Document ID: FDA-2013-E-0969-0005
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; OVUGEL
Posted Date: 2015-05-07T04:00Z

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26274-26275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11003]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0968 and FDA-2013-E-0969]

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

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 OVUGEL and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of U.S. 
Patents and Trademarks 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, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Bldg., Rm. 3180, 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 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 OVUGEL 
(triptorelin acetate). OVUGEL, an animal drug product, is indicated for 
the synchronization of time of insemination in weaned sows to 
facilitate a single fixed-time artificial insemination. Subsequent to 
this approval, the USPTO received patent term restoration applications 
for OVUGEL (U.S. Patent Nos. 5,985,320 and RE 42,072) from Penn State 
Research Foundation and Massachusetts Institute of Technology, and the 
USPTO requested FDA's assistance in determining the patents' 
eligibility for patent term restoration. In a letter dated March 25, 
2014, FDA advised the Patent and Trademark Office that this animal drug 
product had undergone a regulatory review period and that the approval 
of OVUGEL represented the first permitted commercial marketing or use 
of the product. Thereafter, the USPTO requested that the FDA determine 
the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
OVUGEL is 3,692 days. Of this time, 3,644 days occurred during the 
testing phase of the regulatory review period, while 48 days occurred 
during the

[[Page 26275]]

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: August 12, 2002. The applicant claims February 13, 2002, as 
the date the investigational new animal drug application (INAD) became 
effective. However, FDA records indicate that the INAD effective date 
was August 12, 2002, 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): August 2, 2012. The applicant claims July 20, 2012, as the date 
the new animal drug Application (NADA) for OVUGEL RE42072 (NADA 141-
339) was initially submitted. However, FDA records indicate that NADA 
141-339 was submitted on August 2, 2012.
    3. The date the application was approved: September 18, 2012. FDA 
has verified the applicant's claim that NADA 141-339 was approved on 
September 18, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its applications for patent extension, 
this applicant seeks 331 or 1,826 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 July 6, 2015. 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 November 3, 2015. 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.

    Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11003 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P