Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the ...

Delaying Medicare’s ability to negotiate prices on small-molecule drugs until 13 years after FDA approval will decrease the ...

The FDA has created a new category of semi-exclusivity for generic drug manufacturers who rush their products to the market. At issue was how to implement the provision in the Hatch-Waxman Act ...

BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system ...

In a precedential decision issued May 6, 2025, the Federal Circuit reversed in part and vacated in part a Delaware district ...

BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system ...