale of all cox-2 inhibitors. (The University has filed a patent infringement suit against Searle and Pfizer, the pharmaceutical companies that jointly market Celebrex.)

Over the 17-year life of the patent, royalty payments could yield the University billions of dollars, making it the most lucrative pharmaceutical patent in history.

The Rochester team was the first to discover and clone cyclooxygenase-2, which is the formal name of cox-2, an enzyme believed to be at the root of much common pain and inflammation.

Over-the-counter pain relievers such as aspirin and ibuprofen inhibit cox-2, but they also target the closely related enzyme cox-1.

Researchers now believe that cox-1 plays a role in the production of gastric acid in the stomach and that knocking it out can cause gastro-intestinal irritation, bleeding, and ulcers.

Studies of cox-2 inhibitors show considerably fewer such side effects.

Other research, including work being carried out at Rochester, indicate the drugs may help in the treatment of Alzheimer's disease and cancer.

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