81_FR_86211 81 FR 85982 - 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

81 FR 85982 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 229 (November 29, 2016)

Page Range85982-85983
FR Document2016-28698

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.

Federal Register, Volume 81 Issue 229 (Tuesday, November 29, 2016) 
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85982-85983]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: [email protected].

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.

[[Page 85983]]

    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.

    Dated: November 23, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-28698 Filed 11-28-16; 8:45 am]
 BILLING CODE 4140-01-P

85982 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices notify the Contact Person listed below Dated: November 22, 2016. DATES: Only written comments and/or in advance of the meeting. David Clary, applications for a license which are The meetings will be closed to the Program Analyst, Office of Federal Advisory received by the NCI Technology public in accordance with the Committee Policy. Transfer Center on or before December provisions set forth in sections [FR Doc. 2016–28625 Filed 11–28–16; 8:45 am] 14, 2016 will be considered. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P ADDRESSES: Requests for copies of the as amended. The grant applications patent applications, inquiries, and and/or contract proposals and the comments relating to the contemplated discussions could disclose confidential DEPARTMENT OF HEALTH AND Exclusive Patent License should be trade secrets or commercial property HUMAN SERVICES directed to: Martha Lubet, Ph.D., such as patentable material, and National Institutes of Health Licensing and Patenting Manager, NCI personal information concerning Technology Transfer Center, 9609 individuals associated with the grant National Institute of Allergy and Medical Center Drive, RM 1E530 MSC applications and/or contract proposals, Infectious Diseases; Amended Notice 9702, Bethesda, MD 20892–9702 (for the disclosure of which would of Meeting business mail), Rockville, MD 20850– constitute a clearly unwarranted 9702 Telephone: (240)–276–5530; invasion of personal privacy. Notice is hereby given of a change in Facsimile: (240)–276–5504; Email: the meeting of the National Institute of lubetm@mail.nih.gov. Name of Committee: Cures Acceleration Allergy and Infectious Diseases Special Network Review Board. Emphasis Panel, December 14, 2016, SUPPLEMENTARY INFORMATION: United Date: January 12, 2017. States Provisional Patent Application 8:00 a.m. to December 15, 2016, 6:00 Time: 8:30 a.m. to 2:30 p.m. No. 62/307600, filed March 14, 2016, Agenda: Report from the Institute Director. p.m., Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 entitled ‘‘Dopamine D3 Receptor Place: National Institutes of Health, Selective Antagonists/Partial Agonists; Building 31, Conference Room 10, 31 Center Wisconsin Avenue, Bethesda, MD 20814 which was published in the Federal Methods of Making and Use Thereof’’ Drive, Bethesda, MD 20892. [HHS Reference No. E–053–2016]; and Contact Person: Anna L. Ramsey-Ewing, Register on November 21, 2016, 81 FR 83253. U.S. 8,748,608, Australian 2007354861, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, 1 This meeting notice is amended to and Canadian 2690789 (which claim Democracy Plaza, Room 1072, Bethesda, MD change the start date of the meeting priority to PCT/US2007/71412 filed 20892, 301–435–0809, anna.ramseyewing@ from December 14, 2016 to December 9, June 15, 2007) entitled ‘‘4- nih.gov. 2016. The meeting is closed to the phenylpiperazine derivatives with Name of Committee: National Center for public. functionalized linkers as dopamine D3 Advancing Translational Sciences Advisory selective ligands and methods of use’’ Dated: November 22, 2016. Council. [HHS Reference No. E–128–2006] (and Natasha M. Copeland, U.S. and foreign patent applications or Date: January 12, 2017. Program Analyst, Office of Federal Advisory patents claiming priority to the Open: 8:30 a.m. to 2:30 p.m. Committee Policy. aforementioned applications). Agenda: Report from the Institute Director and other staff. [FR Doc. 2016–28643 Filed 11–28–16; 8:45 am] With respect to persons who have an Place: National Institutes of Health, BILLING CODE 4140–01–P obligation to assign their right, title and Building 31, Conference Room 10, 31 Center interest to the Government of the United Drive, Bethesda, MD 20892. States of America, the patent rights in Closed: 3:00 p.m. to 4:30 p.m. DEPARTMENT OF HEALTH AND these inventions have been assigned to Agenda: To review and evaluate grant HUMAN SERVICES the Government of the United States of applications. National Institutes of Health America. Place: National Institutes of Health, Building 31, Conference Room 10, 31 Center The prospective Exclusive Patent Drive, Bethesda, MD 20892. Prospective Grant of Exclusive Patent License territory may be worldwide for Contact Person: Anna L. Ramsey-Ewing, License: Development and the treatment opioid use disorder Ph.D., Executive Secretary, National Center Commercialization of Dopamine D3 schizophrenia, bipolar disorder and for Advancing Translational Sciences, 1 Receptor Selective Antagonists/Partial tetrahydrocannabinol dependence, as Democracy Plaza, Room 1072, Bethesda, MD Agonists for the Treatment of Opioid set forth in the Licensed Patent Rights. 20892, 301–435–0809, anna.ramseyewing@ Use Disorder, Schizophrenia Bipolar The present invention describes nih.gov. Disorder and Tetrahydrocannabinol Dopamine D3 receptor ligands and In the interest of security, NIH has Dependence methods of using the ligands to treat instituted stringent procedures for entrance substance use disorders, schizophrenia, onto the NIH campus. All visitor vehicles, AGENCY: National Institutes of Health, HHS. bipolar disorder and other mental including taxicabs, hotel, and airport shuttles disorders. will be inspected before being allowed on ACTION: Notice. This notice is made in accordance campus. Visitors will be asked to show one form of identification (for example, a SUMMARY: The National Institute on with 35 U.S.C. 209 and 37 CFR part 404. government-issued photo ID, driver’s license, Drug Abuse, National Institutes of The prospective Exclusive Patent Health, Department of Health and License will be royalty bearing and may asabaliauskas on DSK3SPTVN1PROD with NOTICES or passport) and to state the purpose of their visit. Human Services, is contemplating the be granted unless within fifteen (15) (Catalogue of Federal Domestic Assistance grant of an Exclusive Patent License to days from the date of this published Program Nos. 93.859, Pharmacology, Braeburn Pharmaceuticals, Inc. notice, the National Institute on Drug Physiology, and Biological Chemistry (‘‘Braeburn’’) located in Princeton, New Abuse receives written evidence and Research; 93.350, B—Cooperative Jersey to practice the inventions argument that establishes that the grant Agreements; 93.859, Biomedical Research embodied in the patent applications of the license would not be consistent and Research Training, National Institutes of listed in the SUPPLEMENTARY with the requirements of 35 U.S.C. 209 Health, HHS) INFORMATION section of this notice. and 37 CFR part 404. VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1

Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85983 Complete applications for a license in Alcoholism, Terrace Conference Room 508, (SAMHSA) is requesting an approval the prospective field of use that are 5635 Fishers Lane, Rockville, MD 20892. from the Office of Management and timely filed in response to this notice Contact Person: Richard A. Rippe, Ph.D., Budget (OMB) for an amendment to the will be treated as objections to the grant Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, 5635 FY 2016–2017 Uniform Application, of the contemplated Exclusive Patent Fishers Lane, Room 2109, Rockville, MD Section III. Behavioral Health License. Comments and objections 20852, 301–443–8599, rippera@mail.nih.gov. Assessment and Plan, C. Environmental submitted to this notice will not be Factors and Plan. The intent of this (Catalogue of Federal Domestic Assistance made available for public inspection Program Nos. 93.271, Alcohol Research amendment is to gather information and, to the extent permitted by law, will Career Development Awards for Scientists regarding the states’ and jurisdictions’ not be released under the Freedom of and Clinicians; 93.272, Alcohol National plans to implement elements of a Information Act, 5 U.S.C. 552. Research Service Awards for Research syringe services program at 1 or more Dated: November 23, 2016. Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; community-based organizations that Richard U. Rodriguez, receive amounts from the grant to 93.701, ARRA Related Biomedical Research Associate Director, Technology Transfer and Research Support Awards, National provide substance use disorder Center, National Cancer Institute. Institutes of Health, HHS) treatment and recovery services to [FR Doc. 2016–28698 Filed 11–28–16; 8:45 am] persons who inject drugs. In response to Dated: November 21, 2016. BILLING CODE 4140–01–P the emergence of prescription drug and Melanie J. Pantoja, heroin overdoses and associated deaths Program Analyst, Office of Federal Advisory in many states and jurisdictions, DEPARTMENT OF HEALTH AND Committee Policy. HUMAN SERVICES SAMHSA issued guidance on April 2, [FR Doc. 2016–28626 Filed 11–28–16; 8:45 am] 2014, to the states and jurisdictions BILLING CODE 4140–01–P National Institutes of Health regarding the use of SABG funds for prevention education and training National Institute on Alcohol Abuse regarding overdoses and the purchase of and Alcoholism; Notice of Closed DEPARTMENT OF HEALTH AND HUMAN SERVICES naloxone (Narcan®) and related Meeting materials to assemble overdose Pursuant to section 10(d) of the Substance Abuse and Mental Health prevention kits. Federal Advisory Committee Act, as Services Administration Respondents are the 50 states and the amended (5 U.S.C. App.), notice is jurisdictions (District of Columbia, the hereby given of the following meeting. Agency Information Collection Commonwealth of Puerto Rico, the U.S. The meeting will be closed to the Activities: Submission for OMB Review; Comment Request Virgin Islands, American Samoa, public in accordance with the Commonwealth of Northern Mariana provisions set forth in sections Periodically, the Substance Abuse and Islands, Federated States of Micronesia, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Mental Health Services Administration Guam, Republic of Marshall Islands, as amended. The grant applications and (SAMHSA) will publish a summary of Republic of Palau, and the Red Lake the discussions could disclose information collection requests under confidential trade secrets or commercial Band of Chippewa Indians of OMB review, in compliance with the Minnesota). property such as patentable material, Paperwork Reduction Act (44 U.S.C. and personal information concerning The following reporting burden is Chapter 35). To request a copy of these individuals associated with the grant documents, call the SAMHSA Reports based on estimates developed applications, the disclosure of which Clearance Officer on (240) 276–1243. considering the State substance abuse would constitute a clearly unwarranted and mental health authorities invasion of personal privacy. Project: Uniform Application for the responsible for these activities and Name of Committee: National Institute on Community Mental Health Services represents the average total hours to Alcohol Abuse and Alcoholism Special Block Grant and Substance Abuse and assemble, format, and produce the Emphasis Panel; NIAAA Fellowship Review. Prevention Treatment Block Grant FY requested information. Date: March 28, 2017. 2016–2017 Application Guidance and Time: 8:30 a.m. to 5:00 p.m. Instructions (OMB No. 0930–0168)— Agenda: To review and evaluate grant NEW applications. Place: National Institutes of Health, The Substance Abuse and Mental National Institute on Alcohol Abuse and Health Services Administration Number of Response per Total Respondents Total burden respondents respondent responses States and Jurisdictions ............................................ 60 1 60 40 hours per State (1,500 hours). Link for the application, Guidance, Office of Management and Budget send their comments via email, asabaliauskas on DSK3SPTVN1PROD with NOTICES and Amendment: http:// (OMB). To ensure timely receipt of commenters may also fax their www.samhsa.gov/grants/block-grants/. comments, and to avoid potential delays comments to: 202–395–7285. Written comments and in OMB’s receipt and processing of mail Commenters may also mail them to: recommendations concerning the sent through the U.S. Postal Service, Office of Management and Budget, proposed information collection should commenters are encouraged to submit Office of Information and Regulatory be sent by December 29, 2016 to the their comments to OMB via email to: SAMHSA Desk Officer at the Office of OIRA_Submission@omb.eop.gov. Information and Regulatory Affairs, Although commenters are encouraged to VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1


Document Created: 2016-11-29 00:33:14
Document Modified: 2016-11-29 00:33:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly 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.
FR Citation81 FR 85982 
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