Document ID: FDA-2012-E-0163-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; POTIGA
Posted Date: 2014-04-02T04:00Z

[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18564-18565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07334]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0163]

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

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 POTIGA and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an

[[Page 18565]]

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 
http:[sol][sol]www.regulations.gov. Submit written petitions (two 
copies are required) and written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Submit petitions electronically to 
http:[sol][sol]www.regulations.gov at Docket No. FDA 2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Center for Drug 
Evaluation and Research, Office of Management, Food and Drug 
Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6257, 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 has approved for marketing the human drug product POTIGA 
(ezogabine). POTIGA is a potassium channel opener indicated as 
adjunctive treatment of partial-onset seizures in patients aged 18 
years and older. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for POTIGA (U.S. 
Patent No. 6,538,151) from Valeant Pharmaceuticals North America, and 
the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated July 10, 2012, FDA advised the Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of POTIGA 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 period.
    FDA has determined that the applicable regulatory review period for 
POTIGA is 5,021 days. Of this time, 4,432 days occurred during the 
testing phase of the regulatory review period, while 589 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: September 12, 1997. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on September 12, 1997.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: October 
30, 2009. FDA has verified the applicant's claim that the new drug 
application (NDA) for POTIGA (NDA 22-345) was submitted on October 30, 
2009.
    3. The date the application was approved: June 10, 2011. FDA has 
verified the applicant's claim that NDA 22-345 was approved on June 10, 
2011.
    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 1,794 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 2, 2014. 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 September 29, 2014. 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 or 
electronic petitions. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. If you submit a written petition, two copies 
are required. A petition submitted electronically must be submitted to 
http:[sol][sol]www.regulations.gov, Docket No. FDA 2013-S-0610. 
Comments and petitions that have not been made publicly available on 
http:[sol][sol]www.regulations.gov may be viewed in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07334 Filed 4-1-14; 8:45 am]
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