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Ask the Advisor: Stealth Legislation Extends Drug Patents, Costs Seniors
The patent rights for several high priced prescription drugs are about to expire. Those drugs are on track to become available soon as less costly generics. Drug makers are using lucrative lobbying tactics to get legislators in Washington to vote for patent extensions, thus delaying the generic versions.
Members of Congress have committed themselves to keeping the cost of prescription drugs down. They owe it to their loyal constituents to vote NO to any patent rights extension. Yet in the recent past, legislators have allowed the patent rights of a certain drug to be extended, blaming the vote on a Congressional “oversight.” This cost seniors many millions of dollars in higher drug prices. Call, write, or e-mail your legislators in Washington to vote NO for any request from pharmaceutical companies for extensions of patent rights.—J.P., Seatac, WA
From the editor: More than one generic drug has been slow making it to the market place. Delay of a generic introduction can mean millions in profit for the brand name manufacturer as well as millions in higher costs to seniors. Patents on 21 best-selling drugs will expire over the next five years. The typical patent for a brand name prescription drug is supposed to be 20 years, but in 2001 the generic delay problem caused the Federal Trade Commission (FTC) to launch a nation-wide investigation of anti-competitive drug industry practices.
According to an article that appeared in the July 2001 issue of “Consumer Reports,” drug manufacturers have recently been accused of stalling generics with a variety of tactics including:
- Legislative stealth techniques. Patent extending “riders” are quietly inserted into complicated, unrelated legislation. In 1996 a clause that extended the patent on the drug Daypro (oxaprozin) passed as part of legislation that prevented a government shutdown.
- Competitors prevented from obtaining needed ingredients. Mylan Laboratories recently settled FTC charges that it conspired with three chemical suppliers to prevent other generic drug manufacturers from getting necessary ingredients. With no competition, Mylan then raised the wholesale price of clorazepate from $11.36 to $377 for a 500-count bottle of 7.5 mg tablets in January of 1998, says the FTC.
- Competitors paid to stay out of market. The FTC testified that the maker of Cardizem CD, a widely prescribed drug for hypertension and angina, paid a generic manufacturer to refrain from bringing a competing generic drug to market. The price? Eighty million. Because the first generic manufacturer who first wins Food and Drug Administration approval for its version also receives a 180-day competition free head start, other generic manufacturers were also stalled.
- Questionable lawsuits. Some drug manufacturers wait until their patent is almost up, make a very minor change to the product, then register a new patent. They then sue the generic companies for patent infringement. Lawsuits give the brand name company up to another 30 months of market exclusivity.
Sources: “The Stalling Game,” “Consumer Reports,” July 2001. “Generics May Lower Health Care Cost,” Theresa Agovino, The Associated Press, May 2, 2002.
September 2002
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