[Federal Register: May 12, 2005 (Volume 70, Number 91)]
[Page 25091-25092]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004E-0316]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for

[[Page 25092]]

ERTACZO 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 Director of Patents and Trademarks, Department of 
Commerce, for the extension of a patent that claims that human drug 

ADDRESSES: Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-453-6699.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 Director 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 ERTACZO 
(sertaconazole nitrate). ERTACZO is indicated for the topical treatment 
of athlete's foot (interdigital tinea pedis) caused by certain fungus 
(Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum). 
ERTACZO is for people 12 years of age and older who have a normal 
immune system. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for ERTACZO (U.S. 
Patent No. 5,135,943) from Ferrer Internacional, S.A., and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
August 31, 2004, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of ERTACZO represented the first permitted commercial 
marketing or use of the product. Thereafter, the Patent and Trademark 
Office requested that FDA determine the product's regulatory review 
    FDA has determined that the applicable regulatory review period for 
ERTACZO is 2,718 days. Of this time, 1,914 days occurred during the 
testing phase of the regulatory review period, while 804 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: July 
3, 1996. The applicant claims June 11, 1996, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 3, 1996, 
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 of the act: September 28, 
2001. FDA has verified the applicant's claim that the new drug 
application (NDA) for ERTACZO (NDA 21-385) was initially submitted on 
September 28, 2001.
    3. The date the application was approved: December 10, 2003. FDA 
has verified the applicant's claim that NDA 21-385 was approved on 
December 10, 2003.
    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 1,776 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written comments and ask for a redetermination by July 11, 
2005. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by November 8, 2005. 
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 
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 05-9462 Filed 5-11-05; 8:45 am]