[Federal Register Volume 78, Number 101 (Friday, May 24, 2013)]
[Notices]
[Page 31570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of a Start-Up Exclusive Patent License 
Agreement: Treatment of Graves' Disease, Hyperthyroidism and 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(c)(1) and 37 
CFR 404.7(a)(1)(i), 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:

    1. PCT Application No.: PCT/US2011/031752 filed 08 Apr 2011, HHS 
Ref. No.: E-067-2010/0-PCT-02, Titled: Inverse Agonists and Neutral 
Antagonists for the TSH Receptor, Inventors: Marvin Gershengorn 
(NIDDK), Susanne Neumann (NIDDK), Wenwei Huang (NCATS), Craig Thomas 
(NCATS).
    2. Australian Application No.: 2011237421 filed 15 Aug 2012, HHS 
Ref. No.: E-067-2010/0-AU-03.
    3. Canadian Application No.: 2,789,818 filed 15 Aug 2012, HHS 
Ref. No.: E-067-2010/0-CA-04.
    4. Chinese Application No.: 201180013235.9 filed 15 Aug 2012, 
HHS Ref. No.: E-067-2010/0-CN-05.
    5. European Application No.: 11766807.9 filed 15 Aug 2012, HHS 
Ref. No.: E-067-2010/0-EP-06.
    6. Indian Application No.: 2055/KOLNP/2012 filed 15 Aug 2012, 
HHS Ref. No.: E-067-2010/0-IN-07.
    7. Japanese Application No.: 2013-503984 filed 15 Aug 2012, HHS 
Ref. No.: E-067-2010/0-JP-08.
    8. U.S. Application No.: 13/579,251 filed 15 Aug 2012, HHS Ref. 
No.: E-067-2010/0-US-09.

    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: Treatment of Graves' 
Disease, hyperthyroidism and 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 June 10, 2013 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., 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 antagonize the activity of the thyroid stimulating 
hormone receptor (``TSHR''). These antagonists are classified into two 
functional categories: (a) Neutral antagonists that prevent TSHR from 
being turned on, and (b) inverse agonists that turn off active TSHR. 
Both categories of antagonists may be useful in treating 
hyperthyroidism and Graves' disease, an autoimmune disease that is 
commonly associated with hyperthyroidism. In addition, certain small 
molecule compounds that function as inverse agonists of TSHR may be 
effective in reducing the recurrence of thyroid cancer.
    The prospective Start-Up Exclusive Patent License is being 
considered under the small business initiative launched on 1 October 
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR 404.7. 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 404.7.
    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: May 20, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-12375 Filed 5-23-13; 8:45 am]
BILLING CODE 4140-01-P