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

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National Institutes of Health, Public Health Service, HHS.




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 Start Printed Page 36557Government 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.


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.


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:

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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.

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Dated: June 15, 2011.

Richard U. Rodriguez,

Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 2011-15486 Filed 6-21-11; 8:45 am]