Patent litigation routinely delays generic drug launches by years, costing patients billions. Despite FDA approval, legal battles, pay-for-delay deals, and patent thickets keep cheaper drugs off the market. This is how the system works-and why reform is urgently needed.
The Federal Circuit Court controls U.S. pharmaceutical patent law, deciding when generics can enter the market, which patents hold up, and where lawsuits are filed. Its rulings impact drug prices, innovation, and patient access.