[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59708-59709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Commercialization License: The Use 
of Cysteamine for the Treatment of Pancreatic Cancer, Breast Cancer and 
Hepatocellular Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 
404, indicates that the National Institutes of Health, Department of 
Health and Human Services, is contemplating the grant of an exclusive 
commercialization license to practice the inventions embodied in 
technology family E-219-2013/0, including U.S. patent application 61/
814,010 entitled ``A Novel Role of Cysteamine in Suppression of Cancer 
Invasion and Metastasis and Prolonging Survival of Host Through 
Inhibition of Matrix Metalloproteinases in Human Cancer'' [HHS Ref. E-
219-2013/0-US-01], Canadian patent application 2,813,514 entitled ``Use 
of Cysteamine and Derivatives Thereof to Suppress Tumor Metastases'' 
[HHS Ref. E-219-2013/0-CA-02], South Korean patent application 10-2013-
43713 entitled ``Use of Cysteamine and Derivatives Thereof to Suppress 
Tumor Metastases''[HHS Ref. E-219-2013/0-KR-03], Australian patent 
application 2013205350 entitled ``Use of Cysteamine and Derivatives 
Thereof to Suppress Tumor Metastases'' [HHS Ref. E-219-2013/0-AU-04], 
and Mexican patent application MX/a/2013/004423 entitled ``Use of 
Cysteamine and Derivatives Thereof to Suppress Tumor Metastases'' [HHS 
Ref. E-219-2013/0-MX-05]; and all related continuing and foreign 
patents/patent applications for these technology families, to Raptor 
Pharmaceuticals, Inc. The patent rights in these inventions have been 
assigned to and/or exclusively licensed to the Government of the United 
States of America.
    The prospective exclusive commercialization license territory may 
be worldwide, and the field of use may be limited to:
    The treatment of pancreatic cancer, breast cancer and 
hepatocellular carcinoma (HCC) by using compositions containing 
cysteamine.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 28, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
commercialization license should be directed to: David A. Lambertson, 
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) 435-4632; 
Facsimile: (301) 402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: Cysteamine is a naturally occurring 
degradation product of the amino acid cysteine that is most commonly 
used for the treatment of cystinosis. The inventors on this technology 
have demonstrated that cysteamine suppresses the activity of matrix 
metalloproteinases (MMPs), enzymes that have been implicated in tumor 
invasion and metastasis. Importantly, administration of cysteamine was 
able to reduce invasion and metastasis in mouse xenograft tumor models 
for pancreatic cancer, prolonging the survival of the mice while having 
no adverse side effects. Based on these findings, cysteamine could 
represent a novel therapeutic treatment of cancer with fewer side-
effects than current therapies.
    The prospective exclusive commercialization license 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 the NIH 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 within thirty (30) days from the date of this 
published notice.
    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 exclusive license. Comments and objections

[[Page 59709]]

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 20, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-23528 Filed 9-26-13; 8:45 am]
BILLING CODE 4140-01-P