IP Verse

Controlled Release Pharmaceutical Composition - EP2345410

The patent EP2345410 was granted to Astellas Pharma on Dec 30, 2020. The application was originally filed on Sep 28, 2009 under application number EP09817723A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2345410

ASTELLAS PHARMA
Application Number
EP09817723A
Filing Date
Sep 28, 2009
Status
Granted And Under Opposition
Nov 27, 2020
Grant Date
Dec 30, 2020
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

BRAND MURRAY FULLERSep 30, 2021BRAND MURRAY FULLERADMISSIBLE
TEVA PHARMACEUTICALSSep 30, 2021D YOUNGADMISSIBLE
BULLE DRSep 29, 2021KUTZENBERGER WOLFF & PARTNERADMISSIBLE
HAMM & WITTKOPPSep 29, 2021HAMM & WITTKOPPADMISSIBLE
SANOVEL ILAC SANAYI VE TICARET ANONIM SIRKETISep 29, 2021SONNENHAUSERADMISSIBLE
SANDOZSep 23, 2021ELKINGTON AND FIFEADMISSIBLE

Patent Citations (35) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONJP2005162736
DESCRIPTIONJP2005162737
DESCRIPTIONWO2004041276
DESCRIPTIONWO9406414
DESCRIPTIONWO9920607
INTERNATIONAL-SEARCH-REPORTJP2005162737
INTERNATIONAL-SEARCH-REPORTJP2005519884
INTERNATIONAL-SEARCH-REPORTWO2004041276
INTERNATIONAL-SEARCH-REPORTWO2008084698
INTERNATIONAL-SEARCH-REPORTWO9406414
OPPOSITIONEP0661045
OPPOSITIONEP1028111
OPPOSITIONEP1205190
OPPOSITIONEP1440969
OPPOSITIONEP1529526
OPPOSITIONEP1559427
OPPOSITIONEP1568361
OPPOSITIONEP2554168
OPPOSITIONJP2005162737
OPPOSITIONJP2005519884
OPPOSITIONJPS402053
OPPOSITIONUS10842780
OPPOSITIONUS2005100602
OPPOSITIONUS2006115540
OPPOSITIONUS6436441
OPPOSITIONUS6488963
OPPOSITIONWO03039531
OPPOSITIONWO2004041276
OPPOSITIONWO2008084698
OPPOSITIONWO9406414
OTHEREP1559427
OTHERUS2010144807
OTHERWO9406414
SEARCHEP1028111
SEARCHEP1440969

Non-Patent Literature (NPL) Citations (52) 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, "Annual Report 2008", Astellas, (20080101), pages 1 - 78, Astellas, URL: https://www.annualreports.com/HostedData/AnnualReportArchive/a/TSX_4503_2008.pdf, (20211022), XP055854069-
OPPOSITION- Anonymous, "A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, MulticenterStudy to Assess the Efficacy and Safety of Mirabegron in Subjects with Symptoms of Overactive Bladder; Protocol 178-CL-046 (SCORPIO)", Astellas Pharma Global Development, (201004), pages 1 - 21, XP055855962-
OPPOSITION- Anonymous, "A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)", ClinicalTrials.gov; NCT00337090, (20080415), ClinicalTrials.gov; NCT00337090, URL: https://clinicaltrials.gov/study/NCT00337090?tab=history&a=7, (20231130), XP093107563-
OPPOSITION- Anonymous, "Betanis® Tablets 25mg, 50mg", Astellas Pharma Inc., (201907), pages 1 - 14, XP055855969-
OPPOSITION- Anonymous, "EudraCT Number. 2005-002256-17", EU Clinical Trials Register, (20051111), URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-002256-17/GB, XP055855532-
OPPOSITION- Anonymous, "First approval for Yamanouchi's OCAS tech", Outsourcing Pharma.com, (20040927), pages 1 - 2, Outsourcing Pharma.com, URL: https://www.outsourcing-pharma.com/Article/2004/09/28/First-approval-for-Yamanouchi-s-OCAS-tech, (20211022), XP055854063-
OPPOSITION- Anonymous, "History of Changes for Study: NCT00940121 - Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron", ClinicalTrials.gov archive, (20090803), ClinicalTrials.gov archive, URL: https://clinicaltrials.gov/ct2/history/NCT00940121?A=2&B=2&C=merged#StudyPageTop, (20211022), XP055854112-
OPPOSITION- Anonymous, "Hydroxypropyl Betadex and Methylcellulose", Handbook of Pharmaceutical Excipients Sixth Edition, (20090101), pages 315 - 317,438-441, ISBN 978-1-58212-135-2, XP055586686-
OPPOSITION- Anonymous, "Mirabegron", center for drugs evaluation and research apllicationnumber 202611Orig1s000 medical review, (20110826), page 12,34, XP055854067-
OPPOSITION- Anonymous, "Title of Study: A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi center Long-termStudy to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qdin Subjects With Symptoms of Overactive Bladder", Astellas Pharma Europe B.V., (201012), pages 1 - 26, XP055855964-
OPPOSITION- Anonymous, "VALIUM® brand of diazepam TABLETS", FDA Label, Roche, (20080101), pages 1 - 12, XP093115512-
OPPOSITION- Anonymous, "Yamanouchi, Fujisawa become Astellas", Outsourcing Pharma.com, (20040524), pages 1 - 2, Outsourcing Pharma.com, URL: https://www.outsourcing-pharma.com/Article/2004/05/25/Yamanouchi-Fujisawa-become-Astellas, (20211022), XP055854091-
OPPOSITION- Anonymous, "Yamanouchi Shaklee Pharma Licenses OCAS Drug Delivery Technology from Yamanouchi Pharmaceutical Co., Ltd.", Pharmaceutical online, (19990511), pages 1 - 1, Pharmaceutical online, URL: https://www.pharmaceuticalonline.com/doc/yamanouchi-shaklee-pharma-licenses-ocas-drug-0001, (20211022), XP055854061-
OPPOSITION- Bahadur Namrata, "Overview of Drug Development", (200803), URL: https://admin.ich.org/sites/default/files/inline-files/Clinical_Dev_Plans_-_Namrata_Bahadur.pdf, XP055854158-
OPPOSITION- Bauer et al., Pharmazeutische Technologie, 4. Auflage, (1993), pages 424 - 425, XP055854182-
OPPOSITION- Chapple, C.R., "The Oral Controlled Absorption System (OCAS^(R)): The Evolution of Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)", European Urology Supplements, Elsevier BV, NL, NL, (20051001), vol. 4, no. 7, ISSN 1569-9056, pages 20 - 22, XP027626794-
OPPOSITION- Chapple, "The Development of the Oral Controlled Absorption System (OCAS®): A New Improved Formulation of Tamsulosin", European Urology Supplements, (20050000), vol. 4, pages 1 - 4, XP027626789-
OPPOSITION- "Chapter 17: Antioxidants", Melgardt M. de Villiers, Contemporary Pharmacy Practice and Compounding, 20170714, LWW, pages 216 - 223, XP055855972-
OPPOSITION- "Chapters 11 & 12", Dressman et al, Oral Drug Absorption - Prediction and Assessment, (2000), pages 183 - 228, XP055854174-
OPPOSITION- FDA, "Guidance for Industry, Food-Effect Bioavailability and Fed Bioequivalence Studies", (20021200), XP008138108-
OPPOSITION- FDA, "Guidance for Industry - Food-Effect Bioavailability and Fed Bioequivalence Studies", (200212), XP008138108-
OPPOSITION- FDA, "Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies", Guidance for industry, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, US, US, (20021201), pages 1 - 12, XP008138108-
OPPOSITION- FDA, "MYRBETRIQâ„¢ (mirabegron) extended-release tablets, for oral use", HIGHLIGHTS OF PRESCRIBING INFORMATION, (201206), pages 1 - 23, URL: https://www.fda.gov/, XP055855967-
OPPOSITION- "History of Changes for Study: NCT00662909 - Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder (ARIES)", ClinicalTrials.gov Archive, (20080417), XP055854105-
OPPOSITION- "History of Changes for Study: NCT00662909 - Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder (ARIES)", ClinicalTrials.gov Archive, (20090520), XP055854106-
OPPOSITION- "History of Changes for Study: NCT00689104 - Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder (SCORPIO)", Clinical Trials.gov, (20080602), XP055854097-
OPPOSITION- "History of Changes for Study: NCT00689104 - Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder (SCORPIO)", ClinicalTrials.gov Archive, (20090416), XP055854102-
OPPOSITION- "History of Changes for Study: NCT00939757 - Study of the Effect of Food on the Pharmacokinetics of Mirabegron", ClinicalTrials.gov Archive, (20090803), XP055854110-
OPPOSITION- "History of Changes for Study: NCT00940121 - Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron", ClinicalTrials.gov Archive, (20090803), XP055854112-
OPPOSITION- "History of Changes for Study: NCT00965926 - A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers", ClinicalTrials.gov Archive, (20090908), XP055854108-
OPPOSITION- "International Nonproprietary Names for Pharmaceutical Substances (INN)", Recommended INN: List 60, Prepublication copy, pages 1 - 30-
OPPOSITION- K.-E. ANDERSSON et al., "Pharmacological treatment of overactive bladder: report from the International Consultation on Incontinence", Curr Opin Urol, (20090000), vol. 19, pages 380 - 394, XP055525123-
OPPOSITION- Malhotra Harinder S., Greg L. Plosker, "Barnidipine: New Drug Profile", Drugs, (20010101), vol. 61, no. 7, pages 989 - 996, XP093115513-
OPPOSITION- Michael E. Aulton, PHARMACEUTICS - THE SCIENCE OF DOSAGE FORM DESIGN, 2nd ED., (2002), pages 294 - 302, XP055298170-
OPPOSITION- Nicholas G. Lordi, "Chapter 14 - Sustained Release Dosage Forms", Nicholas G. Lordi, Lachman et al., The Theory and Practice of Industrial Pharmacy, 3rd ed., (1986), pages 430 - 456, XP055854167-
OPPOSITION- "Table of Contents", (20020101), pages 1 - 9, ISBN 3-87193-228-0, XP009550306-
OPPOSITION- Li Yanxiang, Ruigang Liu, Yong Huang, "Synthesis and phase transition of cellulose-graft-poly(ethylene glycol) copolymers", Journal of Applied Polymer Science, (20081101), vol. 110, no. 3, doi:10.1002/app.28541, pages 1797 - 1803, XP093115500
OPPOSITION- Michel, M.C et al, "The Pharmacokinetic Profile of Tamsulosin Oral Controlled Absorption System (OCAS^(R))", European Urology Supplements, Elsevier BV, NL, NL, (20050201), vol. 4, no. 2, doi:10.1016/j.eursup.2004.11.002, ISSN 1569-9056, pages 15 - 24, XP004719760
OPPOSITION- Chapple, C.R., "The Development of the Oral Controlled Absorption System (OCAS^(R)): A New Improved Formulation of Tamsulosin", European Urology Supplements, Elsevier BV, NL, NL, (20051001), vol. 4, no. 7, doi:10.1016/j.eursup.2005.07.001, ISSN 1569-9056, pages 1 - 4, XP005029724
OPPOSITION- Baer, I. Gurny, R. Margot, P., "NIR analysis of cellulose and lactose-Application to ecstasy tablet analysis", FORENSIC SCIENCE INTERNATIONAL, Elsevier B.V., AMSTERDAM, NL, AMSTERDAM, NL , (20070325), vol. 167, no. 2-3, doi:10.1016/j.forsciint.2006.06.056, ISSN 0379-0738, pages 234 - 241, XP022001729
OPPOSITION- Chapple, C.R et al, "674 CLINICAL PROOF OF CONCEPT STUDY (BLOSSOM) SHOWS NOVEL @b3 ADRENOCEPTOR AGONIST YM178 IS EFFECTIVE AND WELL TOLERATED IN THE TREATMENT OF SYMPTOMS OF OVERACTIVE BLADDER", European Urology Supplements, Elsevier BV, NL, NL, (20080301), vol. 7, no. 3, doi:10.1016/S1569-9056(08)60672-7, ISSN 1569-9056, page 239, XP022521335
OPPOSITION- Chapple et al., "Clinical Proof of Concept Study (BLOSSOM) Shows Novel beta3 Adrenoceptor Agonist YM178 Is Effective And Well Tolerated In The Treatment Of Symptoms Of Overactive Bladder", European Urology Supplements, (2008), vol. 7, no. 3, page 239, XP022521335
OPPOSITION- Chapple et al., "Clinical Proof of Concept Study (BLOSSOM) Shows Novel beta3 Adrenoceptor Agonist YM178 Is Effective And Well Tolerated In The Treatment Of Symptoms Of Overactive Bladder", Eur Urol Suppl, (20080000), vol. 7, no. 3, page 239, XP022521335
OPPOSITION- De Leon Jose et al, "Haloperidol Half-life After Chronic Dosing : ", JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY., Lippincott Williams & Wilkins, US, US , (20041201), vol. 24, no. 6, doi:10.1097/01.jcp.0000145340.53417.ca, ISSN 0271-0749, pages 656 - 660, XP093095846
OPPOSITION- A.T. HANNA-MITCHELL et al., "New insights into the pharmacology of the bladder", Curr Opin Urol, (20080700), vol. 18, no. 4, doi:10.1097/MOU.0b013e3283023bfc, pages 347 - 352, XP009110844
OPPOSITION- Toshiyuki Takasu et al, "Effect of (R)-2-(2-Aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} Acetanilide (YM178), a Novel Selective beta3-Adrenoceptor Agonist, on Bladder Function.", JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS, American Society for Pharmacology and Experimental Therapeutics, US, US, (20070501), vol. 321, no. 2, doi:10.1124/jpet.106.115840, ISSN 0022-3565, pages 642 - 647, XP008161740
OPPOSITION- T. TAKASU et al., "Effect of (R)-2-(2-Aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} Acetanilide (YM 178), a Novel Selective beta3-Adrenoceptor Agonist, on Bladder Function", JPET, (20070000), vol. 321, pages 642 - 647, XP008161740
OPPOSITION- Sudharsan Reddy K., Prabhakar M. N., Kumara Babu P., Venkatesulu G., Kumarji Rao U. Sajan, Chowdoji Rao K., Subha M. C. S., "Miscibility Studies of Hydroxypropyl Cellulose/Poly(Ethylene Glycol) in Dilute Solutions and Solid State", International Journal of Carbohydrate Chemistry, Hindawi Publishing Corporation, US, US , (20120926), vol. 2012, doi:10.1155/2012/906389, ISSN 1687-9341, pages 1 - 9, XP093115498
OPPOSITION- K.-E. ANDERSSON, "Prospective pharmacologic therapies for the overactive bladder", Ther Adv Urol, (20090000), vol. 1, no. 2, doi:10.1177/1756287209103937, pages 71 - 83, XP055526839
OPPOSITION- Tiwari Atul, Naruganahalli Krishna S, "Current and emerging investigational medical therapies for the treatment of overactive bladder", Expert Opinion on Investigational Drugs, Informa Healthcare, UK, UK, (20060901), vol. 15, no. 9, doi:10.1517/13543784.15.9.1017, ISSN 1354-3784, pages 1017 - 1037, XP055854081
OPPOSITION- Basra Ramandeep, Kelleher Con, "A review of solifenacin in the treatment of urinary incontinence", Therapeutics and clinical risk management, Taylor & Francis Ltd, New Zealand, New Zealand, doi:10.2147/TCRM.S1274, (20080201), pages 117 - 128, Therapeutics and clinical risk management, URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2503647/pdf/tcrm-0401-117.pdf, (20211022), XP055854098
OPPOSITION- K.-E. ANDERSSON et al., "Bladder Pharmacology and Treatment of Lower Urinary Tract Symptoms: Recent Advances", UroToday International Journal, (20080800), vol. 1, no. 2, XP055854122

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