[Federal Register Volume 60, Number 110 (Thursday, June 8, 1995)]
[Notices]
[Pages 30309-30310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14060]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 95P-0061, 95S-0117, 95S-0126, and 95S-0135]


Patent Term Extensions Under the Uruguay Round Agreements Act and 
Their Effects on Marketing Applications for Human and Animal Drug 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of its response to a citizen petition from Glaxo 
Pharmaceuticals, Inc. (Glaxo). The petition requested that the agency 
announce how the Uruguay Round Agreements Act (URAA) will affect the 
patent information submission and patent certification requirements for 
applications to market drug products under the Federal Food, Drug, and 
Cosmetic Act (the act). FDA responded to the petition on May 25, 1995. 
The response provides applicants with current information on how the 
URAA will affect patent term extension requirements for applications to 
market human and animal drugs.

DATES: Amended patent information, reflecting any extended patent terms 
under the URAA, should be submitted to FDA before July 8, 1995, but no 
earlier than June 8, 1995.

ADDRESSES: Copies of the citizen petition (95P-0061/CP1), comments 
submitted to FDA regarding the citizen petition, and FDA's response to 
the citizen petition may be obtained from the Freedom of Information 
Staff (HFI-35), Food and Drug Administration, rm. 12A-16, 5600 Fishers 
Lane, Rockville, MD 20857. Copies are also available for public 
examination at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug 
Evaluation and Research (HFD-362), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1049.

SUPPLEMENTARY INFORMATION: On December 8, 1994, the URRA (Pub. L. 103-
465) was signed into law. The URAA made amendments to Title 35 of the 
United States Code. These amendments relate to patent terms for 
existing and future patents, and they will become effective on June 8, 
1995. Certain provisions of the URAA patent amendments will change the 
terms of some existing patents from 17 years from the date of the 
granting of the patent to 20 years from the filing of the patent 
application.
    On February 16, 1995, the Patent and Trademark Office (PTO) held a 
public hearing on the patent provisions amended by the URAA. The PTO 
devoted a portion of the hearing to addressing several issues 
pertaining to the effect of these changes in patent law on FDA's 
enforcement of the act. (See the Federal Register notice of January 17, 
1995 (60 FR 3398).) Oral testimony was given at the hearing and written 
submissions were made to PTO and FDA. Glaxo submitted its citizen 
petition to FDA on March 7, 1995. The petition requested that the 
agency announce the effect the URAA will have on the patent information 
submission and patent certification requirements for applicants to 
market drug products under the act. FDA has received a number of 
responses to Glaxo's citizen petition from generic and innovator drug 
manufacturers. Glaxo submitted an additional comment on the responses 
dated April 13, 1995. These documents are included in Docket No. 95P-
0061. These oral and written submissions were considered by FDA in 
developing its response to the petition.
     A brief summary of FDA's position on patent term extensions under 
the URAA is set out below in this document. A fuller exposition of the 
agency's position may be found in the response to Glaxo's petition.

I. Submission of Patent Information

    FDA has determined that if the patent term expiration date for a 
listed human or animal drug product is extended by the URAA, the new 
drug application (NDA) or new animal drug application (NADA) holder 
must submit information on the new patent term expiration date to FDA 
after June 8, 1995, but before July 8, 1995. NDA holders who have 
already submitted information indicating that listed patents will be 
extended by the URAA should resubmit this information on or after June 
8, 1995.
    Two copies of amended patent information pertaining to human drug 
products regulated under section 505 of the act (21 U.S.C. 355) by the 
Center for Drug Evaluation and Research (CDER) should be submitted to 
the assigned reviewing division. The submission should bear the 
pertinent NDA number. Two copies of amended patent information 
pertaining to human drug products regulated under section 505 of the 
act by the Center for Biologics Evaluation and Research (CBER) should 
be sent to the Document Control Center, Center for Biologics Evaluation 
and Research (HFM-99), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448.
    To expedite the availability to the public of the updated patent 
information, a third copy of the amended patent information pertaining 
to human drug products regulated under section 505 of the act by either 
CDER or CBER should be sent to the Drug Information Services Branch, 
Center for Drug Evaluation and Research, Food and Drug Administration 
(HFD-84), 5600 Fishers Lane, Rockville, MD 20857.
    Amended patent information pertaining to animal drug products 
should be sent to the Document Control Unit, Center for Veterinary 
Medicine (HFV-199), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855.

II. Public Availability of Updated Patent Information

     Updated information related to patents on human drug products 
regulated by CDER will be placed on public display in the Dockets 
Management Branch (address above) under Docket No. 95S-0117, after June 
8, 1995. Updated information related to patents on human drug products 
regulated by CBER will be placed on [[Page 30310]] public display in 
the Dockets Management Branch under Docket No. 95S-0135. Updated 
information related to patents on animal drug products will be placed 
on public display in the Dockets Management Branch under Docket No. 
95S-0126. Updated patent information for human drug products will be 
published in the monthly supplements to ``Approved Drug Products with 
Therapeutic Equivalence Evaluations'' (the Orange Book) and updated 
patent information for animal drug products will be published in the 
monthly supplements to ``FDA Approved Animal Drug Products'' (the Green 
Book) after June 8, 1995.

III. Amended Patent Certifications

     Abbreviated new drug applications (ANDA's), abbreviated new animal 
drug applications (ANADA's), and applications provided for in section 
505(b)(2) of the act (505(b)(2) applications) pending before the agency 
on June 8, 1995, including such applications that may have received 
tentative approval letters, must be amended to respond to the URAA-
extended patent expiration dates, if information on the new expiration 
dates is submitted to the agency by the NDA or NADA holder in a timely 
manner. ANDA's, ANADA's, and 505(b)(2) applications submitted after 
June 8, 1995, likewise must provide patent certifications with respect 
to the URAA-extended patent expiration dates. After June 8, 1995, FDA 
will not approve any application that does not contain a correct 
certification with respect to a URAA-extended patent expiration date 
that was submitted in a timely manner to the agency. The agency expects 
that an applicant that wishes to market a drug under an approved ANDA, 
ANADA, or 505(b)(2) application before the expiration of a URAA-
extended patent, for which information was submitted to FDA in a timely 
manner, will file a paragraph IV certification with respect to that 
patent (See sections 505(b)(2)(A), (j)(2)(A)(vii), and 512(n)(1)(H) of 
the act.)
    Amended patent certification statements for abbreviated new drug 
applications (ANDA's) and 505(b)(2) applications reviewed by the Office 
of Generic Drugs should be sent to the Office of Generic Drugs, Center 
for Drug Evaluation and Research (HFD-600), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855. Amended patent 
certification statements for 505(b)(2) applications reviewed by the new 
drug reviewing divisions within CDER should be sent to the appropriate 
review division. Amended patent certification statements pertaining to 
animal drug products should be sent to the Document Control Unit, 
Center for Veterinary Medicine (HFV-199), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855. Amended patent certification 
statements pertaining to biological products should be sent to the 
Document Control Center, Center for Biologics Evaluation and Research 
(HFM-99), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448.

    Dated: June 2, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-14060 Filed 6-5-95; 2:29 pm]
BILLING CODE 4160-01-F