A recent article in Bloomberg Law, U.S. Patent System Crimps Drug Innovation for Toughest Diseases, looks at the research of Professor Erika Lietzan and Kristina M.L. Acri about how the development of new drugs is affected by the U.S. patent system. Their research will be published in a forthcoming article.
Their empirical research looked at 642 approved drugs to determine how various factors affect the period between when the product is approved and when the patent expires. Because of the time needed to generate the research required for approval, the average patent term remaining once drugs reach the market averages around 8 or 9 years — or 12 with patent term restoration — much less than the roughly 17 years other inventors have. The new paper finds that longer drug research programs result in shorter patent life. This research contributes data and analysis to discussions about whether U.S. law might be steering inventors away from certain types of medical research.
Although the paper does not advocate for any change to patent law, Lietzan noted the possibility of reducing the time needed for premarket research. “By all means we should be thinking about ways that [drug development] process can be more efficient, more streamlined—not less rigorous,” Lietzan said. “If we can reduce the cost at the front end that will give them a longer period, they will be on the market sooner and they’ll have more time to recoup” costs.