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EP1313508
European procedure
Extract from the Register of European Patents
EP About this file: EP1313508
| EP1313508 - COMBINATION CONTAINING AN ANTIFOLATE AND METHYLMALONIC ACID LOWERING AGENT [Right-click to bookmark this link] | Status | Opposition rejected Status updated on 12.08.2016 Database last updated on 05.04.2025 | Most recent event Tooltip | 12.08.2016 | Opposition rejected | published on 14.09.2016 [2016/37] | Applicant(s) | For all designated states ELI LILLY AND COMPANY Lilly Corporate Center Indianapolis, IN 46285 / US | [N/P] |
| Former [2007/16] | For all designated states ELI LILLY AND COMPANY Lilly Corporate Center Indianapolis IN 46285 / US | ||
| Former [2003/22] | For all designated states ELI LILLY AND COMPANY Lilly Corporate Center Indianapolis, Indiana 46285 / US | Inventor(s) | 01 /
NIYIKIZA, Clet 6802 Antietam Place Indianapolis, IN 46278 / US | 02 /
PAOLETTI, Paolo 8015 Hayward Drive Indianapolis, IN 46240 / US | 03 /
RUSTHOVEN, James, Jacob 15 Lovers Lane Ancaster, Ontario L9G 1G4 / CA | [2003/22] | Representative(s) | Burnside, Ivan John, et al Eli Lilly and Company Limited 8 Arlington Square West Downshire Way Bracknell, Berkshire RG12 1PU / GB | [N/P] |
| Former [2003/22] | Burnside, Ivan John, et al Eli Lilly and Company Limited, European Patent Operations, Lilly Research Centre, Erl Wood Manor, Sunnighill Road Windlesham, Surrey GU20 6PH / GB | Application number, filing date | 01948214.0 | 15.06.2001 | [2003/22] | WO2001US14860 | Priority number, date | US20000215310P | 30.06.2000 Original published format: US 215310 P | US20000235859P | 27.09.2000 Original published format: US 235859 P | US20010284448P | 18.04.2001 Original published format: US 284448 P | [2003/22] | Filing language | EN | Procedural language | EN | Publication | Type: | A2 Application without search report | No.: | WO0202093 | Date: | 10.01.2002 | Language: | EN | [2002/02] | Type: | A2 Application without search report | No.: | EP1313508 | Date: | 28.05.2003 | Language: | EN | The application published by WIPO in one of the EPO official languages on 10.01.2002 takes the place of the publication of the European patent application. | [2003/22] | Type: | B1 Patent specification | No.: | EP1313508 | Date: | 18.04.2007 | Language: | EN | [2007/16] | Search report(s) | International search report - published on: | EP | 06.02.2003 | Classification | IPC: | A61K45/06, A61P35/00, A61K31/505, A61K31/70 | [2003/22] | CPC: |
A61K31/525 (EP,US);
A61K31/519 (EP,US);
A61K31/70 (EP,US);
A61K31/714 (EP,US);
A61P3/00 (EP);
A61P3/02 (EP);
| C-Set: |
A61K31/519, A61K2300/00 (US,EP);
A61K31/525, A61K2300/00 (EP,US);
A61K31/70, A61K2300/00 (US,EP);
A61K31/714, A61K2300/00 (US,EP) | Designated contracting states | AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LI, LU, MC, NL, PT, SE, TR [2003/22] | Extension states | AL | 06.08.2003 | LT | 06.08.2003 | LV | 06.08.2003 | MK | 06.08.2003 | RO | 06.08.2003 | SI | 06.08.2003 | Title | German: | ZUSAMMENSETZUNG, WELCHE EIN ANTIFOLATE UND EIN METHYLMALONSÄURESENKENDES MITTEL ENTHÄLT | [2003/22] | English: | COMBINATION CONTAINING AN ANTIFOLATE AND METHYLMALONIC ACID LOWERING AGENT | [2003/22] | French: | COMPOSITION COMPRENANT UN ANTIFOLATE ET UN AGENT REDUCTEUR D'ACIDE METHYLMALONIQUE | [2003/22] | Entry into regional phase | 30.01.2003 | National basic fee paid | 06.08.2003 | Designation fee(s) paid | 06.08.2003 | Examination fee paid | Examination procedure | 10.12.2001 | Request for preliminary examination filed International Preliminary Examining Authority: EP | 06.08.2003 | Examination requested [2003/41] | 09.03.2004 | Despatch of a communication from the examining division (Time limit: M06) | 23.12.2004 | Reply to a communication from the examining division | 17.05.2005 | Despatch of a communication from the examining division (Time limit: M06) | 09.01.2006 | Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time | 08.03.2006 | Reply to a communication from the examining division | 04.10.2006 | Communication of intention to grant the patent | 14.02.2007 | Fee for grant paid | 14.02.2007 | Fee for publishing/printing paid | 16.11.2011 | Observations by third parties | 15.06.2012 | Observations by third parties | Opposition(s) | Opponent(s) | 01
17.01.2008
29.02.2008
ADMISSIBLE Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petah Tiqva / IL Opponent's representative Pohlman, Sandra M., et al, et al df-mp Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | 02
30.10.2012
30.10.2012
INTERVENTION Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München / DE Opponent's representative Gillard, Richard Edward Elkington and Fife LLP Thavies Inn House 3-4 Holborn Circus London EC1N 2HA / GB | [N/P] |
| Former [2012/51] | |||
| Opponent(s) | 01
17.01.2008
29.02.2008
ADMISSIBLE Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petah Tiqva / IL Opponent's representative Pohlman, Sandra M., et al, et al df-mp Fünf Höfe Theatinerstrasse 16 80333 München / DE | ||
| 02
30.10.2012
30.10.2012
INTERVENTION Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München / DE Opponent's representative Gillard, Richard Edward Elkington and Fife LLP Thavies Inn House 3-4 Holborn Circus GB-London EC1N 2HA / GB | |||
| Former [2008/41] | |||
| Opponent(s) | 01
17.01.2008
29.02.2008
ADMISSIBLE Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petah Tiqva / IL Opponent's representative Pohlman, Sandra M., et al, et al df-mp Fünf Höfe Theatinerstrasse 16 80333 München / DE | ||
| Former [2008/19] | |||
| Opponent(s) | 01
17.01.2008
29.02.2008
ADMISSIBLE Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petah Tiqva / IL Opponent's representative Pohlman, Sandra M., et al, et al df-mp Fünf Höfe Theatinerstrasse 16 80333 München / DE | ||
| Former [2008/10] | |||
| Opponent(s) | 01
17.01.2008
Teva Pharmaceutical Industries Ltd. 5 Basel Street 49131 Petah Tiqva / IL Opponent's representative Biagini, Giuditta, et al, et al df-mp Fünf Höfe Theatinerstraße 16 D-80333 München / DE | 31.07.2008 | Invitation to proprietor to file observations on the notice of opposition | 09.04.2009 | Reply of patent proprietor to notice(s) of opposition | 08.06.2009 | Communication of observations of patent proprietor (Time limit: M04) | 15.10.2009 | Reply of parties involved to observations of patent proprietor | 18.11.2010 | Date of oral proceedings | 27.12.2010 | Despatch of minutes of oral proceedings | 27.12.2010 | Date of despatch of rejection of opposition | 28.10.2015 | Legal effect of rejection of opposition [2016/37] | Appeal following opposition | 03.03.2011 | Appeal received No. T0542/11 | 05.05.2011 | Statement of grounds filed | 28.10.2015 | Result of appeal procedure: appeal of the opponent withdrawn | Request for further processing for: | 08.03.2006 | Request for further processing filed | 08.03.2006 | Full payment received (date of receipt of payment) Request granted | 22.05.2006 | Decision despatched | 23.12.2004 | Request for further processing filed | 23.12.2004 | Full payment received (date of receipt of payment) Request granted | 13.01.2005 | Decision despatched | 08.03.2006 | Request for further processing filed | 08.03.2006 | Full payment received (date of receipt of payment) Request granted | 22.05.2006 | Decision despatched | 23.12.2004 | Request for further processing filed | 23.12.2004 | Full payment received (date of receipt of payment) Request granted | 13.01.2005 | Decision despatched | Fees paid | Renewal fee | 30.06.2003 | Renewal fee patent year 03 | 30.06.2004 | Renewal fee patent year 04 | 30.06.2005 | Renewal fee patent year 05 | 30.06.2006 | Renewal fee patent year 06 |
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| Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court. | Cited in | International search | [X]EP0546870 (SNOW BRAND MILK PROD CO LTD [JP]) [X] 1-8,10-14,16-22,24-26,28 * page 7; tables 3,4 *; | [X]US5405839 (TORAYA TETSUO [JP], et al) [X] 1-3,7,11,13,17,18,21,25,26 * example 15 *; | [T] - CALVERT H., "Folate status and the safety profile of antifolates.", SEMINARS IN ONCOLOGY, (2002) 29/2 SUPPL. 5 (3-7)., XP008005755 [T] 1-28 * see discussion; page 5, column 1 * DOI: http://dx.doi.org/10.1016/S0093-7754(02)70209-1 | [T] - CALVERT H., "Future directions in the development of pemetrexed", SEMINARS IN ONCOLOGY, (2002) 29/2 SUPPL. 5 (54-61)., XP008005744 [T] 1-28 * see conclusions; page 57 * DOI: http://dx.doi.org/10.1053/sonc.2002.30748 | [Y] - WESTERHOF, G. ROBBIN ET AL, "Carrier- and receptor-mediated transport of folate antagonists targeting folate -dependent enzymes: correlates of molecular-structure and biological activity", MOL. PHARMACOL. (1995), 48(3), 459-71, XP008005762 [Y] 4-10,12-16,19-28 * page 467, column 2 * * page 469, column 1 * | [Y] - WORZALLA, JOHN F. ET AL, "Role of folic acid in modulating the toxicity and efficacy of the multitargeted antifolate, LY231514", ANTICANCER RESEARCH (1998), 18(5A), 3235-3239, XP008005757 [Y] 4-10,12-16,19-28 * abstract * * page 3236, column 2 * | [T] - HANAUSKE A-R ET AL, "PEMETREXED DISODIUM: A NOVEL ANTIFOLATE CLINICALLY ACTIVE AGAINST MULTIPLE SOLID TUMORS", ONCOLOGIST, ALPHAMED PRESS, US, (2001), vol. 4, no. 6, ISSN 1083-7159, pages 363 - 373, XP008005751 [T] 1-28 * abstract * * page 370, column 2 - page 371, column 1 * DOI: http://dx.doi.org/10.1634/theoncologist.6-4-363 | [T] - BUNN P ET AL, "VITAMIN B12 AND FOLATE REDUCE TOXICITY OF ALIMTA (PEMETREXED DISODIUM, LY231514, MTA), A NOVEL ANTIFOLATE/ANTIMETABOLITE", PROGRAM/PROCEEDINGS - AMERICAN SOCIETY OF CLINICAL ONCOLOGY, THE SOCIETY, US, (2001), vol. 76A, no. 20, ISSN 1081-0641, page 300, XP008005885 [T] 1-28 * abstract * | other | - "Methotrexate", IBIS Guide to Drug-Herb and Drug-Nutrient Interactions, Integrative Medical Arts Group, Inc.,, (19980000), pages 1 - 13, XP055245765 | - RUSTHOVEN J.J. ET AL, "Multitargeted antifolate LY231514 as first-line chemotherapy for patients with advanced non-small-cell lung cancer: A phase II study", JOURNAL OF CLINICAL ONCOLOGY, (199904), vol. 17, no. 4, pages 1194 - 1199, XP003028633 | - DEN HEIJER M. ET AL, "Vitamin supplementation reduces blood homocysteine levels a controlled trial in patients with venous thrombosis and healthy volunteers", ARTERIOSCLER. THROMB. VASC. BIOL., (1998), vol. 18, pages 356 - 361, XP000910826 | - BRONSTRUP A. ET AL, "Effects of folic acid and combinations of folic acid and vitamin B-12 on plasma homocysteine concentrations in healthy, young women", AM. J. CLIN. NUTR., (1998), vol. 68, pages 1104 - 1110, XP003028634 | - OMENN G.S. ET AL, "Preventing coronary heart disease B vitamins and homocysteine", CIRCULATION, (1998), vol. 97, pages 421 - 424, XP003028635 DOI: http://dx.doi.org/10.1161/01.CIR.97.5.421 | - MORGAN S.L. ET AL, "The effect of folic acid supplementation on the toxicity of low-dose methotrexate in patients with rheumatoid arthritis", ARTHRITIS AND RHEUMATISM, (199001), vol. 33, no. 1, pages 9 - 18, XP003028636 DOI: http://dx.doi.org/10.1002/art.1780330102 | - NIYIKIZA C. ET AL, "LY231514 (MTA): relationship of vitamin metabolite profile to toxicity", PROCEEDINGS OF ASCO, ABSTRACT NO. 2139, (1998), vol. 17, page 558A, XP003028637 | - HAMMOND L. ET AL, "A phase I and pharmacokinetic (PK) study of the multitargeted antifol (MTA) LY231514 with folic acid", 1998 ASCO ANNUAL MEETING, ABSTRACT NO. 866, (1998), page 1, XP003028638 | - BISHOP M.L. ET AL, Clinical Chemistry: Principles, Procedures, Correlations, Third Edition, (1996), pages 618 - 627, XP003028639 | - ELI LILLY AND COMPANY LIMITED, "Label for Alimta(R)", pages 1 - 25, XP003028640 | - CALVERT H., "An overview of folate metabolism: features relevant to the action and toxicities of antifolate anticancer agents", SEMINARS IN ONCOLOGY, (199904), vol. 26, no. 2, pages 3 - 10, XP008005750 | - BUNN P. ET AL, "Vitamin B12 and folate reduce toxicity of AlimtaTM (Pemetrexed Disodium, LY231514, MTA), a novel antifolate/antimetabolite", PROCEEDINGS OF ASCO, ABSTRACT NO. 300, (2001), vol. 20, page 302, XP008005885 | - NIYIKIZA C. ET AL, "Homocysteine and methylmalonic acid: Markers to predict and avoid toxicity from pemetrexed therapy", MOLECULAR CANCER THERAPEUTICS, (200205), vol. 1, pages 545 - 552, XP002987306 | - CLARKE R. ET AL, "Lowering blood homocysteine with folic acid based supplements: meta-analysis of randomised trials", BMJ, (19980321), vol. 316, pages 894 - 898, XP003028641 |