In a significant legal victory for thegeneric drug industry, the SupremeCourt struck down a key strategyused by branded pharmaceuticalmanufacturers to delay competitionfrom lower-cost generics. The highcourt's decision in MedImmune vGenentech effectively nullified theFederal Circuit's controversial "reasonableapprehension" test—astandard that critics claim hadmade it more difficult and time-consumingfor generic firms to prevailin drug patent disputes.
In 2003, Congress closed a loopholein the original Hatch-Waxman generic drug law by allowinggeneric manufacturers to seek declaratory judgments from thecourts as an alternative to lengthy patent litigation. The FederalCircuit, however, created a new stumbling block by ruling thatgeneric firms must "have a reasonable apprehension of suit by thepatentee" before securing such a declaratory judgment. This wasthe legal barrier removed by the high court in the Genentech case.
Generic Pharmaceutical Association President and ChiefExecutive Officer Kathleen Jaeger called the new ruling "a victoryfor consumers and the entire health care system in the fightto reduce health care costs while improving care. By strikingdown the Federal Circuit's ‘reasonable apprehension'test, theSupreme Court has ruled in favor of American consumers bymaking it harder for brand companies to delay generics fromcoming to market," she said.