Pharmacy Times, Volume 0, 0

The US Supreme Court shot downrequests to review a case that lawyers forthe generic drug industry hoped wouldspeed the marketing of lower-cost genericpharmaceuticals. The case, filed byWinnipeg, Canada-based Apotex Inc,sought to invalidate Pfizer Inc's patent forZoloft (sertraline) on the grounds that thebrand name manufacturer refused tobring legal action against Apotex duringthe FDA approval process. A brandedmanufacturer's refusal to sue a potentialgeneric competitor at this stage of theprocess can create uncertainty for themarket because it leaves open the possibilityof a patent challenge after the genericfirm begins manufacturing its product.

In its unsuccessful appeal to the highcourt, Apotex argued that the possibilityof litigation after distribution of its versionof Zoloft was under way would leave thecompany facing "potentially cripplingpatent liability." The Generic PharmaceuticalAssociation, which had filed a"friend of the court" brief in support ofApotex'position, expressed disappointmentin the Supreme Court's action, notingthat the justices failed to seize theopportunity "to improve consumers' timely access to affordable medicine."