Methods For Reducing Lipoprotein(A) Levels By Administering An Inhibitor Of Proprotein Convertase Subtilisin Kexin-9 (Pcsk9) - EP2756004

The patent EP2756004 was granted to Regeneron Pharmaceuticals on Dec 25, 2019. The application was originally filed on Sep 12, 2012 under application number EP12761864A. The patent is currently recorded with a legal status of "Opposition Rejected".

EP2756004

REGENERON PHARMACEUTICALS
Application Number
EP12761864A
Filing Date
Sep 12, 2012
Status
Opposition Rejected
Apr 19, 2024
Grant Date
Dec 25, 2019
External Links
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Patent Oppositions (3)

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BOEHMERT & BOEHMERT ANWALTSPARTNERSCHAFT MBBSep 25, 2020ENGELHARDADMISSIBLE
AMGENDec 27, 2019DORRIESADMISSIBLE
AMGENDec 27, 2019DORRIES, HANS ULRICH , DF-MP DORRIES FRANK-MOLNIA & POHLMANADMISSIBLE

Patent Citations (7) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2010166768
DESCRIPTIONUS6596541
EXAMINATIONUS2010166768
INTERNATIONAL-SEARCH-REPORTWO2011028938
OPPOSITIONUS2010166768
OPPOSITIONWO2015054619
OTHERUS2010166768

Non-Patent Literature (NPL) Citations (59) 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- BROWN W V ET AL, "Management of Lp(a)", JOURNAL OF CLINICAL LIPIDOLOGY, ELSEVIER, NEW YORK, NY, US, vol. 4, no. 4, ISSN 1933-2874, (20100701), pages 240 - 247, (20100714), XP027229066-
EXAMINATION- Clinical lipidology . A companion to Braunwald's Hear Disease, Philadelphia, Elsevier, (20090101), pages 136 - 143-
EXAMINATION- J.B. Dubé ET AL, "Lipoprotein(a): more interesting than ever after 50 years", Curr Opin Lipidol., (20120401), vol. 23, no. 2, pages 133 - 140, XP055264229-
EXAMINATION- LAMON-FAVA STEFANIA ET AL, "Lipoprotein(a) levels, apo(a) isoform size, and coronary heart disease risk in the Framingham Offspring Study.", JOURNAL OF LIPID RESEARCH JUN 2011, (201106), vol. 52, no. 6, ISSN 1539-7262, pages 1181 - 1187-
EXAMINATION- M.L.KOSCHINSKY ET AL, "Lipoprotein(a): An Important Cardiovascular Risk Factor and a Clinical Conundrum", ENDOCRINOLOGY AND METABOLISM CLINICS OF NORTH AMERICA, (20141201), vol. 43, no. 4, pages 949 - 962, XP055264218-
EXAMINATION- PARHOFER KLAUS G, "Lipoprotein(a): Medical Treatment Options for an Elusive Molecule", CURRENT PHARMACEUTICAL DESIGN, (201103), vol. 17, no. 9, ISSN 1381-6128, pages 871 - 876-
EXAMINATION- Santica M. Marcovina ET AL, "Differences in Lp[a] concentrations and apo[a] polymorphs between black and white Americans", JOURNAL OF LIPID RESEARCH, US, (19961201), vol. 37, no. 12, ISSN 0022-2275, pages 2569 - 2585, XP055620574-
EXAMINATION- Sm Marcovina ET AL, "Effect of the number of apolipoprotein(a) kringle 4 domains on immunochemical measurements of lipoprotein(a)", Clinical Chemistry, (19950201), vol. 41, no. 2, ISSN 0009-9147, pages 246 - 255, XP055244600-
EXAMINATION- SOTIRIOS TSIMIKAS ET AL, "Antisense therapy targeting apolipoproteine(a): a randomised, double-blind, placebo-controlled phase 1 study", THE LANCET, (20151010), vol. 386, no. 10002, pages 1472 - 1483, XP055264248-
EXAMINATION- JOHN J ALBERS ET AL, "Immunochemical quantification of human plasma Lp(a) lipoprotein", LIPIDS, SPRINGER-VERLAG, BERLIN/HEIDELBERG, (19740101), vol. 9, no. 1, doi:10.1007/BF02533209, ISSN 1558-9307, pages 15 - 26, XP035174266
EXAMINATION- GAUDET DANIEL ET AL, "Effect of Alirocumab, a Monoclonal Proprotein Convertase Subtilisin/Kexin 9 Antibody, on Lipoprotein(a) Concentrations (a Pooled Analysis of 150 mg Every Two Weeks Dosing from Phase 2 Trials)", AMERICAN JOURNAL OF CARDIOLOGY, CAHNERS PUBLISHING CO., NEWTON, MA, US, (20140618), vol. 114, no. 5, doi:10.1016/J.AMJCARD.2014.05.060, ISSN 0002-9149, pages 711 - 715, XP029045241
EXAMINATION- GAUDET DANIEL ET AL, "Effect of Alirocumab on Lipoprotein(a) Over >=1.5 Years (from the Phase 3 ODYSSEY Program)", AMERICAN JOURNAL OF CARDIOLOGY, CAHNERS PUBLISHING CO., NEWTON, MA, US, (20160929), vol. 119, no. 1, doi:10.1016/J.AMJCARD.2016.09.010, ISSN 0002-9149, pages 40 - 46, XP029844555
EXAMINATION- MAYA S. SAFAROVA ET AL, "Effect of specific lipoprotein(a) apheresis on coronary atherosclerosis regression assessed by quantitative coronary angiography", ATHEROSCLEROSIS SUPPLEMENTS, AMSTERDAM, NL, (20130101), vol. 14, no. 1, doi:10.1016/j.atherosclerosissup.2012.10.015, ISSN 1567-5688, pages 93 - 99, XP055497849
EXAMINATION- POKROVSKY S N ET AL, "Specific Lp(a) apheresis: A tool to prove lipoprotein(a) atherogenicity", ATHEROSCLEROSIS SUPPLEMENTS, (20170101), vol. 30, doi:10.1016/J.ATHEROSCLEROSISSUP.2017.05.004, ISSN 1567-5688, pages 166 - 173, XP085276945
EXAMINATION- SCHATZ U ET AL, "Most significant reduction of cardiovascular events in patients undergoing lipoproteinapheresis due to raised Lp(a) levels - A multicenter observational study", ATHEROSCLEROSIS SUPPLEMENTS, (20170101), vol. 30, doi:10.1016/J.ATHEROSCLEROSISSUP.2017.05.047, ISSN 1567-5688, pages 246 - 252, XP085276986
EXAMINATION- FORBANG NKETI I ET AL, "Sex and ethnic differences in the associations between lipoprotein(a) and peripheral arterial disease in the Multi-Ethnic Study of Atherosclerosis", JOURNAL OF VASCULAR SURGERY, C.V. MOSBY CO., ST. LOUIS, MO, US, (20151027), vol. 63, no. 2, doi:10.1016/J.JVS.2015.08.114, ISSN 0741-5214, pages 453 - 458, XP029393006
EXAMINATION- J. S. DANIK ET AL, "Lipoprotein(a), polymorphisms in the LPA gene, and incident venous thromboembolism among 21?483 women : Letters to the Editor", JOURNAL OF THROMBOSIS AND HAEMOSTASIS, GB, (20130101), vol. 11, no. 1, doi:10.1111/jth.12056, ISSN 1538-7933, pages 205 - 208, XP055497839
EXAMINATION- E Boerwinkle ET AL, "Apolipoprotein(a) gene accounts for greater than 90% of the variation in plasma lipoprotein(a) concentrations.", JOURNAL OF CLINICAL INVESTIGATION, US, (19920701), vol. 90, no. 1, doi:10.1172/JCI115855, ISSN 0021-9738, pages 52 - 60, XP055363901
EXAMINATION- BYAMBAA ENKHMAA ET AL, "Lipoprotein (a): impact by ethnicity and environmental and medical conditions", JOURNAL OF LIPID RESEARCH, US, (20160701), vol. 57, no. 7, doi:10.1194/jlr.R051904, ISSN 0022-2275, pages 1111 - 1125, XP055497837
EXAMINATION- Hiroki Ikenaga ET AL, "Usefulness of Lipoprotein (a) for Predicting Progression of Non-Culprit Coronary Lesions After Acute Myocardial Infarction", CIRCULATION JOURNAL, JP, (20110101), vol. 75, no. 12, doi:10.1253/circj.CJ-11-0365, ISSN 1346-9843, pages 2847 - 2852, XP055540050
EXAMINATION- Ioanna Gouni-Berthold ET AL, "Lipoprotein(a): Current Perspectives", CURRENT VASCULAR PHARMACOLOGY, NL, (20111101), vol. 9, no. 6, doi:10.2174/157016111797484071, ISSN 1570-1611, pages 682 - 692, XP055497835
OPPOSITION- "Cholesterol Management Guide for Healthcare Practitioners", ., (20180000), American Heart Association, Inc, URL: https://www.heart.org/-/media/files/health-topics/cholesterol/chlstrmngmntgd_181110.pdf, XP055662885-
OPPOSITION- DUBÉ et al., "Lipoprotein(a): more interesting than ever after 50 years", Current Opinion Lipidology, (20120400), vol. 23, pages 133 - 140, XP055264229-
OPPOSITION- Evan A Stein, "Supplementary Appendix Effect of a Monoclonal Antibody to PCSK9 on LDL Cholesterol", (20120322), pages 1 - 52, XP055190603-
OPPOSITION- Excerpt from clinical trials.gov, (20110902), URL: https://clinicaltrials.gov/ct2/history/NCT01288443?V_1 0=View#StudyPageTop-
OPPOSITION- KOSCHINSKY et al., "Lipoprotein(a): An Important Cardiovascular Risk Factor and a Clinical Conundrum", Endocrinol Metab Clin N Am, (20140000), vol. 45, pages 949 - 962, XP055264218-
OPPOSITION- KULKARNI et al., "Quantification of cholesterol in all lipoprotein classes by the VAP-II method", Journal of Lipid Research, (19940000), vol. 35, pages 159 - 168, XP002425352-
OPPOSITION- MACH et al., "2019 ESC /EAS guidelines for management of dyslipidaemias: lipid modification to reduce cardiovascular risk", European Heart Journal, (20190831), pages 1 - 78, XP055662916-
OPPOSITION- REINER et al., "ESC/EAS guidelines for management of dyslipidaemias", European Heart Journal, (20110700), vol. 32, pages 1769 - 1818, XP055662895-
OPPOSITION- REINER et al., "ESC/EAS guidelines for management of dyslipidaemias", European Heart Journal, vol. 32, pages 1769 - 1818, XP055662895-
OPPOSITION- STORM C., "ringt die 2. Testgeneration den Durchbruch für Lp(a) ?", Diagnostik im Dialog, (20130800), pages 11 - 12, XP055575872-
OPPOSITION- "Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III", National Institutes of health, (20010500), pages 1 - 28, XP055662890-
OPPOSITION- DANIK et al., "Lipoprotein(a), Measured With an Assay Independent of Apolipoprotein(a) Isoform Size, and Risk of Future Cardiovascular Events Among Initially Healthy Women", JAMA, (20060920), vol. 296, no. 11, pages 1363 - 1370, XP002609986
OPPOSITION- KOSCHINSKY, "A Companion to Braunwald's Heart Disease", Clinical Lipidology, (20090000), pages 136 - 143, XP055522743
OPPOSITION- Marit S Nenseter; Henriette Walaas Lindvig; Thor Ueland; Gisle Langslet; Leiv Ose; Kirsten B Holven; Kjetil Retterstl, "Lipoprotein(a) levels in coronary heart disease-susceptible and -resistant patients with familial hypercholesterolemia", Atherosclerosis, (20110203), vol. 216, pages 426 - 432, XP028226580
OPPOSITION- NENSETER et al., "Lipoprotein(a) levels in coronary heart disease-susceptible and -resistant patients with familial hypercholesterolemia", Atherosclerosis, (20110303), vol. 216, pages 426 - 432, XP028226580
OPPOSITION- GOLDSTEIN et al., "A Century of Cholesterol and Coronaries: From Plaques to Genes to Statins", Cell, (20150326), vol. 161, no. 1, pages 161 - 172, XP029209805
OPPOSITION- CHEN et al., "A Common PCSK9 Haplotype, Encompassing the E670G Coding Single Nucleotide Polymorphism, Is a Novel Genetic Marker for Plasma Low-Density Lipoprotein Cholesterol Levels and Severity of Coronary Atherosclerosis", N Am Coll Cardiol., (20050517), vol. 45, no. 10, pages 1611 - 1619, XP004889602
OPPOSITION- Suet N. Chen, Ballantyne Christie M., Gotto Antonio M., Tan Yanli, Willerson James T., Marian Ali J., "A Common PCSK9Haplotype, Encompassing the E670G Coding Single Nucleotide Polymorphism, Is a Novel Genetic Marker for Plasma Low-Density Lipoprotein Cholesterol Levels and Severity of Coronary Atherosclerosis /NIH Author Manuscript/", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, (20050517), vol. 45, no. 10, pages 1611 - 1619, XP055740331
OPPOSITION- Tsimikas Sotirios, "A Test in Context: Lipoprotein(a) Diagnosis, Prognosis, Controversies, and Emerging Therapies", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY,, (20170214), vol. 69, no. 6, pages 692 - 711, XP029916238
OPPOSITION- Terry A. Jacobson, "Lipoprotein (a), Cardiovascular Disease, and Contemporary Management", Mayo Clinic Proceedings, (20131100), vol. 88, no. 11, pages 1294 - 1311, XP055740338
OPPOSITION- TSIMIKAS et al., "Antisense therapy targeting apolipoprotein(a): a randomised, double-blind, placebo-controlled phase 1 study", LANCET, (20151010), vol. 386, pages 1472 - 1483, XP055535698
OPPOSITION- SWERGOLD et al., "REGN727/SAR236553,A FULLY HUMAN PROPROTEIN CONVERTASE SUBTILISIN KEXIN 9 (PCSK9) MONOCLONAL ANTIBODY: EFFECTS ON SAFETY AND LIPID AND LIPOPROTEIN PROFILES WHEN ADMINISTERED SUBCUTANEOUSLY", ACC.11, (20110403), vol. 57, no. 14, XP055662879
OPPOSITION- Evan A Stein; Scott Mellis; George D Yancopoulos; Neil Stahl; Douglas Logan; William B Smith; Eleanor Lisbon; Maria Gutierrez; Cheryle Webb; Richard Wu; Yunling Du; Therese Kranz; Evelyn Gasparino; Gary D Swergold, "Effect of a Monoclonal Antibody to PCSK9 on LDL Cholesterol", New England Journal of Medicine, (20100322), vol. 366, pages 11008 - 1118, XP055049842
OPPOSITION- STEIN et al., "Effect of a Monoclonal Antibody to PCSK9 on LDL Cholesterol"", N Engl J Med, (20120322), vol. 366, pages 11008 - 1118, XP055049842
OPPOSITION- GARG A., "What is the role of alternative biomarkers for coronary heart disease?", Clinical Endocrinology, (20110316), vol. 75, pages 289 - 293, XP055662926
OPPOSITION- VAN WISSEN et al., "Long term statin treatment reduces lipoprotein(a) concentrations in heterozygous familial hypercholesterolaemia", Heart, (20030000), vol. 89, pages 893 - 896, XP055393647
OPPOSITION- NICHOLLS et al., Journal of Lipid Research, (20100702), vol. 51, pages 3055 - 3061, XP055662887
OPPOSITION- LAMON-FAVA et al., "Lipoprotein(a) levels, apo(a) isoform size, and coronary heart disease risk in the Framingham Offspring Study", Journal of Lipid Research, (20110407), vol. 52, pages 1181 - 1187, XP055264234
OPPOSITION- ENKHMAA et al., "Lipoprotein (a): impact by ethnicity and environmental and medical conditions", Journal of Lipid Research, (20161204), vol. 57, no. 7, pages 1111 - 1125, XP055497837
OPPOSITION- IKENAGA et al., "Usefulness of Lipoprotein (a) for Predicting Progression of Non-Culprit Coronary Lesions After Acute Myocardial Infarction", Circulation Journal, (20110913), vol. 75, pages 2847 - 2852, XP055522737
OPPOSITION- WARNICK et al., "Standardization of Measurements for Cholesterol, Triglycerides, and Major Lipoproteins", Labmedicine, (20080800), vol. 39, no. 8, pages 481 - 490, XP055139701
OPPOSITION- PARHOFER KLAUS G, "Lipoprotein(a): Medical Treatment Options for an Elusive Molecule", Current Pharmaceutical Design, (20110301), vol. 17, no. 9, pages 871 - 876, XP002688212
OPPOSITION- PARHOFER K, "Lipoprotein(a): Medical Treatment Options for an Elusive Molecule", Current Pharmaceutical Design, (20110301), vol. 17, no. 9, pages 871 - 876, XP002688212
OPPOSITION- GOUNI-BERTHOLD et al., "Lipoprotein(a): Current Perspectives", Current Vascular Pharmacology, (20110526), vol. 9, pages 682 - 692, XP055497835
OTHER- Joseph B. DUBE et al., "Lipoprotein(a): more interesting than ever after 50 years", Curr Opin Lipidol., (201204), vol. 23, no. 2, pages 133 - 140, XP055264229-
OTHER- KOSCHINSKY; BOFFA, "Lipoprotein(a): An Important Cardiovascular Risk Factor and a Clinical Conundrum", Endocrinol Metab Clin North Am, (201412), vol. 43, no. 4, pages 949 - 962, XP055264218-
OTHER- Sotirios TSIMIKAS et al., "Antisense therapy targeting apolipoproteine(a): a randomised, double-blind, placebo-controlled phase 1 study", Lancet, (20151010), vol. 386, no. 10002, pages 1472 - 1483, XP055264248-
OTHER- Stefania Lamon-Fava; Et Al, "Lipoprotein(a) levels, apo(a) isoform size, and coronary heart disease risk in the Framingham Offspring Study", J Lipid Res, (2011), vol. 52, pages 1181 - 1187, XP055264234

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