Citations to This Work
- Erika Lietzan & Julia Post, The Law Of 180--Day Exclusivity, 71 Food Drug L.J. 327 (2016)
The America Invents Act has put in place quick and efficient mechanisms for challenging granted patents in an Article I adversarial setting. And the Hatch-Waxman Act has been the roadmap for generic drug approval-related patent infringement action in Article III courts. An interesting, heretofore unaddressed question lurks at an intersection of the two pieces of enterprising legislation: What impact should a final decision canceling patent claims under the AIA setting have on the forfeiture of 180-day exclusivity under the Hatch-Waxman Act? The 180-day exclusivity is an important piece in the Hatch-Waxman game of chess. This comment presents both the case for and against pulling the forfeiture trigger on the 180-day exclusivity via the new AIA setting. Going further, the comment highlights pragmatic and policy justifications for pulling the trigger, thereby proposing grounds for a conformant legislative action.
Jaimin Shah, Pulling the 'Trigger' on the Hatch-Waxman Act's 180-Day Exclusivity Using Inter Partes Review, 14 J. Marshall Rev. Intell. Prop. L. 453 (2015)