Anti-Androgens For The Treatment Of Non-Metastatic Castrate-Resistant Prostate Cancer - EP3305285

The patent EP3305285 was granted to Aragon Pharmaceuticals on Sep 2, 2020. The application was originally filed on Sep 23, 2013 under application number EP17187458A. The patent is currently recorded with a legal status of "Revoked".

EP3305285

ARAGON PHARMACEUTICALS
Application Number
EP17187458A
Filing Date
Sep 23, 2013
Status
Revoked
Aug 22, 2024
Grant Date
Sep 2, 2020
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (3)

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 DateRepresentativeOpposition Status

Get instant alerts for new oppositions and patent status changes

SANDOZJun 2, 2021MAIWALDADMISSIBLE
SYNTHONJun 2, 2021HAMM & WITTKOPPADMISSIBLE
TEVA PHARMACEUTICALSJun 2, 2021D YOUNGADMISSIBLE

Patent Citations (3) New

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

Citation PhasePublication NumberPublication Link
OPPOSITIONEP1007080
SEARCHWO2012158884
SEARCHWO2013079964

Non-Patent Literature (NPL) Citations (60) 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- CHEMICAL ABSTRACTS, Database accession no. 915087-27-3-
DESCRIPTION- CHEMICAL ABSTRACTS, Database accession no. 915087-33-1-
DESCRIPTION- CHEMICAL ABSTRACTS, Database accession no. 956104-40-8-
DESCRIPTION- CLEGG et al., Cancer Res, (20120315), vol. 72, page 1494-
DESCRIPTION- J Clin Oncol, (19930000), vol. 11, no. 8, pages 1566 - 72-
DESCRIPTION- Nat. Med, (20040000), vol. 10, pages 33 - 39-
DESCRIPTION- Science, (20090508), vol. 324, no. 5928, pages 787 - 90-
EXAMINATION- FDA ODAC Briefing Document September 14, 2011 Issues concerning the development of products for the treatment of patients with non-metastatic castration-resistant prostate cancer.-
EXAMINATION- MATTHEW R. SMITH ET AL, "Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer", THE NEW ENGLAND JOURNAL OF MEDICINE, - NEJM -, US, (20180412), vol. 378, no. 15, doi:10.1056/NEJMoa1715546, ISSN 0028-4793, pages 1408 - 1418, XP055492046
OPPOSITION- Akaza, Et Al, "Combined Androgen BlockadeWith Bicalutamide for AdvancedProstate Cancer", Cancer, (20090101), pages 3437 - 3445, XP055818809-
OPPOSITION- Anonymous, "A Phase 1a/1b Study to Evaluate the Safety of EZN-4176, in Adult Patients With Castration-Resistant Prostate Cancer NCT01337518", ClinicalTrials.gov, (20120418), pages 1 - 7, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT01337518, (20210701), XP055820075-
OPPOSITION- Anonymous, "A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer NCT00510718", ClinicalTrials.gov, (20120403), pages 1 - 9, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT00510718, (20210629), XP055819320-
OPPOSITION- Anonymous, "A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer NCT55819333", ClinicalTrials.gov, (20120611), pages 1 - 11, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT01212991, (20210629), XP055819340-
OPPOSITION- Anonymous, "A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer NCT01288911", ClinicalTrials.gov, (20120824), pages 1 - 12, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT01288911, (20210629), XP055819345-
OPPOSITION- Anonymous, "Casodex", FDA Document, (20080101), pages 1 - 24, XP055820077-
OPPOSITION- Anonymous, "Casodex®", NDA 20-498, (19950101), pages 1 - 3, NDA 20-498, URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020498Orig1s000rev.pdf, (20210701), XP055820108-
OPPOSITION- Anonymous, "Euxelin Capsules Product Information Sheet", Labeling NDA 18554, (20010101), pages 1 - 2, Labeling NDA 18554, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18554s23lbl.pdf, (20210628), XP055818800-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01171898", ClinicalTrials.gov NCT01171898, (20210221), pages 1 - 16, ClinicalTrials.gov NCT01171898, URL: https://clinicaltrials.gov/ct2/history/NCT01171898?V_29=View#StudyPageTop, (20210628), XP055818747-
OPPOSITION- Anonymous, "NOVANTRONE ®", FDA, (20080801), pages 1 - 36, XP055818773-
OPPOSITION- Anonymous, "Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer nct01664923", ClinicalTrials.gov, (20120830), pages 1 - 10, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/nct01664923, (20210629), XP055819349-
OPPOSITION- Anonymous, "Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy NCT00974311", ClinicalTrials.gov NCT00974311, (20120710), pages 1 - 11, ClinicalTrials.gov NCT00974311, URL: https://clinicaltrials.gov/ct2/show/NCT00974311, (20210629), XP055819333-
OPPOSITION- Anonymous, "Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer NCT01317641", ClinicalTrials.gov, (20120806), pages 1 - 8, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT01317641, (20210701), XP055820070-
OPPOSITION- Anonymous, "Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC) NCT01171898", ClinicalTrials.gov, (20120322), pages 1 - 10, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT01171898, (20210629), XP055819351-
OPPOSITION- Anonymous, "Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer NCT01547299", ClinicalTrials.gov, (20120709), pages 1 - 12, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT01547299, (20210701), XP055820128-
OPPOSITION- Anonymous, "Table of Content", Annals of Oncology, (20121002), vol. 23, no. 9, pages 1 - 2, XP055818728-
OPPOSITION- Anonymous, "The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer NCT01790126", ClinicalTrials.gov NCT01790126, (20130912), pages 1 - 10, ClinicalTrials.gov NCT01790126, URL: https://clinicaltrials.gov/ct2/show/NCT01790126, (20210628), XP055818780-
OPPOSITION- Anonymous, "Xtandi® Highlights of prescribing information", Xtandi® label, (20120101), pages 1 - 16, Xtandi® label, (20210209), XP055774057-
OPPOSITION- Comprehensive Cancer Center Vienna regarding Abstract-Deadline of ESMA 2012 congress, (20120000), URL: www.ccc.ac.at/news/sinqleview/konqress-der-esmo-2012-in-wien- abstract-deadline-ist-der-16- mai/04b878b896bfd0bbcfdab54983674ced-
OPPOSITION- Courtney K. D., Mary-Ellen Taplin, "The evolving paradigm of second-line hormonal therapy options for castration-resistant prostate cancer", CURR. OPIN. ONCOL., (20120101), vol. 24, pages 272 - 277, XP055774446-
OPPOSITION- Gomella Leonard G, "Effective Testosterone Suppression for Prostate Cancer: Is There a Best Castration Therapy?", REVIEWS IN UROLOGY, (20090101), pages 52 - 60, REVIEWS IN UROLOGY, URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2725306/pdf/RIU011002_0052.pdf, (20210629), XP055819287-
OPPOSITION- HEIDENREICH, A. et al., "Guidelines and Counselling for Treatment Options in the Management of Prostate Cancer", Prostate Cancer, Berlin Heidelberg, (20070000), pages 1 - 273-
OPPOSITION- Kliment, "European Urology", European Urology, (20110101), vol. 59, pages 1066 - 1067, XP055820111-
OPPOSITION- Mok, "ESMO 2012 late-breaking, press and deferred publication abstracts", Annals of Oncology, (20120101), vol. 23, no. 9, pages 1 - 1, XP055818735-
OPPOSITION- Rathkopf, Dana E. et al, "A phase II study of the androgen signaling inhibitor ARN - 509 in patients with castration - resistant prostate cancer (CRPC).", Journal of Clinical Oncology, American Society of Clinical Oncology, US, US, (20120520), vol. 30, no. 15, SUPPL. 1, ISSN 0732-183X, page Abstr. TPS4697, XP008166219-
OPPOSITION- Smith, "ARN-509 IN MEN WITH HIGH RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER", ESMO Congress Vienna, (20120101), pages 1 - 1, XP055820120-
OPPOSITION- S MITH M. R. et al., "ARN-509 in Men with High Risk Non-Metastatic Castration-Resistant Prostate Cancer", ESMO, (20120000), URL: https://register.event-works.com/ elsevier /esmo2012/ps/sf-
OPPOSITION- Marianne D. Sadar, "Advances in small molecule inhibitors of androgen receptor for the treatment of advanced prostate cancer", World Journal of Urology ;, Springer, Berlin, DE, Berlin, DE, (20110811), vol. 30, no. 3, doi:10.1007/s00345-011-0745-5, ISSN 1433-8726, pages 311 - 318, XP035062113
OPPOSITION- Menon Manoj P., Higano Celestia S., "Enzalutamide, a Second Generation Androgen Receptor Antagonist: Development and Clinical Applications in Prostate Cancer", CURRENT ONCOLOGY REPORTS, CURRENT SCIENCE, GB, GB, (20130401), vol. 15, no. 2, doi:10.1007/s11912-013-0293-9, ISSN 1523-3790, pages 69 - 75, XP055820132
OPPOSITION- M.R. Smith et al, "ARN-509 IN MEN WITH HIGH RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER", Annals of Oncology, Kluwer Dordrecht, NL, NL, (20120901), vol. 23, no. Suppl. 9, doi:10.1093/annonc/mds400, ISSN 0923-7534, page 303, XP008166216
OPPOSITION- SMITH M. R. et al., "ARN-509 IN MEN WITH HIGH RISK .NON- METASTATIC CASTRATION-RESISTANT PROSTATE CANCER", Annals of Oncology; Abstract Book of the 37th ESMO Congress, Vienna, Austria, (20120917), vol. 23, no. Suppl. 9, doi:10.1093/annonc/mds400, page 303, XP008166216
OPPOSITION- Clegg N J et al, "ARN-509: a novel antiandrogen for prostate cancer treatment.", Cancer Research, American Association for Cancer Research, US, US, (20120315), vol. 72, no. 6, doi:10.1158/0008-5472.CAN-11-3948, ISSN 0008-5472, pages 1494 - 1503, XP002756285
OPPOSITION- Michael T. Schweizer, Emmanuel S. Antonarakis, "Abiraterone and other novel androgen-directed strategies for the treatment of prostate cancer: a new era of hormonal therapies is born", Therapeutic Advances in Urology, Sage Publications Ltd., GB, GB, (20120801), vol. 4, no. 4, doi:10.1177/1756287212452196, ISSN 1756-2872, pages 167 - 178, XP055491443
OPPOSITION- Scher Howard I. et al, "Conclusion", Journal of Clinical Oncology, American Society of Clinical Oncology, US, US, (20080301), vol. 26, no. 7, doi:10.1200/JCO.2007.12.4487, ISSN 0732-183X, pages 1148 - 1159, XP055819281
OPPOSITION- Ryan Charles J; Tindall Donald J, "Androgen receptor rediscovered: the new biology and targeting the androgen receptor therapeutically", Journal of Clinical Oncology, Lippincott Williams & Wilkins, USA, USA, (20110920), vol. 29, no. 27, doi:10.1200/JCO.2011.35.2005, ISSN 1527-7755, pages 3651 - 3658, XP009160280
OPPOSITION- G S Harrison, "Gonadotropin-releasing hormone and its receptor in normal and malignant cells", Endocrine Related Cancer, Published for the Society of Endocrinology by the Journal of Endocrinology Ltd., (20041201), vol. 11, no. 4, doi:10.1677/erc.1.00777, ISSN 13510088, pages 725 - 748, XP055024952
OPPOSITION- Antonarakis Emmanuel, Golshayan, "Enzalutamide: an evidence-based review of its use in the treatment of prostate cancer", Core Evidence, (20130101), vol. 8, doi:10.2147/CE.S34747, pages 27 - 35, XP055820140
OPPOSITION- R. Leibowitz-amit, Joshua A., "Targeting the androgen receptor in the management of castrationresistant prostate cancer: rationale, progress, and future directions", Current Oncology, (20121201), vol. 19, no. Suppl. 3, doi:10.3747/co.19.1281, pages S22 - S31, XP055312138
OPPOSITION- El-Amm Joelle, Patel Nihar, Freeman Ashley, Aragon-Ching Jeanny B., "Metastatic Castration-Resistant Prostate Cancer: Critical Review of Enzalutamide", Clinical Medicine Insights: Oncology, Libertas Academica Ltd., NZL, NZL, (20130101), vol. 7, doi:10.4137/CMO.S11670, ISSN 1179-5549, pages CMO.S11670 - 245, XP055820143
OPPOSITION- Stephanie B Mccutcheon, "Enzalutamide: a new agent for the prostate cancer treatment armamentarium", Journal of the advanced practitioner in oncology, United States, United States, doi:10.6004/jadpro.2013.4.3.7, (20130501), pages 182 - 185, Journal of the advanced practitioner in oncology, XP055311011
SEARCH- Anonymous, "NCT01946204 on 2013_09_18: A Study of ARN-509 in Men With Non-Metastatic Castration-Resistant Prostate Cancer", ClinicalTrials.gov Archive, (20130918), pages 1 - 4, URL: https://clinicaltrials.gov/archive/NCT01946204/2013_09_18, (20160217), XP055251019 [XP] 1-18 * the whole document *-
SEARCH- Dana E. Rathkopf ET AL, "A phase I study of the androgen signaling inhibitor ARN-509 in patients with metastatic castration-resistant prostate cancer (mCRPC).", J. Clin. Oncol. 30, Suppl. Abstr. 4548, (20120530), URL: http://jco.ascopubs.org/gca?gca=ascomtg%3B30%2F15_suppl%2F4548&allch=citmgr&submit=Go, (20131209), XP055092165 [Y] 1-18 * the whole document *-
SEARCH- HEATH ELISABETH I ET AL, "A phase I dose-escalation study of oral BR-DIM (BioResponse 3,3 '-Diindolylmethane) in castrate-resistant, non-metastatic prostate cancer", AMERICAN JOURNAL OF TRANSLATIONAL RESEARCH, (2010), vol. 2, no. 4, ISSN 1943-8141, pages 402 - 411, XP008166075 [X] 1-7 * abstract * * figure 2 *-
SEARCH- RATHKOPF D E (CORRESPONDENCE) ET AL, "A first-in-human, open-label, phase I/II safety, pharmacokinetic, and proof-of-concept study of ARN - 509 in patients with progressive advanced castration - resistant prostate cancer ( CRPC )", JOURNAL OF CLINICAL ONCOLOGY; ASCO ANNUAL MEETING 2011, AMERICAN SOCIETY OF CLINICAL ONCOLOGY, US; CHICAGO, IL, UNITED STATES, (20110520), vol. 29, no. 15, SUPPL. 1, ISSN 0732-183X, page TPS190, XP008166220 [Y] 1-18 * the whole document *-
SEARCH- REAGAN-SHAW S ET AL, "Dose translation from animal to human studies revisited", FASEB JOURNAL, FED. OF AMERICAN SOC. FOR EXPERIMENTAL BIOLOGY, US, (20070101), vol. 22, ISSN 0892-6638, pages 659 - 661, XP007916336 [A] 1-18 * page 2, column 1, paragraph l * * table 1 *-
SEARCH- ALVIN Y. LIU ET AL, "Lineage relationship between LNCaP and LNCaP-derived prostate cancer cell lines", PROSTATE., US, (20040101), vol. 60, no. 2, doi:10.1002/pros.20031, ISSN 0270-4137, pages 98 - 108, XP055439461 [A] 1-18 * page 104, column 2, paragraph 1 *
SEARCH- KLIMENT JAN, "Re: Salvage Therapy With Bicalutamide 150 mg in Nonmetastatic Castration-resistant Prostate Cancer", EUROPEAN UROLOGY, (201106), vol. 59, no. 6, ISSN 0302-2838, pages 1066 - 1067, XP055090937 [X] 1-9,16,17 * page 1066, column 2, paragraph 1 - page 1067, column 1, paragraph 2 * * page 1067, column 2, paragraph 5 * * page 1067, column 2, paragraphs 1, 3 *
SEARCH- SMITH M R ET AL, "ARN-509 in men with high risk non-metastatic castration-resistant prostate cancer", EUROPEAN JOURNAL OF CANCER; EUROPEAN CANCER CONGRESS 2013, ECC 2013, PERGAMON PRESS, OXFORD, GB; AMSTERDAM, NETHERLANDS, vol. 49, no. Suppl. 2, doi:10.1016/S0959-8049(13)70064-9, ISSN 0959-8049, (20130901), page S695, (20131002), XP008166215 [XP] 1-18 * the whole document *
SEARCH- SMITH M R ET AL, "ARN-509 IN MEN WITH HIGH RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER", ANNALS OF ONCOLOGY; ABSTRACT BOOK OF THE 37TH ESMO CONGRESS, KLUWER, DORDRECHT, NL; VIENNA, AUSTRIA, (20120917), vol. 23, no. Suppl. 9, doi:10.1093/ANNONC/MDS400, ISSN 0923-7534, page 303, XP008166216 [X] 1-15 * the whole document * [Y] 1-18
SEARCH- TRAN CHRIS ET AL, "Development of a Second-Generation Antiandrogen for Treatment of Advanced Prostate Cancer", SCIENCE (WASHINGTON D C), (200905), vol. 324, no. 5928, ISSN 0036-8075, pages 787 - 790, XP002696684 [X] 1-9,16,17 * abstract * * page 788, column 1, paragraph 1 - page 789, column 1, paragraph 1 * * figures 2, 4 * * page 790, column 1 - column 3 *
SEARCH- CLEGG NICOLA J ET AL, "ARN-509: A Novel Antiandrogen for Prostate Cancer Treatment", CANCER RESEARCH, (201203), vol. 72, no. 6, ISSN 0008-5472, pages 1494 - 1503, XP008166073 [X] 1-13,15-18 * abstract * * page 1495, column 1, paragraphs 1-2 * * page 1495, column 1, paragraph 4 - column 2, paragraph 1 * * figures 3-5 * * page 1499, column 1, paragraph 2 - page 1501, column 1, paragraph 1 * * page 1502, column 1, paragraph 5 * [Y] 1-18

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