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

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.“

To learn more:

• patent term extension
• application requirements
• FDA approval
• regulatory review
• patent claims