IP Verse

Tablet Formulation Comprising A Peptide And A Delivery Agent - EP2863895

The patent EP2863895 was granted to Novo Nordisk on Apr 14, 2021. The application was originally filed on Jun 19, 2013 under application number EP13729743A. The patent is currently recorded with a legal status of "Revoked".

EP2863895

NOVO NORDISK
Application Number
EP13729743A
Filing Date
Jun 19, 2013
Status
Revoked
Oct 21, 2022
Grant Date
Apr 14, 2021
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (7)

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 DateOpposition Status

Get instant alerts for new oppositions and patent status changes

CMS CAMERON MCKENNA NABARRO OLSWANGJan 14, 2022ADMISSIBLE
GALENICUM HEALTH SLUJan 14, 2022ADMISSIBLE
KRKAJan 14, 2022ADMISSIBLE
SANDOZJan 14, 2022ADMISSIBLE
GENERICS UKJan 13, 2022ADMISSIBLE
MERCK SHARP & DOHMEJan 13, 2022ADMISSIBLE
TEVA PHARMACEUTICALSJan 11, 2022ADMISSIBLE

Patent Citations (16) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTWO2008109385
INTERNATIONAL-SEARCH-REPORTWO2010020978
INTERNATIONAL-SEARCH-REPORTWO2012080471
OPPOSITIONJP4585037B
OPPOSITIONUS2009124639
OPPOSITIONUS2011142800
OPPOSITIONWO2004104018
OPPOSITIONWO2006097537
OPPOSITIONWO2007011958
OPPOSITIONWO2007121318
OPPOSITIONWO2008109385
OPPOSITIONWO2010020978
OPPOSITIONWO2012080471
OPPOSITIONWO2013139694
OPPOSITIONWO2013139695
OPPOSITIONWO2013189988

Non-Patent Literature (NPL) Citations (49) 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- AENUGU H P R ET AL, "Near infra red spectroscopy- An overview", INTERNATIONAL JOURNAL OF CHEMTECH RESEARCH 2011 SPHINX KNOWLEDGE HOUSE IND, (201104), vol. 3, no. 2, ISSN 0974-4290, pages 825 - 836, XP002714793 [X] 15 * page 833, column 1, paragraph 2 *-
INTERNATIONAL-SEARCH-REPORT- Jeckel, Steffens, "Importance of particle size knowledge for tablet porosity determination by NIRS", (20071025), Tablet Tech Seminar, FMC Biopolymer, URL: http://www.pharmtech.uni-bonn.de/forschung/arbeitskreis-prof.-steffens/download-16, (20131015), XP002714794 [X] 15 * the whole document *-
INTERNATIONAL-SEARCH-REPORT- SHAH RAKH B ET AL, "Process analytical technology: Chemometric analysis of Raman and near infra-red spectroscopic data for predicting physical properties of extended release matrix tablets", JOURNAL OF PHARMACEUTICAL SCIENCES, (200705), vol. 96, no. 5, ISSN 0022-3549, pages 1356 - 1365, XP002714792 [X] 15 * page 1360 - page 1361 * * page 1364 *
INTERNATIONAL-SEARCH-REPORT- OTSUKA ET AL, "Chemoinformetrical evaluation of granule and tablet properties of pharmaceutical preparations by near-infrared spectroscopy", CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, ELSEVIER SCIENCE PUBLISHERS B.V. AMSTERDAM, NL, vol. 82, no. 1-2, doi:10.1016/J.CHEMOLAB.2005.04.015, ISSN 0169-7439, (20060526), pages 109 - 114, (20060526), XP024894971 [X] 15 * page 112 - page 113 *
INTERNATIONAL-SEARCH-REPORT- DONOSO M ET AL, "Prediction of tablet hardness and porosity using near-infrared diffuse reflectance spectroscopy as a nondestructive method.", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY 2003, (2003), vol. 8, no. 4, ISSN 1083-7450, pages 357 - 366, XP009173508 [X] 15 * the whole document *
OPPOSITION- A.M. JUPPO, "Porosity parameters of lactose, glucose and mannitol tablets obtained by mercury porosimetry", International Journal of Pharmaceutics, (19960000), vol. 129, pages 1 - 12, XP055891184-
OPPOSITION- Anonymous, "434798", Drug Data Report, Prous Science, (20060101), vol. 28, no. 10, page 933, XP055883473-
OPPOSITION- Anonymous, "Clinical Trial Report", Synopsis of NCT01037582, (20110406), page 7pp-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01037582, A two part trial investigating the safety of NN9924 in healthy male subjects", Clinicaltrials.Gov, (20091201), pages 1 - 6, Clinicaltrials.Gov, URL: https:Hclinicaltrials.gov/ct2/history/NCT01037582?A=1&B=1&C=merged#StudyPageTo, (20190528), XP055592569-
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN) RECOMMENDED International Non proprietary Names: List 63", WHO Drug Information, (20100101), vol. 24, no. 1, pages 41, 72 - 73, XP055760752-
OPPOSITION- Beglinger C, Et Al, "Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36: A Proof-of-concept Study in Healthy Subjects", Clinical Pharmacology & Therapeutics, (20081001), vol. 84, no. 4, pages 468 - 474, XP055883898-
OPPOSITION- "Bioavailability of Drugs and Bioequivalence", Encyclopedia of PHARMACEUTICAL TECHNOLOGY, (20070000), pages 164 - 175, XP055891224-
OPPOSITION- "chapter 6 Dissolution", Vijai Kumar, Remington Essentials of Pharmaceutics, (2012), XP055891208-
OPPOSITION- C. M. Keck, Et Al, "Kapitel 1.2. Delivery Systeme für die perorale Applikation von Peptiden", Moderne Pharmazeutische Technologie - Lehbuch fur Studierende. 1. Auflage, (20090101), pages 8 - 14, XP055520578-
OPPOSITION- C. M. KECK et al., "Kapitel 1.2. Delivery Systeme für die perorale Applikation von Peptiden", Moderne Pharmazeutische Technologie - Lehbuch fur Studierende, (20090000), pages 8 - 14, XP055520578-
OPPOSITION- Cox S., Pharmaceutical Manufacturing Handbook textbook, (20080000), pages 1 - 391-
OPPOSITION- "Developing Solid Oral Dosage Forms", Developing Solid Oral Dosage Forms, (20090000), pages 175 - 186, XP055891220-
OPPOSITION- HANCOCK, B.-C. et al., "The relative densities of pharmaceutical powders, blends, dry granulations, and immediate-release tablets", Pharmaceutical Technology, (20030000), pages 64 - 80, XP055064508-
OPPOSITION- Hari Prasad Reddy Aenugu; Sathis Kumar D; Srisudharson; Parthiban N; Som Subhra Ghosh; David Banji, "Near infra red spectroscopy- An overview", International Journal of ChemTech Research, vol. 3, no. 2, pages 825 - 836, XP002714793-
OPPOSITION- HOFFMANN, A. et al., "Eligen insulin - a system for the oral delivery of insulin for diabetes", IDrugs, (20080000), vol. 11, pages 433 - 441, XP055891176-
OPPOSITION- Humphrey M, J, "The Oral Bioavailability of Peptides and Related Drugs", Delivery Systems for Peptide Drugs, (19860101), pages 139 - 151, XP055883890-
OPPOSITION- Jeckel P; Steffens K-J, "Improtance of particle size knowledge for tablet porosity determination by NIRS", FMC Biopolymer, Tablet Tech Seminar, Brussels, Belgium, (20070000), page 1, URL: http://www.pharmtech.unibonn.de/forschung/arbeitskreis-prof.-steffens/download- 16, XP002714794-
OPPOSITION- "Kapitel 1.2. Delivery Systeme für die perorale Applikation von Peptiden", C. M. Keck, Et Al, Moderne Pharmazeutische Technologie - Lehbuch fur Studierende. 1. Auflage, (20090101), pages 8 - 14, XP055520578-
OPPOSITION- K. Close, "Diabetes Close Up, Baby Steps", Close Concerns, (20110301), no. 106, pages 1 - 50, XP055592583-
OPPOSITION- King Chiu Kwan,, Fred O. Swart, And Albert M. Mattocks, "Factors Affecting Tablet Disintegration", journal of the american pharmaceutical association, (19570401), vol. 46, no. 4, pages 236 - 239, XP055891497-
OPPOSITION- Lieberman, Herbert A., "D. unique identification markings", Pharmaceutical dosage forms: Tablets, (19900101), pages 321,331,333, - 337, XP055891517-
OPPOSITION- Michael E. Aulton, Et Al., "Bioavailability - physicochemical and dosage form factors", Pharmaceutics, The Science of Dosage Form Design, (20020101), pages 234 - 252, XP055466214-
OPPOSITION- M. Kidron, Et Al, "A novel per-oral insulin formulation: proof of concept study in non-diabetic subjects", Diabetes Medicine, (20040322), vol. 21, pages 354 - 357, XP055520543-
OPPOSITION- M. KIDRON et al., "A novel per-oral insulin formulation: proof of concept study in non-diabetic subjects", Diabetic Medicine, (20040000), vol. 21, no. 4, pages 354 - 357, XP055520543-
OPPOSITION- POOLE J W, "Chapter 3: Effects of Formulation and Dosage Form on Drug Bioavailability", Principles and Perspectives in Drug Bioavailability, (19790000), pages 59 - 89, XP055891594-
OPPOSITION- RUDNIC et al., Remington - The Science and Practice of Phamacy, (20060000), pages 889 - 927, XP055891573-
OPPOSITION- SOFIA MATTSSON, "Pharmaceutical Binders and Their Function in Directly Compressed Tablets, Mechanistic Studies on the Effect of Dry Binders on Mechanical Strength, Pore Structure and Disintegration of Tablets", Dissertation for the Degree of Doctor of Philosophy (Faculty of Pharmacy) in Pharmaceutics, (20000000), pages 32 - 34, XP055892249-
OPPOSITION- STEINERT, R.-E. et al., "Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects", Clinical Pharmacology and Therapeutics, (20090000), vol. 86, pages 644 - 650, XP055592565-
OPPOSITION- TONG Wei-Qin, "Chapter 2 : Molecular and Physicochemical properties Impacting Oral Absorption of Drugs", Biopharmaceutics Applications in Drug Development, (20080000), pages 26 - 46, XP055891586-
OPPOSITION- Shah R B; Tawakkul M A; Khan M A, "Process analytical technology: Chemometric analysis of Raman and near infra-red spectroscopic data for predicting physical properties of extended release matrix tablets", Journal of Pharmaceutical Sciences, (20070520), vol. 96, no. 5, pages 1356 - 1365, XP002714792
OPPOSITION- LOWENTHAL W, "Disintegration of Tablets", J of Pharmaceutical Sciences, (19720000), vol. 61, no. 11, pages 1695 - 1711, XP002126338
OPPOSITION- OTSUKA M, "Chemoinformetrical evaluation of granule and tablet properties of pharmaceutical preparations by near-infrared spectroscopy", Chemometrics and Intelligent Laboratory Systems, (20051006), vol. 82, no. 1-2, pages 109 - 114, XP005409485
OPPOSITION- BEGLINGER, C. et al., "Pharmacokinetics and pharmacodynamics effects of oral GLP-1 and PYY3-36: A proof-of-concept study in healthy subjects", Clinical Pharmacology and Therapeutics, (20080000), vol. 84, doi:10.1038/clpt.2008.35, pages 468 - 474, XP008149454
OPPOSITION- BEGLINGER et al., "Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY-3-36: A Proof-of-concept Study in Healthy Subjects", Clinical Pharmacology & Therapeutics, (20080000), vol. 84, no. 4, doi:10.1038/clpt.2008.35, pages 468 - 474, XP008149454
OPPOSITION- R.E. STEINERT, B. POLLER, M.C. CASTELLI, K. FRIEDMAN, A.R. HUBER, J. DREWE AND C. BEGLINGER, "Orally Administered Glucagon-Like Peptide-1 Affects Glucose Homeostasis Following an Oral Glucose Tolerance Test in Healthy Male Subjects", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20091201), vol. 86, no. 6, doi:10.1038/clpt.2009.159, ISSN 0009-9236, pages 644 - 650, XP002635568
OPPOSITION- R.E. STEINERT, B. POLLER, M.C. CASTELLI, K. FRIEDMAN, A.R. HUBER, J. DREWE AND C. BEGLINGER, "Orally Administered Glucagon-Like Peptide-1 Affects Glucose Homeostasis Following an Oral Glucose Tolerance Test in Healthy Male Subjects", Clinical Pharmacology and Therapeutics, US , (20091201), vol. 86, no. 6, doi:10.1038/clpt.2009.159, ISSN 0009-9236, pages 644 - 650, XP002635568
OPPOSITION- STEINERT, R.-E. et al., "Orally administered glucagon-like peptide-1 affects glucose homeostasis following an oral glucose tolerance test in healthy male subjects", Clinical Pharmacology, (20090000), vol. 86, doi:10.1038/clpt.2009.159, pages 644 - 650, XP002635568
OPPOSITION- Michael Goldberg, Isabel Gomez-Orellana, "Challenges for the oral delivery of macromolecules", Nature Reviews Drug Discovery, (20030401), vol. 2, no. 4, doi:10.1038/nrd1067, ISSN 14741776, pages 289 - 295, XP055085694
OPPOSITION- DONOSO M et al., "Prediction of tablet hardness and porosity using near-infrared diffuse reflectance spectroscopy as a nondestructive method", Pharmaceutical Development and Technology, (20030000), vol. 8, no. 4, pages 357 - 366, XP002714795
OPPOSITION- Arbit Ehud; Goldberg Michael; Gomez-Orellana Isabel; Majuru Shingai, "Oral heparin: status review", THROMBOSIS JOURNAL, GB , (20060510), vol. 4, no. 1, doi:10.1186/1477-9560-4-6, ISSN 1477-9560, page 6, XP021018843
OPPOSITION- GOMEZ-ORELLANA I, "STRATEGIES TO IMPROVE ORAL DRUG BIOAVAILABILITY", Expert Opinion on Drug Delivery, GB , (20050501), vol. 02, no. 03, doi:10.1517/17425247.2.3.419, ISSN 1742-5247, pages 419 - 433, XP009055345
OPPOSITION- Michael A Valentino, Francheska Colon-Gonzalez, Jieru E Lin, Scott A Waldman, "Current trends in targeting the hormonal regulation of appetite and energy balance to treat obesity", EXPERT REVIEW OF ENDOCRINOLOGY & METABOLISM, FUTURE DRUGS LTD.,, GB, GB , (20100901), vol. 5, no. 5, doi:10.1586/eem.10.33, ISSN 1744-6651, pages 765 - 783, XP055520546
OPPOSITION- Michael A Valentino, Francheska Colon-Gonzalez, Jieru E Lin, Scott A Waldman, "Current trends in targeting the hormonal regulation of appetite and energy balance to treat obesity", EXPERT REVIEW OF ENDOCRINOLOGY & METABOLISM, GB , (20100901), vol. 5, no. 5, doi:10.1586/eem.10.33, ISSN 1744-6651, pages 765 - 783, XP055520546
OPPOSITION- Steinert Robert E et al, "Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects.", American Journal of Clinical Nutrition, (20101001), vol. 92, no. 4, doi:10.3945/​ajcn.2010.29663, ISSN 0002-9165, pages 810 - 817, XP009147021

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