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ROCHESTER, N.Y.–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.”
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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 Dr. Donald Young’s lab work, which is linked to the invention of the popular Celebrex drug.
At the heart of the clash is a 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 product?
The Food and Drug Administration has recommended approval of G.D. Searle’s Cox-2 inhibitor Celebrex (celecoxib) for the treatment of osteoarthritis and rheumatoid arthritis. Monsanto subsidiary Searle, co-marketing the drug with Pfizer, was seeking a third indication-for the management of acute pain-which was not approved, but continues to be studied by the FDA’s arthritis advisory panel. Although the drug must carry a warning that it could cause gastrointestinal problems, clinical trials suggest those are minimal compared to those associated with NSAIDs.
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