Determination of Regulatory Review Period for Purposes of Patent Extension; DUTASTERIDE, 34374-34375 [E6-9224]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 114 (Wednesday, June 14, 2006)]
[Notices]
[Pages 34374-34375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002E-0100]


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

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 DUTASTERIDE 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 product.

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. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-

[[Page 34375]]

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 human drug product 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 
DUTASTERIDE (dutasteride). DUTASTERIDE is indicated for the treatment 
of symptomatic benign prostatic hyperplasia in men with an enlarged 
prostate gland. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for DUTASTERIDE 
(U.S. Patent No. 5,565,467) from GlaxoSmithKline, and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
October 31, 2002, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of DUTASTERIDE 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 
DUTASTERIDE is 2,373 days. Of this time, 2,038 days occurred during the 
testing phase of the regulatory review period, while 335 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 (the act) (21 U.S.C. 355(i)) became effective: 
May 25, 1995. The applicant claims April 24, 1995, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was May 25, 1995, 
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 act: December 21, 
2000. FDA has verified the applicant's claim that the new drug 
application (NDA) for DUTASTERIDE (NDA 21-319) was initially submitted 
on December 21, 2000.
    3. The date the application was approved: November 20, 2001. FDA 
has verified the applicant's claim that NDA 21-319 was approved on 
November 20, 2001.
    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 769 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 or electronic comments and ask for a redetermination 
by August 14, 2006. 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 December 11, 
2006. 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 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: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9224 Filed 6-13-06; 8:45 am]
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