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Extract from the Register of European Patents

EP About this file: EP3287447

EP3287447 - SALTS OR CO-CRYSTALS OF 3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL [Right-click to bookmark this link]
StatusExamination is in progress
Status updated on  12.02.2019
Database last updated on 20.05.2024
FormerRequest for examination was made
Status updated on  31.08.2018
FormerThe application has been published
Status updated on  26.01.2018
Most recent event   Tooltip14.05.2024New entry: Reply to examination report 
Applicant(s)For all designated states
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen / DE
[2018/09]
Inventor(s)01 / GRUSS, Michael
Hermannstrasse 8
52062 Aachen / DE
02 / KRASZEWSKI, Magda
Alfonsstrasse 38
52070 Aachen / DE
 [2018/09]
Representative(s)Kutzenberger Wolff & Partner
Waidmarkt 11
50676 Köln / DE
[N/P]
Former [2018/09]Kutzenberger Wolff & Partner
Theodor-Heuss-Ring 23
50668 Köln / DE
Application number, filing date17191453.422.07.2011
[2018/09]
Priority number, dateEP2010000767223.07.2010         Original published format: EP 10007672
[2018/09]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP3287447
Date:28.02.2018
Language:EN
[2018/09]
Search report(s)(Supplementary) European search report - dispatched on:EP04.01.2018
ClassificationIPC:C07D275/06, C07D291/06, C07C215/54, A61K31/137, C07D239/545, C07C59/255
[2018/09]
CPC:
C07D275/06 (EP,US); C07C215/54 (EP,CN,KR,US); A61K31/137 (EP,KR,US);
A61P25/04 (EP); C07C53/08 (EP); C07C53/126 (EP);
C07C55/02 (EP,US); C07C55/06 (EP); C07C55/08 (EP,CN,US);
C07C55/10 (EP); C07C55/20 (EP,CN,US); C07C57/12 (EP);
C07C57/145 (EP); C07C57/15 (EP,CN,US); C07C57/44 (EP);
C07C59/08 (EP); C07C59/105 (EP); C07C59/11 (EP);
C07C59/245 (EP); C07C59/255 (EP,KR); C07C59/265 (EP);
C07C59/285 (EP); C07C63/06 (EP); C07C63/08 (EP,US);
C07C63/36 (EP,US); C07C65/03 (EP); C07C65/11 (EP,CN,US);
C07C69/78 (EP,CN); C07D213/80 (EP,CN,US); C07D239/545 (EP,US);
C07D291/06 (EP,US); A61K31/455 (EP,US); C07B2200/07 (EP,US);
C07B2200/13 (CN) (-)
Designated contracting statesAL,   AT,   BE,   BG,   CH,   CY,   CZ,   DE,   DK,   EE,   ES,   FI,   FR,   GB,   GR,   HR,   HU,   IE,   IS,   IT,   LI,   LT,   LU,   LV,   MC,   MK,   MT,   NL,   NO,   PL,   PT,   RO,   RS,   SE,   SI,   SK,   SM,   TR [2018/40]
Former [2018/09]AL,  AT,  BE,  BG,  CH,  CY,  CZ,  DE,  DK,  EE,  ES,  FI,  FR,  GB,  GR,  HR,  HU,  IE,  IS,  IT,  LI,  LT,  LU,  LV,  MC,  MK,  MT,  NL,  NO,  PL,  PT,  RO,  RS,  SE,  SI,  SK,  SM,  TR 
TitleGerman:SALZE ODER KOKRISTALLE AUS 3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)PHENOL[2018/09]
English:SALTS OR CO-CRYSTALS OF 3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL[2018/09]
French:SELS OU CO-CRISTAUX DE 3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)- PHÉNOL[2018/09]
Examination procedure15.09.2017Date on which the examining division has become responsible
27.08.2018Amendment by applicant (claims and/or description)
28.08.2018Examination requested  [2018/40]
15.02.2019Despatch of a communication from the examining division (Time limit: M06)
26.04.2019Observations by third parties
08.08.2019Reply to a communication from the examining division
20.11.2019Despatch of a communication from the examining division (Time limit: M11)
11.08.2020Observations by third parties
26.10.2020Reply to a communication from the examining division
20.11.2020Observations by third parties
18.12.2020Observations by third parties
21.01.2021Despatch of a communication from the examining division (Time limit: M04)
19.05.2021Observations by third parties
31.05.2021Reply to a communication from the examining division
10.11.2021Observations by third parties
12.07.2022Despatch of a communication from the examining division (Time limit: M08)
20.03.2023Observations by third parties
14.04.2023Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time
23.06.2023Reply to a communication from the examining division
16.11.2023Despatch of a communication from the examining division (Time limit: M06)
13.05.2024Reply to a communication from the examining division
Parent application(s)   TooltipEP11743775.6  / EP2595971
Divisional application(s)EP19191640.2  / EP3597628
EP19206638.9  / EP3636629
EP19214270.1  / EP3650439
EP19214275.0  / EP3656765
EP19215642.0  / EP3653600
EP20204993.8  / EP3800179
Request for further processing for:The application is deemed to be withdrawn due to failure to reply to the examination report
23.06.2023Request for further processing filed
23.06.2023Full payment received (date of receipt of payment)
Request granted
30.06.2023Decision despatched
Fees paidRenewal fee
15.01.2018Renewal fee patent year 03
15.01.2018Renewal fee patent year 04
15.01.2018Renewal fee patent year 05
15.01.2018Renewal fee patent year 06
15.01.2018Renewal fee patent year 07
11.07.2018Renewal fee patent year 08
15.07.2019Renewal fee patent year 09
14.07.2020Renewal fee patent year 10
15.07.2021Renewal fee patent year 11
15.06.2022Renewal fee patent year 12
14.06.2023Renewal fee patent year 13
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Documents cited:Search[I]EP0693475  (GRUENENTHAL GMBH [DE]) [I] 1-16 * examples 24,25; claims 1-10 *;
 [X]WO02067651  (GRUENENTHAL GMBH [DE], et al) [X] 1,6-16 * example 1; claims 1,12,22-39 *;
 [A]WO2008110323  (GRUENENTHAL GMBH [DE], et al) [A] 1-16 * page 28; claims 1-8 *;
 [A]WO2009067703  (NECTID INC [US], et al) [A] 1-16* claims 1,2,18-25 *
by applicantEP0693475
 EP1439829
    - CHEMICAL ABSTRACTS, Database accession no. 175591-23-8
otherUS6248737
 US6696496
 US2005176790
 USRE39593E
 US7569610
 EP0693475
 EP0693475
 US6344558
 US2005058706
 WO2006034451
 WO2007067727
 EP1612203
 WO2007144005
 WO2008021559
 US2008269326
 WO2009007853
 WO2012010316
 EP2595971
    - PHILIP L. GOULD, "Salt selection for basic drugs", International Journal of Pharmaceutics, (19860000), vol. 33, pages 201 - 217, XP002074725

DOI:   http://dx.doi.org/10.1016/0378-5173(86)90055-4
    - Anonymous, "Highlights of Prescribing Information on Tradename™ (tapentadol)", Ortho-McNeil-Janssen Pharmaceuticals, Inc., (200811), pages 1 - 27, XP055764961
    - David Lee, Suresh Doddapaneni, "APPLICATION NUMBER: 22-304 Clinical Pharmacology and Biopharmaceutics Review(s)", Centre for Drug Evaluation and Research, (20080930), pages 1 - 147, XP055764971
    - ABU T.M. SERAJUDDIN, "Salt formation to improve drug solubility", Advanced Drug Delivery Reviews, (20070000), vol. 59, doi:10.1016/j.addr.2007.05.010, pages 603 - 616, XP022211982

DOI:   http://dx.doi.org/10.1016/j.addr.2007.05.010
    - Steffen Paulekuhn G; Jennifer B Dressman; Christoph Saal, "Trends in Active Pharmaceutical Ingredient Salt Selection based on Analysis of the Orange Book Database", J. Med. Chem., (20070000), vol. 50, doi:10.1021/jm701032y, pages 6665 - 6672, XP055536811

DOI:   http://dx.doi.org/10.1021/jm701032y
    - JIE LU, Sohrab Rohani, "Polymorphism and Crystallization of Active Pharmaceutical Ingredients (APIs)", Current Medicinal Chemistry, (20090000), vol. 16, no. 7, pages 884 - 905, XP055764976
    - EXHIBIT-E1 Evidence Affidavit with Experimental Data for Repition of Prior Art process.pdf
    - David Lee, Suresh Doddapaneni, "APPLICATION NUMBER: 22-304 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S)", CENTER FOR DRUG EVALUATION AND RESEARCH, (20080930), pages 1 - 147, XP055764971
    - G Steffen Paulekuhn et al, "Trends in Active Pharmaceutical Ingredient Salt Selection based on Analysis of the Orange Book Database", Journal of Medicinal Chemistry, American Chemical Society, US, US , (20071227), vol. 50, no. 26, doi:10.1021/jm701032y, ISSN 0022-2623, pages 6665 - 6672, XP002651069

DOI:   http://dx.doi.org/10.1021/jm701032y
    - JIE LUSOHRAB ROHANI, "Polymorphism and Crystallization of Active Pharmaceutical Ingredients (APIs", Current Medicinal Chemistry, (20090000), vol. 16, pages 884 - 905, XP055764976
    - Anonymous, "Regulatory Classification of Pharmaceutical Co-Crystals Guidance for Industry", U.S. Department of Health and Human Services Food and Drug Administration, (20180201), pages 1 - 4, XP055814449
    - Anonymous, "Nucynta®ER Highlights of Prescribing Information", U.S. food and Dug Administration, (2008), page 34pp
    - David Lee; Suresh Doddapaneni, "APPLICATION NUMBER: 22-304 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S)", CENTER FOR DRUG EVALUATION AND RESEARCH, (20080930), pages 1-3, 10 - 11, XP055764971
    - G. STEFFEN PAULEKUHN et al., "Trends in Active Pharmaceutical Ingredient Salt Selection based on Analysis of the Orange Book Database", J. Med. Chem., (20070000), vol. 50, doi:10.1021/jm701032y, pages 6665 - 6672, XP055536811

DOI:   http://dx.doi.org/10.1021/jm701032y
    - JIE LUSOHRAB ROHANI, "Polymorphism and Crystallization of Active Pharmaceutical Ingredients (APIs)", Current Medicinal Chemistry, (20090000), vol. 16, pages 884 - 905, XP055764976
    - Anonymous, "Regulatory Classification of Pharmaceutical Co-Crystals Guidance for Industry", U.S. Department of Health and Human Services Food and Drug Administration, (20180200), pages 1 - 4, XP055814449
The EPO accepts no responsibility for the accuracy of data originating from other authorities; in particular, it does not guarantee that it is complete, up to date or fit for specific purposes.