Published Online: Friday, December 1, 2006

The US Supreme Court shot down requests to review a case that lawyers for the generic drug industry hoped would speed the marketing of lower-cost generic pharmaceuticals. The case, filed by Winnipeg, Canada-based Apotex Inc, sought to invalidate Pfizer Inc's patent for Zoloft (sertraline) on the grounds that the brand name manufacturer refused to bring legal action against Apotex during the FDA approval process. A branded manufacturer's refusal to sue a potential generic competitor at this stage of the process can create uncertainty for the market because it leaves open the possibility of a patent challenge after the generic firm begins manufacturing its product.

In its unsuccessful appeal to the high court, Apotex argued that the possibility of litigation after distribution of its version of Zoloft was under way would leave the company facing "potentially crippling patent liability." The Generic Pharmaceutical Association, which had filed a "friend of the court" brief in support of Apotex'position, expressed disappointment in the Supreme Court's action, noting that the justices failed to seize the opportunity "to improve consumers' timely access to affordable medicine."

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