Prospective Grant of a Start-Up Exclusive Patent License Agreement: Treatment of Graves' Disease, Hyperthyroidism and Thyroid Cancer, 31570 [2013-12375]

Download as PDF 31570 Federal Register / Vol. 78, No. 101 / Friday, May 24, 2013 / Notices Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814 Contact Person: Zhiqiang Zou, MD, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, 7W242, Bethesda, MD 20892, 240–276–6372, zouzhiq@mail.nih.gov Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: May 20, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–12377 Filed 5–23–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on DSK4VPTVN1PROD with NOTICES National Cancer Institute: Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, June 20, 2013, 03:00 p.m. to June 21, 2013, 06:00 p.m., Hilton Washington/ Rockville, 1750 Rockville Pike, Rockville, MD 20852 which was published in the Federal Register on May 06, 2013, 78FR10574. This notice is being amended due to a change in the meeting date and time from 3:00 p.m. to 6:00 p.m. on June 20 to 21, 2013 to 8:00 a.m. to 5:00 p.m. on June 20, 2013. The meeting is closed to the public. Dated: May 20, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–12376 Filed 5–23–13; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 21:14 May 23, 2013 Jkt 229001 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. 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: SUMMARY: 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 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: Lauren.Nguyen-antczak@nih.gov. 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 E:\FR\FM\24MYN1.SGM 24MYN1

Agencies

[Federal Register Volume 78, Number 101 (Friday, May 24, 2013)]
[Notices]
[Page 31570]
From the Federal Register Online via the Government Printing 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.

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

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: Lauren.Nguyen-antczak@nih.gov. 
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

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