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EP3013318
European procedure
Extract from the Register of European Patents
EP About this file: EP3013318
| EP3013318 - STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE) [Right-click to bookmark this link] | Status | Opposition rejected Status updated on 12.08.2022 Database last updated on 11.09.2024 | |
| Former | The patent has been granted Status updated on 20.03.2017 | ||
| Former | Grant of patent is intended Status updated on 17.11.2016 | Most recent event Tooltip | 12.08.2022 | Opposition rejected | published on 14.09.2022 [2022/37] | Applicant(s) | For all designated states Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320 / US | [2016/18] | Inventor(s) | 01 /
MACLEAN, Derek 750 Jordan Avenue Los Altos, California 94022 / US | 02 /
YIN, Qun 747 Coastland Drive Palo Alto, California 94030 / US | [2016/18] | Representative(s) | Dörries, Hans Ulrich, et al df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstrasse 16 80333 München / DE | [N/P] |
| Former [2016/18] | Gibson, Mark Sagittarius IP Three Globeside Fieldhouse Lane Marlow, Buckinghamshire SL7 1HZ / GB | Application number, filing date | 14742093.9 | 27.06.2014 | [2016/18] | WO2014US44622 | Priority number, date | US201361840618P | 28.06.2013 Original published format: US 201361840618 P | [2016/18] | Filing language | EN | Procedural language | EN | Publication | Type: | A1 Application with search report | No.: | WO2014210489 | Date: | 31.12.2014 | Language: | EN | [2014/53] | Type: | A1 Application with search report | No.: | EP3013318 | Date: | 04.05.2016 | Language: | EN | The application published by WIPO in one of the EPO official languages on 31.12.2014 takes the place of the publication of the European patent application. | [2016/18] | Type: | B1 Patent specification | No.: | EP3013318 | Date: | 19.04.2017 | Language: | EN | [2017/16] | Search report(s) | International search report - published on: | EP | 31.12.2014 | Classification | IPC: | A61K9/08, A61K38/08, A61P5/00, A61P3/14 | [2016/18] | CPC: |
A61K38/08 (EP,US);
F04D25/0606 (US);
A61K47/12 (EP,US);
A61K9/0019 (EP,US);
A61K9/08 (EP,US);
A61P3/00 (EP);
A61P3/14 (EP);
A61P43/00 (EP);
A61P5/00 (EP);
| Designated contracting states | AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR [2016/18] | Extension states | BA | 21.12.2015 | ME | 21.12.2015 | Title | German: | STABILE, FLÜSSIGE FORMULIERUNG VON AMG 416 (VELCALCETID) | [2016/18] | English: | STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE) | [2016/18] | French: | FORMULATION LIQUIDE STABLE D'AMG 416 (VELCALCÉTIDE) | [2016/18] | Entry into regional phase | 21.12.2015 | National basic fee paid | 21.12.2015 | Designation fee(s) paid | 21.12.2015 | Examination fee paid | Examination procedure | 21.12.2015 | Examination requested [2016/18] | 23.08.2016 | Amendment by applicant (claims and/or description) | 18.11.2016 | Communication of intention to grant the patent | 10.03.2017 | Fee for grant paid | 10.03.2017 | Fee for publishing/printing paid | 10.03.2017 | Receipt of the translation of the claim(s) | 31.01.2022 | Observations by third parties | Divisional application(s) | EP17160312.9 / EP3246017 | EP21156687.2 / EP3878433 | Opposition(s) | Opponent(s) | 01
19.01.2018
25.01.2018
ADMISSIBLE Hexal AG Industriestrasse 25 83607 Holzkirchen / DE Opponent's representative Ter Meer Steinmeister & Partner Patentanwälte mbB Nymphenburger Straße 4 80335 München / DE | [2018/09] | 01.02.2018 | Invitation to proprietor to file observations on the notice of opposition | 11.06.2018 | Reply of patent proprietor to notice(s) of opposition | 09.05.2019 | Date of oral proceedings | 21.06.2019 | Despatch of minutes of oral proceedings | 21.06.2019 | Date of despatch of rejection of opposition | 21.06.2022 | Legal effect of rejection of opposition [2022/37] | Appeal following opposition | 21.08.2019 | Appeal received No. T2342/19 | 31.10.2019 | Statement of grounds filed | 21.06.2022 | Result of appeal procedure: appeal of the opponent was rejected | 27.07.2022 | Despatch of the decision of the Board of Appeal | 21.06.2022 | Date of oral proceedings | Fees paid | Renewal fee | 10.06.2016 | Renewal fee patent year 03 |
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| Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court. | Lapses during opposition Tooltip | deleted | [2021/01] |
| Former [2017/49] | AT | 19.04.2017 | Cited in | International search | [AD]WO2011014707 (KAI PHARMACEUTICALS INC [US], et al) [AD] 1-15 * the whole document * * examples 4,11; claim 23; tables 2,4 * * paragraphs [0060] , [0117] , [0223] - [0227] *; | [A] - SHEN JUN ET AL, "A pharmacokinetic/pharmacodynamic model for AMG 416, a novel calcimimetic peptide, following a single intravenous dose in healthy subjects.", JOURNAL OF CLINICAL PHARMACOLOGY OCT 2014, vol. 54, no. 10, ISSN 1552-4604, (201410), pages 1125 - 1133, URL: http://onlinelibrary.wiley.com/doi/10.1002/jcph.314/pdf, (20140923), XP002730170 [A] 1-14 * the whole document * * abstract * DOI: http://dx.doi.org/10.1002/jcph.314 | by applicant | WO2011014707 | other | - W-CHANG JOHN WANG, MUSETTA A. HANSON, "Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers", Journal of Parenteral Science and Technology, vol. 42, no. 2 suppl, pages S3 - S26, XP055877945 | - Christina Avanti, "Innovative Strategies for Stabilization of Therapeutic Peptides in Aqueous Formulations", Dissertation, University of Groningen, (20120101), pages 1 - 157, URL: http://www.tipharma.com/fileadmin/user_upload/Theses/PDF/Christina_Avanti_D6-202.pdf, (20140709), XP055127921 | - Gaozhonj Zhu, Y. John Wang, "Formulation of protein- and peptide-basedparenteral products", Gaozhonj Zhu, Y. John Wang, Sandeep Nema, John D. Ludwig, Pharmaceutical Dosage Forms Parenteral Medications. 3rd ed., Informa Healthcare, (2010), vol. 1, pages 222 - 253, XP055874783 | - "Kapitel 9: Parenteralia, einschließlich Blutzubereitungen, Sera und Impfstoffe", Kurt H. Bauer, Karl-Heinz Frbmming, Claus Fuhrer, Pharmazeutische Technologic, Georg Thieme Verlag, (1993), pages 225 - 228, XP055808357 | Opposition | WO2012170955 | WO2013071262 | - Akers et al, "Peptides and Proteins as Parenteral Solutions", Pharmaceutical Formulation Development of Peptides and Proteins, (20000000), pages 145 - 155, XP055454710 | - L. LACHMAN et al., "Preformulation", The Theory and Practice of Industrial Pharmacy, Bombay, Varghese Publishing House, (19870000), pages 190 - 195 , 764-768, XP055455515 | - "Haltbarkeit von Wirkstoffenund Arneizubereitungen", H. FELTKAMP et al., Pharmazeutische Qualitatskontrolle, Stuttgart New York, Georg Thieme, (19830000), pages 502 - 504, XP055455519 | - "Design of dosage forms", Michael E Aulton, Aulton's Pharmaceutics, Churchill Livingstone, Churchill Livingstone Elsevier, vol. 8, pages 8, 368 - 369 , 616-620, XP055455526 | - K. H. BAUER et al., "Parenteralia, einschliesslich Blutzubereitungen, Sera und Impfstoffe", K. H. BAUER et al., Bernhard C Lippold, Christel Müller-Goymann, Rolf Schubert, Lehrbuch der Pharmazeutischen Technologie, Stuttgart, (20060000), pages 238 - 243, ISBN 3-8047-2222-9, XP055455531 | - Y.-C. J. WANG et al., "Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers", Journal of Parenteral Science and Technology, (19880000), vol. 42, pages S4 - S26, XP000984636 | - Edward F Nemeth, "Calcimimetics and calcilytics in the treatment of chronic kidney disease-mineral and bone disorder", Edward F Nemeth, Olgaard et al., The Spectrum of Mineral and Bone Disorders in Chronic Kidney Disease secnd edition, pages 443 - 461, XP055447380 | - Jonathan immelfarb, Mohammed H Sayegh, Chronic Kidney Disease, Dialysis, and Transplantation Third Edition, Saunders Elsevier, (20100000), vol. 112, pages 92 - 93,112,335,349-352, XP055455576 | - Leaflet of Epoetin Alfa Hexal | - D. VOET, J.G. VOET, "Säuren, Basen und Puffersysteme", D. VOET, J.G. VOET, A Maelicke and W Müller-Esterl, Biochemie, VCH Verlag, (19940000), pages 35 - 41, XP055455581 |