Opinion: Put limits on patents for drugs

The pharmaceutical giants know that every day they can keep generic equivalents of their best-selling medications off the market is another day of big profits. To that end, companies such as Bristol-Myers Squibb use every tool at their disposal to delay the introduction of generics, including filing meritless lawsuits, devising nonexistent patent disputes and registering groundless safety complaints about generic pills. Consumers, of course, are the big losers, paying billions of dollars more for drugs than they should.

Congress could put an end to this bilking, but federal lawmakers have exhibited a remarkable lack of resolve. You don't suppose the $177-million the pharmaceutical lobby spent in 1999 and 2000 could have anything to do with the political spinelessness on Capitol Hill?

Paying for prescription drugs is the No. 1 medical concern of today's senior citizens, many of whom can't afford the monthly costs of their life-sustaining drugs. Estimates are that consumers would save $71-billion over 10 years if generic drugs were allowed to come to market immediately after patents expire. Yet Congress has allowed the drug giants to employ delaying tactics and predatory practices. Legislation to address some of these abuses has gone nowhere.

Other public officials aren't waiting for Congress to act. Last month, attorneys general from 29 states, including Florida, sued Bristol-Myers Squibb for antitrust violations in illegally blocking a generic equivalent to BuSpar, a widely used antianxiety drug. Specifically the states allege that the company lied to the Food and Drug Administration in order to extend its patent on BuSpar. A 1984 law directs the FDA to hold off on approving a generic drug for up to 30 months if there is a patent dispute.

The incentive for using any opportunity for delay is millions of dollars. Last year, sales of BuSpar reached $700-million.

Another tactic by drug companies is to exploit a law that allows the extension of a patent for an additional six months if the companies evaluate the drugs for use by children. Bristol-Myers Squibb took advantage of the law for its highly popular diabetes pill Glucophage. But after finding the drug effective in treating type II diabetes in children, the company decided six months was not enough. It tried to claim the pediatric test findings qualified it for a patent extension of three years -- an extension given by the FDA when there are new uses found for a drug. Last month, the company, in a rare political defeat, failed to convince Congress to go along with the extra extension. The House joined the Senate in renewing the six-month pediatric study patent extension but did so without adopting Bristol-Myers Squibb's request.

Some drug companies simply pay generic competitors to keep out of the market. Florida and two other states are suing three pharmaceutical companies over the practice. As a result of anticompetitive dealmaking, the states claim, state health agencies and consumers paid excessive prices.

Patent protection is necessary in order to give pharmaceutical firms the incentive to invest in research and development. But consumers have a right to expect that after 20 years the patents will expire and the price of those medications will come down to better represent the real cost of the drug's manufacture.

There is a crisis in this country over the spiraling cost of prescription medications. It should be laid at the doorstep of the pharmaceutical giants and the government that refuses to regulate them.

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