Patent Law Change Urged to Speed Generic Drugs
The Federal Trade Commission called on Congress tonight to revise the nation's patent laws to prevent brand-name drug companies from unduly delaying the sale of low-cost generic drugs.

In a report to be issued on Tuesday, the commission says several provisions of a landmark 1984 law "have the potential for abuse" and may have been exploited by brand-name drug companies to prevent the marketing of generic drugs.

Under current law, a maker of brand-name drugs can often get a 30-month delay in federal approval of generic drugs by filing a lawsuit asserting infringement of its patents. The commission said some companies had delayed generic competition for years — up to 40 months beyond the initial 30-month period — by filing new patents for brand-name drugs already on the market.

The commission found eight instances in which brand-name companies had filed new patents to protect their monopolies after generic drug companies sought approval from the Food and Drug Administration to market low-cost copies of those medicines.

Accordingly, the commission recommended that Congress change the law to allow only one 30-month delay for each drug product. This would reduce the ability of drug companies to stave off generic competition by securing multiple delays.

The study, based on documents subpoenaed from pharmaceutical companies, examined the marketing of brand-name drugs like Cardizem CD, Cipro, Claritin, Paxil, Pravachol, Prilosec, Prozac, Vasotec, Zantac and Zoloft
http://www.nytimes.com/2002/07/30/politics/30DRUG.html