[Federal Register Volume 63, Number 136 (Thursday, July 16, 1998)]
[Notices]
[Pages 38410-38411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18878]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97E-0271]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PANDEL Cream
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 PANDEL Cream 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, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-6620.
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
[[Page 38411]]
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 PANDEL
Cream (hydrocortisone buteprate). PANDEL Cream is indicated for the
relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in patients 18 years of age or
older. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for PANDEL Cream (U.S.
Patent No. 4,290,962) from Taisho Pharmaceutical Co. Ltd., and the
Patent and Trademark Office requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated July 18, 1997, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of PANDEL Cream 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
PANDEL Cream is 4,165 days. Of this time, 3,078 days occurred during
the testing phase of the regulatory review period, 1,087 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505 of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective:
October 6, 1985. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
October 6, 1985.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the act: March 10, 1994.
The applicant claims March 1, 1994, as the date the new drug
application (NDA) for PANDEL Cream (NDA 20-453) was initially
submitted. However, FDA records indicate that NDA 20-453 was submitted
on March 10, 1994.
3. The date the application was approved: February 28, 1997. FDA
has verified the applicant's claim that NDA 20-453 was approved on
February 28, 1997.
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 1,096 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before September 14, 1998, 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 January 12, 1999, 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: June 23, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-18878 Filed 7-15-98; 8:45 am]
BILLING CODE 4160-01-F
