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)

Page Range		16337-16338
FR Document		2017-06640

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 Issue 63 (Tuesday, April 4, 2017)

[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.

-----------------------------------------------------------------------

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]
BILLING CODE 3410-34-P

Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices 16337

DEPARTMENT OF AGRICULTURE For information concerning the license was issued. Although only a
regulatory review period determination portion of a regulatory review period
Animal and Plant Health Inspection contact Dr. Patricia L. Foley, Center for may count toward the actual amount of
Service Veterinary Biologics, Policy, Evaluation, extension that the Commissioner of
[Docket No. APHIS–2016–0115] and Licensing, VS, APHIS, 1920 Dayton Patents and Trademarks may award,
Avenue, P.O. Box 844, Ames, IA 50010; APHIS’ determination of the length of a
Determination of Regulatory Review (515) 337–6100. regulatory review period for a veterinary
Period for Purposes of Patent SUPPLEMENTARY INFORMATION: The biologic will include all of the testing
Extension; Lawsonia Intracellularis provisions of 35 U.S.C. 156, ’’ Extension phase and approval phase as specified
Bacterin Vaccine of patent term,’’ provide, generally, that in 35 U.S.C. 156(g)(5)(B).
a patent for a product may be extended APHIS recently licensed for
AGENCY: Animal and Plant Health production and marketing the veterinary
Inspection Service, USDA. for a period of up to 5 years as long as
the patent claims a product that, among biologic Lawsonia Intracellularis
ACTION: Notice. Bacterin Vaccine. Subsequent to this
other things, was subject to a regulatory
review period before its commercial approval, the Patent and Trademark
SUMMARY: We are advising the public
marketing or use. (The term ‘‘product’’ Office received a patent term restoration
that the Animal and Plant Health
is defined in that section as ‘‘a drug application for Lawsonia Intracellularis
Inspection Service has determined the
product’’ [which includes veterinary Bacterin Vaccine (U.S. Patent No.
regulatory review period for Lawsonia
5,610,059) from Intervet Inc., a
Intracellularis Bacterin Vaccine and is biological products] or ‘‘any medical
subsidiary of Merck Animal Health, and
publishing this notice of that device, food additive, or color additive
the Patent and Trademark Office
determination as required by law. We subject to regulation under the Federal
requested APHIS’ assistance in
have made this determination in Food, Drug, and Cosmetic Act.’’) A
determining this patent’s eligibility for
response to the submission of an product’s regulatory review period
patent term restoration. In a letter dated
application to the Commissioner of forms the basis for determining the
February 19, 2016, APHIS advised the
Patents and Trademarks, Department of amount of extension an applicant may
Patent and Trademark Office that this
Commerce, for the extension of a patent receive.
veterinary biologic had undergone a
that claims that veterinary biologic. The regulations in 9 CFR part 124,
regulatory review period and that the
DATES: We will consider all requests for ‘‘Patent Term Restoration’’ (referred to approval of Lawsonia Intracellularis
revision of the regulatory review period below as the regulations), set forth Bacterin Vaccine represented the first
determination that we receive on or procedures and requirements for the permitted commercial licensing or use
before May 4, 2017. We will consider all Animal and Plant Health Inspection of the product. Subsequently, the Patent
due diligence petitions that we receive Service’s (APHIS’) review of and Trademark Office requested that
on or before October 2, 2017. applications for the extension of the APHIS determine the product’s
ADDRESSES: You may submit revision term of certain patents for veterinary regulatory review period.
requests and due diligence petitions by biological products pursuant to 35 APHIS has determined that the
either of the following methods: U.S.C. 156. As identified in the applicable regulatory review period for
• Federal eRulemaking Portal: Go to regulations, the responsibilities of Lawsonia Intracellularis Bacterin
http://www.regulations.gov/ APHIS include: Vaccine is 1,544 days. Of this time, 186
#!docketDetail;D=APHIS-2016-0115. • Assisting Patent and Trademark days occurred during the testing phase
• Postal Mail/Commercial Delivery: Office of the U.S. Department of of the regulatory review period, and
Please send your request or petition to Commerce in determining eligibility for 1,358 days occurred during the approval
Docket No. APHIS–2016–0115, patent term restoration; phase. These periods were derived from
Regulatory Analysis and Development, • Determining the length of a the following dates:
PPD, APHIS, Station 3A–03.8, 4700 product’s regulatory review period; 1. The date that APHIS started
River Road Unit 118, Riverdale, MD • If petitioned, reviewing and ruling confirmatory testing on the master seed
20737–1238. on due diligence challenges to APHIS’ for use in products containing Lawsonia
A copy of the regulatory review regulatory review period intracellularis: June 20, 2011. APHIS
period determination and any revision determinations; and has verified the applicant’s claim that
requests or due diligence petitions that • Conducting hearings to review the master seed to be used in the
we receive on this determination may be initial APHIS findings on due diligence Lawsonia Intracellularis Bacterin
viewed at http://www.regulations.gov/ challenges. Vaccine was first put on test by APHIS
#!docketDetail;D=APHIS-2016-0115 or The regulations are designed to be on June 20, 2011.
in our reading room, which is located in used in conjunction with regulations 2. The date the application for a
room 1141 of the USDA South Building, issued by the Patent and Trademark license was initially submitted for
14th Street and Independence Avenue Office concerning patent term approval under the Virus-Serum-Toxin
SW., Washington, DC. Normal reading extension, which may be found at 37 Act: December 23, 2011. APHIS has
room hours are 8 a.m. to 4:30 p.m., CFR 1.710 through 1.791. verified the applicant’s claim that the
Monday through Friday, except A regulatory review period consists of application was initially submitted on
holidays. To be sure someone is there to two periods of time: A testing phase and December 23, 2011.
help you, please call (202) 799–7039 an approval phase. For veterinary 3. The date the license was issued:
asabaliauskas on DSK3SPTVN1PROD with NOTICES

before coming. biologics, the testing phase begins on September 11, 2015. APHIS has verified
FOR FURTHER INFORMATION CONTACT: Dr. the date the authorization to prepare an the applicant’s claim that the license for
Donna Malloy, Operational Support experimental veterinary biologic became the commercial marketing of the vaccine
Section, Center for Veterinary Biologics, effective and runs until the approval was issued on September 11, 2015.
Policy, Evaluation, and Licensing, VS, phase begins. The approval phase This determination of the regulatory
APHIS, 4700 River Road Unit 148, begins on the date an application for a review period establishes the maximum
Riverdale, MD 20737–1231; (301) 851– license was initially submitted for potential length of a patent extension.
3426. approval and ends on the date such However, the Patent and Trademark

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16338 Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices

Office applies several statutory implement certain types of surveys and Type of Request: Extension with a
limitations in its calculations of the related collection of information. FSA revision.
actual period for patent extension. In its uses the approval to cover the Abstract: FSA program staff have
application for patent extension, this instruments of collection (such as a created several feedback instruments
applicant seeks 1,544 days of patent survey, a window pop-up survey, a (customer surveys) and submitted them
term extension. focus group, or a comment card), which to the FSA information collection
Section 124.22 of the regulations are designed to get customer feedback coordinator for approval under the
provides that any interested person may on FSA service delivery for various current approved information collection
request a revision of the regulatory programs. This request for approval of 0560–0286, Generic Clearance for the
review period determination within 30 broadly addresses FSA’s need for Collection of Qualitative Customer
days of the date of this notice (see DATES information about what our customers Feedback on Farm Service Agency
above). The request must specify the think of our services so that we can Service Delivery. FSA program staff
following: improve service delivery; specific continue to use the fast track approval
• The identity of the product; information collection activities will be to submit a new customer instruments
• The identity of the applicant for incorporated into the approval as the to the FSA information collection
patent term restoration; need for the information is identified. coordinator for approval, which takes
• The docket number of this notice; For example, when we implement a less time rather than going through a
and new program and provide information regular Paperwork Reduction Act
• The basis for the request for about the services for the program on process. As a result, program staff are
revision, including any documentary our Web site, we may provide a able to quickly implement certain types
evidence. voluntary customer service of surveys and related collection of
Further, under § 124.30 of the questionnaire about how well the information using OMB control number
regulations, any interested person may program is working for our customers, of 0560–0286. For example, when we
file a petition with APHIS, no later than specifically within the area of customer implement a new program and provide
180 days after the date of this notice (see service. FSA is requesting to increase information about the programs on our
DATES above), alleging that a license the number of respondents in the fast Web site, FSA may provide a voluntary
applicant did not act with due diligence track approval due to an anticipated customer service questionnaire about
in seeking APHIS approval of the increase in the number of customer how well the program is working for our
product during the regulatory review respondents responding to customer customers, specifically within the area
period. The filing, format, and content service surveys that will be sent to a of customer service. The information
of a petition must be as described in the broader scope and greater number of collection provides a means to gather
regulations in ‘‘Subpart D–Due FSA customers. qualitative customer and stakeholder
Diligence Petitions’’ (§§ 124.30 through feedback in an efficient, timely manner
DATES: We will consider comments that that is consistent with FSA’s
124.33).
we receive by June 5, 2017. commitment to improving service
Authority: 35 U.S.C. 156; 7 CFR 2.22, 2.80,
ADDRESSES: We invite you to submit delivery. By qualitative feedback, we
and 371.4.
comments on this notice. In your mean information, generally from
Done in Washington, DC, this 30th day of comments, include the date, volume, customers, that provides useful insights
March 2017. and page number of this issue of the on perceptions and opinions based on
Jere L. Dick, Federal Register, the OMB control experiences with FSA service delivery.
Acting Administrator, Animal and Plant number and the title of the information Such information does not include
Health Inspection Service. collection. You may submit comments statistical surveys that yield quantitative
[FR Doc. 2017–06640 Filed 4–3–17; 8:45 am] by any of the following methods: results that can be generalized to the
BILLING CODE 3410–34–P • Federal eRulemaking Portal: Go to population. The qualitative feedback
http://www.regulations.gov. Follow the will:
online instructions for submitting • Provide insights into customer or
DEPARTMENT OF AGRICULTURE comments. stakeholder perceptions, experiences,
• Mail: Mary Ann Ball, USDA, Farm and expectations,
Farm Service Agency • Provide an early warning of issues
Service Agency, Room 3754–S, 1400
Information Collection Request; Independence Ave SW., Washington, with service, and
DC 20250–0572. • Focus attention on areas where
Generic Clearance for the Collection of
You may also send comments to the communication, training, or changes in
Qualitative Customer Feedback on the
Desk Officer for Agriculture, Office of operations might improve delivery of
Farm Service Agency Service Delivery
Information and Regulatory Affairs, products or services.
AGENCY: Farm Service Agency, USDA. Office of Management and Budget, The collection will allow for ongoing,
ACTION: Notice; request for comments. Washington, DC 20503. collaborative, and actionable
Copies of the information collection communication between FSA and its
SUMMARY: In accordance with the instruments may be requested by customers and stakeholders. It will also
Paperwork Reduction Act of 1995, the contacting Mary Ann Ball at the above allow feedback to contribute directly to
Farm Service Agency (FSA) is address. the improvement of program
requesting comments from all interested management.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

individuals and organizations on an FOR FURTHER INFORMATION CONTACT: The solicitation of feedback will target
extension with a revision of a currently Mary Ann Ball, (202) 720–4283. areas such as: Timeliness,
approved information collection SUPPLEMENTARY INFORMATION: appropriateness, accuracy of
associated with the Generic Clearance Title: Generic Clearance for the information, courtesy, efficiency of
for the Collection of Qualitative Collection of Qualitative Customer service delivery, and resolution of
Customer Feedback on FSA Service Feedback on Farm Service Agency issues with service delivery. Responses
Delivery. This option is a fast track for Service Delivery. will be assessed to plan and inform
approval to streamline the timing to OMB Control Number: 0560–0286. efforts to improve or maintain the

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Document Created: 2017-04-03 23:53:17
Document Modified: 2017-04-03 23:53:17

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		82 FR 16337

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

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

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

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service