WASHINGTON -- A new foray into the patent extension battle was made at the end of April with the Patent Fairness Act of 1999 bill, introduced to the House of Representatives by Reps. Ed Bryant, R-Tenn., and Jim McDermott, D-Wash. The proposed legislation would extend patent protection for seven pipeline drugs with U.S. sales of nearly $2.5 billion, including Claritin, which had sales of $1.8 billion in 1998.
The remaining drugs seeking extra patent life are Dermatop (Hoechst Marion Roussel), Penetrex (Rhone-Poulenc-Rorer); Cardiogen-82 (Bristol-Myers Squibb); Nimotap (Bayer AG) and Relafen (SmithKline Beecham).
This is the first time a formal bill on the matter has been introduced. Other patent review bills have often been tacked on to larger and faster-moving legislative pieces. An attempt to extend the patent on Searle's Daypro in 1996 was attached to emergency legislation to avert a government shutdown.
"Although the decision by the brand name industry to introduce a bill is a refreshing change to their previous forays during the last two years, the facts remain the same," said Dr. Alice Till, president of the Generic Pharmaceutical Industry Association. "The bill, as introduced, paves the way for extending the monopolies of several highly profitable drugs and is merely a recycled version of the proposal that was rejected, justifiably, at the end of the 105th Congress."
During the negotiations of the 1984 Hatch-Waxman Act, the branded pharmaceutical industry agreed to limit patent extensions for those drugs under Food and Drug Administration review, such as pipeline drugs, to two years. GPIA noted that all of the drugs discussed in the new bill received a two-year patent extension under the agreement.
COPYRIGHT 1999 Lebhar-Friedman, Inc.
COPYRIGHT 2000 Gale Group
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