[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]
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