Source: https://regulations.justia.com/regulations/fedreg/2014/11/24/2014-27680.html
Timestamp: 2020-08-04 21:01:58
Document Index: 423739971

Matched Legal Cases: ['Application No. 61', 'Application No. 13', 'Application No. 61', 'Application No. 13', 'art 404', 'art 404', 'Application No. 61', 'Application No. 13', 'Application No. 61', 'Application No. 13', 'art 404']

Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma, 69866 [2014-27680] :: National Institutes Of Health :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services National Institutes Of Health Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma, 69866 [2014-27680]
Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma, 69866 [2014-27680]
Download as PDF 69866 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices National Institutes of Health Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma AGENCY: National Institutes of Health, HHS. ACTION: Notice. asabaliauskas on DSK5VPTVN1PROD with NOTICES 1. U.S. Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled ‘‘Adoptive cell therapy with young T cells’’ (HHS Ref No. E–273–2009/0–US–01); 2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled ‘‘Adoptive cell therapy with young T cells’’ (HHS Ref No. E– 273–2009/0–US–02); 3. U.S. Patent Application No. 13/742,541 filed January 16, 2013 entitled ‘‘Adoptive cell therapy with young T cells’’ (HHS Ref No. E– 273–2009/0–US–03); 4. U.S. Provisional Patent Application No. 61/466,200 filed March 22, 2011 entitled ‘‘Methods of growing tumor infiltrating lymphocytes in gas-permeable containers’’ (HHS Ref No. E–114–2011/0–US–01); 5. PCT Application No. PCT/US2012/ 029744 filed March 20, 2012 entitled ‘‘Methods of growing tumor infiltrating lymphocytes in gas-permeable containers’’ (HHS Ref No. E–114–2011/0–US–01); 6. U.S. Patent Application No. 13/424,646 filed May 20, 2012 entitled ‘‘Methods of growing tumor infiltrating lymphocytes in gas-permeable containers’’ (HHS Ref No. E– 114–2011/0–US–01); The patent rights in these inventions have been assigned to 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 the Licensed Patent Rights to develop, manufacture, distribute, sell and use autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma as a stand-alone therapy. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before December 24, 2014 will be considered. 20:32 Nov 21, 2014 Isolating cells from the tumor infiltrating lymphocytes (TIL) of a patient tumor sample provides a suitable initial lymphocyte culture for further in vitro manipulations. NIH scientists have discovered that taking the isolated cells through one cycle of rapid expansion (including exposure to IL–2), rather than multiple cycles, yields lymphocyte cultures with higher affinity and longer persistence in patients. In addition, they have found that through the use of gas permeable (GP) flasks, they could obtain large quantities of highly reactive TIL from patient tumor samples for anticancer immunotherapy. If an adoptive T cell transfer immunotherapy is to gain regulatory approval and successfully treat a wide array of patients, it will need to be rapid, reliable, and technically simple. One of the most critical factors to this approach is the generation of effective lymphocyte cultures that will rapidly and repeatedly attack the target cells when infused into patients. The prospective exclusive license may be granted unless within thirty (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 part 404. Complete 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. SUPPLEMENTARY INFORMATION: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: SUMMARY: VerDate Sep<11>2014 Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Whitney A. Hastings, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 451–7337; Facsimile: (301) 402– 0220; Email: hastingw@mail.nih.gov. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 235001 Dated: November 17, 2014. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–27680 Filed 11–21–14; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel Production, Analysis, and Distribution of Cannabis and Related Materials (7793). Date: December 2, 2014. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Lyle Furr, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892– 9550, (301) 435–1439, lf33c.nih.gov. 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.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: November 18, 2014. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–27669 Filed 11–21–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the E:\FR\FM\24NON1.SGM 24NON1
[Page 69866]
[FR Doc No: 2014-27680]
[[Page 69866]]
Prospective Grant of Exclusive License: Development of Autologous
Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of
license to the current licensee, Lion Biotechnologies, Inc., which is
located in Woodland Hills, California to practice the inventions
embodied in the following patent applications and applications claiming
priority to these applications:
1. U.S. Provisional Patent Application No. 61/237,889, filed
August 26, 2009 entitled ``Adoptive cell therapy with young T
cells'' (HHS Ref No. E-273-2009/0-US-01);
2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled
``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-
2009/0-US-02);
3. U.S. Patent Application No. 13/742,541 filed January 16, 2013
entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No.
E-273-2009/0-US-03);
4. U.S. Provisional Patent Application No. 61/466,200 filed
March 22, 2011 entitled ``Methods of growing tumor infiltrating
lymphocytes in gas-permeable containers'' (HHS Ref No. E-114-2011/0-
US-01);
5. PCT Application No. PCT/US2012/029744 filed March 20, 2012
entitled ``Methods of growing tumor infiltrating lymphocytes in gas-
permeable containers'' (HHS Ref No. E-114-2011/0-US-01);
6. U.S. Patent Application No. 13/424,646 filed May 20, 2012
the field of use may be limited to the use of the Licensed Patent
Rights to develop, manufacture, distribute, sell and use autologous
tumor infiltrating lymphocyte adoptive cell therapy products for the
treatment of metastatic melanoma as a stand-alone therapy.
December 24, 2014 will be considered.
license should be directed to: Whitney A. Hastings, Ph.D., Senior
Licensing and Patenting Manager, Office of Technology Transfer,
Rockville, MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301)
402-0220; Email: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: Isolating cells from the tumor infiltrating
lymphocytes (TIL) of a patient tumor sample provides a suitable initial
lymphocyte culture for further in vitro manipulations. NIH scientists
have discovered that taking the isolated cells through one cycle of
rapid expansion (including exposure to IL-2), rather than multiple
cycles, yields lymphocyte cultures with higher affinity and longer
persistence in patients. In addition, they have found that through the
use of gas permeable (GP) flasks, they could obtain large quantities of
highly reactive TIL from patient tumor samples for anti-cancer
immunotherapy. If an adoptive T cell transfer immunotherapy is to gain
regulatory approval and successfully treat a wide array of patients, it
will need to be rapid, reliable, and technically simple. One of the
most critical factors to this approach is the generation of effective
lymphocyte cultures that will rapidly and repeatedly attack the target
cells when infused into patients.
The prospective exclusive license may be granted unless within
thirty (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 part 404.
Complete 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
Acting Director, Office of Technology Transfer, National Institutes of
[FR Doc. 2014-27680 Filed 11-21-14; 8:45 am]