Prospective Grant of Exclusive Patent License: Radiotherapy for Metastatic Castration-Resistant Prostate Cancer, 35667 [2018-16066]

Download as PDF Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices represented on HHS Federal advisory committees and, therefore, the Department encourages nominations of qualified candidates from these groups. The Department also encourages geographic diversity in the composition of the Committee. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Requests for reasonable accommodation to enable participation on the Committee should be indicated in the nomination submission. Member Terms: Non-Federal public members of the Committee serve for a term of 3 years, and may serve for an unlimited number of terms if reappointed. Members may serve after the expiration of their terms, until their successors have taken office. Meetings and Travel: As specified by Public Law 113–166, the MDCC ‘‘shall meet no fewer than two times per calendar year.’’ Travel expenses are provided for non-federal public Committee members to facilitate attendance at in-person meetings. Members are expected to make every effort to attend all full committee meetings, twice per year, either in person or via remote access. Participation in relevant subcommittee, working and planning group meetings, and workshops, is also encouraged. Submission Instructions and Deadline: Nominations are due by 5 p.m. EDT on August 31, 2018, and should be sent to Glen Nuckolls, Ph.D., by email to nuckollg@ninds.nih.gov. Nominations must include contact information for the nominee, a current curriculum vitae or resume of the nominee and a paragraph describing the qualifications of the person to represent some portion(s) of the muscular dystrophy research, advocacy and/or patient care communities. More information about the MDCC is available at https://mdcc.nih.gov/. Dated: July 24, 2018. amozie on DSK3GDR082PROD with NOTICES1 Walter J. Koroshetz, Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health. [FR Doc. 2018–16112 Filed 7–26–18; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Radiotherapy for Metastatic Castration-Resistant Prostate Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to Sinotau Pharmaceutical Group, headquartered in Beijing, China, to practice the inventions embodied in the patent application(s) listed in the Supplementary Information section of this notice. DATES: Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development August 27, 2018 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: Michael Shmilovich, Esq., Senior Licensing and Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479, phone number 301–435–5019, or shmilovm@ mail.nih.gov. SUMMARY: The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to Sinotau Pharmaceutical Group: U.S. Provisional Patent Application 62/633,648, ‘‘Chemical Conjugates Of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents For Targeting Prostate Cancer,’’ filed February 22, 2018 (HHS Ref. No. E–054–2018–0). The patent rights in this invention have been assigned to the Government of the United States of America. The perspective license would be granted worldwide and in a field of use not broader than radiotherapeutics for metastatic castration-resistant prostate cancer. The invention covered by the patents and patent applications pertaining to HHS Ref. No. E–054–2018–0 pertain to a therapeutic agent that includes a SUPPLEMENTARY INFORMATION: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 35667 chemically conjugated residue derived from (((R-)-1-carboxy-2mercaptoethyl)carbamoyl)-L-glutamic acid that is further bound to an Evans blue analog (EB). The EB analog reversibly binds to circulating serum albumin to provide a radiopharmaceutical that retains affinity and specificity to prostate specific membrane antigen (PSMA; in this case PSMA-617). PSMA is a surface molecule shown to be specifically expressed by prostate tumor cells. PSMA expression levels correlate with disease stage and with hormone refractory cancers. Although most PSMA expression appears to be restricted to the prostate cancer, low levels of expression can also be detected in the brain, kidneys, salivary glands, and small intestine. The antigen is also shown to be expressed by neovascular tumor vessels of multiple other cancers. Inclusion of the Evans blue analog promotes high internalization and retention rates of the conjugated target ligand, and therefore, higher accumulation in PSMA positive tumors. Labeling EB-PSMA-617 derivatives with the therapeutic beta emitters, e.g., 90Y, 86Y, and 177Lu gives rise to improved tumor response and survival rates. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the NHLBI 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 timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent 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: July 19, 2018. Michael A. Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2018–16066 Filed 7–26–18; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Radiotherapy for 
Metastatic Castration-Resistant Prostate Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive commercialization patent 
license to Sinotau Pharmaceutical Group, headquartered in Beijing, 
China, to practice the inventions embodied in the patent application(s) 
listed in the Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
August 27, 2018 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: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-435-5019, or [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to Sinotau 
Pharmaceutical Group: U.S. Provisional Patent Application 62/633,648, 
``Chemical Conjugates Of Evans Blue Derivatives And Their Use As 
Radiotherapy And Imaging Agents For Targeting Prostate Cancer,'' filed 
February 22, 2018 (HHS Ref. No. E-054-2018-0). The patent rights in 
this invention have been assigned to the Government of the United 
States of America. The perspective license would be granted worldwide 
and in a field of use not broader than radiotherapeutics for metastatic 
castration-resistant prostate cancer.
    The invention covered by the patents and patent applications 
pertaining to HHS Ref. No. E-054-2018-0 pertain to a therapeutic agent 
that includes a chemically conjugated residue derived from (((R-)-1-
carboxy-2-mercaptoethyl)carbamoyl)-L-glutamic acid that is further 
bound to an Evans blue analog (EB). The EB analog reversibly binds to 
circulating serum albumin to provide a radiopharmaceutical that retains 
affinity and specificity to prostate specific membrane antigen (PSMA; 
in this case PSMA-617). PSMA is a surface molecule shown to be 
specifically expressed by prostate tumor cells. PSMA expression levels 
correlate with disease stage and with hormone refractory cancers. 
Although most PSMA expression appears to be restricted to the prostate 
cancer, low levels of expression can also be detected in the brain, 
kidneys, salivary glands, and small intestine. The antigen is also 
shown to be expressed by neovascular tumor vessels of multiple other 
cancers. Inclusion of the Evans blue analog promotes high 
internalization and retention rates of the conjugated target ligand, 
and therefore, higher accumulation in PSMA positive tumors. Labeling 
EB-PSMA-617 derivatives with the therapeutic beta emitters, e.g., 
\90\Y, \86\Y, and \177\Lu gives rise to improved tumor response and 
survival rates.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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 timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 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: July 19, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-16066 Filed 7-26-18; 8:45 am]
 BILLING CODE 4140-01-P
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