How can I request a patent term extension under the Hatch-Waxman Act?
Patent term extensions under the Hatch-Waxman Act are available for certain patents related to drug products, medical devices, and food additives. According to MPEP 1002.02(b), these requests are handled by the Deputy Commissioner who oversees the Office of Petitions or assigned staff:
Applications relating to Hatch-Waxman patent term extension, 37 CFR 1.710 – 1.791 and petitions relating to Hatch-Waxman patent term extension, 37 CFR 1.182 or 1.183.
To request a patent term extension:
- File an application for extension within the required timeframe
- Provide information about the regulatory review period
- Demonstrate that the product has been subject to regulatory review
- Pay the required fees
For detailed information on the requirements and process, refer to MPEP § 2750 and the regulations in 37 CFR 1.710 – 1.791.
To learn more: