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METHODS OF TREATING HFPEF EMPLOYING DAPAGLIFLOZIN AND COMPOSITIONS COMPRISING THE SAME

Publication No. EP3823631

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App No. EP19759294

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Filed by Astrazeneca AB

•

Filed on 2019-07-18

•

Issued/Published on 2026-05-20

Official EPO Register

Publication No. EP3823631 A1

Application No. EP19759294 Filed: 2019-07-18

Grant Date 2026-05-20 Mention of grant

Active Oppositions 4 Active EPO Oppositions

Patent Abstract / Summary

Patent abstract is being processed or was not provided in English by the publishing office.

IPC Classifications

A61K31/70, A61P9/00, A61P9/04

Priority Claims

US 201862700463P Date: 2018-07-19

Designated Contracting States (38 EPC States)

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

Parties & Representation

Applicants

Astrazeneca AB

151 85 Södertälje

Inventors (1)

LANGKILDE, Anna, Maria

AstraZeneca, 151 85 Södertälje

Representatives / Agents

Mewburn Ellis LLP

Aurora Building, Counterslip

AstraZeneca

Milstein Building, Granta Park

AWA Denmark A/S

Strandgade 56, 1401 Copenhagen K

Busse & Busse

Patent- und Rechtsanwälte, Partnerschaft mbB

Elkington and Fife LLP

Prospect House, 8 Pembroke Road

D Young & Co LLP

3 Noble Street, London EC2V 7BQ

Key Procedural Dates

Request-For-Examination 2021-02-19

First-Examination-Report-Despatched 2023-04-19

Patent Oppositions

Official opposition proceedings filed against European Patent EP3823631 under EPC Article 99.

4 ACTIVE OPPONENTS

Opponent Company

AWA Denmark A/S

Strandgade 56, DK

Representative

AWA Denmark A/S

Filing Date

2026-05-20

Opposition in Progress

Opponent Company

Busse & Busse Patent- und Rechtsanwälte Partnerschaft mbB

Großhandelsring 6, DE

Representative

Busse & Busse

Filing Date

2026-05-20

Opposition in Progress

Opponent Company

Generics [UK] Limited

Building 4, Trident Place, GB

Representative

Elkington and Fife LLP

Filing Date

2026-05-20

Opposition in Progress

Opponent Company

Teva Pharmaceutical Industries Ltd.

124 Dvora HaNevi'a St., IL

Representative

D Young & Co LLP

Filing Date

2026-07-15

Opposition in Progress

Legal Status & Event History

Official European Patent Office legal and procedural status changes recorded for this file.

62 Events Recorded

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Patent & Non-Patent Citations

Cited documents and prior art referenced in search and examination reports.

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- INZUCCHI SILVIO E, BRIAN L CLAGGETT, MUTHIAH VADUGANATHAN, AKSHAY S DESAI, PARDEEP S JHUND, RUDOLF A DE BOER, ADRIAN F HERNANDEZ, : "Efficacy and safety of dapagliflozin in patients with heart failure with mildly reduced or preserved ejection fraction by baseline glycaemic status (DELIVER): a subgroup analysis from an international, multicentre, double-blind, randomised, placebo-controlled trial", THE LANCET DIABETES & ENDOCRINOLOGY, ELSEVIER, GB, vol. 10, no. 12, 10 November 2022 (2022-11-10), GB , pages 869 - 881, XP093361149, ISSN: 2213-8595, DOI: 10.1016/S2213-8587(22)00308-4

- AL KHZEM ABDULAZIZ, WALI SAAD: "Drug Repurposing as an Effective Drug Discovery Strategy: A Critical Review", DRUG DESIGN, DEVELOPMENT AND THERAPY, DOVE MEDICAL PRESS LTD., UNITED KINGDOM, vol. 19, no. Issue 1, 1 January 2025 (2025-01-01), United Kingdom , pages 12019 - 12034, XP093371407, ISSN: 1177-8881, DOI: 10.2147/DDDT.S576701

- BUTLER JAVED, RICH JONATHAN: "Epidemiology of Heart Failure and the Discovery of the Cardioprotective Effects of SGLT2 Inhibitors", JACC: HEART FAILURE, vol. 12, no. 6, 1 June 2024 (2024-06-01), pages S1 - S3, XP093371186, ISSN: 2213-1779, DOI: 10.1016/j.jchf.2024.01.025

- FIORETTO PAOLA, AVOGARO ANGELO: "Dapagliflozin: potential beneficial effects in the prevention and treatment of renal and cardiovascular complications in patients with type 2 diabetes", EXPERT OPIN PHARMACOTHER, ASHLEY PUBLICATIONS LTD, LONDON, UK, vol. 18, no. 5, 24 March 2017 (2017-03-24), London, UK , pages 517 - 527, XP093400830, ISSN: 1465-6566, DOI: 10.1080/14656566.2017.1300253

- DEKKERS CLAIRE C.; GANSEVOORT RON T.; HEERSPINK HIDDO J.: "New Diabetes Therapies and Diabetic Kidney Disease Progression: the Role of SGLT-2 Inhibitors", CURRENT DIABETES REPORTS, CURRENT SCIENCE, PHILADELPHIA, VA, US, vol. 18, no. 5, 27 March 2018 (2018-03-27), US , pages 1 - 12, XP036467947, ISSN: 1534-4827, DOI: 10.1007/s11892-018-0992-6

- AL-SHAREA ANNAS, MURPHY ANDREW J., HUGGINS L.A., HU Y., GOLDBERG IRA J., NAGAREDDY PRABHAKARA R.: "SGLT2 inhibition reduces atherosclerosis by enhancing lipoprotein clearance in Ldlr type 1 diabetic mice", ATHEROSCLEROSIS, ELSEVIER, AMSTERDAM, NL, vol. 271, 1 April 2018 (2018-04-01), AMSTERDAM, NL , pages 166 - 176, XP093400833, ISSN: 0021-9150, DOI: 10.1016/j.atherosclerosis.2018.02.028

- J. DZIUBA, P. ALPERIN, J. RACKETA, U. ILOEJE, D. GOSWAMI, E. HARDY, I. PERLSTEIN, H. L. GROSSMAN, M. COHEN: "Modeling effects of SGLT-2 inhibitor dapagliflozin treatment versus standard diabetes therapy on cardiovascular and microvascular outcomes : Modeling effects of SGLT-2 inhibitor dapagliflozin", DIABETES, OBESITY AND METABOLISM, BLACKWELL SCIENCE, GB, vol. 16, no. 7, 1 July 2014 (2014-07-01), GB , pages 628 - 635, XP055608010, ISSN: 1462-8902, DOI: 10.1111/dom.12261

- HEERSPINK HIDDO J, STEFANSSON BERGUR V, CHERTOW GLENN M, CORREA-ROTTER RICARDO, GREENE TOM, HOU FAN-FAN, LINDBERG MAGNUS, MCMURRAY: "Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial", NEPHROLOGY DIALYSIS TRANSPLANTATION, OXFORD UNIVERSITY PRESS, vol. 35, no. 2, 1 February 2020 (2020-02-01), pages 274 - 282, XP093282731, ISSN: 0931-0509, DOI: 10.1093/ndt/gfz290

- DOI R, MASUYAMA TOHRU, YAMAMOTO KAZUHIRO, DOI YASUJI, MANO TOSHIAKI, SAKATA YASUSHI, ONO KEIKO, KUZUYA TSUNEHIKO, HIROTA SEIICHI, : "Development of different phenotypes of hypertensive heart failure: systolic versus diastolic failure in Dahl salt-sensitive rats", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 18, no. 1, 1 February 1998 (1998-02-01), AMSTERDAM, NL, pages 111 - 120, XP093400838, ISSN: 0735-1097

- OMORI YOSUKE, ET AL.: "L-carnitine prevents the development of ventricular fibrosis and heart failure with preserved ejection fraction in hypertensive heart disease", JOURNAL OF HYPERTENSION, vol. 30, no. 9, 1 September 2012 (2012-09-01), pages 1834 - 1844, XP093400849, DOI: 10.1097/HJH.0b013e3283569c5a

- KOSHIZUKA RUMI; ISHIZU TOMOKO; KAMEDA YURI; KAWAMURA RYO; SEO YOSHIHIRO; AONUMA KAZUTAKA: "Longitudinal Strain Impairment as a Marker of the Progression of Heart Failure with Preserved Ejection Fraction in a Rat Model", JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY., MOSBY-YEAR BOOK, INC. ST. LOUIS, MO, US, vol. 26, no. 3, 6 January 2013 (2013-01-06), US , pages 316 - 323, XP028984515, ISSN: 0894-7317, DOI: 10.1016/j.echo.2012.11.015

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- ANONYMOUS: "COMMISSION IMPLEMENTING DECISION of 12.11.2012 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Forxiga - dapagliflozin", a medicinal product for human use (Text with EEA relevance)", EUROPEAN COMMISSION, 12 November 2012 (2012-11-12), XP093400861, Retrieved from the Internet <URL:https://ec.europa.eu/health/documents/community-register/2012/20121112124487/dec_124487_en.pdf>

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- SAINT LUKE'S HEALTH SYSTEM: "NCT03030235 Dapagliflozin in PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF)", CLINICALTRIALS.GOV, NLM, pages 1 - 19, XP093417292, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT03030235?tab=history&a=5#version-content-panel>

- BOEHRINGER INGELHEIM: "NCT03057951 EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)", CLINICALTRIALS.GOV, NLM, pages 1 - 20, XP093417293, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT03057951?tab=history&a=4#version-content-panel>

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- KOSIBOROD MIKHAIL, LAM CAROLYN S.P., KOHSAKA SHUN, KIM DAE JUNG, KARASIK AVRAHAM, SHAW JONATHAN, TANGRI NAVDEEP, GOH SU-YEN, THURE: "Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 71, no. 23, 1 June 2018 (2018-06-01), AMSTERDAM, NL, pages 2628 - 2639, XP093211957, DOI: 10.1016/j.jacc.2018.03.009

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- RAPP JOHN: "Will the real Dahl S rat please stand up?", AM J PHYSIOL RENAL PHYSIOL, 23 September 2019 (2019-09-23), pages F1231 - F1240, XP93131276

- SOLOMON SCOTT D. ET AL: "Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction", THE NEW ENGLAND JOURNAL OF MEDICINE, vol. 387, no. 12, 22 September 2022 (2022-09-22), US, pages 1089 - 1098, XP093271153, ISSN: 0028-4793, DOI: 10.1056/NEJMoa2206286

- INZUCCHI SILVIO E ET AL: "Efficacy and safety of dapagliflozin in patients with heart failure with mildly reduced or preserved ejection fraction by baseline glycaemic status (DELIVER): a subgroup analysis from an international, multicentre, double-blind, randomised, placebo-controlled trial", THE LANCET DIABETES & ENDOCRINOLOGY, vol. 10, no. 12, 10 November 2022 (2022-11-10), GB, pages 869 - 881, XP093361149, ISSN: 2213-8595, DOI: 10.1016/S2213-8587(22)00308-4

- AL KHZEM ABDULAZIZ ET AL: "Drug Repurposing as an Effective Drug Discovery Strategy: A Critical Review", DRUG DESIGN, DEVELOPMENT AND THERAPY, vol. 19, no. Issue 1, 1 January 2025 (2025-01-01), United Kingdom, pages 12019 - 12034, XP093371407, ISSN: 1177-8881, DOI: 10.2147/DDDT.S576701

- BUTLER JAVED ET AL: "Epidemiology of Heart Failure and the Discovery of the Cardioprotective Effects of SGLT2 Inhibitors", JACC: HEART FAILURE, vol. 12, no. 6, 1 June 2024 (2024-06-01), pages S1 - S3, XP093371186, ISSN: 2213-1779, DOI: 10.1016/j.jchf.2024.01.025

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SI	SI3823631T1	T1	2026-08-31	Espacenet
UA	UA129183C2	C2	2025-02-05	Espacenet
US	US2020078382A1	A1	2020-03-12	Espacenet
US	US11826376B2	B2	2023-11-28	Espacenet
US	US20240082278A1	A1	2024-03-14	Espacenet
US	US12472194B2	B2	2025-11-18	Espacenet
US	US20260216222A1	A1	2026-07-30	Espacenet
WO	WO2020016335A1	A1	2020-01-23	Espacenet

Official File Inspection EPC Art. 128 Public Dossier

Complete European Patent Register Dossier (148 Total Documents)

The full inspection file for Application EP19759294 contains 148 total documents, including all notices of opposition, proprietor counter-statements, examination communications, third-party observations, and procedural forms. Below are all major recorded procedural filings and publication specifications.

Open 148-Doc Register Dossier

Recorded Filings & Patent Specifications

Official publication specifications, opposition filings, proprietor replies, and procedural submissions.

84 Filings Listed

European Patent Specification - Granted Patent (B1)

Publication Specification

Date: 2026-05-20 Procedure: Grant EP3823631B1

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Official European Patent Register Full Dossier

Publication Specification

Date: 2026-05-20 Procedure: All Proceedings (Examination & Opposition) EP19759294

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European Patent Application with Search Report (A1)

Publication Specification

Date: 2020-01-23 Procedure: Publication EP3823631A1

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Opposition filed

Dossier Filing

Date: 2026-07-17 Procedure: Opposition 0009260

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Change - opposition data/opponent's data or that of the opponent's representative

Dossier Filing

Date: 2026-05-29 Procedure: Opposition 0009299OPPO

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Opposition filed

Dossier Filing

Date: 2026-05-22 Procedure: Opposition 0009260

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Change - divisional application(s)

Dossier Filing

Date: 2026-05-15 Procedure: Examination 0008299DANR

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(Expected) grant

Dossier Filing

Date: 2026-04-17 Procedure: Grant 0009210

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New entry: Payment of fee for grant

Dossier Filing

Date: 2026-04-10 Procedure: Grant EPIDOSNIGR3

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New entry: Payment of fee for publishing/printing

Dossier Filing

Date: 2026-04-10 Procedure: Examination EPIDOSNIGR5

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New entry: Receipt of the translation of the claim(s)

Dossier Filing

Date: 2026-04-10 Procedure: Examination EPIDOSNIGR7

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New entry: Despatch of minutes of oral proceedings

Dossier Filing

Date: 2026-03-18 Procedure: Examination EPIDOSNORA9E

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METHODS OF TREATING HFPEF EMPLOYING DAPAGLIFLOZIN AND COMPOSITIONS COMPRISING THE SAME

Patent Abstract / Summary

IPC Classifications

Priority Claims

Designated Contracting States (38 EPC States)

Parties & Representation

Applicants

Inventors (1)

Representatives / Agents

Key Procedural Dates

Patent Oppositions

AWA Denmark A/S

Busse & Busse Patent- und Rechtsanwälte Partnerschaft mbB

Generics [UK] Limited

Teva Pharmaceutical Industries Ltd.

Legal Status & Event History

Patent & Non-Patent Citations

Cited Patent Documents

Non-Patent Scientific Literature (NPL)

Worldwide Patent Family

Complete European Patent Register Dossier (148 Total Documents)

Recorded Filings & Patent Specifications

European Patent Specification - Granted Patent (B1)

Official European Patent Register Full Dossier

European Patent Application with Search Report (A1)

Opposition filed

Change - opposition data/opponent's data or that of the opponent's representative

Opposition filed

Change - divisional application(s)

(Expected) grant

New entry: Payment of fee for grant

New entry: Payment of fee for publishing/printing

New entry: Receipt of the translation of the claim(s)

New entry: Despatch of minutes of oral proceedings

New entry: Communication of intention to grant a patent

Intention to grant the patent

Oral proceedings

New entry: Observations by third parties

Observations by a third party

New entry: Observations by third parties

Observations by a third party

New entry: Observations by third parties

Observations by a third party

New entry: Date of oral proceedings

New entry: Observations by third parties

New entry: Renewal fee paid

Renewal fee payment

Observations by a third party

New entry: Reply to examination report

New entry: Despatch of examination report + time limit

Communication from the examining division

New entry: Observations by third parties

New entry: Reply to examination report

Observations by a third party

New entry: Despatch of examination report + time limit

Communication from the examining division

New entry: Decision on request for further processing

New entry: Reply to examination report

New entry: Fee payment for request for further processing

New entry: Receipt of request for further processing

Request for further processing

New entry: Application deemed to be withdrawn: despatch of communication + time limit

Application deemed to be withdrawn

New entry: Renewal fee paid

Renewal fee payment

Change - representative

Change: Despatch of examination report + time limit

New entry: Despatch of examination report + time limit

Communication from the examining division

New entry: Reply to examination report

Change: Despatch of examination report + time limit

New entry: Renewal fee paid

Renewal fee payment

First examination report

New entry: Despatch of examination report + time limit

Communication from the examining division

New entry: Renewal fee paid

Renewal fee payment

Change: Validation states

New entry: Renewal fee paid