Opposition Filed Opposition filed by Lumara Bio Oncologics GmbH, Withers & Rogers LLP / Greg Stepney / Howard Wright / Nicholas Wallin EP Register Verified

STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS

Publication No. EP4541381

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App No. EP25162403

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Filed by Advanced Accelerator Applications S.A.

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Filed on 2018-09-25

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Issued/Published on 2026-02-04

Official EPO Register

Publication No. EP4541381 A2

Application No. EP25162403 Filed: 2018-09-25

Grant Date 2026-02-04 Mention of grant

Active Oppositions 2 Active EPO Oppositions

Patent Abstract / Summary

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

IPC Classifications

A61K51/08, A61P35/00, A61K103/30, A61K9/00, A61K9/08, A61K47/12, A61K47/22, A61K51/12 A61K51/08

Priority Claims

WO 2018IB55575 Date: 2018-07-25

US 201816045484 Date: 2018-07-25

Designated Contracting States (38 EPC States)

Albania (AL)

Austria (AT)

Belgium (BE)

Bulgaria (BG)

Switzerland (CH)

Cyprus (CY)

Czech Republic (CZ)

Germany (DE)

Denmark (DK)

Estonia (EE)

Spain (ES)

Finland (FI)

France (FR)

United Kingdom (GB)

Greece (GR)

Croatia (HR)

Hungary (HU)

Ireland (IE)

Iceland (IS)

Italy (IT)

Liechtenstein (LI)

Lithuania (LT)

Luxembourg (LU)

Latvia (LV)

Monaco (MC)

North Macedonia (MK)

Malta (MT)

Netherlands (NL)

Norway (NO)

Poland (PL)

Portugal (PT)

Romania (RO)

Serbia (RS)

Sweden (SE)

Slovenia (SI)

Slovakia (SK)

San Marino (SM)

Turkey (TR)

Parties & Representation

Applicants

Advanced Accelerator Applications S.A.

8 rue Henri Sainte-Claire Deville, CS10150

Inventors (7)

CHICCO, Daniela

86077 Pozzilli Isernia

BARBATO, Donato

86077 Pozzilli Isernia

DE PALO, Francesco

86077 Pozzilli Isernia

FUGAZZA, Lorenza

86077 Pozzilli Isernia

MARIANI, Maurizio

86077 Pozzilli Isernia

TESORIERE, Giovanni

86077 Pozzilli Isernia

BRAMBATI, Clementina

86077 Pozzilli Isernia

Representatives / Agents

Carpmaels & Ransford LLP

One Southampton Row, London WC1B 5HA

Maiwald GmbH

Elisenhof, Elisenstraße 3

Key Procedural Dates

Request-For-Examination 2025-03-07

Mention Of Grant Published 2026-02-04

First-Examination-Report-Despatched 2025-07-04

Patent Oppositions

Official opposition proceedings filed against European Patent EP4541381 under EPC Article 99.

2 ACTIVE OPPONENTS

Opponent Company

Lumara Bio Oncologics GmbH

Lichtenbergstraße 1, DE

Representative

Maiwald GmbH

Filing Date

2026-11-03

Opposition in Progress

Opponent Company

Withers & Rogers LLP / Greg Stepney / Howard Wright / Nicholas Wallin

2 London Bridge, GB

Representative

—

Filing Date

2026-11-04

Opposition in Progress

Patent & Non-Patent Citations

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

23 Citations

Cited Patent Documents

WO2008009444

Espacenet

US6780996

Espacenet

WO02066470

Espacenet

US5621002

Espacenet

WO03064383

Espacenet

WO03077914

Espacenet

WO0035436

Espacenet

WO0206213

Espacenet

US2779780

Espacenet

WO2007014011

Espacenet

WO03076424

Espacenet

US4261989

Espacenet

Non-Patent Scientific Literature (NPL)

ANUPAM MATHUR ET AL: "Bulk Scale Formulation of Therapeutic Doses of Clinical Grade Ready-to-Use 177 Lu-DOTA-TATE: The Intricate Radiochemistry Aspects", CANCER BIOTHERAPY & RADIOPHARMACEUTICALS, vol. 32, no. 7, 1 September 2017 (2017-09-01), US, pages 266 - 273, XP055558673, ISSN: 1084-9785, DOI: 10.1089/cbr.2017.2208

STEPHAN MAUS ET AL: "Aspects on radiolabeling of 177Lu-DOTA-TATE: After C18 purification re-addition of ascorbic acid is required to maintain radiochemical purity", INTERNATIONAL JOURNAL OF DIAGNOSTIC IMAGING, SCIEDU PRESS, CA, vol. 1, no. 1, 1 March 2014 (2014-03-01), pages 5 - 11, XP002738789, ISSN: 2331-5857, [retrieved on 20140221], DOI: 10.5430/IJDI.V1N1P5

LUNA-GUTIRREZ MYRNA ET AL: "Freeze-dried multi-dose kits for the fast preparation of177Lu-Tyr3-octreotide and177Lu-PSMA(inhibitor) under GMP conditions", JOURNAL OF RADIOANALYTICAL AND NUCLEAR CHEMISTRY, AKADEMIAI KIADO RT, HU, vol. 314, no. 3, 2 November 2017 (2017-11-02), pages 2181 - 2188, XP036380439, ISSN: 0236-5731, [retrieved on 20171102], DOI: 10.1007/S10967-017-5595-1

DE BARBOZA M ET AL: "PRODUCTION and QUALITY CONTROL of 177 Lu-DOTATATE [ 177 Lu-DOTA-Tyr3]-OCTREOTATE: CLINICAL APPLICATION", 31 December 2009 (2009-12-31), XP093192831, Retrieved from the Internet <URL:https://inis.iaea.org/collection/NCLCollectionStore/_Public/43/004/43004240.pdf>

DE BARBOZA M ET AL: "PRODUCTION AND QUALITY CONTROL OF 177 LU-DOTATATE [ 177 LU-DOTA-TRY3]-OCTREOTATE: CLINICAL APPLICATION", 31 December 2009 (2009-12-31), XP093192833, Retrieved from the Internet <URL:https://inis.iaea.org/collection/NCLCollectionStore/_Public/43/005/43005461.pdf>

EMA: "Assessment report: Lutathera", 17 January 2018 (2018-01-17), XP093192834, Retrieved from the Internet <URL:https://www.ema.europa.eu/en/documents/assessment-report/lutathera-epar-public-assessment-report_en.pdf>

DAS ET AL., J RADIOANAL NUCL CHEM, vol. 299, 2014, pages 1389 - 1398

DAS ET AL., CURRENT RADIOPHARMACEUTICALS, vol. 7, 2014, pages 12 - 19

LUNA-GUTIERREZ ET AL., J RADIOANAL NUCL CHEM, vol. 314, 2017, pages 2181 - 2188

MATHUR ET AL., CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS,, vol. 32, no. 7, 2017, pages 266 - 273

no. 1204531-25-80

Official File Inspection EPC Art. 128 Public Dossier

Complete European Patent Register Dossier (148 Total Documents)

The full inspection file for Application EP25162403 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

Procedural Step

Date: 2025-12-16 Procedure: Grant IGRA

Inspect on Register

STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS

Patent Abstract / Summary

IPC Classifications

Priority Claims

Designated Contracting States (38 EPC States)

Parties & Representation

Applicants

Inventors (7)

Representatives / Agents

Key Procedural Dates

Patent Oppositions

Lumara Bio Oncologics GmbH

Withers & Rogers LLP / Greg Stepney / Howard Wright / Nicholas Wallin

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 Search Report (A3)

European Patent Application without Search Report (A2)

Opposition filed

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)

New entry: Communication of intention to grant a patent

Intention to grant the patent

New entry: Reply to examination report

New entry: Renewal fee paid

Renewal fee payment

New entry: Despatch of examination report + time limit

First examination report

Change - applicant

Communication from the examining division

Date on which the examining division has become responsible

Change - classification

Publication of search report

The date on which the examining division becomes responsible, has been established

Publication in section I.1 EP Bulletin

Request for examination filed

New entry: Renewal fee paid

Change - representative

Renewal fee payment

Language of the procedure

International searching authority

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