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Therapeutic Uses Of Empagliflozin - EP2981271

The patent EP2981271 was granted to Boehringer Ingelheim on Nov 14, 2018. The application was originally filed on Apr 3, 2014 under application number EP14715578A. The patent is currently recorded with a legal status of "Opposition Rejected".

EP2981271

BOEHRINGER INGELHEIM
Application Number
EP14715578A
Filing Date
Apr 3, 2014
Status
Opposition Rejected
Mar 20, 2024
Grant Date
Nov 14, 2018
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Oppositions (9)

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GENERICS UKAug 14, 2019TER MEER STEINMEISTER & PARTNERADMISSIBLE
GILLARDAug 14, 2019ELKINGTON AND FIFEADMISSIBLE
POLPHARMAAug 14, 2019ELKINGTON AND FIFEADMISSIBLE
STADA ARZNEIMITTELAug 14, 2019KERNEBECKADMISSIBLE
TEVA PHARMACEUTICALSAug 14, 2019KRAUS & LEDERERADMISSIBLE
TEVA PHARMACEUTICALSAug 14, 2019KRAUS & LEDERER PARTGMBBADMISSIBLE
EGISAug 12, 2019STOLMAR & PARTNERADMISSIBLE
ALFRED E TIEFENBACHERAug 9, 2019HAMM & WITTKOPPWITHDRAWN
KRKAAug 2, 2019KUTZENBERGER WOLFF & PARTNERADMISSIBLE

Patent Citations (9) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTWO2011039337
INTERNATIONAL-SEARCH-REPORTWO2013007557
OPPOSITIONCA2812519
OPPOSITIONEP2981271
OPPOSITIONWO2006117359
OPPOSITIONWO2009022007
OPPOSITIONWO2011039337
OPPOSITIONWO2013007557
OPPOSITIONWO2014161919

Non-Patent Literature (NPL) Citations (61) 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
INTERNATIONAL-SEARCH-REPORT- Anonymous, "Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment - Full Text View - ClinicalTrials.gov", (20130108), URL: http://www.clinicaltrials.gov/ct2/show/study/NCT01164501?term=empagliflozin&rank=26, (20140526), XP055120166 [A] 1-30 * the whole document *-
INTERNATIONAL-SEARCH-REPORT- Anonymous, "Prevalence of Chronic Kidney Disease and Associated Risk Factors --- United States, 1999--2004", (20070302), URL: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5608a2.htm, (20140522), XP055119515 [A] 1-30 * see Table *-
INTERNATIONAL-SEARCH-REPORT- BARNETT ANTHONY H ET AL, "Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial", THE LANCET DIABETES & ENDOCRINOLOGY, GB, vol. 2, no. 5, doi:10.1016/S2213-8587(13)70208-0, ISSN 2213-8595, (20140501), pages 369 - 384, (20140124), XP009178027 [XP] 1-30 * the whole document *
INTERNATIONAL-SEARCH-REPORT- USHA PANCHAPAKESAN ET AL, "Effects of SGLT2 Inhibition in Human Kidney Proximal Tubular Cells-Renoprotection in Diabetic Nephropathy?", PLOS ONE, (20130204), vol. 8, no. 2, doi:10.1371/journal.pone.0054442, ISSN 1932-6203, page e54442, XP055119255 [A] 1-30 * abstract *
OPPOSITION- Anonymous, "Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin", Press release, (20130107), pages 1 - 3, URL: https://investor.lilly.com/news-releases/news-release-details/boehringer-ingelheim-and-eli-lilly- and-company-announce-positive (with link to pdf file which itself is available from https://investor.lilly.com/static-files/291950e8-369e-4e75-af1 b-b8360541 b498, XP055633016-
OPPOSITION- Anonymous, "Clinical Study Synopsis for Public Disclosure BI Trial No.: 1245.44", Boehringer Ingelheim, (20120727), URL: https://trials.boehrinaer-inaelheim.com/public/trial, XP055630676-
OPPOSITION- Anonymous, "Efficacy and Safety of BI 10773 in Patients With Type 2 Diabetes and Renal Impairment. Study NCT01164501", (20100715), pages 1 - 8, URL: https://clinicaltrials.gov/ct2/history/NCT01164501 ?V_1=View#StudyPage T op, XP055632891-
OPPOSITION- Anonymous, "Efficacy and safety of empagliflozin (BI 10773) in patients with type 2 diabetes and renal impairment", clinicaltrial.gov, (20130108), pages 1 - 7, URL: https://clinicaltrials..2ov/ct2/show/record/NCT01164501?term=empagliflozin&recr s=e&cond=diabetes&strd e=04%2F05%2F2013&rank=22 b clinical trial NCT01164501, XP055632918-
OPPOSITION- Anonymous, "Efficacy and Safety of Empagliflozin (Bi 10773) in Patients With Type 2 Diabetes and Renal Impairment", ClinicalTrials.gov Identifier: NCT01164501. Glossary, (20100716), URL: https://clinicaltrials.gov/ct2/show/NCT01164501?term=NCT01164501&rank=1, XP055632899-
OPPOSITION- Anonymous, "Efficacy and safety of empagliflozin (BI 10773) in patients with type 2 diabetes and renal impairment. NCT01164501", (20140616), ClinicalTrials.gov, URL: https://clinicaltrials.aov/ct2/show/NCT01164501, (20190719), XP055630614-
OPPOSITION- Anonymous, "Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment. Study NCT01164501", Clinicaltrials.gov archive, (20130108), pages 1 - 14, URL: https://clinicaltrials.gov/ct2/history/NCT01164501?V_35=View#StudyPageTop, XP055632887-
OPPOSITION- Anonymous, "Guidance for Industry, Pharmacokinetics in Patients with Impaired Renal Function - Study Design Data Analysis, and Impact on Dosing and Labeling", FDA, (19980500), pages 1 - 19, XP002744727-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01164501: efficacy and safety of empagliflozin (BI 10773) in patients with type 2 diabetes and renal impairment", ClinicalTrials.gov archive, (20130108), pages 1 - 8, XP055632977-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01907113, Phase 1", ClinicalTrials.gov archive, (20130722), pages 1 - 6, XP055628510-
OPPOSITION- Anonymous, "Invokana (canagliflozin) tablets for oral use", web.archive; Invokana® prescribing information, (20130300), URL: https://web.archive.org/web/20130418013721/http://www.invokanahcp.comlprescribing-information.pdf, (20190731), XP055628608-
OPPOSITION- "An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-28431754 in Healthy Male Subjects Following a Single Oral Dose Administration of 14C-JNJ-28431754", (20090612), XP055630680-
OPPOSITION- "Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company to Feature 30 Presentations on Type 1 and Type 2 Diabetes at the 72nd American Diabetes Association Scientific Sessions®", LILLY, Philadelphia, (20120605), URL: https://investor.lilly.com/static-files/9da9f754-ccdd-4b46-9164-980945d061bb, (20190727), XP055628584-
OPPOSITION- "Boehringer lngelheim and Eli Lilly and Company announce positive top-line pivotal Phase Ill data results for empagliflozin", Announcement, (20130107), LILLY, URL: https://investor.lilly.com/releasedetail.cfm?ReleaselD=731715, (20190719), XP055630666-
OPPOSITION- "Clinical Study Synopsis for Public Disclosure", Boehringer Ingelheim BI Trial No.: 1245.12, Synopsis, (20110111), pages 1 - 8, URL: https:// trials. boehringer-ingelheim. com/public/trial_results_documents/1245/_ english_ 124512U12922COpdf.pdf, (20190727), XP055628509-
OPPOSITION- E. FERRANNI et al., "Impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabete s", Diabetes Care, (20130000), vol. 36, pages 1260 - 1265, XP055633023-
OPPOSITION- E. FERRANNINI et al., "A Phase Ilb, randomized, placebo-controlled study of the SGLT-2 inhibitor empagliflozin in patients with type 2 diabetes", Diabetes Obes Metab., (20130000), pages 721 - 728, XP055633019-
OPPOSITION- E. FERRANNINI et al., "The potent and highly selective sodium-glucose co-cransporter (SGLT-2) inhibitor BI 10773 is safe and efficacious as monotherapy in patients with type 2 diabetes mellitus", Diabetologia, (20100000), vol. 53, page S351, XP055632876-
OPPOSITION- Efficacy and Safety of Empagliflozin (BI 10773) in Patients with Type 2 Diabetes and Renal Impairment, (20130108), URL: https://clinicaltrials.gov/ct2/history/NCT01164501?V_35=VieW#StudyPageTop, XP055120166-
OPPOSITION- G. PEREZ LOPEZ et al., "Sodium-glucose cotransporter 2 (SGLT2) inhibitors: from renal glycosuria to the treatment of type 2 diabetes", Nefrologia, (20100000), vol. 30, no. 6, pages 618 - 25, XP055633030-
OPPOSITION- "History of Changes for Study: NCT01164501", ClinicalTrials.gov archive, (20130108), pages 1 - 14, XP055628501-
OPPOSITION- I. AIRES et al., "BI-10773, a sodium-glucose cotransporter 2 inhibitor for the potential oral treatment of type 2 diabetes mellitus", CURRENT OPINION IN INVESTIGATIONAL DRUGS, (20101000), vol. 11, no. 10, pages 1 - 9, XP055632983-
OPPOSITION- JARDIANCE: EPAR, Product Information, URL: https://www.ema. europa .eu/en/medicines/human/EPAR/jardiance-
OPPOSITION- J.-F. YALE et al., "Abstracts / Can Journal of Diabetes", Canadian Diabetes Association, Professional Conference and Annual Meetings, Vancouver , British Columbia, (20121010), vol. 36, pages S40 - S41, XP055628597-
OPPOSITION- J.-F. YALE et al., "Canagliflozon (CANA) Aa sodium glucose co-transporter 2 (SGLT2) inhibitor improves gylcemia and is well tolerated in type 2 diabetes mellitus (T2DM) subjects with moderate renal impairment", Poster Session 41-LB, page 1, URL: https://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=b266eaf6-c060-450a-9a54-ae244aae03af&cKey =062eb968-9ab7-4c0d-baa7-7272b7db6a6d&mKey=%7B0F70410F-8DF3-49F5- A63D-3165359F5371%7D, (20190727), XP055628580-
OPPOSITION- "Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes", Clinicaltrials.gov, (20130129), pages 1 - 7, URL: https://clinicaltrials.gov/ct2/show/NCT01778049, XP055633034-
OPPOSITION- M. HANEDA et al., "The Effect of Luseogliflozin (TS-071), a Selective SGLT2 Inhibitor, on Pharmacodynamics and Pharmacokinetics in Japanese Type 2 Diabetic Subjects With Renal Impairment", Diabetes, (20120000), vol. 61, page A273, XP055633027-
OPPOSITION- "Mild-to-moderate Chronic Kidney Disease", Google, (20190807), pages 1 - 5, URL: https://www.google.com/uri?sa=t&rct=j&q=&esrc=s&source=web&cd=9&ved=2ahUKEwjswNymrfDjAhWO-KQKHW2zC9wQFjAIegQIABAC&url =http%3A %2F%2Fwww.impakt.org.uk%2Fresources%2FPatient-co-uk_CKD_mild_to_ moderate.pdf&usg=AOvVawl4rOPk06YLTmU33GfKJzdO, XP055632996-
OPPOSITION- PHARMACOKINETICS, "Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients with Different Degrees of Renal Impairment", Globaldata-
OPPOSITION- "Prevalence of Chronic Kidney Disease and Associated Risk Factors - United States , 1999-2004", MMWR Weekly, vol. 56, no. 08, (20070302), pages 161 - 165, URL: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5608a2.htm, (20190725), XP055119515-
OPPOSITION- S.A. VELTKAMP et al., "The Effect of Renal Impairment on the Pharmacokinetics and Urinary Glucose Excretion of the SGLT2 Inhibitor ASP1941 in Type 2 Diabetes Mellitus Patients", Diabetes, (20110000), vol. 60, pages A309 - A310, XP055633026-
OPPOSITION- S. KASICHAYANULA et al., "The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus", Br J Clin Pharmacol, (20120000), vol. 76, no. 3, pages 432 - 444, XP055628523-
OPPOSITION- S. KASICHAYANULA, "The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus", Br J Clin Pharmacol, (20120000), vol. 76, no. 3, pages 432 - 444, XP055628523-
OPPOSITION- S. SAYDAH et al., "Prevalence of Chronic Kidney Disease and Associated Risk Factors - United States 1999-2004", CDC, (20070000), URL: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5608a2.htm, XP055119515-
OPPOSITION- T. HEISE et al., "BI 10773, a sodium-glucose co-transporter inhibitor (SGLT-2), is safe and efficacious following 4-week treatment in patients with type 2 diabetes", Diabetes, (20100000), vol. 59, page 629, XP055632881-
OPPOSITION- YALE, J.F. et al., "Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease", Diabetes Obes Metab., vol. 15, no. 5, (20130500), pages 1 - 18, URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3654568/-
OPPOSITION- L. SEMAN et al., "Empagliflozin (BI 10773), a Potent and Selective SGLT2 Inhibitor, Induces Dose-Dependent Glucosuria in Healthy Subjects.", Clinical Pharmacology in Drug Development, vol. 2, (20130000), pages 1 - 20, URL: https://doi.org/10.1002/cpdd.16, XP055632901
OPPOSITION- E. GOODCHILD et al., "Managing diabetes in the presence of renal impairment", The Prescriber, (20170000), pages 24 - 30, XP055633021
OPPOSITION- M.A. ABDUL-GHANI et al., "Efficacy and Safety of SGLT2 Inhibitors in the Treatment of Type 2 Diabetes Mellitus", Curr Diab Rep, (20120000), vol. 12, no. 3, pages 230 - 238, XP035050399
OPPOSITION- M.A. ABDUL-GHANI et al., "Efficacy and Safety of SGLT2 Inhibitors in the Treatment of Type 2 Diabetes Mellitus", Curr Diab Rep, (20120415), vol. 12, pages 230 - 238, XP035050399
OPPOSITION- C. FRIEDRICH et al., "A randomized, open-label, crossover study to evaluate the pharmacokinetics of empagliflozin and linagliptin after coadministration in healthy male volunteers", Clinical Therapeutics, (20130100), vol. 35, doi:10.1016/j.clinthera.2012.12.002, pages A33 - A42, XP055073023
OPPOSITION- A.H. BARNETT et al., "Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double- blind, placebo-controlled trial", Lancet Diabetes Endocrinol, (20140000), vol. 2, pages 369 - 384, XP009178027
OPPOSITION- C.C. GEDDES et al., "Glomerular filtration rate-what is the rationale and justification of normalizing GFR for body surface area?", Nephrol Dial Transplant, (20080000), vol. 23, pages 4 - 6, XP055633018
OPPOSITION- E. KOMALA et al., "Sodium glucose cotransporter 2 and the diabetic kidney", Curr Opin Nephrol Hypertens, (20130100), vol. 22, no. 1, doi:10.1097/MNH.0b013e32835a17ae, pages 113 - 119, XP055176215
OPPOSITION- J.-F. YALE et al., "Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease", (20130000), vol. 15, pages 463 - 473, XP055632934
OPPOSITION- J.-F. YALE et al., "Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease", Diabetes Obesity and Metabolism, (20130000), vol. 15, pages 463 - 473, XP055628592
OPPOSITION- J.F. YALE et al., "Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease", Diabetes Obes Metab, (20130328), vol. 15, no. 5, pages 463 - 473, XP055628592
OPPOSITION- Yale et al., "Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease", Diabetes, Obesity and Metabolism, (2013), vol. 15, no. 5, doi:10.1111/dom.12090, pages 463 - 473, XP055630668
OPPOSITION- R. GREMPLER et al., "Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors", Diabetes , Obesity and Metabolism, (20120000), vol. 14, pages 83 - 90, XP055228524
OPPOSITION- LEVEY, A.S. et al., "Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO", Kidney Int., (20050600), vol. 67, no. 6, doi:10.1111/j.1523-1755.2005.00365.x, pages 2089 - 100, XP055268773
OPPOSITION- C. J. BAILEY et al., "Diabetes therapies in renal impairment", The British Journal Of Diabetes And Vascular Disease, (20120000), vol. 12, no. 4, pages 167 - 171, XP055632885
OPPOSITION- U. PANCHAPAKESAN et al., "Effects of SGLT2 inhibition in human kidney proximal tubular cells--renoprotection in diabetic nephropathy?", PLOS ONE, (20030204), vol. 8, no. 2, pages 1 - 8, XP055119255
OPPOSITION- U. PANCHAPAKESAN et al., "Effects of SGLT-2 Inhibition in Human Kidney Proximal Tubular Cells-Renoprotection in Diabetic Nephropathy", Plos One, (20130204), pages 1 - 8, XP055119255
OPPOSITION- A .K. LANGLEY et al., "Dipeptidyl Peptidase IV Inhibitors and the Incretin System in Type 2 Diabetes Mellitus", Pharmacotherapy, (20070000), vol. 27, pages 1163 - 1180, XP055633032
OPPOSITION- J.B. MCGILL et al., "Long-term Efficacy and Safety of Linagliptin in Patients with Type 2 Diabetes and Severe Renal Impairment", Diabetes Care, (20130000), vol. 36, doi:10.2337/dc12-0706, pages 237 - 244, XP055073250
OPPOSITION- E. FERRANNINI et al., "Renal Glucose Handling: Impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes", Diabetes Care, (20130100), vol. 36, pages 1260 - 1265, XP055632986
OPPOSITION- B. DOKKEN, "The kidney as a treatment target for type 2 diabetes", Diabetes Spectrum, (20120000), vol. 25, no. 1, pages 29 - 36, XP055628513

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