[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33763-33764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13637]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-1233]


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

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 ZUPREVO 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 the U.S. 
Patent and Trademark Office (USPTO), 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, 301-796-7900.

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 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 (the FD&C 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 USPTO 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 ZUPREVO 
(tildipirosin). ZUPREVO is an animal drug product indicated for the 
treatment of bovine respiratory disease (BRD) associated with 
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in 
beef and non-lactating dairy cattle at high risk of developing BRD 
associated with M. haemolytica, P. multocida, and H. somni. Subsequent 
to this approval, USPTO received a patent term restoration application 
for ZUPREVO (U.S. Patent No. 6,514,946) from Koueki Zaidan Hojin 
Biseibutsu Kagaku Kenkyu Kai, and USPTO requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated February 19, 2013, FDA advised USPTO that this animal drug 
product had undergone a regulatory review period and that the approval 
of ZUPREVO represented the first permitted commercial marketing or use 
of the product. Thereafter, USPTO requested that FDA determine the 
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
ZUPREVO is 2,903 days. Of this time, 2,842 days occurred during the 
testing phase of the regulatory review period, while 61 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: June 4, 2004. The applicant claims March 8, 2004, as the 
date the investigational new animal drug application (INAD) became 
effective. However, FDA records indicate that the INAD effective date 
was June 4, 2004, which was the date 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 for a new 
animal drug, whichever is earlier.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the FD&C Act (21 U.S.C. 
360b): March 15, 2012. The applicant claims March 14, 2012, as the date 
the new animal drug application (NADA) for ZUPREVO (NADA 141-334) was 
initially submitted. However, FDA records indicate that NADA 141-334 
was submitted on March 15, 2012.
    3. The date the application was approved: May 14, 2012. FDA has 
verified the applicant's claim that NADA 141-334 was approved on May 
14, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, USPTO applies 
several statutory limitations in its calculations of the actual period 
for patent extension. In its application for patent extension, this 
applicant seeks 1,524 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 August 11, 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 December 9, 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://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.


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    Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13637 Filed 6-11-14; 8:45 am]
BILLING CODE 4160-01-P