Academia, corporate giants clash over patent

At first glance, the matchup looks lopsided: America’s pharmaceutical goliaths versus a semiretired professor at a midsize college dreaming of becoming a big player in biomedicine.

By Ben Dobbin
Associated Press Oakland Tribune

In the unpredictable arena of patent litigation, however, the University of Rochester is willing to defend Dr. Donald Young’s lab work with an eight-figure legal fund. Hiring a prestigious patent law firm, it has already piled up well over $10 million in costs.

The colossal prize: billions in royalties from a new class of "super aspirin" that alleviates pain and minimizes side effects by blocking an enzyme Young discovered in 1990. Celebrex, the first such drug to hit the market in 1999, generated $3.1 billion in sales last year alone.

The clash between academia and corporate giants led by Pfizer Inc. is a concept versus application conundrum: Should schools get a share of the riches if they make a fundamental discovery, 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 drug companies scored a first-round win in federal court here this month, as a judge agreed to send the case to an appeals court in Washington that specializes in patent disputes.

In a judgment on March 5, U.S. District Judge David Larimer invalidated the school’s unusually broad patent, which was granted in April 2000 after a 71/2-year examination by the U.S. Patent and Trademark Office. The judge called Young’s method of treatment no more than "a wish or plan or first step" that "did not blossom into a full-fledged complete invention."

"What the court is saying is you can’t patent a discovery about how the human body operates," observed Steven Bauer, a patent attorney with Testa, Hurwitz & Thibeault in Boston. "What you can patent is a drug that’s made to cure a problem. That leaves the university doing the hard work and not getting any protection."

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

The 17-year patent relates to all cox-2 inhibitor painkillers, including Vioxx, a similar drug to Celebrex made by Merck & Co. Dodson thinks the patent 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, a hefty $1.1 billion endowment and lofty ambitions in the biological sciences.

While it already commands a research budget of $260 million a year, the school hopes to garner the sort of gilt-edged reputation that attracts 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 believe 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," Bauer said.

Assisted by two colleagues, Young, a professor of medicine and biochemistry, pinpointed a new cyclo-oxygenase enzyme that relieves pain without the risky stomach and gastrointestinal ailments associated with regular use of aspirin, ibuprofen and other anti-inflammatory drugs.

When his 1992 patent claim was finally issued, the school immediately sued the drug companies that had gone ahead and developed cox-2 inhibitor drugs.

"The court would have been happier if the university had tested a number of compounds and found that certain classes work," said Ronald Cahill of Nutter, McClennen & Fish, a Boston law firm. "Very often researchers at academic institutions have a good concept and don’t always have the time or the budget to follow up with lots of testing."

Rather than trying to "hit a home run," he said, the ruling might help 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.

"There are some things that are so basic they’re not patentable — Einstein discovers relativity or Newton discovers gravity," acknowledged the University of Rochester’s president, Thomas Jackson. "On the other end, there’s the specific compound.

"We provided a method for screening defined compounds. My argument would be, we gave them a blueprint to enormously simplify the kind of work they had to do to find a 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.

Dodson was hired after his success in a patent lawsuit in 1999 that ended with biotechnology giant Genentech Inc. agreeing to pay the University of California $200 million.

"I cannot say there was anybody interested in taking a license" on Young’s work, Dodson said. "And, to me, that’s not uncommon. Why license it if you think you don’t have to pay anything at all?"

The battle always looked destined to end up before the appellate court, where no less than 30 percent to 40 percent of patent rulings are overturned.

If that happens, and the dispute heads to trial, the odds would tilt sharply back in the school’s favor since a jury must presume a patent is valid unless proven otherwise, Dodson said. Such a prospect, he said, would mean a settlement "becomes a much greater possibility.",1413,82~10834~1268155,00.html#

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