IP Verse

Process For Lyophilized Pharmaceutical Formulation Of A Therapeutic Protein - EP3681483

The patent EP3681483 was granted to Amgen on May 18, 2022. The application was originally filed on Sep 10, 2018 under application number EP18779167A. The patent is currently recorded with a legal status of "Revoked".

EP3681483

AMGEN
Application Number
EP18779167A
Filing Date
Sep 10, 2018
Status
Revoked
Sep 5, 2025
Grant Date
May 18, 2022
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (3)

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OETKEFeb 20, 2023OETKEADMISSIBLE
WITHERS & ROGERSFeb 20, 2023TOMBLINGADMISSIBLE
JG OPPOSITIONSFeb 17, 2023ROBINSONADMISSIBLE

Patent Citations (25) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0171496
DESCRIPTIONEP0173494
DESCRIPTIONGB2177096
DESCRIPTIONUS2012028877
DESCRIPTIONUS4751180
DESCRIPTIONUS4816397
DESCRIPTIONUS4816567
DESCRIPTIONUS4935233
DESCRIPTIONUS4946778
DESCRIPTIONUS5939598
DESCRIPTIONWO2004039337
DESCRIPTIONWO8809344
DESCRIPTIONWO9954440
INTERNATIONAL-SEARCH-REPORTUS2016000921
INTERNATIONAL-SEARCH-REPORTWO2013096791
OPPOSITIONEP1977763
OPPOSITIONUS2010144631
OPPOSITIONUS2016000921
OPPOSITIONWO03041637
OPPOSITIONWO2007124090
OPPOSITIONWO2011012637
OPPOSITIONWO2012066058
OPPOSITIONWO2013096791
OPPOSITIONWO2015150968
OPPOSITIONWO2017129585

Non-Patent Literature (NPL) Citations (17) 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, "AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS", Amgen, (20230131), pages 1 - 2, XP093239776-
OPPOSITION- Anonymous, "Assessment report, BLINCYTO, International non-proprietary name: blinatumomab, EMA/CHMP/469312/2015", EUROPEAN MEDICINES AGENCY, SCIENCE MEDICINES HEALTH, (20150101), pages 1 - 124, XP093045274-
OPPOSITION- Anonymous, "Guideline on manufacture of the finished dosage form", EUROPEAN MEDICINES AGENCY, EMA/CHMP/QWP/245074/2015, (20170704), pages 1 - 15, XP093239765-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION, BLINCYTO® (blinatumomab) ", FDA, (20140101), pages 1 - 40, XP093239771-
OPPOSITION- Anonymous, "Pharmaceutical Dosage Forms ", United States Pharmacopeia, General Information,, The United States Pharmacopeial Convention., (20120101), no. 1151, pages 765 - 784, XP093045271-
OPPOSITION- Anonymous, "Sterile Filtration, Filling, and Lyophilization of Product", Introduction to Biomanufacturing, Chapter 14, Montgomery County Community College, (20160101), pages 1 - 85, XP093045266-
OPPOSITION- Babu Medi, Ramesh Chintala, Akhilesh Bhambhani, "Excipient selection in biologics and vaccines formulation development", EPR, pages 1 - 13, EPR, URL: https://www.europeanpharmaceuticalreview.com/article/24136/excipient-selection-biologics-vaccines -formulation-development, XP093239768-
OPPOSITION- D24: “Relative density”, European Pharmacopoeia 11.0-
OPPOSITION- D30: Excerpt of Webpage of Drugs.com for NPlate-
OPPOSITION- Neumüller Otto-Albrecht, "Dichte", Rompps Chemie-Lexikon, Stuttgar, Franckh’sche Verlagshandlung, (19730101), page 833, XP093045252-
OPPOSITION- Patro Sugunakar Y; Freund Erwin; Chang Byeong S, "Protein formulation and fill-finish operations.", Biotechnology Annual Review, Elsevier, NL, NL , (20020101), vol. 8, ISSN 1387-2656, pages 55 - 84, XP008123020-
OPPOSITION- Peterson Alan, "Chapter 6: Viral Processing -Accumulating, Conveying, Filling and Stoppering the Most Common Parenteral Container, Chapter 7: Checkweighing Fill Weight of Parenteral Product is the Hart of Process Quality, Chapter 8: Filling Methods as they Apply to Parenteral Product Quality and Biopharmaceutical Microdosing, in Practical Aseptic Processing", Peterson Alan, Jack Lysfjord, Practical Aseptic Processing fill and Finish, Volume 1, Bethesda, MD, USA, PDA, (20090101), pages 105 - 150, XP093045258-
OPPOSITION- Jameel Feroz, Undey Cenk, Kovach Paul M., Tanglertpaibul Jart, "Application of QbD Elements in the Development and Scale-up of Commercial Filling Process", Quality by Design for Biopharmaceutical Drug Product Development, Springer New York, New York, NY, New York, NY, (20150101), vol. 18, doi:10.1007/978-1-4939-2316-8_13, pages 265 - 302, XP093029948
OPPOSITION- Wiberg Nils B B, "Atom und Molekül", JOURNAL OF CHEMICAL EDUCATION, US , AMERICAN CHEMICAL SOCIETY , (19850101), vol. 79, page 30, doi:10.1021/ed079p944, ISSN 0021-9584, XP093045249
OPPOSITION- FROKJAER SVEN , OTZEN DANIEL E, "Protein drug stability: a formulation challenge.", Nature Reviews. Drug Discovery, Nature Publishing Group, GB, GB , (20050401), vol. 4, no. 4, doi:10.1038/nrd1695, ISSN 1474-1784, pages 298 - 306, XP002492211
OPPOSITION- Mascarenhas S.K., Schoeffel, R.E., Handley, B.M., King, G.G., "ANZSRS Poster Presentations", Respirology, Hoboken, USA, (20170301), vol. 22, doi:10.1111/resp.13008, ISSN 1323-7799, pages 11 - 17, XP093045315
OPPOSITION- Kanojia Gaurav et al, "The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production", PLOS ONE, vol. 11, no. e0163109, doi:10.1371/journal.pone.0163109, pages 1 - 14, XP093029949

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