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EP2059232
European procedure
Extract from the Register of European Patents
EP About this file: EP2059232
| EP2059232 - USE OF POLYOLS TO OBTAIN STABLE POLYMORPHOUS FORMS OF RIFAXIMIN [Right-click to bookmark this link] | Status | The patent has been granted Status updated on 17.03.2017 Database last updated on 14.09.2024 | |
| Former | Grant of patent is intended Status updated on 18.12.2016 | Most recent event Tooltip | 13.12.2023 | Change - representative | Applicant(s) | For all designated states Alfasigma S.p.A. Via Ragazzi del '99, 5 40133 Bologna / IT | [N/P] |
| Former [2018/35] | For all designated states Alfasigma S.p.A. Via Ragazzi del '99 n. 5 40133 Bologna / IT | ||
| Former [2017/38] | For all designated states Alfasigma S.p.A. Viale Sarca, 223 20126 Milano / IT | ||
| Former [2009/21] | For all designated states ALFA WASSERMANN S.p.A. Via Enrico Fermi, 1 65020 Alanno (PE) / IT | Inventor(s) | 01 /
MAFFEI, Paola Via Ragazzi del '99 n. 5 I-40133 Bologna / IT | 02 /
BACHETTI, Milena Via Ragazzi del '99 n. 5 I-40133 Bologna / IT | 03 /
BOTTONI, Giuseppe Via Ragazzi del '99 n. 5 I-40133 Bologna / IT | 04 /
VISCOMI, Giuseppe, Claudio Via Ragazzi del '99 n. 5 I-40133 Bologna / IT | [2009/21] | Representative(s) | Kraus & Lederer PartGmbB Thomas-Wimmer-Ring 15 80539 München / DE | [N/P] |
| Former [2017/16] | Hiebl, Inge Elisabeth Kraus & Weisert Patentanwälte PartGmbB Thomas-Wimmer-Ring 15 80539 München / DE | ||
| Former [2009/21] | Hiebl, Inge Elisabeth Kraus & Weisert Patent- und Rechtsanwälte Thomas-Wimmer-Ring 15 80539 München / DE | Application number, filing date | 07804680.2 | 31.07.2007 | [2009/21] | WO2007IB02199 | Priority number, date | IT2006MI01692 | 05.09.2006 Original published format: IT MI20061692 | [2009/21] | Filing language | EN | Procedural language | EN | Publication | Type: | A1 Application with search report | No.: | WO2008029208 | Date: | 13.03.2008 | Language: | EN | [2008/11] | Type: | A1 Application with search report | No.: | EP2059232 | Date: | 20.05.2009 | Language: | EN | The application published by WIPO in one of the EPO official languages on 13.03.2008 takes the place of the publication of the European patent application. | [2009/21] | Type: | B1 Patent specification | No.: | EP2059232 | Date: | 19.04.2017 | Language: | EN | [2017/16] | Search report(s) | International search report - published on: | EP | 13.03.2008 | Classification | IPC: | A61K9/16, A61K9/20, A61K9/50, A61K31/437, A61K9/28, A61K47/10, A61K47/26, A61K47/36, A61K47/38 | [2009/21] | CPC: |
C07D491/22 (EP,US);
A61K9/16 (NO);
C07D498/22 (KR);
A61K31/437 (EP,KR,NO,US);
A61K31/44 (KR);
A61K47/10 (EP,US);
A61K47/26 (EP,NO,US);
A61K47/36 (NO);
A61K9/1617 (US);
A61K9/1623 (US);
A61K9/1652 (US);
A61K9/20 (NO);
A61K9/2013 (US);
A61K9/2054 (US);
A61K9/2081 (EP,US);
A61K9/28 (NO,US);
A61K9/50 (NO);
A61K9/501 (EP,US);
A61K9/5015 (EP,US);
A61K9/5026 (EP,US);
A61P31/00 (EP);
| Designated contracting states | AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MT, NL, PL, PT, RO, SE, SI, SK, TR [2017/16] |
| Former [2009/21] | AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MT, NL, PL, PT, RO, SE, SI, SK, TR | Extension states | AL | 05.03.2009 | BA | 05.03.2009 | HR | 05.03.2009 | MK | 05.03.2009 | RS | 05.03.2009 | Title | German: | VERWENDUNG VON POLYOLEN ZUM ERHALT VON STABILEN POLYMORPHEN FORMEN VON RIFAMIXIN | [2009/21] | English: | USE OF POLYOLS TO OBTAIN STABLE POLYMORPHOUS FORMS OF RIFAXIMIN | [2009/21] | French: | UTILISATION DE POLYOLS POUR OBTENIR DES FORMES POLYMORPHES STABLES DE RIFAXIMINE | [2009/21] | Entry into regional phase | 05.03.2009 | National basic fee paid | 05.03.2009 | Designation fee(s) paid | 05.03.2009 | Examination fee paid | Examination procedure | 10.03.2008 | Request for preliminary examination filed International Preliminary Examining Authority: EP | 05.03.2009 | Examination requested [2009/21] | 17.10.2011 | Amendment by applicant (claims and/or description) | 17.07.2012 | Communication of intention to grant the patent | 10.10.2012 | Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO | 16.01.2013 | Despatch of a communication from the examining division (Time limit: M04) | 25.03.2013 | Reply to a communication from the examining division | 17.11.2014 | Despatch of a communication from the examining division (Time limit: M04) | 12.01.2015 | Reply to a communication from the examining division | 20.03.2015 | Observations by third parties | 23.06.2015 | Despatch of a communication from the examining division (Time limit: M04) | 07.10.2015 | Reply to a communication from the examining division | 19.01.2016 | Observations by third parties | 02.05.2016 | Observations by third parties | 27.10.2016 | Cancellation of oral proceeding that was planned for 15.11.2016 | 15.11.2016 | Date of oral proceedings (cancelled) | 15.11.2016 | Observations by third parties | 21.11.2016 | Observations by third parties | 19.12.2016 | Communication of intention to grant the patent | 02.03.2017 | Fee for grant paid | 02.03.2017 | Fee for publishing/printing paid | 02.03.2017 | Receipt of the translation of the claim(s) | Divisional application(s) | EP17157159.9 / EP3187174 | The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is 17.07.2012 | Opposition(s) | Opponent(s) | 01
18.01.2018
24.01.2018
ADMISSIBLE ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. ul. Pelplinska 19 83-200 Starogard Gdanski / PL Opponent's representative Isarpatent Patent- und Rechtsanwälte Barth Charles Hassa Peckmann & Partner mbB Friedrichstrasse 31 80801 München / DE | 02
19.01.2018
25.01.2018
ADMISSIBLE Sandoz GmbH Biochemiestrasse 10 6250 Kundl / AT Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | 03
19.01.2018
25.01.2018
ADMISSIBLE PENTAFARMA, Sociedade Técnico-Medicinal, SA Rua da Tapada Grande, n° 2 Abrunheira 2710-089 Sintra / PT Opponent's representative Patentree, et al, et al Edificio Net Rua de Salazares, 842 4149-002 Porto / PT | [N/P] |
| Former [2021/20] | |||
| Opponent(s) | 01
18.01.2018
24.01.2018
ADMISSIBLE ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. ul. Pelplinska 19 83-200 Starogard Gdanski / PL Opponent's representative Isarpatent Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann & Partner mbB Friedrichstrasse 31 80801 München / DE | ||
| 02
19.01.2018
25.01.2018
ADMISSIBLE Sandoz GmbH Biochemiestrasse 10 6250 Kundl / AT Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
| 03
19.01.2018
25.01.2018
ADMISSIBLE PENTAFARMA, Sociedade Técnico-Medicinal, SA Rua da Tapada Grande, n° 2 Abrunheira 2710-089 Sintra / PT Opponent's representative Patentree, et al, et al Edificio Net Rua de Salazares, 842 4149-002 Porto / PT | |||
| Former [2018/09] | |||
| Opponent(s) | 01
18.01.2018
24.01.2018
ADMISSIBLE ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. ul. Peplinska 19 83-200 Starogard Gdanski / PL Opponent's representative Isarpatent Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann & Partner mbB Friedrichstrasse 31 80801 München / DE | ||
| 02
19.01.2018
25.01.2018
ADMISSIBLE Sandoz GmbH Biochemiestrasse 10 6250 Kundl / AT Opponent's representative Ter Meer Steinmeister & Partner, et al, et al Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | |||
| 03
19.01.2018
25.01.2018
ADMISSIBLE PENTAFARMA, Sociedade Técnico-Medicinal, SA Rua da Tapada Grande, n° 2 Abrunheira 2710-089 Sintra / PT Opponent's representative Patentree, Lda., et al, et al Rua de Salazares 842 4149-002 Porto / PT | |||
| Former [2018/08] | |||
| Opponent(s) | 01
18.01.2018
ADMISSIBLE ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. ul. Peplinska 19 83-200 Starogard Gdanski / PL Opponent's representative Isarpatent Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann & Partner mbB Friedrichstrasse 31 80801 München / DE | 07.02.2018 | Invitation to proprietor to file observations on the notice of opposition | 01.06.2018 | Reply of patent proprietor to notice(s) of opposition | 24.01.2019 | Date of oral proceedings | 04.04.2019 | Despatch of minutes of oral proceedings | 28.02.2023 | Date of oral proceedings | 30.03.2023 | Despatch of minutes of oral proceedings | 30.03.2023 | Despatch of communication that the patent will be revoked | Appeal following opposition | 15.05.2019 | Appeal received No. T1406/19 | 01.08.2019 | Statement of grounds filed | 03.05.2022 | Result of appeal procedure: continuation of opposition procedure | 18.05.2022 | Despatch of the decision of the Board of Appeal | Fees paid | Renewal fee | 28.07.2009 | Renewal fee patent year 03 | 29.07.2010 | Renewal fee patent year 04 | 29.07.2011 | Renewal fee patent year 05 | 24.07.2012 | Renewal fee patent year 06 | 24.07.2013 | Renewal fee patent year 07 | 23.07.2014 | Renewal fee patent year 08 | 24.07.2015 | Renewal fee patent year 09 | 22.07.2016 | Renewal fee patent year 10 |
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| Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court. | Cited in | International search | [Y]EP1676847 (ALFA WASSERMANN SPA [IT]) [Y] 1-15 * claims 11-15 * * paragraphs [0048] - [0050] *; | [PA]WO2006094737 (ALFA WASSERMANN SPA [IT], et al) [PA] 1-15 * claims 8,9 * * examples 1,3,4 ** page 8, lines 22-26 *; | [Y] - KIBBE ARTHUR H., Handbook of Pharmaceutical Excipients, USA, AMERICAN PHARMACEUTICAL ASSOCIATION AND PHARMACEUTICAL PRESS, (2000), XP002461298 [Y] 1-15 * page 165, item 6 page 442, item 6 * | [Y] - URESTI R M ET AL, "Effect of sugars and polyols on the functional and mechanical properties of pressure-treated arrowtooth flounder (Atheresthes stomias) proteins", FOOD HYDROCOLLOIDS, ELSEVIER, (200511), vol. 19, no. 6, ISSN 0268-005X, pages 964 - 973, XP004932158 [Y] 1-15 * page 971, right-hand column, last paragraph - page 972, left-hand column, first paragraph * DOI: http://dx.doi.org/10.1016/j.foodhyd.2004.12.006 | [Y] - LI Q ET AL, "Solvothermal growth of vaterite in the presence of ethylene glycol, 1,2-propanediol and glycerin", JOURNAL OF CRYSTAL GROWTH, NORTH-HOLLAND PUBLISHING, AMSTERDAM, NL, (200203), vol. 236, no. 1-3, ISSN 0022-0248, pages 357 - 362, XP004339690 [Y] 1-15 * page 362, column LEFT, paragraph LAST * DOI: http://dx.doi.org/10.1016/S0022-0248(01)02130-3 | Examination | - SPC (Summary of product characteristics) of the market product Normix in Italy. | - SPC (Summary of product characteristics) of the market product Normix in Czech. | Opposition | WO2005000123 | WO2005044823 | WO2006094737 | EP1874273 | EP0155421 | EP0547294 | EP0616808 | US2002107200 | US2005101598 | US2005272754 | GB2079270 | EP1557421 | WO2006008512 | EP1676847 | ITMI20061692 | WO2008029208 | EP2059232 | - G. C. VISCOMI et al., "Crystal forms of rifaximin and their effect on pharmaceutical properties", CrystEngComm, (20080000), vol. 10, pages 1074 - 1081, XP009152378 DOI: http://dx.doi.org/10.1039/B717887E | - Partial EN translation of TM8 | - "kapitel 1 and 9", W. A. RITSCHEL, der pharmazeutische betrieb, (20020000), page 28,584, XP055454514 | - SPC of Normix in the Czech Republic, (20030000), XP055360378 | - "Cyclodextrins", Raymond c rowe et al, Handbook of Pharmaceutical excipients, (20060000), pages 217 - 221, XP055454518 | - URESTI et al., "Effect of sugars and polyols on the functional and mechanical properties...", Food Hydrocolloids, (20050000), vol. 19, no. 6, pages 964 - 973, XP004932158 DOI: http://dx.doi.org/10.1016/j.foodhyd.2004.12.006 | - LI Q. ET AL, "Solvothermal growth of vaterite in the presence of ethylene glycol, 1,2-propanediol and glycerin", Journal of Crystal Growth, (20020000), vol. 236, pages 357 - 362, XP004339690 DOI: http://dx.doi.org/10.1016/S0022-0248(01)02130-3 | - Viscomi G C et al, "Crystal forms of rifaximin and their effect on pharmaceutical properties", CrystEngComm, (20080000), vol. 10, pages 1074 - 1081, XP009152378 DOI: http://dx.doi.org/10.1039/B717887E | - "Rifaximin", Wikipedia, (20171231), XP055454521 | - "Cellulose", Wikipedia, (20180107), XP055454522 | - ICH Expert Working Group, "ICH HARMONISED TRIPARTITE GUIDELINE - SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES Q6A", INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE, (19991006), XP055268664 |