[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Page 25683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: AAV-Mediated Aquaporin 
Gene Transfer To Treat Sj[ouml]gren's Syndrome

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive license 
to MeiraGTx, having a principal place of business in New York, New 
York, U.S.A. to practice the inventions embodied in the following 
patent applications, entitled ``AAV-mediated aquaporin gene transfer to 
treat Sj[ouml]gren's syndrome'':

    1. U.S. Provisional Patent Application No. 61/695,753 filed 
August 31, 2012 (HHS Ref. No. E-139-2011/1-US-01);
    2. PCT Application No. PCT/US2013/057632, filed August 30, 2013 
(HHS Ref. No. E-139-2011/1-PCT-02);
    3. Australia Patent Application No. 2013308470, filed February 
25, 2015 (HHS Ref. No. E-139-2011/1-AU-03);
    4. Canada Patent Application No. 2882763, filed February 20, 
2015 (HHS Ref. No. E-139-2011/1-CA-04);
    5. European Patent Application No. 13773443.0, filed March 30, 
2015 (HHS Ref. No. E-139-2011/1-EP-05);
    6. U.S. Patent Application No. 14/423,774, filed February 25, 
2015 (HHS Ref. No. E-139-2011/1-US-06).

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The territory of the 
prospective license may be worldwide, and the field of use may be 
limited to adeno-associated virus (AAV) vector mediated gene delivery 
of human aquaporin-1 (hAQP1) in Sj[ouml]gren's syndrome patients with 
associated xerostomia and/or xerophthalmia.

DATES: Only written comments and/or applications for a license that are 
received by the National Institute of Dental and Craniofacial Research, 
Office of Technology Transfer and Innovation Access on or before May 
16, 2016 will be considered.

FOR FURTHER INFORMATION CONTACT: Requests for a copy of the patent 
application(s), inquiries, comments and other materials relating to the 
contemplated license should be directed to: Sally Hu, Ph.D., M.B.A., 
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Innovation Access, National Institute of Dental and Craniofacial 
Research, National Institutes of Health, BLDG 1 DEM, RM667, 6701 
Democracy Blvd., Bethesda, MD 20817; Telephone: (301) 594-2616; 
Facsimile: (301) 496-1005; Email: [email protected]. A signed 
confidential disclosure agreement may be required to receive copies of 
the patent application assuming it has not already been published under 
the publication rules of either the United States Patent and Trademark 
Office or the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: This subject technology is directed to the 
methods of using AAV vectors to deliver the hAQP gene into a salivary 
gland or a lachrymal gland in patients who suffer from Sj[ouml]gren's 
syndrome. Sj[ouml]gren's syndrome is a systemic autoimmune disease in 
which immune cells attack and destroy the glands that produce saliva 
and tears, resulting in progressive dry mouth and dry eyes. In a mouse 
model of Sj[ouml]gren's syndrome, administration of hAQP-1 to salivary 
glands can restore salivary secretion and reduce inflammation in the 
glands.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless, within 
fifteen (15) days from the date of this published notice, the Office of 
Technology Transfer and Innovation Access, National Institute of Dental 
and Craniofacial Research receives written evidence and argument that 
establishes that the grant of the contemplated license would not be 
consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Properly filed competing 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 contemplated license. Comments and 
objections submitted in response 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: April 22, 2016.
David W. Bradley,
Director, Office of Technology Transfer and Innovation Access, National 
Institute of Dental and Craniofacial Research, National Institutes of 
Health.
[FR Doc. 2016-09978 Filed 4-28-16; 8:45 am]
 BILLING CODE 4140-01-P