[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Page 73601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of a Start-Up Exclusive Patent License 
Agreement: Use of Compounds Covered by Patent Rights for Diagnosis of 
Human Thyroid Cancer Requiring FDA Premarket Approval or an Equivalent 
Authority Outside of the United States, and Treatment of Human Thyroid 
Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of a Start-Up Exclusive 
Patent License to Nova Therapeutics LLC, a company having a place of 
business in Delaware, to practice the inventions embodied in the 
following patent applications:

(a) PCT Patent Application No. PCT/US2008/11958, Filed: October 20, 
2008, HHS Ref. No.: E-284-2008/0-PCT-01
(b) Australian Patent No. 2008-363295, Filed: October 20, 2008, HHS Ref 
No.: E-284-2008/0-AU-02
(c) Canadian Patent Application No. 2,741,030, Filed: October 20, 2008, 
HHS Ref. No.: E-284-2008/0-CA-03
(d) European Patent Application No. 08876356.0, Filed: October 20, 
2008, HHS Ref. No.: E-284-2008/0-EP-04
(e) Indian Patent Application No. 3684/DELNP/2011, Filed: October 20, 
2008, HHS Ref. No.: E-284-2008/0-IN-05
(f) Japanese Patent Application No. 2011-532048, Filed: October 20, 
2008, HHS Ref. No.: E-284-2008/0-JP-06
(g) U.S. Patent No. 8,741,259 U.S. Patent Application No. 13/125,045, 
Filed: October 20, 2008, HHS Ref. No.: E-284-2008/0-US-07
(h) U.S. Patent Application No. 13/897,330, Filed: October 20, 2008, 
HHS Ref. No.: E-284-2008/0-US-08 Current status: pending
(i) U.S. Patent Application No. 14/243,821, Filed: October 20, 2008, 
HHS Ref. No.: E-284-2008/0-US-10

    The patent rights in this invention have been assigned to the 
Government of the United States of America. The territory of the 
prospective Start-Up Exclusive Patent License Agreement may be 
worldwide and the field of use may be limited to: Use of compounds 
covered by Patent Rights for diagnosis of human thyroid cancer 
requiring FDA premarket approval or an equivalent authority outside of 
the United States, and treatment of human thyroid cancer.

DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before December 26, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated Start-Up 
Exclusive Patent License Agreement should be directed to: Lauren 
Nguyen-Antczak, Ph.D., J.D., Licensing and Patenting Manager, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
4074; Facsimile: (301) 402-0220; Email: [email protected]. 
A signed confidentiality nondisclosure agreement will be required to 
receive copies of any patent application(s) that have not been 
published or issued by the United States Patent and Trademark Office of 
the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: This invention concerns small molecule 
compounds that agonize the activity of the thyroid stimulating hormone 
receptor (``TSHR''). These TSHR agonists enhance or activate the 
thyroid stimulating hormone (``TSH'') signaling pathway by directly 
binding to the transmembrane domain of TSHR. Invention compounds may be 
administered alone or in combination with radioactive iodine to detect 
thyroid cancer cells. Additionally, invention compounds may be 
administered in combination with radioactive iodine to treat thyroid 
cancer, such as to ablate thyroid remnants in patients after a 
thyroidectomy.
    The prospective Start-Up Exclusive Patent License that is being 
considered can be found at http://www.ott.nih.gov/forms-model-agreements#SUMLA, which complies with the terms and conditions of 35 
U.S.C. 209 and 37 CFR part 404. The prospective Start-Up Exclusive 
Patent License is being provided under the small business initiative 
launched on 1 October 2011. The prospective Start-Up Exclusive Patent 
License may be granted unless the NIH receives written evidence and 
argument, within fifteen (15) days from the date of this published 
notice, that establishes that the grant of the license would not be 
consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Start-Up Exclusive Patent License. 
Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: December 4, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2014-29017 Filed 12-10-14; 8:45 am]
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