Sept. 10, 2024
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.
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