[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45865-45866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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