[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