MPEP § 2757 — MPEP § 2757
Current through: 2022-07-01

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

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2757 
 

 
 
 
 
 
 2757 Regulatory Agency Determination of the Length of the Regulatory
 Review Period [R-10.2019]
 

 Under 35
 U.S.C. 156 , 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. See, e.g., 21 CFR Ch. 1, Subpart C. The
 determination of the length of the regulatory review period is solely the responsibility of
 the regulatory agency. Aktiebolaget Astra v. Lehman, 71 F.3d 1578,
 1580-81, 37 USPQ2d 1212, 1214-15 (Fed. Cir. 1995) (regarding U.S. Patent No. 4,215,113). 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,
 as defined by 35 U.S.C.
 156(g)(4)(B)(ii) , begins on the date of the submission of the
 administrative NADA. See Wyeth Holdings Corp. v. Sebelius, 603 F.3d
 1291, 1299-1300, 95 USPQ2d 1233,1240 (Fed. Cir. 2010).
 

 Once the determination has been made, the regulatory agency publishes the
 information in the Federal Register and forwards a letter to the Office with the same
 information. Included in both the Federal Register Notice and the letter to the Office are
 the total length of the regulatory review period and the relevant dates on which the
 determination is based. Both the letter to the Office and the Federal Register Notice
 separate the total regulatory period into the initial or testing phase and the final
 approval phase. This provides the Office with the information necessary to determine the
 actual length of extension for which the patent may be eligible. The Federal Register
 Notice also sets a date, 180 days after publication of the notice, as a deadline for filing
 written comments concerning any of the information set forth in the notice or a petition
 for a determination regarding whether the marketing applicant has acted with due diligence
 during the regulatory review period. The Federal Register Notice also sets a date, which is
 60 days after publication of the notice, for anyone with information that the published
 dates are incorrect to request redetermination. The letter to the Office makes clear that
 the determination does not take into account the issue date of the patent nor does it
 exclude one-half of the testing phase.
 

 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 under
 35 U.S.C.
 156(d)(5) and (e)(2) . 
 

 
 2757.01 Due Diligence Determination [R-11.2013]

 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. The term “due diligence” is
 defined in 35 U.S.C.
 156(d)(3) as “that degree of attention, continuous directed
 effort, and timeliness as may reasonably be expected from, and are ordinarily exercised
 by, a person during a regulatory review period.” 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. See 21 CFR Ch. 1, Subparts
 D and E.
 

 

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 2701-Patent Term 

 2702-2709-[Reserved] 

 2710-Term Extensions or Adjustments for Delays Within the USPTO Under 35 U.S.C. 154 

 2711-2719-[Reserved] 

 2720-Applications Filed Between June 8, 1995, and May 28, 2000 

 2721-2729-[Reserved] 

 2730-Applications Filed on or After May 29, 2000; Grounds for Adjustment 

 2731-Period of Adjustment 

 2732-Reduction of Period of Adjustment of Patent Term 

 2733-Patent Term Adjustment Determination 

 2734-Application for Patent Term Adjustment; Due Care Showing 

 2735-[Reserved] 

 2736-Third-Party Papers 

 2737-2749-[Reserved] 

 2750-Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156 

 2751-Eligibility Requirements 

 2752-Patent Term Extension Applicant 

 2753-Application Contents 

 2754-Filing Date 
 2754.01-Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) 

 2754.02-Filing Window for an Application Under 35 U.S.C. 156(d)(5) 

 2754.03-[Removed and Reserved] 

 
 

 2755-Eligibility Determination 
 2755.01-Interim Extension of Patent Term During the Processing of the Application 

 2755.02-Interim Extension of Patent Term Before Product Approval 

 
 

 2756-Correspondence Between the USPTO and the Regulatory Agency 

 2757-Regulatory Agency Determination of the Length of the Regulatory Review Period 
 2757.01-Due Diligence Determination 

 
 

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

 2759-Certificate of Extension of Patent Term 

 2760-Trade Secret, Confidential, and Protective Order Material 

 2761-Multiple Applications for Extension of Term of the Same Patent or of Different Patents for the Same Regulatory Review Period
 for a Product 

 2762-Duty of Disclosure in Patent Term Extension Proceedings 
 2762.01-Duty of Disclosure When a Terminal Disclaimer is Filed During Patent Term Extension Proceedings 

 
 

 2763-Limitation of Third-Party Participation 

 2764-Express Withdrawal of Application for Extension of Patent Term 

 2765-Petition for Stay in Processing of Patent Term Extension Application 

 2766-Processing of Patent Term Extension Applications When Reissue Has Been Filed 

 

 

 
 

 
 
 

 
 

 

 
 
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 Last Modified: 
 
 03/09/2026 20:49:41