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U.S. Department of Health and Human Services

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MOU 225-86-8251

Memorandum of Understanding

Between
The Patent and Trademark Office

and

The Food and Drug Administration

 

I. PURPOSE

This agreement establishes the procedures whereby the Food and Drug Administration (FDA) assists the Patent and Trademark Office (PTO) in determining a product's eligibility for patent term restoration under 35 U.S.C. 156. It also establishes procedures for exchanging information between FDA and PTO regarding regulatory review period determinations, due diligence petitions and informal FDA hearings under the law.

 

II. BACKGROUND

The patent term restoration portion of the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417) was designed to create new incentives for research and development of certain products which are subject to premarket government approval. These provisions enable the owners of patents on certain human drugs, medical devices, and food or color additives to attempt to restore to the terms of those patents some of the patent time lost while awaiting premarket government approval.

 

Under the patent term restoration sections of the Act, a patent which claims a human drug product, medical device, food or color additive first approved for marketing after September 24, 1984 may qualify for patent term extension. Regardless of whether the patent claims a product, a method of using a product, or a method of manufacturing a product, the applicant for a patent term extension must establish that:

(1) the patent has not expired (35 U.S.C. 156(a)(1)),

(2) the patent has never been extended (35 U.S.C. 156(a)(2)),

(3) the application for extension is submitted by the owner of record of the patent or its agent and includes details relating to the patent and regulatory review time spent in securing FDA approval (35 U.S.C. 156(a)(3)),

(4) the product has been subject to a regulatory review period within the meaning of 35 U.S.C. 156(g) before its commercial marketing or use (35 U.S.C. 156(a)(4)),

(5) the approval:

(A) is the first permitted commercial marketing or use of the product, or

(B) in the case of products manufactured using recombinant DNA technology, it is the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent (35 U.S.C. 156(a)(5)), and

(6) the application for extension of the term of the patent was submitted to PTO within 60 days of FDA approval of the commercial marketing application (35 U.S.C. 156(d)(1)).

 

While it is the responsibility of the Commissioner of Patents and Trademarks to decide whether an applicant has satisfied these six conditions, FDA possesses expertise and records regarding the last four 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 FDA and PTO to carry out their responsibilities under 35 U.S.C. 156, the FDA and PTO have entered into this agreement. This agreement is consistent with the authority contained in section 702(d) of the Federal Food, Drug, and Cosmetic Act.

 

Under this agreement, FDA, upon, receipt of a written request from PTO, will convey to PTO the following information regarding eligibility for extension: (1) whether a product has undergone a regulatory review period within the meaning of 35 U.S.C. 156(g) prior to commercialization, (2) 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, and (3) whether the patent term extension application was submitted within 60 days after the product was approved, as well as any other relevant information. Similarly, upon a request by PTO and the receipt of a copy of the application for patent term extension, FDA will determine the length of the regulatory review period for the approved product.

 

The procedures covered by this agreement extend from the date of PTO's request for information on eligibility to the resolution of due diligence petitions and informal hearings. 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 PTO until the regulatory review period determination is final unless an interim extension appears warranted under 35 U.S.C. 156(e)(2).

 

III. SUBSTANCE OF THE AGREEMENT:
PATENT TERM EXTENSION APPLICATIONS UNDER 35 U.S.C. 156

 

A. Eligibility Determination Assistance

1. Upon deciding that a patent term extension application is complete and meets basic formal requirements, the PTO will send a written request to FDA requesting that FDA:

a. verify whether the product:
(1) was subject to a regulatory review period within the meaning of 35 U.S.C. 156(g) prior to its commercial marketing or use, and
(2) represents either the first permitted commercial marketing or use of that product, or, in the case of recombinant DNA technology, the first permitted commercial marketing or use of the product manufactured under the process claimed in the patent.

b. inform PTO whether the patent term restoration application was submitted within 60 days after the product was approved.

2. Additionally, PTO, in its written request, shall clearly state that it is not requesting determination of the product's regulatory review period at this time.

3. FDA will consult its records and experts and, through the Director of the Health Assessment Policy Staff, Office of Health Affairs, issue a written response to the Director of Patent Examining Group 120, PTO, and each of these questions.

4. FDA, consistent with the authority contained in section 702(d) of the Federal Food, Drug, and Cosmetic Act with respect to drugs, will provide PTO with any other information relevant to the product's eligibility.

5. FDA, upon written request, will also provide assistance to PTO in petitions before the Commissioner of Patents and Trademarks regarding eligibility determinations.

 

B. Regulatory Review Period Determinations

1. Should the PTO decide that the product is eligible for patent term restoration, it will send FDA a copy of the application for patent term restoration and a written request to determine the length of the product's regulatory review period. The copy and request will be sent to FDA within 60 days of the application's receipt by PTO.

2. FDA will consult its records, determine, the entire length of the regulatory review period, and, through the Associate Commissioner for Health Affairs, issue a written statement of that determination to the Commissioner of Patents and Trademarks. The determination will be made within 30 days after the receipt of the application and written request from PTO. Additionally, FDA will publish its determination in the Federal Register.

 

C. Due Diligence Petitions and Hearing Requests

1. Due diligence petitions must be filed at FDA within 180 days of the publication of a product's regulatory review period in the Federal Register.

a. If no due diligence petition is received by FDA within the 180-day filing period, FDA will promptly notify PTO in writing that the regulatory review period determination is final.

b. If a due diligence petition which satisfies statutory and regulatory requirements is received by FDA,
(1) FDA will promptly notify PTO in writing of the receipt of the petition,
(2) PTO will refrain from issuing a certificate of extension pending a final determination of the regulatory review period unless an interim extension appears warranted under 35 U.S.C. 156(e)(2),
(3) FDA will determine whether the applicant acted with due diligence within 90 days after receipt of such a petition and will send written notification to the Commissioner of Patents and Trademarks as to any modification in the length of the regulatory review period, and
(4) FDA will also publish its due diligence determination, together with the full factual and legal bases for FDA's decision, in the Federal Register.

2. Requests for an informal hearing on FDA's due diligence determination must be received by FDA within 60 days of the publication of the due diligence determination in the Federal Register.

a. If FDA does not receive any request for an informal hearing within the 60 day filing period, FDA will notify PTO in writing that the regulatory review period determination, as modified, if at all, by the due diligence determination, is final.

b. If FDA receives a request for an informal hearing within the 60 day filing period,
(1) FDA will notify PTO in writing of the hearing request,
(2) PTO will refrain from issuing a certificate of extension pending final determination of the regulatory review period unless an interim extension appears warranted under 35 U.S.C. 156(e)(2), and
(3) FDA will affirm or revise the determination that was the subject of the hearing within 30 days after completion of the hearing and will notify the Commissioner of Patents and Trademarks in writing of its decision and whether the determination of the regulatory review period is now final. Additionally, FDA will publish its findings in the Federal Register.

 

D. Supplemental Information

Should either agency receive information which is relevant to the patent term restoration of a patent during any stage of these eligibility or regulatory review period determinations, that agency will promptly notify the other and provide documentation as available.

 

E. Availability of Information

Copies of all letters required by this agreement and exchanged between PTO and FDA will be placed in the file for each product subject to patent term restoration. These files are available for review at FDA's Dockets Management Branch (HFA-305), Room 4-62, 5600 Fishers Lane, Rockville, Maryland 20857 and at the Patent and Trademark Office, Crystal Plaza Building 2-9A09, 2011 Jefferson Davis Highway, Arlington, Virginia 22202.

 

IV. NAMES AND ADDRESSES OF PARTICIPATING PARTIES

A. Patent and Trademark Office,
Washington, DC 20231.

 

B. Food and Drug Administration,
5600 Fishers Lane,
Rockville, Maryland 20857.

 

V. LIAISON OFFICERS

A. Liaison Officer for the Patent and Trademark Office:
Director, Patent Examining Group 120,
(currently Charles E. Van Horn, Esq.),
Patent and Trademark Office,
Washington, DC 20231,
(703-557-3637).

 

B. Liaison Officer for the Food and Drug Administration:
Director, Health Assessment Policy Staff (HFY-20),
(currently Ronald L. Wilson),
Office of Health Affairs,
Food and Drug Administration,
5600 Fishers Lane,
Rockville, Maryland 20857,
(301-443-1382).

 

VI. PERIOD OF AGREEMENT

This agreement, when accepted by both parties, will be effective indefinitely. It may be modified by mutual written consent or terminated by either party upon a thirty day advance written notice to the other party.

Approved and Accepted
for the Patent and Trademark Office

Signed by: Donald J. Quigg
Assistant Secretary and
Commissioner of Patents and Trademarks

Date: September 17, 1986

Approved and Accepted
for the Food and Drug Administration

Signed by: John M. Taylor
Acting Associate Commissioner for Regulatory Affairs

Date: September 3, 1986