[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Page 47759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Use of 
Pharmaceutical and Biological Compositions Comprising Gram-Negative 
Bacteria for the Topical Treatment of Dermatological Diseases and 
Dermatological Conditions

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an Exclusive 
Commercialization Patent License to practice the inventions embodied in 
the Patents and Patent Applications listed in the Summary Information 
section of this notice to Forte Biosciences, Inc. located in San Diego, 
California.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Allergy and Infectious 
Diseases' Technology Transfer and Intellectual Property Office on or 
before October 30, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: David Yang, Technology Transfer 
and Patenting Specialist, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, National 
Institutes of Health, 5601 Fishers Lane, Suite 6D, Rockville, MD 20852-
9804; Email: [email protected]; Telephone: (240) 627-3413; Facsimile: 
(240) 627-3117.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    U.S. Provisional Application 62/324,762, filed April 19, 2016, and 
PCT Patent Application PCT/US2017/028133, filed April 17, 2017, both 
entitled ``Use of Gram Negative Species to Treat Atopic Dermatitis'' 
[HHS Ref. E-099-2016/0], and U.S. and foreign patent applications 
claiming priority to the aforementioned applications.
    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the following field of use: ``Use of 
pharmaceutical and biological compositions comprising Gram-negative 
bacteria for the topical treatment of dermatological diseases and 
dermatological conditions''.
    Atopic dermatitis (AD) is a common, recurrent, chronic inflammatory 
skin disease that is a cause of considerable economic and social 
burden. It is one of the most prevalent skin disorders, affecting ~25% 
of children in developed and developing countries and is expected to 
continue to escalate. This increased rate of incidence has changed the 
focus of research on AD toward epidemiology, prevention, and treatment.
    The subject technology describes pharmaceutical and biological 
compositions comprising Gram-negative bacteria that can be developed 
into a topical treatment for atopic dermatitis (AD), as well as methods 
and kits using these compositions.
    NIAID scientists have recently identified probiotic strains of 
Roseomonas mucosa bacteria that were shown to be beneficial in a pre-
clinical mouse model of AD. With this promising data, NIAID launched a 
phase I/II clinical trial in March 2017 (link; https://clinicaltrials.gov/ct2/show/NCT03018275) and preliminary results from 
this ongoing study show that the technology may be highly effective at 
treating and reducing the symptoms of atopic dermatitis. If 
successfully developed, this invention would be the first live 
biotherapeutic product approved by the FDA for the treatment of AD.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Institute of Allergy and Infectious Diseases 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 filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Commercialization Patent 
License Agreement. 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: October 4, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-22148 Filed 10-12-17; 8:45 am]
 BILLING CODE 4140-01-P