MPEP § 2756 — MPEP § 2756
Current through: 2022-07-01

2756-Correspondence Between the USPTO and the Regulatory Agency 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2756 
 

 
 
 
 
 
 2756 Correspondence Between the USPTO and the Regulatory
 Agency [R-01.2024]
 

 It is the Director’s responsibility to decide whether an applicant has
 satisfied the requirements of the statute and whether the patent qualifies for patent term
 extension. The regulatory agency possesses expertise and records regarding some of the
 statutory requirements and has certain direct responsibilities under 35 U.S.C. 156 for
 determining the length of the regulatory review period. Consequently, to facilitate
 eligibility decisions and permit the regulatory agency and the Office to carry out their
 responsibilities under 35
 U.S.C. 156 , both the Food and Drug Administration and the Department
 of Agriculture have entered into an “agreement” of cooperation with the Office.
 Memorandum of Understanding Between the Patent and Trademark Office and the
 Food and Drug Administration, 52 FR 17830 (May 12, 1987); Memorandum
 of Understanding Between the Patent and Trademark Office and the Animal and Plant Health
 Inspection Service, 54 FR 26399 (June 23, 1989); 1104 OG 18 (July 11, 1989).
 The agreements establish the procedures whereby the regulatory agency assists the Office in
 determining a patent’s eligibility for patent term extension under 35 U.S.C. 156 . They
 also establish procedures for exchanging information between the regulatory agency and
 the Office regarding regulatory review period determinations, due diligence petitions and
 informal regulatory agency hearings under the law. The patent term extension applicant
 receives a copy of all correspondence between the Office and the regulatory agency. 
 

 The Animal and Plant Health Inspection Service of the United States
 Department of Agriculture approves veterinary biological products and is responsible for
 both (i) assisting the Office in determining the eligibility for term extension of a patent
 which claims a veterinary biological product that has been subject to review under the
 Virus-Serum-Toxin Act (21 U.S.C. 151-59) and (ii) determining the regulatory review period
 of the veterinary biological product. The Secretary of Health and Human Services of the
 Food and Drug Administration is responsible for assisting the Office in determining the
 eligibility of patents for patent term extension which claim any other product for which
 regulatory review is required and for determining the regulatory review period for such
 products. 21 CFR 60.10.
 

 I. INFORMATION REGARDING ELIGIBILITY FOR EXTENSION If the Office has no clear reason to deny eligibility for patent term
 extension (even if there are questions concerning eligibility), or if the applicant has
 been notified of any informalities and it is anticipated that the informalities will be
 corrected or explained, a first letter is sent to the regulatory agency to request
 information regarding eligibility. The letter is accompanied by a copy of the patent
 term extension application. This letter does not request the determination
 of the applicable regulatory review period.
 

 The regulatory agency reply is usually in the form of a written
 response:
 

 
 (A) verifying whether the product has undergone a regulatory review
 period within the meaning of 35 U.S.C. 156(g) prior to
 commercial marketing or use; 
 

 (B) stating whether the marketing permission was for the first
 permitted commercial marketing or use of that product, or, in the case of
 recombinant DNA technology, whether such commercial marketing or use was the first
 permitted under the process claimed in the patent; 
 

 (C) informing the Office whether the patent term extension
 application was submitted within sixty days after the product was approved for
 marketing or use; and 
 

 (D) providing the Office with any other information relevant to the
 determination of whether a patent related to a product is eligible for patent term
 extension.
 

 
 While the Office has primary responsibility for the eligibility
 determination, the regulatory agency often possesses information which is not readily
 available to the Office. The assistance of the regulatory agency enables both the Office
 and the agency to process applications efficiently and to conserve resources. 
 

 II. PRELIMINARY ELIGIBILITY DECISION Upon receipt of a reply from the regulatory agency to the first letter
 from the Office requesting assistance on determining eligibility, a preliminary
 eligibility decision (not the final decision) is made as to whether the patent is
 eligible for an extension of its term. As noted above, the reply from the regulatory
 agency will usually inform the Office as to whether the permission for commercial
 marketing or use of the product on which the application for patent term extension is
 based is the first such approval for that product. Furthermore,
 the regulatory agency usually provides information regarding the date of product
 approval to permit a determination as to whether the application was filed within the
 sixty-day statutory period set forth in 35 U.S.C. 156(d)(1) . The information
 provided by the regulatory agency is then compared with the related information from the
 application. If no major discrepancies are found and the patent is determined to be
 eligible for patent term extension, a second letter requesting a determination of the
 length of the regulatory review period of the product is sent to the regulatory agency
 not later than sixty (60) days after the Office receipt date of the reply from the
 regulatory agency. In the interest of efficiency, if the patent is determined to be
 ineligible for patent term extension, the Office will dismiss the application rather
 than request a determination of the regulatory review period. In re Allen &
 Hansbury, Ltd., 227 USPQ 955, 960 n. 9 (Comm’r Pat. & Tm. 1985). The
 second letter states that, subject to final review, the patent is considered eligible
 for patent term extension and requests a determination of the applicable regulatory
 review period.
 

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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 20:50:49