HOW MUCH PROTECTION from copycats should inventors have? The law says that 17 years is the appropriate time over which replication of patented products should be prohibited. Nowdays, for a variety of reasons, few inventors receive that much protected marketing time. The drug companies--with the support of other regulated industries--are asking Congress to restore patent time lost to government review of their products.
Since Congress strengthened drug testing requirements in 1962, the review process has come to consume an increasing part of a new drug's patent life. This, the drug companies say, discourages research and, in the end, hurts the consumer by stalling medical breakthroughs and reducing the number of new drugs competing in the market.
There is not, in fact, much evidence to support the companies' claims of stifled research--and none to support their claims of resultant poverty. But there is a strong fairness argument in favor of the notion that innovation should not be discouraged by reason of government regulation. The drug industry, moreover, has made enormous contributions to medical progress in this and other countries, and, despite their often high prices, drugs still remain far and away the cheapest form of medical treatment.
Speeding up the review process for important new drugs can help--and the Food and Drug Administration has instituted a fast-track clearance for this purpose--but thorough testing of drugs is too important to public safety to push too far along this avenue. A safer form of relief would be to add some years to patent life to compensate for time lost in the government review process. How much extension is reasonable?
The drug companies, of course, would prefer to have the patent clock start running only after FDA approval has been given. But that would give the companies a degree of protection rarely enjoyed by non-regulated inventors. As modern technology makes the indentification of unique products increasingly difficult--especially in the highly competitive field of electronics--many inventors receive no protection at all. And patents cannot protect a product from being made obsolete by someone else's better invention. Even without government control, moreover, drug companies would need time to test their products for safety, assess their markets and develop a sales strategy.
The drug companies have built strong support for their case in key congressional committees. Their position, however, is strongly opposed by consumer groups and generic drug companies, which argue that longer patent protection will push up drug prices and give the major drug companies unfair advantage. What is needed is--you guessed it--a compromise. A full 17 years after FDA approval is too much. But compensation for time actually lost to the review process--adjusting for delays caused by the company--is patently fair.