What is the purpose of patent term extension under 35 U.S.C. 156?
The purpose of patent term extension under 35 U.S.C. 156 is to compensate patent owners for time lost during the premarket regulatory review process. As stated in the MPEP:
“The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket government approval from a regulatory agency.”
This provision aims to address two distortions in the normal patent term:
- Loss of patent term during early years due to inability to commercialize without regulatory approval
- Delayed market entry for competitors after patent expiration due to regulatory requirements
To learn more:
Topics:
Adjustments,
And Extensions,
MPEP 2700 - Patent Terms,
MPEP 2750 - Patent Term Extension For Delays At Other Agencies Under 35 U.S.C. 156,
Patent Law,
Patent Procedure