[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18563-18564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0677 and FDA-2011-E-0678]


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

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 ONSIOR and is publishing this notice of 
that determination as required by law. FDA has made the determination

[[Page 18564]]

because of the submission of applications 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 (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://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Center for Drug Evaluation and Research, 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 animal 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 animal drug product and 
continues until FDA grants permission to market the animal 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 has approved for marketing the animal drug product ONSIOR 
(robenacoxib). ONSIOR is indicated for control of postoperative pain 
associated with orthopedic surgery, ovariohysterectomy and castration 
in cats >= 5.5 pounds and > 6 months of age; for up to a maximum of 3 
days. Subsequent to this approval, the Patent and Trademark Office 
received patent term restoration applications for ONSIOR (U.S. Patent 
Nos. 6,291,523 and 7,115,662) from Novartis Animal Health US, Inc., and 
the Patent and Trademark Office requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated July 9, 2012, FDA advised the Patent and Trademark Office 
that this animal drug product had undergone a regulatory review period 
and that the approval of ONSIOR 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 
ONSIOR is 1,704 days. Of this time, 1,650 days occurred during the 
testing phase of the regulatory review period, while 54 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 (the FD&C Act) (21 U.S.C. 360b(j)) became 
effective: July 10, 2006. The applicant claims March 2, 2004, as the 
date the investigational new animal drug application (INAD) became 
effective. However, FDA records indicate that the INAD effective date 
was July 10, 2006, which was the received date of the first submission 
that includes a study with substantial data (submission of a major 
health test) or the first submission containing a Notice of Claimed 
Investigational Exemption.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the FD&C Act: January 14, 
2011. The applicant claims January 13, 2011, as the date the new animal 
drug application (NADA) for ONSIOR (NADA 141-320) was initially 
submitted. However, FDA records indicate that NADA 141-320 was 
submitted on January 14, 2011.
    3. The date the application was approved: March 8, 2011. FDA has 
verified the applicant's claim that NADA 141-320 was approved on March 
8, 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 
applications for patent extension, this applicant seeks 1,308 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 numbers 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://www.regulations.gov, Docket No. FDA 2013-S-0610. 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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07336 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P