What are the formal requirements for a patent term extension application?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

The formal requirements for a patent term extension application are outlined in 37 CFR 1.740. Some key requirements include:

• Complete identification of the approved product
• Identification of the federal statute under which regulatory review occurred
• Date of product approval for commercial marketing or use
• For drug products, identification of each active ingredient
• Statement that the application is being submitted within the 60-day period
• Complete identification of the patent for which extension is sought
• Copy of the patent and any disclaimers or corrections
• Statement showing how the patent claims the approved product or method
• Relevant dates and information for determining the regulatory review period
• Description of the applicant’s activities during the regulatory review period
• Statement of the length of extension claimed and how it was calculated
• Acknowledgment of duty to disclose material information
• Payment of the required fee

As stated in the MPEP: “37 CFR 1.740 sets forth the requirements for a formal application for extension of patent term.“