Determination of Regulatory Review Period for Purposes of Patent Extension; CERENIA INJECTABLE SOLUTION, 10596-10597 [E9-5112]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Notices]
[Pages 10596-10597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5112]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0462]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CERENIA INJECTABLE SOLUTION

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 CERENIA INJECTABLE SOLUTION 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.

[[Page 10597]]


ADDRESSES: Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.regulations.gov.

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 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 (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 recently approved for marketing the animal drug product CERENIA 
INJECTABLE SOLUTION (maropitant). CERENIA INJECTABLE SOLUTION is 
indicated for the prevention and treatment of acute vomiting in dogs. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for CERENIA INJECTABLE SOLUTION 
(U.S. Patent No. 6,222,038) 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 May 
6, 2008, FDA advised the Patent and Trademark Office that this animal 
drug product had undergone a regulatory review period and that the 
approval of CERENIA INJECTABLE SOLUTION represented the first permitted 
commercial marketing or use of the product. Shortly 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 
CERENIA INJECTABLE SOLUTION is 1,887 days. Of this time, 1,841 days 
occurred during the testing phase of the regulatory review period, 
while 46 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: December 
1, 2001. The applicant claims June 28, 2000, 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, December 1, 2001, 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 Federal Food, Drug, 
and Cosmetic Act: December 15, 2006. The applicant claims December 13, 
2006, as the date the new animal drug application (NADA) for CERENIA 
INJECTABLE SOLUTION (NADA 141-263) was initially submitted. However, a 
review of FDA records reveals that NADA 141-263 was initially submitted 
on December 15, 2006.
    3. The date the application was approved: January 29, 2007. FDA has 
verified the applicant's claim that NADA 141-263 was approved on 
January 29, 2007.
    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 1,078 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) written or electronic comments and ask for a redetermination 
by May 11, 2009. 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 8, 
2009. 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: February 17, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-5112 Filed 3-10-09; 8:45 am]
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