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Curb the Drug Patent Tricks

July 10, 2002

Patients suffering from anxiety disorders should have been able to get an affordable generic equivalent for the brand-name drug BuSpar when the patent on the drug expired in November 2000. They didn't. Just hours before the deadline, BuSpar's manufacturer, Bristol-Myers, filed a "secondary patent," saying beneficial effects come from a metabolite produced by the patient's body after BuSpar is taken. The company's ownership claim on the metabolite effectively barred the release of a generic version of BuSpar that would produce the same metabolite.

As outlandish as they may be, such bogus claims are common as drug companies increasingly resort to tricks aimed at delaying generic competitors.

Congress has a chance to slow the tricksters. Senate Bill 812, by Sens. John McCain (R-Ariz.) and Charles E. Schumer (D-N.Y.) and scheduled to be considered today in a Senate committee, would make it tougher for brand-name drug companies to keep generics off the market beyond the original patent.

Brand-name drug companies have been fighting the measure tooth and nail. They assert, reasonably, that they are entitled to the law's full patent protections for genuine innovations. The bill, however, wouldn't undermine the sort of profit incentive that drove Swiss drug company Roche and the North Carolina biotech firm Trimeris Inc. to develop their promising anti-HIV drug T-20, unveiled Monday at an AIDS summit in Barcelona, Spain.

The bill does not alter the patent code. All it does is help get generics to market. Firms' ability to collect triple damages for infringement of legitimate patents would remain.

Generic drug introductions are automatically delayed for 30 months if a brand-name company files even a trivial patent claim. The McCain-Schumer bill would require companies to persuade a judge that their claim had merit before triggering any delay.

Since any wide-ranging prescription drug benefit for Medicare recipients seems dead for the year, the most that patients can hope for are actions around the edges, including the McCain-Schumer bill.

Another small step forward comes from pioneering states like Michigan, which is trying to knock down prices through the leverage of its state-paid Medicaid program. It has asked drug makers to submit proposed discounts, or risk being dropped from the program.

Health and Human Services Secretary Tommy G. Thompson approved Michigan's program in January, but on July 1 the chief drug industry lobbying group sued Thompson, asking the U.S. District Court to bar Michigan from implementing the law.

The drug industry must know how bad it looks. If the industry wants to keep from killing its golden goose, it should embrace the modest efforts of the Senate and bargain directly with states like Michigan.

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