[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Notices]
[Pages 44862-44864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Anti-
Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or 
Proadrenomedullin N-Terminal 20 Peptide (PAMP)

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, is contemplating the grant of 
an exclusive patent license to practice the inventions embodied in U.S. 
Patent Application No. 60/002,514, filed on August 18, 1995, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/0-US-01); U.S. Patent Application No. 60/002,936, filed on August 
30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the 
Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS 
Reference No. E-206-1995/1-US-01); U.S. Patent Application No. 60/
013,172, filed on March 12, 1996, entitled ``Functional Role of 
Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human 
Pathology and Physiology'' (HHS Reference No. E-206-1995/2-US-01); PCT 
Application No. PCT/US96/13286, filed on August 16, 1996, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-PCT-01); Australian Patent No. 710662, issued on October 5, 
2000, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-
Related Product (PAMP) in Human Pathology and Physiology'' (HHS 
Reference No. E-206-1995/3-AU-02); Canadian Patent Application No. 
2229741, filed on August 16, 1996, entitled ``Functional Role of

[[Page 44863]]

Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human 
Pathology and Physiology'' (HHS Reference No. E-206-1995/3-CA-03); U.S. 
Patent No. 6,320,022, issued on November 20, 2001, entitled 
``Adrenomedullin Peptides'' (HHS Reference No. E-206-1995/3-US-04); 
European Patent No. 0845036, issued on June 2, 1999, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-EP-07), and validated in France, Germany, and the United 
Kingdom; Japanese Patent Application No. 509499/97, filed on August 16, 
1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-
Related Product (PAMP) in Human Pathology and Physiology'' (HHS 
Reference No. E-206-1995/3-JP-09); U.S. Patent No. 7,101,548, issued on 
September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) 
and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' 
(HHS Reference No. E-206-1995/3-US-10); U.S. Patent Application No. 11/
517,599, filed on September 5, 2006, entitled ``Functional Role of 
Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human 
Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-11); 
Japanese Patent No. 4077861, issued on February 8, 2008, entitled 
``Functional Role of Adrenomedullin (AM) and the Gene-Related Product 
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-
1995/3-JP-12); U.S. Patent Application No. 60/153,397, filed on 
September 10, 1999, entitled ``Determination of AM-Binding Proteins and 
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. 
E-256-1999/0-US-01); PCT Application No. PCT/US00/24722, filed on 
September 8, 2000, entitled ``Determination of AM-Binding Proteins and 
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. 
E-256-1999/0-PCT-02); Australian Patent No. 774725, issued on May 25, 
2004, entitled ``Determination of AM-Binding Proteins and the 
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-
256-1999/0-AU-03); Canadian Patent Application No. 2383419, filed on 
September 8, 2000, entitled ``Determination of AM-Binding Proteins and 
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. 
E-256-1999/0-CA-04); European Patent No. 1214600, issued on December 
21, 2005, entitled ``Determination of AM-Binding Proteins and the 
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-
256-1999/0-EP-05), and validated in France, Germany, the United 
Kingdom, Italy, Spain, and Portugal; U.S. Patent Application No. 10/
070,853, filed on March 8, 2002, entitled ``Determination of AM-Binding 
Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS 
Reference No. E-256091999/0-US-06); U.S. Patent Application No. 11/
530,411, filed on September 8, 2006, entitled ``Determination of AM-
Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' 
(HHS Reference No. E-256-1999/0-US-13); U.S. Patent Application No. 12/
236,418, filed on September 23, 2008, entitled ``Determination of AM-
Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' 
(HHS Reference No. E-256-1999/0-US-14); U.S. Patent Application No. 60/
425,018, filed on November 7, 2002, entitled ``A New Target for 
Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-
2002/0-US-01); PCT Application No. PCT/US03/35633, filed on November 7, 
2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis 
Therapy'' (HHS Reference No. E-294-2002/0-PCT-02); U.S. Patent No. 
7,462,593, issued on December 9, 2008, entitled ``Compositions and 
Methods for Promoting Angiogenesis'' (HHS Reference No. E-294-2002/0-
US-03); European Patent Application No. 03786608.4, filed on November 
7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis 
Therapy'' (HHS Reference No. E-294-2002/0-EP-04); Australian Patent 
Application No. 2003295422, filed on April 18, 2005, entitled ``A New 
Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference 
No. E-294-2002/0-AU-05); Canadian Patent Application No. 2504953, filed 
on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-
Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-CA-06); Japanese 
Patent Application No. 2004-551922, filed on May 9, 2005, entitled ``A 
New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS 
Reference No. E-294-2002/0-JP-07); U.S. Patent Application No. 12/
240,656, filed on September 29, 2008, entitled ``Target for Anti-
Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-US-08); U.S. 
Patent Application No. 60/500,650, filed on September 8, 2003, entitled 
``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And 
Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/0-US-01); PCT 
Application No. PCT/US04/29293, filed on September 8, 2004, entitled 
``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And 
Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-PCT-01); 
European Patent Application No. 04783513.7, filed on September 8, 2004, 
entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) 
And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-EP-03); 
Canadian Patent Application No. 2539467, filed on September 8, 2004, 
entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) 
And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-CA-04); 
Australian Patent Application No. 2004273057, filed on September 8, 
2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin 
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-
AU-05); and U.S. Patent Application No. 10/571,012, filed on March 8, 
2006, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin 
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-
US-06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of 
business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria 
3052, Australia, a wholly-owned subsidiary of Arana Therapeutics 
Limited, having a place of business at Level 2, 37 Epping Road, 
Macquarie Park, NSW 2113, Australia, a wholly-owned subsidiary of 
Cephalon, Inc., having a place of business at 41 Moores Road, Frazer, 
PA 19355, USA. The patent rights in this invention have been assigned 
to the United States of America.
    The contemplated exclusive license territory may be worldwide, and 
the field of use may be limited to ``use of peptide and affinity 
binding reagents (including but not limited to antibodies) that 
neutralize the action of PAMP or adrenomedullin to treat cancer''.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before October 
30, 2009 will be considered.

ADDRESSES: Requests for copies of the patents, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Tara L. Kirby, 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-
4426; Facsimile: 301-402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: These technologies relate to adrenomedullin 
and proadrenomedullin N-terminal 20

[[Page 44864]]

peptide (PAMP), two potent angiogenic factors that are products of the 
same gene. Therapies that reduce (antagonize) the action of these 
factors have the potential to treat conditions where angiogenesis plays 
a pathological role, such as cancer and macular degeneration. 
Conversely, increasing (agonizing) the action of these factors may be 
useful for conditions where enhanced angiogenesis is desired, such as 
wound healing and cardiovascular disease. Adrenomedullin and PAMP have 
also been shown to play a role in other diseases, such as 
neurodegenerative disorders, diabetes, and allergic and inflammatory 
disease.
    More specifically, these technologies include peptides, antibodies 
and small molecules that agonize or antagonize the activity of 
adrenomedullin and PAMP. They also include methods for inhibiting or 
inducing angiogenesis, methods for inhibiting tumor growth, methods for 
treating cancer, and methods of treating a number of other conditions, 
such as wounds, neurological disease, allergic or inflammatory disease, 
diabetes, and cardiovascular disease.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, 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 404.7.
    Applications for a license in the prospective field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive 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: August 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-20881 Filed 8-28-09; 8:45 am]
BILLING CODE 4140-01-P