Syringe - EP3656373

The patent EP3656373 was granted to Novartis on Feb 16, 2022. The application was originally filed on Jan 25, 2013 under application number EP19210117A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3656373

NOVARTIS
Application Number
EP19210117A
Filing Date
Jan 25, 2013
Status
Granted And Under Opposition
Jan 14, 2022
Grant Date
Feb 16, 2022
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (3)

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.

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HAMM & WITTKOPPNov 16, 2022HAMM & WITTKOPPWITHDRAWN
HOFFMANN EITLENov 15, 2022HOFFMANN EITLEWITHDRAWN
KEIL & SCHAAFHAUSEN PATENTANWALTE PARTGMBBNov 14, 2022KEIL & SCHAAFHAUSEN PATENTANWALTE PARTGMBBWITHDRAWN

Patent Citations (40) New

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

Citation PhasePublication NumberPublication Link
EXAMINATIONUS2011276005
OPPOSITIONAU2012101677
OPPOSITIONAU2012101678
OPPOSITIONAU2013100070
OPPOSITIONAU2013100071
OPPOSITIONDE202012011016U
OPPOSITIONDE202012011259U
OPPOSITIONDE202012011260U
OPPOSITIONDE202013000688U
OPPOSITIONEP0738517
OPPOSITIONEP2047877
OPPOSITIONJP2001340455
OPPOSITIONJP2002177388
OPPOSITIONJP2004313369
OPPOSITIONJP2012045046
OPPOSITIONJPH0725963Y
OPPOSITIONUS2007250017
OPPOSITIONUS2012078224
OPPOSITIONUS2012091026
OPPOSITIONUS31789
OPPOSITIONUS4946441
OPPOSITIONUS5405326
OPPOSITIONUS6688252
OPPOSITIONWO2004075958
OPPOSITIONWO2007035621
OPPOSITIONWO2008154630
OPPOSITIONWO2009030976
OPPOSITIONWO2009099641
OPPOSITIONWO2009158613
OPPOSITIONWO2011006877
OPPOSITIONWO2012117837
OPPOSITIONWO9744068
OTHERUS6090081
OTHERWO2007035621
OTHERWO2011059823
OTHERWO2014005728
SEARCHDE102008005938
SEARCHUS2006293270
SEARCHUS2011257601
SEARCHWO2007035621

Non-Patent Literature (NPL) Citations (34) 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- Adler Micheal, "Challenges in the Development of Pre-filled Syringes for Biologics from a Formulation Scientist's Point of View", American Pharmaceutical Review, (20120201), pages 1 - 7, XP055951840-
OPPOSITION- Anonymous, "A basic guide to particle characterization", Malvern Instruments Limited, (20150101), pages 1 - 24, (20200604), XP055701324-
OPPOSITION- Anonymous, "ADVANCEMENTS IN PREFILLED SYRINGE TECHNOLOGY: IMPROVING COMPATIBILITY WITH BIOLOGICS WITH A NOVEL CROSS-LINKED SILI- CONE COATING", INJECTABLE DRUG DELIVERY 2012: DEVICES FOCUS, (20120630), pages 1 - 5, XP055951917-
OPPOSITION- Anonymous, "Components for prefilled syringes ", Datwyler, (20110101), pages 1 - 2, XP093144175-
OPPOSITION- Anonymous, "COVID-19 Related Goods: The U.S. Industry, Market, Trade, and Supply Chain Challenges", United States International Trade Commission, (20201201), pages 1 - 368, XP093144116-
OPPOSITION- Anonymous, "Division of Transplant and Ophthalmology Products Advisory Committee Meeting", Regeneron - Briefing Package-
OPPOSITION- Anonymous, "Fachinformation Novartis Pharma Lucentis®", Lucentis®, (20070100), pages 1 - 5, XP055889817-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION- LUCENTIS®; (ranibizumab injection)", Genentech, Inc., (20060101), pages 1 - 7, Genentech, Inc.,, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125156lbl.pdf, (20191114), XP055642530-
OPPOSITION- Anonymous, "Methods of Particle size determination - a review", Innopharma Technology, (20190901), pages 1 - 24, Innopharma Technology, URL: https://www.innopharmatechnology.com/docs/default-source/eyecon2-whitepapers/methods-of-particle-size-determination.pdf, (20221201), XP093004148-
OPPOSITION- Anonymous, "Particle Counting in Injectable Solutions 2007 Updates", Particle Measuring Systems, Inc., (20070101), page 6pp, XP055642519-
OPPOSITION- Anonymous, "Particulate Matter in Ophthalmic Solutions", The United States Pharmacopeia USP 35, (20111202), pages 342 - 343, URL: https://www.drugfuture.com/Pharmacopoeia/usp35/PARTICULATEMATTERINOPHTHALMICSOLUTIONS.pdf, XP055897740-
OPPOSITION- Anonymous, "Prefilled syringes Part 4: Glass barrels for injectables Seringues préremplies", ISO 11040-4, (20070000), pages 1 - 16, XP093003655-
OPPOSITION- Anonymous, "PRODUCT INFORMATION EYLEA® aflibercept (rch)", Australian Register of Therapeutic Goods, (20120307), pages 1 - 18, XP055642472-
OPPOSITION- Anonymous, "West introduces the Daiko crystal zenit RU prefillable syringe system", Pharmaceutical Online - Press release, (20080625), URL: https://www.pharmaceuticalonline.com/doc/west-introduces-prefillable-syringe-system-0001, XP093004152-
OPPOSITION- Arno Fries, "Drug delivery of sensitive biopharmaceuticals with prefilled syringes", Drug Delivery Technology, (20090101), vol. 9, no. 5, pages 22 - 27, XP055952517-
OPPOSITION- Arno Fries, "Drug delivery of sensitive biopharmaceuticals with prefilled syringes", Drug Delivery Technology, (20090500), vol. 9, no. 5, pages 1 - 8, XP055952517-
OPPOSITION- Bruno Reuter, Petersen Claudia, Gerresheimer BÜNDE, Gmbh, BÜNDE, "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- Bruno Reuter; Petersen Claudia; Gerresheimer Bünde; Gmbh; Bünde, "Syringe Siliconization Trends, methods, analysis procedures", TechnoPharm, (20120801), vol. 2, no. 4, pages 238 - 244, XP055658634-
OPPOSITION- Din, "Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling", DIN ISO 11040-4 : 1996, (19960101), pages 1 - 5, DIN ISO 11040-4 : 1996, (20221202), XP093004250-
OPPOSITION- Din, "Sterile hypodermic syringes for single use - Part 1: Syringes for manual use", DIN ISO 7886-1 : 1997, (19971001), DIN ISO 7886-1 : 1997, (20221202), XP093004255-
OPPOSITION- DR. BÖTTGER, "BIO PRODUCTION FORUM: BRIDGING RESEARCH AND INDUSTRY", GMPjournal, (20101004), pages 1 - 3, XP093003608-
OPPOSITION- DR FRANK BÖTTGER, "More than Filling - New Developments in Siliconization and Silicone Layer Analytics", Bio Production Forum - Fill and Finish for Biopharmaceuticals, (20100615), pages 1 - 43, XP055642524-
OPPOSITION- Frank BÖTTGER, "More than Filling. New Developments in Siliconization and Silicone Layer Analytics", Bio Production Forum - Fill and Finish for Biopharmaceuticals, (20100601), pages 1 - 43, XP055642524-
OPPOSITION- Hlobik Tibor, "Reducing quality risks to drug products and meeting needs of patient with enhanced components for prefillable syringe systems", ONdrugdelivery, (20120101), vol. 2012, no. 30, pages 32 - 34, XP093004158-
OPPOSITION- Iso, "Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling", ISO 11040-6 : 2012, (20120401), ISO 11040-6 : 2012, (20221202), XP093004251-
OPPOSITION- Mintz C., "Prefilled syringes: The Next "Big Thing"", Bioprocess Online, (20120930), Bioprocess Online, URL: https://www.bioprocessonline.com/doc/prefilled-syringes-the-next-big-thing-0001, (20190206), XP002788671-
OPPOSITION- T. P. SCHOENKNECHT, "Requirements on pre-fillable glass syringes", AAPS Na- tional Biotechnology Conference, (20070000), page 1, XP003035654-
OPPOSITION- JOUBERT, "Classification and Characterization of Therapeutic Antibody Aggregates", The journal of biological chemistry, (20110715), vol. 286, no. 28, doi:10.1074/jbc.M110.160457, pages 25118 - 25133, XP055650027
OPPOSITION- BAKRI et al., "Intravitreal silicone oil droplets after intravitreal drug injections", Retina, (20080700), vol. 28, no. 7, doi:10.1097/IAE.0b013e31816c6868, pages 996 - 1001, XP055186525
OPPOSITION- Liu L; Ammar D A; Ross L A; Mandava N; Kahook M Y; Carpenter J F, "Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-term Storage and Product Mishandling", Investigative Ophthalmology & Visual Science, vol. 52, no. 2, (20110222), pages 1023 - 1034, URL: https://iovs.arvojournals.org/arti- cle.aspx?articleid=2126227, XP055059283
OPPOSITION- Advait Badkar; Amanda Wolf; Leigh Bohack; Parag Kolhe, "Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches", AAPS PHARMSCITECH, Springer New York LLC, US, US , (20110504), vol. 12, no. 2, doi:10.1208/s12249-011-9617-y, ISSN 1530-9932, pages 564 - 572, XP019925550
OTHER- BERNIE LAHENDRO, "THE NEXT GENERATION OF READY-TO-USE PREFILLABLE SYRINGES: FIRST IN SILICONE-FREE SOLUTIONS", PREFILLED SYRINGES: THE CONTAINER OF CHOICE FOR TODAY'S INJECTABLES, (20080611), pages 24 - 26, URL: http://www.ondrugdelivery.com/publications/prefilled_syringes_2008.pdf, XP055371894-
OTHER- SEBASTIEN JOUFFRAY, "ADVANCEMENTS IN PREFILLED SYRINGE TECHNOLOGY: IMPROVING COMPATIBILITY WITH BIOLOGICS WITH A NOVEL CROSS-LINKED SILICONE COATING", Injectable Drug Delivery 2012: Devices Focus, (20120630), pages 4 - 8, URL: https://www.ondrugdelivery.com/wp-content/uploads/2018/11/JunJul2012.pdf, XP055762947-
OTHER- Liu L; Ammar D A; Ross L A; Mandava N; Kahook M Y; Carpenter J F, "Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-term Storage and Product Mishandling", Investigative Ophthalmology & Visual Science,, (20110200), vol. 52, no. 2, pages 1023 - 1034, XP055059283

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