[Federal Register: July 7, 2004 (Volume 69, Number 129)]
[Notices]
[Page 40944-40945]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy04-103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2003E-0405 and 2003E-0452]
Determination of Regulatory Review Period for Purposes of Patent
Extension; NEUTERSOL
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 NEUTERSOL and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of two applications to the Director of
Patents and Trademarks, Department of Commerce, for the extension of
two patents which claim 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
240-453-6699.
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 a 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
NEUTERSOL (zinc gluconate). NEUTERSOL is indicated for chemical
sterilization in 3- to 10-month-old male puppies. Subsequent to this
approval, the Patent and Trademark Office received two patent term
restoration applications for NEUTERSOL (U.S. Patent Nos. 5,070,808 and
4,937,234) from Technology Transfer, Inc., and the Patent and Trademark
Office requested FDA's assistance in determining these patents'
eligibility for patent term restoration. In a letter dated November 18,
2003, FDA advised the Patent and Trademark Office that this animal drug
product had undergone a regulatory review period and that the approval
of NEUTERSOL 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
NEUTERSOL is 4,222 days. Of this time, 4,188 days occurred during the
testing phase of the regulatory review period, and 34 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 (the act) (21 U.S.C. 360b(j)) involving this
animal drug product became effective: August 27, 1991. The applicant
claims November 14, 1991, as the date the investigational new animal
drug application (INAD) became effective. The applicant relied on this
date based on a letter sent to the applicant by the document room on
November 14, 1991 which provided the INAD number to the applicant.
However, this letter was not intended to serve as an official
acknowledgment of the INAD filing. FDA records indicate that the filing
of a notice of claimed investigational exemption was August 27, 1991,
which is considered to be the effective date for the INAD.
2. The date the application was initially submitted with respect to
the animal drug product under section 512(b) of the act: February 12,
2003. The applicant claims February 10, 2003, as the date the new
animal drug application (NADA) for NEUTERSOL (NADA 141-217) was
initially submitted. However, FDA records reveal that NADA 141-217 was
submitted on February 12, 2003.
3. The date the application was approved: March 17, 2003. FDA has
verified the applicant's claim that NADA 141-217 was approved on March
17, 2003.
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 5 years 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 September 7, 2004. 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 January
3, 2005. 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
[[Page 40945]]
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: June 21, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-15301 Filed 7-6-04; 8:45 am]
BILLING CODE 4160-01-S