Prospective Grant of an Exclusive Patent License: Development and Commercialization of Fenoterol and Certain Fenoterol Analogues for the Treatment of Cancer, 37464-37466 [2020-13316]

Download as PDF 37464 Federal Register / Vol. 85, No. 120 / Monday, June 22, 2020 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Prospective Grant of an Exclusive Patent License: Development and Commercialization of Fenoterol and Certain Fenoterol Analogues for the Treatment of Cancer Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; RFA AA–20–007 Medications Development for the Treatment of Alcohol Use Disorder (AUD) or AlcoholRelated Organ Damage (AROD), or the Combination of AUD and AROD (U01 Clinical Trial Optional). Date: July 24, 2020. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Health, National Institute on Alcohol Abuse and Alcoholism, 6700 B Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ranga Srinivas, Ph.D., Chief Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 6700 B Rockledge Drive, Room 2114, Bethesda, MD 20892, (301) 451–2067, srinivar@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) Name of Committee: Microbiology, Infectious Diseases and AIDS Initial Review Group; Microbiology and Infectious Diseases B Subcommittee MID–B Review Committee July 2020. Date: July 13–15, 2020. Time: 9:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F30, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Ellen S. Buczko, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F30, Rockville, MD 20892–7616, 301–451–2676, ebuczko1@ niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: June 16, 2020. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–13321 Filed 6–19–20; 8:45 am] BILLING CODE 4140–01–P Dated: June 16, 2020. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–13327 Filed 6–19–20; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 18:08 Jun 19, 2020 Jkt 250001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Institute on Aging, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Paz Pharmaceuticals, LLC of the State of Delaware. 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 July 7, 2020 will be considered. SUMMARY: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior Technology Transfer Manager, National Institutes of Health, NCI Technology Transfer Center by email (richard.girards@nih.gov) or phone (240–276–6825). SUPPLEMENTARY INFORMATION: ADDRESSES: Intellectual Property E–205–2006: Preparation of (R,R)fenoterol and (R,R)-or (R,S)-fenoterol analogues and their use in treating congestive heart failure 1. United States Provisional Patent Application No. 60/837,161, filed 10 August 2006 (HHS Reference No. E–205–2006–0– US–01); 2. United States Provisional Patent Application No. 60/927,825, filed 03 May 2007 (HHS Reference No. E–205–2006–1– US–01); 3. United States Patent Application No. 12/ 376,945, filed 09 February 2009 (HHS Reference No. E–205–2006–2–US–13); 4. United States Patent No. 8,703,826, issued 22 April 2014 (HHS Reference No. E– 205–2006–2–US–15); 5. United States Patent No. 9,522,871, issued 20 December 2016 (HHS Reference No. E–205–2006–2–US–19); 6. United States Patent No. 9,908,841, issued 06 March 2018 (HHS Reference No. E– 205–2006–2–US–22); E:\FR\FM\22JNN1.SGM 22JNN1 Federal Register / Vol. 85, No. 120 / Monday, June 22, 2020 / Notices 7. United States Patent No. 10,308,591, issued 04 June 2019 (HHS Reference No. E– 205–2006–2–US–26); 8. United States Patent No. 10,562,843, issued 18 February 2020 (HHS Reference No. E–205–2006–2–US–27); 9. International Patent Application No. PCT/US2007/075731, filed 10 August 2007 (HHS Reference No. E–205–2006–2–PCT–01); 10. Australia Patent No. 2007286051, issued 26 April 2013 (HHS Reference No. E– 205–2006–2–AU–02); 11. Australia Patent No. 2013202127, issued 25 September 2014 (HHS Reference No. E–205–2006–2–AU–16); 12. Australia Patent Application No. 2014224073, filed 11 September 2014 (HHS Reference No. E–205–2006–2–AU–20); 13. Brazil Patent Application No. PI0716495–5, filed 18 June 2009 (HHS Reference No. E–205–2006–2–BR–03); 14. Canada Patent No. 2660707, issued 08 July 2014 (HHS Reference No. E–205–2006– 2–CA–04); 15. China Patent No. 200780036155.9, issued 29 January 2014 (HHS Reference No. E–205–2006–2–CN–05); 16. China Patent Application No. 201310705914.3, filed 10 August 2007 (HHS Reference No. E–205–2006–2–CN–18); 17. European Patent No. 2064174, issued 26 October 2016 (HHS Reference No. E–205– 2006–2–EP–06) and all of its national validations; 18. Hong Kong Patent Application No. 14107948.2, filed 04 August 2014 (HHS Reference No. E–205–2006–2–HK–21); 19. Israel Patent No. 196965, issued 30 January 2016 (HHS Reference No. E–205– 2006–2–IL–07); 20. India Patent No. 266343, issued 28 April 2015 (HHS Reference No. E–205–2006– 2–IN–08); 21. Japan Patent No. 5302194, issued 28 June 2013 (HHS Reference No. E–205–2006– 2–JP–09); 22. Japan Patent Application No. 2013– 129406, filed 20 June 2013 (HHS Reference No. E–205–2006–2–JP–17); 23. Korea (South) Patent No. 10–1378067, issued 19 March 2014 (HHS Reference No. E– 205–2006–2–KR–10); 24. Mexico Patent No. 331996, issued 30 July 2015 (HHS Reference No. E–205–2006– 2–MX–11); 25. Philippines Patent Application No. 1– 2009–500267, filed 10 August 2007 (HHS Reference No. E–205–2006–2–PH–12); 26. South Africa Patent No. 2009/00938, issued 28 April 2010 (HHS Reference No. E– 205–2006–2–ZA–14); and 27. any and all other U.S. and ex-U.S. patents and patent applications claiming priority to any one of the foregoing, now or in the future. E–013–2010: Use of fenoterol and fenoterol analogues in the treatment of glioblastomas and astrocytomas 1. United States Provisional Patent Application No. 61/312,642, filed 10 March 2010 (HHS Reference No. E–013–2010–0– US–01); 2. United States Patent No. 9,492,405, issued 15 November 2016 (HHS Reference No. E–013–2010–0–US–08); VerDate Sep<11>2014 18:08 Jun 19, 2020 Jkt 250001 3. United States Patent No. 10,130,594, issued 20 November 2018 (HHS Reference No. E–013–2010–0–US–10); 4. United States Patent No. 10,617,654, issued 14 April 2020 (HHS Reference No. E– 013–2010–0–US–15); 5. United States Patent Application No. 16/ 806,659, filed 02 March 2020 (HHS Reference No. E–013–2010–0–US–16); 6. International Patent Application No. PCT/US2011/027988, filed 10 March 2011 (HHS Reference No. E–013–2010–0–PCT–02); 7. Australia Patent No. 2011224241, issued 21 August 2014 (HHS Reference No. E–013– 2010–0–AU–03); 8. Australia Patent No. 2014210656, issued 30 June 2016 (HHS Reference No. E–013– 2010–0–AU–09); 9. Brazil Patent Application No. BR112012022552–9, filed 10 March 2011 (HHS Reference No. E–013–2010–0–BR–04); 10. Canada Patent No. 2791702, issued 29 May 2018 (HHS Reference No. E–013–2010– 0–CA–05); 11. European Patent No. 2544676, issued 19 September 2018 (HHS Reference No. E– 013–2010–0–EP–06) and all of its national validations; 12. Japan Patent No. 5837890, issued 13 November 2015 (HHS Reference No. E–013– 2010–0–JP–07); 13. any and all other U.S. and ex-U.S. patents and patent applications claiming priority to any one of the foregoing, now or in the future. E–139–2012: Methods of regulating cannabinoid receptor activity-related disorders and diseases 1. United States Provisional Patent Application No. 61/651,961, filed 25 May 2012 (HHS Reference No. E–139–2012–0– US–01); 2. United States Provisional Patent Application No. 61/789,629, filed 15 March 2013 (HHS Reference No. E–139–2012–1– US–01); 3. United States Patent Application No. 14/ 403,516, filed 24 November 2014 (HHS Reference No. E–139–2012–2–US–06); 4. United States Patent No. 10,130,593, issued 20 November 2018 (HHS Reference No. E–139–2012–2–US–11); 5. United States Patent No. 10,485,771, issued 26 November 2019 (HHS Reference No. E–139–2012–2–US–13); 6. United States Patent Application No. 16/ 600,234, filed 11 October 2019 (HHS Reference No. E–139–2012–2–US–14); 7. International Patent Application No. PCT/US2013/042457, filed 23 May 2013 (HHS Reference No. E–139–2012–2–PCT–01); 8. Australia Patent No. 2013266235, issued 21 September 2017 (HHS Reference No. E– 139–2012–2–AU–02); 9. Canada Patent Application No. 2874655, filed 23 May 2013 (HHS Reference No. E– 139–2012–2–CA–03); 10. European Patent No. 2854855, issued 27 April 2016 (HHS Reference No. E–139– 2012–2–EP–04) and all of its national validations; 11. Japan Patent No. 6130495, issued 21 April 2017 (HHS Reference No. E–139–2012– 2–JP–05); 12. any and all other U.S. and ex-U.S. patents and patent applications claiming PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 37465 priority to any one of the foregoing, now or in the future. The patent and patent application rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the fields of use may be limited to the following: The development, manufacture, distribution, sale and use for the treatment of cancer of one or more of fenoterol and its analogues, either in combination or not in combination with one or more other therapeutic agents. These technologies disclose, e.g., the use of fenoterol and its analogues for regulating cannabinoid (CB) receptor activity-related disorders and disease, such as dysregulated CB receptors, including treating a disorder or disease. These diseases may include but are not limited to glioblastoma, hepatocellular carcinoma, liver cancer, colon cancer, and/or lung cancer, all of which may be associated with altered cannabinoid receptor activity. In one example, the technologies include administering to a subject having or at risk of developing a disorder or disease regulated by CB receptor activity an effective amount of fenoterol or one of its analogues to reduce one or more symptoms associated with the disorder or disease regulated by CB receptor activity. This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 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 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. E:\FR\FM\22JNN1.SGM 22JNN1 37466 Federal Register / Vol. 85, No. 120 / Monday, June 22, 2020 / Notices Dated: June 12, 2020. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2020–13316 Filed 6–19–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [1651–0109] Agency Information Collection Activities: Guam-CNMI Visa Waiver Information U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day notice and request for comments; extension of an existing collection of information. AGENCY: The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and must be submitted (no later than August 21, 2020) to be assured of consideration. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1651–0109 in the subject line and the agency name. To avoid duplicate submissions, please use only one of the following methods to submit comments: (1) Email. Submit comments to: CBP_ PRA@cbp.dhs.gov. (2) Mail. Submit written comments to CBP Paperwork Reduction Act Officer, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, Economic Impact Analysis Branch, 90 K Street NE, 10th Floor, Washington, DC 20229–1177. FOR FURTHER INFORMATION CONTACT: Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229–1177, Telephone number 202–325–0056 or via email CBP_PRA@cbp.dhs.gov. Please note that the contact information provided here is solely for questions SUMMARY: VerDate Sep<11>2014 18:08 Jun 19, 2020 Jkt 250001 regarding this notice. Individuals seeking information about other CBP programs should contact the CBP National Customer Service Center at 877–227–5511, (TTY) 1–800–877–8339, or CBP website at https://www.cbp.gov/. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record. Overview of This Information Collection Title: Guam-CNMI Visa Waiver Information. OMB Number: 1651–0109. Form Number: I–736. Current Action: Renewal. Type of Review: Extension/Revision (with change). Affected Public: Individuals. Abstract: Public Law 110–229 provides for certain aliens to be exempt from the nonimmigrant visa requirement if seeking entry into Guam or the Commonwealth of the Northern Mariana Islands (CNMI) as a visitor for a maximum stay of 45 days, provided that no potential threat exists to the welfare, safety, or security of the United States, or its territories, and other criteria are met. Upon arrival at the Guam or CNMI Ports-of-Entry, each applicant for admission presents a completed Form I–736 to CBP, which collects information about the PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 applicant’s identity and travel documents. Several elements have been added to the Form I–736. Updates are necessary to be able to automate Form I–736, Guam-CNMI Visa Waiver Information that is use in compliance with the Guam-CNMI Visa Waiver Program. The new data elements are: the foreign passport type, social media identifier, valid email address, and social media provider/platform. The automation will facilitate CBP to gather information on travelers from Guam-CNMI Visa Waiver Program countries to determine their admissibility to enter Guam or the CNMI. In addition, CBP intends to migrate from paper I–736 to a mandatory automated environment; therefore, the collection of a paper form will no longer be acceptable. However, after the regulation implementing mandatory automation is published, CBP will grant a transition period of three months to facilitate travelers adjusting to the new collection method. At the end of the transition period, the paper I–736 form will become obsolete and travelers must input and submit in advance their personal information and respond to the eligibility questions using the new electronic format. The travelers’ information is pre-screened or vetted against law enforcement databases. Based on the results of the pre-screening, the application is approved or denied. The system generates a board or no board status message to the carrier indicating a denied or approved authorization to board before the flight. The applicant also receives a message with the application status: approved, denied, canceled or pending. All information will be saved in the newly created Guam-CNMI Visa Waiver Program database. Estimated Number of Respondents: 1,560,000. Estimated Number of Annual Responses per Respondent: 1. Estimated Number of Total Annual Responses: 1,560,000. Estimated Time per Response: 19 minutes (0.316 hours). Estimated Total Annual Burden Hours: 492,960. Dated: June 16, 2020. Seth D. Renkema, Branch Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection. [FR Doc. 2020–13296 Filed 6–19–20; 8:45 am] BILLING CODE 9111–14–P E:\FR\FM\22JNN1.SGM 22JNN1

Agencies

[Federal Register Volume 85, Number 120 (Monday, June 22, 2020)]
[Notices]
[Pages 37464-37466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Fenoterol and Certain Fenoterol Analogues for the 
Treatment of Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institute on Aging, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this Notice to Paz 
Pharmaceuticals, LLC of the State of Delaware.

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 July 7, 2020 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior 
Technology Transfer Manager, National Institutes of Health, NCI 
Technology Transfer Center by email ([email protected]) or phone 
(240-276-6825).

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-205-2006: Preparation of (R,R)-fenoterol and (R,R)-or (R,S)-fenoterol 
analogues and their use in treating congestive heart failure

    1. United States Provisional Patent Application No. 60/837,161, 
filed 10 August 2006 (HHS Reference No. E-205-2006-0-US-01);
    2. United States Provisional Patent Application No. 60/927,825, 
filed 03 May 2007 (HHS Reference No. E-205-2006-1-US-01);
    3. United States Patent Application No. 12/376,945, filed 09 
February 2009 (HHS Reference No. E-205-2006-2-US-13);
    4. United States Patent No. 8,703,826, issued 22 April 2014 (HHS 
Reference No. E-205-2006-2-US-15);
    5. United States Patent No. 9,522,871, issued 20 December 2016 
(HHS Reference No. E-205-2006-2-US-19);
    6. United States Patent No. 9,908,841, issued 06 March 2018 (HHS 
Reference No. E-205-2006-2-US-22);

[[Page 37465]]

    7. United States Patent No. 10,308,591, issued 04 June 2019 (HHS 
Reference No. E-205-2006-2-US-26);
    8. United States Patent No. 10,562,843, issued 18 February 2020 
(HHS Reference No. E-205-2006-2-US-27);
    9. International Patent Application No. PCT/US2007/075731, filed 
10 August 2007 (HHS Reference No. E-205-2006-2-PCT-01);
    10. Australia Patent No. 2007286051, issued 26 April 2013 (HHS 
Reference No. E-205-2006-2-AU-02);
    11. Australia Patent No. 2013202127, issued 25 September 2014 
(HHS Reference No. E-205-2006-2-AU-16);
    12. Australia Patent Application No. 2014224073, filed 11 
September 2014 (HHS Reference No. E-205-2006-2-AU-20);
    13. Brazil Patent Application No. PI0716495-5, filed 18 June 
2009 (HHS Reference No. E-205-2006-2-BR-03);
    14. Canada Patent No. 2660707, issued 08 July 2014 (HHS 
Reference No. E-205-2006-2-CA-04);
    15. China Patent No. 200780036155.9, issued 29 January 2014 (HHS 
Reference No. E-205-2006-2-CN-05);
    16. China Patent Application No. 201310705914.3, filed 10 August 
2007 (HHS Reference No. E-205-2006-2-CN-18);
    17. European Patent No. 2064174, issued 26 October 2016 (HHS 
Reference No. E-205-2006-2-EP-06) and all of its national 
validations;
    18. Hong Kong Patent Application No. 14107948.2, filed 04 August 
2014 (HHS Reference No. E-205-2006-2-HK-21);
    19. Israel Patent No. 196965, issued 30 January 2016 (HHS 
Reference No. E-205-2006-2-IL-07);
    20. India Patent No. 266343, issued 28 April 2015 (HHS Reference 
No. E-205-2006-2-IN-08);
    21. Japan Patent No. 5302194, issued 28 June 2013 (HHS Reference 
No. E-205-2006-2-JP-09);
    22. Japan Patent Application No. 2013-129406, filed 20 June 2013 
(HHS Reference No. E-205-2006-2-JP-17);
    23. Korea (South) Patent No. 10-1378067, issued 19 March 2014 
(HHS Reference No. E-205-2006-2-KR-10);
    24. Mexico Patent No. 331996, issued 30 July 2015 (HHS Reference 
No. E-205-2006-2-MX-11);
    25. Philippines Patent Application No. 1-2009-500267, filed 10 
August 2007 (HHS Reference No. E-205-2006-2-PH-12);
    26. South Africa Patent No. 2009/00938, issued 28 April 2010 
(HHS Reference No. E-205-2006-2-ZA-14); and
    27. any and all other U.S. and ex-U.S. patents and patent 
applications claiming priority to any one of the foregoing, now or 
in the future.

E-013-2010: Use of fenoterol and fenoterol analogues in the treatment 
of glioblastomas and astrocytomas

    1. United States Provisional Patent Application No. 61/312,642, 
filed 10 March 2010 (HHS Reference No. E-013-2010-0-US-01);
    2. United States Patent No. 9,492,405, issued 15 November 2016 
(HHS Reference No. E-013-2010-0-US-08);
    3. United States Patent No. 10,130,594, issued 20 November 2018 
(HHS Reference No. E-013-2010-0-US-10);
    4. United States Patent No. 10,617,654, issued 14 April 2020 
(HHS Reference No. E-013-2010-0-US-15);
    5. United States Patent Application No. 16/806,659, filed 02 
March 2020 (HHS Reference No. E-013-2010-0-US-16);
    6. International Patent Application No. PCT/US2011/027988, filed 
10 March 2011 (HHS Reference No. E-013-2010-0-PCT-02);
    7. Australia Patent No. 2011224241, issued 21 August 2014 (HHS 
Reference No. E-013-2010-0-AU-03);
    8. Australia Patent No. 2014210656, issued 30 June 2016 (HHS 
Reference No. E-013-2010-0-AU-09);
    9. Brazil Patent Application No. BR112012022552-9, filed 10 
March 2011 (HHS Reference No. E-013-2010-0-BR-04);
    10. Canada Patent No. 2791702, issued 29 May 2018 (HHS Reference 
No. E-013-2010-0-CA-05);
    11. European Patent No. 2544676, issued 19 September 2018 (HHS 
Reference No. E-013-2010-0-EP-06) and all of its national 
validations;
    12. Japan Patent No. 5837890, issued 13 November 2015 (HHS 
Reference No. E-013-2010-0-JP-07);
    13. any and all other U.S. and ex-U.S. patents and patent 
applications claiming priority to any one of the foregoing, now or 
in the future.

E-139-2012: Methods of regulating cannabinoid receptor activity-related 
disorders and diseases

    1. United States Provisional Patent Application No. 61/651,961, 
filed 25 May 2012 (HHS Reference No. E-139-2012-0-US-01);
    2. United States Provisional Patent Application No. 61/789,629, 
filed 15 March 2013 (HHS Reference No. E-139-2012-1-US-01);
    3. United States Patent Application No. 14/403,516, filed 24 
November 2014 (HHS Reference No. E-139-2012-2-US-06);
    4. United States Patent No. 10,130,593, issued 20 November 2018 
(HHS Reference No. E-139-2012-2-US-11);
    5. United States Patent No. 10,485,771, issued 26 November 2019 
(HHS Reference No. E-139-2012-2-US-13);
    6. United States Patent Application No. 16/600,234, filed 11 
October 2019 (HHS Reference No. E-139-2012-2-US-14);
    7. International Patent Application No. PCT/US2013/042457, filed 
23 May 2013 (HHS Reference No. E-139-2012-2-PCT-01);
    8. Australia Patent No. 2013266235, issued 21 September 2017 
(HHS Reference No. E-139-2012-2-AU-02);
    9. Canada Patent Application No. 2874655, filed 23 May 2013 (HHS 
Reference No. E-139-2012-2-CA-03);
    10. European Patent No. 2854855, issued 27 April 2016 (HHS 
Reference No. E-139-2012-2-EP-04) and all of its national 
validations;
    11. Japan Patent No. 6130495, issued 21 April 2017 (HHS 
Reference No. E-139-2012-2-JP-05);
    12. any and all other U.S. and ex-U.S. patents and patent 
applications claiming priority to any one of the foregoing, now or 
in the future.

    The patent and patent application rights in these inventions have 
been assigned and/or exclusively licensed to the government of the 
United States of America.
    The prospective exclusive license territory may be worldwide and 
the fields of use may be limited to the following: The development, 
manufacture, distribution, sale and use for the treatment of cancer of 
one or more of fenoterol and its analogues, either in combination or 
not in combination with one or more other therapeutic agents.
    These technologies disclose, e.g., the use of fenoterol and its 
analogues for regulating cannabinoid (CB) receptor activity-related 
disorders and disease, such as dysregulated CB receptors, including 
treating a disorder or disease. These diseases may include but are not 
limited to glioblastoma, hepatocellular carcinoma, liver cancer, colon 
cancer, and/or lung cancer, all of which may be associated with altered 
cannabinoid receptor activity. In one example, the technologies include 
administering to a subject having or at risk of developing a disorder 
or disease regulated by CB receptor activity an effective amount of 
fenoterol or one of its analogues to reduce one or more symptoms 
associated with the disorder or disease regulated by CB receptor 
activity.
    This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
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 404.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information from these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.


[[Page 37466]]


    Dated: June 12, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-13316 Filed 6-19-20; 8:45 am]
BILLING CODE 4140-01-P
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