[Federal Register Volume 74, Number 142 (Monday, July 27, 2009)]
[Notices]
[Pages 37000-37001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17795]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2009-0056]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; NAHVAX[supreg] Marek's Disease 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 
NAHVAX[supreg] Marek's Disease Vaccine and is publishing this notice of 
that determination as required 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 August 26, 
2009. We will consider all due diligence petitions that we receive on 
or before January 25, 2010.

ADDRESSES: You may submit revision requests and due diligence petitions 
by either of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0056 to submit or view revision 
requests and due diligence petitions and to view supporting and related 
materials available electronically.
    <bullet> Postal Mail/Commercial Delivery: Please send two copies of 
your request or petition to Docket No. APHIS-2009-0056, Regulatory 
Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, 
Unit 118, Riverdale, MD 20737-1238. Please state that your revision 
request or due diligence petition refers to Docket No. APHIS-2009-0056.
    Reading Room: A copy of the regulatory review period determination 
and any revision requests or due diligence petitions that we receive on 
this determination are available for public inspection 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:
    <bullet> Assisting Patent and Trademark Office of the U.S. 
Department of Commerce in determining eligibility for patent term 
restoration;
    <bullet> Determining the length of a product's regulatory review 
period;
    <bullet> If petitioned, reviewing and ruling on due diligence 
challenges to APHIS' regulatory review period determinations; and
    <bullet> 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

[[Page 37001]]

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 NAHVAX[supreg] Marek's Disease Vaccine. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for NAHVAX[supreg] Marek's Disease Vaccine 
(U.S. Patent No. 5, 965, 138) from Schering Plough Animal Health 
Corporation, and the Patent and Trademark Office requested APHIS' 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated February 2, 2009, APHIS advised the 
Patent and Trademark Office that this veterinary biologic had undergone 
a regulatory review period and that the approval of NAHVAX[supreg] 
Marek's Disease Vaccine (Marek's Disease Vaccine, Serotypes 1 & 3, Live 
Herpesvirus Chimera) 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 NAHVAX[supreg] Marek's Disease Vaccine is 1,539 days. Of this time, 
0 days occurred during the testing phase of the regulatory review 
period, and 1,539 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: July 14, 2004. APHIS has 
verified the applicant's claim that the application was initially 
submitted on July 14, 2004.
    2. The date the license was issued: September 29, 2008. APHIS has 
verified the applicant's claim that the license for the commercial 
marketing of the vaccine was issued on September 29, 2008.
    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 1,539 days of 
patent term extension.
    Section 124.22 of the regulations provides that any interested 
person may request a revision of the regulatory review period 
determination within 30 days of the date of this notice (see DATES 
above). The request must specify the following:
    <bullet> The identity of the product;
    <bullet> The identity of the applicant for patent term restoration;
    <bullet> The docket number of this notice; and
    <bullet> 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 21st day of July 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-17795 Filed 7-24-09; 8:45 am]
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