What information about the regulatory review period must be included in a patent term extension application?

A patent term extension application must include specific information about the regulatory review period as outlined in 37 CFR 1.740(a)(10). The required information varies depending on the type of product:

• For human drugs, antibiotics, and biological products:
  • Effective date and number of the investigational new drug (IND) application
  • Date and number of the new drug application (NDA) or Product License Application (PLA) submission
  • NDA approval date or Product License issuance date
• For animal drugs:
  • Date of major health or environmental effects test initiation or exemption date
  • Date and number of new animal drug application (NADA) submission
  • NADA approval date
• For medical devices:
  • Effective date and number of investigational device exemption (IDE), if applicable, or date of first clinical investigation
  • Date of application for product approval submission and application number
  • Date of application approval or protocol completion declaration

The MPEP states: “In cases where there is no regulatory event to reflect the commencement of the testing or approval phase of the regulatory review period, applicants should include in the application the dates that they claim initiate either the approval or the testing phases and an explanation of their reasonable bases for why they conclude that these dates are the relevant dates.“

This information is crucial for determining the applicable regulatory review period and calculating the appropriate patent term extension.

To learn more:

• regulatory review period
• patent term extension
• FDA approval process
• clinical trials
• investigational new drug