[Federal Register: September 17, 2007 (Volume 72, Number 179)]
[Notices]
[Page 52847-52849]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se07-21]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0121]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Fel-O-Vax[supreg] LvK/FIV Vaccine
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has determined the regulatory review period for Fel-
O-Vax[supreg] LvK/FIV Vaccine and is publishing this notice of that
determination as required
[[Page 52848]]
by law. We have made this determination in response to the submission
of an application to the Commissioner of Patents and Trademarks,
Department of Commerce, for the extension of a patent that claims that
veterinary biologic.
DATES: We will consider all requests for revision of the regulatory
review period determination that we receive on or before October 17,
2007. We will consider all due diligence petitions that we receive on
or before March 17, 2008.
ADDRESSES: You may submit revision requests and due diligence petitions
by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov,
select ``Animal and Plant Health Inspection Service'' from the agency
drop-down menu, then click ``Submit.'' In the Docket ID column, select
APHIS-2007-0121 to submit or view public comments and to view
supporting and related materials available electronically. Information
on using Regulations.gov, including instructions for accessing
documents, submitting comments, and viewing the docket after the close
of the comment period, is available through the site's ``User Tips''
link.
Postal Mail/Commercial Delivery: Please send four copies of your
request or petition (an original and three copies) to Docket No. APHIS-
2007-0121, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that the request or petition refers to Docket No. APHIS-2007-0121.
Reading Room: You may read the regulatory review period
determination and any revision requests or due diligence petitions that
we receive on this determination in our reading room. The reading room
is located in room 1141 of the USDA South Building, 14th Street and
Independence Avenue, SW., Washington, DC. Normal reading room hours are
8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure
someone is there to help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader,
Operational Support Section, Center for Veterinary Biologics, Policy
Evaluation and Licensing, VS, APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737-1231; phone (301) 734-8245; fax (301) 734-4314.
For information concerning the regulatory review period
determination, contact Dr. Patricia L. Foley, Center for Veterinary
Biologics, Policy Evaluation and Licensing, VS, APHIS, 510 South 17th
Street, Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232-
7120.
SUPPLEMENTARY INFORMATION: The provisions of 35 U.S.C. 156, ``Extension
of patent term,'' provide, generally, that a patent for a product may
be extended for a period of up to 5 years as long as the patent claims
a product that, among other things, was subject to a regulatory review
period before its commercial marketing or use. (The term ``product'' is
defined in that section as ``a drug product'' [which includes
veterinary biological products] or ``any medical device, food additive,
or color additive subject to regulation under the Federal Food, Drug,
and Cosmetic Act.'') A product's regulatory review period forms the
basis for determining the amount of extension an applicant may receive.
The regulations in 9 CFR part 124, ``Patent Term Restoration''
(referred to below as the regulations), set forth procedures and
requirements for the Animal and Plant Health Inspection Service's
(APHIS) review of applications for the extension of the term of certain
patents for veterinary biological products pursuant to 35 U.S.C. 156.
As identified in the regulations, the responsibilities of APHIS
include:
Assisting the Patent and Trademark Office of the U.S. Department of
Commerce in determining eligibility for patent term restoration;
Determining the length of a product's regulatory review period;
If petitioned, reviewing and ruling on due diligence challenges to
APHIS' regulatory review period determinations; and
Conducting hearings to review initial APHIS findings on due
diligence challenges.
The regulations are designed to be used in conjunction with
regulations issued by the Patent and Trademark Office concerning patent
term extension, which may be found at 37 CFR 1.710 through 1.791.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For veterinary biologics, the
testing phase begins on the date the authorization to prepare an
experimental veterinary biologic became effective and runs until the
approval phase begins. The approval phase begins on the date an
application for a license was initially submitted for approval and ends
on the date such license was issued. Although only a portion of a
regulatory review period may count toward the actual amount of
extension that the Commissioner of Patents and Trademarks may award,
APHIS' determination of the length of a regulatory review period for a
veterinary biologic will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(5)(B).
APHIS recently licensed for production and marketing the veterinary
biologic Fel-O-Vax[supreg] LvK/FIV (Feline Immunodeficiency-Leukemia
Virus Vaccine, Killed Virus) Vaccine. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for Fel-O-Vax[supreg] LvK/FIV Vaccine (U.S. Patent No.
5,510,106) from the Regents of the University of California, and the
Patent and Trademark Office requested APHIS' assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated January 16, 2007, APHIS advised the Patent and Trademark Office
that this veterinary biologic had undergone a regulatory review period
and that the approval of Fel-O-Vax[supreg] LvK/FIV Vaccine represented
the first permitted commercial licensing or use of the product.
Subsequently, the Patent and Trademark Office requested that APHIS
determine the product's regulatory review period.
APHIS has determined that the applicable regulatory review period
for Fel-O-Vax[supreg] LvK/FIV Vaccine is 1,348 days. Of this time, 0
days occurred during the testing phase of the regulatory review period,
and 1,348 days occurred during the approval phase. These periods were
derived from the following dates:
1. The date the application for a license was initially submitted
for approval under the Virus-Serum-Toxin Act: October 15, 1999. APHIS
has verified the applicant's claim that the application was initially
submitted on October 15, 1999.
2. The date the license was issued: June 23, 2003. APHIS has
verified the applicant's claim that the license for the commercial
marketing of the vaccine was issued on June 23, 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 1,348 days of
patent term extension.
Section 124.22 of the regulations provides that any interested
person may request a revision of the regulatory
[[Page 52849]]
review period determination within 30 days of the date of this notice
(see DATES above). The request must specify the following:
The identity of the product;
The identity of the applicant for patent term restoration;
The docket number of this notice; and
The basis for the request for revision, including any documentary
evidence.
Further, under Sec. 124.30 of the regulations, any interested
person may file a petition with APHIS, no later than 180 days after the
date of this notice (see DATES above), alleging that a license
applicant did not act with due diligence in seeking APHIS approval of
the product during the regulatory review period. The filing, format,
and content of a petition must be as described in the regulations in
``Subpart D--Due Diligence Petitions'' (Sec. Sec. 124.30 through
124.33).
Authority: 35 U.S.C. 156.
Done in Washington, DC, this 11th day of September, 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-18266 Filed 9-14-07; 8:45 am]
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