[Federal Register Volume 59, Number 139 (Thursday, July 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17738]
[[Page Unknown]]
[Federal Register: July 21, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93E-0435]
Determination of Regulatory Review Period for Purposes of Patent
Extension; DemadexTM
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 DemadexTM 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
DemadexTM. DemadexTM (torsemide) is indicated for the
treatment of edema associated with congestive heart failure, renal
disease, or hepatic disease. Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
DemadexTM (U.S. Patent No. Re. 30,633) from A. Christians Societe
Anonyme, 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 December 9, 1993, advised the Patent and
Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of DemadexTM
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
DemadexTM is 2,790 days. Of this time, 1,882 days occurred during
the testing phase of the regulatory review period, while 908 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: January 4, 1986. FDA has
verified the applicant's claim that January 4, 1986, was the date the
investigational new drug application (IND) became effective. The
applicant claims January 10, 1986, as the date the IND became
effective. However, FDA records indicate that the IND effective date
was January 4, 1986, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the Federal Food, Drug,
and Cosmetic Act: February 28, 1991. FDA has verified the applicant's
claim that February 28, 1991, was the date the new drug application
(NDA) for DemadexTM (NDA 20-136) was initially submitted.
3. The date the application was approved: August 23, 1993. FDA has
verified the applicant's claim that NDA 20-136 was approved on August
23, 1993.
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 5 years of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before September 19, 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 January 17, 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: July 14, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-17738 Filed 7-20-94; 8:45 am]
BILLING CODE 4160-01-F
