Prospective Grant of Exclusive License: Start-Up Commercial License for the Development of Fenoterol and Fenoterol Analogues for the Treatment of Brain, Liver, and Pancreatic Cancers and Congestive Heart Failure, 37234 [2013-14645]

Download as PDF 37234 Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Start-Up Commercial License for the Development of Fenoterol and Fenoterol Analogues for the Treatment of Brain, Liver, and Pancreatic Cancers and Congestive Heart Failure AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Mitchell Woods Pharmaceuticals, LLC, of an exclusive commercialization license to practice the inventions embodied in the following U.S. Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/651,961, filed May 25, 2012, entitled, ‘‘Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases’’ [HHS Reference E–139–2012/0–US–1]; Serial No. 61/789,629, filed March 15, 2013, entitled, ‘‘Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases’’ [HHS Reference E–139–2012/1–US–1]; Serial No. 61/ 312,642, filed March 10, 2010, entitled, ‘‘The Use of Fenoterol and Fenoterol Analogues in the Treatment of Glioblastomas and Astrocytomas’’ [HHS Reference E–013–2010/0–US–01]; Serial No. 60/837,161, filed August 10, 2006, entitled, ‘‘Preparation of R,R-Fenoterol and R,R-Fenoterol Analogues and Their Use in Congestive Heart Failure’’ [HHS Reference E–205–2006/0–US–1]; and Serial No. 60/927,825, filed May 3, 2007, entitled ‘‘Preparation of R,RFenoterol and R,R-Fenoterol Analogues and Their Use in Congestive Heart Failure’’ [HHS Reference E–205–2006/ 1–US–1]. The patent rights in these inventions have been assigned or exclusively licensed to the Government of the United States of America. The prospective exclusive commercialization license territory may be worldwide, and the scope may be limited to the following two fields of use: TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: Licensed Field of Use I: An exclusive license to the Patent Rights for research, development, manufacture, distribution, sale, and use in humans for the treatment of brain cancer, liver cancer, or pancreatic cancer within the Licensed Territory of (R,R′)-4′methoxy-1-napthylfenoterol (MNF), (R,S′)-4′methoxy-1-napthylfenoterol, (R,R′)ethylMNF, (R,R′)-napthylfenoterol, (R,S′) VerDate Mar<15>2010 17:01 Jun 19, 2013 Jkt 229001 napthylfenoterol, (R,R′)-ethylnapthylfenoterol, and (R,R′)-4′-amino-1napthylfenoterol, (R,R′)-4′-hydroxy-1napthylfenoterol, (R,R′)-4-methoxyethylfenoterol, (R,R′)-methoxyfenoterol, (R,R′)-ethylfenoterol, (R,R′)-fenoterol; and their respective stereoisomers. Licensed Field of Use II: An exclusive license to the Patent Rights for research, development, and manufacture of Licensed Products incorporating the Licensed Patent Rights; and distribution, sale, and use of such Licensed Products in humans for the treatment of congestive heart failure within the Licensed Territory. Dated; June 14, 2013. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. Only written comments or applications for a license (or both) which are received by the NIH Office of Technology Transfer on or before July 5, 2013 will be considered. Notice of Invitation; Coal Exploration License Application NDM 105349, ND DATES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Patrick McCue, 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) 435–5560; Facsimile: (301) 402–0220; Email: mccuepat@mail.nih.gov. ADDRESSES: This invention concerns the use of fenoterol analogues in treatments for tumors expressing a cannabinoid receptor, and in treatments for congestive heart failure. The prospective exclusive commercialization 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 exclusive commercialization license may be granted unless the NIH receives written evidence and argument 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 404.7 within fifteen (15) days from the date of this published notice. Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive commercialization 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 [FR Doc. 2013–14645 Filed 6–19–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLMT921000–13–L13200000–EL0000–P; NDM 105349] Bureau of Land Management, Interior. ACTION: Notice. AGENCY: Members of the public are invited to participate with BNI Coal Ltd. on a pro rata cost sharing basis in a program for the exploration of coal deposits owned by the United States of America in lands located in Oliver County, North Dakota, encompassing 480 acres. DATES: Any party seeking to participate in this exploration program must send written notice to both the Bureau of Land Management (BLM) and BNI Coal Ltd. as provided in the ADDRESSES section below no later than July 22, 2013 or 10 calendar days after the last publication of this Notice in the Bismarck Tribune newspaper, whichever is later. This Notice will be published once a week for 2 consecutive weeks in the Bismarck Tribune, Bismarck, North Dakota. Such written notice must refer to serial number NDM 105349. ADDRESSES: The proposed exploration license and plan are available for review from 9 a.m. to 4 p.m., Monday through Friday, in the public room at the BLM Montana State Office, 5001 Southgate Drive, Billings, Montana. A written notice to participate in the exploration license should be sent to the State Director, BLM Montana State Office, 5001 Southgate Drive, Billings, MT 59101–4669 and BNI Coal, 2360 35th Ave. SW., Center, ND 58530. FOR FURTHER INFORMATION CONTACT: Anne Allen by telephone at 406–896– 5082 or by email at amallen@blm.gov; or Kym Dowdle by telephone at 406–896– 5046 or by email at kdowdle@blm.gov. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 to contact the above individual during normal business hours. The FIRS is available 24 SUMMARY: E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Page 37234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14645]



[[Page 37234]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Start-Up Commercial 
License for the Development of Fenoterol and Fenoterol Analogues for 
the Treatment of Brain, Liver, and Pancreatic Cancers and Congestive 
Heart Failure

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 Part 404.7(a)(1)(i), that the National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant to 
Mitchell Woods Pharmaceuticals, LLC, of an exclusive commercialization 
license to practice the inventions embodied in the following U.S. 
Patent Applications (and all continuing applications and foreign 
counterparts): Serial No. 61/651,961, filed May 25, 2012, entitled, 
``Methods of Regulating Cannabinoid Receptor Activity-related Disorders 
and Diseases'' [HHS Reference E-139-2012/0-US-1]; Serial No. 61/
789,629, filed March 15, 2013, entitled, ``Methods of Regulating 
Cannabinoid Receptor Activity-related Disorders and Diseases'' [HHS 
Reference E-139-2012/1-US-1]; Serial No. 61/312,642, filed March 10, 
2010, entitled, ``The Use of Fenoterol and Fenoterol Analogues in the 
Treatment of Glioblastomas and Astrocytomas'' [HHS Reference E-013-
2010/0-US-01]; Serial No. 60/837,161, filed August 10, 2006, entitled, 
``Preparation of R,R-Fenoterol and R,R-Fenoterol Analogues and Their 
Use in Congestive Heart Failure'' [HHS Reference E-205-2006/0-US-1]; 
and Serial No. 60/927,825, filed May 3, 2007, entitled ``Preparation of 
R,R-Fenoterol and R,R-Fenoterol Analogues and Their Use in Congestive 
Heart Failure'' [HHS Reference E-205-2006/1-US-1]. The patent rights in 
these inventions have been assigned or exclusively licensed to the 
Government of the United States of America.
    The prospective exclusive commercialization license territory may 
be worldwide, and the scope may be limited to the following two fields 
of use:

    Licensed Field of Use I: An exclusive license to the Patent 
Rights for research, development, manufacture, distribution, sale, 
and use in humans for the treatment of brain cancer, liver cancer, 
or pancreatic cancer within the Licensed Territory of (R,R')-4'-
methoxy-1-napthylfenoterol (MNF), (R,S')-4'-methoxy-1-
napthylfenoterol, (R,R')-ethylMNF, (R,R')-napthylfenoterol, (R,S') 
napthylfenoterol, (R,R')-ethyl-napthylfenoterol, and (R,R')-4'-
amino-1-napthylfenoterol, (R,R')-4'-hydroxy-1-napthylfenoterol, 
(R,R')-4-methoxy-ethylfenoterol, (R,R')-methoxyfenoterol, (R,R')-
ethylfenoterol, (R,R')-fenoterol; and their respective 
stereoisomers.
    Licensed Field of Use II: An exclusive license to the Patent 
Rights for research, development, and manufacture of Licensed 
Products incorporating the Licensed Patent Rights; and distribution, 
sale, and use of such Licensed Products in humans for the treatment 
of congestive heart failure within the Licensed Territory.

DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before July 5, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Patrick McCue, 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) 435-5560; Facsimile: (301) 
402-0220; Email: mccuepat@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This invention concerns the use of fenoterol 
analogues in treatments for tumors expressing a cannabinoid receptor, 
and in treatments for congestive heart failure.
    The prospective exclusive commercialization 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 exclusive commercialization license 
may be granted unless the NIH receives written evidence and argument 
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 404.7 within 
fifteen (15) days from the date of this published notice.
    Complete applications for a license in the field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive commercialization 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; June 14, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-14645 Filed 6-19-13; 8:45 am]
BILLING CODE 4140-01-P
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