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Subcutaneous Formulations Of Anti-Cd38 Antibodies And Their Uses - EP3370770

The patent EP3370770 was granted to Janssen Biotech on Jan 20, 2021. The application was originally filed on Nov 1, 2016 under application number EP16862791A. The patent is currently recorded with a legal status of "Revoked".

EP3370770

JANSSEN BIOTECH
Application Number
EP16862791A
Filing Date
Nov 1, 2016
Status
Revoked
Jan 22, 2025
Grant Date
Jan 20, 2021
External Links
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Patent Oppositions (5)

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BREUEROct 20, 2021DORRIESADMISSIBLE
BREUEROct 20, 2021DORRIES, HANS ULRICH , DF-MP DORRIES FRANK-MOLNIA & POHLMANADMISSIBLE
PATENT BOUTIQUEOct 19, 2021PATENT BOUTIQUEADMISSIBLE
KONIG SZYNKA TILMANN VON RENESSEOct 6, 2021KONIG SZYNKA TILMANN VON RENESSE DUSSELDORFADMISSIBLE
KONIG SZYNKA TILMANN VON RENESSEOct 6, 2021KONIG SZYNKA TILMANN VON RENESSE PATENTANWALTE PARTNERSCHAFT MBB DUSSELDORFADMISSIBLE

Patent Citations (61) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2007287170
DESCRIPTIONUS2009182127
DESCRIPTIONUS2010015133
DESCRIPTIONUS2010286374
DESCRIPTIONUS2011123532
DESCRIPTIONUS2012149876
DESCRIPTIONUS2015118251
DESCRIPTIONUS4683195
DESCRIPTIONUS5223409
DESCRIPTIONUS5403484
DESCRIPTIONUS5427908
DESCRIPTIONUS5571698
DESCRIPTIONUS5580717
DESCRIPTIONUS5885793
DESCRIPTIONUS5932448
DESCRIPTIONUS5969108
DESCRIPTIONUS6172197
DESCRIPTIONUS6521404
DESCRIPTIONUS6544731
DESCRIPTIONUS6555313
DESCRIPTIONUS6582915
DESCRIPTIONUS6593081
DESCRIPTIONUS6737056
DESCRIPTIONUS6833441
DESCRIPTIONUS7695936
DESCRIPTIONUS7767429
DESCRIPTIONUS7829693
DESCRIPTIONUS8088896
DESCRIPTIONUS8153765
DESCRIPTIONWO2004078140
DESCRIPTIONWO2004111233
DESCRIPTIONWO2005103083
DESCRIPTIONWO2006125640
DESCRIPTIONWO2007042309
DESCRIPTIONWO2008047242
DESCRIPTIONWO2008077546
DESCRIPTIONWO2008119353
DESCRIPTIONWO2009085462
DESCRIPTIONWO2009134776
DESCRIPTIONWO2011131746
DESCRIPTIONWO2011143545
DESCRIPTIONWO2012022811
DESCRIPTIONWO2014178820
DESCRIPTIONWO8801649
DESCRIPTIONWO9201047
DESCRIPTIONWO9413804
DESCRIPTIONWO9844001
INTERNATIONAL-SEARCH-REPORTUS2015231235
INTERNATIONAL-SEARCH-REPORTWO2009128917
OPPOSITIONEP2459167
OPPOSITIONUS2011076273
OPPOSITIONUS2015118251
OPPOSITIONUS2015231235
OPPOSITIONWO2004078140
OPPOSITIONWO2011012637
OPPOSITIONWO2013102144
OPPOSITIONWO2016187546
OPPOSITIONWO2016209921
SEARCHUS2015118251
SEARCHWO2016187546
SEARCHWO2016209921

Non-Patent Literature (NPL) Citations (65) 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- CHIARUGI et al., Nature Reviews, (20120000), vol. 12, pages 741 - 52-
DESCRIPTION- CHOTHIALESK, Mol Biol, (19870000), vol. 196, pages 901 - 17-
DESCRIPTION- FERRARA et al., Biotechnol Bioeng, (20060000), vol. 93, pages 851 - 861-
DESCRIPTION- FERRARA et al., J Biol Chem, (20060000), vol. 281, pages 5032 - 5036-
DESCRIPTION- FUNARO et al., J Immunol, (19900000), vol. 145, pages 2390 - 6-
DESCRIPTION- "GenBank", Database accession no. NP_001766-
DESCRIPTION- GUSE et al., Nature, (19990000), vol. 398, pages 70 - 3-
DESCRIPTION- HOOGENBOOMWINTER, J Mol Biol, (19910000), vol. 222, page 581-
DESCRIPTION- KNAPPIK et al., J Mol Biol, (20000000), vol. 296, pages 57 - 86-
DESCRIPTION- KONNO et al., Cytotechnology, (20120000), vol. 64, pages 249 - 65-
DESCRIPTION- KREBS et al., J Immunol Meth, (20010000), vol. 254, pages 67 - 84-
DESCRIPTION- LEFRANC et al., Dev Comparat Immunol, (20030000), vol. 27, pages 55 - 77-
DESCRIPTION- MACLENNAN et al., Acta Physiol Scand Suppl, (19980000), vol. 643, pages 55 - 67-
DESCRIPTION- MAHJ et al., Exp Toxicol Path, (20060000), vol. 57, pages 341 - 5-
DESCRIPTION- MORI et al., Biotechnol Bioeng, (20040000), vol. 88, pages 901 - 908-
DESCRIPTION- OLIVIER et al., MAbs, vol. 2, no. 4, page 2010-
DESCRIPTION- SASAKI et al., Adv Biophys, (19980000), vol. 35, pages 1 - 24-
DESCRIPTION- SHEETS et al., PITAS (USA, (19980000), vol. 95, pages 6157 - 6162-
DESCRIPTION- SHIELDS et al., J Biol Chem, (20020000), vol. 277, pages 26733 - 26740-
DESCRIPTION- SHI et al., J Mol Biol, (20100000), vol. 397, pages 385 - 96-
DESCRIPTION- SHI et al., J. Mol. Biol., (20100000), vol. 397, pages 385 - 96-
DESCRIPTION- SHINKAWA et al., J Biol Chem, (20030000), vol. 278, pages 3466 - 3473-
DESCRIPTION- TERHORST et al., Cell, (19810000), pages 771 - 80-
DESCRIPTION- VAUGHAN et al., Nature Biotechnology, (19960000), vol. 14, pages 309 - 314-
DESCRIPTION- WUKABAT, J Exp Med, (19700000), vol. 132, pages 211 - 50-
DESCRIPTION- XHOU et al., Biotechnol Bioeng, (20080000), vol. 99, pages 652 - 65-
INTERNATIONAL-SEARCH-REPORT- ARTHUR., "Innovations in subcutaneous infusions.", J Infus Nurs., (20150600), vol. 38, no. 3, pages 179 - 87, XP009510495 [Y] 1-3, 42-44 * ; Abstract, pg 180, col 2 *
OPPOSITION- Anonymous, "Assessment report Mabthera International non-proprietary name: RITUXIMAB Procedure No. EMEA/ H/C/ 000165/ X/ 0083", EUROPEAN MEDICINES AGENCY EMA/CHMP/71722/2014, (20140123), pages 1 - 103, XP055858066-
OPPOSITION- Anonymous, "CHMP assessment report Herceptin International non-proprietary name trastuzumab Procedure No. EMEA/ H/ C/ 000278", European Medicines Agency / EMA/CHMP/751770/2012/corr1, (20130627), pages 1 - 70, XP055858060-
OPPOSITION- Anonymous, "DARZALEX (daratumumab)", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20150101), pages 1 - 24, XP055857084-
OPPOSITION- Anonymous, " Halozyme Therapeutics Reports Selection Of First Product Candidate Under Janssen Collaboration", Halozyme Therapeutics, (20150310), pages 1 - 4, Halozyme Therapeutics, URL: http://halozyme2015.q4web.com/investors/news-releases/news-release-details/2015/Halozyme-Therapeutics-Reports-Selection-Of-First-Product-Candidate-Under-Janssen-Collaboration/default.aspx, (20211104), XP055858046-
OPPOSITION- Anonymous, "Herceptin - CHMP assessment report", European Medicines Agency, (20130627), pages 1 - 70, European Medicines Agency, (20210714), XP055824328-
OPPOSITION- Anonymous, "HERCEPTIN® (trastuzumab)", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20101001), pages 1 - 33, XP055857081-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION HYLENEX", NDA 21-859/S-009, (20050000), pages 3 - 11-
OPPOSITION- Anonymous, "History of Changes for Study: NCT02519452 A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma", ClinicalTrials.gov, (20150806), pages 1 - 12, XP055856922-
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN)", WHO Drug Information, (20090101), vol. 23, no. 2, pages 129 - 192, XP055858023-
OPPOSITION- Anonymous, "Mabthera - CHMP assessment report", European Medicines Agency, (20140123), pages 1 - 103, European Medicines Agency, (20211104), XP055857967-
OPPOSITION- Anonymous, "Phase 3 COLUMBA study investigating a subcutaneous formulation of DARZALEX® (daratumumab) showed non-inferiority to intravenous administration in patients with relapsed/refractory multiple Myeloma", (20190602), pages 1 - 7, XP055857953-
OPPOSITION- Antonio Salar, Iritavivi, Beate Bittner, Reda Bouabdallah, Mike Brewster, Olivier Catalani, George Follows, Andrew Haynes, Florence Hourcade-Potelleret, Andrea Janikova, Jean-Franfois Farouche, Christine Mcintyre,Michael Pedersen, Juliana Pereira, Pakeeza Sayyed, Ofer Shpilberg, And Gayane Tumyan, "Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, PhaseIB Study", Journal of Clinical Oncology, (20140710), vol. 32, no. 17, pages 1782 - 1791, XP055858042-
OPPOSITION- Bittner B., W. F. Richter, F. Hourcade-Potelleret, C. Mcintyre, F. Herting, M. L. Zepeda, J. Schmidt, "Development of a Subcutaneous Formulation for Trastuzumab - Nonclinical and Clinical Bridging Approach to the Approved Intravenous Dosing Regimen", ARZNEIMITTELFORSCHUNG, (20120101), vol. 62, pages 401 - 409, XP055824302-
OPPOSITION- "CD38 Antigen", Ortolani, C., FLOW CYTOMETRY OF HEMATOLOGICAL MALIGNANCIES 1st Edition, Blackwell Publishing , (20110101), pages 68 - 70, XP055858004-
OPPOSITION- Colin Phipps, Yunxin Chen, Sathish Gopalakrishnan And Daryl Tan, "Daratumumab and its potential in the treatment of multiple myeloma: overview of the preclinical and clinical development", Therapeutic Advances in Hematology, (20150101), vol. 6, no. 3, pages 120 - 127, XP055858013-
OPPOSITION- Dominique Leveque, "Subcutaneous Administration of Anticancer Agents", Anticancer Research, (20140401), vol. 34, pages 1579 - 1586, XP055344175-
OPPOSITION- Eva-Maria Ruberg, Wolfgang Frieß, "Proteinarzneistoffe: Sensibel und stressanfällig | PZ - Pharmazeutische Zeitung", (20111209), pages 1 - 15, URL: https://www.pharmazeutische-zeitung.de/ausgabe-502011/sensibel-und-stressanfaellig/, (20211102), XP055856931-
OPPOSITION- Haller M F, "Converting intravenous dosing to subcutaneous dosing: With recombinant human hyaluronidase", Pharmaceutical Technology, ADVANSTAR COMMUNICATIONS,INC., US, US , (20071201), vol. 31, no. 12, ISSN 1543-2521, page 118, 120, 122, 124, 126, 128, 130, 132, XP009122858-
OPPOSITION- Henk M Lokhorst, Torben Plesner; Jacob P Laubach; Hareth Nahi; Peter Gimsing; Markus Hansson; Monique C Minnema; Ulrik Lassen; Jakub Krejcik; Antonio Palumbo; Niels W C J Van De Donk; Tahamtan Ahmadi; Imran Khan; Clarissa M Uhlar; Jianping Wang; Kate Sasser A; Nedjad Losic; Steen Lisby; Linda Basse; Nikolai Brun; Paul G Richardson, "Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma /Supplementary Appendix/", The New England journal of medicine, (20150101), pages 1 - 22, XP055858040-
OPPOSITION- Janssen Research & Development, Llc, "Daratumumab (HuMax -CD38) Safety Study in Multiple Myeloma / NCT00574288", ClinicalTrials.gov, (20180427), XP055858034-
OPPOSITION- Nahi Hareth, Et Al, "An open-label, dose-escalation phase 1b study of subcutaneous daratumumab with recombinant human hyaluronidase in patients with relapsed or refractory multiple myeloma (PAVO)", Journal of Clinical Oncology, (20160520), pages 1 - 4, XP055857955-
OPPOSITION- Pia Sondergeld, Niels W. C. J. Van De Donk, Paul G. Richardson, And Torben Plesner,, "Monoclonal Antibodies in Myeloma", Clinical Advances in Hematology Oncology, (20150901), vol. 13, no. 9, pages 599 - 609, XP055858016-
OPPOSITION- Pivot X, J Gligorov , V Müller , G Curigliano , A Knoop , S Verma 6, V Jenkins , N Scotto , S Osborne , L Fallowfield, Prefher Study Group, "Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study", Annals of Oncology, (20140101), vol. 25, pages 1979 - 1987, XP055824228-
OPPOSITION- Raritan, N.J, "Janssen Initiates Rolling Submission of Biologic License Application (BLA) for daratumumab with U.S. FDA for the Treatment of Multiple Myeloma | Johnson & Johnson", News Releases, (20150605), pages 1 - 3, News Releases, URL: https://www.jnj.com/media-center/press-releases/janssen-initiates-rolling-submission-of-biologic-license-application-bla-for-daratumumab-with-us-fda-for-the-treatment-of-multiple-myeloma, (20211102), XP055856903-
OPPOSITION- WANG W; SINGH S; ZENG D L; KING K; NEMA S, "ANTIBODY STRUCTURE, INSTABILITY, AND FORMULATION", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, US, US , (20070101), vol. 96, no. 1, doi:10.1002/jps.20727, ISSN 0022-3549, pages 1 - 26, XP009084505
OPPOSITION- Nicholas W. Warne, "Development of high concentration protein biopharmaceuticals: The use of platform approaches in formulation development", EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM., NL, NL , (20110601), vol. 78, no. 2, doi:10.1016/j.ejpb.2011.03.004, ISSN 0939-6411, pages 208 - 212, XP055534222
OPPOSITION- Davies Andrew, Et Al, "Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study", TheLancet, (20140210), vol. 15, pages 343 - 352, XP055857954
OPPOSITION- SHPILBERG et al., "Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) 2013 (Pub) using hyaluronidase", British Journal of Cancer, vol. 109, doi:10.1038/bjc.2013.371, pages 1556 - 1561, XP002782443
OPPOSITION- SHPILBERG O. & JACKISH C., "Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase", BRITISH J. CANCER, (20130903), vol. 109, doi:10.1038/bjc.2013.371, pages 1556 - 1561, XP002782443
OPPOSITION- E M Ocio, P G Richardson, S V Rajkumar, A Palumbo, M V Mateos, R Orlowski, S Kumar, S Usmani, D Roodman, R Niesvizky, H Einsele, K C Anderson, M A Dimopoulos, H Avet-Loiseau, U-H Mellqvist, I Turesson, G Merlini, R Schots, P Mccarthy, L Bergsagel, C S Chim, J J Lahuerta, J Shah, A Reiman, J Mikhael, S Zweegman, S Lonial, R Comenzo, W J Chng, P Moreau, P Sonneveld, H Ludwig, B G M Durie, J F S Miguel, "New drugs and novel mechanisms of action in multiple myeloma in 2013: a report from the International Myeloma Working Group (IMWG)", Leukemia, Nature Publishing Group UK, London, London, (20140301), vol. 28, no. 3, doi:10.1038/leu.2013.350, ISSN 0887-6924, pages 525 - 542, XP055538306
OPPOSITION- BITTNER, B. et al., "Non-clinical pharmacokinetic/pharmacodynamic and early clinical studies supporting development of a novel subcutaneous formulation for the monoclonal antibody rituximab", Drug Research, (20140000), vol. 64, no. 11, pages 569 - 575, XP055857994
OPPOSITION- C. Jackisch, Müller V., Maintz C., Hell S., Ataseven B., "Subcutaneous Administration of Monoclonal Antibodies in Oncology", GEBURTSHILFE UND FRAUENHEILKUNDE, Georg Thieme Verlag, DE, DE , (20140428), vol. 74, no. 04, doi:10.1055/s-0034-1368173, ISSN 0016-5751, pages 343 - 349, XP055344155
OPPOSITION- Henk M. Lokhorst, Torben Plesner, Jacob P. Laubach, Hareth Nahi, Peter Gimsing, Markus Hansson, Monique C. Minnema, Ulrik Lassen, Jakub Krejcik, Antonio Palumbo, Niels W.C.J. Van De Donk, Tahamtan Ahmadi, Imran Khan, Clarissa M. Uhlar, Jianping Wang, A. Kate Sasser, Nedjad Losic, Steen Lisby, Linda Basse, Nikolai Brun, Paul G. Richardson, "Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma", The New England journal of medicine, Massachusetts Medical Society, US, US , (20150924), vol. 373, no. 13, doi:10.1056/NEJMoa1506348, ISSN 0028-4793, pages 1207 - 1219, XP055413700
OPPOSITION- Arthur Annette, "Innovations in Subcutaneous Infusions", JOURNAL OF INFUSION NURSING, Lippincott Williams & Wilkins, US, US , (20150531), vol. 38, no. 3, doi:10.1097/NAN.0000000000000099, ISSN 1533-1458, pages 179 - 187, XP009510495
OPPOSITION- ARTHUR, "Innovations in subcutaneous infusions", J Infus. Nurs., (20150603), vol. 38, doi:10.1097/NAN.0000000000000099, pages 179 - 87, XP009510495
OPPOSITION- Rosengren Sanna, Dychter Samuel S, Printz Marie A, Huang Lei, Schiff Richard I, Schwarz Hans-Peter, Mcvey John K, Drake Fred H, Maneval Dan C, Kennard Don A, Frost Gregory I, Sugarman Barry J, Muchmore Douglas B, "Clinical Immunogenicity of rHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration", AAPS JOURNAL, AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS, US, US , (20150513), vol. 17, no. 5, doi:10.1208/s12248-015-9782-0, ISSN 1550-7416, pages 1144 - 1156, XP055856917
OPPOSITION- Frost Gregory I, "Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration.", Expert Opinion on Drug Delivery, Informa Healthcare, GB, GB , (20070701), vol. 4, no. 4, doi:10.1517/17425247.4.4.427, ISSN 1742-5247, pages 427 - 440, XP008177677
OPPOSITION- Salima Hamizi, Freyer Gilles; Bakrin Naoual; Henin Emilie; Mohtaram Amina; Le Saux Olivia; Falandry Claire, "Subcutaneous trastuzumab: development of a new formulation for treatment of HER2-positive early breast cancer", OncoTargets and Therapy, (20130213), vol. 6, doi:10.2147/OTT.S27733, pages 89 - 94, XP055476980

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