Use Of C-Type Natriuretic Peptide Variants To Treat Skeletal Dysplasia - EP3328416

The patent EP3328416 was granted to Biomarin Pharmaceutical on Mar 13, 2024. The application was originally filed on Aug 1, 2016 under application number EP16750584A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3328416

BIOMARIN PHARMACEUTICAL
Application Number
EP16750584A
Filing Date
Aug 1, 2016
Status
Granted And Under Opposition
Feb 9, 2024
Grant Date
Mar 13, 2024
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (3)

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GRAF VON STOSCH PATENTANWALTSGESELLSCHAFTDec 13, 2024LEPTHIENADMISSIBLE
SANDOZDec 12, 2024TER MEER STEINMEISTER & PARTNERADMISSIBLE
TEVA PHARMACEUTICALSDec 12, 2024KRAUS & LEDERER PARTGMBBADMISSIBLE

Patent Citations (18) New

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

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OPPOSITIONEP2432489
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Non-Patent Literature (NPL) Citations (19) 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, "A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and E cacy in Children With Achondroplasia (ACH)", ClinicalTrials.gov; NCT02055157, (20150128), ClinicalTrials.gov; NCT02055157 , URL: https://clinicaltrials.gov/study/NCT02055157?term=NCT02055157%20&rank=1&tab=history&a=2#version-content-panel, XP093239613-
OPPOSITION- Anonymous, "Benzyl alcohol and benzoic acid group used as excipients", European Medicines Agency, (20171009), URL: https://www.ema.europa.eu/en/documents/report/benzyl-alcohol-and-benzoic-acid-group-used-excipients-report-published-support-questions-and-answers-benzyl-alcohol-used-excipient-medicinal-products-human-use-emachmp5081882013-and-t_en.pdf, (20240125), XP093123729-
OPPOSITION- Anonymous, "BMN 111 (vosoritide) Improves Growth Velocity in Children With Achondroplasia in Phase 2 Study", BIOMARIN, (20150617), BIOMARIN, URL: https://www.biomarin.com/news/press-releases/bmn-111-vosoritide-improves-growth-velocity-in-children-with-achondroplasia-in-phase-2-study/, XP093239618-
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN) - Proposed INN: List 112", WHO Drug Information, (20140101), vol. 28, no. 4, pages 485 - 563, XP093239624-
OPPOSITION- D11 - Excerpts from drug label information for several pharmaceuticals available at the filing or priority date of the patent-
OPPOSITION- D29 - Annex including post-filed data-
OPPOSITION- D31 - T 0116/18, decision dated 28 July 2023-
OPPOSITION- D32 - T 1989/19, decision dated 30 June 2023-
OPPOSITION- D34 - Decision T 314/20)-
OPPOSITION- D4 - Applicant’s submission during examination, November 10, 2020-
OPPOSITION- Mahesh V. Chaubal, James Kipp, Barrett Rabinow, "Chapter 16: Excipient Selection and Criteria for Injectable Dosage Forms", Mahesh V. Chaubal, James Kipp, Barrett Rabinow, Ashok Katdare; Mahesh V. Chaubal, Excipient development for pharmaceutical, biotechnology, and drug delivery systems, New York [u.a.] , Informa Healthcare , (20060728), pages 271 - 290, ISBN 978-0-8493-2706-3, XP009559029-
OPPOSITION- Sougata Pramanick, Singodia, Chandel, "Excipient Selection In Parenteral Formulation Development", Pharma Times, (20130301), vol. 45, no. 3, pages 65 - 77, XP055449954-
OPPOSITION- Lincoln R. Potter, Et Al., "Natriuretic Peptides: Their Structures, Receptors, Physiologic Functions and Therapeutic Applications", Handbook of Experimental Pharmacology, SPRINGER VERLAG, BERLIN, DE, BERLIN, DE , (20090101), vol. 191, no. 1, doi:10.1007/978-3-540-68964-5_15, ISBN 978-3-642-14540-7, pages 341 - 366, XP055464846
OPPOSITION- Leiva-Gea Antonio, Martos Lirio María F., Barreda Bonis Ana Coral, Marín Del Barrio Silvia, Heath Karen E., Marín Reina Purificacion, Guillén-Navarro Encarna, Santos Simarro Fernando, Riaño Galán Isolina, Yeste Fernández Diego, Leiva-Gea Isabel, "Achondroplasia: Update on diagnosis, follow-up and treatment", Anales de Pediatría (English Edition), (20221201), vol. 97, no. 6, doi:10.1016/j.anpede.2022.10.004, ISSN 2341-2879, pages 423.e1 - 423.e11, XP093239620
OPPOSITION- Hada Shavron; Kim Nam Ah; Lim Dae Gon; Lim Jun Yeul; Kim Ki Hyun; Adhikary Pratik; Jeong Seong Hoon, "Evaluation of antioxidants in protein formulation against oxidative stress using various biophysical methods", International Journal of Biological Macromolecules, ELSEVIER BV, NL, NL , (20151021), vol. 82, doi:10.1016/j.ijbiomac.2015.10.048, ISSN 0141-8130, pages 192 - 200, XP029357951
OPPOSITION- J. K. Kaushik, R. Bhat, "Why Is Trehalose an Exceptional Protein Stabilizer?: AN ANALYSIS OF THE THERMAL STABILITY OF PROTEINS IN THE PRESENCE OF THE COMPATIBLE OSMOLYTE TREHALOSE", Journal of Biological Chemistry, American Society for Biochemistry and Molecular Biology, (20030711), vol. 278, no. 29, doi:10.1074/jbc.M300815200, ISSN 00219258, pages 26458 - 26465, XP055191121
OPPOSITION- D. J. Wendt, M. Dvorak-Ewell, S. Bullens, F. Lorget, S. M. Bell, J. Peng, S. Castillo, M. Aoyagi-Scharber, C. A. O'neill, P. Krejci, W. R. Wilcox, D. L. Rimoin, S. Bunting, "Neutral Endopeptidase-Resistant C-Type Natriuretic Peptide Variant Represents a New Therapeutic Approach for Treatment of Fibroblast Growth Factor Receptor 3-Related Dwarfism", Journal of Pharmacology and Experimental Therapeutics, (20150227), vol. 353, no. 1, doi:10.1124/jpet.114.218560, pages 132 - 149, XP055282054
OPPOSITION- Lene Jorgensen, Susanne Hostrup, Eva Horn Moeller, Holger Grohganz, "Recent trends in stabilising peptides and proteins in pharmaceutical formulation - considerations in the choice of excipients", Expert Opinion on Drug Delivery, Informa Healthcare, GB, GB , (20091101), vol. 6, no. 11, doi:10.1517/17425240903199143, ISSN 1742-5247, pages 1219 - 1230, XP055528446
OPPOSITION- Nema S; Brendel R J, "Excipients and their role in approved injectable products: Current usage and future directions", PDA Journal of Pharmaceutical Science and Technology, Parenteral Drug Association, US, US , (20110501), vol. 65, no. 3, doi:10.5731/pdajpst.2011.00634, ISSN 1079-7440, pages 287 - 332, XP009166667

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