For many medicines, FDA approval doesn't mean a product has reached the finish line. That’s because research doesn’t stop the moment a medicine reaches patients. Researchers often continue to explore new uses to treat a different disease or patient population, or they work on possible improvements to the medicine to make it easier to take or reduce side effects.
Investment in this research is driven by intellectual property (IP) incentives, like patents, which encourage ongoing risk taking. A patent is a reward for a new, useful and non-obvious innovation, which often carries immense value for patients. Although researchers recognize the importance of post-approval R&D, critics often dismiss new uses or improvements as meaningless gaming of the IP system, overlooking their real-world benefits. Here is what they continue to get wrong:
Myth: Brand drug makers file applications for additional patents on a drug for post-approval innovations to extend market exclusivity and shut out competition.
Fact: A patent granted reflects a legitimate innovation that meets statutory standards which require that a patented invention to be novel, useful and nonobvious. Despite claims to the contrary, new patents do not extend old patents. Technologically advanced innovations like medicines often have multiple patents because, like any technologically advanced product, they incorporate multiple inventions. Even something as apparently simple as a golf ball can have as many as 68 patents covering different features, whereas drugs have an average of five.
A 2024 USPTO report concluded that there is no correlation between the number of patents on a product and length of market exclusivity. The report found that simply counting patents and exclusivities is a misleading way to assess a medicine’s intellectual property landscape or market exclusivity period. Importantly, on average, generics enter the market typically after just 13 years after initial FDA approval.
Myth: Patents filed after FDA approval are minute changes used as a tactic to delay generic competition.
Fact: The USPTO only awards patents to inventions that meet strict standards of novelty, utility and non-obviousness. Just as in every other field, the biopharmaceutical R&D process is iterative, and researchers continually seek to build upon, refine and optimize medicines after they are FDA approved. A patent on a new use or feature does not prevent FDA approval of a generic of the original product.
The bottom line: Biopharmaceutical innovation builds on itself. Each new discovery adds to previous advances, helping more patients live healthier lives. Patents protect these inventions by making them public, which enables generics to enter the market and supports ongoing breakthroughs.
Post-approval research doesn’t just stop at FDA approval, and neither should the innovations that make much of modern medicine possible.
Learn more at PhRMA.org/IP.
Andrew Powaleny
Andrew Powaleny is the Deputy Vice President of Public Affairs at PhRMA, where he leads communications on scientific, regulatory and intellectual property issues, highlighting the biopharmaceutical industry’s efforts in developing innovative medicines and vaccines while promoting an environment that encourages necessary risk-taking. For five years starting in 2019, he launched and led PhRMA’s grassroots initiative, Voters for Cures, bringing patients and caregivers together to advocate for access to medicine and biopharmaceutical innovation. He also co-founded and co-chaired PRIDE Umbrella, a resource group for LGBTQ+ individuals. Prior to joining PhRMA in 2015, Andrew worked as a communications consultant in Washington, D.C., and as Deputy Press Secretary for the U.S. House Committee on Energy and Commerce under Chairman Fred Upton. He holds a degree in public policy and government from Eastern Connecticut State University, with a minor in music. Outside of work, Andrew enjoys exercise, musical theater and mentoring college students through The Fund for American Studies alumni association.
Andrew Powaleny