Extract from the Register of European Patents

EP About this file: EP3127542

EP3127542 - ANTIVIRAL THERAPY [Right-click to bookmark this link]
StatusOpposition rejected
Status updated on  20.12.2024
Database last updated on 31.03.2026
FormerThe patent has been granted
Status updated on  20.07.2018
FormerGrant of patent is intended
Status updated on  08.03.2018
FormerExamination is in progress
Status updated on  21.02.2018
FormerGrant of patent is intended
Status updated on  24.11.2017
FormerExamination is in progress
Status updated on  12.05.2017
FormerRequest for examination was made
Status updated on  06.01.2017
Most recent event   Tooltip20.12.2024Opposition rejectedpublished on 22.01.2025  [2025/04]
Applicant(s)For all designated states
VIIV Healthcare Company
251 Little Falls Drive
Wilmington, DE 19808 / US
[2017/40]
Former [2017/06]For all designated states
VIIV Healthcare Company
Corporation Service Company
2711 Centerville Road
Suite 400
Wilmington DE 19808 / US
Inventor(s)01 / UNDERWOOD, Mark Richard
c/o GlaxoSmithKline, Global Patents Dept
P.O. Box 13398
Five Moore Drive
Research Triangle Park, NC North Carolina 27709 / US
 [2017/06]
Representative(s)Wilkinson, Johanna Elise
GSK
Legal & Compliance - Global Patents
79 New Oxford Street
London WC1A 1DG / GB
[N/P]
Former [2017/06]Gladwin, Amanda Rachel
GlaxoSmithKline
Global Patents (CN925.1)
980 Great West Road
Brentford, Middlesex TW8 9GS / GB
Application number, filing date16187411.024.01.2011
[2017/06]
Priority number, dateUS20100298589P27.01.2010         Original published format: US 298589 P
[2017/06]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP3127542
Date:08.02.2017
Language:EN
[2017/06]
Type: B1 Patent specification 
No.:EP3127542
Date:22.08.2018
Language:EN
[2018/34]
Search report(s)(Supplementary) European search report - dispatched on:EP01.12.2016
ClassificationIPC:A61K31/5365, A61K31/52, A61P31/18
[2017/06]
CPC:
A61K31/5365 (EP,EA,IL,KR,US); A61K31/536 (IL,KR,US); A61K31/505 (EP,EA,IL,US);
A61K31/4985 (EP,IL,KR,US); A61K31/513 (EP,IL,KR,US); A61K31/52 (IL,KR,US);
A61K31/675 (IL,US); A61K45/06 (EP,IL,US); A61K9/0014 (EP,IL,US);
A61K9/0019 (EP,IL,US); A61K9/0053 (EP,IL,US); A61P31/00 (EP,IL);
A61P31/12 (EP,IL); A61P31/18 (EP,EA,IL); A61P37/04 (EP,IL);
A61P43/00 (EP,IL); A61K2121/00 (KR); A61K2300/00 (IL) (-)
C-Set:
A61K31/4985, A61K2300/00 (EP);
A61K31/505, A61K2300/00 (EP);
A61K31/513, A61K2300/00 (EP,US);
A61K31/5365, A61K2300/00 (US,EP)
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 [2017/06]
Extension statesBA06.09.2016
ME06.09.2016
TitleGerman:ANTIVIRALE THERAPIE[2017/06]
English:ANTIVIRAL THERAPY[2017/06]
French:THERAPIE ANTIVIRALE[2017/06]
Examination procedure06.09.2016Examination requested  [2017/06]
06.09.2016Date on which the examining division has become responsible
19.05.2017Despatch of a communication from the examining division (Time limit: M04)
05.09.2017Reply to a communication from the examining division
22.11.2017Communication of intention to grant the patent
15.02.2018Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO
09.03.2018Communication of intention to grant the patent
04.07.2018Fee for grant paid
04.07.2018Fee for publishing/printing paid
04.07.2018Receipt of the translation of the claim(s)
Parent application(s)   TooltipEP11737484.3  / EP2531027
EP15164931.6  / EP2932970
Opposition(s)Opponent(s)01  20.05.2019  23.05.2019  ADMISSIBLE
Cooke, Richard
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 02  22.05.2019  28.05.2019  ADMISSIBLE
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 03  22.05.2019  28.05.2019  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
 04  22.05.2019  28.05.2019  ADMISSIBLE
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel / DE
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB
Jungfernstieg 38
20354 Hamburg / DE
 [N/P]
Former [2021/47]
Opponent(s)01  20.05.2019  23.05.2019  ADMISSIBLE
Cooke, Richard
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 02  22.05.2019  28.05.2019  ADMISSIBLE
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 03  22.05.2019  28.05.2019  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
 04  22.05.2019  28.05.2019  ADMISSIBLE
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel / DE
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB
Jungfernstieg 38
20354 Hamburg / DE
Former [2019/27]
Opponent(s)01  20.05.2019  23.05.2019  ADMISSIBLE
Cooke, Richard
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
Opponent's representative
Elkington & Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 02  22.05.2019  28.05.2019  ADMISSIBLE
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 03  22.05.2019  28.05.2019  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
 04  22.05.2019  28.05.2019  ADMISSIBLE
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel / DE
Opponent's representative
Hamm&Wittkopp Patentanwälte PartmbB
Jungfernstieg 38
20354 Hamburg / DE
Former [2019/26]
Opponent(s)01  20.05.2019  23.05.2019  ADMISSIBLE
Cooke, Richard
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 02  22.05.2019    ADMISSIBLE
Sandoz AG
Lichtstrasse 35
4056 Basel / CH
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 03  22.05.2019    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
07.06.2019Invitation to proprietor to file observations on the notice of opposition
28.11.2019Reply of patent proprietor to notice(s) of opposition
01.09.2020Cancellation of oral proceeding that was planned for 05.11.2020
05.11.2020Date of oral proceedings
07.06.2021Date of oral proceedings
21.07.2021Despatch of minutes of oral proceedings
22.07.2021Date of despatch of rejection of opposition
10.10.2024Legal effect of rejection of opposition [2025/04]
Appeal following opposition27.09.2021Appeal received No.  T1698/21
27.09.2021Payment of appeal fee
30.11.2021Statement of grounds filed
02.10.2024Result of appeal procedure: appeal of the opponent was rejected
18.12.2024Despatch of the decision of the Board of Appeal
15.09.2021Appeal received No.  T1698/21
15.09.2021Payment of appeal fee
30.11.2021Statement of grounds filed
02.10.2024Result of appeal procedure: appeal of the opponent was rejected
18.12.2024Despatch of the decision of the Board of Appeal
22.09.2021Appeal received No.  T1698/21
22.09.2021Payment of appeal fee
25.11.2021Statement of grounds filed
02.10.2024Result of appeal procedure: appeal of the opponent was rejected
18.12.2024Despatch of the decision of the Board of Appeal
28.09.2021Appeal received No.  T1698/21
28.09.2021Payment of appeal fee
17.11.2021Statement of grounds filed
02.10.2024Result of appeal procedure: appeal of the opponent was rejected
18.12.2024Despatch of the decision of the Board of Appeal
02.10.2024Date of oral proceedings
Fees paidRenewal fee
06.09.2016Renewal fee patent year 03
06.09.2016Renewal fee patent year 04
06.09.2016Renewal fee patent year 05
06.09.2016Renewal fee patent year 06
09.01.2017Renewal fee patent year 07
08.01.2018Renewal fee patent year 08
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Documents cited:Search[AP] WO2010011812  (SMITHKLINE BEECHAM CORP et al.)
 [A] WO2009148600  (CONCERT PHARMACEUTICALS INC et al.)
 [A] US2006084627  (MARDH GORAN et al.)
 [A] US2009318421  (JOHNS BRIAN ALVIN et al.)
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 [A]   SONG I ET AL: "The Effect of Ritonavir-Boosted Protease Inhibitors on the HIV Integrase Inhibitor, S/GSK1349572, in Healthy Subjects", 15 September 2009 (2009-09-15), XP002697436, Retrieved from the Internet [retrieved on 20130521]
Examination  DATABASE REGISTRY [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; 22 September 2008 (2008-09-22), Database accession no. 1051375-16-6
   MIN ET AL: "Pharmacokinetics and Safety of S/GSK1349572, a Next-Generation HIV Integrase Inhibitor, in Healthy Volunteers", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, vol. 54, no. 1, 2 November 2009 (2009-11-02), pages 254 - 258, XP055280415

DOI:   http://dx.doi.org/10.1128/AAC.00842-09
by applicantUS5034394
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 US5840990
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 US5808147
 US6392085
 US6448403
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   PHARMACEUTICAL RESEARCH, vol. 3, no. 6, 1986, pages 318
   SELLESETH, D.W. ET AL., ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, vol. 47, 2003, pages 1468 - 1471
OppositionEP1874117
 WO2006116764
 US7511037
 WO2006116764
   KOBAYASHI ET AL.: "In Vitro Antiretroviral Properties of S/GSK1349572, a Next- Generation HIV Integrase Inhibitor", ANTIMICROB. AGENTS CHEMOTHER., vol. 55, no. 2, February 2011 (2011-02-01), pages 813 - 821, XP002680283, DOI: doi:10.1128/AAC.01209-10

DOI:   http://dx.doi.org/10.1128/AAC.01209-10
   DHHS: "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents", OFFICE OF AIDS RESEARCH ADVISORY COUNCIL (OARAC), 1 December 2009 (2009-12-01), pages 1 - 161, XP055275315
   "EPZICOM Prescribing Information", NDA 21-652, 2004, pages 5 - 26
   SOMBOONWIT ET AL.: "Abacavir and lamivudine combination", EXPERT. OPIN. DRUG METAB. TOXICOL., vol. 5, no. 12, December 2009 (2009-12-01), pages 1599 - 1606, XP055275319, DOI: doi:10.1517/17425250903439720

DOI:   http://dx.doi.org/10.1517/17425250903439720
   YOUNG ET AL.: "A Pilot Study of Abacavir/Lamivudine and Raltegravir in Antiretroviral-Nave HIV-1-Infected Patients: 48-Week Results of the SHIELD Trial", HIV CLIN TRIALS., vol. 11, no. 5, October 2010 (2010-10-01), pages 260 - 269, XP055275323

DOI:   http://dx.doi.org/10.1310/hct1105-260
   JOHNS ET AL.: "The Discovery of S/GSK1349572: A Once Daily Next Generation Integrase Inhibitor with a Superior Resistance Profile", 17TH CROI, CONFERENCE ON RETROVIRUSES AND OPPORTUNISTIC INFECTIONS,, February 2010 (2010-02-01), XP055275444
   ANONYMOUS: "Antiviral activity of S/GSK1349572, the only once-daily, unboosted integrase inhibitor in clinical development, evaluated in phase 2 study", GSK PRESS RELEASE, July 2009 (2009-07-01), XP055544606
   ANONYMOUS: "A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects (ING11276)", INTERNET ARCHIVE WAYBACK MACHINE, 4 September 2009 (2009-09-04), XP055598041, Retrieved from the Internet
   ARRIBAS ET AL.: "Once-daily S/GSK1349572 as part of combination therapy in antiretroviral nave adults: rapid and potent antiviral responses in the interim 16 week- analysis from SPRING-1 (ING112276)", XVIII INTERNATIONAL AIDS CONFERENCE, 18 July 2010 (2010-07-18), Vienna, Austria, XP055275419
   ANONYMOUS: "EPZICOM Prescribing Information", 2007, pages 3 - 28
   DAMOND ET AL.: "Virological and immunological response to HAART regimen containing integrase inhibitors in HIV-2-infected patients", AIDS, vol. 22, no. 5, 2008, pages 665 - 666, XP055280519

DOI:   http://dx.doi.org/10.1097/QAD.0b013e3282f51203
   TRICOT ET AL.: "Safety and Efficacy of Raltegravir in HIV-Infected Transplant Patients Cotreated with Immunosuppressive Drugs", AMERICAN JOURNAL OF TRANSPLANTATION, vol. 9, no. 8, 1 August 2009 (2009-08-01), pages 1946 - 1952, XP055275441

DOI:   http://dx.doi.org/10.1111/j.1600-6143.2009.02684.x
   PATRICIA PECORA FULCO; ET AL: "Raltegravir-Based HAART Regimen in a Patient with Large B-Cell Lymphoma", THE ANNALS OF PHARMACOTHERAPY, vol. 44, 2010, pages 377 - 382, XP055280525

DOI:   http://dx.doi.org/10.1345/aph.1M370
   21 January 2010 (2010-01-21), XP055600260, Retrieved from the Internet [retrieved on 20190514]
   DATABASE REGISTRY [online] CAS; 22 September 2008 (2008-09-22), XP055600264, Database accession no. RN 1051375-16-6
   LALEZARI ET AL.: "Potent Antiviral Activity of S/GSK1349572, A Next Generation D3 Integrase Inhibitor (INI) , in IN 1-Nave HIV-1 -Infected Patients: ING111521 Protocol", IAS 2009 - 5TH CONFERENCE ON HIV PATHOGENESIS, TREATMENT AND PREVENTION, 19 July 2009 (2009-07-19), Cape Town South Africa, XP055280561
   "Antiviral activity of S/GSK1349572, the only once-daily, unboosted integrase inhibitor in clinical development, evaluated in phase 2 study", GSK PRESS RELEASE, July 2009 (2009-07-01), XP055544606
   UNDERWOOD ET AL.: "S/GSK1349572: A Next Generation integrase Inhibitor with Activity Against Integrase Inhibitor-Resistant Clinical Isolates from Patients D5 Experiencing Virologic Failure while on Raltegravir Therapy", IAS 2009 - 5TH CONFERENCE ON HIV PATHOGENESIS, 19 July 2009 (2009-07-19), Cape Town South Africa, XP055544612
   ROCKSTROH K.J.: "Integrase inhibitors: Why do we need a new drug class for HIV therapy?", EUR J MED RES, vol. 14, no. suppl. III, 24 November 2009 (2009-11-24), pages 1 - 3, XP021130215

DOI:   http://dx.doi.org/10.1186/2047-783X-14-S3-1
   JOHNS ET AL.: "The Discovery of S/GSK1349572: A Once Daily Next-Generation Integrase Inhibitor with a Superior Resistance Profile", 17TH CROIT, CONFERENCE ON RETROVIRUSES AND OPPORTUNISTIC INFECTIONS, 16 February 2010 (2010-02-16), San Francisco CA, XP055539843
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   HAMMER ET AL.: "Antiretroviral Treatment of Adult HIV Infection 2008 Recommendations of the International AIDS Society", JAMA, vol. 300, no. 5, 6 August 2008 (2008-08-06), pages 555 - 570, XP008134902

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   GARVEY ET AL.: "The Naphthyridinone GSK364735 Is a Novel, Potent Human Immunodeficiency Virus Type 1 Integrase Inhibitor and Antiretroviral", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, vol. 52, no. 3, March 2008 (2008-03-01), pages 901 - 908, XP055600300

DOI:   http://dx.doi.org/10.1128/AAC.01218-07
   FDA: "patient information leaflet", ISENTRESS (RALTEGRAVIR) TABLETS;, July 2009 (2009-07-01), XP055600305
   "EPZICOM (abacavir sulfate and lamivudine) Tablets, for oral use", PRESCRIBING INFORMATION FOR EPZICOM, March 2012 (2012-03-01), XP055600307
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.