[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Notices]
[Pages 12216-12217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6413]


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


Expiration Dates for Patents Extended by the Uruguay Round 
Agreements Act; Submission by Applicants of New Drug and New Animal 
Drug Applications; Withdrawal of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a notice 
published in the Federal Register of July 21, 1995 (60 FR 37652), which 
announced the agency's position on patent information submitted by 
applicants of new drug applications (NDA's) and new animal drug 
applications (NADA's). On April 4, 1996, the U.S. Court of Appeals for 
the Federal Circuit issued a decision establishing the correct method 
for calculating 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 U.S. Code. All NDA and NADA 
applicants should calculate patent term expiration dates in conformance 
with the court's decision and submit corrected patent term expiration 
dates to the agency.

DATES: NDA and NADA applicants that have already submitted patent term 
expiration dates should submit patent term expiration dates calculated 
in accordance with this notice by April 14, 1997.

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 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

[[Page 12217]]

Evaluation and Research (CBER) should be submitted 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.
    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 Database Management, Drug 
Information Services Branch (HFD-85), Center for Drug Evaluation and 
Research, Food and Drug Administration, 1901 Chapman Ave., rm. 218, 
Rockville, MD 20852.
    Two copies of 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-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1049.

SUPPLEMENTARY INFORMATION: FDA is withdrawing the July 21, 1995, 
notice, which announced the agency's position on patent information 
submitted by applicants of NDA's and NADA's. In that notice, FDA stated 
that patent term expiration dates for certain patents that are subject 
to both the URAA and the patent term extension provisions of Title II 
of the Drug Price Competition and Patent Term Restoration Act and Title 
II of the Generic Animal Drug and Patent Term Restoration Act, both 
codified at 35 U.S.C. 156, should be calculated in accordance with the 
Patent and Trademark Office's determination (PTO determination) 
published in the Federal Register of June 7, 1995 (60 FR 30069). FDA 
also announced that it would not publish dates in ``Approved Drug 
Products with Therapeutic Equivalence Evaluations'' (the Orange Book) 
or the ``FDA Approved Animal Drug Products'' (the Green Book) that the 
NDA or NADA applicant stated were not in accordance with the PTO 
determination.
    The PTO determination and the July 21, 1995, notice were challenged 
in Federal court by a number of pharmaceutical companies that hold 
NDA's or NADA's. On April 4, 1996, the U.S. Court of Appeals for the 
Federal Circuit issued a decision in Merck & Co. v. Kessler, 80 F.3d 
1543 (Fed. Cir. 1996) establishing the correct method for calculating 
patent expiration dates for patents subject to both patent extension 
under the URAA and the patent term extension provisions of 35 U.S.C. 
156. The Federal Circuit remanded the case to the U.S. District Court 
for the Eastern District of Virginia, which issued orders that, among 
other things, established the patent expiration dates for the patents 
at issue in the litigation. (Merck & Co. v. Kessler, Civ. No. 95-1005-A 
(E.D. Va. Sept. 5, 1996); and Organon, Inc. v. Kessler, Civ. No. 95-
1380-A (E.D. Va. Sept. 13, 1996).)
    In conformance with the district court order, FDA is publishing the 
patent expiration dates determined in the order for the patents 
directly at issue in the litigation in the monthly supplement to the 
Orange Book. FDA advises that NDA and NADA applicants should submit to 
FDA within 30 days, new patent expiration dates calculated in 
accordance with the courts' orders for any patents that have already 
been submitted to FDA. Patent expiration dates already submitted to the 
agency that were calculated by the method described in the court's 
order need not be resubmitted. Expiration dates for patents first 
submitted to FDA after the date of this notice must be calculated in 
accordance with the method described in Merck & Co. v. Kessler.
    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, 1401 
Rockville Pike, 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 Database Management, 
Drug Information Services Branch (HFD-85), Center for Drug Evaluation 
and Research, Food and Drug Administration, 1901 Chapman Ave., rm. 218, 
Rockville, MD 20852.
    Two copies of 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.

    Dated: March 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6413 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F