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Methods Of Reducing The Risk Of A Cardiovascular Event In A Subject On Statin Therapy - EP3363433

The patent EP3363433 was granted to Amarin Pharmaceuticals Ireland on Dec 9, 2020. The application was originally filed on Jun 28, 2013 under application number EP17206714A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3363433

AMARIN PHARMACEUTICALS IRELAND
Application Number
EP17206714A
Filing Date
Jun 28, 2013
Status
Granted And Under Opposition
Nov 6, 2020
Grant Date
Dec 9, 2020
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (3)

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HOFFMANN EITLESep 9, 2021HOFFMANN EITLE -
COOKESep 7, 2021ELKINGTON AND FIFEADMISSIBLE
ELKINGTON AND FIFESep 3, 2021ELKINGTON AND FIFEADMISSIBLE

Patent Citations (5) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
OPPOSITIONUS2011178105
OPPOSITIONUS2012035262
OPPOSITIONUS2012121698
OPPOSITIONWO2010014799
OPPOSITIONWO2012074930

Non-Patent Literature (NPL) Citations (44) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
EXAMINATION- Deepak L Bhatt, "Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia", (20190103), URL: https://www.nejm.org/doi/pdf/10.1056/NEJMoa1812792?articleTools=true, (20200303), XP055673350
OPPOSITION- Anonymous, "Amarin's AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints with Statistically Significant Reductions in Triglycerides at Both 4 Gram and 2 Gram Doses and Statistically Significant Decrease in LDL-C", AMARIN, (20110408), pages 1 - 3, XP055843598-
OPPOSITION- Anonymous, "AMARIN'S AMR101 PHASE 3 ANCHOR TRIAL MEETS ALL PRIMARY AND SECONDARY ENDPOINTS WITH STATISTICALLY SIGNIFICANT REDUCTIONS IN TRIGLYCERIDES AT BOTH 4 GRAM AND 2 GRAM DOSES AND STATISTICALLY SIGNIFICANT DECREASE IN LDL-C", AMARIN, (20110418), pages 1 - 3, XP055844794-
OPPOSITION- Anonymous, "A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE- IT", ClinicalTrials.gov archive, (20120316), no. NCT01492361, pages 1 - 17, XP055843555-
OPPOSITION- Anonymous, "A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)", ClinicalTrials.gov Identifier: NCT01492361, (20120319), pages 1 - 8, URL: http://clinicaltrials.gov, XP055844777-
OPPOSITION- Anonymous, "Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (ANCHOR)", ClinicalTrials.gov Identifier: NCT01047501, (20110725), pages 1 - 8, XP055844781-
OPPOSITION- Anonymous, "High blood cholesterol: What you need to know", National Cholesterol Education Program, (20050600), pages 1 - 6, XP055843603-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01492361 A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)", ClinicalTrials.gov archive, (20120316), pages 1 - 17, XP055844076-
OPPOSITION- Anonymous, "LOVAZA (omega-3-acid ethyl esters) Capsules, for oral use", FDA. HIGHLIGHTS OF PRESCRIBING INFORMATION, (20130601), pages 1 - 27, FDA. HIGHLIGHTS OF PRESCRIBING INFORMATION, (20231219), XP093113583-
OPPOSITION- Anonymous, "Overview Coronary angioplasty and stent insertion", NHS, (20221004), NHS, URL: https://www.nhs.uk/conditions/coronary-angioplasty/#:~:text=The%20term%20%22angioplasty%22%20means%20using,blood%20to%20flow%20more%20freely., (20231219), XP093113571-
OPPOSITION- Anonymous, "Trilipix Fenofibric Acid Delayed Release Capsules", FDA, (20181101), pages 1 - 59, FDA, (20231219), XP093113578-
OPPOSITION- Ballantyne Christie M; Bays Harold E; Kastelein John J; Stein Evan A; Isaacsohn Jonathan; Braeckman Rene A; Soni Paresh N, "AMR101 Lowers Triglycerides, Atherogenic Lipoprotein, Phospholipase A(2), and High-sensitivity C-reactive Protein Levels in Patients With High Triglycerides and on Background Statin Therapy (the ANCHOR Study)", Circulation, (20110000), vol. 124, page A15071, XP009184942-
OPPOSITION- Christie M Ballantyne; Harold E Bays; John J Kastelein; Evan A Stein; Jonathan Isaacsohn; Rene A Braeckman; Paresh N Soni, "Abstract 15071: AMR101 Lowers Triglycerides, Atherogenic Lipoprotein, Phospholipase A2, and High-sensitivity C-reactive Protein Levels in Patients With High Triglycerides and on Background Statin Therapy", the ANCHOR Study, (20111122), vol. 124, no. 21, XP002752620-
OPPOSITION- IGGY IGETTE, "Amarin's Fish Oil: Blazing a New Path against Cardiovascular Disease", Seeking Alpha, (20120502), pages 1 - 23, URL: https://seekingalpha.com/article/552781-ama rins-fish-oi l-blazi ng-a-new-path-aga inst- cardiovascular-disease, XP055844745-
OPPOSITION- M. MATSUZAKI et al., "Incremental Effects of Eicosapentaenoic Acid on Cardiovascular Events in Statin-Treated Patients With Coronary Artery Disease - Secondary Prevention Analysis From JELIS", Circ J, (20090000), vol. 73, pages 1283 - 1290, XP055844740-
OPPOSITION- PANIKAR, V., "Mixed Dyslipidaemia", Medicine Update, (20080000), vol. 18, no. 101, pages 1 - 6, XP055843594-
OPPOSITION- REMINGTON et al., The Science and Practice of Pharmacy 22nd Edition,, (20130000), pages 2595 - 2599, XP055843587-
OPPOSITION- "REMINGTON", The Science and Practice of Pharmacy 22nd Edition, (20130000), pages 2595 - 2599, XP055843587-
OPPOSITION- Rene Braeckman; Mehar S Manku; Christie M Ballantyne; William G Stirtan; Paresh N Soni, "Abstract 18549: Effects of AMR101, a Pure Eicosapentaenoic Omega-3 Fatty Acid, on the Fatty Acid Profile in Plasma and Red Blood Cells in Statin-Treated Patients With Persistent High Triglycerides (Results from the ANCHOR Study)", Circulation, (20120000), vol. 126, no. 21S, page A18549, XP002752590-
OPPOSITION- Rene Braeckman; Mehar S Manku; Christie M Ballantyne; William G Stirtan; Paresh N Soni, "Abstract 18549: Effects of AMR101, a Pure Eicosapentaenoic Omega-3 Fatty Acid, on the Fatty Acid Profile in Plasma and Red Blood Cells in Statin-Treated Patients With Persistent High Triglycerides (Results from the ANCHOR Study", Circulation, (20121120), vol. 126, no. 21S, page A15071, XP002752590-
OPPOSITION- Supplementary data to D8-
OPPOSITION- V. PANIKAR, "Chapter 101- Mixed Dyslipidemia", Medicine Update, (20080000), vol. 18, pages 764 - 769, XP055843594-
OPPOSITION- NAKAMURA N. et al., "Joint effects of HMG-CoA reductase inhibitors and eicosapentaenoic acids on serum lipid profile and plasma fatty acid concentrations in patients with hyperlipidemia", International Journal of Clinical and Laboratory Research, (19990000), vol. 29, doi:10.1007/s005990050057, pages 22 - 25, XP002558875
OPPOSITION- NAKAMURA N et al., "Joint effects of HMG-CoA reductase inhibitors and eicosapentaenoic acids on serum lipid profile and plasma fatty acid concentrations in patients with hypertipidemia", INTERNATIONAL JOURNAL OF CLINICAL AND LABORATORY RESEARCH, BERLIN, DE, (19990301), vol. 29, no. 1, ISSN 0940-5437, pages 22 - 25, XP002558875
OPPOSITION- N. NAKAMURA et al., "Joint effects of HMG-CoA reductase inhibitors and eicosapentaenoic acids on serum lipid profile and plasma fatty acid concentrations in patients with hyperlipidemia", International Journal of Clinical and Laboratory Research, (19990000), vol. 29, no. 1, pages 22 - 25, XP002558875
OPPOSITION- Beatriz G Talayero; Frank M Sacks, "The Role of Triglycerides in Atherosclerosis", Current Cardiology Reports, (20110000), vol. 13, pages 544 - 552, XP019972113
OPPOSITION- Beatriz G Talayero; Frank M Sacks, "The Role of Triglycerides in Atherosclerosis", Current Cardiology Reports, (20111004), vol. 13, no. 6, doi:10.1007/s11886-011-0220-3, pages 544 - 552, XP019972113
OPPOSITION- Harold E. Bays; Christie M. Ballantyne; John J. Kastelein; Jonathan L. Isaacsohn; Rene A. Braeckman; Paresh N. Soni;, "Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Patients With Very High Triglyceride Levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] Trial)", AMERICAN JOURNAL OF CARDIOLOGY., CAHNERS PUBLISHING CO., NEWTON, MA,, US, US , (20110424), vol. 108, no. 5, doi:10.1016/j.amjcard.2011.04.015, ISSN 0002-9149, pages 682 - 690, XP028262633
OPPOSITION- DAVIDSON MH et al., "Efficacy and Tolerability of Adding Prescription Omega-3 Fatty Acids 4 g/d to Simvastatin 40 mg/d in Hypertriglyceridemic Patients: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study", Clinical Therapeutics, (20070000), vol. 29, no. 7, doi:10.1016/j.clinthera.2007.07.018, pages 1354 - 1367, XP022230024
OPPOSITION- Erin D Michos; Christopher T Sibley; Jefferson T Baer; Michael J Blaha; Roger S Blumenthal, "Niacin and Statin Combination Therapy for Atherosclerosis Regression and Prevention of Cardiovascular Disease Events", Journal of the American College of Cardiology, (20120000), vol. 59, no. 23, pages 2058 - 2064, XP028510520
OPPOSITION- Erin D Michos; Christopher T Sibley; Jefferson T Baer; Michael J Blaha; Roger S Blumenthal, "Niacin and Statin Combination Therapy for Atherosclerosis Regression and Prevention of Cardiovascular Disease Events", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, (20120125), vol. 59, no. 23, pages 2058 - 2064, XP028510520
OPPOSITION- GISSI-HF investigators, "Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20081004), vol. 372, no. 9645, doi:10.1016/S0140-6736(08)61239-8, ISSN 0140-6736, pages 1223 - 1230, XP025480735
OPPOSITION- "Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (19990831), vol. 354, no. 9177, doi:10.1016/S0140-6736(99)07072-5, ISSN 0140-6736, pages 447 - 455, XP029609485
OPPOSITION- NORDOY A. et al., "Effects of Simvastatin and omega-3 fatty acids on plasma lipoproteins and lipid peroxidation in patients with combined, hyperlipidaemia", Journal of Internal Medicine, (19980000), vol. 243, doi:10.1046/j.1365-2796.1998.00297.x, pages 163 - 170, XP002371430
OPPOSITION- Anonymous, "COMPARISON OF CORONARY BYPASS SURGERY WITH ANGIOPLASTY IN PATIENTS WITH MULTIVESSEL DISEASE", The New England Journal of Medicine, Elsevier Ltd, (19960725), vol. 336, no. 4, doi:10..1056/NEJM199607253350401, pages 217 - 225, XP093113566
OPPOSITION- C.P. CANNON et al., "Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes", New England Journal of Medicine, (20040408), vol. 350, no. 15, doi:10.1056/NEJMoa040583, pages 1495 - 1504, XP009065992
OPPOSITION- C.P. CANNON, "INTENSIVE VERSUS MODERATE LIPID LOWERING WITH STATINS AFTER ACUTE CORONARY SYNDROMES", New England Journal of Medicine, (20040000), vol. 350, no. 15, pages 1495 - 1504, XP009065992
OPPOSITION- Deepak L Bhatt, "Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia", New England Journal of Medicine, (20190103), vol. 380, no. 1, pages 11 - 22, XP055673350
OPPOSITION- DEEPAK L BHATT, "Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia", The New England Journal of Medicine, (20190103), pages 1 - 12, XP055673350
OPPOSITION- MATSUZAKI et al., "Incremental Effects of Eicosapentaenoic Acid on Cardiovascular Events in Statin-Treated Patients With Coronary Artery Disease", CIRC J, (20090000), vol. 73, pages 1283 - 1290, XP055181321
OPPOSITION- M. MATSUZAKI et al., "Incremental Effects of Eicosapentaenoic Acid on Cardiovascular Events in Statin-Treated Patients With Coronary Artery Disease", Circ. J., (20090000), vol. 73, pages 1283 - 1290, XP055181321
SEARCH- Christie M Ballantyne; Harold E Bays; John J Kastelein; Evan A Stein; Jonathan Isaacsohn; Rene A Braeckman; Paresh N Soni, "Abstract 15071: AMR101 Lowers Triglycerides, Atherogenic Lipoprotein, Phospholipase A2, and High-sensitivity C-reactive Protein Levels in Patients With High Triglycerides and on Background Statin Therapy (the ANCHOR Study)", (20111122), URL: http://circ.ahajournals.org/cgi/content/meeting_abstract/124/21_MeetingAbstracts/A15071, (20160105), XP002752620 [I] 1-15 * the whole document *-
SEARCH- Rene Braeckman; Mehar S Manku; Christie M Ballantyne; William G Stirtan; Paresh N Soni, "Abstract 18549: Effects of AMR101, a Pure Eicosapentaenoic Omega-3 Fatty Acid, on the Fatty Acid Profile in Plasma and Red Blood Cells in Statin-Treated Patients With Persistent High Triglycerides (Results from the ANCHOR Study)", Circulation, vol. 126, no. 21S, (20121120), page A15071, URL: http://circ.ahajournals.org/cgi/content/meeting_abstract/126/21_MeetingAbstracts/A18549, (20160104), XP002752590 [XP] 1-15 * the whole document *-
SEARCH- NAKAMURA N ET AL, "Joint effects of HMG-CoA reductase inhibitors and eicosapentaenoic acids on serum lipid profile and plasma fatty acid concentrations in patients with hyperlipidemia", INTERNATIONAL JOURNAL OF CLINICAL AND LABORATORY RESEARCH, SPRINGER, BERLIN, DE, (19990301), vol. 29, no. 1, doi:10.1007/S005990050057, ISSN 0940-5437, pages 22 - 25, XP002558875 [X] 1-15 * the whole document *

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