BMJ 2002;324:1176 ( 11 May )
Deborah Josefson Nebraska
The US Senate is considering a bill to close a loophole in the drug patent laws that has enabled drugs companies to get easy and frequent extensions of 30 months to their patents.
The hotly debated new Greater Access to Pharmaceuticals Bill, also known as the McCain-Schumer bill after the senators who sponsored it, seeks to reform an earlier law, the Waxman-Hatch Act of 1984. This law sought to foster price competition while preserving patent rights.
The Waxman-Hatch Act allows manufacturers to file applications for generic equivalents of brand name drugs before the patent on the original brand expires. The patent holder then gets an automatic 30 month extension of the original patent to resolve the issue between the patent holder and the manufacturer of the generic drug.
But some drug companies took advantage of the act by filing frivolous new patents designed to extend their hold on the market, the two senators say. "Drug companies are not spending all their time innovating new drugs. They’re innovating new patents," Senator Charles Schumer of New York told a Senate subcommittee.
Instead of filing patents on active ingredients, many manufacturers get patent extensions that are based on minor alterations in drug formulations, packaging, and dispensing methods. Some of them file patent claims late, file patents that do not relate to their product, or file frivolous claims of patent infringement.
These claims trigger multiple 30 month stays of approval and impede competition by delaying the launch of cheaper generic drugs.
The McCain-Schumer bill would eliminate the automatic 30 month extension and leave it up to the courts to decide whether to allow a generic drug on the market on a case by case basis. Over the next 4-5 years dozens of drugs with annual sales of over $35bn (£24bn; €38bn) will come off patent.
According to a recent study by Stephen Schondelmeyer, an economist at the University of Minnesota and director of a pharmaceutical research institute, the average number of patents per new drug marketed in the United States rose from 1.9 in 1982-4 to 3.3 in 2000-1. This drove up the average length of market exclusivity of drugs from 9.0 years in 1982 to 10.1 years in 1999.
Any delay in allowing generic drugs to come to market, even for a short while, yields profits to the original manufacturer. But an attorney for the Pharmaceutical Research and Manufacturers Association of America, Gregory Glover, argues that it would be unfair to enact the McCain-Schumer bill as it would inhibit pharmaceutical companies from defending their intellectual property rights and prevent them from recouping costs of drug development.