82 FR 45865 - Prospective Modification of Exclusive Patent License Potent and Selective Analogues of: Monamine Transporters; Methods of Making; and Uses Thereof
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 189 (October 2, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 189 (October 2, 2017)
| Page Range | 45865-45866 | |
| FR Document | 2017-21048 |
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)] [Notices] [Pages 45865-45866] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21048] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Modification of Exclusive Patent License Potent and Selective Analogues of: Monamine Transporters; Methods of Making; and Uses Thereof AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Institute of Drug Abuse, an institute of the National Institutes of Health, Department of Health and Human Services is contemplating the modification of grant of an Exclusive Patent License to EncepHeal Therapeutics, Inc., located in Winston-Salem, North Carolina, 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 National Institute on Drug Abuse's Technology Transfer Office on or before October 17, 2017 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated modification of the Exclusive Patent License should be directed to Martha Lubet, Ph.D., Technology Transfer Manager, NCI TTC, 9609 Medical Center Drive, Room IE350, MSC 9702, Rockville, MD 20850. Telephone: 240 276-5508. Facsimile: 240 276- 5505. Email: [email protected]. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: U.S. provisional application 61/774,878, filed March 8, 2013 entitled ``Potent and Selective Inhibitors of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-US- 01]; PCT application PCT/US2014/021514, filed March 7, 2014 entitled ``Potent and Selective Analogues of: Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-PCT-02]; U.S. application 14/772,486, filed September 3, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-US-06]; EPO application 14714043.8, filed September 1, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-EP-05]; Australian application 2014225550, filed September 8, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-AU-03]; Australian application 2017202849, filed April 28, 2017 entitled Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-AU-07]; Canadian application 2903746, filed September 2, 2015 entitled ``Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof'' [HHS Ref. No. E-073-2013/0-CA-04]; The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The Government previously announced its intention to grant an exclusive license to EncepHeal at FR 80:245 (December 22, 2015), pp. 79595-79596. The Notice of Intent to Grant (NOITG) specified a Field of Use as ``Use of [[Page 45866]] analogues of monamine transporters to treat substance use disorders and sleep disorders within the scope of the Licensed Patent Rights''. Comments/Objections were not received in response to the NOITG. After consideration, an exclusive license was granted to EncepHeal with a Licensed Field of Use of: ``Use of analogues of monamine transporters to treat substance use disorders within the scope of the Licensed Patent Rights''. This Notice advises the public that the NIH intends to modify the Licensed Field of Use originally granted to EncepHeal. Specifically, the National Institute on Drug Abuse is proposing to modify the Licensed Field of Use to be ``use of a lead compound to treat one or more of the following: Substance use disorders, cognitive deficits, sleep disorders, attention deficit hyperactivity disorder and depressive disorders. The modification to the Licensed Field of Use in the Exclusive Patent License requires EncepHeal to select a lead compound for each of the disorders listed in the Field of Use and that upon selection of a lead compound for a disorder, the other compounds of the technology will become available for licensing to other companies. The technology is directed to novel analogues of modafinil. Modafinil (marketed as Provisil in United States) is approved by FDA to treat narcolepsy and other sleep disorders. Modafinil has been studied as a possible treatment for cognitive dysfunction in disorders such as attention-deficit hyperactivity disorders (ADHD) as well as cocaine and methamphetamine addiction. However, it has a relatively low affinity for dopamine transporter (DAT) and is water-insoluble, thus requiring large doses to achieve pharmacological effects. Early studies indicated that modafinil reduced cocaine intake more effectively than placebo; however, subsequent larger studies reported only modest effectiveness in reducing cocaine intake. The library of compounds in the technology are analogs of modafinil and are designed to have higher affinities for DAT and improved water solubility. The National Institute on Drug Abuse has conducted preliminary experiments on many of the compounds and has identified several compounds that have higher affinities than modafinil for the DAT and lower affinity than modafinil for several other off target receptors. Preliminary studies at the National Institute on Drug Abuse indicate that some of the compounds have in vivo activity in rodents to inhibit cocaine taking behavior and are not selectively self-administered themselves (i.e. have low abuse liability). This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404 and incorporates by reference: ``Prospective Grant of Exclusive Option License: Potent and Selective Analogues of: Monamine Transporters; Methods of Making; and Uses Thereof'' FR 80:245 (December 22, 2015), pp. 79595-79596. The prospective modification of the Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from date of this published notice, the National Institute on Drug Abuse receives written evidence and argument that establishes that the grant of modification to 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 field of use filed in response to this notice will be treated as objections to the grant of the contemplated modification to 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: September 22, 2107. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017-21048 Filed 9-29-17; 8:45 am] BILLING CODE 4040-01-P
![Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45865
the corresponding reference listed drugs Streaming Webcast of the Public ADDRESSES: Requests for copies of the
or reference standards: Workshop: This public workshop will patent application, inquiries, and
a. How to effectively integrate systems also be webcast. A live webcast of this comments relating to the contemplated
pharmacology, PBPK, and the exposure- workshop will be viewable at https:// modification of the Exclusive Patent
clinical response relationship to collaboration.fda.gov/dqmm1017/on the License should be directed to Martha
evaluate product risk and assist BE day of the workshop. Lubet, Ph.D., Technology Transfer
evaluation? If you have never attended a Connect Manager, NCI TTC, 9609 Medical Center
b. What will be the next generation Pro event before, test your connection at Drive, Room IE350, MSC 9702,
methodologies in postmarket signal https://collaboration.fda.gov/common/ Rockville, MD 20850. Telephone: 240
detection to evaluate product help/en/support/meeting_test.htm. To 276–5508. Facsimile: 240 276–5505.
substitution or compare product get a quick overview of the Connect Pro Email: lubetm@mail.nih.gov.
performance using the Sentinel database program, visit https://www.adobe.com/ SUPPLEMENTARY INFORMATION: The
or complementary toolsets? go/connectpro_overview. FDA has following represents the intellectual
III. Participating in the Public verified the Web site addresses in this property to be licensed under the
Workshop document, as of the date this document prospective agreement:
publishes in the Federal Register, but U.S. provisional application 61/
Registration: Persons interested in
attending this public workshop must Web sites are subject to change over 774,878, filed March 8, 2013 entitled
register online at https://survey.co1. time. ‘‘Potent and Selective Inhibitors of
qualtrics.com/jfe/form/SV_3eiJOCsnr Transcripts: Please be advised that as Monamine Transporters; Methods of
PdTZU9. Please provide complete soon as a transcript of the public Making; and Uses Thereof’’ [HHS Ref.
contact information for each attendee, workshop is available, it will be No. E–073–2013/0–US–01];
including name, title, affiliation, accessible at https:// PCT application PCT/US2014/021514,
address, email, and telephone. www.regulations.gov. It may be viewed filed March 7, 2014 entitled ‘‘Potent and
Registration is free and based on at the Dockets Management Staff (see Selective Analogues of: Monamine
space availability, with priority given to ADDRESSES). A link to the transcript will Transporters; Methods of Making; and
early registrants. Persons interested in also be available on the internet at Uses Thereof’’ [HHS Ref. No. E–073–
attending this public workshop must http://www.fda.gov/Drugs/NewsEvents/ 2013/0–PCT–02];
register by September 25, 2017, ucm554182.htm. U.S. application 14/772,486, filed
midnight, Eastern Standard Time. Early Dated: September 26, 2017. September 3, 2015 entitled ‘‘Potent and
registration is recommended because Anna K. Abram, Selective Analogues of Monamine
seating is limited; therefore, FDA may Transporters; Methods of Making; and
Deputy Commissioner for Policy, Planning,
limit the number of participants from Legislation, and Analysis. Uses Thereof’’ [HHS Ref. No. E–073–
each organization. 2013/0–US–06];
[FR Doc. 2017–21017 Filed 9–29–17; 8:45 am]
If you need special accommodations EPO application 14714043.8, filed
BILLING CODE 4164–01–P
due to a disability, please contact September 1, 2015 entitled ‘‘Potent and
Lanyan (Lucy) Fang (see FOR FURTHER Selective Analogues of Monamine
INFORMATION CONTACT) no later than 7 DEPARTMENT OF HEALTH AND Transporters; Methods of Making; and
days before the workshop. HUMAN SERVICES Uses Thereof’’ [HHS Ref. No. E–073–
Requests for Oral Presentations: 2013/0–EP–05];
During online registration you may National Institutes of Health Australian application 2014225550,
indicate if you wish to present during a filed September 8, 2015 entitled ‘‘Potent
public comment session, and which Prospective Modification of Exclusive and Selective Analogues of Monamine
topic(s) you wish to address. We will do Patent License Potent and Selective Transporters; Methods of Making; and
our best to accommodate requests to Analogues of: Monamine Transporters; Uses Thereof’’ [HHS Ref. No. E–073–
make public comments. Individuals and Methods of Making; and Uses Thereof 2013/0–AU–03];
organizations with common interests are Australian application 2017202849,
urged to consolidate or coordinate their AGENCY: National Institutes of Health, filed April 28, 2017 entitled Potent and
presentations, and to request time for a HHS. Selective Analogues of Monamine
joint presentation, or to submit requests ACTION: Notice. Transporters; Methods of Making; and
for designated representatives to Uses Thereof’’ [HHS Ref. No. E–073–
participate in the focused sessions. SUMMARY: The National Institute of Drug 2013/0–AU–07];
Following the close of registration, we Abuse, an institute of the National Canadian application 2903746, filed
will determine the amount of time Institutes of Health, Department of September 2, 2015 entitled ‘‘Potent and
allotted to each presenter and the Health and Human Services is Selective Analogues of Monamine
approximate time each oral presentation contemplating the modification of grant Transporters; Methods of Making; and
is to begin, and will select and notify of an Exclusive Patent License to Uses Thereof’’ [HHS Ref. No. E–073–
participants by September 27, 2017. All EncepHeal Therapeutics, Inc., located in 2013/0–CA–04];
requests to make oral presentations Winston-Salem, North Carolina, to The patent rights to these inventions
must be received by the close of practice the inventions embodied in the have been assigned to and/or
registration on September 25, 2017. If patent applications listed in the exclusively licensed to the Government
selected for presentation, any Supplementary Information section of of the United States of America.
sradovich on DSK3GMQ082PROD with NOTICES
presentation materials must be emailed this notice. The Government previously
to Lanyan (Lucy) Fang (see FOR FURTHER DATES: Only written comments and/or announced its intention to grant an
INFORMATION CONTACT) no later than applications for a license which are exclusive license to EncepHeal at FR
September 28, 2017. No commercial or received by the National Institute on 80:245 (December 22, 2015), pp. 79595–
promotional material will be permitted Drug Abuse’s Technology Transfer 79596.
to be presented or distributed at the Office on or before October 17, 2017 The Notice of Intent to Grant (NOITG)
public workshop. will be considered. specified a Field of Use as ‘‘Use of
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![45866 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices
analogues of monamine transporters to themselves (i.e. have low abuse Date: October 23, 2017.
treat substance use disorders and sleep liability). Time: 8:00 a.m. to 6:00 p.m.
disorders within the scope of the This notice is made in accordance Agenda: To review and evaluate grant
with 35 U.S.C. 209 and 37 CFR part 404 applications.
Licensed Patent Rights’’. Comments/
Place: National Institutes of Health,
Objections were not received in and incorporates by reference: Neuroscience Center, 6001 Executive
response to the NOITG. After ‘‘Prospective Grant of Exclusive Option Boulevard, Rockville, MD 20852
consideration, an exclusive license was License: Potent and Selective Analogues (Teleconference Meeting).
granted to EncepHeal with a Licensed of: Monamine Transporters; Methods of Contact Person: Ana Olariu, Ph.D.,
Field of Use of: ‘‘Use of analogues of Making; and Uses Thereof’’ FR 80:245 Scientific Review Officer, Scientific Review
monamine transporters to treat (December 22, 2015), pp. 79595–79596. Branch, NINDS/NIH/DHHS, Neuroscience
substance use disorders within the The prospective modification of the Center, 6001 Executive Blvd., Suite 3204,
Exclusive Patent License will be royalty MSC 9529, Bethesda, MD 20892–9529, (301)
scope of the Licensed Patent Rights’’.
496–9223, ana.olariu@nih.gov.
This Notice advises the public that the bearing and may be granted unless
within fifteen (15) days from date of this Name of Committee: National Institute of
NIH intends to modify the Licensed
Neurological Disorders and Stroke Initial
Field of Use originally granted to published notice, the National Institute
Review Group; Neurological Sciences and
EncepHeal. Specifically, the National on Drug Abuse receives written Disorders A.
Institute on Drug Abuse is proposing to evidence and argument that establishes Date: October 23–24, 2017.
modify the Licensed Field of Use to be that the grant of modification to the Time: 8:00 a.m. to 6:00 p.m.
‘‘use of a lead compound to treat one or license would not be consistent with the Agenda: To review and evaluate grant
more of the following: Substance use requirements of 35 U.S.C. 209 and 37 applications.
disorders, cognitive deficits, sleep CFR Part 404. Place: Melrose Hotel, 2430 Pennsylvania
disorders, attention deficit hyperactivity Complete applications for a license in Avenue NW., Washington, DC 20037.
the field of use filed in response to this Contact Person: Natalia Strunnikova,
disorder and depressive disorders. The
notice will be treated as objections to Ph.D., Scientific Review Officer, Scientific
modification to the Licensed Field of Review Branch, NINDS/NIH/DHHS,
Use in the Exclusive Patent License the grant of the contemplated
Neuroscience Center, 6001 Executive Blvd.,
requires EncepHeal to select a lead modification to Exclusive Patent Suite 3204, MSC 9529, Bethesda, MD 20892–
compound for each of the disorders License. Comments and objections 9529, (301) 402–0288, natalia.strunnikova@
listed in the Field of Use and that upon submitted to this notice will not be nih.gov.
selection of a lead compound for a made available for public inspection Name of Committee: National Institute of
disorder, the other compounds of the and, to the extent permitted by law, will Neurological Disorders and Stroke Special
technology will become available for not be released under the Freedom of Emphasis Panel; K99/R00 Review.
licensing to other companies. Information Act, 5 U.S.C. 552. Date: October 23, 2017.
Time: 11:30 a.m. to 1:30 p.m.
The technology is directed to novel Dated: September 22, 2107.
Agenda: To review and evaluate grant
analogues of modafinil. Modafinil Richard U. Rodriguez, applications.
(marketed as Provisil in United States) Associate Director, Technology Transfer Place: Hilton Crystal City, 2399 Jefferson
is approved by FDA to treat narcolepsy Center, National Cancer Institute. Davis Highway, Arlington, VA 22202.
and other sleep disorders. Modafinil has [FR Doc. 2017–21048 Filed 9–29–17; 8:45 am] Contact Person: Elizabeth A. Webber,
been studied as a possible treatment for BILLING CODE 4040–01–P Ph.D., Scientific Review Officer, Scientific
cognitive dysfunction in disorders such Review Branch, NINDS/NIH/DHHS,
as attention-deficit hyperactivity Neuroscience Center, 6001 Executive Blvd.,
disorders (ADHD) as well as cocaine DEPARTMENT OF HEALTH AND Suite 3204, MSC 9529, Bethesda, MD 20892–
9529, (301) 496–1917, webbere@mail.nih.gov.
and methamphetamine addiction. HUMAN SERVICES
However, it has a relatively low affinity Name of Committee: National Institute of
National Institutes of Health Neurological Disorders and Stroke Initial
for dopamine transporter (DAT) and is Review Group; Neurological Sciences and
water-insoluble, thus requiring large Disorders B.
National Institute of Neurological
doses to achieve pharmacological Date: October 26–27, 2017.
Disorders and Stroke; Notice of Closed
effects. Early studies indicated that Time: 8:00 a.m. to 6:00 p.m.
Meetings
modafinil reduced cocaine intake more Agenda: To review and evaluate grant
effectively than placebo; however, Pursuant to section 10(d) of the applications.
subsequent larger studies reported only Federal Advisory Committee Act, as Place: Admiral Fell Inn, 888 South
modest effectiveness in reducing amended, notice is hereby given of the Broadway, Baltimore, MD 21231.
cocaine intake. The library of Contact Person: Birgit Neuhuber, Ph.D.,
following meetings.
Scientific Review Officer, Scientific Review
compounds in the technology are The meetings will be closed to the Branch, NINDS/NIH/DHHS, Neuroscience
analogs of modafinil and are designed to public in accordance with the Center, 6001 Executive Blvd., Suite 3204,
have higher affinities for DAT and provisions set forth in sections MSC 9529, Bethesda, MD 20892–9529, (301)
improved water solubility. The National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 496–9223, neuhuber@ninds.nih.gov@nih.gov.
Institute on Drug Abuse has conducted as amended. The grant applications and Name of Committee: National Institute of
preliminary experiments on many of the the discussions could disclose Neurological Disorders and Stroke Special
compounds and has identified several confidential trade secrets or commercial Emphasis Panel; Ruth L. Kirschstein National
compounds that have higher affinities property such as patentable material, Research Service Award (NRSA) Institutional
than modafinil for the DAT and lower and personal information concerning Research Training Grant (T32) Program.
sradovich on DSK3GMQ082PROD with NOTICES
affinity than modafinil for several other individuals associated with the grant Date: October 30–31, 2017.
off target receptors. Preliminary studies applications, the disclosure of which Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
at the National Institute on Drug Abuse would constitute a clearly unwarranted applications.
indicate that some of the compounds invasion of personal privacy. Place: Hotel Monaco, 700 F Street NW.,
have in vivo activity in rodents to Name of Committee: National Institute of Washington, DC 20001.
inhibit cocaine taking behavior and are Neurological Disorders and Stroke Special Contact Person: William Benzing, Ph.D.,
not selectively self-administered Emphasis Panel; Program Project Grant P01. Scientific Review Officer, Scientific Review
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Document Created: 2017-09-30 04:40:50
Document Modified: 2017-09-30 04:40:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments and/or applications for a license which are received by the National Institute on Drug Abuse's Technology Transfer Office on or before October 17, 2017 will be considered. | |
| FR Citation | 82 FR 45865 |
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