Document ID: FDA-2009-E-0087-0005
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extensions; CONVENIA
Posted Date: 2011-04-29T04:00Z

[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Notices]
[Pages 24034-24035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10379]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0087]

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

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 CONVENIA 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

[[Page 24035]]

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. 6222, 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 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 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 CONVENIA 
(cefovecin sodium). CONVENIA is indicated for the treatment of skin 
infections (wounds and abscesses) caused by susceptible strains of 
Pasteurella multocida in cats; and the treatment of skin infections 
(secondary superficial pyoderma, abscesses and wounds) caused by 
susceptible strains of Staphylococcus intermedius and Streptococcus 
canis (Group G) in dogs. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
CONVENIA (U.S. Patent No. 6,020,329) from Pfizer, Inc., and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
September 2, 2009, FDA advised the Patent and Trademark Office that 
this animal drug product had undergone a regulatory review period and 
that the approval of CONVENIA 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 
CONVENIA is 2,841 days. Of this time, 2,801 days occurred during the 
testing phase of the regulatory review period, while 40 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 FD&C Act 
became effective: July 17, 2000. The applicant claims November 16, 
1999, as the date the investigational new animal drug application 
(INAD) 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 for a new animal drug, whichever is earlier, is the effective 
date for the INAD. According to FDA records, July 17, 2000, is the 
effective date for the INAD.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the FD&C Act: March 17, 
2008. The applicant claims March 15, 2008, as the date the new animal 
drug Application (NADA) for CONVENIA (NADA 141-285) 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-
285 was March 17, 2008, which is considered to be the initially 
submitted date for NADA 141-285.
    3. The date the application was approved: April 25, 2008. FDA has 
verified the applicant's claim that NADA 141-285 was approved on April 
25, 2008. 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 1,462 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 28, 2011. 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 26, 2011.
    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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 15, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-10379 Filed 4-28-11; 8:45 am]
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