[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Notices]
[Pages 26646-26647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive License: 1. Catalytic 
Domains of Beta (1,4)-Galactosyltransferase I Having Altered Donor and 
Acceptor Specificities Domains, That Promote in Vitro Protein Folding 
and Methods for Their Use; 2. Targeted Delivery System for Bioactive 
Agents

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR Part 404.7(a)(1)(i), that the National

[[Page 26647]]

Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of a start-up exclusive patent license to 
practice the inventions embodied in:

    1. U.S. Patent 7,482,133 and AU Patent 2004204463, HHS Ref. E-
230-2002/2-US-03 and E-230-2002/2-AU-07; Title: Catalytic Domains of 
Beta (1,4)-Galactosyltransferase I Having Altered Donor And Acceptor 
Specificities Domains, That Promote In Vitro Protein Folding And 
Methods For Their Use; Inventors: Pradman K. Qasba and Boopathy 
Ramakrishnan (NCI).
    2. U.S. Patent Application 10/580,108, HHS Ref E-037-2004/0-US-
03; Title: Efficient Tagging of The Modified Galactose to the Free 
N-acetylglucosamine Moieties Of Glycoproteins With Tyr289Leu-Gal-T1 
Mutant; Inventors: Pradman K. Qasba and Boopathy Ramakrishnan (NCI).

to SynAffix B.V., which is located in The Netherlands. The exclusive 
license is one which qualifies under the Start-Up License Agreement 
program which is in place from October 1, 2011 through September 30, 
2013. The patent rights in these inventions have been assigned to the 
United States of America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before May 22, 
2013 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: John Stansberry, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: 301-
435-5236; Facsimile: 301-402-0220.

SUPPLEMENTARY INFORMATION:  The prospective worldwide start-up 
exclusive license will be royalty bearing and will comply with the 
terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective 
exclusive license may be granted unless, within fifteen (15) days from 
the date of this published Notice, 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 404.7.
    E-230-2002/0,/1,/2--The present invention is based on the discovery 
that the enzymatic activity of [beta]-(1,4)-galactosyltransferase can 
be altered such that the enzyme can make chemical bonds that are very 
difficult to make by other methods. The ability to synthesize these 
types of bonds has many applications in research and medicine and maybe 
helpful in developing pharmaceutical agents and improved vaccines that 
can be used to treat diseases.
    E-037-2004/0--This invention describes the synthesis by the 
genetically engineered enzyme, Y289L-Gal-T1, of a unique disaccharide 
linkage of a glycoprotein, a modified UDP-[alpha]-galactose, that 
contains a chemically reactive ketone group (-CH2C(=O)-CH3) 
at the C2 position of galactose. In Y289L-Gal-Tl, the binding pocket 
for DOP-[alpha]-galactose has been enlarged to accommodate 
modifications at the C2 position of galactose, like the 
ketone moiety above, that can serve as a neutral, yet versatile 
chemical handle. Glycoproteins containing a reactive ketone, such as 
monoclonal antibodies, could be then labeled with other agents useful 
for imaging or therapy.
    The field of use may be limited to conjugated glycoproteins for 
pharmaceuticals made using Licensed Patent Rights in combination with 
Licensee's proprietary or exclusively in-licensed Intellectual Property 
rights. For the avoidance of doubt, this Licensed Field of Use excludes 
use of Licensed Patent Rights solely.
    Properly filed competing applications for a license 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 29, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-10721 Filed 5-6-13; 8:45 am]
BILLING CODE 4140-01-P