Document ID: FDA-2011-E-0139-0006
Agency: fda
Document Type: Notice
Title: Regulatory Review Period for Purposes of Patent Extension: EQUIDONE GEL
Posted Date: 2012-05-04T04:00Z

[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Notices]
[Pages 26556-26557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10853]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-E-0139]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; EQUIDONE GEL

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for EQUIDONE GEL 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 animal drug product.

ADDRESSES: Submit electronic comments to http://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. 6284, 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

[[Page 26557]]

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 animal drug products, the 
testing phase begins on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360b(j)) became effective and runs until the approval 
phase begins. The approval phase starts with the initial submission of 
an application to market the animal 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 an animal 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA approved for marketing the animal drug product EQUIDONE GEL 
(domperidone). EQUIDONE GEL is indicated for prevention of fescue 
toxicosis in periparturient mares. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for EQUIDONE GEL (U.S. Patent No. 5,372,818) from Dechra, 
Ltd., and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated April 26, 2011, FDA advised the Patent and Trademark 
Office that this animal drug product had undergone a regulatory review 
period and that the approval of EQUIDONE GEL 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 
EQUIDONE GEL is 6,378 days. Of this time, 6,336 days occurred during 
the testing phase of the regulatory review period, while 42 days 
occurred during the approval phase. These periods of time were derived 
from the following dates:
    1. The date an exemption under section 512(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(j)) became effective: March 26, 
1993. The applicant claims February 24, 1992, as the date the 
investigational new animal drug application (IND) became effective. 
However, the date that a major health or environmental effects test is 
begun or the date on which the Agency acknowledges the filing of a 
notice of claimed investigational exemption (NCIE) for a new animal 
drug, whichever is earlier, is the effective date for the IND. 
According to FDA records, the applicant's first submission of an NCIE 
was March 26, 1993, which is the effective date for the IND.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the Federal Food, Drug, 
and Cosmetic Act: July 30, 2010. The applicant claims July 27, 2010, as 
the date the new animal drug application (NADA) for EQUIDONE GEL (NADA 
141-314) was initially submitted. However, a review of FDA records 
reveals that the date of FDA's official acknowledgement letter 
assigning a number to NADA 141-314 was July 30, 2010, which is 
considered to be the initially submitted date for NADA 141-314.
    3. The date the application was approved: September 9, 2010. FDA 
has verified the applicant's claim that NADA 141-314 was approved on 
September 9, 2010.
    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 5 years 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 written or electronic comments and ask for a 
redetermination by July 3, 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 31, 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 http://www.regulations.gov may be viewed in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-10853 Filed 5-3-12; 8:45 am]
BILLING CODE 4160-01-P