[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36556-36557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License; The Development of 
Ulipristal Acetate for the Treatment of Symptomatic Uterine Fibroids

AGENCY: National Institutes of Health, Public Health Service, 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 Institutes of Health, 
Department of Health and Human Services, is contemplating the grant to 
PregLem SA of an exclusive patent license to practice the inventions 
embodied in US Patent Application 12/021,610 entitled, ``Method for 
Treating Uterine Fibroids'' [HHS Ref. E-057-2008/0-US-01], and all 
continuing applications and foreign counterparts. The patent rights in 
this invention have been assigned to the Government of the United 
States of America and to Laboratoire HRA Pharma. The exclusive license 
contemplated in this notice is solely to the patent rights assigned to 
the

[[Page 36557]]

Government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to:
    The use of ulipristal acetate for the treatment of symptomatic 
uterine fibroids.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
22, 2011 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Patrick P. McCue, PhD, Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5560; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: This invention concerns methods for the 
treatment of symptomatic uterine fibroids using a selective 
progesterone receptor modulator compound, ulipristal acetate (a.k.a. 
CDB-2914). Ulipristal acetate reversibly binds the progesterone 
receptor with high affinity and little or no anti-glucocorticoid 
activity. Proposed clinical indications for ulipristal acetate include 
emergency/daily contraception, treatment of uterine fibroids, 
endometriosis, dysfunctional uterine bleeding, and cancer.
    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 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 within thirty (30) days from the date 
of this published notice.
    Applications for a license in the 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 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: June 15, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-15486 Filed 6-21-11; 8:45 am]
BILLING CODE 4140-01-P