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Composition For Nasal Application With Improved Stability - EP2818163

The patent EP2818163 was granted to Maria Clementine Martin Klosterfrau Vertriebsgesellschaft on Jun 26, 2024. The application was originally filed on Sep 25, 2012 under application number EP14182601A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2818163

MARIA CLEMENTINE MARTIN KLOSTERFRAU VERTRIEBSGESELLSCHAFT
Application Number
EP14182601A
Filing Date
Sep 25, 2012
Status
Granted And Under Opposition
May 24, 2024
Grant Date
Jun 26, 2024
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (4)

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KRKAMar 26, 2025KUTZENBERGER WOLFF & PARTNERADMISSIBLE
HAMM & WITTKOPPMar 20, 2025HAMM & WITTKOPPADMISSIBLE
RATIOPHARMFeb 26, 2025DORRIESADMISSIBLE
RATIOPHARMFeb 26, 2025DORRIES, HANS ULRICH , DF-MP DORRIES FRANK-MOLNIA & POHLMANADMISSIBLE

Patent Citations (16) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONDE10337186
DESCRIPTIONDE10356248
DESCRIPTIONDE19541919
DESCRIPTIONDE19549421
DESCRIPTIONEP1663141
DESCRIPTIONWO2005018601
OPPOSITIONCN101756964
OPPOSITIONEP0773022
OPPOSITIONWO2010015253
OPPOSITIONWO2013097911
OTHEREP0773022
SEARCHDE10000612
SEARCHDE202008012494U
SEARCHEP0773022
SEARCHEP1532986
SEARCHWO2005018601

Non-Patent Literature (NPL) Citations (45) 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- RÖMPP Lexikon Chemie, GEORG-THIEME-VERLAG, (1998), vol. 4, pages 3230 - 3232-
DESCRIPTION- RÖMPP Lexikon Chemie, GEORG-THIEME-VERLAG, (1998), vol. 5, pages 3618 - 3619-
OPPOSITION- Anonymous, "Dexpanthenol", European Pharmacopoeia 7.0, (20080101), pages 1815 - 1816, XP093267990-
OPPOSITION- Anonymous, "Dexpanthenolum", EUROPEAN PHARMACOPOEIA 11.1, (20230401), pages 4663 - 4664, XP093267979-
OPPOSITION- Anonymous, "Fachinformation ", Nasic, (20120201), pages 1 - 2, XP093267671-
OPPOSITION- Anonymous, "ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products ", EMA - European Medicines Agecny, (20030801), pages 1 - 20, EMA - European Medicines Agecny , URL: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-r2-stability-testing-new-drug-substances-and-products-step-5_en.pdf, (20250407), XP093267654-
OPPOSITION- Anonymous, "Nasic Nasenspray", Nasic, (20100301), pages 1 - 2, XP093268985-
OPPOSITION- Anonymous, "Nasic - Nasic für Kinder", Rote Liste 2005 - Arzneimittelverzeichnis für Deutschland (einschließlich EU-Zulassungen und bestimmter Medizinprodukte), ECV - Edito Cantor Verlag , (20050101), pages 1 - 2, XP093268023-
OPPOSITION- Anonymous, "Nasic O.K Nasenspray ", Nasic - Gebrauchsinformation, (20110601), pages 1 - 4, XP093268991-
OPPOSITION- Anonymous, "Passage ; Arzneiformenlehre", Arzneiformenlehre - Ein Lehrbuch der Galenik für Theorie und Praxis, Stuttgart, Deutscher Apotheker Verlag, (19980101), pages 241 - 243, ISBN 978-3-7692-2254-8, XP093268043-
OPPOSITION- Anonymous, "Passage; Europaisches Arzneibuch - 7. Ausgabe Grundwerk 2011 Band 2 Monographien A-J", Europaisches Arzneibuch - 7. Ausgabe Grundwerk 2011 Band 2 Monographien A-J, Germany, Deutscher Apotheker Verlag, (20110101), pages 2717 - 2718, XP093268938-
OPPOSITION- Anonymous, "Passage ; Formel­ sammlung Pharmazie - für Studium und Beruf", Anonymous, Heiko A. Schiffter, Andreas S. Ziegler, Formel­ sammlung Pharmazie für Studium und Beruf, Stuttgart, Wissenschaftliche Verlagsgesellschaft, (20130101), pages 200 - 200, ISBN 978-3-8047-3012-0, XP093268700-
OPPOSITION- Anonymous, "Passage: Hagers andbuch der Pharmazeutischen Praxis 5 vollständig neubearbeitete Auflage", Europäisches Arzneibuch - 7. Ausgabe Grundwerk 2011 Band 7 Monographien K-Z, Deutscher Apotheker Verlag, (20110101), pages 1231 - 1234, ISBN 978-3-7692-5360-3, XP093268928-
OPPOSITION- Anonymous, "Passage ; Hagers andbuch der Pharmazeutischen Praxis 5 - vollständig neubearbeitete Auflage -Stoffe P-Z", Hagers andbuch der Pharmazeutischen Praxis 5 - vollständig neubearbeitete Auflage -Stoffe P-Z, Springer-Verlag, (19940101), pages 1217 - 1219, XP093268132-
OPPOSITION- Anonymous, "Passage ; Pharmazeutische Technologie - Mit Einführung in die Biopharmazie", Anonymous, Bauer Kurt H , Frömming Karl-Heinz , Führe Claus, Pharmazeutische Technologie - Mit Einführung in die Biopharmazie, Stuttgart, Wissenschaftliche Verlagsgesellschaft, (20120101), pages 718 - 720, ISBN 978-3-8047-2552-2, XP093268966-
OPPOSITION- Anonymous, "Passage; Rechentafeln für die Chemische Analytik", Formel­ sammlung Pharmazie - für Studium und Beruf, Stuttgart, Wissenschaftliche Verlagsgesellschaft, (19850101), pages 1 - 4, ISBN 978-3-8047-3012-0, XP093268709-
OPPOSITION- Anonymous, "Passage; The Extra Pharmacopoeia Incorporating Squire’s Companion", Anonymous, Wade Ainley, The Extra Pharmacopoeia Incorporating Squire’s Companion, The Pharmaceutical Press , The Pharmaceutical Press, (19770101), pages 1682 - 1682, XP093268932-
OPPOSITION- Anonymous, "Passage ; Vademecum fur Pharmazeuten ", Vademecum fur Pharmazeuten , Germany, Deutscher Apotheker Verlag, (20130101), pages 137 - 138, ISBN 978-3-7692-5307-8, XP093268058-
OPPOSITION- Anonymous, "Rhinologika/Sinusitismittel ", ROTE LISTE 2011 - Arzneimittelinformationen für Deutschland (einschließlich EU-Zulassungen und bestimmter Medizinprodukte), (20110101), pages 1601 - 1601, ISBN 978-3-939192-50-3, XP093268019-
OPPOSITION- Anonymous, "Sympathomimetics", Anonymous, Kathleen Parfitt, MARTINDALE The Extra Pharmacopoeia - Twenty-ninth Edition, London, The Pharmaceutical Press , (19890101), pages 1486 - 1486, XP093268137-
OPPOSITION- Anonymous, "Xylometazoline Hydrochloride", European Pharmacopoeia 11.0, (20080101), pages 4409 - 4410, XP093267973-
OPPOSITION- Anonymous, "Xylometazolinhydrochlorid Xylometazolini hydrochloridum", Europäisches Arzneibuch - 7. Ausgabe Grundwerk 2011 Band 7 Monographien K-Z, Germany, Deutscher Apotheker Verlag, (20110101), pages 4813 - 4814, ISBN 978-3-7692-5360-3, XP093268673-
OPPOSITION- Anoonymous, Leiter, Forschungsabteilung Pharmazeutischen, Hoffmann F, Roche La, Co & Ag, In Basel Pharmazie, Am Phar, , "Passage ; Galenisches Praktikum", Anoonymous, Leiter, Forschungsabteilung Pharmazeutischen, Hoffmann F, Roche La, Co & Ag, In Basel Pharmazie, Am Phar, , Münzel Kurt , Jakob Büchi , Schulz Otto-Erich, Galenisches Praktikum, Stuttgart , Wissenschaftliche Verlagsgesellschaft, (19590101), pages 118 - 121, XP093268685-
OPPOSITION- Claudia Sikora, "Einfluss von Rezepturverbesserungen auf die Zytotoxizität von Nasalia", (20040101), URL: http://ub-ed.ub.uni-greifswald.de/opus/volltexte/2006/128/pdf/sikora_claudia.pdf, (20140319), XP055108889-
OPPOSITION- D12 - Excerpt from Laboratory Journal describing pH determination of the product “Nasic”-
OPPOSITION- D30 - Patient leaflet corresponding to Russian registration number ЛП-000985-
OPPOSITION- D31 - Rules for maintaining the State Register of Medicinal Products as of August 31, 2010-
OPPOSITION- D32 - State Register of Medicines, Registration certificate LP-000985 number, Registration date 18.10.2011-
OPPOSITION- D33 - Preparation of a solution according to the composition of K02 and determination of pH value and osmolality-
OPPOSITION- D34 - Declaration of conformity signed by Klosterfrau Berlin for Nasic® as registered in Russia-
OPPOSITION- D36 - Invoice of the "Inter Apotheke" for purchase of the commercial product Nasic-
OPPOSITION- D38 - Excerpt from a laboratory journal, page 199 describing the experiments undertaken on July 26, 2011 with the commercial Nasic® O.K. formulation for determining the sodium and potassium content-
OPPOSITION- D39 - Excerpt from a laboratory journal, page 160 describing the experiments undertaken on July 21, 2011 with the commercial Nasic® O.K. formulation for determining the pH value and the osmolality-
OPPOSITION- D8 - European Search Opinion relating to the Opposed Patent-
OPPOSITION- D9 - Third Party Observation filed by Kutzenberger Wolff & Partner dated November 30, 2022-
OPPOSITION- Gharehbach R K, Ebel S, "Stabilitätsanalytik von Dexpanthenol, 1.: HPLC-Bestimmung von Dexpanthenol, Pantolacton und Pantosäure", Pharmazie, (19950101), vol. 50, pages 39 - 40, XP093268941-
OPPOSITION- Sikora Claudia , "Einfluss von Rezepturverbesserungen auf die zytotoxizät von Nasalia", Doctoral Thesis, (20060714), pages 1 - 116, XP093268973-
OPPOSITION- Troy David B, Allen Loyd V, Popovich Nicholas G, "Chapter 17 • Special Solutions and Suspensions ", Troy David B, Allen Loyd V, Popovich Nicholas G, Loyd V. Allen, Nicholas G. Popovich , Howard C Ansel, Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems Eight edition , Philadelphia , Lippincott Williams & Wilkins , (20050101), pages 558 - 559, XP093268047-
OPPOSITION- W. Kehrl , U. Sonnemann , U. Dethlefsen, "fortschritt in der therapie der akuten rhinitis", Laryngo-Rhino-Otol, (20030101), pages 266 - 271, XP055306938-
OPPOSITION- Rubinf Saul H, "The Comparative Stability of Pantothenic Acid and Panthenol ", Journal of the American Pharmaceutical Association, (19481201), vol. 37, no. 12, doi:10.1002/jps.3030371208, pages 502 - 504, XP093268946
OTHER- Anonymous, "Fachinformation - nasic®", Rote Liste Service GmbH, (201202), pages 1 - 2, XP055808508-
OTHER- Anonymous, "ИНСТРУКЦИЯ по применению лекарственного препарата для медицинского применения Назик /INSTRUCTIONS on the use of a medicinal product for medical use NAZIK nasal spray dosed 5 mg + 0.1 mg / dose/", МИНИСТЕРСТВО ЗДРАВООХРАНЕНИЯ И СОЦИАЛЬНОГО РАЗВИТИЯ РОССИЙСКОЙ ФЕДЕРАЦИИ /MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION/, (20111018), pages 1 - 7-
OTHER- D. SCHERTLE, Buch 25, (20090420), page 138-
SEARCH- Cassella Med, "nasic f�r Kinder", (20080601), pages 1 - 2, URL: http://shop.schwan-apotheke.de/media/beipackzettel/1356124.pdf, (20121017), XP055041369 [X] 1-15 * paragraph [2 and 6.1] *-
SEARCH- Claudia Sikora, "Einfluss von Rezepturverbesserungen auf die Zytotoxizit�t von Nasalia", (20060714), URL: http://ub-ed.ub.uni-greifswald.de/opus/volltexte/2006/128/pdf/sikora_claudia.pdf, (20140319), XP055108889 [X] 1-15 * page 13 - page 16 * * page 106 - page 107 *-

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