[Federal Register Volume 59, Number 172 (Wednesday, September 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22036]


[[Page Unknown]]

[Federal Register: September 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94E-0236]

 

Determination of Regulatory Review Period for Purposes of Patent 
Extension; PrografTM

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for PrografTM and is publishing this 
notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Commissioner of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that human drug product.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:  Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 100-670) generally provide 
that a patent may be extended for a period of up to 5 years so long as 
the patented item (human drug product, animal drug product, medical 
device, food additive, or color additive) was subject to regulatory 
review by FDA before the item was marketed. Under these acts, a 
product's regulatory review period forms the basis for determining the 
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: a 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Commissioner of Patents and 
Trademarks may award (for example, half the testing phase must be 
subtracted as well as any time that may have occurred before the patent 
was issued), FDA's determination of the length of a regulatory review 
period for a human drug product will include all of the testing phase 
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product 
PrografTM. PrografTM (tacrolimus) is indicated for the 
prophylaxis of organ rejection in patients receiving allogeneic liver 
transplants. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application of PrografTM 
(U.S. Patent No. 4,894,366) from Fujisawa Pharmaceutical Co., Ltd., and 
the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. FDA, 
in a letter dated July 6, 1994, advised the Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of PrografTM represented the first permitted 
commercial marketing or use of the product. Shortly thereafter, the 
Patent and Trademark Office requested that FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
PrografTM is 1,290 days. Of this time, 1,033 days occurred during 
the testing phase of the regulatory review period, while 257 days 
occurred during the approval phase. These periods of time were derived 
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act became effective: September 28, 1990. The 
applicant claims April 2, 1990, as the date the Investigationl New Drug 
(IND) became effective. The IND was received on March 30, 1990. It was 
placed on clinical hold April 26, 1990 and was removed from hold on 
September 28, 1990. Therefore, the IND effective date is September 28, 
1990 (the date IND 34,654 was removed from hold).
    2. The date the application was initially submitted with respect to 
the human drug product under section 507 of the Federal Food, Drug, and 
Cosmetic Act: July 26, 1993 (NDA 50-708) and August 4, 1993, (NDA 50-
709). The applicant claims July 23, 1993 (NDA 50-708) and August 3, 
1993 (NDA 50-709), as the dates the New Drug Applications (NDA's) for 
PrografTM were initially submitted. However, FDA records indicate 
that the NDA's for PrografTM were submitted on July 26, 1993 (NDA 
50-708) and August 4, 1993 (NDA 50-709).
    3. The date the application was approved: April 8, 1994. FDA has 
verified the applicant's claim that NDA's 50-708 and 50-709 were 
approved on April 8, 1994.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 448 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before November 7, 1994, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before March 6, 1995, for a determination regarding whether the 
applicant for extension acted with due diligence during the regulatory 
review period. To meet its burden, the petition must contain sufficient 
facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th 
Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format 
specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit single copies) and identified with the docket 
number found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: August 25, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-22036 Filed 9-6-94; 8:45 am]
BILLING CODE 4160-01-F