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Methods For Preventing Cardiovascular Events Through Proprotein Convertase Subtilisin Kexin 9 (Pcsk9) Protein Reduction - EP3529360

The patent EP3529360 was granted to Novartis on Apr 17, 2024. The application was originally filed on Oct 18, 2017 under application number EP17800976A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3529360

NOVARTIS
Application Number
EP17800976A
Filing Date
Oct 18, 2017
Status
Granted And Under Opposition
Mar 15, 2024
Grant Date
Apr 17, 2024
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (5)

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CompanyOpposition DateRepresentativeOpposition Status

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GRAF VON STOSCH PATENTANWALTSGESELLSCHAFTJan 17, 2025LEPTHIENADMISSIBLE
TEVA PHARMACEUTICALSJan 17, 2025VON KAUFFMANNADMISSIBLE
INTAS PHARMACEUTICALSJan 16, 2025BRAND MURRAY FULLERADMISSIBLE
POLPHARMAJan 15, 2025WICHMANNADMISSIBLE
SYNTHONJan 10, 2025REDDIE & GROSEADMISSIBLE

Patent Citations (5) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO2016US48666-
INTERNATIONAL-SEARCH-REPORTWO2014089313
OPPOSITIONWO2014089313
OPPOSITIONWO2017035340
OPPOSITIONWO2018075658

Non-Patent Literature (NPL) Citations (26) 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
OPPOSITION- Anonymous, "ALN-PCSsc Achieves Quarterly and Potentially Bi-Annual Subcutaneous Dose Regimen Profile for Effective LDL-C Lowering in Phase 1 Clinical Study", businesswire, businesswire, URL: https://www.businesswire.com/news/home/20150830005024/en/ALN-PCSsc-Achieves-Quarterly-and-Potentially-Bi-Annual-Subcutaneous-Dose-Regimen-Profile-for-Effective-LDL-C-Lowering-in-Phase-1-Clinical-Study, XP093254783-
OPPOSITION- Anonymous, "Alnylam and The Medicines Company Announce Filing of a Clinical Trial Application to Initiate a Phase 1 Study for ALN-PCSsc, an Investigational, Subcutaneously Administered RNAi Therapeutic Targeting PCSK9 for the Treatment of Hypercholesterolemia", Press RElease, Press RElease, URL: https://investors.alnylam.com/press-release?id=15166, XP093254755-
OPPOSITION- Anonymous, "Alnylam Pharmaceuticals and The Medicines Company Announce Publication of Phase 1 Clinical Data with Inclisiran (ALN-PCSsc) in the New England Journal of Medicine", businesswire, businesswire, URL: https://www.businesswire.com/news/home/20161113005052/en/Alnylam-Pharmaceuticals-and-The-Medicines-Company-Announce-Publication-of-Phase-1-Clinical-Data-with-Inclisiran-ALN--PCSsc-in-the-New-England-Journal-of-Medicine, XP093254793-
OPPOSITION- Anonymous, " Alnylam Presents New Pre-Clinical Data on RNAi Therapeutic Programs for Cardio- Metabolic Diseases at American Heart Association Scientific Sessions 2014", businesswire, businesswire, URL: https://www.businesswire.com/news/home/20141117006370/en/Alnylam-Presents-New-Pre-Clinical-Data-on-RNAi-Therapeutic-Programs-for-Cardio-Metabolic-Diseases-at-American-Heart-Association-Scientific-Sessions-2014, XP093254757-
OPPOSITION- Anonymous, "A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH) (ORION-2)", ClinicalTrials.gov; NCT02963311, ClinicalTrials.gov; NCT02963311, URL: https://clinicaltrials.gov/study/NCT02963311?term=NCT02963311&rank=1&tab=history&a=2#version-content-panel, XP093254780-
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN); Proposed INN: List 114", WHO Drug Information, (20151218), vol. 29, no. 4, pages 503 - 602, XP093254760-
OPPOSITION- Anonymous, "Leqvio - SUMMARY OF PRODUCT CHARACTERISTICS", EMA, (20200101), XP093254788-
OPPOSITION- Anonymous, "ORION I: Durability of response with PCSK9 RNA interference agent [Press release]", PCSK9 Forum: Press release, PCSK9 Forum: Press release, URL: https://www.pcsk9forum.org/orion-i-durability-of-response-with-pcsk9-rna-interference-agent/, XP009561123-
OPPOSITION- Anonymous, "Proposed INN: List 115: International Nonproprietary Names for Pharmaceutical Substances (INN)", WHO DRUG INFORMATION, GENEVA, CH, CH , (20160101), vol. 30, no. 2, ISSN 1010-9609, pages 241 - 357, XP009553774-
OPPOSITION- Anonymous, "The Medicines Company and Alnylam Pharmaceuticals Present Positive Results from ORION-1 Phase 2 Study of Inclisiran (formerly PCSK9si)", Press Release, Press Release, URL: https://www.sec.gov/Archives/edgar/data/1113481/000110465916157180/a16-21669_1ex99d1.htm, XP093254790-
OPPOSITION- Anonymous, "Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) (ORION-1)", ClinicalTrials.gov; NCT02597127, ClinicalTrials.gov; NCT02597127, URL: https://clinicaltrials.gov/study/NCT02597127?term=NCT02597127&rank=1&tab=history&a=4#version-content-panel, XP093254766-
OPPOSITION- Comparison of LDL-c lowering-
OPPOSITION- D20 - EPO’s Communication regarding EP 3 340 994 dated 6 September 2019-
OPPOSITION- D32 - Alnylam, "Alnylam Pharmaceuticals and The Medicines Company Announce that New ALN-PCSsc Results from Late-Breaking Presentation at American Heart Association Meeting Confirm Potential for Bi-Annual Hypercholesterolemia Dose Regimen" 11.11.2015-
OPPOSITION- D33 - Alnylam Pharmaceuticals, Inc., "ALN-PCSsc, an Investigational RNAiTherapeutic for the Treatment of Hypercholesterolemia" RNAi Roundtables, 16 September 2015-
OPPOSITION- D34 - Thomson Reuters, "ALNY- Alnylam Pharmaceuticals Inc RNAi Roundtable: ALN-PCSsc for the Treatment of Hypercholesterolemia" THOMSON REUTERS STREETEVENTS, 16 September 2015-
OPPOSITION- Kevin Fitzgerald, Simon Amy, White Suellen, Borodovsky Anna, Patel Nirav, Bettencourt Brian, Clausen Valerie, Horton Jay, Wijngaard Peter, Kauffman Robert, Kallend David, "ALN-PCSsc, an RNAi Investigational Agent That Inhibits PCSK9 Synthesis With the Potential for Effective Bi-Annual Dosing: Interim Results", (20151111), URL: http://www.alnylam.com/web/assets/AHA_PCS-Ph-1_111115.pdf, (20161028), XP055314803-
OPPOSITION- Michael G. Silverman, Brian A. Ference, Kyungah Im, Stephen D. Wiviott, Robert P. Giugliano, Scott M. Grundy, Eugene Braunwald, Marc S. Sabatine, "Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions : A Systematic Review and Meta-analysis", JAMA, Clyancourt Corporation, Chicago, IL, Chicago, IL, (20160927), vol. 316, no. 12, doi:10.1001/jama.2016.13985, ISSN 0098-7484, page 1289, XP055474152
OPPOSITION- Urban Daniel; Pöss Janine; Böhm Michael; Laufs Ulrich , "Targeting the Proprotein Convertase Subtilisin/Kexin Type 9 for the Treatment of Dyslipidemia and Atherosclerosis", Journal of the American College of Cardiology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20130821), vol. 62, no. 16, doi:10.1016/j.jacc.2013.07.056, ISSN 0735-1097, pages 1401 - 1408, XP028733869
OPPOSITION- Fitzgerald Kevin, White Suellen, Borodovsky Anna, Bettencourt Brian R., Strahs Andrew, Clausen Valerie, Wijngaard Peter, Horton Jay D., Taubel Jorg, Brooks Ashley, Fernando Chamikara, Kauffman Robert S., Kallend David, Vaishnaw Akshay, Simon Amy, "A Highly Durable RNAi Therapeutic Inhibitor of PCSK9", The New England journal of medicine, Massachusetts Medical Society, US, US , (20170105), vol. 376, no. 1, doi:10.1056/NEJMoa1609243, ISSN 0028-4793, pages 41 - 51, XP055795283
OPPOSITION- Ray Kausik K., Landmesser Ulf, Leiter Lawrence A., Kallend David, Dufour Robert, Karakas Mahir, Hall Tim, Troquay Roland P.T., Turner Traci, Visseren Frank L.J., Wijngaard Peter, Wright R. Scott, Kastelein John J.P., "Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol", The New England journal of medicine, Massachusetts Medical Society, US, US , (20170413), vol. 376, no. 15, doi:10.1056/NEJMoa1615758, ISSN 0028-4793, pages 1430 - 1440, XP093254796
OPPOSITION- Khorova Anastasia, "Oligonucleotide Therapeutics -A New Class of Cholesterol-Lowering Drugs", The New England Journal of Medicine, (20170105), vol. 376, no. 1, doi:10.1056/NEJMp1614154, pages 4 - 7, XP093254795
OPPOSITION- Jernberg Tomas, Hasvold Pål, Henriksson Martin, Hjelm Hans, Thuresson Marcus, Janzon Magnus, "Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective", European Heart Journal, Oxford University Press, GB, GB , (20150514), vol. 36, no. 19, doi:10.1093/eurheartj/ehu505, ISSN 0195-668X, pages 1163 - 1170, XP093300677
OPPOSITION- Weinreich Michael, Frishman William H., "Antihyperlipidemic Therapies Targeting PCSK9", CARDIOLOGY IN REVIEW, LIPPINCOTT WILLIAMS AND WILKINS, HAGERSTOWN, MD, US, US , (20140501), vol. 22, no. 3, doi:10.1097/CRD.0000000000000014, ISSN 1061-5377, pages 140 - 146, XP009559763
OPPOSITION- Nathalie Bergeron, Binh An P. Phan, Yunchen Ding, Aleyna Fong, Ronald M. Krauss, "Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition : A New Therapeutic Mechanism for Reducing Cardiovascular Disease Risk", Circulation, American Heart Association, US, US , (20151027), vol. 132, no. 17, doi:10.1161/CIRCULATIONAHA.115.016080, ISSN 0009-7322, pages 1648 - 1666, XP055664366
OPPOSITION- Hooper Amanda J; Burnett John R, "Anti-PCSK9 therapies for the treatment of hypercholesterolemia", EXPERT OPINION ON BIOLOGICAL THERAPY, Informa Healthcare, (20130101), vol. 13, no. 3, doi:10.1517/14712598.2012.748743, ISSN 1471-2598, pages 429 - 435, XP009172526

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