[Federal Register: July 7, 2004 (Volume 69, Number 129)]
[Page 40944-40945]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

Regulatory Policy (HFD-013), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 

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 

[[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]