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Semaglutide In Cardiovascular Conditions - EP3448416

The patent EP3448416 was granted to Novo Nordisk on Aug 10, 2022. The application was originally filed on Apr 28, 2017 under application number EP17721109A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3448416

NOVO NORDISK
Application Number
EP17721109A
Filing Date
Apr 28, 2017
Status
Granted And Under Opposition
Jul 8, 2022
Grant Date
Aug 10, 2022
External Links
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Patent Summary

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Patent Family

Patent Oppositions (8)

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APPLEYARD LEESMay 10, 2023ADMISSIBLE
DR SCHONMay 10, 2023ADMISSIBLE
GENERICS UKMay 10, 2023ADMISSIBLE
ADALVOMay 9, 2023ADMISSIBLE
ELKINGTON AND FIFEMay 9, 2023ADMISSIBLE
SANDOZMay 9, 2023ADMISSIBLE
TEVA PHARMACEUTICALSMay 9, 2023ADMISSIBLE
STADA ARZNEIMITTELMay 5, 2023ADMISSIBLE

Patent Citations (11) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTWO03084563
INTERNATIONAL-SEARCH-REPORTWO2012107476
INTERNATIONAL-SEARCH-REPORTWO2013037690
INTERNATIONAL-SEARCH-REPORTWO2015071355
OPPOSITIONWO03084563
OPPOSITIONWO2006097537
OPPOSITIONWO2012080471
OPPOSITIONWO2012107476
OPPOSITIONWO2013037690
OPPOSITIONWO2015071355
OPPOSITIONWO2017186896

Non-Patent Literature (NPL) Citations (84) 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
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OPPOSITION- Anonymous, "Assessment report - Ozempic - International non-proprietary name: semaglutide - Procedure No. EMEA/H/C/004174/0000", EUROPEAN MEDICINES AGENCY ; EMA/CHMP/715701/2017 ; Committee for Medicinal Products for Human Use (CHMP), (20171214), EUROPEAN MEDICINES AGENCY ; EMA/CHMP/715701/2017 ; Committee for Medicinal Products for Human Use (CHMP), URL: https://www.ema.europa.eu/en/documents/assessment-report/ozempic-epar-public-assessment-report_en.pdf, XP093157461-
OPPOSITION- Anonymous, "Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes (SUSTAIN™1) - History of Changes for Study: NCT02054897", ClincalTrials.gov; NCT02054897, (20160317), ClincalTrials.gov; NCT02054897, URL: https://classic.clinicaltrials.gov/ct2/history/NCT02054897?A=16&B=16&C=merged#StudyPageTop, XP093157413-
OPPOSITION- Anonymous, " Guidance for Industry - Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes", U.S. Department of Health and Human Services - Food and Drug Administration - Center for Drug Evaluation and Research (CDER), (20081201), U.S. Department of Health and Human Services - Food and Drug Administration - Center for Drug Evaluation and Research (CDER), XP093157392-
OPPOSITION- Anonymous, "Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus", EUROPEAN MEDICINES AGENCY - SCIENCE MEDICINES HEALTH - CPMP/EWP/1080/00 Rev. 1 Committee for Medicinal Products for Human Use (CHMP), (20120514), EUROPEAN MEDICINES AGENCY - SCIENCE MEDICINES HEALTH - CPMP/EWP/1080/00 Rev. 1 Committee for Medicinal Products for Human Use (CHMP), XP093157396-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION Victoza® (liraglutide [rDNA origin] injection), solution for subcutaneous use", Novo Nordisk A/S, (20100101), page 23pp, Novo Nordisk A/S, (20220518), XP055922445-
OPPOSITION- Anonymous, "Novo Nordisk successfully completes first phase 3a trial with semaglutide in people with type 2 diabetes", Novo Nordisk A/S Company Announcement No 41/2015, Novo Nordisk A/S Company Announcement No 41/2015, (20170530), XP055377163-
OPPOSITION- Anonymous, "Novo Nordisk successfully completes first phase 3a trial with semaglutide in people with type 2 diabetes", Novo Nordisk Company Announcement, (20150710), Novo Nordisk Company Announcement, XP093153451-
OPPOSITION- Anonymous, "Oral semaglutide showing promise as type 2 diabetes treatment", diabetes.co.uk., (20160405), diabetes.co.uk., URL: https://www.diabetes.co.uk/news/2016/apr/oral-semaglutide-showing-promise-as-type-2-diabetes-treatment-95318018.html, XP093160260-
OPPOSITION- Anonymous, "Phenol", Drugbank online, (20050613), Drugbank online, URL: https://go.drugbank.com/drugs/DB03255, XP093160157-
OPPOSITION- Anonymous, "Semaglutide reduced major cardiovascular events by 26% in adults with type 2 diabetes at high cardiovascular risk.", Novo Nordisk Press Release, (20160916), Novo Nordisk Press Release, URL: https://www.prnewswire.com/news-releases/semaglutide-reduced-major-cardiovascular-events-by-26-in-adults-with-type-2-diabetes-at-high-cardiovascular-risk-593658161.html, XP093153434-
OPPOSITION- Anonymous, "Semaglutide signi cantly reduces the risk of major adverse cardiovascular events in the SUSTAIN 6 trial", Novo Nordisk, (20160428), Novo Nordisk, URL: https://www.globenewswire.com/news-release/2016/04/28/1600310/0/en/Semaglutide-significantly-reduces-the-risk-of-major-adverse-cardiovascular-events-in-the-SUSTAIN-6-trial.html, XP093160270-
OPPOSITION- Anonymous, "Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6) - History of Changes for Study: NCT01720446", ClinicalTrials.gov; NCT01720446, (20160125), ClinicalTrials.gov; NCT01720446, URL: https://classic.clinicaltrials.gov/ct2/history/NCT01720446?A=25&B=25&C=merged#StudyPageTop, XP093157404-
OPPOSITION- Anonymous, "Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6); History of Changes for Study: NCT01720446", ClinicalTrials.gov; NCT01720446, (20160404), ClinicalTrials.gov; NCT01720446, URL: https://classic.clinicaltrials.gov/ct2/history/NCT01720446?A=26&B=26&C=merged#StudyPageTop, XP093153442-
OPPOSITION- Anonymous, "Victoza® significantly reduces the risk of major adverse cardiovascular events in the LEADER trial", Novo Nordisk, (20160304), Novo Nordisk, URL: https://www.fiercepharma.com/pharma/victoza%C2%AE-significantly-reduces-risk-of-major-adverse-cardiovascular-events-leader-trial, XP093157485-
OPPOSITION- Caterson Ian D, Et Al, "Abstract 12630: Cardiovascular Safety of Liraglutide: Pooled Analysis of Major Adverse Cardiovascular Events across Weight Management and Type 2 Diabetes Development Programs", Circulation, (20151106), vol. 132, pages 1 - 2, XP055922551-
OPPOSITION- Committee For Proprietary Medicinal Products (cpmp), "Points to consider on switching between superiority and noninferiority (CPMP/EWP/482/99)", Evaluation of Medicines for Human Use, The European Agency for the Evaluation of Medicinal Products, (20000727), pages 1 - 11, Evaluation of Medicines for Human Use, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-switching-between-superiority-and-non-inferiority_en.pdf, XP093181890-
OPPOSITION- D82a - CV Søren Østergaard Hardt-Lindberg-
OPPOSITION- D82 - Declaration of Søren Østergaard Hardt- Lindberg-
OPPOSITION- D83 - Declaration of Søren Østergaard Hardt- Lindberg-
OPPOSITION- Ferrannini Ele, Et Al, "Impact of glucose-lowering drugs on cardiovascular disease in type 2 diabetes", European Heart Journal, (20150101), vol. 36, pages 2288 - 2296, XP093049097-
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OPPOSITION- Nainggolan Lisa, "Now Novo Says Semaglutide Cuts CV Risk: SUSTAIN-6 Top-line Data", URL: https://www.medscape.com/viewarticle/862644?form=fpf, (20240105), XP093116360-
OPPOSITION- NAUCK et al., "A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared with Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes", Diabetes Care, (20160200), vol. 39, pages 231 - 241, XP009191212-
OPPOSITION- NAUCK M.A. et al., "A Phase 2, Randomized, Dose-Finding Study of the Novel Once- Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open- Label Liraglutide in Patients With Type 2 Diabetes", Diabetes Care, (20160200), vol. 39, no. 2, pages 231 - 41, XP009191212-
OPPOSITION- Nauck M A; Petrie J R; Sesti G; Mannucci E; Courreges J -P; Lindegaard M L; Jensen C B; Atkin S L, "A phase 2, randomized, dose-finding study of the novel once-weekly human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in patients with type 2 diabetes", DIABETES CARE, AMERICAN DIABETES ASSOCIATION, ALEXANDRIA, VA, US, US , (20160201), vol. 39, no. 2, ISSN 0149-5992, pages 231 - 241, XP009191212-
OPPOSITION- "Novo Nordisk successfully completes first phase 3a trial with semaglutide in people with type 2 diabetes", Novo Nordisk A/S Company Announcement, (20150600), XP055377163-
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OPPOSITION- Weimann Nina, Ken Inchaust, "Novo Nordisk successfully completes first phase 3a trial with semaglutide in people with type 2 diabetes", Novo Nordisk -Company announcement No 41 / 2015, (20150710), Novo Nordisk -Company announcement No 41 / 2015, (20231218), XP093112980-
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OPPOSITION- Steven P. Marso, Neil R. Poulter, Steven E. Nissen, Michael A. Nauck, Bernard Zinman, Gilbert H. Daniels, Stuart Pocock, William M. Steinberg, Richard M. Bergenstal, Johannes F.E. Mann, Lasse Steen Ravn, Kirstine Brown Frandsen, Alan C. Moses, John B. Buse, "Design of the liraglutide effect and action in diabetes: Evaluation of cardiovascular outcome results (LEADER) trial", American Heart Journal, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20131101), vol. 166, no. 5, doi:10.1016/j.ahj.2013.07.012, ISSN 0002-8703, pages 823 - 830.e5, XP055291252
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OPPOSITION- Gejl Michael; Starup-Linde Jakob; Scheel-Thomsen Jan; Gregersen Soeren; Vestergaard Peter, "Risk of cardiovascular disease: The effects of diabetes and anti-diabetic drugs — A nested case-contr", International Journal of Cardiology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20141112), vol. 178, doi:10.1016/j.ijcard.2014.11.096, ISSN 0167-5273, pages 292 - 296, XP029099257
OPPOSITION- Gejl Michael; Starup-Linde Jakob; Scheel-Thomsen Jan; Gregersen Soeren; Vestergaard Peter, "Risk of cardiovascular disease: The effects of diabetes and anti-diabetic drugs — A nested case-control study", International Journal of Cardiology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20141112), vol. 178, doi:10.1016/j.ijcard.2014.11.096, ISSN 0167-5273, pages 292 - 296, XP029099257
OPPOSITION- The Emerging Risk Factors Collaboration, "Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20100626), vol. 375, no. 9733, doi:10.1016/S0140-6736(10)60484-9, ISSN 0140-6736, pages 2215 - 2222, XP027104499
OPPOSITION- The Emerging Risk Factors Collaboration, "Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20100626), vol. 375, no. 9733, doi:10.1016/S0140-6736(10)60484-9, ISSN 0140-6736, pages 2215 - 2222, XP027291388
OPPOSITION- Rury R Holman, "Cardiovascular outcome trials of glucose-lowering drugs or strategies in type 2 diabetes", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20140627), vol. 383, no. 9933, doi:10.1016/S0140-6736(14)60794-7, ISSN 0140-6736, pages 2008 - 2017, XP093157410
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OPPOSITION- J. LAU et al., "Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide", J. Med Chem, (20150000), vol. 58, no. 18, doi:10.1021/acs.jmedchem.5b00726, pages 7370 - 7380, XP002764741
OPPOSITION- Jacob Sivertsen, Jaya Rosenmeier, Jens J. Holst, Tina Vilsbøll, "The effect of glucagon-like peptide 1 on cardiovascular risk", Nature Reviews Cardiology, Nature Publishing Group, GB, GB , vol. 9, no. 4, doi:10.1038/nrcardio.2011.211, ISSN 1759-5002, pages 209 - 222, XP055292490
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OPPOSITION- HAFFNER S.M. et al., "Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction", N Engl J Med, (19980723), vol. 339, no. 4, doi:10.1056/NEJM199807233390404, pages 229 - 34, XP055849076
OPPOSITION- S.M. HAFFNER et al., "Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction", New England Journal of Medicine, (19980000), vol. 339, no. 4, doi:10.1056/NEJM199807233390404, pages 229 - 234, XP055849076
OPPOSITION- White William B., Cannon Christopher P., Heller Simon R., Nissen Steven E., Bergenstal Richard M., Bakris George L., Perez Alfonso T., Fleck Penny R., Mehta Cyrus R., Kupfer Stuart, Wilson Craig, Cushman William C., Zannad Faiez, "Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes", The New England journal of medicine, Massachusetts Medical Society, US, US , (20131003), vol. 369, no. 14, doi:10.1056/NEJMoa1305889, ISSN 0028-4793, pages 1327 - 1335, XP093181893
OPPOSITION- ZINMAN BERNARD ET AL, "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes", NEW ENGLAND JOURNAL OF MEDICINE, (20151101), vol. 373, no. 22, doi:10.1056/NEJMoa1504720, pages 2117 - 2128, XP002769966
OPPOSITION- MARSO et al., "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes", The New England Journal of Medicine, (20160916), vol. 375, no. 19, doi:10.1056/NEJMoa1607141, pages 1834 - 1844, XP093097921
OPPOSITION- MARSO S.P. et al., "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes", N Engl J Med, (20160915), vol. 375, no. 19, doi:10.1056/NEJMoa1607141, pages 1834 - 1844, XP093097921
OPPOSITION- Marso Steven P., Bain Stephen C., Consoli Agostino, Eliaschewitz Freddy G., Jódar Esteban, Leiter Lawrence A., Lingvay Ildiko, Rosenstock Julio, Seufert Jochen, Warren Mark L., Woo Vincent, Hansen Oluf, Holst Anders G., Pettersson Jonas, Vilsbøll Tina, "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes", The New England journal of medicine, Massachusetts Medical Society, US, US , (20161110), vol. 375, no. 19, doi:10.1056/NEJMoa1607141, ISSN 0028-4793, pages 1834 - 1844, XP093097921
OPPOSITION- S. P. MARSO et al., "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes", New England Journal of Medicine, (20160916), vol. 375, doi:10.1056/NEJMoa1607141, pages 1834 - 44, XP093097921
OPPOSITION- S.P. MARSO, "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes", New England Journal of Medicine, (20160000), vol. 375, doi:10.1056/NEJMoa1607141, pages 1834 - 1844, XP093097921
OPPOSITION- Ele Ferrannini, "Impact of glucose-lowering drugs on cardiovascular disease in type 2 diabetes", European Heart Journal, Oxford University Press, GB, GB , (20150907), vol. 36, no. 34, doi:10.1093/eurheartj/ehv239, ISSN 0195-668X, pages 2288 - 2296, XP093153445
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OPPOSITION- Monami M.et al, "Effects of glucagon-like peptide-1 receptor agonists on cardiovascular risk: a meta-analysis of randomized clinical trials", Diabetes, Obesity and Metabolism, GB , (20140101), vol. 16, no. 1, doi:10.1111/dom.12175, ISSN 1462-8902, pages 38 - 47, XP055922460
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OPPOSITION- Y. M. CHO, "Cardiovascular effects of the incretin-based therapy: the good, the bad, or the ugly?", J. Diabetes Investig., (20151100), vol. 6, doi:: 10.1111/jdi.12386, pages 597 - 599, XP093138466
OPPOSITION- Rachel Huxley, Federica Barzi, Mark Woodward, "Excess risk of fatal coronary heart disease associated with diabetes in men and women: meta-analysis of 37 prospective cohort studies", BMJ, B M J Group, GB, GB , (20060114), vol. 332, no. 7533, doi:10.1136/bmj.38678.389583.7C, ISSN 0959-8138, pages 73 - 78, XP093160148
OPPOSITION- Matteo Monami, Francesco Cremasco, Caterina Lamanna, Claudia Colombi, Carla Maria Desideri, Iacopo Iacomelli, Niccolò Marchionni, Edoardo Mannucci, "Glucagon-Like Peptide-1 Receptor Agonists and Cardiovascular Events: A Meta-Analysis of Randomized Clinical Trials", Experimental Diabetes Research, Hindawi Publishing Corporation, US, US , (20110101), vol. 2011, doi:10.1155/2011/215764, ISSN 1687-5214, pages 1 - 10, XP093157388
OPPOSITION- Venu Menon, "Cardiovascular Safety Evaluation in the Development of New Drugs for Diabetes Mellitus", Circulation, American Heart Association, US, US , (20140624), vol. 129, no. 25, doi:10.1161/CIRCULATIONAHA.113.008221, ISSN 0009-7322, pages 2705 - 2713, XP093157463
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