83_FR_35812 83 FR 35667 - Prospective Grant of Exclusive Patent License: Radiotherapy for Metastatic Castration-Resistant Prostate Cancer

83 FR 35667 - Prospective Grant of Exclusive Patent License: Radiotherapy for Metastatic Castration-Resistant Prostate Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 145 (July 27, 2018)

Page Range35667-35667
FR Document2018-16066

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.

Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018) 
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35667]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35667 represented on HHS Federal advisory DEPARTMENT OF HEALTH AND chemically conjugated residue derived committees and, therefore, the HUMAN SERVICES from (((R-)-1-carboxy-2- Department encourages nominations of mercaptoethyl)carbamoyl)-L-glutamic qualified candidates from these groups. National Institutes of Health acid that is further bound to an Evans The Department also encourages blue analog (EB). The EB analog Prospective Grant of Exclusive Patent reversibly binds to circulating serum geographic diversity in the composition License: Radiotherapy for Metastatic albumin to provide a of the Committee. Appointment to this Castration-Resistant Prostate Cancer Committee shall be made without radiopharmaceutical that retains affinity discrimination on the basis of age, race, AGENCY: National Institutes of Health, and specificity to prostate specific ethnicity, gender, sexual orientation, HHS. membrane antigen (PSMA; in this case disability, and cultural, religious, or ACTION: Notice. PSMA-617). PSMA is a surface molecule shown to be specifically expressed by socioeconomic status. Requests for SUMMARY: The National Heart, Lung and prostate tumor cells. PSMA expression reasonable accommodation to enable Blood Institute (NHLBI), National levels correlate with disease stage and participation on the Committee should Institutes of Health, Department of with hormone refractory cancers. be indicated in the nomination Although most PSMA expression Health and Human Services, is submission. appears to be restricted to the prostate contemplating the grant of an exclusive Member Terms: Non-Federal public commercialization patent license to cancer, low levels of expression can also members of the Committee serve for a Sinotau Pharmaceutical Group, be detected in the brain, kidneys, term of 3 years, and may serve for an headquartered in Beijing, China, to salivary glands, and small intestine. The unlimited number of terms if practice the inventions embodied in the antigen is also shown to be expressed by reappointed. Members may serve after patent application(s) listed in the neovascular tumor vessels of multiple the expiration of their terms, until their Supplementary Information section of other cancers. Inclusion of the Evans successors have taken office. this notice. blue analog promotes high DATES: Only written comments and/or internalization and retention rates of the Meetings and Travel: As specified by conjugated target ligand, and therefore, applications for a license which are Public Law 113–166, the MDCC ‘‘shall higher accumulation in PSMA positive received by the NHLBI Office of meet no fewer than two times per tumors. Labeling EB-PSMA-617 Technology Transfer and Development calendar year.’’ Travel expenses are August 27, 2018 will be considered. derivatives with the therapeutic beta provided for non-federal public emitters, e.g., 90Y, 86Y, and 177Lu gives ADDRESSES: Requests for copies of the Committee members to facilitate rise to improved tumor response and patent applications, inquiries, and attendance at in-person meetings. survival rates. comments relating to the contemplated Members are expected to make every exclusive patent license should be This notice is made in accordance effort to attend all full committee directed to: Michael Shmilovich, Esq., with 35 U.S.C. 209 and 37 CFR part 404. meetings, twice per year, either in Senior Licensing and Patent Manager, The prospective exclusive patent license person or via remote access. 31 Center Drive, Room 4A29, MSC2479, will be royalty bearing and may be Participation in relevant subcommittee, Bethesda, MD 20892–2479, phone granted unless within fifteen (15) days working and planning group meetings, number 301–435–5019, or shmilovm@ from the date of this published notice, and workshops, is also encouraged. mail.nih.gov. the NHLBI receives written evidence Submission Instructions and SUPPLEMENTARY INFORMATION: The and argument that establishes that the Deadline: Nominations are due by 5 following and all continuing U.S. and grant of the license would not be p.m. EDT on August 31, 2018, and foreign patents/patent applications consistent with the requirements of 35 should be sent to Glen Nuckolls, Ph.D., thereof are the intellectual properties to U.S.C. 209 and 37 CFR part 404. by email to nuckollg@ninds.nih.gov. be licensed under the prospective Complete applications for a license in agreement to Sinotau Pharmaceutical the prospective field of use that are Nominations must include contact Group: U.S. Provisional Patent timely filed in response to this notice information for the nominee, a current Application 62/633,648, ‘‘Chemical will be treated as objections to the grant curriculum vitae or resume of the Conjugates Of Evans Blue Derivatives of the contemplated exclusive patent nominee and a paragraph describing the And Their Use As Radiotherapy And qualifications of the person to represent license. Imaging Agents For Targeting Prostate some portion(s) of the muscular Comments and objections submitted Cancer,’’ filed February 22, 2018 (HHS dystrophy research, advocacy and/or to this notice will not be made available Ref. No. E–054–2018–0). The patent patient care communities. for public inspection and, to the extent rights in this invention have been permitted by law, will not be released More information about the MDCC is assigned to the Government of the under the Freedom of Information Act, available at https://mdcc.nih.gov/. United States of America. The 5 U.S.C. 552. perspective license would be granted Dated: July 24, 2018. Dated: July 19, 2018. worldwide and in a field of use not Walter J. Koroshetz, broader than radiotherapeutics for Michael A. Shmilovich, Director, National Institute of Neurological metastatic castration-resistant prostate Senior Licensing and Patenting Manager, amozie on DSK3GDR082PROD with NOTICES1 Disorders and Stroke, National Institutes of cancer. National Heart, Lung, and Blood Institute, Health. The invention covered by the patents Office of Technology Transfer and [FR Doc. 2018–16112 Filed 7–26–18; 8:45 am] and patent applications pertaining to Development. BILLING CODE 4140–01–P HHS Ref. No. E–054–2018–0 pertain to [FR Doc. 2018–16066 Filed 7–26–18; 8:45 am] a therapeutic agent that includes a BILLING CODE 4140–01–P VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1


Document Created: 2018-07-27 04:04:43
Document Modified: 2018-07-27 04:04:43
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 NHLBI Office of Technology Transfer and Development August 27, 2018 will be considered.
FR Citation83 FR 35667 
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