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2757    Regulatory Agency Determination of the Length of the Regulatory Review Period  

MPEP SECTION SUMMARY The regulatory agency is responsible for the determination of the length of the regulatory review period for the approved product on which the application for patent term extension is based. The determination by the regulatory agency is made based on the application as well as the official regulatory agency records for the approved product. The determination of the length of the regulatory review period is solely the responsibility of the regulatory agency. Further details are discussed on the regulatory agencies determination of the length of the regulatory review period.

To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase begins on the date of the submission of the administrative NADA.

The regulatory review period determination is not final until due diligence petitions and informal hearings, if any, have been resolved.

• A certificate for extension of the term of a patent may not issue from the Office until the regulatory review period determination is final unless an interim extension appears warranted.
  
  

MPEP SECTION SUMMARY If a due diligence petition is filed during the 180-day period following publication of the regulatory agency determination of the regulatory review period, the regulatory agency (e.g., FDA) makes the determination under 35 U.S.C. 156(d)(2)(B) whether the applicant for patent term extension acted with due diligence during the regulatory review proceedings. Further details on the due diligence determination are covered in this section.

After affirming or revising the determination of the regulatory review period, the regulatory agency notifies the Office and publishes the results in the Federal Register.

If no comment or petition is filed in the time period provided, the regulatory agency notifies the Office that the period for filing a due diligence petition pursuant to the notice has expired and that the regulatory agency therefore considers its determination of the regulatory review period for the product to be final.

• Following notification from the regulatory agency, the Office will proceed with the final eligibility determination.

 

» 2758 Notice of Final Determination - Calculation of Patent Term Extension