Extract from the Register of European Patents

About this file: EP1381346

EP1381346 - PHARMACEUTICAL COMPOSITIONS CONTAINING FORMOTEROL [Right-click to bookmark this link]
Former [2004/04]AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO THE LUNGS VIA NEBULIZATION
[2015/04]
StatusThe patent has been granted
Status updated on  11.02.2018
Database last updated on 09.12.2019
Most recent event   Tooltip29.05.2019Change: Date of oral proceedings 
29.05.2019Deletion: Despatch of minutes of oral proceedings 
Applicant(s)For all designated states
Mylan Specialty L.P.
2751 Napa Valley Corporate Drive
Napa, CA 94558 / US
[2015/47]
Former [2004/04]For all designated states
Dey L.P.
2751 Napa Valley Corporate Drive
Napa, CA 94558 / US
Inventor(s)01 / BANERJEE, Partha, S.
108 Rosario Court
San Ramon, CA 94583 / US
02 / PHAM, Stephen
5242 Abel Merrill Road, BLDG., 21
Columbus, OH 43221 / US
03 / CHAUDRY, Imtiaz, A.
76 Golden Gate Circle
Napa, CA 94558 / US
 [2009/20]
Former [2004/39]01 / BANERJEE, Partha, S.
108 Rosario Court
San Ramon, CA 94583 / US
02 / PHAM, Stephen
5242 Abel Merrill Road, BLDG., 21
Columbus, OH 43221 / US
03 / AKAPO, Samuel, O.
293 Shasta Drive, 115
Vacabille, CA 95687 / US
04 / CHAUDRY, Imtiaz, A.
76 Golden Gate Circle
Napa, CA 94558 / US
Former [2004/04]01 / BANERJEE, Partha, S.
108 Rosario Court
San Ramon, CA 94583 / US
02 / PHAM, Stephen
7950 Pocket Road, 40
Sacramento, CA 95831 / US
03 / AKAPO, Samuel, O.
293 Shasta Drive, 115
Vacabille, CA 95687 / US
04 / CHAUDRY, Imtiaz, A.
76 Golden Gate Circle
Napa, CA 94558 / US
Representative(s)Boult Wade Tennant LLP
Salisbury Square House
8 Salisbury Square
London EC4Y 8AP / GB
[N/P]
Former [2014/02]Boult Wade Tennant
Verulam Gardens
70 Gray's Inn Road
London WC1X 8BT / GB
Former [2004/04]Baldock, Sharon Claire , et al
BOULT WADE TENNANT, Verulam Gardens 70 Gray's Inn Road
London WC1X 8BT / GB
Application number, filing date02709742.728.02.2002
[2004/04]
WO2002US06240
Priority number, dateUS20010284606P17.04.2001         Original published format: US 284606 P
US2001088728122.06.2001         Original published format: US 887281
[2004/04]
Filing languageEN
Procedural languageEN
PublicationType: A2  Application without search report
No.:WO02083079
Date:24.10.2002
Language:EN
[2002/43]
Type: A2 Application without search report 
No.:EP1381346
Date:21.01.2004
Language:EN
The application has been published by WIPO in one of the EPO official languages on 24.10.2002
[2004/04]
Type: B1 Patent specification 
No.:EP1381346
Date:18.11.2015
Language:EN
[2015/47]
Search report(s)International search report - published on:EP13.02.2003
ClassificationInternational:A61K9/12, A61K9/72, A61K9/08, A61P11/08, A61K31/167
[2015/04]
Former International [2004/04]A61K7/00
Designated contracting statesAT,   BE,   CH,   CY,   DE,   DK,   ES,   FI,   FR,   GB,   GR,   IE,   IT,   LI,   LU,   MC,   NL,   PT,   SE,   TR [2015/47]
Former [2004/04]AT,  BE,  CH,  CY,  DE,  DK,  ES,  FI,  FR,  GB,  GR,  IE,  IT,  LI,  LU,  MC,  NL,  PT,  SE,  TR 
Extension statesAL30.07.2003
LT30.07.2003
LV30.07.2003
MK30.07.2003
RO30.07.2003
SI30.07.2003
TitleGerman:PHARMAZEUTISCHE ZUSAMMENSETZUNG ENTHALTEND FORMOTEROL[2015/04]
English:PHARMACEUTICAL COMPOSITIONS CONTAINING FORMOTEROL[2015/04]
French:COMPOSITIONS PHARMACEUTICALES COMPRENANT FORMOTEROL[2015/04]
Former [2004/04]AEROSOL ZUSAMMENSETZUNG ENTHALTEND FORMOTEROL ZUR VERABREICHUNG IN DIE LUNGEN VIA VERNEBUNG
Former [2004/04]AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO THE LUNGS VIA NEBULIZATION
Former [2004/04]COMPOSITIONS BRONCHODILATATRICES ET METHODES ASSOCIEES
Entry into regional phase30.07.2003National basic fee paid 
30.07.2003Designation fee(s) paid 
30.07.2003Examination fee paid 
Examination procedure31.07.2002Request for preliminary examination filed
International Preliminary Examining Authority: US
30.07.2003Examination requested  [2004/04]
17.12.2003Amendment by applicant (claims and/or description)
27.12.2006Despatch of a communication from the examining division (Time limit: M06)
03.07.2007Reply to a communication from the examining division
11.07.2011Despatch of a communication from the examining division (Time limit: M06)
05.01.2012Reply to a communication from the examining division
13.10.2014Despatch of a communication from the examining division (Time limit: M06)
10.12.2014Reply to a communication from the examining division
13.02.2015Communication of intention to grant the patent
31.07.2015Despatch of communication that the application is deemed to be withdrawn, reason: fee for grant / fee for printing not paid in time
08.10.2015Fee for grant paid
08.10.2015Fee for publishing/printing paid
08.10.2015Receipt of the translation of the claim(s)
Divisional application(s)The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is  27.12.2006
Opposition(s)Opponent(s)01  18.08.2016   
Teva Pharmaceutical Industries Ltd
5 Basel Street
P.O. Box 3190
49131 Petah Tiqva / IL
Opponent's representative
D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
 [2016/38]
23.09.2016Invitation to proprietor to file observations on the notice of opposition
03.02.2017Reply of patent proprietor to notice(s) of opposition
06.11.2017Date of oral proceedings
12.02.2018Despatch of minutes of oral proceedings
12.02.2018Despatch of communication that the patent will be revoked
Appeal following opposition20.04.2018Appeal received No.  T1025/18
22.06.2018Statement of grounds filed
07.04.2020Date of oral proceedings
Request for further processing for:The application is deemed to be withdrawn due to failure to fulfill actions required for granting the patent
08.10.2015Request for further processing filed
08.10.2015Full payment received (date of receipt of payment)
Request granted
20.10.2015Decision despatched
Fees paidRenewal fee
18.02.2004Renewal fee patent year 03
22.02.2005Renewal fee patent year 04
27.02.2006Renewal fee patent year 05
27.02.2007Renewal fee patent year 06
25.02.2008Renewal fee patent year 07
26.02.2009Renewal fee patent year 08
25.03.2010Renewal fee patent year 09
23.02.2011Renewal fee patent year 10
24.02.2012Renewal fee patent year 11
27.02.2013Renewal fee patent year 12
27.02.2014Renewal fee patent year 13
26.02.2015Renewal fee patent year 14
Penalty fee
Additional fee for renewal fee
28.02.201009   M06   Fee paid on   25.03.2010
Lapses during opposition  TooltipAT18.11.2015
CY18.11.2015
DK18.11.2015
FI18.11.2015
MC18.11.2015
TR18.11.2015
GR19.02.2016
IE28.02.2016
LU28.02.2016
CH29.02.2016
LI29.02.2016
[2018/33]
Former [2018/28]AT18.11.2015
CY18.11.2015
DK18.11.2015
FI18.11.2015
MC18.11.2015
GR19.02.2016
IE28.02.2016
LU28.02.2016
CH29.02.2016
LI29.02.2016
Former [2017/07]AT18.11.2015
DK18.11.2015
FI18.11.2015
MC18.11.2015
GR19.02.2016
IE28.02.2016
LU28.02.2016
CH29.02.2016
LI29.02.2016
Former [2016/46]AT18.11.2015
DK18.11.2015
FI18.11.2015
MC18.11.2015
GR19.02.2016
LU28.02.2016
CH29.02.2016
LI29.02.2016
Former [2016/43]AT18.11.2015
DK18.11.2015
FI18.11.2015
MC18.11.2015
GR19.02.2016
LU28.02.2016
Former [2016/42]AT18.11.2015
DK18.11.2015
FI18.11.2015
MC18.11.2015
GR19.02.2016
Former [2016/39]AT18.11.2015
DK18.11.2015
FI18.11.2015
GR19.02.2016
Former [2016/24]AT18.11.2015
FI18.11.2015
GR19.02.2016
Cited inInternational search[PX]WO0178745  (GLAXO GROUP LTD ;ROCHE TREVOR CHARLES (GB); GAVIN BRIAN CHARLES (I) [PX] 1-54 * the whole document * * claims 1-6,9,13,14 * * page 7, lines 14-17; example 9 *;
 [XD]US6150418  (HOCHRAINER DIETER ET AL) [XD] 1-54 * the whole document * * column 2, lines 24-28 * * column 2, line 34 * * column 3, line 38 * * column 3, lines 44,45 * * column 4, lines 55,56 * * examples 1-3; claims 1-22 *;
 [XD]US6040344  (HETT ROBERT ET AL) [XD] 1-54 * the whole document * * column 20, paragraph 1 *;
 [X]WO9925359  (MOLIN OVE ;ASTRA AB (SE); KARLSSON ANN KRISTIN (SE); LARRIVEE ELKI) [X] 1-54 * the whole document * * page 8, line 8 - page 10, line 3; examples 4,5; table 5 * * page 10, lines 24-31 *;
 [X]WO9531964  (GLAXO WELLCOME AUSTRALIA LTD ;TAINSH DAVID ALEXANDER (GB); ILOTT T) [X] 1-54 * the whole document * * examples 1,2; claims 1,8-16 *;
 [A]WO0000181  (KLYASHCHITSKY BORIS ;SAIDI ZAHIR (US); LDS TECHNOLOGIES INC (US)) [A] 1-54 * the whole document * * examples 1-12; claims 1-4,6,8,13-15 * * page 9, line 28 - page 10, line 23 *;
 [X]EP0370632  (FISONS PLC) [X] 15,30,40-44,46-49 * the whole document * * page 2, line 17 - page 3, line 8 *;
 [A]WO0023037  (BOEHRINGER INGELHEIM PHARMA ;HOCHRAINER DIETER (DE); ZIERENBERG BE) [A] 1-54 * the whole document * * page 9; claim 21 *
OppositionUS6040344
    - PÉREZ PUIGBÓ A. et al., "A NEW ALTERNATIVE THERAPY IN THE MANAGEMENT OF ACUTE ASTHMA(Preliminary Report)", Allergy Asthma and Inmunologia, (20000000), vol. 2, no. 2, pages 73 - 76, XP055399311
    - PÉREZ PUIGBÓ A. et al., "Nebulized Saline Solution of Dry Powder Formoterol is Useful for Acute Bronchospasm", Archivos Venezolanos de Farmacología y Terapéutica, (20010000), vol. 20, no. 2, pages 128 - 130, XP055399314
    - REDDI B.A.J., "Why Is Saline So Acidic (and Does It Really Matter?)", Int. J. Med. Sci., (20130000), vol. 10, no. 6, pages 747 - 750, XP055319041

DOI:   http://dx.doi.org/10.7150/ijms.5868
    - BEASLEY R. et al., "Adverse reactions to the non-drug constituents of nebuliser solutions", Br. J. clin. Pharmac., (19880000), vol. 25, pages 283 - 287, XP055399317

DOI:   http://dx.doi.org/10.1111/j.1365-2125.1988.tb03305.x
    - "Foradil", Center for Drug Evaluation and Research (CDER) as part of the U.S. Food and Drug Administration (FDA, (19980212), pages 1 - 29, XP055399319
    - "chapter38 Stability of Pharmaceutical Products·", Ellzobeth D Vodas,, Remington; The Science and Practice of Pharmacy, (19950000), pages 639 - 647, XP055399323
    - "formulating nebulizer and manufacture", AULTON M.E., Pharmaceutics: The Science of Dosage Form Design, (20011211), page 484, ISBN 9780443055171, XP055399325