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October 1997

Patent Laws: Could Changes Enhance Drug Development?

Arch Gen Psychiatry. 1997;54(10):970. doi:10.1001/archpsyc.1997.01830220100015

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Having spent the past 8 years conducting clinical trials for pharmaceutical companies, I have the impression that current patent laws often inhibit optimal research. One of the most common reasons for discontinuing development of a drug, or not evaluating a drug for a new indication, is "limited patent life."

The patent laws were intended to encourage the development of new drugs by providing financial incentives (ie, patent protection). These laws, however (understandably), did not consider current issues related to drug development, eg, the average time from patent application to Food and Drug Administration approval for marketing is 10 years. Much of the delay in having drugs approved for marketing is due to increased Food and Drug Administration requirements, eg, the need for extensive safety and efficacy data, studies of the minimum effective dose, and others. I think that most clinicians and researchers would agree that it is good for the

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