82 FR 16337 - Determination of Regulatory Review Period for Purposes of Patent Extension; Lawsonia Intracellularis Bacterin Vaccine

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 63 (April 4, 2017)

We are advising the public that the Animal and Plant Health Inspection Service has determined the regulatory review period for Lawsonia Intracellularis Bacterin 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.

[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Pages 16337-16338]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06640]



[[Page 16337]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0115]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Lawsonia Intracellularis Bacterin 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 
Lawsonia Intracellularis Bacterin 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 May 4, 2017. 
We will consider all due diligence petitions that we receive on or 
before October 2, 2017.

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/#!docketDetail;D=APHIS-2016-0115.
     Postal Mail/Commercial Delivery: Please send your request 
or petition to Docket No. APHIS-2016-0115, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238.
    A copy of the regulatory review period determination and any 
revision requests or due diligence petitions that we receive on this 
determination may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0115 or in our reading room, which 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support 
Section, Center for Veterinary Biologics, Policy, Evaluation, and 
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; (301) 851-3426.
    For information concerning the regulatory review period 
determination contact Dr. Patricia L. Foley, Center for Veterinary 
Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton 
Avenue, P.O. Box 844, Ames, IA 50010; (515) 337-6100.

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 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 Lawsonia Intracellularis Bacterin Vaccine. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for Lawsonia Intracellularis Bacterin Vaccine 
(U.S. Patent No. 5,610,059) from Intervet Inc., a subsidiary of Merck 
Animal Health, and the Patent and Trademark Office requested APHIS' 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated February 19, 2016, APHIS advised the 
Patent and Trademark Office that this veterinary biologic had undergone 
a regulatory review period and that the approval of Lawsonia 
Intracellularis Bacterin 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 Lawsonia Intracellularis Bacterin Vaccine is 1,544 days. Of this 
time, 186 days occurred during the testing phase of the regulatory 
review period, and 1,358 days occurred during the approval phase. These 
periods were derived from the following dates:
    1. The date that APHIS started confirmatory testing on the master 
seed for use in products containing Lawsonia intracellularis: June 20, 
2011. APHIS has verified the applicant's claim that the master seed to 
be used in the Lawsonia Intracellularis Bacterin Vaccine was first put 
on test by APHIS on June 20, 2011.
    2. The date the application for a license was initially submitted 
for approval under the Virus-Serum-Toxin Act: December 23, 2011. APHIS 
has verified the applicant's claim that the application was initially 
submitted on December 23, 2011.
    3. The date the license was issued: September 11, 2015. APHIS has 
verified the applicant's claim that the license for the commercial 
marketing of the vaccine was issued on September 11, 2015.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the Patent and 
Trademark

[[Page 16338]]

Office applies several statutory limitations in its calculations of the 
actual period for patent extension. In its application for patent 
extension, this applicant seeks 1,544 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:
     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; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 30th day of March 2017.
Jere L. Dick,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-06640 Filed 4-3-17; 8:45 am]
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