[Federal Register Volume 75, Number 169 (Wednesday, September 1, 2010)]
[Page 53704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21818]



National Institutes of Health

Prospective Grant of Exclusive License: Use of Pentosan 
Polysulfate To Treat Certain Conditions of the Prostate

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

ACTION: Notice.


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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to practice the invention embodied in U.S. 
Patent Application No. 10/209,331, filed July 30, 2002, which was 
issued as U.S. Patent 6,828,309 on December 07, 2004, entitled, ``USE 
developed by Dr. Gary Striker (formerly of NIDDK) [HHS Ref. No. E-104-
1997/0-US-03], to Swati Spentose Private Limited, having a place of 
business in Mumbai, India. The patent rights in this invention have 
been assigned to the United States of America.
    The contemplated exclusive license territory may be worldwide, and 
the field of use may be limited to ``the use of pentosan polysulfate 
for the treatment or prevention of benign prostatic hyperplasia.''

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before October 
1, 2010 will be considered.

ADDRESSES: Requests for copies of the patents, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Suryanarayana Vepa, PhD, J.D., Licensing and Patenting Manager, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 
301-435-5020; Facsimile: 301-402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: This technology is a method for treating 
Benign Prostatic Hyperplasia (BHP) using the oral medication pentosan 
polysulfate (PPS). PPS is a well known, semi-synthetic polysaccharide 
extracted from beech wood cellulose that is FDA approved for the 
treatment of interstitial fibrosis. The current technology builds on 
the surprising discovery that PPS can cause regression of scarring and 
lesions in prostatic tissue. PPS reduces or eliminates both smooth 
muscle cell proliferation and extracellular matrix deposition, and so 
reduces the size of the prostate gland and decreases associated 
obstructive symptoms.
    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 404.7. 
The prospective exclusive license may be granted unless, within 30 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 404.7.
    Applications for a license in the prospective 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 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: August 25, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-21818 Filed 8-31-10; 8:45 am]