[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31697-31698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0458 (formerly Docket No. 2007E-0144) and Docket 
No. FDA-2007-E-0460 (formerly Docket No. 2007E-0176)]


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

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 VEREGEN and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of patents 
which claim 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 http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

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

[[Page 31698]]

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 approved for marketing the human drug product VEREGEN 
(kunecatechins). VEREGEN is indicated for the topical treatment of 
external genital and perianal warts in immunocompetent patients 18 
years and older. Subsequent to this approval, the Patent and Trademark 
Office received patent term restoration applications for VEREGEN (U.S. 
Patent Nos. 5,795,911 and 5,968,973) from Mitsui Norin Co., Ltd., and 
Cancer Institute (Hospital), Chinese Academy of Medical Sciences, and 
the Patent and Trademark Office requested FDA's assistance in 
determining these patents' eligibility for patent term restoration. In 
a letter dated July 24, 2007, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of VEREGEN 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 
VEREGEN is 3,002 days. Of this time, 2,605 days occurred during the 
testing phase of the regulatory review period, while 397 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: 
August 14, 1998. The applicant claims August 13, 1998, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 14, 1998, 
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: September 30, 
2005. The applicant claims September 23, 2005, as the date the new drug 
application (NDA) for VEREGEN (NDA 21-902) was initially submitted. 
However, FDA records indicate that NDA 21-902 was submitted on 
September 30, 2005.
    3. The date the application was approved: October 31, 2006. FDA has 
verified the applicant's claim that NDA 21-902 was approved on October 
31, 2006.
    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 1,300 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 4, 2008. 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 1, 
2008. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

    Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-12296 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S