Will Claritin Continue to Reign Supreme?
Nov. 16, 1999 (Washington) -- A recent Capitol Hill debate over extending the patent of Schering-Plough's antihistamineClaritin (loratadine) could have prompted an allergic reaction in someone previously unexposed to federal regulatory language and "intellectual property" jargon.
Representatives from Claritin's maker, Schering-Plough; makers of generic drugs -- cheaper versions of brand-name drugs that are sold after the brand-name products' patents expire; and consumer groups clashed as the Senate Judiciary Committee held a hearing on legislation sponsored by Robert Torricelli (D, N.J.) and Jeff Sessions (R, Ala.). If passed, it would extend Claritin's patent for three more years -- thus granting Claritin three more years of market exclusivity. House lawmakers have introduced a similar bill.
The main question the lawmakers clashed over was one of perspective: Would the legislation provide an unjustified financial advantage for the makers of a highly profitable drug -- or would it be fair treatment for a firm burdened by FDA delays?
As almost everyone knows, Claritin has been a multimillion-dollar cash cow, with sales of almost $2 billion just last year. But it is slated to lose patent protection in 2002 -- and generic-drug manufacturers are eager to begin making and selling their cheaper versions of it. Schering-Plough is arguing to have its Claritin patent extended and hold off the generic drug makers, on the basis that although Schering-Plough received its patent for Claritin in 1981, the antihistamine was under FDA "approval review" for more than 5 years afterwards. As a result, it didn't hit the market until 1993.
The firm's CEO, Richard Kogan, testified at the hearing that because of the FDA's delay, Claritin will have had only about 9 years of market exclusivity, even though, on average, new prescription drugs enjoy more than 12 years of patent protection. "Claritin received the worst of both worlds -- extraordinarily lengthy regulatory review and minimum patent restoration," he said.
Claritin is a "pipeline" drug, meaning that it was under FDA review in 1984 when Congress passed the landmark "Hatch-Waxman" drug-patent legislation. "Pipeline" drugs received a less generous patent extension allowance than drugs that were not yet under review in 1984.