[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]


[Docket No. 93E-0435]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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]