Document ID: FDA-2008-E-0112-0006
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension: VETMEDIN
Posted Date: 2009-02-10T05:00Z

[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6639-6640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe09-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0112]

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

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 VETMEDIN 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 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 http://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 (the 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
VETMEDIN (pimobendan). VETMEDIN is indicated for the management of the
signs of mild, moderate, or severe (modified NYHA Class II, III, or IV)
congestive heart failure in dogs due to atrioventricular valvular
insufficiency or dilated cardiomyopathy. VETMEDIN is indicated for use
with concurrent therapy for congestive heart failure (e.g., furosemide,
etc.) as appropriate on a case-by-case basis. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for VETMEDIN (U.S. Patent No. 5,364,646) from
Dr. Karl Thomae GmbH, 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 VETMEDIN represented
the first permitted commercial marketing or use of the product. Shortly
thereafter,

[[Page 6640]]

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
VETMEDIN is 2,751 days. Of this time, 2,715 days occurred during the
testing phase of the regulatory review period, while 36 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 act (21 U.S.C.
360b(j)) became effective: October 20, 1999. The applicant claims April
8, 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, October 20, 1999, 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 act: March 26, 2007.
FDA has verified the applicant's claim that the new animal drug
application (NADA) for VETMEDIN (NADA 141-273) was initially submitted
on March 26, 2007.
    3. The date the application was approved: April 30, 2007. FDA has
verified the applicant's claim that NADA 141-273 was approved on April
30, 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 1,492 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 April 13, 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 August 10,
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 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2684 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S