2015-27454. Prospective Grant of Exclusive License: Development of Therapeutics To Treat Obesity, Type 2 Diabetes, Fatty Liver Disease, and Liver Fibrosis in Humans

AGENCY:

National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the following inventions embodied in the following patent applications, entitled “CB1 receptor mediating compounds”:

1. U.S. Provisional Patent Application No.: 61/991,333

HHS Ref. No.: E-140-2014/0-US-01

Filed: May 09, 2014

2. PCT Application No.: PCT/US2015/029946

HHS Ref. No.: E-140-2014/0-PCT-02

Filed: May 08, 2015

3. U.S. Provisional Patent Application No.: 61/725,949

HHS Ref. No.: E-282-2012/0-US-01

Filed: November 13, 2012

4. PCT Application No.: PCT/US2013/069686

HHS Ref. No.: E-282-2012/0-PCT-02

Filed: November 12, 2013

5. U.S. Patent Application No.: 14/442,383

HHS Ref. No.: E-282-2012/0-US-03

Filed: May 12, 2015

6. Canadian Patent Application No.: 2889697

HHS Ref. No.: E-282-2012/0-CA-04

Filed: April 27, 2015

7. European Patent Application No.: 13802153.0

HHS Ref. No.: E-282-2012/0-EP-05

Filed: June 01, 2015

8. Indian Patent Application No.: 3733/DELNP/2015

HHS Ref. No.: E-282-2012/0-IN-06

Filed: May 01, 2015

9. Japanese Patent Application No.: 2015-542015

HHS Ref. No.: E-282-2012/0-JP-07

Filed: May 11, 2015

10. Chinese Patent Application No.: 201380069389.9

HHS Ref. No.: E-282-2012/0-CN-08

Filed: July 3, 2015

11. U.S. Provisional Application No.: 62/171,179

HHS Ref. No.: E-282-2012/1-US-01

Filed: June 04, 2015

to Inversago Pharma Inc., (“Inversago”), a company incorporated under the laws of Canada having an office in at least Montreal-Ouest, Quebec, Canada. The patent rights in these inventions have been assigned to the United States of America. This license may be worldwide. The field of use may be related to “Development of therapeutics to treat obesity, type 2 diabetes, fatty liver disease and liver fibrosis in humans.”

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before November 12, 2015 will be considered.

ADDRESSES:

Requests for copies of the patent application, patents, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Patrick McCue, Ph.D., Senior Licensing and Patenting Manager, Technology Advancement Office, The National Institute of Diabetes and Digestive and Kidney Diseases, 12A South Drive, Bethesda, MD 20892, Telephone: [phone]; Email: [e-mail]. A signed confidentiality non-disclosure agreement will be required to receive copies of any patent applications that have not been published by the United States Patent and Trademark Office or the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION:

This technology, and its corresponding patent applications, is directed to methods of treating obesity and associated diseases such as type 2 diabetes, hepatic steatosis, and liver fibrosis by administering an agent that reduces appetite, body weight, and insulin resistance. This technology may be useful as a means for treating obesity and metabolic syndrome without serious adverse neuropsychiatric side effects.

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 404.7. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, 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 404.7.

Properly-filed and complete competing applications for a license 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: October 19, 2015.

Anna Z. Amar,

Acting Deputy Director, Technology Advancement Office, National Institute of Diabetes and Digestive and Kidney, Diseases, National Institutes of Health.