Opposition Filed Opposition filed by SANDOZ AG, Teva Pharmaceutical Industries Ltd EP Register Verified

METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOMAL IRINOTECAN

Publication No. EP3919048

•

App No. EP21171689

•

Filed by Ipsen Biopharm Ltd.

•

Filed on 2013-06-12

•

Issued/Published on 2026-01-28

Official EPO Register

Publication No. EP3919048 A1

Application No. EP21171689 Filed: 2013-06-12

Grant Date 2026-01-28 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

A61K9/00, A61K31/4745, A61K31/513, A61K31/517, A61P35/00, A61K9/127, A61K31/519, A61K45/06, A61P1/18, A61P9/00, A61P43/00

Priority Claims

US 201261659211P Date: 2012-06-13

US 201361784382P Date: 2013-03-14

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

Ipsen Biopharm Ltd.

Ash Road, Wrexham Industrial Estate

Ipsen Biopharm Limited

Ash Road, Wrexham Industrial Estate

Inventors (8)

BAYEVER, Eliel

New York

DHINDSA, Navreet

Boston

FITZGERALD, Jonathan Basil

Arlington

LAIVINS, Peter

Scituate

MOYO, Victor

Ringoes

NIYIKIZA, Clet

Gulph Mills

KIM, Jaeyeon

Lexington

FITZGERALD, Jonathan, Basil

Arlington

Representatives / Agents

Carpmaels & Ransford LLP

One Southampton Row, London WC1B 5HA

Kraus & Lederer PartGmbB

Thomas-Wimmer-Ring 15, 80539 München

D Young & Co LLP

3 Noble Street, London EC2V 7BQ

Elkington and Fife LLP

Prospect House, 8 Pembroke Road

Graf von Stosch Patentanwaltsgesellschaft mbH

Prielmayerstr. 1, 80335 München

Key Procedural Dates

Request-For-Examination 2022-06-08

First-Examination-Report-Despatched 2023-09-05

Patent Oppositions

Official opposition proceedings filed against European Patent EP3919048 under EPC Article 99.

4 ACTIVE OPPONENTS

Opponent Company

SANDOZ AG

Centralbahnstrasse 4, CH

Representative

Kraus & Lederer PartGmbB

Filing Date

2026-10-27

Opposition in Progress

Opponent Company

Teva Pharmaceutical Industries Ltd

124 Dvora HaNevi'a St., IL

Representative

D Young & Co LLP

Filing Date

2026-10-27

Opposition in Progress

Opponent Company

Generics (U.K.) Limited

Building 4, Trident Place, GB

Representative

Elkington and Fife LLP

Filing Date

2026-10-27

Opposition in Progress

Opponent Company

Lepthien, Sandra

c/o Graf von Stosch Patentanwaltsgesellschaft mbH, DE

Representative

Graf von Stosch Patentanwaltsgesellschaft mbH

Filing Date

2026-10-28

Opposition in Progress

Patent & Non-Patent Citations

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

67 Citations

Cited Patent Documents

WO2012146610

Espacenet

US8147867

Espacenet

WO2013138371

Espacenet

WO2013188586

Espacenet

EP2861210

Espacenet

US201261659211

Espacenet

US201361784382

Espacenet

Non-Patent Scientific Literature (NPL)

"Study of MM-398 Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer", 11 December 2011 (2011-12-11), pages 1 - 3, XP055075223, Retrieved from the Internet <URL:http://clinicaltrials.gov/archive/NCT01494506/2011_12_16> [retrieved on 20130814]

CHANG-SUNG TSAI ET AL: "Nanovector-based therapies in advanced pancreatic cancer", JOURNAL OF GASTROINTESTINAL ONCOLOGY, 1 September 2011 (2011-09-01), pages 185 - 194, XP055075231, Retrieved from the Internet <URL:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397610/pdf/jgo-02-03-185.pdf> [retrieved on 20130814], DOI: 10.3978/j.issn.2078-6891.2011.034

HEDIA BRIXI-BENMANSOUR ET AL: "Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma", DIGESTIVE AND LIVER DISEASE, W.B. SAUNDERS, GB, vol. 43, no. 11, 1 July 2011 (2011-07-01), pages 912 - 916, XP028296448, ISSN: 1590-8658, [retrieved on 20110707], DOI: 10.1016/J.DLD.2011.07.001

D. C. DRUMMOND ET AL: "Development of a Highly Active Nanoliposomal Irinotecan Using a Novel Intraliposomal Stabilization Strategy", CANCER RESEARCH, vol. 66, no. 6, 15 March 2006 (2006-03-15), US, pages 3271 - 3277, XP055329486, ISSN: 0008-5472, DOI: 10.1158/0008-5472.CAN-05-4007

T. H. CORBETT ET AL., CANCER TREATMENT REPORTS, vol. 66, 1982, pages 1187

EISENHAUER, E.A.: "New response evaluation criteria in solid tumors: Revised RECIST guideline", EUROPEAN JOURNAL OF CANCER, vol. 45, 2009, pages 228 - 247

L. CHEN; H. SHIAH; T. CHAO; R. K. HSIEH; G. CHEN; J. CHANG; G. YEH: "Phase I study of liposome irinotecan (PEP02) in combination with weekly infusion of 5-FU/LV in advanced solid tumors", JOURNAL OF CLINICAL ONCOLOGY, vol. 28, no. 15_Suppl., 1 January 2010 (2010-01-01), XP002763720, Retrieved from the Internet <URL:http://ascopubs.org/doi/abs/10.1200/jco.2010.28.15_suppl.e13024> [retrieved on 20161102], DOI: 10.1200/jco.2010.28.15_suppl.e13024

CHEN LI-TZONG, HER-SHYONG SHIAH, PENG-CHAN LIN, JENQ-CHANG LEE, WU-CHOU SU, YI-WEN WANG, GRACE YEH, JANG-YANG CHANG: "#613: Phase I study of biweekly liposome irinotecan (PEP02, MM-398) in metastatic colorectal cancer failed on first-line oxaliplatin-based chemotherapy", 2012 GASTROINTESTINAL CANCERS SYMPOSIUM; JANUARY 1921, 2012; SAN FRANCISCO, CALIFORNIA, USA, ASCO, 19 January 2012 (2012-01-19) - 21 January 2012 (2012-01-21), pages 1 - 1, XP093452470

LI-TZONG CHEN, HER-SHYONG SHIAH, PENG-CHAN LIN, JENQ-CHANG LEE, WU-CHOU SU, YI-WEN WANG, GRACE YEH, JANG-YANG CHANG: "Phase I study of biweekly liposome irinotecan (PEP02, MM-398) in metastatic colorectal cancer failed on first-line oxaliplatin-based chemotherapy", JOURNAL OF CLINICAL ONCOLOGY, AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO), ALEXANDRIA, VA, vol. 30, no. 4S, 1 February 2012 (2012-02-01) - 21 January 2012 (2012-01-21), Alexandria, VA, pages 1 - 2, XP055893447, ISSN: 0732-183X, DOI: 10.1200/jco.2012.30.4_suppl.613

KO A H, TEMPERO M A, SHAN Y S, SU W C, LIN Y L, DITO E, ONG A, WANG Y W, YEH G, CHENS L T: "Abstract 4069: A multinational phase II study of PEP02 (liposome irinotecan) for patients with gemcitabine-refractory metastatic pancreatic cancer", 2011 ASCO ANNUAL MEETING (THE 47TH ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY); JUNE 37, 2011, CHICAGO, USA, ASCO, 3 June 2011 (2011-06-03) - 7 June 2011 (2011-06-07), pages 1 - 9, XP093452504

A. H. KO; TEMPERO M. A.; SHAN Y.; SU W.; LIN Y.; DITO E.; ONG A.; WANG Y.; YEH G.; CHEN L.: "A multinational phase II study of PEP02 (liposome irinotecan) for patients with gemcitabine-refractory metastatic pancreatic cancer.", JOURNAL OF CLINICAL ONCOLOGY, vol. 29, no. 15_suppl, 20 May 2011 (2011-05-20), pages 4069 - 4069, XP055462083, DOI: 10.1200/jco.2011.29.15_suppl.4069

CHEN L., CHANG T., CHENG A., YANG C., SHIAH H., CHANG J., YEH G.: "Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients", ASCO ANNUAL MEETING 2008 (44TH ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY), MAY 30 TO JUNE 3, 2008, CHICAGO, ILLINOIS, USA, AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO), 30 May 2008 (2008-05-30) - 3 June 2008 (2008-06-03), pages 1 - 9, XP093452512 [PX] 1,12-27 * the whole document *[I] 2-11

L. CHEN; CHANG T.; CHENG A.; YANG C.; SHIAH H.; CHANG J.; YEH G.: "Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients", JOURNAL OF CLINICAL ONCOLOGY, AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO), ALEXANDRIA, VA, vol. 26, no. 15_suppl, 20 May 2008 (2008-05-20), Alexandria, VA, pages 2565 - 2565, XP055462011, ISSN: 0732-183X, DOI: 10.1200/jco.2008.26.15_suppl.2565

MERRIMACK PHARMACEUTICALS: "NCT01494506 Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer (NAPOLI-1)", CLINICALTRIALS.GOV, NLM, 8 August 2012 (2012-08-08), pages 1 - 16, XP093452519, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01494506?cond=NCT01494506%20&viewType=Card&rank=1&tab=history&a=13#version-content-panel> [X] 1,9-10 * the whole document *[I] 1,9-10,12

MERRIMACK PHARMACEUTICALS: "NCT01494506 Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer (NAPOLI-1)", CLINICALTRIALS.GOV, NLM, 29 May 2012 (2012-05-29), pages 1 - 13, XP093452517, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01494506?cond=NCT01494506%20&viewType=Card&rank=1&tab=history&a=9#version-content-panel> [X] 1,5,9-11 * page 189, column r, paragraph 2 * [I] 1-15

MERRIMACK PHARMACEUTICALS: "NCT01494506 Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer (NAPOLI-1)", CLINICALTRIALS.GOV, NLM, 25 January 2013 (2013-01-25), pages 1 - 18, XP093452526, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01494506?cond=NCT01494506%20&viewType=Card&rank=1&tab=history&a=18#version-content-panel> [I] 2-10,13-15 * page 915, column r, paragraph 5 *

MERRIMACK PHARMACEUTICALS: "NCT01494506 Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer (NAPOLI-1)", CLINICALTRIALS.GOV, NLM, 15 December 2011 (2011-12-15), pages 1 - 12, XP093452530, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01494506?cond=NCT01494506%20&viewType=Card&rank=1&tab=history&a=1#version-content-panel>

GERCOR - MULTIDISCIPLINARY ONCOLOGY COOPERATIVE GROUP: "NCT01375816 Liposome-encapsulated Irinotecan Hydrochloride PEP02 or Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil as Second-Line Therapy in Treating Patients With Metastatic Colorectal Cancer (PEPCOL)", CLINICALTRIALS.GOV, NLM, 16 June 2011 (2011-06-16), pages 1 - 12, XP093452557, Retrieved from the Internet <URL:https://clinicaltrials.gov/study/NCT01375816?cond=NCT01375816&viewType=Card&rank=1&tab=history&a=1#version-content-panel> * the whole document *

CHANG-SUNG TSAI; JOHN W. PARK; LI-TZONG CHEN: "Nanovector-based therapies in advanced pancreatic cancer", JOURNAL OF GASTROINTESTINAL ONCOLOGY, AME PUBLISHING COMPANY, vol. 2, no. 3, 1 September 2011 (2011-09-01), pages 185 - 194, XP055075231, ISSN: 2078-6891, DOI: 10.3978/j.issn.2078-6891.2011.034

ANONYMOUS: "Camptosar irinotecan hydrochloride injection", CAMPTOSAR, 1 January 1996 (1996-01-01), pages 1 - 38, XP055894298, [retrieved on 20220222]

ANONYMOUS: "HIGHLIGHTS OF PRESCRIBING INFORMATION Levoleucovorin (for Injection) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAVENOUS use", HIGHLIGHTS OF PRESCRIBING INFORMATION, FDA, 1 January 2008 (2008-01-01), pages 1 - 7, XP093452561, Retrieved from the Internet <URL:https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf>

C YOO; J Y HWANG; J-E KIM; T W KIM; J S LEE; D H PARK; S S LEE; D W SEO; M-H KIM; D J HAN; S C KIM; J-L LEE: "A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer", BRITISH JOURNAL OF CANCER, NATURE PUBLISHING GROUP UK, LONDON, vol. 101, no. 10, 17 November 2009 (2009-11-17), London, pages 1658 - 1663, XP055326781, ISSN: 0007-0920, DOI: 10.1038/sj.bjc.6605374

D. C. DRUMMOND; C. O. NOBLE; Z. GUO; K. HONG; J. W. PARK; D. B. KIRPOTIN: "Development of a Highly Active Nanoliposomal Irinotecan Using a Novel Intraliposomal Stabilization Strategy", CANCER RESEARCH, AMERICAN ASSOCIATION FOR CANCER RESEARCH (AACR), UNITED STATES, vol. 66, no. 6, 15 March 2006 (2006-03-15), United States, pages 3271 - 3277, XP055329486, ISSN: 0008-5472, DOI: 10.1158/0008-5472.CAN-05-4007

JENNIFER H E BAKER, JEFFREY LAM, ALAISTAIR H KYLE, JONATHAN SY, THOMAS OLIVER, STEVEN J CO, WIESLAWA H DRAGOWSKA, EUAN RAMSAY, MAL: "Irinophore C, a Novel Nanoformulation of Irinotecan, Alters Tumor Vascular Function and Enhances the Distribution of 5-Fluorouracil and Doxorubicin", CLINICAL CANCER RESEARCH, AMERICAN ASSOCIATION FOR CANCER RESEARCH INC, vol. 14, no. 22, 15 November 2008 (2008-11-15), pages 7260 - 7271, XP055892711, ISSN: 1078-0432, DOI: 10.1158/1078-0432.CCR-08-0736

VINCENT J VENDITTO, ERIC E SIMANEK: "Cancer Therapies Utilizing the Camptothecins: A Review of the In Vivo Literature", MOLECULAR PHARMACEUTICS, AMERICAN CHEMICAL SOCIETY (ACS), vol. 7, no. 2, 5 April 2010 (2010-04-05), pages 307 - 349, XP055892704, ISSN: 1543-8384, DOI: 10.1021/mp900243b

D14 - Decision of the Opposition Division revoking grandparent EP 2861210

D15 - Preliminary opinion of Board of Appeal 3.3.07 in the appeal against the decision of the Opposition Division revoking grandparent EP 2861210 B1

D16 - Decision T 2963/19 of Board of Appeal 3.3.07 dismissing the appeal against the decision of the Opposition Division revoking grandparent EP 2861210

D17 - Preliminary opinion of the Opposition Division in the oppositions against parent EP 3266456

D18 - Decision T 98/24 of Board of Appeal 3.3.07 dismissing the appeal against the decision of the Opposition Division revoking parent EP 3266456

ANONYMOUS ASHISH, KLINZ STEPHAN, PAZ NANCY, KIM JAEYEON, CHALISHAZAR MILIND, DRUMMOND DARYL, KIRPOTIN DMITRI, MOYO VICTOR, NIYIKIZ: "Abstract 5696: Evaluating determinants for enhanced activity of MM-398/PEP02; a novel nanotherapeutic encapsulation of irinotecan (CPT-11)", CANCER RESEARCH, AMERICAN ASSOCIATION FOR CANCER RESEARCH (AACR), vol. 72, no. 8_Supplement, 15 April 2012 (2012-04-15) - 4 April 2012 (2012-04-04), pages 5696 - 5696, XP093452567, ISSN: 0008-5472, DOI: 10.1158/1538-7445.am2012-5696

ANONYMOUS D., PARK S., KANG Y., CHAO Y., CHEN L., REES C., LIM H., TABERNERO J., YEH G., DE GRAMONT A.: "Randomized phase II study of PEP02, irinotecan, or docetaxel as a second-line therapy in gastric or gastroesophageal junction adenocarcinoma. Journal of Clinical Oncology", JOURNAL OF CLINICAL ONCOLOGY, AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO), vol. 29, no. 4_suppl, 1 February 2011 (2011-02-01) - 22 January 2011 (2011-01-22), pages 6 - 6, XP093452572, ISSN: 0732-183X, DOI: 10.1200/jco.2011.29.4_suppl.6

ANONYMOUS: "PEP02", PHARMAENGINE, PHARMAENGINE, INC., 4 August 2011 (2011-08-04), pages 1 - 4, XP093452585, Retrieved from the Internet <URL:https://www.pharmaengine.com/pep02.html>

HEDIA BRIXI-BENMANSOUR; JEAN-LOUIS JOUVE; EMMANUEL MITRY; FRANCK BONNETAIN; BRUNO LANDI; OLIVIA HENTIC; LAURENT BEDENNE; GUILLAUME: "Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma", DIGESTIVE AND LIVER DISEASE, W.B. SAUNDERS, GB, vol. 43, no. 11, 1 July 2011 (2011-07-01), GB, pages 912 - 916, XP028296448, ISSN: 1590-8658, DOI: 10.1016/j.dld.2011.07.001

D23 - T 790/10

CHEN PIN-YUAN; OZAWA TOMOKO; DRUMMOND DARYL C.; KALRA ASHISH; FITZGERALD JONATHAN B.; KIRPOTIN DMITRI B.; WEI KUO-CHEN; BUTOWSKI N: "Comparing routes of delivery for nanoliposomal irinotecan shows superior anti-tumor activity of local administration in treating intracranial glioblastoma xenografts", NEURO-ONCOLOGY, OXFORD UNIVERSITY PRESS (OUP), vol. 15, no. 2, 1 February 2013 (2013-02-01), pages 189 - 197, XP055892860, ISSN: 1522-8517, DOI: 10.1093/neuonc/nos305

VITTORIO GEBBIA; MAIELLO EVARISTO; GIULIANI FRANCESCO; BORSELLINO NICOL; ARCARA CARLO; COLUCCI GIUSEPPE: "Irinotecan Plus Bolus/Infusional 5-Fluorouracil and Leucovorin in Patients With Pretreated Advanced Pancreatic Carcinoma : A Multicenter Experience of the Gruppo Oncologico Italia Meridionale", AMERICAN JOURNAL OF CLINICAL ONCOLOGY (CANCER CLINICAL TRIALS)., RAVEN PRESS LTD., NEW YORK NY., US, vol. 33, no. 5, 1 October 2010 (2010-10-01), US, pages 461 - 464, XP055461997, ISSN: 0277-3732, DOI: 10.1097/COC.0b013e3181b4e3b0

ALBERTO ZANIBONI; ENRICO AITINI; SANDRO BARNI; DARIS FERRARI; STEFANO CASCINU; VINCENZO CATALANO; GIUSEPPE VALMADRE; DOMENICA FERR: "FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study", CANCER CHEMOTHERAPY AND PHARMACOLOGY ; 2012-05-11 ; SPRINGER-VERLAG ; BERLIN/HEIDELBERG, SPRINGER, BERLIN, DE, vol. 69, no. 6, 11 May 2012 (2012-05-11), Berlin, DE, pages 1641 - 1645, XP035062678, ISSN: 1432-0843, DOI: 10.1007/s00280-012-1875-1

CINDY NEUZILLET: "FOLFIRI regimen in metastatic pancreatic adenocarcinoma resistant to gemcitabine and platinum-salts", WORLD JOURNAL OF GASTROENTEROLOGY, WJG PRESS, CN, vol. 18, no. 33, 1 January 2012 (2012-01-01), CN , pages 4533, XP055075357, ISSN: 1007-9327, DOI: 10.3748/wjg.v18.i33.4533

J TAIEB; T LECOMTE; T APARICIO; A ASNACIOS; T MANSOURBAKHT; P ARTRU; D FALLIK; J. SPANO; B LANDI; G LLEDO; J DESRAME: "FOLFIRI.3, a new regimen combining 5-fluorouracil, folinic acid and irinotecan, for advanced pancreatic cancer: results of an Association des Gastro-Enterologues Oncologues (Gastroenterologist Oncologist Association) multicenter phase II study", ANNALS OF ONCOLOGY, ELSEVIER LTD, vol. 18, no. 3, 1 March 2007 (2007-03-01), pages 498 - 503, XP055462003, ISSN: 0923-7534, DOI: 10.1093/annonc/mdl427

TARDI; P.G. GALLAGHER; R.C. JOHNSTONE; S. HARASYM; N. WEBB; M. BALLY; M.B. MAYER; L.D.: "Coencapsulation of irinotecan and floxuridine into low cholesterol-containing liposomes that coordinate drug release in vivo", BBA - BIOMEMBRANES, ELSEVIER, AMSTERDAM, NL, vol. 1768, no. 3, 22 February 2007 (2007-02-22), AMSTERDAM, NL, pages 678 - 687, XP005900726, ISSN: 0005-2736, DOI: 10.1016/j.bbamem.2006.11.014

J. M. HOSKINS; R. M. GOLDBERG; P. QU; J. G. IBRAHIM; H. L. MCLEOD: "UGT1A1*28 Genotype and Irinotecan-Induced Neutropenia: Dose Matters", JOURNAL OF THE NATIONAL CANCER INSTITUTE, OXFORD UNIVERSITY PRESS, GB, vol. 99, no. 17, 5 September 2007 (2007-09-05), GB , pages 1290 - 1295, XP055022025, ISSN: 0027-8874, DOI: 10.1093/jnci/djm115

JEFFREY R. INFANTE; VICKI L. KEEDY; SUZANNE F. JONES; WILLIAM C. ZAMBONI; EMILY CHAN; JOHANNA C. BENDELL; WOOIN LEE; HUALI WU; SAT: "Phase I and pharmacokinetic study of IHL-305 (PEGylated liposomal irinotecan) in patients with advanced solid tumors", CANCER CHEMOTHERAPY AND PHARMACOLOGY ; 2012-09-02 ; SPRINGER-VERLAG ; BERLIN/HEIDELBERG, SPRINGER, BERLIN, DE, vol. 70, no. 5, 2 September 2012 (2012-09-02), Berlin, DE, pages 699 - 705, XP035132528, ISSN: 1432-0843, DOI: 10.1007/s00280-012-1960-5

ANONYMOUS: "COMMISSION IMPLEMENTING DECISION of 14.10.2016 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Onivyde - irinotecan", an orphan medicinal product for human use", EUROPEAN COMMISSION, 14 October 2016 (2016-10-14), XP093386437

WANG-GILLAM ANDREA: "Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial", THE LANCET, ELSEVIER, AMSTERDAM, NL, vol. 387, no. 10018, 1 February 2016 (2016-02-01), AMSTERDAM, NL, pages 545 - 557, XP093322641, ISSN: 0140-6736, DOI: 10.1016/S0140-6736(15)00986-1

FDA: "FDA approves new treatment for advanced pancreatic cancer", FDA - NEWS RELEASE, 22 October 2015 (2015-10-22), XP055892881, Retrieved from the Internet <URL:https://web.archive.org/web/20151025001410/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468654.htm> [retrieved on 20220217]

ANONYMOUS: "Fluorouracil 50mg/ml Solution for Injection or Infusion PL 20851/0010 PL 20851/0011 PL 20851/0012 PL 20851/0013", PUBLIC ASSESSMENT REPORT, MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY, 19 September 2006 (2006-09-19), pages 1 - 60, XP093452597, Retrieved from the Internet <URL:https://mhraproducts4853.blob.core.windows.net/docs/9d2f80c05547c4f90da56816849179be0072e826>

HOSPIRA UK LIMITED: "SUMMARY OF PRODUCT CHARACTERISTICS: Calcium Folinate 15mg Tablets", SUMMARY OF PRODUCT CHARACTERISTICS, 29 March 2022 (2022-03-29), pages 1 - 7, XP093452606

D39 - Decision of the board in T2963/19 of 18 March 2022, concerning EP 2 861 210

CHARLES O. NOBLE; MICHAL T. KRAUZE; DARYL C. DRUMMOND; YOJI YAMASHITA; RYUTA SAITO; MITCHEL S. BERGER; DMITRI B. KIRPOTIN; KRYSTOF: "Novel nanoliposomal CPT-11 infused by convection-enhanced delivery in intracranial tumors: pharmacology and efficacy.", CANCER RESEARCH, AMERICAN ASSOCIATION FOR CANCER RESEARCH (AACR), UNITED STATES, vol. 66, no. 5, 1 March 2006 (2006-03-01), United States, pages 2801 - 2806, XP002536516, ISSN: 0008-5472, DOI: 10.1158/0008-5472.CAN-05-3535

KRAUZE M T; NOBLE C O; KAWAGUCHI T; DRUMMOND D; KIRPOTIN D B; YAMASHITA Y; KULLBERG E; FORSAYETH J; PARK J W; BANKIEWICZ K S: "Convection-emhanced delivery of nanoliposomal CPT-11 (irinotecan) and PEGYlated liposomal doxorubicin (Doxil) in rodent intracranial brain tumor xenografts", NEURO-ONCOLOGY, OXFORD UNIVERSITY PRESS (OUP), vol. 9, no. 4, 1 October 2007 (2007-10-01), pages 393 - 403, XP002690547, ISSN: 1522-8517, DOI: 10.1215/15228517-2007-019

D42 - Decision of the board in T2506/12

EISENHAUER, E.A.; THERASSE, P.; BOGAERTS, J.; SCHWARTZ, L.H.; SARGENT, D.; FORD, R.; DANCEY, J.; ARBUCK, S.; GWYTHER, S.; MOONEY, : "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)", EUROPEAN JOURNAL OF CANCER, ELSEVIER, BARCELONA, SPAIN, vol. 45, no. 2, 1 January 2009 (2009-01-01), Barcelona, Spain, pages 228 - 247, XP025841550, ISSN: 0959-8049, DOI: 10.1016/j.ejca.2008.10.026

TEMPERO MARGARET A, BEHRMAN STEPHEN W, BENSON AL B, CASPER EPHRAIM S, CANCER SLOAN-KETTERING, CHIOREAN CENTER E GABRIELA, CHUNG VI: "NCCN Guidelines Version 1.2013 Pancreatic Adenocarcinoma", NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES), NATIONAL COMPREHENSIVE CANCER NETWORK, 9 April 2013 (2013-04-09), pages 1 - 109, XP093452615, Retrieved from the Internet <URL:https://www2.tri-kobe.org/nccn/guideline/archive/pancreas2013/english/pancreatic.pdf>

HO WING M., MA B., MOK TONY, YEO W., LAI PAUL, LIM R., KOH JANE, WONG Y. Y., KING ANN, LEOW C. K., CHAN A. T.C.: "Liver Resection after Irinotecan, 5-Fluorouracil, and Folinic Acid for Patients with Unresectable Colorectal Liver Metastases: A Multicenter Phase II Study by the Cancer Therapeutic Research Group", MEDICAL ONCOLOGY, SPRINGER SCIENCE AND BUSINESS MEDIA LLC, vol. 22, no. 3, 1 September 2005 (2005-09-01), pages 303 - 312, XP093452757, ISSN: 1357-0560, DOI: 10.1385/mo:22:3:303

ANONYMOUS U., KUBICA K., STIELER J., SCHWANER I., HEIL G., GRNER M., MLLE M., HILBIG A., DRKEN B., RIESS H., OETTLE H.: "A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study Journal of Clinical Oncology", JOURNAL OF CLINICAL ONCOLOGY, AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO), vol. 26, no. 15_suppl, 20 May 2008 (2008-05-20) - 3 June 2008 (2008-06-03), pages 4508 - 4508, XP093452761, ISSN: 0732-183X, DOI: 10.1200/jco.2008.26.15_suppl.4508

DAHAN LAETITIA, BONNETAIN FRANK, YCHOU MARC, MITRY EMMANUEL, GASMI MOHAMED, RAOUL JEAN-LUC, CATTAN STPHANE, PHELIP JEAN-MARC, HAM: "Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301)", GUT, BMJ, vol. 59, no. 11, 1 November 2010 (2010-11-01), pages 1527 - 1534, XP093452765, ISSN: 0017-5749, DOI: 10.1136/gut.2010.216135

WANG-GILLAM ANDREA; HUBNER RICHARD A.; SIVEKE JENS T.; VON HOFF DANIEL D.; BELANGER BRUCE; DE JONG FLORIS A.; MIRAKHUR BELOO; CHEN: "NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors", EUROPEAN JOURNAL OF CANCER ; 0000-00-00 ; ELSEVIER ; AMSTERDAM, NL, ELSEVIER, BARCELONA, SPAIN, vol. 108, Barcelona, Spain, pages 78 - 87, XP085591196, ISSN: 0959-8049, DOI: 10.1016/j.ejca.2018.12.007

D51 - Main Request of the revoked grandparent patent EP 2 861 210

H L PARNES, C CIRRINCIONE, J AISNER, D A BERRY, S L ALLEN, J ABRAMS, E CHUANG, M R COOPER, M C PERRY, D B DUGGAN, T P SZATROWSKI, : "Phase III study of cyclophosphamide, doxorubicin, and fluorouracil (CAF) plus leucovorin versus CAF for metastatic breast cancer: Cancer and Leukemia Group B 9140", JOURNAL OF CLINICAL ONCOLOGY, AMERICAN SOCIETY OF CLINICAL ONCOLOGY, BALTIMORE, MD, vol. 21, no. 9, 1 May 2003 (2003-05-01), Baltimore, MD, pages 1819 - 1824, XP009569525, ISSN: 0732-183X, DOI: 10.1200/JCO.2003.05.119

Official File Inspection EPC Art. 128 Public Dossier

Complete European Patent Register Dossier (148 Total Documents)

The full inspection file for Application EP21171689 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.

58 Filings Listed

European Patent Specification - Granted Patent (B1)

Publication Specification

Date: 2026-01-28 Procedure: Grant EP3919048B1

View / Download PDF

Official European Patent Register Full Dossier

Publication Specification

Date: 2026-01-28 Procedure: All Proceedings (Examination & Opposition) EP21171689

View / Download PDF

European Patent Application with Search Report (A1)

Publication Specification

Date: 2021-12-08 Procedure: Publication EP3919048A1

View / Download PDF

Invitation to proprietor to file observations on the notice of opposition

Procedural Step

Date: 2026-11-09 Procedure: Opposition OBSO

Inspect on Register

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

Dossier Filing

Date: 2026-11-08 Procedure: Opposition EPIDOSNOBS2

Inspect on Register

Opposition filed

Dossier Filing

Date: 2026-11-06 Procedure: Opposition 0009260

Inspect on Register

Change - divisional application(s)

Dossier Filing

Date: 2026-01-23 Procedure: Examination 0008299DANR

Inspect on Register

(Expected) grant

Dossier Filing

Date: 2025-12-26 Procedure: Grant 0009210

Inspect on Register

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

Dossier Filing

Date: 2025-12-12 Procedure: Examination EPIDOSNIGR7

Inspect on Register

New entry: Payment of fee for grant

Dossier Filing

Date: 2025-12-11 Procedure: Grant EPIDOSNIGR3

Inspect on Register

New entry: Payment of fee for publishing/printing

Dossier Filing

Date: 2025-12-11 Procedure: Examination EPIDOSNIGR5

Inspect on Register

New entry: Communication of intention to grant a patent

Dossier Filing

Date: 2025-11-25 Procedure: Grant EPIDOSNIGR1

Inspect on Register

METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOMAL IRINOTECAN

Patent Abstract / Summary

IPC Classifications

Priority Claims

Designated Contracting States (38 EPC States)

Parties & Representation

Applicants

Inventors (8)

Representatives / Agents

Key Procedural Dates

Patent Oppositions

SANDOZ AG

Teva Pharmaceutical Industries Ltd

Generics (U.K.) Limited

Lepthien, Sandra

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

Change - divisional application(s)

(Expected) grant

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

New entry: Payment of fee for grant

New entry: Payment of fee for publishing/printing

New entry: Communication of intention to grant a patent

Intention to grant the patent

Change - applicant

Change - inventor

New entry: Reply to 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: 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: Renewal fee paid

Renewal fee payment

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

Application deemed to be withdrawn

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: Decision on request for further processing

Amendment by applicant

New entry: Receipt of request for further processing

New entry: Fee payment for request for further processing

Amendments

Request for further processing

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

New entry: Fee payment for extension state

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

Request for examination filed

Change - designated states

Change - extension states

Date on which the examining division has become responsible

Extension of the patent

New entry: Renewal fee paid

Renewal fee payment

Publication in section I.1 EP Bulletin

Change - representative

New entry: Renewal fee paid

Change - representative

Renewal fee payment

Language of the procedure

International searching authority