Last April, both the importance and potential dangers of the coming wave of gene patents became clear when the University of Rochester was granted a patent on a gene called Cox-2. University officials immediately filed a lawsuit against G.D. Searle, a subsidiary of Pharmacia, whose blockbuster painkiller Celebrex acts by blocking the enzyme encoded by the Cox-2 gene. Rochester claims Searle’s drug infringes its patent, which describes not just the DNA letters of the gene, but also the general idea of using a drug that blocks Cox-2 as a way to alleviate pain.
The financial stakes are immense. Dubbed “super aspirin,” Cox-2 inhibitors are the hottest new pain drugs. In 1999, its first year on the market, Celebrex logged $1.5 billion in sales and eclipsed Pfizer’s potency miracle Viagra as pharmacies’ fastest-selling pill. (Merck of Whitehouse Station, N.J., also makes a Cox-2 inhibitor called Vioxx but is not named in the suit.) A University of Rochester press release giddily predicted the university’s patent is “likely to be the most lucrative in U.S. history.”
The case highlights several troubling aspects of gene patenting. As a tactic to pressure Searle into paying royalties, Rochester has asked a judge to force the company to take the drug off the market, despite the fact that it is used by nearly seven million people, many of whom suffer from severe arthritis. The case also raises new and difficult questions about what a patentable ” invention” really is. Is it Celebrex, a drug developed by industry at a cost of millions of dollars? Or is it the knowledge of Cox-2’s role in pain and inflammation, a fundamental scientific discovery paid for with federal research monies?
Gerald Dodson, a litigator Rochester has hired from the firm Morrison & Foerster, says, “If you discover something that opens a new area of research, then it should be patentable. That is what’s at the heart of this. Somehow there is a school of thought that different rules should apply to basic research in medicine, and I don’t think that washes under any kind of scrutiny. “
Searle freely admits it used scientific findings about Cox-2 as the starting point for its hunt for a drug. (The Cox-2 discovery has also prompted drug research aimed at treatments for Alzheimer’s disease and cancer.) But Searle lawyers say the Rochester patent is invalid because it doesn’t give precise enough directions for finding a drug. In the parlance of patent law, Rochester’s claim qualifies as a classic “submarine patent”: a broad early claim that quietly sits at the Patent Office only to surface when another inventor’s work gives it commercial significance.