[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Notices]
[Pages 43605-43606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Glucocerebrosidase 
Activators for the Treatment of Gaucher Disease and Central Nervous 
System Proteinopathies, Including Parkinson's Disease

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive evaluation option license to Lysosomal Therapeutics, Inc., a 
company having a place of business in Boston, Massachusetts, to 
practice the inventions embodied in U.S. Provisional Patent Application 
No. 61/420,946, filed December 8, 2010 (HHS Ref. No. E-257-2010/0-US-
01) and PCT Patent Application No. PCT/US2011/063928, filed December 8, 
2011 (HHS Ref. No. E-257-2010/0-PCT-02), both entitled ``Substituted 
Pyrazolopyrimidines as Glucocerebrosidase Activators.'' The patent 
rights in these inventions have been assigned to the United States of 
America. The prospective exclusive evaluation option license territory 
may be ``worldwide'', and the field of use may be limited to 
``Treatment of Gaucher disease and human central nervous system 
proteinopathies, including without limitation Parkinson's disease.'' 
Upon the expiration or termination of the exclusive evaluation option 
license, Lysosomal Therapeutics, Inc. will have the right to execute an 
exclusive patent commercialization license which will supersede and 
replace the exclusive evaluation option license with no greater field 
of use and territory than granted in the evaluation license.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 9, 2012 will be considered.

ADDRESSES: Requests for copies of the patent application(s), inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Tara L. Kirby, Ph.D., Senior Licensing and Patenting 
Manager, Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-4426; Facsimile: (301) 402-0220; Email: 
[email protected]. A signed confidentiality nondisclosure agreement 
will be required to receive copies of any patent applications that have 
not been published or issued by the United States Patent and Trademark 
Office or the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: Gaucher disease is a rare lysosomal storage 
disease caused by mutations in the glucocerebrosidase (GCase) gene; 
GCase is localized in the lysosome and is responsible for the breakdown 
of glucocerebroside, an intermediate in glycolipid metabolism. This 
technology provides small molecule activators of GCase that facilitate 
the proper folding of GCase and its transport to the lysosome, without 
inhibiting its activity in the lysosome. Thus, these compounds are 
extremely promising candidates for the development of a small molecule 
drug to treat Gaucher disease. Mutations in the GCase gene have also 
been associated with the development of Parkinson's disease, and 
therefore, these compounds may also be useful for the treatment of 
Parkinson's disease. It is also possible that these compounds could be 
utilized to treat other proteinopathy-based diseases.
    The prospective exclusive evaluation option license will comply 
with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The 
prospective exclusive evaluation option license may be granted unless 
within fifteen (15) days from the date of this published notice, the 
NIH receives written

[[Page 43606]]

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 404.7.
    Only applications for a license in the field of use set forth in 
this notice and filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive 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: July 18, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-18053 Filed 7-24-12; 8:45 am]
BILLING CODE 4140-01-P