Determination of Regulatory Review Period for Purposes of Patent Extension; FLECTOR, 20644 [2012-8235]

Agencies

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

[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Page 20644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0482]


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

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 FLECTOR 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 
which claims that human drug product.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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 (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 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 FLECTOR 
(diclofenac epolamine). FLECTOR is indicated for the topical treatment 
of acute pain due to minor strains, sprains, and contusions. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for FLECTOR (U.S. Patent No. 5,607,690) 
from Altergon S.A., and Teikoku Seiyaku Co., Ltd., and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration and that FDA determine 
the product's regulatory review period. In a letter dated March 20, 
2012, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of FLECTOR represented the first permitted commercial marketing or use 
of the product.
    FDA has determined that the applicable regulatory review period for 
FLECTOR is 4,031 days. Of this time, 1,796 days occurred during the 
testing phase of the regulatory review period, while 2,235 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 FD&C Act) (21 U.S.C. 355(i)) became 
effective: January 20, 1996. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on January 20, 1996.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: December 
19, 2000. The applicant claims December 18, 2000, as the date the new 
drug application (NDA) for FLECTOR (NDA 21-344) was initially 
submitted. However, FDA records indicate that NDA 21-234 is the correct 
application number for FLECTOR, rather than NDA 21-344. NDA 21-234 for 
FLECTOR was submitted on December 19, 2000.
    3. The date the application was approved: January 31, 2007. FDA has 
verified the applicant's claim that FLECTOR (NDA 21-234) was approved 
on January 31, 2007.
    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 1,825 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) either electronic or written comments and ask for a 
redetermination by June 4, 2012. 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 October 2, 2012. 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-8235 Filed 4-4-12; 8:45 am]
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