80_FR_13030 80 FR 12982 - Grant of Interim Extension of the Term of U.S. Patent No. 5,610,059; Monovalent Lawsonia Intracellularis Bacterin Vaccine

80 FR 12982 - Grant of Interim Extension of the Term of U.S. Patent No. 5,610,059; Monovalent Lawsonia Intracellularis Bacterin Vaccine

DEPARTMENT OF COMMERCE
United States Patent and Trademark Office

Federal Register Volume 80, Issue 48 (March 12, 2015)

Page Range12982-12982
FR Document2015-05581

The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one- year interim extension of the term of U.S. Patent No. 5,610,059.

Federal Register, Volume 80 Issue 48 (Thursday, March 12, 2015)
[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Page 12982]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05581]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. PTO-P-2015-0009]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,610,059; Monovalent Lawsonia Intracellularis Bacterin Vaccine

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of Interim Patent Term Extension.

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SUMMARY: The United States Patent and Trademark Office has issued an 
order granting interim extension under 35 U.S.C. 156(d)(5) for a one-
year interim extension of the term of U.S. Patent No. 5,610,059.

FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 
272-7755; by mail marked to her attention and addressed to the 
Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, 
Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-
7755; or by email to Mary.Till@uspto.gov.

SUPPLEMENTARY INFORMATION: Section 156 of Title 35, United States Code, 
generally provides that the term of a patent may be extended for a 
period of up to five years if the patent claims a product, or a method 
of making or using a product, that has been subject to certain defined 
regulatory review, and that the patent may be extended for interim 
periods of up to one year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On January 15, 2015, the Arizona Board of Regents, on behalf of the 
University of Arizona, the patent owner of record, timely filed a 
second application under 35 U.S.C. 156(d)(5) for an interim extension 
of the term of U.S. Patent No. 5,610,059. The patent claims the 
veterinary biological product monovalent Lawsonia intracellularis 
bacterin vaccine. The original application indicates that Intervet, a 
licensee of the patent owner, submitted two Product License 
Applications (PLA) to the United States Department of Agriculture 
(USDA). In a letter dated April 12, 2011, USDA acknowledged receipt of 
the PLA for a multi-valent vaccine and assigned the vaccine product 
code 49L5.RO. In a letter dated December 22, 2011, USDA acknowledged 
receipt of a PLA for a monovalent vaccine of Lawsonia intracellularis 
bacterin and assigned the vaccine product code 2799.20.
    Review of the application indicates that, except for permission to 
market or use the product commercially, the subject patent would be 
eligible for an extension of the patent term under 35 U.S.C. 156, and 
that the patent should be extended for one year as required by 35 
U.S.C. 156(d)(5)(B). Because the regulatory review period will continue 
beyond the extended expiration date of the patent, March 11, 2015, 
interim extension of the patent term under 35 U.S.C. 156(d)(5) is 
appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 5,610,059 is granted for a period of one year from the 
extended expiration date of the patent.

    Dated: March 2, 2015.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2015-05581 Filed 3-11-15; 8:45 am]
 BILLING CODE 3510-16-P



                                                    12982                        Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices

                                                    alcohol, is a clear, water white to pale                at weighted-average dumping margins                   a product, that has been subject to
                                                    yellow liquid. THFA is a member of the                  up to 136.86 percent.                                 certain defined regulatory review, and
                                                    heterocyclic compounds known as                                                                               that the patent may be extended for
                                                                                                            Notification Regarding Administrative
                                                    furans and is miscible with water and                                                                         interim periods of up to one year if the
                                                                                                            Protective Orders
                                                    soluble in many common organic                                                                                regulatory review is anticipated to
                                                    solvents. THFA is currently classifiable                   This notice also serves as the only                extend beyond the expiration date of the
                                                    in the Harmonized Tariff Schedules of                   reminder to parties subject to                        patent.
                                                    the United States (‘‘HTSUS’’) under                     administrative protective orders
                                                    subheading 2932.13.00.00. Although the                  (‘‘APO’’) of their responsibility                        On January 15, 2015, the Arizona
                                                    HTSUS subheadings are provided for                      concerning the return or destruction of               Board of Regents, on behalf of the
                                                    convenience and for customs purposes,                   proprietary information disclosed under               University of Arizona, the patent owner
                                                    the Department’s written description of                 APO in accordance with 19 CFR                         of record, timely filed a second
                                                    the merchandise subject to the order is                 351.305. Timely notification of the                   application under 35 U.S.C. 156(d)(5)
                                                    dispositive.                                            return or destruction of APO materials                for an interim extension of the term of
                                                                                                            or conversion to judicial protective                  U.S. Patent No. 5,610,059. The patent
                                                    Analysis of Comments Received                           order is hereby requested. Failure to                 claims the veterinary biological product
                                                       A complete discussion of all issues                  comply with the regulations and terms                 monovalent Lawsonia intracellularis
                                                    raised in this sunset review is provided                of an APO is a violation which is subject             bacterin vaccine. The original
                                                    in the accompanying Issues and                          to sanction.                                          application indicates that Intervet, a
                                                    Decision Memorandum, which is hereby                       We are issuing and publishing the                  licensee of the patent owner, submitted
                                                    adopted by this notice.4 The issues                     results and notice in accordance with                 two Product License Applications (PLA)
                                                    discussed in the Issues and Decision                    sections 751(c), 752(c), and 777(i)(1) of             to the United States Department of
                                                    Memorandum include the likelihood of                    the Act and 19 CFR 351.218.                           Agriculture (USDA). In a letter dated
                                                    continuation or recurrence of dumping                     Dated: March 3, 2015.                               April 12, 2011, USDA acknowledged
                                                    and the magnitude of the margins of                     Paul Piquado,                                         receipt of the PLA for a multi-valent
                                                    dumping likely to prevail if the order                                                                        vaccine and assigned the vaccine
                                                                                                            Assistant Secretary for Enforcement and
                                                    were revoked. The Issues and Decision                   Compliance.                                           product code 49L5.RO. In a letter dated
                                                    Memorandum is a public document and                                                                           December 22, 2011, USDA
                                                                                                            [FR Doc. 2015–05713 Filed 3–11–15; 8:45 am]
                                                    is on file electronically via Enforcement
                                                                                                            BILLING CODE 3510–DS–P                                acknowledged receipt of a PLA for a
                                                    and Compliance’s Antidumping and
                                                                                                                                                                  monovalent vaccine of Lawsonia
                                                    Countervailing Duty Centralized
                                                    Electronic Service System (‘‘ACCESS’’).5                                                                      intracellularis bacterin and assigned the
                                                                                                            DEPARTMENT OF COMMERCE                                vaccine product code 2799.20.
                                                    ACCESS is available to registered users
                                                    at http://access.trade.gov and to all                   United States Patent and Trademark                       Review of the application indicates
                                                    parties in the Central Records Unit,                    Office                                                that, except for permission to market or
                                                    Room 7046 of the main Department of                                                                           use the product commercially, the
                                                    Commerce building. In addition, a                       [Docket No. PTO–P–2015–0009]
                                                                                                                                                                  subject patent would be eligible for an
                                                    complete version of the Issues and                      Grant of Interim Extension of the Term                extension of the patent term under 35
                                                    Decision Memorandum can be accessed                     of U.S. Patent No. 5,610,059;                         U.S.C. 156, and that the patent should
                                                    at http://enforcement.trade.gov/frn/.                   Monovalent Lawsonia Intracellularis                   be extended for one year as required by
                                                    The signed Issues and Decision                          Bacterin Vaccine                                      35 U.S.C. 156(d)(5)(B). Because the
                                                    Memorandum and the electronic                                                                                 regulatory review period will continue
                                                    version of the Issues and Decision                      AGENCY: United States Patent and                      beyond the extended expiration date of
                                                    Memorandum are identical in content.                    Trademark Office, Commerce.                           the patent, March 11, 2015, interim
                                                    Final Results of the Sunset Review                      ACTION: Notice of Interim Patent Term                 extension of the patent term under 35
                                                                                                            Extension.                                            U.S.C. 156(d)(5) is appropriate.
                                                      Pursuant to sections 751(c)(1) and
                                                    752(c)(1) and (3) of the Act, the                       SUMMARY:   The United States Patent and                  An interim extension under 35 U.S.C.
                                                    Department determines that revocation                   Trademark Office has issued an order                  156(d)(5) of the term of U.S. Patent No.
                                                    of the Order would be likely to lead to                 granting interim extension under 35                   5,610,059 is granted for a period of one
                                                    continuation or recurrence of dumping                   U.S.C. 156(d)(5) for a one-year interim               year from the extended expiration date
                                                                                                            extension of the term of U.S. Patent No.              of the patent.
                                                      4 See the Department’s memorandum from                5,610,059.                                              Dated: March 2, 2015.
                                                    Christian Marsh, Deputy Assistant Secretary for         FOR FURTHER INFORMATION CONTACT:
                                                    Antidumping and Countervailing Duty Operations,                                                               Andrew Hirshfeld,
                                                    to Paul Piquado, Assistant Secretary for                Mary C. Till by telephone at (571) 272–
                                                                                                                                                                  Deputy Commissioner for Patent Examination
                                                    Enforcement and Compliance, entitled, ‘‘Issues and      7755; by mail marked to her attention                 Policy, United States Patent and Trademark
                                                    Decision Memorandum for the Final Results of the        and addressed to the Commissioner for                 Office.
                                                    Expedited Second Sunset Review of the                   Patents, Mail Stop Hatch-Waxman PTE,
                                                    Antidumping Duty Order on Tetrahydrofurfuryl                                                                  [FR Doc. 2015–05581 Filed 3–11–15; 8:45 am]
                                                    Alcohol From the People’s Republic of China,’’          P.O. Box 1450, Alexandria, VA 22313–
                                                                                                                                                                  BILLING CODE 3510–16–P
                                                    dated concurrently with this notice.                    1450; by fax marked to her attention at
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                      5 On November 24, 2014, Enforcement and               (571) 273–7755; or by email to
                                                    Compliance changed the name of Enforcement and          Mary.Till@uspto.gov.
                                                    Compliance’s AD and CVD Centralized Electronic
                                                    Service System (‘‘IA ACCESS’’) to AD and CVD            SUPPLEMENTARY INFORMATION: Section
                                                    Centralized Electronic Service System (‘‘ACCESS’’).     156 of Title 35, United States Code,
                                                    The Web site location was changed from http://          generally provides that the term of a
                                                    iaaccess.trade.gov to http://access.trade.gov. The
                                                    Final Rule changing the references to the
                                                                                                            patent may be extended for a period of
                                                    Regulations can be found at 79 FR 69046                 up to five years if the patent claims a
                                                    (November 20, 2014).                                    product, or a method of making or using


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Document Created: 2018-02-21 09:36:14
Document Modified: 2018-02-21 09:36:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of Interim Patent Term Extension.
ContactMary C. Till by telephone at (571)
FR Citation80 FR 12982 

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