Prospective Grant of Exclusive License: Use of Pentosan Polysulfate To Treat Certain Conditions of the Prostate, 53704 [2010-21818]

Download as PDF 53704 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices Name of Committee: Center for Inherited Disease Research Access Committee. Date: September 14, 2010. Time: 11:30 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Suite 4069, Bethesda, MD 20892, (Telephone Conference Call) Contact Person: Ken D. Nakamura, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD 20852, 301–402–0838. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: August 26, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–21819 Filed 8–31–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Use of Pentosan Polysulfate To Treat Certain Conditions of the Prostate National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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.’’ hsrobinson on DSK69SOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:24 Aug 31, 2010 Jkt 220001 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: vepas@mail.nih.gov. [Docket No. FDA–2010–N–0427] DATES: ADDRESSES: 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. SUPPLEMENTARY INFORMATION: Food and Drug Administration Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 23, 2010 (75 FR 51829). The notice announced the public workshop entitled ‘‘Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.’’ The notice was published with an incorrect registration Web site. This document corrects that Web site. SUMMARY: Paul Gadiock, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4432, Silver Spring, MD 20993–0002, 301–796–5736. FOR FURTHER INFORMATION CONTACT: In FR Doc. 2010–20837, appearing on page 51829 in the Federal Register of Monday, August 23, 2010, the following correction is made: 1. On page 51829, in the second column, in the Registration and Requests for Oral Presentations section, in the first full paragraph, beginning in the third line, ‘‘https://www.fda.gov/ MedicalDevices/NewsEvents/ WorskshopsConferences/default.htm’’ is corrected to read ‘‘https://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm’’. SUPPLEMENTARY INFORMATION: Dated: August 27, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–21801 Filed 8–31–10; 8:45 am] BILLING CODE 4160–01–S 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] BILLING CODE 4140–01–P PO 00000 Frm 00075 Fmt 4703 Sfmt 9990 E:\FR\FM\01SEN1.SGM 01SEN1

Agencies

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


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 
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: 
301-435-5020; Facsimile: 301-402-0220; E-mail: vepas@mail.nih.gov.

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]
BILLING CODE 4140-01-P

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