Federal Register: August 31, 2009 (Volume 74, Number 167)
DOCID: fr31au09-101 FR Doc E9-20881
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
NOTICE: NOTICES
DOCID: fr31au09-101
ACTION: Meetings:
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Prospective Grant of Exclusive License: Development of Anti- Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or Proadrenomedullin N-Terminal 20 Peptide (PAMP)
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.
DOCUMENT 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 GeneRelated Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E206
1995/0US01); U.S. Patent Application No. 60/002,936, filed on August
30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the
GeneRelated Product (PAMP) in Human Pathology and Physiology'' (HHS
Reference No. E2061995/1US01); U.S. Patent Application No. 60/
013,172, filed on March 12, 1996, entitled ``Functional Role of
Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology'' (HHS Reference No. E2061995/2US01); PCT
Application No. PCT/US96/13286, filed on August 16, 1996, entitled
``Functional Role of Adrenomedullin (AM) and the GeneRelated Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E206
1995/3PCT01); 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. E2061995/3AU02); Canadian Patent Application No.
2229741, filed on August 16, 1996, entitled ``Functional Role of [[Page 44863]]
Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology'' (HHS Reference No. E2061995/3CA03); U.S.
Patent No. 6,320,022, issued on November 20, 2001, entitled
``Adrenomedullin Peptides'' (HHS Reference No. E2061995/3US04);
European Patent No. 0845036, issued on June 2, 1999, entitled
``Functional Role of Adrenomedullin (AM) and the GeneRelated Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E206
1995/3EP07), 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. E2061995/3JP09); U.S. Patent No. 7,101,548, issued on
September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM)
and the GeneRelated Product (PAMP) in Human Pathology and Physiology''
(HHS Reference No. E2061995/3US10); U.S. Patent Application No. 11/
517,599, filed on September 5, 2006, entitled ``Functional Role of
Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human
Pathology and Physiology'' (HHS Reference No. E2061995/3US11);
Japanese Patent No. 4077861, issued on February 8, 2008, entitled
``Functional Role of Adrenomedullin (AM) and the GeneRelated Product
(PAMP) in Human Pathology and Physiology'' (HHS Reference No. E206
1995/3JP12); U.S. Patent Application No. 60/153,397, filed on
September 10, 1999, entitled ``Determination of AMBinding Proteins and
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No.
E2561999/0US01); PCT Application No. PCT/US00/24722, filed on
September 8, 2000, entitled ``Determination of AMBinding Proteins and
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No.
E2561999/0PCT02); Australian Patent No. 774725, issued on May 25,
2004, entitled ``Determination of AMBinding Proteins and the
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E
2561999/0AU03); Canadian Patent Application No. 2383419, filed on
September 8, 2000, entitled ``Determination of AMBinding Proteins and
the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No.
E2561999/0CA04); European Patent No. 1214600, issued on December
21, 2005, entitled ``Determination of AMBinding Proteins and the
Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E
2561999/0EP05), 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 AMBinding
Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS
Reference No. E256091999/0US06); 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. E2561999/0US13); 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. E2561999/0US14); U.S. Patent Application No. 60/
425,018, filed on November 7, 2002, entitled ``A New Target for
Angiogenesis and AntiAngiogenesis Therapy'' (HHS Reference No. E294
2002/0US01); PCT Application No. PCT/US03/35633, filed on November 7,
2003, entitled ``A New Target for Angiogenesis and AntiAngiogenesis
Therapy'' (HHS Reference No. E2942002/0PCT02); U.S. Patent No.
7,462,593, issued on December 9, 2008, entitled ``Compositions and
Methods for Promoting Angiogenesis'' (HHS Reference No. E2942002/0
US03); European Patent Application No. 03786608.4, filed on November
7, 2003, entitled ``A New Target for Angiogenesis and AntiAngiogenesis
Therapy'' (HHS Reference No. E2942002/0EP04); Australian Patent
Application No. 2003295422, filed on April 18, 2005, entitled ``A New
Target for Angiogenesis and AntiAngiogenesis Therapy'' (HHS Reference
No. E2942002/0AU05); Canadian Patent Application No. 2504953, filed
on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti
Angiogenesis Therapy'' (HHS Reference No. E2942002/0CA06); Japanese
Patent Application No. 2004551922, filed on May 9, 2005, entitled ``A
New Target for Angiogenesis and AntiAngiogenesis Therapy'' (HHS
Reference No. E2942002/0JP07); U.S. Patent Application No. 12/
240,656, filed on September 29, 2008, entitled ``Target for Anti
Angiogenesis Therapy'' (HHS Reference No. E2942002/0US08); U.S.
Patent Application No. 60/500,650, filed on September 8, 2003, entitled
``NonPeptide Agonists and Antagonists of Adrenomedullin (AM) And
Gastrin Releasing Peptide'' (HHS Reference No. E2462003/0US01); PCT
Application No. PCT/US04/29293, filed on September 8, 2004, entitled
``NonPeptide Agonists and Antagonists of Adrenomedullin (AM) And
Gastrin Releasing Peptide'' (HHS Reference No. E2462003/1PCT01);
European Patent Application No. 04783513.7, filed on September 8, 2004,
entitled ``NonPeptide Agonists and Antagonists of Adrenomedullin (AM)
And Gastrin Releasing Peptide'' (HHS Reference No. E2462003/1EP03);
Canadian Patent Application No. 2539467, filed on September 8, 2004,
entitled ``NonPeptide Agonists and Antagonists of Adrenomedullin (AM)
And Gastrin Releasing Peptide'' (HHS Reference No. E2462003/1CA04);
Australian Patent Application No. 2004273057, filed on September 8,
2004, entitled ``NonPeptide Agonists and Antagonists of Adrenomedullin
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E2462003/1
AU05); and U.S. Patent Application No. 10/571,012, filed on March 8,
2006, entitled ``NonPeptide Agonists and Antagonists of Adrenomedullin
(AM) And Gastrin Releasing Peptide'' (HHS Reference No. E2462003/1
US06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of
business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria
3052, Australia, a whollyowned subsidiary of Arana Therapeutics
Limited, having a place of business at Level 2, 37 Epping Road,
Macquarie Park, NSW 2113, Australia, a whollyowned 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''.
SUMMARY:
Prospective Grant of Exclusive License
SUPPLEMENTAL INFORMATION
These technologies relate to adrenomedullin and proadrenomedullin Nterminal 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 royaltybearing 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. E920881 Filed 82809; 8:45 am]
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