Glp-1 Compositions And Uses Thereof - EP3474820

The patent EP3474820 was granted to Novo Nordisk on Feb 7, 2024. The application was originally filed on Aug 24, 2018 under application number EP18756449A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3474820

NOVO NORDISK
Application Number
EP18756449A
Filing Date
Aug 24, 2018
Status
Granted And Under Opposition
Jan 5, 2024
Grant Date
Feb 7, 2024
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (8)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

CompanyOpposition DateRepresentativeOpposition Status

Get instant alerts for new oppositions and patent status changes

ADALVONov 7, 2024CASALPRIM CASTELLAADMISSIBLE
ELKINGTON AND FIFENov 7, 2024ELKINGTON AND FIFEADMISSIBLE
GENERICS UKNov 7, 2024TER MEER STEINMEISTER & PARTNERADMISSIBLE
POLPHARMANov 7, 2024ELKINGTON AND FIFEADMISSIBLE
SANDOZNov 7, 2024ELKINGTON AND FIFEADMISSIBLE
STRAWMANNov 7, 2024HOFFMANN EITLEADMISSIBLE
KRAUS & LEDERER PARTGMBBNov 6, 2024KRAUS & LEDERER PARTGMBBADMISSIBLE
MAIWALDNov 6, 2024MAIWALDADMISSIBLE

Patent Citations (19) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO2006097537
INTERNATIONAL-SEARCH-REPORTWO2006097537
INTERNATIONAL-SEARCH-REPORTWO2014060472
OPPOSITIONCN105963257
OPPOSITIONWO03002136
OPPOSITIONWO2006097537
OPPOSITIONWO2012080471
OPPOSITIONWO2012112626
OPPOSITIONWO2013037690
OPPOSITIONWO2013139694
OPPOSITIONWO2013167455
OPPOSITIONWO2014005858
OPPOSITIONWO2014060472
OPPOSITIONWO2014202780
OPPOSITIONWO2015000942
OPPOSITIONWO2015155151
OPPOSITIONWO2016111971
OPPOSITIONWO2018055539
OPPOSITIONWO2019038412

Non-Patent Literature (NPL) Citations (45) 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- Akers, Michael J., "Chapter 26 : Parenteral Preparations", Remington, Essentials of Pharmaceutics, GB, Pharmaceutical Press , (20130101), pages 495 - 532, ISBN 978-0-85711-105-0, XP093236262-
OPPOSITION- Akers Michael J., "Chapter 41 - Parenteral Preparations", Remington The Science and Practice of Pharmacy 21st edition, (20050101), pages 802 - 836, ISBN 978-0-7817-4673-1, XP093236374-
OPPOSITION- Amylin Pharmaceuticals, Inc., "BYETTA: HIGHLIGHTS OF PRESCRIBING INFORMATION ", (20050101), pages 1 - 26, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf, (20170831), XP055402757-
OPPOSITION- "Assessment report Ozempic", European Medicines Agency, (20171214), URL: https://www.ema.europa.eu/en/documents/assessment-report/ozempic-epar-public-assessment-report_en.pdf, (20200715), XP055715143-
OPPOSITION- Bhansali A; Maji D; Rao P V; Banerjee S; Kumar H, "Historical Overview of Incretin Based Therapies", Journal of Association of Physicians of India, (20100601), vol. 58, no. Spec. Iss., ISSN 0004-5772, pages 1 - 14, XP055592040-
OPPOSITION- Bonner M C, "Sodium Phosphate, Dibasic", Bonner M C, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090212), pages 656 - 658, ISBN 978-0-85369-792-3, XP093236295-
OPPOSITION- Broadhead J, Gibson, M, "Chapter 9: Parenteral Dosage Forms", Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, CRC Press, (20090101), vol. 199, pages 325 - 347, XP055882149-
OPPOSITION- CHMP - Committee For Medicinal Products For Human Use, " GUIDELINE ON EXCIPIENTS IN THE DOSSIER FOR APPLICATION FOR MARKETING AUTHORISATION OF A MEDICINAL PRODUCT - EMEA/CHMP/QWP/396951/2006", (20070619), pages 1 - 12, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-excipients-dossier-application-marketing-authorisation-medicinal-product-revision-2_en.pdf, XP093236373-
OPPOSITION- CPMP - Committee For Proprietary Medicinal Products & CVMP - Committee For Veterinary Medicinal Products, "NOTE FOR GUIDANCE ON INCLUSION OF ANTIOXIDANTS AND ANTIMICROBIAL PRESERVATIVES IN MEDICINAL PRODUCTS - CPMP/CVMP/QWP/115/95", (19970708), pages 1 - 4, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-antioxidants-and-antimicrobial-preservatives-medicinal-products_en.pdf, XP093236370-
OPPOSITION- CPMP - Committee For Proprietary Medicinal Products, "DRAFT - NOTE FOR GUIDANCE ON EXCIPIENTS, ANTIOXIDANTS AND ANTIMICROBIAL PRESERVATIVES IN THE DOSSIER FOR APPLICATION FOR MARKETING AUTHORISATION OF A MEDICINAL PRODUCT - CPMP/QWP/419/03 ", (20030220), pages 1 - 9, XP093236371-
OPPOSITION- CPMP - Committee For Proprietary Medicinal Products, "EMA - NOTE FOR GUIDANCE ON DEVELOPMENT PHARMACEUTICS - CPMP/QWP/155/96 ", The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit, (19980128), pages 1 - 8, The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-development-pharmaceutics_en.pdf, XP093236369-
OPPOSITION- D40 - BASF: “BASF Chemical Emergency Medical Guidelines”, 1 January 2013, Retrieved from the internet: URL: https://basf.com/documents/corp/en/sustainability/employees-andsociety/employees/occupational-medicine/medicalguidance/Phenol_B_BASF_medGuidelines_E014.pdf-
OPPOSITION- D42 - Stability evaluation of pharmaceutical compositions comprising Semaglutide as per patent EP3474820B1-
OPPOSITION- D45 - Guideline on Excipients in The Dossier for Application or Marketing Authorisation of a Medicinal Product, EMEA/CHMP/QWP/396951/2006-
OPPOSITION- D57 - ANNEX I - SUMMARY OF PRODUCT CHARACTERISTICS - Wegovy-
OPPOSITION- D62 - NCT02648204, Version 16.06.2017-
OPPOSITION- D64 - Label for LYXUMIA-
OPPOSITION- GEIER D.A. ET AL., "The relative toxicity of compounds used as preservatives in vaccines and biologics", MEDICAL SCIENCE MONITOR, (20100101), vol. 16, no. 5, pages SR21 - 27, XP002773216-
OPPOSITION- "HIGHLIGHTS OF PRESCRIBING INFORMATION - TRULICITY - Reference ID: 3631020", CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125469Orig1s000 Labeling, (20140901), pages 1 - 62, XP093236294-
OPPOSITION- "HIGHLIGHTS OF PRESCRIBING INFORMATION - TRULICITY - Reference ID: 4047562", (20170101), pages 1 - 51, XP093236293-
OPPOSITION- "HIGHLIGHTS OF PRESCRIBING INFORMATION - VICTOZA -", (20100101), pages 1 - 23, XP093236299-
OPPOSITION- "HIGHLIGHTS OF PRESCRIBING INFORMATION - WEGOVY", (20210601), pages 1 - 34, XP093236303-
OPPOSITION- "Kapitel 9 - Parenteralia, einschliesslich Blutzubereitungen, Sera und Impfstoffe", Lippold Berhard C.; Müller-Goymann Christel ; Schübert Rolf, Lehrbuch der Pharmazeutischen Technologie, Stuttgart, wissenschaftliche Verlagsgesellschaft mbH , (20060101), pages 238 - 253, ISBN 978-3-8047-2222-4, XP009558847-
OPPOSITION- Na, "HIGHLIGHTS OF PRESCRIBING INFORMATION - TANZEUM - Reference ID: 3489494 ", (20140401), pages 1 - 56, XP093236287-
OPPOSITION- Novo Nordisk, "Novo Nordisk files for regulatory approval of onceweekly semaglutide for the treatment of type 2 diabetes in Japan", (20170228), pages 1 - 4, URL: https://hugin.info/2013/R/2082302/784617.pdf, XP093236258-
OPPOSITION- Novo Nordisk, "Novo Nordisk reports up to 13.8% weight loss in people with obesity receiving semaglutide in phase 2 trial", (20170623), pages 1 - 2, URL: https://hugin.info/2013/R/2115373/804945.pdf, XP093236259-
OPPOSITION- "OZEMPIC (semaglutide) injection, for subcutaneous use - Ref.ID: 4190425", US prescribing information, (20171201), US prescribing information, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf, XP093236252-
OPPOSITION- "Sodium Phosphate, Monobasic", Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, (20090107), pages 659 - 661, XP093236296-
OPPOSITION- U.S. Department Of Health And Human Services Food And Drug Administration, Center For Drug Evaluation And Research (cder) ; Center For Biologics Evaluation And Research (cber), "Guidance for Industry Q8(R2) Pharmaceutical Development - revision 2", (20091101), pages 1 - 25, URL: https://www.fda.gov/media/71535/download, XP093236372-
OPPOSITION- Meyer Brian K; Ni Alex; Hu Binghua; Shi Li, "Antimicrobial preservative use in parenteral products: past and present.", Journal of Pharmaceutical Sciences, (20070101), vol. 96, no. 12, doi:10.1002/jps.20976, ISSN 0022-3549, pages 3155 - 3167, XP009099142
OPPOSITION- Gerardo M. Castillo; Sandra Reichstetter; Elijah M. Bolotin, "Extending Residence Time and Stability of Peptides by Protected Graft Copolymer (PGC) Excipient: GLP-1 Example", Pharmaceutical Research, NL , (20110804), vol. 29, no. 1, doi:10.1007/s11095-011-0542-2, ISSN 1573-904X, pages 306 - 318, XP019993275
OPPOSITION- NamKoong Cherl; Kim Min Sun; Jang Byeong-Tak; Lee Young Hee; Cho Young-Min; Choi Hyung Jin, "Central administration of GLP-1 and GIP decreases feeding in mice", Biochemical and Biophysical Research Communications, NL, (20170610), vol. 490, no. 2, doi:10.1016/j.bbrc.2017.06.031, ISSN 0006-291X, pages 247 - 252, XP085129609
OPPOSITION- Lorenz Martin; Evers Andreas; Wagner Michael, "Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity", Bioorganic & Medicinal Chemistry Letters, NL, (20130516), vol. 23, no. 14, doi:10.1016/j.bmcl.2013.05.022, ISSN 0960-894X, pages 4011 - 4018, XP028573319
OPPOSITION- Jensen Lene; Helleberg Hans; Roffel Ad; van Lier Jan Jaap; Bjørnsdottir Inga; Pedersen Palle Jacob; Rowe Everton; Derving Karsbøl Julie; Pedersen Mette Lund, "Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species", European Journal of Pharmaceutical Sciences, NL , (20170316), vol. 104, doi:10.1016/j.ejps.2017.03.020, ISSN 0928-0987, pages 31 - 41, XP085093781
OPPOSITION- Christopher Sorli, Shin-Ichi Harashima, George M Tsoukas, Jeffrey Unger, Julie Derving Karsbøl, Thomas Hansen, Stephen C Bain, "Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial", The lancet / Diabetes & Endocrinology, GB, (20170117), vol. 5, no. 4, doi:10.1016/S2213-8587(17)30013-X, ISSN 2213-8587, pages 124-125 - 150-151, XP009554958
OPPOSITION- Jesper Lau, Paw Bloch, Lauge Schäffer, Ingrid Pettersson, Jane Spetzler, Jacob Kofoed, Kjeld Madsen, Lotte Bjerre Knudsen, James McGuire, Dorte Bjerre Steensgaard, Holger Martin Strauss, Dorte X. Gram, Sanne Møller Knudsen, Flemming Seier Nielsen, Peter Thygesen, Steffen Reedtz-Runge,Thomas Kruse, "Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide", Journal of Medicinal Chemistry, US , (20150826), vol. 58, no. 18, doi:10.1021/acs.jmedchem.5b00726, ISSN 0022-2623, pages 7370 - 7380, XP002764741
OPPOSITION- Zapadka Karolina L., Becher Frederik J., Uddin Shahid, Varley Paul G., Bishop Steve, Gomes Dos Santos A. L., Jackson Sophie E., "A pH-Induced Switch in Human Glucagon-like Peptide-1 Aggregation Kinetics", Journal of the American Chemical Society, (20161221), vol. 138, no. 50, doi:10.1021/jacs.6b05025, ISSN 0002-7863, pages 16259 - 16265, XP093236249
OPPOSITION- Hayes Matthew R., Kanoski Scott E., Alhadeff Amber L., Grill Harvey J., "Comparative Effects of the Long‐Acting GLP‐1 Receptor Ligands, Liraglutide and Exendin‐4, on Food Intake and Body Weight Suppression in Rats", Obesity, US , (20110701), vol. 19, no. 7, doi:10.1038/oby.2011.50, ISSN 1930-7381, pages 1342 - 1349, XP093236284
OPPOSITION- Akers Micheal J, "Drug Delivery: Prenteral Route ", Encyclopedia of Pharmaceutical Technology Third Edition Volume 1, Informa Healthcare , (20070101), pages 1266 - 1287, doi:10.1081/E-EPT-100000368, XP093087574
OPPOSITION- Karolina L. Zapadka, Frederik J. Becher, A. L. Gomes Dos Santos, Sophie E. Jackson, "Factors affecting the physical stability (aggregation) of peptide therapeutics", Interface Focus, GB , (20171206), vol. 7, no. 6, doi:10.1098/rsfs.2017.0030, ISSN 2042-8898, page 20170030, XP055598856
OPPOSITION- John Blundell; Graham Finlayson; Mads Axelsen; Anne Flint; Catherine Gibbons; Trine Kvist; Julie B. Hjerpsted, "Effects of once‐weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity", Diabetes, Obesity and Metabolism, GB , (20170505), vol. 19, no. 9, doi:10.1111/dom.12932, ISSN 1462-8902, pages 1242 - 1251, XP072207962
OPPOSITION- Snitker Søren, Andersen Andreas, Lindskov Pernille Skøtt, Van Marle Sjoerd, Sode Birgitte Fischer, Sparre Thomas, "Comparison of the injection‐site experience of semaglutide in a single‐dose and a multidose pen‐injector", Diabetes, Obesity and Metabolism, GB , (20220801), vol. 24, no. 8, doi:10.1111/dom.14718, ISSN 1462-8902, pages 1643 - 1646, XP093236300
OPPOSITION- Knop Filip K., Vilsbøll Tina, Larsen Steen, Madsbad Sten, Holst Jens J., Krarup Thure, "No Hypoglycemia After Subcutaneous Administration of Glucagon-Like Peptide-1 in Lean Type 2 Diabetic Patients and in Patients With Diabetes Secondary to Chronic Pancreatitis", DIABETES CARE, US , (20030901), vol. 26, no. 9, doi:10.2337/diacare.26.9.2581, ISSN 0149-5992, pages 2581 - 2587, XP093236283
OPPOSITION- Kalra Sanjay, Baruah Manashp, Sahay Rakeshk, Unnikrishnan Ambikagopalakrishnan, Uppal Shweta, Adetunji Omolara, "Glucagon-like peptide-1 receptor agonists in the treatment of type 2 diabetes: Past, present, and future", Indian Journal of Endocrinology and Metabolism, (20160101), vol. 20, no. 2, doi:10.4103/2230-8210.176351, ISSN 2230-8210, page 254, XP093138460
OPPOSITION- Hribal Marta Letizia, Sesti Giorgio, "Glucagon-like peptide-1 analogs in the treatment of Type 2 diabetes: a review of the Phase II and III trials", Clinical Investigation, GB, (20110201), vol. 1, no. 2, doi:10.4155/cli.10.26, ISSN 2041-6792, pages 327 - 343, XP093236289

Download Citation Report

Get a free citation report including examiner, opposition, and international search citations.

Get Citation Report

Dossier Documents

The dossier documents provide a comprehensive record of the patent’s prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent’s legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents