[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37652-37653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18079]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket Nos. 95P-0061, 95S-0117, 95S-0126, and 95S-0135]
Patent Term Expiration Dates for Patents Extended by the Uruguay
Round Agreements Act; Submission by Applicants of New Drug and New
Animal Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
position on patent information submitted by applicants of new drug
applications (NDA's) and new animal drug applications (NADA's). Patent
term expiration dates for certain patents that are subject to both the
Uruguay Round Agreements Act (URAA) and the patent term extension
provisions of the United States Code should be calculated in accordance
with the Patent and Trademark Office's (PTO's) determination of June 7,
1995. FDA will not publish dates that the NDA or NADA applicant states
are not calculated in accordance with the June 7, 1995, determination.
This document is intended to advise all NDA and NADA applicants who
submitted URAA-extended patent term expiration dates that were not
calculated in accordance with the PTO's determination to submit
corrected patent term expiration dates to the agency.
DATES: NDA and NADA applicants that submitted inaccurate patent term
expiration dates should submit patent term expiration dates calculated
in accordance with the PTO's determination by August 21, 1995.
ADDRESSES: Two copies of amended patent information pertaining to human
drug products regulated under section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 355) by 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 CBER should be
submitted to the Document Control Center, Center for Biologics
Evaluation and Research (HFM-99), Food and Drug Administration, suite
200N, Rockville, MD 20852.
A third copy of the amended patent information pertaining to human
drug products regulated under section 505 of the act by either the
Center for Drug Evaluation and Research (CDER) or the Center for
Biologics Evaluation and Research (CBER) should be sent to the Division
of Drug Information Services (HFD-85), Center for Drug Evaluation and
Research, Food and Drug Administration, 1901 Chapman Ave., rm. 212,
Rockville, MD 20852.
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.
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: In the Federal Register of June 8, 1995 (60
FR 30309), FDA announced the availability of the agency's response to a
citizen petition from Glaxo, Inc., requesting that FDA explain how the
URAA affects the patent information submission and patent certification
requirements for applications to market drug products under the act. In
that notice, FDA directed that amended patent information, reflecting
extended patent term expiration dates under the URAA, be submitted to
FDA between June 8 and July 8, 1995.
On June 7, 1995, the PTO published a notice in the Federal Register
(60 FR 30069) entitled ``Determination of New Expiration Dates of
Certain Patents'' (the PTO's determination) that established the method
for calculating the patent term expiration date for any patent subject
to both the terms of the URAA and the patent term extension provisions
at 35 U.S.C. 156. FDA has received from several NDA or NADA applicants
submissions of new patent term expiration dates which the applicant
submitting the information states were not calculated in accordance
with the PTO's determination. In order to comply with the requirements
of sections 505(b) and 512(b) (21 U.S.C. 360b(b)) of the act and 21 CFR
314.53, NDA and NADA applicants must submit accurate patent
information. For the expiration dates for patents that received patent
term extension under the URAA to be accurate, those dates must be
calculated in accordance with the PTO's determination.
FDA is advising all NDA and NADA applicants who submitted URAA-
extended patent term expiration dates that were not calculated in
accordance with the PTO's determination to submit corrected patent term
expiration dates to the agency by August 21, 1995. If the applicant has
already submitted patent expiration dates that are consistent with the
PTO's determination, no additional submission is necessary. FDA will
not verify the patent expiration dates submitted by NDA and NADA
applicants. FDA will not publish any patent expiration date that the
submitter states is not consistent with the PTO's determination.
The agency will publish the new patent term expiration dates
submitted during the June 8 to July 8, 1995, period that are not
expressly identified by the applicant submitting the information as
having been calculated in a manner inconsistent with the PTO's
determination. FDA anticipates that the procedures set out in
Sec. 314.53(f) will govern with respect to challenges by third parties
that the submitted patent term expiration date was not calculated in
accordance with the PTO's determination. For these challenges, the
procedures set out in Sec. 314.53(f) will be modified so that, if the
applicant submitting the challenged patent term expiration date fails
to notify FDA within 30 days of receiving notification from the agency
of a challenge to the patent that the submitted date is consistent with
the PTO's determination, FDA will not continue to publish the
challenged date.
Two copies of amended patent information pertaining to human drug
products regulated under section 505 of the act by 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 CBER should be
submitted to the Document Control Center, Center for Biologics
Evaluation and Research (HFM-99), Food and Drug Administration, suite
200N, Rockville, MD 20852.
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 Division of Drug Information
Services (HFD-85), Center for Drug Evaluation and Research, Food and
Drug Administration, 1901 Chapman Ave., rm. 212, Rockville, MD 20852.
Amended patent information pertaining to animal drug products
[[Page 37653]]
should be sent to the Document Control Unit, Center for Veterinary
Medicine (HFV-199), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855.
Dated: July 18, 1995,
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-18079 Filed 7-19-95; 11:00 am]
BILLING CODE 4160-01-F
