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Congress is considering a bill that would establish an independent review process to consider patent extensions for drugs that spent more time than normal in the FDA review process.
Congress is considering a bill that would establish an independent review process to consider patent extensions for drugs that spent more time than normal in the Food and Drug Administration's review process.
If approved, the Drug Patent Term Restoration Review Procedure Act of 1999 could potentially extend the patents of seven drugs, including Claritin,Â® which last year generated $1.8 billion in revenue for Madison, NJ-based Schering-Plough Corp., Eulexin,Â® Nimotop,Â® Relafen,Â® Dermatop,Â® Penetrexâ¢ and Cardiogen-82.
Patents for pharmaceuticals are issued for 20 years from the date of application of the patent. Because of the lengthy FDA review process necessary to ensure drug safety and efficacy, many drugs don't hit the market until after a substantial portion of their patent time has expired.
In 1984, the Hatch-Waxman bill was passed to provide partial restoration of patent life lost to regulatory review. The bill provided a maximum extension of five years for drugs that entered the regulatory review process after the bill's enactment. The bill also provided a shorter, two-year extension for drugs that entered the pipeline before Hatch-Waxman was enacted, with the assumption that these drugs would be approved quickly. However, proponents of the 1999 bill say the seven drugs that will be affected if the bill passes spent much longer than anticipated in the review process. Claritin, for example, spent more than 10 years in the approval process and received a two-year patent restoration under Hatch-Waxman for a total effective patent life of nine years and two months.
"These medicines were kept off the market and away from the American public, in many cases for 10 years or more, because of administration delays that had nothing to do with their safety to consumers," said Rep. Jim McDermott (D-WA), cosponsor of the new bill in the House of Representatives.
Critics of the bill contend that, if passed, the bill will end up costing consumers money. A report issued by the Prime Institute of Pharmacy at the University of Minnesota estimates the bill would cost consumers over $11 billion from 2000 to 2012. "If legislation is passed to award additional years of patent monopoly to the pipeline drugs, American consumers would experience a delay in the opportunity for savings which result from generic competition in the pharmaceutical market," the report stated.
But the bill does not guarantee patent extensions for any drugs. Rather, it establishes a process through which the affected drug's patent extensions can be considered. "Our bill would take the politics out of the equation and allow each claim to rise and fall on its own merits," McDermott said. "There would be no preferences, no arbitrary decisions, no guarantees. Every petitioner would be treated the same."
"Pharmaceutical research involves both high risk and an enormous investment of resources," said Richard Jay Kogan, chairman and CEO of Schering-Plough, in his testimony in front of the Senate Judiciary Committee. "Without fair patent protection, we simply could not generate the necessary capital that allows us to make these risky and large investments." PR