82_FR_32847 82 FR 32712 - Prospective Grant of Exclusive Patent License: Development, Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers

82 FR 32712 - Prospective Grant of Exclusive Patent License: Development, Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 135 (July 17, 2017)

Page Range32712-32713
FR Document2017-14860

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to NantBioScience, Inc., located in, California, USA.

Federal Register, Volume 82 Issue 135 (Monday, July 17, 2017) 
[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32712-32713]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development, 
Commercial Application and Use of Fulvestrant in Combination Therapy 
for the Treatment of Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Commercialization Patent 
License to practice the inventions embodied in the U.S. Patents and 
Patent Applications listed in the Supplementary Information section of 
this notice to NantBioScience, Inc., located in, California, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before August 1, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Sabarni K. Chatterjee, Ph.D., 
M.B.A., Senior Licensing and Patenting Manager, NCI Technology Transfer 
Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 
20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: 
(240) 276-5530; Facsimile: (240) 276-5504 Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

     United States Provisional Patent Application No. 62/
290,117 filed February 02, 2016, and entitled ``Fulvestrant Improves 
Immune-mediated Cytotoxic Lysis of Cancer Cells.'' [HHS Reference No. 
E-066-2016/0-US-01];
     International PCT Application No. PCT/US2017/015829 filed 
January 31, 2017, entitled ``Fulvestrant Improves Immune-mediated 
Cytotoxic Lysis of Cancer Cells.'' [HHS Reference No. E-066-2016/0-PCT-
02]; and U.S. and foreign patent applications claiming priority to the 
aforementioned applications.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.

[[Page 32713]]

    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Development, commercial application and use of 
fulvestrant in estrogen receptor positive cancers, in combination with 
other products and therapies, excluding poxvirus-based vaccines.'' For 
avoidance of doubt, the field of use specifically excludes the use of 
fulvestrant in combination with poxvirus-based vaccines.
    This technology discloses the use of fulvestrant, an estrogen 
receptor antagonist, as an immune modulating agent that enhances the 
effects of immunotherapy and/or chemotherapy in cancer cells. 
Fulvestrant treatment of mesenchymal-like lung carcinoma cells 
increases immune-mediated lysis by reversing epithelial mesenchymal 
transition (EMT), potentially repairing defective cell death mechanisms 
driven by EMT, and restoring immune-mediated lysis to chemo-resistant 
cells. Overall, treatment of cancer cells with fulvestrant in 
combination with immunotherapy or chemotherapy agents results in 
increased cancer cell death. Although immunotherapy is leading the 
charge in cancer treatments, its efficacy is limited by patient 
resistance to immunotherapy and/or non-responsiveness. Combination 
therapy with fulvestrant that enhances the therapeutic effects of 
immunotherapy and chemotherapy, is a promising strategy to improve the 
clinical outcome for patients with resistant or unresponsive tumors.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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 prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Commercialization Patent 
License Agreement. 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: July 6, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-14860 Filed 7-14-17; 8:45 am]
 BILLING CODE 4140-01-P

32712 Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices government and in accordance with DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND federal travel regulations. HUMAN SERVICES HUMAN SERVICES Estimated Number and Frequency of National Institutes of Health National Institutes of Health Meetings. The Working Group will meet not less than twice a year. The meetings Prospective Grant of Exclusive Patent National Institute of Allergy and will be open to the public, except as License: Development, Commercial Infectious Diseases; Notice of Closed determined otherwise by the Secretary, Application and Use of Fulvestrant in Meeting or another official to whom authority Combination Therapy for the has been delegated, in accordance with Pursuant to section 10(d) of the Treatment of Cancers the guidelines under Government in the Federal Advisory Committee Act, as AGENCY: National Institutes of Health, Sunshine Act, 5 U.S.C. 552b(c). amended (5 U.S.C. App.), notice is HHS. Nominations: Nominations, including hereby given of the following meeting. ACTION: Notice. self-nominations, of individuals who The meeting will be closed to the have the specified expertise and public in accordance with the SUMMARY: The National Cancer Institute, knowledge will be considered for provisions set forth in sections an institute of the National Institutes of appointment as public voting members Health, Department of Health and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., of the Working Group. A nomination Human Services, is contemplating the as amended. The grant applications and should include, at a minimum, the grant of an Exclusive Commercialization the discussions could disclose Patent License to practice the inventions following for each nominee: (1) A letter confidential trade secrets or commercial of nomination that clearly states the embodied in the U.S. Patents and Patent property such as patentable material, Applications listed in the name and affiliation of the nominee, the and personal information concerning basis for the nomination, and a Supplementary Information section of individuals associated with the grant this notice to NantBioScience, Inc., statement from the nominee that applications, the disclosure of which located in, California, USA. indicates that the individual is willing would constitute a clearly unwarranted DATES: Only written comments and/or to serve as a member of the Working invasion of personal privacy. applications for a license which are Group, if selected; (2) the nominator’s Name of Committee: National Institute of received by the National Cancer name, address, and daytime telephone Allergy and Infectious Diseases Special Institute’s Technology Transfer Center number, and the address, telephone on or before August 1, 2017 will be Emphasis Panel; NIAID Clinical Trial number, and email address of the Planning Grant (R34). considered. individual being nominated; and (3) a Date: July 31, 2017. current copy of the nominee’s ADDRESSES: Requests for copies of the Time: 2:00 p.m. to 4:00 p.m. patent application, inquiries, and curriculum vitae or resume, which Agenda: To review and evaluate grant should be limited to no more than 10 comments relating to the contemplated applications. Exclusive Commercialization Patent pages. Place: National Institutes of Health, 5601 License should be directed to: Sabarni Every effort will be made to ensure Fishers Lane, Rockville, MD 20892 K. Chatterjee, Ph.D., M.B.A., Senior that the Working Group is a diverse (Telephone Conference Call). Licensing and Patenting Manager, NCI group of individuals with representation Contact Person: Jay R. Radke, Ph.D., AIDS Technology Transfer Center, 9609 from various geographic locations, racial Review Branch, Scientific Review Program, Medical Center Drive, RM 1E530 MSC Division of Extramural Activities, Room and ethnic minorities, all genders, and 9702, Bethesda, MD 20892–9702 (for #3G11B, National Institutes of Health, NIAID, persons living with disabilities. business mail), Rockville, MD 20850– 5601 Fishers Lane MSC–9823, Bethesda, MD Individuals being considered for 9702 Telephone: (240) 276–5530; 20892–9823, (240) 669–5046, jay.radke@ appointment as public voting members nih.gov. Facsimile: (240) 276–5504 Email: will be required to complete and submit sabarni.chatterjee@nih.gov. This notice is being published less than 15 a report of their financial holdings. An SUPPLEMENTARY INFORMATION: days prior to the meeting due to the urgent ethics review must be conducted to need to meet timing limitations imposed by Intellectual Property ensure that individuals appointed as the intramural research review cycle. • United States Provisional Patent public voting members of the Working (Catalogue of Federal Domestic Assistance Application No. 62/290,117 filed Group are not involved in any activity Program Nos. 93.855, Allergy, Immunology, February 02, 2016, and entitled that may pose a potential conflict of and Transplantation Research; 93.856, ‘‘Fulvestrant Improves Immune- interest for the official duties that are to Microbiology and Infectious Diseases mediated Cytotoxic Lysis of Cancer be performed. This is a federal ethics Research, National Institutes of Health, HHS) Cells.’’ [HHS Reference No. E–066– requirement that must be satisfied upon Dated: July 10, 2017. 2016/0–US–01]; entering the position and annually Natasha M. Copeland, • International PCT Application No. throughout the established term of PCT/US2017/015829 filed January 31, Program Analyst, Office of Federal Advisory appointment on the Working Group. 2017, entitled ‘‘Fulvestrant Improves Committee Policy. Dated: July 12, 2017. Immune-mediated Cytotoxic Lysis of [FR Doc. 2017–14857 Filed 7–14–17; 8:45 am] asabaliauskas on DSKBBXCHB2PROD with NOTICES Cancer Cells.’’ [HHS Reference No. E– Donald Wright, BILLING CODE 4140–01–P 066–2016/0–PCT–02]; and U.S. and Acting Assistant Secretary for Health. foreign patent applications claiming [FR Doc. 2017–14965 Filed 7–14–17; 8:45 am] priority to the aforementioned BILLING CODE 4150–28–P applications. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. VerDate Sep<11>2014 17:45 Jul 14, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1

Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices 32713 The prospective exclusive license Dated: July 6, 2017. Office, National Institute of Allergy and territory may be worldwide and the Richard U. Rodriguez, Infectious Diseases, 5601 Fishers Lane, field of use may be limited to the use Associate Director, Technology Transfer Rockville, MD, 20852; tel. 301–496– of Licensed Patent Rights for the Center, National Cancer Institute. 2644. A signed Confidential Disclosure following: ‘‘Development, commercial [FR Doc. 2017–14860 Filed 7–14–17; 8:45 am] Agreement will be required to receive application and use of fulvestrant in BILLING CODE 4140–01–P copies of unpublished patent estrogen receptor positive cancers, in applications. combination with other products and SUPPLEMENTARY INFORMATION: therapies, excluding poxvirus-based DEPARTMENT OF HEALTH AND Technology description follows. vaccines.’’ For avoidance of doubt, the HUMAN SERVICES Compounds That Treat Malaria and field of use specifically excludes the use National Institutes of Health Prevent Malaria Transmission of fulvestrant in combination with poxvirus-based vaccines. National Institute on Drug Abuse; Description of Technology This technology discloses the use of Amended Notice of Meeting Malaria is the single leading cause of fulvestrant, an estrogen receptor Notice is hereby given of a change in death, especially among children, in the antagonist, as an immune modulating the meeting of the National Institute on developing world. Malaria is caused by agent that enhances the effects of Drug Abuse Special Emphasis Panel, infection with parasites of the genus immunotherapy and/or chemotherapy July 27, 2017, 09:00 a.m. to July 27, Plasmodium, transmitted by mosquitos. in cancer cells. Fulvestrant treatment of 2017, 05:00 p.m., National Institutes of In addition to transmission, vital steps mesenchymal-like lung carcinoma cells Health, Neuroscience Center, 6001 in the parasite lifecycle occur in the increases immune-mediated lysis by Executive Boulevard, Rockville, MD mosquito host. The invention offered for reversing epithelial mesenchymal 20852 which was published in the licensing relates to therapeutic Federal Register on June 29, 2017, 82 compounds and related pharmaceutical transition (EMT), potentially repairing 125 FR 2017–13696. compositions that can be used in the defective cell death mechanisms driven This meeting was amended to change prevention and treatment of malaria by EMT, and restoring immune- infection. More specifically, the mediated lysis to chemo-resistant cells. the date from July 27, 2017 to July 25, 2017. The time of the meeting remains invention is drawn to compounds that Overall, treatment of cancer cells with may kill sexual and mosquito stage the same. The meeting is closed to the fulvestrant in combination with malaria parasites to block transmission. public. immunotherapy or chemotherapy agents Specifically claimed is the results in increased cancer cell death. Dated: July 10, 2017. antihistamine Ketotifen, which has Although immunotherapy is leading the Natasha M. Copeland, demonstrated activity blocking parasite charge in cancer treatments, its efficacy Program Analyst, Office of Federal Advisory development in mosquitoes. Also is limited by patient resistance to Committee Policy. claimed are treatments encompassing immunotherapy and/or non- [FR Doc. 2017–14858 Filed 7–14–17; 8:45 am] Ketotifen with other existing responsiveness. Combination therapy BILLING CODE 4140–01–P antimalarial drugs in a combination with fulvestrant that enhances the treatment aimed at multiple stages in therapeutic effects of immunotherapy the malaria life cycle. DEPARTMENT OF HEALTH AND This technology is available for and chemotherapy, is a promising HUMAN SERVICES licensing for commercial development strategy to improve the clinical outcome for patients with resistant or National Institutes of Health in accordance with 35 U.S.C. 209 and 37 unresponsive tumors. CFR part 404, as well as for further Government-Owned Inventions; development and evaluation under a This notice is made in accordance research collaboration. with 35 U.S.C. 209 and 37 CFR part 404. Availability for Licensing The prospective exclusive license will AGENCY: National Institutes of Health, Potential Commercial Applications be royalty bearing, and the prospective HHS. • Prevention and treatment of malaria exclusive license may be granted unless ACTION: Notice. infections within fifteen (15) days from the date of SUMMARY: The invention listed below is Competitive Advantages this published notice, the National Cancer Institute receives written owned by an agency of the U.S. • Drugs that kill sexual and mosquito evidence and argument that establishes Government and is available for stages of the parasite are important for that the grant of the license would not licensing to achieve expeditious preventing and/or slowing the spread of commercialization of results of malaria infection and ultimately for be consistent with the requirements of federally-funded research and malaria eradication. 35 U.S.C. 209 and 37 CFR part 404. development. Foreign patent • Primaquine, the only currently Complete applications for a license in applications are filed on selected available drug shown to block the prospective field of use that are filed inventions to extend market coverage transmission, is known to cause serious in response to this notice will be treated for companies and may also be available adverse side effects. as objections to the grant of the for licensing. asabaliauskas on DSKBBXCHB2PROD with NOTICES contemplated Exclusive Development Stage FOR FURTHER INFORMATION CONTACT: Dr. Commercialization Patent License Peter Tung; 240–669–5483; peter.tung@ • Pre-Clinical (animal data available) Agreement. Comments and objections nih.gov. Licensing information and Inventors: Xin-zhuan Su and Dipak submitted to this notice will not be copies of the patent applications listed Raj (NIAID). made available for public inspection below may be obtained by Publications: Eastman R.T. and, to the extent permitted by law, will communicating with the indicated Pattaradilokrat S. Raj D.K. Dixit S. Deng not be released under the Freedom of licensing contact at the Technology B. Miura K. Yuan J. Tanaka T.Q. Information Act, 5 U.S.C. 552. Transfer and Intellectual Property Johnson R.L. Jiang H. et al. 2013. A class VerDate Sep<11>2014 17:45 Jul 14, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1


Document Created: 2017-07-15 03:46:07
Document Modified: 2017-07-15 03:46:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before August 1, 2017 will be considered.
FR Citation82 FR 32712 
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