2010-21818. 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 OF PENTOSAN POLYSULFATE TO TREAT CERTAIN CONDITIONS OF THE PROSTATE,” 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: [phone]; Facsimile: 301-402-0220; E-mail: [e-mail].

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.