Prospective Grant of Exclusive Patent License: Development and Commercialization of Dopamine D3 Receptor Selective Antagonists/Partial Agonists for the Treatment of Opioid Use Disorder, Schizophrenia Bipolar Disorder and Tetrahydrocannabinol Dependence

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Braeburn Pharmaceuticals, Inc. (“Braeburn”) located in Princeton, New Jersey to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.

DATES:

Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before December 14, 2016 will be considered.

ADDRESSES:

Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Martha Lubet, Ph.D., Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-276-5504; Email: lubetm@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

United States Provisional Patent Application No. 62/307600, filed March 14, 2016, entitled “Dopamine D3 Receptor Selective Antagonists/Partial Agonists; Methods of Making and Use Thereof” [HHS Reference No. E-053-2016]; and U.S. 8,748,608, Australian 2007354861, and Canadian 2690789 (which claim priority to PCT/US2007/71412 filed June 15, 2007) entitled “4-phenylpiperazine derivatives with functionalized linkers as dopamine D3 selective ligands and methods of use” [HHS Reference No. E-128-2006] (and U.S. and foreign patent applications or patents claiming priority to the aforementioned applications).

With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America.

The prospective Exclusive Patent License territory may be worldwide for the treatment opioid use disorder schizophrenia, bipolar disorder and tetrahydrocannabinol dependence, as set forth in the Licensed Patent Rights.

The present invention describes Dopamine D3 receptor ligands and methods of using the ligands to treat substance use disorders, schizophrenia, bipolar disorder and other mental disorders.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute on Drug Abuse 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.

Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent 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.