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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, 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 (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                               ( print 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-256-1999/0-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:**tarak@mail.nih.gov.*

# SUPPLEMENTARY INFORMATION:

                    These technologies relate to adrenomedullin and proadrenomedullin N-terminal 20                           ( print 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