FTC eyes patent-extension efforts, giving boost to generic drug firms

Drug Store News,  May 20, 2002  by Diane West,  James Frederick

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WASHINGTON -- The Bush administration is turning up the heat on branded drug makers in a new and potentially significant campaign to curb excessive patent-extension efforts and speed new generic drugs to market.

Testifying April 23 before the Senate's Commerce, Science and Transportation Committee, Federal Trade Commission chairman Timothy Muris said pharmaceutical industry "abuse" was impeding the introduction of generics and subverting the intent of the original Hatch-Waxman legislation. Passed nearly two decades ago, Hatch-Waxman paved the way for generic competition, while guaranteeing branded drug makers extended patent life for their products.

"Although many drug manufacturers--including both branded companies and generics--have acted in good faith, some have attempted to 'game' the system, securing greater profits for themselves without providing a corresponding benefit to consumers, "said Muris, a Bush appointee. He told the committee the FTC will act to curb those practices.

Muris said the agency will scrutinize patent settlements between branded and generic firms if those agreements "delay the entry of one or more generics [or maintain] monopolies through abuses of the Hatch-Waxman regime." The FTC also will litigate against unilateral actions by brand-name drug makers to prevent or delay generic competition, if those actions are found to be illegal.

Along those lines, Muris announced an agreement between the FTC and Biovail Corp. to settle charges that the firm had violated patent laws to stave off me-too versions of its blood pressure medication Tiazac. "This is the commission's first enforcement action to remedy the effects of an allegedly anti-competitive Orange Book listing," Muris told senators. He said the agency is also conducting an industrywide study of generic drug competition under HatchWaxman. Results of that study, Muris noted, will be available this summer.

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