IP Verse

Combination Therapy For Prostate Cancer - EP3609497

The patent EP3609497 was granted to Janssen Pharmaceutica on Oct 12, 2022. The application was originally filed on Apr 9, 2018 under application number EP18720895A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3609497

JANSSEN PHARMACEUTICA
Application Number
EP18720895A
Filing Date
Apr 9, 2018
Status
Granted And Under Opposition
Sep 9, 2022
Publication Date
Oct 12, 2022
External Links
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Patent Summary

Patent Family

Patent Family

Patent Oppositions (3)

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GENERICS UKJul 12, 2023RUSSELLADMISSIBLE
SANDOZJul 11, 2023ELKINGTON AND FIFEADMISSIBLE
TEVA PHARMACEUTICALSJul 6, 2023VON KAUFFMANNADMISSIBLE

Patent Citations (5) New

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

Citation PhasePublication Number
DESCRIPTIONUS8071623
DESCRIPTIONUS8436185
INTERNATIONAL-SEARCH-REPORTUS2014336157
OPPOSITIONUS2014336157
OPPOSITIONWO2008084261

Non-Patent Literature (NPL) Citations (62) New

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

Citation PhaseReference Text
DESCRIPTION- JONES P; WILCOXEN K; ROWLEY M; TONIATTI C, "Niraparib: A Poly(ADP-ribose) Polymerase (PARP) Inhibitor for the Treatment of Tumors with Defective Homologous Recombination", J Med Chem., (20150423), vol. 58, no. 8, pages 3302 - 3314
INTERNATIONAL-SEARCH-REPORT- Janssen research & Development, LLC, "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)", ClinicalTrials.gov, (20161005), URL: https://clinicaltrials.gov/ct2/show/NCT02924766, (20180614), XP002782025 [X] 34-36 * page 2 * [I] 1-33
INTERNATIONAL-SEARCH-REPORT- RYAN CHARLES J ET AL, "Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study.", THE LANCET. ONCOLOGY, (201502), vol. 16, no. 2, ISSN 1474-5488, pages 152 - 160, XP002782026 [Y] 1-36 * abstract *
INTERNATIONAL-SEARCH-REPORT- GRAS JORDI, "Niraparib hydrochloride. Poly [ADP-ribose] polymerase (PARP) inhibitor, Oncolytic", DRUGS OF THE FUTURE, PROUS SCIENCE, ES, (20131001), vol. 38, no. 10, doi:10.1358/DOF.2013.38.10.2059820, ISSN 0377-8282, pages 679 - 685, XP009195509 [Y] 1-36 * page 683 *
INTERNATIONAL-SEARCH-REPORT- R. J. AUCHUS ET AL, "Use of Prednisone With Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer", THE ONCOLOGIST, US, (20141031), vol. 19, no. 12, doi:10.1634/theoncologist.2014-0167, ISSN 1083-7159, pages 1231 - 1240, XP055483431 [Y] 1-36 * page 1236 *
OPPOSITION- Al Wasilewski, "Johnson & Johnson Completes Acquisition Of Aragon Pharmaceuticals, Inc.", Johnson & Johnson / Press releases / Pharmaceuticals, Johnson & Johnson Services, Inc., (20130819), pages 1 - 5, Johnson & Johnson / Press releases / Pharmaceuticals, URL: https://www.jnj.com/media-center/press-releases/johnson-johnson-completes-acquisition-of-aragon-pharmaceuticals-inc, XP093161434
OPPOSITION- Anonymous, "Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer | NCT01576172 ", ClinicalTrials.gov, (20161222), URL: https://clinicaltrials.gov/study/NCT01576172?tab=history&a=52, XP093122442
OPPOSITION- Anonymous, "Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic CastrationResistant Prostate Cancer With DNA Repair Defects ", clinicaltrials.gov. History of Changes for Study: NCT03012321, (20170208), clinicaltrials.gov. History of Changes for Study: NCT03012321, URL: https://classic.clinicaltrials.gov/ct2/history/NCT03012321?V_14=View, (20240205), XP093127202
OPPOSITION- Anonymous, "Akeega 50 mg/500 mg film-coated tablets // Akeega 100 mg/500 mg film-coated tablets", ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, European Medicines Agency, (20230602), pages 1 - 57, ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS, URL: https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf, XP093161320
OPPOSITION- Anonymous, "AKEEGA (TM) (niraparib and abiraterone acetate) tablets, for oral use", HIGHLIGHTS OF PRESCRIBING INFORMATION, FDA - U.S. Food and Drug Administration, (20230801), pages 1 - 32, HIGHLIGHTS OF PRESCRIBING INFORMATION, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216793s000lbl.pdf, XP093161323
OPPOSITION- Anonymous, "amending the marketing authorisation granted by Decision C(2011)6379(final) for "Zytiga abiraterone", a medicinal product for human use", European Commission: Amended marketing authorisation for Zytiga; www.ec.europa.eu; 9 November 2016, (20161109), European Commission: Amended marketing authorisation for Zytiga; www.ec.europa.eu; 9 November 2016, (20240205), XP093127210
OPPOSITION- Anonymous, "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) | NCT02924766 ", ClinicalTrials.gov, (20161004), URL: https://clinicaltrials.gov/study/NCT02924766?tab=history&a=1, XP093122395
OPPOSITION- Anonymous, "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) | NCT02924766 ", ClinicalTrials.gov, (20161103), URL: https://clinicaltrials.gov/study/NCT02924766?tab=history&a=2, XP093122407
OPPOSITION- Anonymous, "Cellosaurus VCaP (CVCL_2235)", Expasy, (20120404), Database accession no. CVCL_2235, XP093161332
OPPOSITION- Anonymous, "Clinical Trials: What You Need to Know", All About Cancer > Managing Cancer Care > Making Decisions and Managing Your Treatment > Clinical Trials, American Cancer Society, (20200818), pages 1 - 30, All About Cancer > Managing Cancer Care > Making Decisions and Managing Your Treatment > Clinical Trials , URL: https://www.cancer.org/content/dam/CRC/PDF/Public/6800.00.pdf, (20240129), XP093124853
OPPOSITION- Anonymous, "COMMISSION IMPLEMENTING DECISION of 5.9.2011 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Zytiga -abiraterone", a medicinal product for human use", COMMISSION IMPLEMENTING DECISION, European Commission, (20110905), vol. C(2011)6379, pages 1 - 3, XP093124699
OPPOSITION- Anonymous, "COMMISSION IMPLEMENTING DECISION of 9.11.2016 amending the marketing authorisation granted by Decision C(2011)6379(final) for “Zytiga - abiraterone”, a medicinal product for human use", COMMISSION IMPLEMENTING DECISION, European Commission, (20161109), vol. C(2016) 7287, pages 1 - 3, XP093124705
OPPOSITION- Anonymous, "Full Prescribing Information and Patient Information for ZEJULA(TM) ", Full Prescribing Information and Patient Information for ZEJULA(TM), U.S. Food and Drug Administration, (20170301), pages 1 - 19, Full Prescribing Information and Patient Information for ZEJULA(TM) , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf, (20240129), XP093124692
OPPOSITION- Anonymous, "History of Changes for Study: NCT02924766 A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)", ClinicalTrials.gov NCT02924766, (20170512), ClinicalTrials.gov NCT02924766, URL: https://clinicaltrials.gov/study/NCT02924766?tab=history, (20240205), XP093127193
OPPOSITION- Anonymous, "Janssen Enters Worldwide Collaboration and License Agreement with TESARO, Inc., for Niraparib in Prostate Cancer", News Releases, Johnson & Johnson, (20160406), pages 1 - 3, News Releases, URL: https://web.archive.org/web/20211115052216/https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/janssen-enters-worldwide-collaboration-and-license-agreement, (20240129), XP093124835
OPPOSITION- Anonymous, "Monetizing Focus: Tesaro Adds Runway By Out-licensing Niraparib In Prostate Cancer", The Pink Sheet Daily, Pharma Intelligence UK Limited (Citeline), (20160406), pages 1 - 3, The Pink Sheet Daily, URL: https://pink.pharmaintelligence.informa.com/PS079383, (20240129), XP093124841
OPPOSITION- Anonymous, "NCT01576172 | Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer", ClinicalTrials.gov, US NLM, (20161222), pages 1 - 25, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT01576172?cond=NCT01576172&rank=1&tab=history&a=52, (20240129), XP093124851
OPPOSITION- Anonymous, "NCT02924766: A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)", ClinicalTrials.gov, US NLM, (20180201), pages 1 - 11, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT02924766?tab=history&a=9, (20240129), XP093124848
OPPOSITION- Anonymous, "Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer ", ClinicalTrials.gov. History of Changes for Study: NCT01972217, (20170202), ClinicalTrials.gov. History of Changes for Study: NCT01972217, URL: https://classic.clinicaltrials.gov/ct2/show/NCT01972217, (20240205), XP093127206
OPPOSITION- Anonymous, "TESARO ANNOUNCES GLOBAL PROSTATE CANCER COLLABORATION AND LICENSING AGREEMENT WITH JANSSEN", News Release, GLOBE NEWSWIRE, (20160406), pages 1 - 2, News Release, URL: https://www.sec.gov/Archives/edgar/data/1491576/000110465916110703/a16-8184_1ex99d1.htm, (20240129), XP093124837
OPPOSITION- Carroll John, "UPDATED: J&J grabs prostate cancer rights for Tesaro's niraparib in $500M deal", (20160406), URL: https://www.fiercebiotech.com/partnering/updated-j-j-grabs-prostate-cancer-rights-for-tesaro-s-niraparib-500m-deal, XP093212313
OPPOSITION- "Chapter 12 - Initiating and Managing Therapy", Tozer Thomas N., Malcolm Rowland, Introduction to Pharmacokinetics and Pharmacodynamics - The Quantitative Basis of Drug Therapy, (20060101), pages 249 - 265, XP093122437
OPPOSITION- European Medicines Agency, "Assessment Report For Zytiga (abiraterone)", (20110721), pages 1 - 78, URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002321/WC500112860.pdf, XP002698002
OPPOSITION- Hussain Maha, Stephanie Daignault, Przemyslaw Twardowski, Costantine Albany, Mark N. Stein, Lakshmi Priya Kunju, Javed Siddiqui Et Al., "Co-targeting androgen receptor (AR) and DNA repair: A randomized ETS gene fusion-stratified trial of abiraterone + prednisone (Abi) +/- the PARP1 inhibitor veliparib for metastatic castration-resistant prostate cancer (mCRPC) patients (pts) (NCI9012)—A University of Chicago phase II consortium trial", Journal of Clinical Oncology, (20160520), vol. 34, no. 15 suppl., XP093121755
OPPOSITION- RYAN CHARLES J ET AL, "Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study.", The Lancet Oncology, Elsevier Ltd, (20150201), vol. 16, no. 2, ISSN 1474-5488, pages 152 - 160, XP002782026
OPPOSITION- Yvette Drew, Timothy A. Yap, Stan B. Kaye, "Chapter 7: The future of PARP inhibitors in the treatment of cancer", Yvette Drew, Timothy A. Yap, Stan B. Kaye, Kehoe, Sean, Gynaecological Cancers: Biology and Therapeutics, RCOG Press, (20110601), pages 83 - 98, ISBN 978-1-906985-44-8, XP009554023
OPPOSITION- Saad Fred; Chi Kim N.; Shore Neal D.; Graff Julie N.; Posadas Edwin M.; Lattouf Jean-Baptiste; Espina Byron M.; Zhu Eugene; Yu Alex; Hazra Anasuya; De Meulder Marc; Mamidi Rao N. V. S.; Bradic Branislav; Francis Peter; Hayreh Vinny; Rezazadeh Kalebasty Arash, "Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE)", Cancer chemotherapy and pharmacology, Springer Verlag , Berlin, DE, DE , (20210322), vol. 88, no. 1, doi:10.1007/s00280-021-04249-7, ISSN 0344-5704, pages 25 - 37, XP037463617
OPPOSITION- K.N. Chi, "Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial", Annals of Oncology, Elsevier, (20230901), vol. 34, no. 9, doi:10.1016/j.annonc.2023.06.009, ISSN 0923-7534, pages 772 - 782, XP093161315
OPPOSITION- Knezevic Claire E.; Wright Gabriela; Remsing Rix Lily L.; Kim Woosuk; Kuenzi Brent M.; Luo Yunting; Watters January M.; Koomen John M.; Haura Eric B.; Monteiro Alvaro N.; Radu Caius; Lawrence Harshani R.; Rix Uwe, "Proteome-wide Profiling of Clinical PARP Inhibitors Reveals Compound-Specific Secondary Targets", Cell Chemical Biology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20161117), vol. 23, no. 12, doi:10.1016/j.chembiol.2016.10.011, ISSN 2451-9456, pages 1490 - 1503, XP029861338
OPPOSITION- Drean Amy; Lord Christopher J.; Ashworth Alan, "PARP inhibitor combination therapy", Critical Reviews in Oncology/Hematology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (19000101), vol. 108, doi:10.1016/j.critrevonc.2016.10.010, ISSN 1040-8428, pages 73 - 85, XP029827859
OPPOSITION- Shahneen K Sandhu, William R Schelman, George Wilding, Victor Moreno, Richard D Baird, Susana Miranda, Lucy Hylands, Ruth Riisnaes, Martin Forster, Aurelius Omlin, Nathan Kreischer, Khin Thway, Heidrun Gevensleben, Linda Sun, John Loughney, Manash Chatterjee, Carlo Toniatti, Christopher L Carpenter, Robert Iannone, Stan B Kaye, Johann S De Bono, Robert M Wenham, "The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial", The Lancet Oncology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20130801), vol. 14, no. 9, doi:10.1016/S1470-2045(13)70240-7, pages 882 - 892, XP055407449
OPPOSITION- Ann-Gerd Thorsell, Torun Ekblad, Tobias Karlberg, Mirjam Löw, Ana Filipa Pinto, Lionel Trésaugues, Martin Moche, Michael S. Cohen, Herwig Schüler, "Structural Basis for Potency and Promiscuity in Poly(ADP-ribose) Polymerase (PARP) and Tankyrase Inhibitors", Journal of Medicinal Chemistry, American Chemical Society, US, US , (20170223), vol. 60, no. 4, doi:10.1021/acs.jmedchem.6b00990, ISSN 0022-2623, pages 1262 - 1271, XP055730220
OPPOSITION- Jones Philip, Wilcoxen Keith, Rowley Michael, Toniatti Carlo, "Niraparib: A Poly(ADP-ribose) Polymerase (PARP) Inhibitor for the Treatment of Tumors with Defective Homologous Recombination", Journal of Medicinal Chemistry, American Chemical Society, US, US , (20150423), vol. 58, no. 8, doi:10.1021/jm5018237, ISSN 0022-2623, pages 3302 - 3314, XP055855855
OPPOSITION- Elisabet Wahlberg, Tobias Karlberg, Ekaterina Kouznetsova, Natalia Markova, Antonio Macchiarulo, Ann-Gerd Thorsell, Ewa Pol, Åsa Frostell, Torun Ekblad, Delal Öncü, Björn Kull, Graeme Michael Robertson, Roberto Pellicciari, Herwig Schüler, Johan Weigelt, "Family-wide chemical profiling and structural analysis of PARP and tankyrase inhibitors", Nature Biotechnology, Nature Publishing Group US, New York, New York, vol. 30, no. 3, doi:10.1038/nbt.2121, ISSN 1087-0156, pages 283 - 288, XP055417170
OPPOSITION- Albert A. Antolin, "The kinase polypharmacology landscape of clinical PARP inhibitors", Scientific Reports, Nature Publishing Group, US, US , (20200217), vol. 10, no. 1, doi:10.1038/s41598-020-59074-4, ISSN 2045-2322, pages 2585 - 14, XP093161360
OPPOSITION- E. Lesaffre, "Statistical controversies in clinical research: futility analyses in oncology-lessons on potential pitfalls from a randomized controlled trial", Annals of Oncology, Elsevier, (20170701), vol. 28, no. 7, doi:10.1093/annonc/mdx042, ISSN 0923-7534, pages 1419 - 1426, XP093161340
OPPOSITION- Robert H. Carlson, "PARP Inhibitors Show Promise Against Metastatic Triple-Negative Breast Cancer in Early Studies", Oncology Times, Lippincott Williams & Wilkins, Inc., (20090801), vol. 31, no. Suppl. 1, doi:10.1097/01.COT.0000359114.36813.cb, ISSN 0276-2234, pages 10 - 11, XP093161336
OPPOSITION- Alessandro Tenuta; Laurence Klotz; Jayson L. Parker, "Clinical trial risk in castration‐resistant prostate cancer: immunotherapies show promise", BJU International, Blackwell Science, Hoboken, USA, Hoboken, USA, (20131202), vol. 113, doi:10.1111/bju.12309, ISSN 1464-4096, pages E82 - E89, XP072219152
OPPOSITION- Sandhu S. K., V. Moreno, G. Wilding, A. Omlin, W.R. Schelman Et Al., "112. PHASE I STUDY OF A POLY(ADP)-RIBOSE POLYMERASE (PARP) INHIBITOR MK-4827 (MK) WITH ANTITUMOUR ACTIVITY IN SPORADIC CASTRATION RESISTANT PROSTATE CANCER (CRPC)", Asia-Pacific Journal of Clinical Oncology, John Wiley & Sons, Inc., Hoboken, USA, Hoboken, USA, (20120701), vol. 8, no. suppl. 1, doi:10.1111/j.1743-7563.2012.01575.x, ISSN 1743-7555, page 33, XP093122422
OPPOSITION- Sandhu S. K., V. Moreno, G. Wilding, A. Omlin, W.R. Schelman Et Al., "112. PHASE I STUDY OF A POLY(ADP)-RIBOSE POLYMERASE (PARP) INHIBITOR MK-4827 (MK) WITH ANTITUMOUR ACTIVITY IN SPORADIC CASTRATION RESISTANT PROSTATE CANCER (CRPC)", ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Poster Abstracts, (20120101), vol. 8, no. suppl. 1, page 33, XP093122422
OPPOSITION- J. Murai, S.-Y. N. Huang, B. B. Das, A. Renaud, Y. Zhang, J. H. Doroshow, J. Ji, S. Takeda, Y. Pommier, "Trapping of PARP1 and PARP2 by Clinical PARP Inhibitors", Cancer research, American Association for Cancer Research, US, US, (20121101), vol. 72, no. 21, doi:10.1158/0008-5472.CAN-12-2753, ISSN 0008-5472, pages 5588 - 5599, XP055407452
OPPOSITION- J. P. Palma, Wang Y.-C., Rodriguez L. E., Montgomery D., Ellis P. A., Bukofzer G., Niquette A., Liu X., Shi Y., Lasko L., Zhu G.-D., Penning T. D., Giranda V. L., Rosenberg S. H., Frost D. J., Donawho C. K., "ABT-888 Confers Broad In vivo Activity in Combination with Temozolomide in Diverse Tumors", Clinical Cancer Research, Association for Cancer Research, (20091201), vol. 15, no. 23, doi:10.1158/1078-0432.CCR-09-1245, ISSN 10780432, pages 7277 - 7290, XP055078012
OPPOSITION- Anand G. Patel, "Failure of Iniparib to Inhibit Poly(ADP-Ribose) Polymerase In Vitro", Clinical Cancer Research, Association for Cancer Research, US, US, (20120315), vol. 18, no. 6, doi:10.1158/1078-0432.CCR-11-2890, ISSN 1078-0432, pages 1655 - 1662, XP093161348
OPPOSITION- Todd A. Hopkins, "Mechanistic Dissection of PARP1 Trapping and the Impact on In Vivo Tolerability and Efficacy of PARP Inhibitors", MOLECULAR CANCER RESEARCH, American Association for Cancer Research, US, US , (20151101), vol. 13, no. 11, doi:10.1158/1541-7786.MCR-15-0191-T, ISSN 1541-7786, pages 1465 - 1477, XP093161370
OPPOSITION- Matthew J. Schiewer, "Supplemental Figures: Dual Roles of PARP-1 Promote Cancer Growth and Progression", CANCER DISCOVERY, American Association for Cancer Research, US, US , (20121201), vol. 2, no. 12, doi:10.1158/2159-8290.CD-12-0120, ISSN 2159-8274, pages 1 - 9, XP093161314
OPPOSITION- Schiewer Matthew J., Goodwin Jonathan F., Han Sumin, Brenner J. Chad, Augello Michael A., Dean Jeffry L., Liu Fengzhi, Planck Jamie L., Ravindranathan Preethi, Chinnaiyan Arul M., Mccue Peter, Gomella Leonard G., Raj Ganesh V., Dicker Adam P., Brody Jonathan R., Pascal John M., Centenera Margaret M., Butler Lisa M., Tilley Wayne D., Feng Felix Y., Knudsen Karen E., "Dual Roles of PARP-1 Promote Cancer Growth and Progression", CANCER DISCOVERY, American Association for Cancer Research, US, US , (20121201), vol. 2, no. 12, doi:10.1158/2159-8290.CD-12-0120, ISSN 2159-8274, pages 1134 - 1149, XP093122430
OPPOSITION- Jessica S. Brown, Brent O'carrigan, Stephen P. Jackson, Timothy A. Yap, "Targeting DNA Repair in Cancer: Beyond PARP Inhibitors", CANCER DISCOVERY, American Association for Cancer Research, US, US , (20170101), vol. 7, no. 1, doi:10.1158/2159-8290.CD-16-0860, ISSN 2159-8274, pages 20 - 37, XP055453319
OPPOSITION- Michie Caroline Ogilvie, Sandhu Shahneen Kaur, Schelman William R., Molife L Rhoda, Wilding George, Omlin Aurelius Gabriel, Kansra Vikram, Brooks David G., Martell Robert E., Kaye Stanley B., De Bono Johann Sebastian, Wenham Robert Michael, "Final results of the phase I trial of niraparib (MK4827), a poly(ADP)ribose polymerase (PARP) inhibitor incorporating proof of concept biomarker studies and expansion cohorts involving BRCA1/2 mutation carriers, sporadic ovarian, and castration resistant prostate cancer (CRPC).", Journal of Clinical Oncology, American Society of Clinical Oncology, US, US , (20130520), vol. 31, no. 15_suppl, doi:10.1200/jco.2013.31.15_suppl.2513, ISSN 0732-183X, pages 2513 - 2513, XP093071671
OPPOSITION- Hussain Maha; Daignault-Newton Stephanie; Twardowski Przemyslaw W; Albany Costantine; Stein Mark N; Kunju Lakshmi P; Siddiqui Javed; Wu Yi-Mi; Robinson Dan; Lonigro Robert J; Cao Xuhong; Tomlins Scott A; Mehra Rohit; Cooney Kathleen A; Montgomery Bruce; Antonarakis Emmanuel S; Shevrin Daniel H; Corn Paul G; Whang Young E; Smith David C; Caram Megan V; Knudsen Karen E; Stadler Walter M; Feng Felix Y; Chinnaiyan Arul M, "Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012.", Journal of Clinical Oncology, Grune & Stratton, (20180401), vol. 36, no. 10, doi:10.1200/JCO.2017.75.7310, ISSN 0732-183X, pages 991 - 999, XP009506016
OPPOSITION- Chi Kim N, Rathkopf Dana, Smith Matthew R, Efstathiou Eleni, Attard Gerhardt, Olmos David, Ji ;, Lee Youl, Small Eric J, Pereira De Andrea J, Gomes Santana, Roubaud Guilhem, Saad Marniza, Zurawski Bogdan, Sakalo Valerii, Mason Gary E, Francis Peter, Wang George, Wu Daphne, Diorio Brooke, Lopez-Gitlitz Angela, Sandhu Shahneen, "Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer", J CLIN. ONCOLOGY, (20230323), vol. 41, doi:10.1200/JCO.22, pages 1 - 15, XP093071658
OPPOSITION- Gras Jordi, "Niraparib hydrochloride. Poly [ADP-ribose] polymerase (PARP) inhibitor, Oncolytic.", Drugs of the Future, Prous Science, ES, ES , (20131001), vol. 38, no. 10, doi:10.1358/dof.2013.38.10.2059820, ISSN 0377-8282, pages 679 - 685, XP009195509
OPPOSITION- R. J. Auchus, M. K. Yu, S. Nguyen, S. D. Mundle, "Use of Prednisone With Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer", THE ONCOLOGIST, (20141201), vol. 19, no. 12, doi:10.1634/theoncologist.2014-0167, ISSN 1083-7159, pages 1231 - 1240, XP055483431
OPPOSITION- Albert A. Antolín, "Linking off-target kinase pharmacology to the differential cellular effects observed among PARP inhibitors", Oncotarget, Impact Journals LLC, United States, United States , (20140530), vol. 5, no. 10, doi:10.18632/oncotarget.1814, ISSN 1949-2553, pages 3023 - 3028, XP093161354
OPPOSITION- Taylor Amy K., Kosoff David, Emamekhoo Hamid, Lang Joshua M., Kyriakopoulos Christos E., "PARP inhibitors in metastatic prostate cancer", Frontiers in Oncology, Frontiers Research Foundation, CH, CH , (20230424), vol. 13, doi:10.3389/fonc.2023.1159557, ISSN 2234-943X, pages 1 - 11, XP093127189
OPPOSITION- Jingsong Zhang, "Poly (ADP-ribose) polymerase inhibitor: an evolving paradigm in the treatment of prostate cancer", Asian Journal of Andrology, Nature Publishing Group, US, US , (20140101), vol. 16, no. 3, doi:10.4103/1008-682X.123684, ISSN 1008-682X, page 401, XP055472262
OPPOSITION- J Zhang null, "Poly (AADP-ribose) polymerase inhibitor: an evolving paradigm in the treatment of prostate cancer", Asian Journal of Andrology, (2014), vol. 16, doi:10.4103/1008-682X.123684, XP055472262
OPPOSITION- Antonarakis Emmanuel, Boudadi Karim, "Resistance to Novel Antiandrogen Therapies in Metastatic Castration-Resistant Prostate Cancer", Clinical Medicine Insights: Oncology, Libertas Academica Ltd., NZL, NZL , (20160211), vol. 10, no. S1, doi:10.4137/CMO.S34534, ISSN 1179-5549, pages 1 - 9, XP093124856

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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.

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