Pharmaceutical Focus

Dec. 21, 2004
Schering-Plough seeks new life for Claritin with latest legislative push.

It's old news, but with a new twist. Pharmaceutical company Schering-Plough Corp. long has complained about its blockbuster allergy drug Claritin's short patent life, which it says was cut short unfairly by delays in the approval process. But unlike its past efforts to slip a legislative fix through Congress, the Madison, N.J.-based drug maker now has settled on winning its patent extension in a straightforward manner that may prove far more successful. Reps. Ed Bryant, R-Tenn., and Jim McDermott, D-Wash., are championing the drug maker's cause with the recently introduced Patent Fairness Act of 1999. The legislation would establish an independent panel within the U.S. Patent and Trademark Office to consider whether drugs that are delayed during the approval process should be considered for a three-year patent extension. The Senate defeated a similar effort in October 1998. But that bid became embroiled in political mire because it was introduced as an amendment to the Senate's fiscal 1999 spending measure. The amendment also met with public disapproval because it appeared to be a blatant effort by Schering to circumvent the legislative process. But Schering's latest move is distinctly different, Schering spokesperson Denise K. Foye says, because the company's lobbying has resulted in a bill that now will go through the entire legislative process. In addition, she says, this time it will be evident that Schering is not the only company that stands to benefit. She points out that several drugs will be reviewed: Claritin, Schering's cancer drug Eulexin, Bayer AG's neurological drug Nimotop, SmithKline Beecham PLC's anti-inflammatory drug Relafen, Hoechst Marion Roussel's itch medication Dermatop, and Rhone-Poulenc Rorer Inc.'s antibacterial Penetrex. None of these drug makers stands to win or lose as much as Schering. In 1998, Claritin sales soared 31% to $2.3 billion, or about 28% of the company's total revenues. While this monetary incentive may make Schering's effort seem like typical Washington fodder, the drug maker definitely has a point to make with regard to Claritin. U.S. patent law generally provides for up to 20 years of exclusive rights to a product. But prescription drugs can lose up to 10 years of that potential marketing exclusivity to the regulatory approval process. In recognition of this dilemma for the drug companies, Congress in 1984 enacted the Drug Price and Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act. This law was aimed at enabling generic drugs to get to the market faster and restoring some of the patent life that branded drugs lose during the regulatory review process. The framers of the Hatch-Waxman Act, though, expected a relatively quick FDA-approval process. But Claritin, one of the first nondrowsy allergy products, spent more than 10 years in the approval process, only to receive a two-year patent extension for a total patent life of nine years and two months. This relatively short patent life is unfair, Foye says, because bringing a new drug such as Claritin to the market can cost drug makers up to $500 million and take more than 15 years to get from the lab to the pharmacy. Without at least the opportunity to recoup some of those expenses, Foye says, there would be little to no incentive for drug makers to pioneer new, novel products. Bryant and McDermott agree. "Patent integrity is the cornerstone of research and development by giving innovators the chance to benefit from their work," Bryant said in introducing the bill. "We all know pharmaceutical research is one of the best patient protection policies Americans can buy." But the Bryant-McDermott bill, even if passed, doesn't guarantee that Schering will receive either of its patent extensions. "Our bill would take the politics out of the equation and allow each claim to rise or fall on its merits," McDermott said. "There would be no preferences, no arbitrary decisions, no guarantees. Every petitioner would be treated the same." Nonetheless, even the initiation of this review process could ease some of the pressure now falling on Schering's shoulders. In February 1998, Geneva Pharmaceuticals submitted a drug application to the FDA for a generic form of Claritin. And now, Copely Pharmaceuticals Inc. of Canton, Mass., and Israel's Teva Pharmaceuticals also have submitted applications to the FDA seeking to market a generic form of Claritin. Those applications also were based on allegations that Schering's Claritin patents are invalid. But the point is that at least three companies already are poised to introduce generic equivalents. Therefore, it would be safe to say that any relief Schering might win through the legislative process would be a welcome respite from its presently tenuous position. Ori Twersky writes for Bridge News, Bridge Information Systems

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