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American patients enjoy access to more treatment options than anywhere else in the world. This success is built in large part on two legal foundations:
- Our intellectual property system.
- The landmark Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act.
The history: When Congress passed Hatch-Waxman in 1984, the U.S. generic market barely existed. Without a clear pathway for generics to come to market, options were understandably limited. Thanks to the groundbreaking framework laid by Hatch-Waxman, the results today speak for themselves.
By the numbers:
- Nearly 90% of U.S. prescriptions are filled with generics. But before Hatch-Waxman, that number was just 19%.
- More than 80% of approved brand medicines now have generic versions available, often entering the market immediately upon patent expiration.
- Generic medicines have an average copay of just under $7.
Dive deeper: Hatch-Waxman fostered generic competition by creating a streamlined approval pathway that in part lets generics rely on brand clinical data and resolve patent disputes before launch. In return, it preserved incentives for innovation including by restoring a limited portion of patent term lost during the FDA approval process.
Claims that IP (including patents) unfairly delay generic competition overlook why Congress created these protections: Every generic medicine depends on an innovative brand medicine to first reach the market.
The bottom line: To maintain U.S. biopharmaceutical leadership as China rapidly expands its drug discovery and development capabilities, we must preserve the legal framework that drives innovation, lowers costs and expands treatment options for patients.
Learn more about how Hatch-Waxman supports innovation and lower costs.
David Korn
David Korn is Vice President, Intellectual Property (IP) and Law, for the Pharmaceutical Research and Manufacturers of America (PhRMA). He focuses on IP issues in Congress, the Patent and Trademark Office and other agencies, as well as in amicus briefs in cases of interest to PhRMA. He has degrees in biomedical engineering from Duke and Northwestern and a J.D. from Harvard Law School. Prior to joining PhRMA, he worked in private practice and clerked in the U.S. District Court for the District of Delaware.
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