Iron Complex Compounds For Therapeutic Use - EP3681539

The patent EP3681539 was granted to Pharmacosmos Holding on Jan 1, 2025. The application was originally filed on Sep 10, 2018 under application number EP18762868A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3681539

PHARMACOSMOS HOLDING
Application Number
EP18762868A
Filing Date
Sep 10, 2018
Status
Granted And Under Opposition
Nov 29, 2024
Publication Date
Jan 1, 2025
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (6)

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

BARDEHLE PAGENBERGOct 1, 2025BARDEHLE PAGENBERG SLADMISSIBLE
BRIGHTGENE BIO MEDICAL TECHNOLOGYOct 1, 2025PLASSERAUDADMISSIBLE
SANDOZOct 1, 2025ELKINGTON AND FIFEADMISSIBLE
INTERQUIMSep 30, 2025FERRER INTERNACIONALADMISSIBLE
SCORPIOSep 30, 2025SAGITTARIUSADMISSIBLE
ZIMMERMANN & PARTNER PATENTANWALTE MBBSep 30, 2025ZIMMERMANN & PARTNER PATENTANWALTE MBBADMISSIBLE

Patent Citations (38) New

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

Citation PhasePublication Number
DESCRIPTIONCA2318823
DESCRIPTIONEP1554315
DESCRIPTIONFR607134
DESCRIPTIONUS3639588
DESCRIPTIONUS3906077
DESCRIPTIONUS4056386
DESCRIPTIONUS6977249
DESCRIPTIONUS8926947
DESCRIPTIONUS8929947
DESCRIPTIONWO2008096130
DESCRIPTIONWO2010108493
DESCRIPTIONWO2016066172
DESCRIPTIONWO2016206600
DESCRIPTIONWO2016206699
DESCRIPTIONWO9948533
INTERNATIONAL-SEARCH-REPORTEP2913054
INTERNATIONAL-SEARCH-REPORTWO2010108493
INTERNATIONAL-SEARCH-REPORTWO9948533
OPPOSITIONCA2318823
OPPOSITIONEP2411053
OPPOSITIONEP2913054
OPPOSITIONFR607134
OPPOSITIONIN269965
OPPOSITIONUS1752348
OPPOSITIONUS2008027558
OPPOSITIONUS3574184
OPPOSITIONUS3906077
OPPOSITIONUS3974267
OPPOSITIONUS4056386
OPPOSITIONUS5624668
OPPOSITIONUS8815301
OPPOSITIONWO0030657
OPPOSITIONWO2010108493
OPPOSITIONWO2016066172
OPPOSITIONWO2016181195
OPPOSITIONWO9943408
OPPOSITIONWO9948533
OTHERIN269965

Non-Patent Literature (NPL) Citations (53) 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- CAIN et al., "Preparation of pure iron and iron-carbon alloy", Bulletin of the Bureau of Standards, (19160000), vol. 13
DESCRIPTION- JAHN et al., Eur J Pharm Biopharm, (20110000), vol. 78, pages 480 - 491
DESCRIPTION- KERNKAMP et al., J Anim Sci., (19620000), vol. 21, pages 527 - 532
DESCRIPTION- MOSTAD et al., Hydrometallurgy, (20080000), vol. 90, pages 213 - 220
DESCRIPTION- MULLER et al., "Liquid-liquid extraction of ferric chloride by tri-n-laurylamine hydrochloride", Euratom report, Transplutonium Elements Program, Euratom Contract No. 003-61-2 TPUB, Presses Academiques Europeennes, (19650000), page 2245
DESCRIPTION- ULLREY et al., J Anim Sci., (19590000), vol. 18, pages 256 - 263
DESCRIPTION- ZIMMERMAN et al., J Anim Sci., (19590000), vol. 18, pages 1409 - 1415
OPPOSITION- Anonymous, "<232> ELEMENTAL IMPURITIES—LIMITS ", THE UNITED STATES PHARMACOPEIA (USP 28 NF 23), UNITED STATES PHARMACOPEIAL CONVENTION, INC., Rockville, MD, USA, Rockville, MD, USA, (20151208), vol. USP 39, no. NF 34, ISSN 0190-5384, pages 1 - 3, XP093323618
OPPOSITION- Anonymous, "ALUMINUM HYDROXIDE -aluminum hydroxide gel LLC Federal Solutions", DRUG LABEL INFO, US FDA, pages 1 - 3, DRUG LABEL INFO, URL: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=af9b799f-69c5-401c-9c43-a97b23384cc2, XP093323652
OPPOSITION- Anonymous, "Australian Public Assessment Report for Ferric derisomaltose", Australian Public Assessment Report, Therapeutic Goods Administration (TGA), Australia, Australia, pages 1 - 74, Australian Public Assessment Report, URL: https://www.tga.gov.au/sites/default/files/auspar-ferric_derisomaltose-181105.pdf, XP093324507
OPPOSITION- Anonymous, "Carbonyl iron", Wikipedia, (20161203), pages 1 - 1, Wikipedia, URL: https://en.wikipedia.org/wiki/Carbonyl_iron, XP093324514
OPPOSITION- Anonymous, "EudraCT Number 2017-000776-29 - Clinical trial results - Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: a randomised, comparative, open-label trial", EU Clinical Trials Register, pages 1 - 14, URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000776-29/results, XP093323683
OPPOSITION- Anonymous, "Ferric Chloride 415", Product Information, MG CHemicals, pages 1 - 2, Product Information, URL: https://web.archive.org/web/20071016165335/http://mgchemicals.com/products/415.html, XP093324518
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION MONOFERRIC. MONOFERRIC (ferric derisomaltose) injection, for intravenous use", HIGHLIGHTS OF PRESCRIBING INFORMATION MONOFERRIC, US FDA, pages 1 - 11, HIGHLIGHTS OF PRESCRIBING INFORMATION MONOFERRIC, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s000lbl.pdf, XP093324512
OPPOSITION- Anonymous, "ICH guideline Q3D on elemental impurities Step 5 (EMA/CHMP/ICH/353369/2013)", ICH guideline Q3D on elemental impurities, European Medicines Agency, pages 1 - 84, ICH guideline Q3D on elemental impurities, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-q3d-elemental-impurities-step-5-first-version_en.pdf, XP093324497
OPPOSITION- Anonymous, "ICH HARMONISED GUIDELINE GUIDELINE FOR ELEMENTAL IMPURITIES Q3D Current Step 4 version", INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE, ICH, pages 1 - 77, INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE, URL: https://www.ich.org/page/quality-guidelines, XP093323581
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN) - RECOMMENDED International Nonproprietary Names: List 72", WHO DRUG INFORMATION, GENEVA, CH, CH , (20140101), vol. 28, no. 3, ISSN 1010-9609, pages 379 - 422, XP093266221
OPPOSITION- Anonymous, "Iron Dextran Injection", British Pharmacopeia Volume III, 2017 , TSO, (20170101), vol. 3, pages III - III-753, ISBN 9780113230341, XP009563498
OPPOSITION- Anonymous, "iron isomaltoside 1000, 100mg/mL solution for injection/infusion (Monofer®)", SMC No. (697/11), Scottish Medicines Consortium, pages 1 - 8, SMC No. (697/11), URL: https://scottishmedicines.org.uk/media/1873/iron_isomaltoside_monofer_final_april_2011_amended_030511_for_website.pdf, XP093324487
OPPOSITION- Anonymous, "MONOFERRIC (ferric derisomaltose) injection, for intravenous use", HIGHLIGHTS OF PRESCRIBING INFORMATION MONOFERRIC., US FDA, pages 1 - 11, HIGHLIGHTS OF PRESCRIBING INFORMATION MONOFERRIC. , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s000lbl.pdf, XP093323675
OPPOSITION- Anonymous, "SUMMARY OF PRODUCT CHARACTERISTICS Monofer 100 mg/ml solution for injection/infusion ", SUMMARY OF PRODUCT CHARACTERISTICS, Drugs.com, UK, UK, pages 1 - 13, SUMMARY OF PRODUCT CHARACTERISTICS , URL: https://www.drugs.com/uk/pdf/leaflet/1038404.pdf, XP093324530
OPPOSITION- Anonymous, "UNIFERON 200- iron dextran injection", Uniferon® 200 package display panel, US FDA, pages 1 - 6, Uniferon® 200 package display panel, URL: https://fda.report/DailyMed/a1c4228b-3b8d-4d18-afb9-32e61c99d24b, XP093324510
OPPOSITION- Brian S. Furniss, "2.19 FILTRATION TECHNIQUES", Brian S. Furniss, Vogel, A. I.; Furniss, B.S.; Hannaford, A.J.; Smith, P.W.G.; Tatchell, A.R., Vogel's Textbook of Practical Organic Chemistry, Addison Wesley Longman Limited , (19890101), pages 133 - 135, ISBN 0-582-46236-3, XP009563532
OPPOSITION- Brian S. Furniss, "2.20 RECRYSTALLISATION TECHNIQUES", Brian S. Furniss, Vogel, A. I.; Furniss, B.S.; Hannaford, A.J.; Smith, P.W.G.; Tatchell, A.R., Vogel's Textbook of Practical Organic Chemistry, Addison Wesley Longman Limited , (19890101), pages 135 - 153, ISBN 0-582-46236-3, XP009563533
OPPOSITION- D42 - Drug approval package for MONOFERRIC® (PATENT TERM EXTENSION APPLICATION UNDER 35 U.S.C. § 156)
OPPOSITION- D43 - DECLARATION OF HANS B. ANDREASEN
OPPOSITION- D61 - DECLARATION OF HANS B. ANDREASEN
OPPOSITION- D8a - capture of webpage https://www.usp.org/impurities/elemental-impurities-updates showing that the NF34 which evidences that the version of D8 used (NF34) was published on 01/May/2016
OPPOSITION- Gołoś Aleksandra, Lutyńska Anna, "ALUMINIUM-ADJUVANTED VACCINES -A REVIEW OF THE CURRENT STATE OF KNOWLEDGE", Przeglad Epidemiologiczny, Panstwowy Zaklad Higieny,, PL, PL , (20151217), vol. 69, no. 4, ISSN 0033-2100, pages 731 - 734, XP093323646
OPPOSITION- Mackinnon David, "Ferric Chloride 415 - Material Safety Data Sheet", Material Safety Data Sheet, MG Chemicals, pages 1 - 4, Material Safety Data Sheet, URL: https://web.archive.org/web/20071021091246/http://www.mgchemicals.com/msds/english/liquid/415-liquid.pdf, XP093324517
OPPOSITION- Pharmacosmos A/s, "Monofer 100 mg/ml solution for injection/infusion (iron(III) isomaltoside 1000) SE/H/734/01/DC ", Public Assessment Report Scientific discussion, Swedish Medical Products Agency, pages 1 - 11, Public Assessment Report Scientific discussion, URL: https://docetp.mpa.se/LMF/Monofer%20solution%20for%20injection%20or%20infusion%20ENG%20PAR_09001bee807a625c.pdf, XP093323688
OPPOSITION- Pharmacosmos A/s, "NCT02940860 | Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease", ClinicalTrials.gov, NLM, pages 1 - 29, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT02940860, XP093323640
OPPOSITION- Pharmacosmos Uk Limited, "Monofer 100mg/ml solution for injection/infusion - Summary of Product Characteristics (SmPC)", Summary of Product Characteristics (SmPC), Medicines.org.uk, pages 1 - 8, Summary of Product Characteristics (SmPC), URL: https://www.medicines.org.uk/emc/product/5676/smpc/print, XP093324492
OPPOSITION- Robert H. Perry, Don W. Green, "CONTINUOUS-DISTILLATION OPERATIONS", Robert H. Perry, Don W. Green, D.W Green et al., Perry's Chemical Engineers' Handbook, 7th Edition, US, The McGraw-Hill Companies, Inc., (19970101), pages 13 - 13-9, ISBN 0-07-049841-5, XP009563535
OPPOSITION- Ulrich Reichert, "Elemental Impurities: ICH Q3D finalized - New Implications for Manufacturers of Drug Products, APIs and Excipients", PHARMAZEUTISCHE INDUSTRIE., AULENDORF., DE, DE , (20160501), vol. 78, no. 5, ISSN 0031-711X, pages 670 - 676, XP009563531
OPPOSITION- W. L. F. Armarego, D. D. Perrin, "Chapter 1: Common Physical Techniques in Purification ", W. L. F. Armarego, D. D. Perrin, W.L.F Armarego et al., Purification of Laboratory Chemicals, Fourth Edition, Butterworth-Heinemann, (19970101), pages 1 - 47, ISBN 0-7506-3761-7, XP009563534
OPPOSITION- Markus R. Jahn; Hans B. Andreasen; Sren Ftterer; Thomas Nawroth; Volker Schnemann; Ute Kolb; Wolfgang Hofmeister; Manuel Muoz; Klaus Bock; Morten Meldal; Peter Langguth;, "A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications", European journal of pharmaceutics and biopharmaceutics, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM., NL, NL , (20110315), vol. 78, no. 3, doi:10.1016/j.ejpb.2011.03.016, ISSN 0939-6411, pages 480 - 491, XP028241966
OPPOSITION- Wollein Uwe, Bauer Bettina, Habernegg Renate, Schramek Nicholas, "Potential metal impurities in active pharmaceutical substances and finished medicinal products - A market surveillance study", European Journal of Pharmaceutical Sciences- Author Manuscript, Elsevier Amsterdam, NL, NL , (20150901), vol. 77, doi:10.1016/j.ejps.2015.05.028, ISSN 0928-0987, pages 100 - 105, XP093324476
OPPOSITION- Mostad, E. Rolseth, S. Thonstad, J., "Electrowinning of iron from sulphate solutions", HYDROMETALLURGY., ELSEVIER SCIENTIFIC PUBLISHING CY. AMSTERDAM., NL, NL , (20080201), vol. 90, no. 2-4, doi:10.1016/j.hydromet.2007.07.014, ISSN 0304-386X, pages 213 - 220, XP022459025
OPPOSITION- Araujo-Barbosa Uenderson; Peña-Vazquez Elena; Barciela-Alonso Maria Carmen; Costa Ferreira Sergio Luis; Pinto dos Santos Ana Maria; Bermejo-Barrera Pilar, "Simultaneous determination and speciation analysis of arsenic and chromium in iron supplements used for iron-deficiency anemia treatment by HPLC-ICP-MS", TALANTA, ELSEVIER, AMSTERDAM, NL, NL , (20170420), vol. 170, doi:10.1016/j.talanta.2017.04.034, ISSN 0039-9140, pages 523 - 529, XP085008630
OPPOSITION- Lanphear Bruce P, Rauch Stephen, Auinger Peggy, Allen Ryan W, Hornung Richard W, "Low-level lead exposure and mortality in US adults: a population-based cohort study", The Lancet Public Health, (20180401), vol. 3, no. 4, doi:10.1016/S2468-2667(18)30025-2, ISSN 2468-2667, pages e177 - e184, XP093323575
OPPOSITION- Barbosa Uenderson A., Dos Santos Ivanice F., Dos Santos Ana M. P., Ferreira Sergio L. C., "Determination of Lead in Iron Supplements by Electrothermal Atomization Atomic Absorption Spectrometry", Analytical Letters, Taylor & Francis Inc., US, US , (20160412), vol. 49, no. 6, doi:10.1080/00032719.2015.1079206, ISSN 0003-2719, pages 799 - 807, XP093324469
OPPOSITION- Dahlerup Jens Frederik, Jacobsen Bent A., Van Der Woude Janneke, Bark Lars-Åke, Thomsen Lars L., Lindgren Stefan, "High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23", Scandinavian journal of gastroenterology, Informa UK Ltd, England, England, (20161101), vol. 51, no. 11, doi:10.1080/00365521.2016.1196496, ISSN 0036-5521, pages 1332 - 1338, XP093324465
OPPOSITION- Kalra P. A., "Introducing iron isomaltoside 1000 (Monofer(R))--development rationale and clinical experience", Clinical Kidney Journal, (20110601), vol. 4, no. Suppl 1, doi:10.1093/ndtplus/sfr042, ISSN 2048-8505, pages i10 - i13, XP093323704
OPPOSITION- EMMETT MICHAEL, "A comparison of clinically useful phosphorus binders for patients with chronic kidney failure", Kidney International, Elsevier, United States, United States, (20040901), vol. 66, no. Suppl. 90, doi:10.1111/j.1523-1755.2004.09005.x, ISSN 0085-2538, pages S25 - S32, XP002378636
OPPOSITION- Holm C., Thomsen L. L., Norgaard A., Langhoff‐roos J., "Single‐dose intravenous iron infusion versus red blood cell transfusion for the treatment of severe postpartum anaemia: a randomized controlled pilot study", Vox Sanguinis, S Kager AG Basel, CH, CH , (20170201), vol. 112, no. 2, doi:10.1111/vox.12475, ISSN 0042-9007, pages 122 - 131, XP093324466
OPPOSITION- Charney Pamela J., "A.S.P.E.N. Statement on Aluminum in Parenteral Nutrition Solutions", NUTRITION IN CLINICAL PRACTICE, WILLIAMS AND WLIKINS, BALTIMORE, MD, US, US , (20040801), vol. 19, no. 4, doi:10.1177/0115426504019004416, ISSN 0884-5336, pages 416 - 417, XP093324523
OPPOSITION- Gordeuk Victor R., Brittenham Gary M., Mclaren Christine E., Hughes Margaret A., Keating Louise J., "Carbonyl Iron Therapy for Iron Deficiency Anemia", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (19860301), vol. 67, no. 3, doi:10.1182/blood.V67.3.745.745, ISSN 0006-4971, pages 745 - 752, XP093324467
OPPOSITION- Thomsen Lars Lykke, Nordfjeld Kim, Andreasen Hans, "Pharmacokinetics of iron isomaltoside 1000 in patients with inflammatory bowel disease", Drug Design, Development and Therapy, Dove Medical Press Ltd., United Kingdom, United Kingdom , (20120305), vol. 6, doi:10.2147/DDDT.S30015, ISSN 1177-8881, pages 43 - 51, XP093324456
OPPOSITION- Kalra Philip (phil), Bhandari Sunil, "Efficacy and safety of iron isomaltoside (Monofer®) in the management of patients with iron deficiency anemia", International Journal of Nephrology and Renovascular Disease, (20160310), vol. 2016, no. 9, doi:10.2147/IJNRD.S89704, ISSN 1178-7058, pages 53 - 64, XP093324490
OPPOSITION- Barbosa Uenderson, Silva Laiana, Santos Ivanice, Ferreira Sergio, Santos Ana, "Determination of Mercury in Iron Supplement Using Slurry Sampling and Cold Vapor Atomic Absorption Spectrometry", Current Analytical Chemistry, Bentham Science Publishers, (20150101), vol. 11, no. 1, doi:10.2174/1573411010666141031003321, ISSN 1573-4110, pages 44 - 49, XP093324472
OPPOSITION- Radke Scott, Olsen Chris, Ensley Steve, "Elemental impurities in injectable iron products for swine", JOURNAL OF SWINE HEALTH AND PRODUCTION, AMERICAN ASSOCIATION OF SWINE VETERINARIANS, US, US , (20180501), vol. 26, no. 3, doi:10.54846/jshap/1053, ISSN 1537-209X, pages 142 - 145, XP093323605
OPPOSITION- Cain J R, Schramm E, Cleaves H E, "PREPARATION OF PURE IRON AND IRON-CARBON ALLOYS", Bulletin of the Bureau of Standards, (19160601), vol. 13, no. 1, doi:10.6028/bulletin.292, ISSN 0096-8579, pages 1 - 28, XP093323693

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