IP Verse

High-Purity Quinoline Derivative And Method For Manufacturing Same - EP3524595

The patent EP3524595 was granted to Eisai R&D Management on Aug 10, 2022. The application was originally filed on Aug 26, 2015 under application number EP19151846A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3524595

EISAI R&D MANAGEMENT
Application Number
EP19151846A
Filing Date
Aug 26, 2015
Status
Granted And Under Opposition
Jul 8, 2022
Grant Date
Aug 10, 2022
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (9)

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

ACCORD HEALTHCAREMay 10, 2023UEXKULL & STOLBERGADMISSIBLE
AECHTERMay 10, 2023TER MEER STEINMEISTER & PARTNERADMISSIBLE
GENERICS UKMay 10, 2023RUSSELLADMISSIBLE
MAIWALDMay 10, 2023MAIWALDADMISSIBLE
STADA ARZNEIMITTELMay 10, 2023HAMM & WITTKOPPADMISSIBLE
WELDINGMay 10, 2023HAMM & WITTKOPPADMISSIBLE
HANSENMay 9, 2023MAIWALDADMISSIBLE
TEVA PHARMACEUTICALSMay 9, 2023KRAUS & LEDERER PARTGMBBADMISSIBLE
ELKINGTON AND FIFEMay 4, 2023ELKINGTON AND FIFEADMISSIBLE

Patent Citations (41) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2004053908
DESCRIPTIONUS2007004773
DESCRIPTIONUS2007037849
DESCRIPTIONUS2007078159
DESCRIPTIONUS2007117842
DESCRIPTIONWO2006030826
DESCRIPTIONWO2011021597
OPPOSITIONCN107305202
OPPOSITIONEP1683785
OPPOSITIONEP1698623
OPPOSITIONEP1698923
OPPOSITIONEP1777218
OPPOSITIONEP1797881
OPPOSITIONEP1894918
OPPOSITIONEP3524595
OPPOSITIONJP2014174062
OPPOSITIONJP2015034729
OPPOSITIONUS2004053908
OPPOSITIONUS2007004773
OPPOSITIONUS2007037849
OPPOSITIONUS2007078159
OPPOSITIONUS2007117842
OPPOSITIONUS2008214604
OPPOSITIONWO0232872
OPPOSITIONWO2004101526
OPPOSITIONWO2005044788
OPPOSITIONWO2005063713
OPPOSITIONWO2006030826
OPPOSITIONWO2006137474
SEARCHEP1683785
SEARCHEP1698623
SEARCHEP1777218
SEARCHEP1797881
SEARCHEP1894918
SEARCHUS2007117842
SEARCHWO0232872
SEARCHWO2004101526
SEARCHWO2005044788
SEARCHWO2005063713
SEARCHWO2006030826
SEARCHWO2006137474

Non-Patent Literature (NPL) Citations (34) 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
OPPOSITION- Anonymous, "EISAI LAUNCHES ANTICANCER AGENT LENVIMA™ IN THE UNITED STATES FIRST COUNTRY IN THE WORLD TO GAIN ACCESS TO NEW TREATMENT OPTION", EISAI - News Release, (20150302), EISAI - News Release, URL: https://www.eisai.com/news/news201516.html, (20240404), XP093147840-
OPPOSITION- Anonymous, "Extreme Flexibility - X-Bridge HPLC Columns", Waters, (20150201), Waters, URL: https://www.eisai.com/news/pdf/enews201510pdf.pdf, (20240415), XP093151596-
OPPOSITION- Anonymous, "GUIDELINE ON THE LIMITS OF GENOTOXIC IMPURITIES", European Medicines Agency; COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP); CPMP/SWP/5199/02 EMEA/CHMP/QWP/25 1344/2006, (20060628), European Medicines Agency; COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP); CPMP/SWP/5199/02 EMEA/CHMP/QWP/25 1344/2006 , (20240415), XP093151538-
OPPOSITION- Anonymous, "GUIDELINE ON THE LIMITS OF GENOTOXIC IMPURITIES", European Medicines Agency - Evaluation of Medicines for Human Use; CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006, (20060628), European Medicines Agency - Evaluation of Medicines for Human Use; CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-limits-genotoxic-impurities_en.pdf, XP093160247-
OPPOSITION- Anonymous, "ICH Harmonised Tripartite Guideline - Impurities In New Drug Substances Q3A(R2)", INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE, (20061025), INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE , XP093157689-
OPPOSITION- Anonymous, "May 2013 EMA/CHMP/ICH/83812/2013 ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 3", EUROPEAN MEDICINES AGENCY; EMA/CHM P/ICH/83812/2013, (20130501), EUROPEAN MEDICINES AGENCY; EMA/CHM P/ICH/83812/2013, XP093157680-
OPPOSITION- Anonymous, "OECD Environment Health and Safety Publications - Series on Testing and Assessment ", REPORT ON THE REGULATORY USES AND APPLICATIONS IN OECD MEMBER COUNTRIES OF (QUANTITATIVE) STRUCTURE-ACTIVITY RELATIONSHIP [(Q)SAR] MODELS IN THE ASSESSMENT OF NEW AND EXISTING CHEMICALS, (20070215), no. 58, pages 1 - 79, XP093177420-
OPPOSITION- Anonymous, "U.S. FDA APPROVES ANTICANCER AGENT LENVIMA TM (LENVATINIB MESYLATE) AS TREATMENT FOR RADIOACTIVE IODINE-REFRACTORY DIFFERENTIATED THYROID CANCER", Eisai News Release No. 15-10, (20150216), Eisai News Release No. 15-10, URL: https://www.eisai.com/news/pdf/enews201510pdf.pdf, (20240415), XP093151588-
OPPOSITION- Anonymous, "Waters Chromatography Columns and Supplies (passage)", Brochure 2009-2010, (20090101), pages FP, 1, 2, 155 - 157, 311, 2PP, XP093177434-
OPPOSITION- Blacker John, Michael T. Williams, "CHAPTER 13 Materials Science: Solid Form Design and Crystallisation Process Development", Pharmaceutical Process Development: Current Chemical and Engineering Challenges, RSC Publishing, (20110101), pages 286 - 316, ISBN 978-1-84973-146-1, XP093147836-
OPPOSITION- D66 - Search Results AJCSD-
OPPOSITION- D67 - Search Results NITE-CHRIP-
OPPOSITION- D68b - Notification No. 0205-1 2010-02-05-
OPPOSITION- D68d - Notification No. 0205-2 2010-02-05-
OPPOSITION- D68 - Notification No. 0205-3 - 2010-02-05-
OPPOSITION- D69 - Notification No. 1211-4 - 2012-12-11-
OPPOSITION- Eisai Inc., "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) (SELECT)", ClinicalTrials NCT01321554, (20230622), ClinicalTrials NCT01321554, URL: https://clinicaltrials.gov/study/NCT01321554?cond=NCT01321554&rank=1&tab=history&a=19, XP093177424-
OPPOSITION- Eisai Inc., "A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects ", ClinicalTrials NCT02199379, (20150414), ClinicalTrials NCT02199379, URL: https://clinicaltrials.gov/study/NCT02199379?intr=Lenvatinib&term=dose&rank=26&tab=history&a=2, XP093177429-
OPPOSITION- Eisai Inc., "A Study of E7080 in Subjects With Solid Tumor", ClinicalTrials NCT01268293, (20230622), ClinicalTrials NCT01268293, URL: https://clinicaltrials.gov/study/NCT01268293?intr=Lenvatinib&studyComp=_2016-02-10&rank=2&tab=history&a=6, XP093177426-
OPPOSITION- Ema, "ICH guideline S9 on nonclinical evaluation for anticancer pharmaceuticals Step 5", European Medicines Agency EMA/CHMP/ICH/646107/2008, (20100501), pages 1 - 10, European Medicines Agency EMA/CHMP/ICH/646107/2008, URL: https://www.ema.europa.eu/en/ich-s9-non-clinical-evaluation-anticancer-pharmaceuticals-scientific-guideline, (20240404), XP093147844-
OPPOSITION- Emea, "ICH Topic Q 3 B (R2) Impurities in New Drug Products Step 5 NOTE FOR GUIDANCE ON IMPURITIES IN NEW DRUG PRODUCTS", European Medicines Agency CPMP/ICH/2738/99, (20060601), pages 1 - 14, European Medicines Agency CPMP/ICH/2738/99, URL: https://www.ema.europa.eu/en/ich-q3b-r2-impurities-new-drug-products-scientific-guideline, (20240404), XP093147845-
OPPOSITION- Emea, "ICH Topic Q 6 A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Step 5 NOTE FOR GUIDANCE SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAE SUBSTANCES", European Medicines Agency CPMP/ICH/3 67/96, (20000501), European Medicines Agency CPMP/ICH/3 67/96 , (20240404), XP093147842-
OPPOSITION- European Medicines Agency Ema, "Assessment report Lenvima. International non-proprietary name: lenvatinib", EMA Procedure No. EMEA/H/C/003727/0000, (20150326), pages 1 - 170, XP055910213-
OPPOSITION- G H Jeffery Et Al.,, "CHAPTER 8 - COLUMN AND THIN-LAYER LIQUID CHROMATOGRAPHY", VOGEL’s TEXTBOOK OF QUANTITATIVE CHEMICAL ANALYSIS FIFTH EDITION, (19890101), pages 2PP, 216 - 233, XP055715081-
OPPOSITION- Ich, "Impurities: Guideline for Residual Solvents Q3C(R5", ICH Harmonised Tripartite Guideline, (20210204), pages 1 - 29, ICH Harmonised Tripartite Guideline, URL: https://database.ich.org, (20240404), XP093147851-
OPPOSITION- Satinder Ahuja, Michael W. Dong, "HANDBOOK OF PHARMACEUTICAL ANALYSIS BY HPLC /Passage/", HANDBOOK OF PHARMACEUTICAL ANALYSIS BY HPLC, Elsevier Academic Press , (20050209), pages 2pp, 19 - 377, XP055656652-
OPPOSITION- Tung Hsien-Hsin, Paul Edward L, Midler Michael, Mccauley James A, "Chapter 5 Critical Issues in Crystallization Practice", Crystallization of Organic Compounds An Industrial Perspective W Crystallization of Organic Compounds. An Industrial Perspective, WILEY AIChE , (20090101), pages 101 - 116, XP093147838-
OPPOSITION- Lloyd R. Snyder, Joseph J. Kirkland and Joseph L. Glajch, "Chapter 1: Getting Started", Lloyd R. Snyder, Joseph J. Kirkland and Joseph L. Glajch, L.R. Snyder, Joseph P. Kirkland, Joseph L Glajch, Practical HPLC Method Development (2nd Edition), John Wiley & Sons Inc., (19970101), pages 1 - 20, doi:10.1002/9781118592014.ch1, ISBN 9781118592014, XP009556014
OPPOSITION- Lloyd R. Snyder, Joseph J. Kirkland and Joseph L. Glajch, "Chapter 7: Ionic Samples: Reversed‐Phase, Ion‐Pair, and Ion‐Exchange HPLC", Practical HPLC Method Development, Hoboken, NJ, USA, John Wiley & Sons, Inc, (19970228), pages 292 - 349, doi:10.1002/9781118592014.ch7, ISBN 047100703X, XP009556015
OPPOSITION- Robert C. Shumaker, Jagadeesh Aluri • Jean Fan • Gresel Martinez • Gary A. Thompson • Min Ren, "Effect of Rifampicin on the Pharmacokinetics of Lenvatinib in Healthy Adults", Clinical Drug Investigation, ADIS INTERNATIONAL, AUCKLAND., NZ, NZ , (20140901), vol. 34, no. 9, doi:10.1007/s40261-014-0217-y, ISSN 1173-2563, pages 651 - 659, XP093160244
OPPOSITION- Muller, L. Mauthe, R.J. Riley, C.M. Andino, M.M. Antonis, D.D. Beels, C. DeGeorge, J. De Knaep, A.G.M. Ellison, D. Fagerland, J.A. Frank, R. Fritschel, B. Galloway, S. Harpur, E. Humfrey, C.D.N. Jacks, A.S. Jagota, N. Mackinnon, J. Mohan, G. Ness, D.K. O'Donov, "A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity", REGULATORY TOXICOLOGY AND PHARMACOLOGY, ACADEMIC PRESS,NEW YORK, NY,, US, US , (20060401), vol. 44, no. 3, doi:10.1016/j.yrtph.2005.12.001, ISSN 0273-2300, pages 198 - 211, XP005358650
OPPOSITION- PILANIYA et al., "Recent trends in the impurity profile of pharmaceuticals", J Adv Pharm Technol Res, (20100700), vol. 1, no. 3, doi:10.4103/0110-5558.72422, pages 302 - 310, XP009516872
OPPOSITION- Pilaniya et al., "Recent trends in the impurity profile of pharmaceuticals", Journal of advanced pharmaceutical technology & research : an official publication of Society of Pharmaceutical Education & Research, Medknow Publication, Mumbai, India, Mumbai, India , (20100701), vol. 1, no. 3, doi:10.4103/0110-5558.72422, ISSN 0976-2094, pages 302 - 310, XP009516872
OPPOSITION- PILANIYA K et al., "Recent trends in the impurity profile of pharmaceuticals", J Adv Pharm Technol Res, (20100700), vol. 1, no. 3, doi:10.4103/0110-5558.72422, pages 302 - 10, XP009516872

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