Memorandum of Understanding
The United States Patent and Trademark Office
The Food and Drug Administration
FOOD AND DRUG ADMINISTRATION
COMPLIANCE POLICY GUIDES
CHAPTER 58-MOUs and IAGs-FEDERAL (DOC)
Subject: MOU with United States Patent and Trademark Office, Department of Commerce (DOC) concerning Orphan Drugs (FDA-225-84-8000)
To establish a continuing procedure whereby the United States Patent and Trademark Office determines whether a U.S. Patent may be issued for certain orphan products for certain uses under the provisions to make special of the Manual of Patent Examining Procedure and provides that decision to the patent applicant for transmittal to the Food and Drug Administration.
On January 4, 1983, Public Law 97-414, The Orphan Drug Act (the Act), became law. 21 U.S.C. ss525 et seq. The Act establishes financial and other incentives to encourage potential sponsors of drugs for rare diseases or conditions (orphan drugs) to conduct research and pursue marketing for these drugs.
One of the most important incentives of the Act provides that drugs that are designated as orphan drugs under section 525 of the Act and for which a U.S patent may not be issued are entitled to an exclusive marketing status. 21 U.S.C. ss527. For a period of seven years after the Food and Drug Administration (FDA) approves a new drug application for an officially approve the same drug for the same use for another sponsor only if the Agency finds that the holder of the first approved new drug application cannot assure the availability of sufficient quantities of the drug to meet the needs of the patients or if the holder consents to the approval of other new drug applications. (See Attachment A for text of pertinent sections of the Act.)
There are, in addition, a limited number of orphan products not covered by the Orphan Drug Act for which accelerated patent review may be appropriate. These products, while not officially designated as orphan drugs under the Act, nevertheless, are orphan products vital to an afflicted patient group in need of the product. FDA may decide that an accelerated decision on the patentability for such a product would be an important inducement to the orphan product's development and availability.
This agreement between the U.S. Patent and Trademark Office (PTO) and the United States Food and Drug Administration has been developed to provide for an accelerated determination of the patentability of an orphan drug for a particular use before a grant of exclusive marking is made under the Orphan Drug Act. In addition, this agreement provides for accelerated review of the patentability of certain other orphan products for a particular use upon request by FDA. No additional showing by the patent applicant concerning the need for expedited review is necessary for orphan products falling within the scope of this Memorandum of Understanding.
III. Substance of Agreement:
A. Drugs Designated as Orphan under section 526 of the Orphan Drug Act.
1. Upon receipt of a petition from a patent applicant including as an attachment a letter from the FDA stating that a drug for a particular use has received orphan designation pursuant to section 526 of accelerated review to a patent application for the drug under the Federal Food, Drug, and Cosmetic Act, the PTO will grant accelerated review to a patent application for the drug under the "petition to make special" provisions of the Manual of Patent Examining Procedure, section 708.02.
2. The PTO will notify the patent applicant of the action to grant accelerated patent review as well as any problems requiring resolution.
3. The PTO will notify the patent applicant of the results of examination and either issue a patent or declare the application abandoned after the conclusion of the PTO's examination.
4. The PTO will provide to the patent applicant, at the applicant's request and expense, a certified copy of the patent application or patented file for transmittal to the FDA as evidence of whether a U.S. patent may issue for the orphan drug.
B. Orphan Products not Covered by Provisions of the Orphan Drug Act.
Orphan products identified by FDA but which do not fall within section 526 of the Act will be granted accelerated review upon petition by the patent applicant accompanied by a request by FDA.
When FDA identifies such an orphan product not covered by the Act a procedure similar to that described in part III-A of this memorandum will be followed. In response to a written request from FDA for accelerated review for a particular orphan product, which is filed as an attachment to a petition to make a patent application special, the PTO will accord accelerated review to the patent application for the product under the "petition to make special" provisions in the Manual of Patent Examining Procedure, section 708.2.
IV. Name and address of participating parties:
A. U.S. Patent and Trademark Office
Washington, DC 20231
B. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
V. Liaison Officers:
A. For the U.S. Patent and Trademark Office
Charles Van Horn, Director
Examining Group 120
U.S. Patent and Trademark Office
Washington, DC 20231
For the Food and Drug Administration
Emery J. Sturniolo
Assistant to the Director
Office of Orphan Product Development, HF-35
5600 Fishers Lane
Rockville, MD 20857
V. Period of Agreement
This agreement, when accepted by both parties will 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.
PUBLIC LAW 97-414--JANUARY 4, 1983
PROTECTION FOR UNPATENTED DRUGS FOR RARE DISEASES OR CONDITIONS
21 USC 360 cc. Sec 527. (a) Except as provided in subsection (b), if the Secretary—
" (1) approves an application filed pursuant to section 505 (b), or
"(2) Issues a license under section 351 of the Public Health Service Act
for a drug designed under section 526 for a rare (Ante. P. 2050) disease or condition and for which a United State Letter of Patent may not issued, the Secretary may not approve another application under section 505 (b) or issue another license under section 351 (21 USC 355) of the Public Health Service Act (42 USC 262) for such drug for such disease or condition for a person who is not the holder of such approved application or such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 505 (c)
(2) does not apply to the refusal to approve an application under the preceding sentence. "(b) If an application filed pursuant to section 505 (b) is approved for a drug designated under section 526 for a rare disease or condition or a license is issued under section 351 of the Public Health Service Act for such a drug and if a United States Letter of Patent may not be issued for the drug, the Secretary may, during the seven-year period beginning on the date of the application approval of the issuance of the license, approve another application under section 505 (b) , or, if the drug is a biological product, issue a license under section 351 of the Public Health Service Act, for such drug for such disease or condition for a person who is not a holder of such approved application or of such license if—
" (1) The Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the holder of the
approved application or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or
" ( 2) Such holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period.
Approved and Accepted
Signed by: Donald J. Quigg
Date: January 12, 1984
Approved and Accepted
Signed by: William F. Randolph
Date: March 22, 1984