Syringe - EP3381444

The patent EP3381444 was granted to Novartis on May 19, 2021. The application was originally filed on Jan 25, 2013 under application number EP18162017A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3381444

NOVARTIS
Application Number
EP18162017A
Filing Date
Jan 25, 2013
Status
Granted And Under Opposition
Apr 16, 2021
Grant Date
May 19, 2021
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (4)

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TEVA PHARMACEUTICALSApr 28, 2023ELKINGTON AND FIFEINTERVENTION WITHDRAWN
HAMM & WITTKOPPFeb 21, 2022HAMM & WITTKOPPWITHDRAWN
HOFFMANN EITLEFeb 18, 2022HOFFMANN EITLEWITHDRAWN
KEIL & SCHAAFHAUSEN PATENTANWALTE PARTGMBBFeb 17, 2022KEIL & SCHAAFHAUSEN PATENTANWALTE PARTGMBBWITHDRAWN

Patent Citations (31) New

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

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OPPOSITIONWO2004075958
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Non-Patent Literature (NPL) Citations (33) 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- Anonym, "Fachinformation Novartis Pharma Lucentis®", (20070101), pages 1 - 5, XP055889817-
OPPOSITION- Anonymous, "About Us", Bioprocess Online, (20230101), page 1, Bioprocess Online, URL: https://www.bioprocessonline.com/static/about, (20240121), XP093121868-
OPPOSITION- Anonymous, "Division of Transplant and Ophthalmology Products Advisory Committee Meeting Briefing Package", DTOP - Aflibercept Briefing Package for Advisory Meeting, (20170101), pages 1 - 70, DTOP - Aflibercept Briefing Package for Advisory Meeting, (20220816), XP055951939-
OPPOSITION- Anonymous, "Lucentis highlights of prescribing information", Lucentis, (20100601), pages 1 - 7, Lucentis, (20221128), XP093002595-
OPPOSITION- Anonymous, "MATERIAL SAFETY DATA SHEET- Lucentis®", Genentech Inc., (20090522), pages 1 - 5, XP055895377-
OPPOSITION- Anonymous, "Particle Counting in Injectable Solutions", Particle Measuring Systems, Inc, (20070000), pages 1 - 6, XP055642519-
OPPOSITION- Anonymous, "Particulate Matter in Ophthalimic Solutions", Physical Tests, page 789, XP055899216-
OPPOSITION- Anonymous, "Physical Tests/ (789) Particulate Matter in Ophthalmic Solutions", The United States Pharmacopeia USP 35, (20111202), pages 342 - 343, XP055897740-
OPPOSITION- Anonymous, "Product information EYLEA®® aflibercept (rich)", Division of Transplant and Ophthalmology Products Advisory Committee Meeting, (20120307), pages 1 - 18, XP055899118-
OPPOSITION- Anonymous, "Product information Lucentis", Lucentis, pages 1 - 8, XP055899236-
OPPOSITION- Anonymous, "TechnoPharm ", schweitzer Fachinformation, (20230101), pages 1 - 2, schweitzer Fachinformation, URL: https://www.schweitzer-online.de/zeitschrift/TechnoPharm/21918341/A53687786/, (20240121), XP093121866-
OPPOSITION- Arno Fries, "Drug delivery of sensitive biopharmaceuticals with prefilled syringes", Drug Delivery Technology, (20090101), vol. 9, no. 5, pages 22 - 27, XP055952517-
OPPOSITION- BÖTTGER, "New Developments in Siliconization and Silicone Layer Analytics", Bio Production Forum, (20100600), pages 1 - 43, XP055642524-
OPPOSITION- Bruno Reuter et al, "Syringe Siliconization Trends, methods, analysis procedures", (20120101), URL: https://pdfs.semanticscholar.org/e940/10e357b30dd015752cb005c15e14fa7dd506.pdf?_ga=2.180808103.1640326775.1579172132-188552557.1579172132, (20200116), XP055658634-
OPPOSITION- Iso, "Prefilled syringe - Part 4:Glass barrels for injectables. Seringues préremplies Partie 4: Cylindres en verre pour produits injectables", ISO 11040-4 (2007), (20070201), ISO 11040-4 (2007), (20240121), XP093121869-
OPPOSITION- Mintz C., "Prefilled syringes: The Next "Big Thing"", Bioprocess Online, (20120830), Bioprocess Online, URL: https://www.bioprocessonline.com/doc/prefilled-syringes-the-next-big-thing-0001, XP002788671-
OPPOSITION- MINTZ, "Prefilled syringes: The Next ''Big Thing"", Bioprocess Online, (20120830), pages 1 - 6, XP055899130-
OPPOSITION- N Clunas, Sigg J, Boado L, Momm J, Weber C, Alete D, Peregi E, Picci M, "RANIBIZUMAB PRE-FILLED SYRINGE: RECENTLY APPROVED INNOVATION IN THE EUROPEAN UNION WITH THE POTENTIAL TO REDUCE INFECTION RISK, IMPROVE DOSE ACCURACY, AND ENHANCE EFFICIENT TREATMENT ADMINISTRATION", 5th World Congress on Controversies in Ophthalmology (COPHY), (20140320), 5th World Congress on Controversies in Ophthalmology (COPHY), URL: http://comtecmed.com/COPHY/2014/Uploads/Editor/Group%20A/17.pdf, (20191101), XP055638316-
OPPOSITION- Reuter B., Et Al., "Syringe Siliconization", TechnoPharm, (20120000), vol. 2, no. 4, pages 238 - 244, XP055658634-
OPPOSITION- REUTER et al., "Syringe Siliconization", TechnoPharm, (20120108), vol. 2, no. 4, pages 238 - 244, XP002725465-
OPPOSITION- SCHOENKNECHT T.P. ET AL, "REQUIREMENTS ON PRE-FILLABLE GLASS SYRINGES", AAPS NATIONAL BIOTECHNOLOGY CONFERENCE, (20070627), page 1, XP003035654-
OPPOSITION- Schroeder Axel H., "BIO PRODUCTION FORUM: BRIDGING RESEARCH AND INDUSTRY", GMP Journal, (20101004), GMP Journal, URL: https://www.gmp-journal.com/current-articles/details/bio-production-forum-bridging-research-and-industry.html, (20240121), XP093121862-
OPPOSITION- Thermofisher, "FOCUS ON DRUG DELIVERY: What clinical teams should know about the benefits of auto-injectors", ThermoFisher Scientific, (20190401), pages 1 - 11, ThermoFisher Scientific, (20240121), XP093121865-
OPPOSITION- FUNKE et al., "Analysis of thin baked-on silicone layers by FTIR and 3D- Laser Scanning Microscopy", European Journal of Pharmaceutics and Biopharmaceutics, (20150000), vol. 96, doi:10.1016/j.ejpb.2015.08.009, pages 304 - 313, XP055642550
OPPOSITION- Lode Heidrun Elisabeth, Gjølberg Torleif Tollefsrud, Foss Stian, Sivertsen Magne Sand, Brustugun Jørgen, Andersson Yvonne, Jørstad Øystein Kalsnes, Moe Morten Carstens, Andersen Jan Terje, "A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes", Scientific Reports, Nature Publishing Group, US, US , (20191202), vol. 9, no. 1, doi:10.1038/s41598-019-54226-7, ISSN 2045-2322, page 18021, XP093121863
OPPOSITION- BAKRI et al., "Intravitreal silicone oil droplets after intravitreal drug injections", Retina, vol. 28, no. 7, doi:10.1097/IAE.0b013e31816c6868, pages 996 - 1001, XP055186525
OPPOSITION- Rotella C.; Persson B. N. J.; Scaraggi M.; Mangiagalli P., "Lubricated sliding friction: Role of interfacial fluid slip and surface roughness", The European Physical Journal E, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (20200210), vol. 43, no. 2, doi:10.1140/epje/i2020-11933-4, ISSN 1292-8941, XP037012106
OPPOSITION- L. Liu, D. A. Ammar, L. A. Ross, N. Mandava, M. Y. Kahook, J. F. Carpenter, "Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-term Storage and Product Mishandling", Investigative Ophthalmology & Visual Science, (20110222), vol. 52, no. 2, doi:10.1167/iovs.10-6431, ISSN 01460404, pages 1023 - 1034, XP055059283
OPPOSITION- Advait Badkar; Amanda Wolf; Leigh Bohack; Parag Kolhe, "Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches", AAPS PharmSciTech, (20110600), vol. 12, no. 2, pages 564 - 572, XP019925550
OPPOSITION- CHAN E, ET AL, "SYRINGE SILICONIZATION PROCESS INVESTIGATION AND OPTIMIZATION", PDA Journal of Pharmaceutical Science and Technology, US , (20120101), vol. 66, doi:10.5731/pdajpst.2012.00856, ISSN 1079-7440, pages 136 - 150, XP003035655
OTHER- EUROPEAN MEDICINES AGENCY, "Lucentis (ranibizumab)", EMA/554038/2018 EMEA/H/C/000715, (2018), pages 1-4, 1 - 96, XP055807197-
OTHER- S. JOUFFRAY, "ADVANCEMENTS IN PREFILLED SYRINGE TECHNOLOGY: IMPROVING COMPATIBILITY WITH BIOLOGICS WITH A NOVEL CROSS-LINKED SILICONE COATING", Injectable Drug Delivery 2012: Devices Focus, (20120600), pages 4 - 8, URL: https://www.ondrugdelivery.com/wp-content/uploads/2018/11/JunJul2012.pdf, XP055762947-
SEARCH- SUMIT MAJUMDAR ET AL, "Evaluation of the effect of syringe surfaces on protein formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, (20110211), vol. 100, no. 7, doi:10.1002/jps.22515, ISSN 0022-3549, pages 2563 - 2573, XP055059280 [A] 1-15 * the whole document *

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Dossier Documents

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