[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
