The patent has been granted The patent has been granted, Grant of patent is intended, Examination is in progress, Request for examination was made, The international publication has been made EP Register Verified

ANTIBODY-CONTAINING PREPARATION

Publication No. EP3449940

•

App No. EP17789638

•

Filed by Chugai Seiyaku Kabushiki Kaisha

•

Filed on 2017-04-27

•

Issued/Published on 2025-11-19

Official EPO Register

Publication No. EP3449940 A1

Application No. EP17789638 Filed: 2017-04-27

Grant Date 2025-11-19 Mention of grant

Active Oppositions 3 Active EPO Oppositions

Patent Abstract / Summary

[0001] The present invention relates to stable antibody-containing solution formulations in which aggregate formation of Emicizumab (ACE910) which is a bispecific antibody functionally substituting for FVIII, is suppressed. Specifically, the present invention relates to the above-mentioned antibody-containing solution formulations of pH 4.5 to 6.5 that contain the aforementioned bispecific antibody at 20 to 180 mg/mL, 10 mM to 40 mM histidine-aspartate buffer, Poloxamer 188 at 0.2 to 1 mg/mL, and 100 mM to 300 mM arginine.

IPC Classifications

A61P7/04, C07K16/36 A61K39/395, A61K9/08, A61K47/18, A61K47/34, A61P7/04

Priority Claims

JP 20160090590 Date: 2016-04-28

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

Chugai Seiyaku Kabushiki Kaisha

5-1, Ukima 5-chome, Kita-ku

Inventors (5)

SAEKI, Atsushi

c/o CHUGAI SEIYAKU KABUSHIKI KAISHA, 5-1 Ukima 5-chome

NISHIZAWA, Shaw

c/o CHUGAI SEIYAKU KABUSHIKI KAISHA, 5-1 Ukima 5-chome

SASAKI, Hitoshi

c/o CHUGAI SEIYAKU KABUSHIKI KAISHA, 5-1 Ukima 5-chome

IMAI, Chifumi

c/o CHUGAI SEIYAKU KABUSHIKI KAISHA, 5-1 Ukima 5-chome

IGAWA, Tomoyuki

c/o CHUGAI SEIYAKU KABUSHIKI KAISHA, 135 Komakado 1-chome

Representatives / Agents

Vossius & Partner Patentanwälte Rechtsanwälte mbB

Siebertstrasse 3, 81675 München

Maiwald GmbH

Elisenhof, Elisenstraße 3

Kernebeck, Thomas

Kernebeck Patentanwalts GmbH, Stiftstraße 2

Key Procedural Dates

Request-For-Examination 2018-11-28

Mention Of Grant Published 2025-11-19

First-Examination-Report-Despatched 2022-05-04

Patent Oppositions

Official opposition proceedings filed against European Patent EP3449940 under EPC Article 99.

3 ACTIVE OPPONENTS

Opponent Company

Maiwald GmbH

Elisenstraße 3, DE

Representative

Maiwald GmbH

Filing Date

2026-08-07

Opposition in Progress

Opponent Company

STRAWMAN LIMITED

Office 9, Dalton House, GB

Representative

Maiwald GmbH

Filing Date

2026-08-18

Opposition in Progress

Opponent Company

Kernebeck Patentanwalts GmbH

Stiftstraße 2, DE

Representative

Kernebeck, Thomas

Filing Date

2026-08-19

Opposition in Progress

Legal Status & Event History

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

74 Events Recorded

Date	Code	Event Description	Auth
2019-03-06	AX	REQUEST FOR EXTENSION OF THE EUROPEAN PATENT	EP
2019-03-06	AK	DESIGNATED CONTRACTING STATES	EP
2019-03-06	17P	REQUEST FOR EXAMINATION FILED	EP
2019-08-07	DAX	REQUEST FOR EXTENSION OF THE EUROPEAN PATENT (DELETED)	EP
2020-01-22	RIC1	INFORMATION PROVIDED ON IPC CODE ASSIGNED BEFORE GRANT	EP
2020-01-22	A4	SUPPLEMENTARY SEARCH REPORT DRAWN UP AND DESPATCHED	EP
2019-08-07	RAV	REQUESTED VALIDATION STATE OF THE EUROPEAN PATENT: FEE PAID	EP
2019-02-01	PUAI	PUBLIC REFERENCE MADE UNDER ARTICLE 153(3) EPC TO A PUBLISHED INTERNATIONAL APPLICATION THAT HAS ENTERED THE EUROPEAN PHASE	EP
2019-02-01	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2017-11-04	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2022-05-05	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2022-06-08	17Q	FIRST EXAMINATION REPORT DESPATCHED	EP
2023-03-08	TPAC	OBSERVATIONS FILED BY THIRD PARTIES	EP
2025-05-19	REG	REFERENCE TO A NATIONAL CODE	EP
2025-06-12	GRAP	DESPATCH OF COMMUNICATION OF INTENTION TO GRANT A PATENT	EP
2025-06-12	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2025-06-25	RIC1	INFORMATION PROVIDED ON IPC CODE ASSIGNED BEFORE GRANT	EP
2025-07-16	INTG	INTENTION TO GRANT ANNOUNCED	EP
2025-10-17	GRAA	(EXPECTED) GRANT	EP
2025-10-14	GRAS	GRANT FEE PAID	EP
2025-10-17	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2025-11-19	P01	OPT-OUT OF THE COMPETENCE OF THE UNIFIED PATENT COURT (UPC) REGISTERED	EP
2025-11-19	AK	DESIGNATED CONTRACTING STATES	EP
2025-11-19	REG	REFERENCE TO A NATIONAL CODE	EP
2025-11-20	REG	REFERENCE TO A NATIONAL CODE	EP
2025-12-04	REG	REFERENCE TO A NATIONAL CODE	EP
2025-12-17	REG	REFERENCE TO A NATIONAL CODE	EP
2026-01-14	REG	REFERENCE TO A NATIONAL CODE	EP
2017-04-27	REG	REFERENCE TO A NATIONAL CODE	EP
2026-01-30	REG	REFERENCE TO A NATIONAL CODE	EP
2026-02-17	REG	REFERENCE TO A NATIONAL CODE	EP
2026-04-07	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-09	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-10	REG	REFERENCE TO A NATIONAL CODE	EP
2026-04-13	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-13	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-14	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-15	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-16	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-17	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-20	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-20	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-21	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-08	REG	REFERENCE TO A NATIONAL CODE	EP
2026-04-23	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-24	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-28	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-05-01	REG	REFERENCE TO A NATIONAL CODE	EP
2026-04-29	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-04-30	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-05-08	REG	REFERENCE TO A NATIONAL CODE	EP
2026-06-01	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-05-28	REG	REFERENCE TO A NATIONAL CODE	EP
2026-06-23	VS25	LAPSED IN A VALIDATION STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NAT. OFFICE TO EPO]	EP
2026-06-29	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-03	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-08	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-09	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-11	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-15	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-16	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-17	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-17	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-21	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-25	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-08-14	PLBI	OPPOSITION FILED	EP
2026-08-15	REG	REFERENCE TO A NATIONAL CODE	EP
2026-08-19	REG	REFERENCE TO A NATIONAL CODE	EP
2026-08-21	PLBI	OPPOSITION FILED	EP
2026-08-07	REG	REFERENCE TO A NATIONAL CODE	EP
2026-08-26	REG	REFERENCE TO A NATIONAL CODE	EP
2026-08-30	PLAX	NOTICE OF OPPOSITION AND REQUEST TO FILE OBSERVATION + TIME LIMIT SENT	EP
2026-09-16	26	OPPOSITION FILED	EP
2026-09-23	26	OPPOSITION FILED	EP

Patent & Non-Patent Citations

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

8 Citations

Cited Patent Documents

EP2526963 2012-11-28

Espacenet

EP2238985 2010-10-13

Espacenet

EP2644698 2013-10-02

Espacenet

Non-Patent Scientific Literature (NPL)

- ZENJIRO SAMPEI ET AL: "Identification and Multidimensional Optimization of an Asymmetric Bispecific IgG Antibody Mimicking the Function of Factor VIII Cofactor Activity", PLOS ONE, vol. 8, no. 2, 28 February 2013 (2013-02-28), pages e57479, XP055553036, DOI: 10.1371/journal.pone.0057479

- ANONYMOUS: "Annex 1 - Summary of product characteristics - Hemlibra", 15 September 2022 (2022-09-15), XP093229889

- ZENJIRO SAMPEI, IGAWA TOMOYUKI, SOEDA TETSUHIRO, OKUYAMA NISHIDA YUKIKO, MORIYAMA CHIFUMI, WAKABAYASHI TETSUYA, TANAKA ERIKO, MUTO: "Identification and Multidimensional Optimization of an Asymmetric Bispecific IgG Antibody Mimicking the Function of Factor VIII Cofactor Activity", PLOS ONE, vol. 8, no. 2, 1 February 2013 (2013-02-01), US , pages 1 - 13, XP055127871, ISSN: 1932-6203, DOI: 10.1371/journal.pone.0057479

- D5 - Applicant’s submission of 15 April 2024

- SHIRE STEVEN J; SHAHROKH ZAHRA; LIU JUN: "Challenges in the development of high protein concentration formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 93, no. 6, 1 June 2004 (2004-06-01), pages 1390 - 1402, XP009108986, DOI: 10.1002/jps.20079

Worldwide Patent Family

Related applications and patents in the same INPADOC worldwide family.

46 Family Members

Country	Publication Number	Kind	Publication Date	Action
EP	EP3449940A1	A1	2019-03-06	Espacenet
EP	EP3449940A4	A4	2020-01-22	Espacenet
EP	EP3449940B1	B1	2025-11-19	Espacenet
AR	AR108240A1	A1	2018-08-01	Espacenet
AU	AU2017255077A1	A1	2018-10-04	Espacenet
AU	AU2017255077B2	B2	2024-05-16	Espacenet
BR	BR112018067792A2	A2	2019-02-12	Espacenet
CA	CA3016301A1	A1	2017-11-02	Espacenet
CL	CL2018003022A1	A1	2019-01-18	Espacenet
CN	CN108883178A	A	2018-11-23	Espacenet
CN	CN108883178B	B	2023-03-14	Espacenet
CN	CN116059353A	A	2023-05-05	Espacenet
CN	CN116059353B	B	2026-07-21	Espacenet
CR	CR20180554A	A	2019-01-10	Espacenet
EP	EP4650371A2	A2	2025-11-19	Espacenet
EP	EP4650371A3	A3	2026-02-25	Espacenet
ES	ES3055961T3	T3	2026-02-17	Espacenet
HK	HK1257953A1	A1	2019-11-01	Espacenet
HR	HRP20251588T1	T1	2026-01-30	Espacenet
IL	IL262589A	A	2018-12-31	Espacenet
JP	JP2022037069A	A	2022-03-08	Espacenet
JP	JP2023145766A	A	2023-10-11	Espacenet
JP	JP7544932B2	B2	2024-09-03	Espacenet
JP	JPWO2017188356A1	A1	2019-03-07	Espacenet
JP	JP7320943B2	B2	2023-08-04	Espacenet
KR	KR20190003596A	A	2019-01-09	Espacenet
KR	KR102456742B1	B1	2022-10-19	Espacenet
MA	MA44780A	A	2019-03-06	Espacenet
MX	MX2018012648A	A	2019-01-30	Espacenet
MX	MX428477B	B	2025-11-13	Espacenet
MY	MY200833A	A	2024-01-17	Espacenet
NZ	NZ746002A	A	2025-08-29	Espacenet
PE	PE20181889A1	A1	2018-12-11	Espacenet
PL	PL3449940T3	T3	2026-03-16	Espacenet
RU	RU2018141173A	A	2020-05-28	Espacenet
RU	RU2018141173A3	A3	2020-06-11	Espacenet
RU	RU2748046C2	C2	2021-05-19	Espacenet
SG	SG11201807765PA	A	2018-10-30	Espacenet
SI	SI3449940T1	T1	2026-02-27	Espacenet
TW	TW201737942A	A	2017-11-01	Espacenet
TW	TWI820000B	B	2023-11-01	Espacenet
TW	TW202402326A	A	2024-01-16	Espacenet
UA	UA126900C2	C2	2023-02-22	Espacenet
US	US2021189006A1	A1	2021-06-24	Espacenet
US	US12460014B2	B2	2025-11-04	Espacenet
WO	WO2017188356A1	A1	2017-11-02	Espacenet

Official File Inspection EPC Art. 128 Public Dossier

Complete European Patent Register Dossier (148 Total Documents)

The full inspection file for Application EP17789638 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

Dossier Filing

Date: 2026-05-01 Procedure: Examination 0009250

Inspect on Register

ANTIBODY-CONTAINING PREPARATION

Patent Abstract / Summary

IPC Classifications

Priority Claims

Designated Contracting States (38 EPC States)

Parties & Representation

Applicants

Inventors (5)

Representatives / Agents

Key Procedural Dates

Patent Oppositions

Maiwald GmbH

STRAWMAN LIMITED

Kernebeck Patentanwalts GmbH

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)

Invitation to proprietor to file observations on the notice of opposition

New entry: Communication of a notice of opposition and request to file observations + time limit

Opposition filed

Opposition filed

Lapse of the patent in a contracting state

Lapse of the patent in a contracting state

Lapse of the patent in a contracting state

Lapse of the patent in a contracting state

Lapse of the patent in a contracting state

Lapse of the patent in a contracting state

Lapse of the patent in a contracting state

(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)

Change - divisional application(s)

Intention to grant the patent

New entry: Communication of intention to grant a patent

Change - classification

New entry: Date of cancellation oral proceedings

Oral proceedings

New entry: Renewal fee paid

Renewal fee payment

New entry: Date of oral proceedings

Deletion: Date of oral proceedings

New entry: Date of oral proceedings

New entry: Decision on request for further processing

New entry: Reply to examination report

New entry: Receipt of request for further processing

New entry: Fee payment for 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: Despatch of examination report + time limit

New entry: Despatch of examination report + time limit

Communication from the examining division

New entry: Renewal fee paid

Renewal fee payment

New entry: Observations by third parties

Observations by a third party

New entry: Reply to examination report

Change: Despatch of examination report + time limit

First examination report

New entry: Despatch of examination report + time limit

Communication from the examining division

New entry: Renewal fee paid

Renewal fee payment

New entry: Renewal fee paid

Renewal fee payment

Amendment by applicant

Amendments

New entry: Renewal fee paid

Renewal fee payment

Supplementary search report