Treatment Of Prostate Cancer - EP3518932

The patent EP3518932 was granted to Myovant Sciences on Nov 13, 2024. The application was originally filed on Sep 29, 2017 under application number EP17823017A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3518932

MYOVANT SCIENCES
Application Number
EP17823017A
Filing Date
Sep 29, 2017
Status
Granted And Under Opposition
Oct 11, 2024
Grant Date
Nov 13, 2024
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (2)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

CompanyOpposition DateOpposition Status

Get instant alerts for new oppositions and patent status changes

ABG LAWAug 7, 2025ADMISSIBLE
SANDOZAug 7, 2025ADMISSIBLE

Patent Citations (8) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS7300935
DESCRIPTIONUS8058280
DESCRIPTIONUS8735401
DESCRIPTIONUS9346822
DESCRIPTIONUS9758528
DESCRIPTIONWO2016136849
INTERNATIONAL-SEARCH-REPORTCA2978223
OPPOSITIONCA2978223

Non-Patent Literature (NPL) Citations (32) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
DESCRIPTION- J.D. WESSLERY et al., JACC, (20130000), vol. 61, no. 25, pages 2495 - 502-
DESCRIPTION- MIRANDA et al., The Journal of Urology, (20170516), vol. 197, no. 4, pages e1221 - e1222-
DESCRIPTION- The Journal of Clinical Endocrinology & Metabolism, (20170401), vol. 102, no. 4, pages 1161 - 1173-
DESCRIPTION- TSUMURA et al., World J. Radiol., (20151228), vol. 7, no. 12, pages 494 - 500-
EXAMINATION- Saad Fred ET AL, "Second interim analysis (IA2) results from a phase II trial of TAK-385, an oral GnRH antagonist, in prostate cancer patients (pts). | Journal of Clinical Oncology", Journal of Clinical Oncology, (20160110), URL: https://ascopubs.org/doi/abs/10.1200/jco.2016.34.2_suppl.200, (20210223), XP055778964-
INTERNATIONAL-SEARCH-REPORT- Anonymous, "Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants - Study Results - ClinicalTrials.gov", (20160725), URL: https://www.clinicaltrials.gov/ct2/show/results/NCT02396147?term=relugolix&rank=9, (20180315), XP055459565 [X] 144-152 * the whole document * [Y] 47-49,123-125-
INTERNATIONAL-SEARCH-REPORT- Anonymous, "NCT02083185 on 2016_06_02: ClinicalTrials.gov Archive", (20160602), URL: https://clinicaltrials.gov/archive/NCT02083185/2016_06_02, (20180315), XP055459572 [X] 1-5,11-13,16,32,33,38,43,44,46,50,52,57,63,65,144-152 * the whole document *-
INTERNATIONAL-SEARCH-REPORT- Anonymous, "NCT02135445 on 2016_06_02: ClinicalTrials.gov Archive", (20160602), URL: https://clinicaltrials.gov/archive/NCT02135445/2016_06_02, (20180315), XP055459576 [X] 1-5,11-14,16,17,32,33,38,41-46,50,52,57,64,65,144-152 * the whole document *-
INTERNATIONAL-SEARCH-REPORT- N Shore ET AL, "S474 Abstracts 2502 ORAL TAK-385, an oral GnRH antagonist: efficacy and safety results from a randomized phase 2 trial in prostate cancer patients (pts)", (20150901), URL: http://www.ejcancer.com/article/S0959-8049(16)31324-7/pdf, (20180315), XP055459562 [X] 1-5,11-13,16,32,33,38,43,44,46,50,52,57,63,65,144-152 * abstract *-
INTERNATIONAL-SEARCH-REPORT- NAKATA DAISUKE ET AL, "Suppression of the hypothalamic-pituitary-gonadal axis by TAK-385 (relugolix), a novel, investigational, orally active, small molecule gonadotropin-releasing hormone (GnRH) antagonist: Studies in human GnRH receptor knock", EUROPEAN JOURNAL OF PHARMACOLOGY, (20131211), vol. 723, doi:10.1016/J.EJPHAR.2013.12.001, ISSN 0014-2999, pages 167 - 174, XP028607987 [X] 144-152 * abstract *
INTERNATIONAL-SEARCH-REPORT- SHORE NEAL D ET AL, "PD28-01 TESTOSTERONE LOWERING, PSA RESPONSE AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED HORMONE SENSITIVE PROSTATE CANCER RECEIVING TAK-385, AN ORAL GNRH ANTAGONIST: PHASE 2 INTERIM ANALYSIS", JOURNAL OF UROLOGY, (20160508), vol. 195, no. 4, doi:10.1016/J.JURO.2016.02.388, ISSN 0022-5347, XP029476663 [X] 1-5,11-14,16,17,32,33,38,41-46,50,52,57,63-65,144-152 * abstract * [Y] 1-152
INTERNATIONAL-SEARCH-REPORT- KAZUHIRO MIWA ET AL, "Discovery of 1-{4-[1-(2,6-Difluorobenzyl)-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3- d ]pyrimidin-6-yl]phenyl}-3-methoxyurea (TAK-385) as a Potent, Orally Active, Non-Peptide Antagonist of the Human Gonadotropin-Releasing Hormone Receptor", JOURNAL OF MEDICINAL CHEMISTRY, (20110728), vol. 54, no. 14, doi:10.1021/jm200216q, ISSN 0022-2623, pages 4998 - 5012, XP055012890 [X] 144-152 * abstract * * page 5004, column 2, paragraph 3 - page 5005, column 2, paragraph 2 *
INTERNATIONAL-SEARCH-REPORT- DAVID B. MACLEAN ET AL, "Medical Castration Using the Investigational Oral GnRH Antagonist TAK-385 (Relugolix): Phase 1 Study in Healthy Males", JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM, US, (20151201), vol. 100, no. 12, doi:10.1210/jc.2015-2770, ISSN 0021-972X, pages 4579 - 4587, XP055459555 [X] 144-152 * the whole document * [Y] 1-152
OPPOSITION- Anonymous, "Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer- History of Changes for Study : NCT02135445", ClinicalTrials.gov, (20170301), ClinicalTrials.gov, XP093251789-
OPPOSITION- D18 - Japan Registry of Clinical Trials, jRCT2080222485, “A Phase 1, Randomized, Open-Label Study of TAK-385, an Oral Gonadotropin­ Releasing Hormone (GnRH) Antagonist in Japanese Patients With Androgen Deprivation Treatment-Naive Nonmetastatic Prostate Cancer”, Last modified on 9 July 2015-
OPPOSITION- D22 - Presentation by Lawrence Drudge-Coates delivered at the British Uro-Oncology Group - British Association of Urological Nurses (BUG-BAUN) Joint Meeting, 2015-
OPPOSITION- D3a - Supplemental Materials of MacLean et al., Journal of Clinical Endocrinology and Metabolism, 2016, 100(12), 4579-4587 (OD3) Published online 26.10.2015-
OPPOSITION- D6 - Submission from patentee during prosecution on 15.12.2021 15.12.2021-
OPPOSITION- D7 - Submission from patentee during prosecution on 11.07.2024 11.07.2024-
OPPOSITION- David Burton Maclean, "Safety and Testosterone-Lowering Effects of the Investigational, Oral, GnRH Antagonist, TAK-385 in Healthy Male Volunteers: Results of a Phase 1 Inpatient/Outpatient Study : Breast & Prostate Cancer", (20130615), URL: http://press.endocrine.org/doi/abs/10.1210/endo-meetings.2013.CN.1.SAT-318, (20180314), XP055459501-
OPPOSITION- John H. Collett, Soraya Dhillon, "DOSAGE REGIMENS", Aulton's Pharmaceutics: The Design and Manufacture of Medicines Fourth edition, Elsevier Ltd., (20130101), pages 2pp, 355 - 366, XP055794776-
OPPOSITION- Millennium Pharmaceuticals, Inc., "A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer - NCT02083185", Clinical Trials, clinicaltrials.gov, (20160506), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02083185?term=NCT02083185&rank=1&tab=history&a=9#version-content-panel, XP093305830-
OPPOSITION- N Shore, Bailen J, Pieczonka C, Maclean D, Shi H, Faessel H, Saad F, "S474 Abstracts 2502 ORAL TAK-385, an oral GnRH antagonist: efficacy and safety results from a randomized phase 2 trial in prostate cancer patients (pts)", (20150901), URL: http://www.ejcancer.com/article/S0959-8049(16)31324-7/pdf, (20180315), XP055459562-
OPPOSITION- Saad Fred, James L. Bailen , Christopher Michael Pieczonka , Daniel R. Saltzstein , Paul R. Sieber , David B. Macleanhongliang Shi , Helene M. Faessel , Neal D. Shore, "Second interim analysis (IA2) results from a phase II trial of TAK-385, an oral GnRH antagonist, in prostate cancer patients (pts). | Journal of Clinical Oncology", Journal of Clinical Oncology, Journal of Clinical Oncology, URL: https://ascopubs.org/doi/abs/10.1200/jco.2016.34.2_suppl.200, (20210223), XP055778964-
OPPOSITION- Takeda, "Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants - NCT02396147", Clinical Trials, clinicaltrials.gov, (20160609), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02396147?term=NCT02396147&rank=1&a=3, XP093305832-
OPPOSITION- Nakata Daisuke; Masaki Tsuneo; Tanaka Akira; Yoshimatsu Mie; Akinaga Yumiko; Asada Mari; Sasada Reiko; Takeyama Michiyasu; Miwa Kazuhiro; Watanabe Tatsuya; Kusaka Masami, "Suppression of the hypothalamic-pituitary-gonadal axis by TAK-385 (relugolix), a novel, investigational, orally active, small molecule gonadotropin-releasing hormone (GnRH) antagonist: Studies in human GnRH receptor knock", European Journal of Pharmacology, Elsevier science, NL, NL , (20131211), vol. 723, doi:10.1016/j.ejphar.2013.12.001, ISSN 0014-2999, pages 167 - 174, XP028607987
OPPOSITION- Magnan S.; Pilote L.; Bernier L.; Fradet V.; É. Vigneault; Turgeon A.F. , "Intermittent Versus Continuous Androgen Deprivation Therapy for Prostate Cancer: A Systematic Review and Meta-Analysis", INTERNATIONAL JOURNAL OF RADIATION: ONCOLOGY BIOLOGY PHYSICS., PERGAMON PRESS., USA, USA , (19000101), vol. 87, no. 2, doi:10.1016/j.ijrobp.2013.06.404, ISSN 0360-3016, XP028725666
OPPOSITION- Shore Neal D.; Bailen James L.; Pieczonka Christopher; Saltzstein Daniel R.; Sieber Paul R.; MacLean David B.; Shi Hongliang; Faessel Hélène M.; Lin Huamao Mark; Zhu Yanyan; Saad Fred, "PD28-01 TESTOSTERONE LOWERING, PSA RESPONSE AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED HORMONE SENSITIVE PROSTATE CANCER RECEIVING TAK-385, AN ORAL GNRH ANTAGONIST: PHASE 2 INTERIM ANALYSIS", Journal of Urology, Elsevier, (19000101), vol. 195, no. 4, doi:10.1016/j.juro.2016.02.388, ISSN 0022-5347, XP029476663
OPPOSITION- K. Miwa et al., "Discovery of 1-{4-[1-(2,6-Difluorobenzyl)-5- (dimethylamino)methyl]-3-(6- methoxypyridazin-3-yl)-2,4-dioxo- 1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl]phenyl}-3-methoxyurea (TAK-385) as a Potent, Orally Active, Non-Peptide Antagonist of the Human Gonadotropin-Releasing Hormone Receptor", Journal of Medicinal Chemistr, (2011), vol. 54, no. 14, doi:10.1021/jm200216q, pages 4998 - 5012, XP055012890
OPPOSITION- Beer Tomasz M., Armstrong Andrew J., Rathkopf Dana E., Loriot Yohann, Sternberg Cora N., Higano Celestia S., Iversen Peter, Bhattacharya Suman, Carles Joan, Chowdhury Simon, Davis Ian D., De Bono Johann S., Evans Christopher P., Fizazi Karim, Joshua Anthony M., Kim Choung-Soo, Kimura Go, Mainwaring Paul, Mansbach Harry, Miller Kurt, Noonberg Sarah B., Perabo Frank, Phung De, Saad Fred, Scher Howard I., Taplin Mary-Ellen, Venner Peter M., Tombal Bertrand, "Enzalutamide in Metastatic Prostate Cancer before Chemotherapy", The new England journal of medicine, Eli Lily and Company, USA, USA, (20140731), vol. 371, no. 5, doi:10.1056/NEJMoa1405095, pages 424 - 433, XP055926904
OPPOSITION- Shore Neal D., Saad Fred, Cookson Michael S., George Daniel J., Saltzstein Daniel R., Tutrone Ronald, Akaza Hideyuki, Bossi Alberto, Van Veenhuyzen David F., Selby Bryan, Fan Xiaolin, Kang Vicky, Walling Jackie, Tombal Bertrand, "Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer", New England Journal of Medicine, Massachusetts Medical Society, United States, United States, (20200604), vol. 382, no. 23, doi:10.1056/NEJMoa2004325, ISSN 0028-4793, pages 2187 - 2196, XP093305827
OPPOSITION- David B. Maclean, Hongliang Shi, Hélène M. Faessel, Fred Saad, "Medical Castration Using the Investigational Oral GnRH Antagonist TAK-385 (Relugolix): Phase 1 Study in Healthy Males", Journal of Clinical Endocrinology and Metabolism, The Endocrine Society, US, US , (20151201), vol. 100, no. 12, doi:10.1210/jc.2015-2770, ISSN 0021-972X, pages 4579 - 4587, XP055459555

Download Citation Report

Get a free citation report including examiner, opposition, and international search citations.

Get Citation Report

Dossier Documents

The dossier documents provide a comprehensive record of the patent’s prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent’s legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents