[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80955-80956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Methanocarba 
Analogues of Purine and Pyrimidine Nucleosides and Nucleotides to Treat 
or Prevent Cardiac Diseases in Humans

AGENCY: National Institutes of Health, Public Health Service, 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 (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of a worldwide exclusive evaluation option license, to practice 
the inventions embodied in U.S. Provisional Patent Application No. 60/
176,373, filed January 14, 2000 and currently abandoned [HHS Ref. No. 
E-176-1999/0-US-01]; PCT Application PCT/US01/00981, filed January 12, 
2001 and currently expired [HHS Ref. No. E-176-1999/0-PCT-02]; U.S. 
Patent Application No. 10/169,975, filed July 12, 2002 and issued as 
U.S. Patent No. 7,087,589 on August 8, 2006 [HHS Ref. No. E-176-1999/0-
US-06]; U.S. Patent Application No. 11/500,860, filed August 8, 2006 
and issued as U.S. Patent No. 7,790,735 on September 14, 2006 [HHS Ref. 
No. E-176-1999/0-US-07]; Australian Patent Application No. 2001230913, 
filed January 12, 2001 and issued as Australian Patent No. 2001230913 
on October 13, 2005 [HHS Ref. No. E-176-1999/0-AU-03]; Canadian Patent 
Application No. 2,397,366, filed January 12, 2001 and issued as 
Canadian Patent No. 2,397,366 on March 15, 2011 [HHS Ref. No. E-176-
1999/0-CA-04]; European Patent Application No. 01903043.6, filed 
January 12, 2001 and issued as European Patent No. 1252160 on August 6, 
2006 and currently abandoned [HHS Ref. No. E-176-1999/0-EP-05]; and UK 
Patent Application No. 01903043.6, filed January 12, 2001 and issued as 
UK Patent No. 1252160 on August 16, 2006 [HHS Ref. No. E-176-1999/0-GB-
08], entitled ``Methanocarba Cycloalkyl

[[Page 80956]]

Nucleoside Analogues'' to Cornovus Pharmaceuticals, Inc., a company 
incorporated under the laws of the State of Delaware having its 
headquarters in Farmington, Connecticut. The United States of America 
is the assignee of the rights of the above inventions. The prospective 
exclusive evaluation option license territory may be ``worldwide'', and 
the field of use may be limited to ``The use of (1'S,2R,3S,4'R,5'S)-4-
(6-amino-2-chloro-9H-purin-9-yl)-1-[phosphoryloxymethyl] 
bicycle[3.1.0]hexane-2,3-diol) (MRS2339) to treat and/or prevent 
cardiac diseases in humans.'' Upon the expiration or termination of the 
exclusive evaluation option license, Cornovus Pharmaceuticals, Inc. 
will have the right to execute an exclusive patent commercialization 
license which will supersede and replace the exclusive evaluation 
option license with no greater field of use and territory than granted 
in the evaluation license.

DATES: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before January 11, 2012 
will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Suryanarayana (Sury) Vepa, Ph.D., J.D., Office 
of Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
5020; Facsimile: (301) 402-0220; Email: [email protected]. A signed 
confidentiality nondisclosure agreement will be required to receive 
copies of any patent applications that have not been published or 
issued by the United States Patent and Trademark Office or the World 
Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: The present technology is premised upon the 
novel combination of adenine and uracil and their derivatives with a 
constrained cycloalkyl group, typically a cyclopentyl group. The 
constraint on the cycloalkyl group is introduced by fusion to a second 
cycloalkyl group. In the case of cyclopentane, the fusion is typically 
with cyclopropane. The compounds disclosed in this technology retain a 
surprising binding affinity despite the substitution for the ribose 
group. Moreover, the absence of the glycosidic bond in the compounds 
assists in improving the chemical stability of these compounds and aids 
in overcoming the stability problem associated with the glycosidic bond 
in previously known P1 and P2 receptor ligands. The compounds of the 
present technology are useful in the treatment or prevention of various 
cardiac and other disorders.
    The prospective exclusive evaluation option license will comply 
with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The 
prospective exclusive evaluation option license may be granted unless, 
within fifteen (15) days from the date of this published notice, 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 404.7.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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 20, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-33131 Filed 12-23-11; 8:45 am]
BILLING CODE 4140-01-P