This is Part 4 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing.
Years ago, when a brand-name medication’s patent expired, consumers had to wait a long time for a more affordable generic version to come to market. But in 1984, a little-known law put an end to that waiting period and paved the way for the large quantity of generic drugs available today.
The Drug Price Competition and Patent Term Restoration Act of 1984 — also known as the “Hatch-Waxman Act” after the two legislators who sponsored the bill — makes it easier for generic drugs to enter the industry, including allowing generic drugmakers to start research and development on generics prior to the patent expiration of the brand-name drug without risk of patent infringement. In return, brand-name drugmakers were given a patent extension — five extra years of market exclusivity on their drug.
But Hatch-Waxman isn’t a perfect law. In this video, we explain how the Hatch-Waxman Act works to extend brand-name drug patent protection and also facilitate generic drug market entry, but also how it is limited in its power. We also cover other patent extensions that are used to delay generic drug entry and the ways this can affect consumers.
STAT’s coverage of patent issues is supported by a grant from the Commonwealth Fund. Our financial supporters are not involved in any decisions about our journalism.