'Super-Aspirin' In Legal Battle

The matchup looks lopsided: America's giant drug companies vs. a midsize college over billions of dollars in royalties from a new class of "super aspirin."

But the University of Rochester isn't backing down, despite losing a round in court earlier this month. It has hired a prestigious law firm and piled up more than $10 million in costs defending the lab work of Dr. Donald Young.

At the heart of the clash between academia and industry is a single question: Should schools get a share of the riches if they make a fundamental discovery and secure a patent but don't set down a clear path to developing a commercial product?

"What's at stake here is whether basic research is patentable," said the school's chief counsel, Gerald Dodson, of the law firm Morrison & Foerster in Palo Alto, Calif.

The fight has been brewing since 1990, when Young, a professor of medicine and biochemistry, pinpointed a new cyclo-oxygenase enzyme, cox-2, that causes inflammation. The discovery led to the creation of drugs that relieve pain without the risky stomach and gastrointestinal ailments associated with regular use of aspirin, ibuprofen and other anti-inflammatory drugs.

The university, which received a 17-year patent on Young's research in 2000, sued the pharmaceutical companies that went ahead and developed so-called cox-2 inhibitor drugs, claiming patent infringement.

Celebrex in 1999 was the first such drug to hit the market, and it generated $3.1 billion in sales last year alone.

The drug companies scored a legal win March 5 when U.S. District Judge David Larimer invalidated the patent. The judge said Young's method of treatment "did not blossom into a full-fledged complete invention," and he sent the case to an appeals court in Washington that specializes in patent disputes.

Defendant G.D. Searle & Co. said the ruling confirmed "the university has no role in the discovery or development of Celebrex," its highly successful arthritis drug. Searle is a unit of Pharmacia Corp., which is being acquired by Pfizer.

Dodson thinks the patent, if it stands, could reap royalties and fees ranging from $3 billion to $30 billion, making it the most lucrative patent ever held by a university. That would undoubtedly transform Rochester, a 153-year-old private school with 7,100 students and a $1.1 billion endowment.

While it already commands a research budget of $260 million a year, the school hopes to attract top-notch researchers and huge federal grants, propelling it up the ranks alongside the likes of Stanford and the Massachusetts Institute of Technology.

Some patent experts say a victory by the drug companies could stifle "ivory-tower capitalism," the growing interest among schools to try to profit from inventions through patents and licensing deals to counter a falloff in government aid.

Others wonder if some universities are getting dazzled by dollar signs and losing sight of their public-service mission.

"In the past, publication and prestige was the goal for university researchers and that was sufficient," said Steven Bauer, a patent attorney with Testa, Hurwitz & Thibeault in Boston.

A victory by the drug companies also might reinforce what schools typically do: license their research to a company that can carry the burden of devising a product and, if necessary, enforcing patents.

But university President Thomas Jackson said Young and his researchers gave the drug companies "a blueprint to enormously simplify the kind of work they had to do."

"There are some things that are so basic they're not patentable - Einstein discovers relativity or Newton discovers gravity," Jackson said. "On the other end, there's the specific compound."

If the school succeeds, most royalties would be churned back into research and education. Young, 70, who has cut back on research work, no longer teaches and lives in a modest ranch house with peeling paint, stands to earn millions — but a payout could be years away. He declined to be interviewed because of the litigation.