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Extract from the Register of European Patents

EP About this file: EP3316868

EP3316868 - PHARMACEUTICAL FORMULATIONS COMPRISING TENOFOVIR AND EMTRICITABINE [Right-click to bookmark this link]
StatusOpposition rejected
Status updated on  26.08.2022
Database last updated on 05.10.2024
FormerThe patent has been granted
Status updated on  17.01.2020
FormerGrant of patent is intended
Status updated on  17.09.2019
FormerExamination is in progress
Status updated on  05.07.2019
FormerRequest for examination was made
Status updated on  06.04.2018
FormerThe international publication has been made
Status updated on  06.01.2017
Most recent event   Tooltip26.08.2022Opposition rejectedpublished on 28.09.2022  [2022/39]
Applicant(s)For all designated states
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404 / US
[2018/19]
Inventor(s)01 / KOZIARA, Joanna, M.
c/o Gilead Sciences Inc.
333 Lakeside Drive
Foster City, CA 94404 / US
02 / MCCALLISTER, Scott
c/o Gilead Sciences Inc.
333 Lakeside Drive
Foster City, CA 94404 / US
 [2018/19]
Representative(s)Carpmaels & Ransford LLP
One Southampton Row
London WC1B 5HA / GB
[2018/19]
Application number, filing date16739625.829.06.2016
[2018/19]
WO2016US40158
Priority number, dateUS201562187113P30.06.2015         Original published format: US 201562187113 P
US201662298373P22.02.2016         Original published format: US 201662298373 P
US201662301429P29.02.2016         Original published format: US 201662301429 P
US201662317286P01.04.2016         Original published format: US 201662317286 P
[2018/19]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2017004244
Date:05.01.2017
Language:EN
[2017/01]
Type: A1 Application with search report 
No.:EP3316868
Date:09.05.2018
Language:EN
The application published by WIPO in one of the EPO official languages on 05.01.2017 takes the place of the publication of the European patent application.
[2018/19]
Type: B1 Patent specification 
No.:EP3316868
Date:19.02.2020
Language:EN
[2020/08]
Search report(s)International search report - published on:EP05.01.2017
ClassificationIPC:A61K9/20, A61K9/24, A61K9/28, A61K31/513, A61K31/675, A61P31/18
[2019/41]
CPC:
A61K9/2054 (EP,KR,US); A61K9/0053 (EP,KR,US); A61K31/513 (EP,KR,US);
A61K31/675 (EP,KR,US); A61K9/2013 (KR,US); A61K9/209 (EP,KR,US);
A61K9/284 (KR,US); A61K9/2866 (EP,US); A61P31/18 (EP);
A61P43/00 (EP) (-)
C-Set:
A61K31/513, A61K2300/00 (EP,US);
A61K31/675, A61K2300/00 (US,EP)
Former IPC [2018/19]A61K9/20, A61K9/24, A61K31/513, A61K31/675
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 [2018/19]
Extension statesBA24.01.2018
ME24.01.2018
Validation statesMA24.01.2018
MD24.01.2018
TitleGerman:PHARMAZEUTISCHE ZUBEREITUNGEN BEINHALTEND TENOFOVIR UND EMTRICITABINE[2019/41]
English:PHARMACEUTICAL FORMULATIONS COMPRISING TENOFOVIR AND EMTRICITABINE[2018/19]
French:COMPOSITIONS PHARMACEUTIQUE COMPRENANT TENOFOVIR ET EMTRICITABINE[2019/41]
Former [2018/19]PHARMAZEUTISCHE FORMULIERUNGEN MIT TENOFOVIR UND EMTRICITABIN
Former [2018/19]FORMULATIONS PHARMACEUTIQUES COMPRENANT DU TÉNOFOVIR ET DE L'EMTRICITABINE
Entry into regional phase24.01.2018National basic fee paid 
24.01.2018Designation fee(s) paid 
24.01.2018Examination fee paid 
Examination procedure24.01.2018Examination requested  [2018/19]
24.01.2018Date on which the examining division has become responsible
12.12.2018Amendment by applicant (claims and/or description)
09.07.2019Despatch of a communication from the examining division (Time limit: M04)
30.07.2019Reply to a communication from the examining division
18.09.2019Communication of intention to grant the patent
09.01.2020Fee for grant paid
09.01.2020Fee for publishing/printing paid
09.01.2020Receipt of the translation of the claim(s)
Divisional application(s)EP19199257.7  / EP3607939
EP22176524.1  / EP4070787
EP22176537.3  / EP4070788
EP23162978.3  / EP4233846
Opposition(s)Opponent(s)01  19.11.2020  23.11.2020  ADMISSIBLE
Teva Pharmaceutical Industries Ltd
124 Dvora HaNevi'a St.
6944020 Tel Aviv / IL
Opponent's representative
D Young & Co LLP
3 Noble Street
London EC2V 7BQ / GB
 [N/P]
Former [2021/46]
Opponent(s)01  19.11.2020  23.11.2020  ADMISSIBLE
Teva Pharmaceutical Industries Ltd
124 Dvora HaNevi'a St.
6944020 Tel Aviv / IL
Opponent's representative
D Young & Co LLP
120 Holborn
London EC1N 2DY / GB
Former [2021/01]
Opponent(s)01  19.11.2020  23.11.2020  ADMISSIBLE
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
03.12.2020Invitation to proprietor to file observations on the notice of opposition
13.04.2021Reply of patent proprietor to notice(s) of opposition
19.04.2022Cancellation of oral proceeding that was planned for 14.06.2022
13.05.2022Date of despatch of rejection of opposition
23.05.2022Legal effect of rejection of opposition [2022/39]
14.06.2022Date of oral proceedings
Request for further processing for:12.12.2018Request for further processing filed
12.12.2018Full payment received (date of receipt of payment)
Request granted
03.01.2019Decision despatched
Fees paidRenewal fee
27.06.2018Renewal fee patent year 03
27.06.2019Renewal fee patent year 04
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Patent Court
See the Register of the Unified Patent Court for opt-out data
Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court.
Lapses during opposition  TooltipHU29.06.2016
AL19.02.2020
CY19.02.2020
DK19.02.2020
EE19.02.2020
FI19.02.2020
HR19.02.2020
LT19.02.2020
LV19.02.2020
MC19.02.2020
MK19.02.2020
MT19.02.2020
RO19.02.2020
RS19.02.2020
SM19.02.2020
BG19.05.2020
IS19.06.2020
LU29.06.2020
[2022/31]
Former [2022/28]HU29.06.2016
CY19.02.2020
DK19.02.2020
EE19.02.2020
FI19.02.2020
HR19.02.2020
LT19.02.2020
LV19.02.2020
MC19.02.2020
MT19.02.2020
RO19.02.2020
RS19.02.2020
SM19.02.2020
BG19.05.2020
IS19.06.2020
LU29.06.2020
Former [2021/15]DK19.02.2020
EE19.02.2020
FI19.02.2020
HR19.02.2020
LT19.02.2020
LV19.02.2020
MC19.02.2020
RO19.02.2020
RS19.02.2020
SM19.02.2020
BG19.05.2020
IS19.06.2020
LU29.06.2020
Former [2021/12]DK19.02.2020
EE19.02.2020
FI19.02.2020
HR19.02.2020
LT19.02.2020
LV19.02.2020
MC19.02.2020
RO19.02.2020
RS19.02.2020
SM19.02.2020
BG19.05.2020
IS19.06.2020
Former [2020/50]DK19.02.2020
EE19.02.2020
FI19.02.2020
HR19.02.2020
LT19.02.2020
LV19.02.2020
RO19.02.2020
RS19.02.2020
SM19.02.2020
BG19.05.2020
IS19.06.2020
Former [2020/48]DK19.02.2020
FI19.02.2020
HR19.02.2020
LT19.02.2020
LV19.02.2020
RO19.02.2020
RS19.02.2020
SM19.02.2020
BG19.05.2020
IS19.06.2020
Former [2020/47]DK19.02.2020
FI19.02.2020
HR19.02.2020
LT19.02.2020
LV19.02.2020
RS19.02.2020
BG19.05.2020
IS19.06.2020
Former [2020/40]FI19.02.2020
HR19.02.2020
LV19.02.2020
RS19.02.2020
BG19.05.2020
IS19.06.2020
Former [2020/39]FI19.02.2020
HR19.02.2020
LV19.02.2020
RS19.02.2020
BG19.05.2020
Former [2020/37]FI19.02.2020
HR19.02.2020
LV19.02.2020
RS19.02.2020
Former [2020/35]FI19.02.2020
Cited inInternational search[XI]WO2013116720  (GILEAD SCIENCES INC [US]) [X] 1-10,12-39,42-49 * page 82, lines 13-15, paragraph 247; claims 1-32 * * page 62, lines 17-20 * * page 63, lines 1-5, paragraph 250 * [I] 11,40,41;
 [XY]WO2015022351  (RATIOPHARM GMBH [DE]) [X] 1-9,15-20,25-39,42-49 * page 20, lines 1-12 * [Y] 10-14,21-24,40,41;
 [Y]WO2015085976  (ZENTIVA KS [CZ]) [Y] 10-14,21-24,40,41 * page 2, lines 22-33 *;
 [XP]WO2015196116  (GILEAD SCIENCES INC [US]) [XP] 1-49* paragraph [0096] *
OppositionUS2007077295
 EP1583542
 WO2010091197
 WO2013116720
 EP2744810
    - GILEAD, "Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment", Press Release, (20150407), pages 1 - 2, XP055757389
    - GILEAD, "European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment", Press Release, (20150500), pages 1 - 2, XP055745982
    - Anonymous, "Truvada 200 mg/245 mg film/coated tablets", EMA Scientific Discussion, (20050000), pages 1 - 59, XP055757477
    - Anonymous, "Atripla 600 mg/200 mg/245 mg film coated tablets", EMA Scientific Discussion, (20070000), pages 1 - 85, XP055757489
    - "Tablet Formulation and Design", Garnet Peck E., George J. Baley, Vincent E. Mccurdy, And Gilbert S. Banker, Pharmaceutical Dosage Forms: Tablets, (19890000), vol. 1, pages 75 - 111, XP055757499
    - Anonymous, "History of Changes for Study: NCT02121795 Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF", Clinicaltrial.gov archive, (20150326), pages 1 - 7, XP055757508
    - Prasad Telaprolu; Venkata Anjaneyulu M; Nagarjuna Reddy Y, "A review on pharmaceutical excipients", International Journal of Research in Pharmaceutical and Nano Sciences, (20130000), vol. 2, no. 4, pages 423 - 431, XP055719927
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