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Manufacture Of Degarelix - EP2854831

The patent EP2854831 was granted to Ferring on Jul 10, 2024. The application was originally filed on May 31, 2013 under application number EP13726219A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2854831

FERRING
Application Number
EP13726219A
Filing Date
May 31, 2013
Status
Granted And Under Opposition
Jun 7, 2024
Publication Date
Jul 10, 2024
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (4)

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CompanyOpposition DateRepresentativeOpposition Status

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ACCORD HEALTHCAREApr 10, 2025BRAND MURRAY FULLERADMISSIBLE
GRAF VON STOSCH PATENTANWALTSGESELLSCHAFTApr 10, 2025LEPTHIENADMISSIBLE
ZIMMERMANN & PARTNER PATENTANWALTE MBBApr 10, 2025ZIMMERMANN & PARTNER PATENTANWALTE MBBADMISSIBLE
KRAUS & LEDERER PARTGMBBMar 24, 2025KRAUS & LEDERER PARTGMBBADMISSIBLE

Patent Citations (23) New

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

Citation PhasePublication Number
DESCRIPTIONWO2010012835
DESCRIPTIONWO2011066386
DESCRIPTIONWO2012055903
DESCRIPTIONWO2012055905
DESCRIPTIONWO9846634
EXAMINATIONWO2011066386
INTERNATIONAL-SEARCH-REPORTCN102204889
INTERNATIONAL-SEARCH-REPORTUS2005282731
INTERNATIONAL-SEARCH-REPORTWO2010125468
INTERNATIONAL-SEARCH-REPORTWO2011004260
INTERNATIONAL-SEARCH-REPORTWO2012013331
OPPOSITIONCN102329373
OPPOSITIONUS2002099018
OPPOSITIONUS2005282731
OPPOSITIONUS2006135405
OPPOSITIONUS2007161571
OPPOSITIONWO0230463
OPPOSITIONWO2009101530
OPPOSITIONWO2010121835
OPPOSITIONWO2011004260
OPPOSITIONWO2011066386
OPPOSITIONWO2012055905
OPPOSITIONWO2013178788

Non-Patent Literature (NPL) Citations (26) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference Text
DESCRIPTION- DOEHN ET AL., DRUGS, (2006), vol. 9, no. 8, pages 565 - 571
DESCRIPTION- JAMES, E.F. ET AL., DRUGS, (2009), vol. 69, no. 14
DESCRIPTION- JIANG ET AL., J. MED. CHEM., (2001), vol. 44, pages 453 - 467
DESCRIPTION- VAN POPPEL, CANCER MANAGEMENT AND RESEARCH, (2010), vol. 2, pages 39 - 52
DESCRIPTION- VAN POPPEL ET AL., UROLOGY, (2008), vol. 71, no. 6, pages 1001 - 1006
EXAMINATION- Yi Xu ET AL, "A novel antiangiogenic peptide derived from hepatocyte growth factor inhibits neovascularization in vitro and in vivo", Molecular vision, United States, (20100101), page 1982, URL: http://www.molvis.org/molvis/v16/a214/mv-v16-a214-xu.pdf, XP055316061
EXAMINATION- RHOADES ET AL, "Interactions of an antimicrobial peptide (Ac-RRWWRF-NH"2) and surfactants: Towards antimicrobial peptide additives for coatings applications", PROCESS IN ORGANIC COATINGS, ELSEVIER BV, NL, (20070220), vol. 58, no. 2-3, doi:10.1016/J.PORGCOAT.2006.09.034, ISSN 0300-9440, pages 209 - 216, XP005895568
EXAMINATION- SANNES-LOWERY K A ET AL, "HIV-1 TAT PEPTIDE BINDING TO TAR RNA BY ELECTROSPRAY IONIZATION MASS SPECTROMETRY", ANALYTICAL CHEMISTRY, AMERICAN CHEMICAL SOCIETY, US, (19971215), vol. 69, no. 24, doi:10.1021/AC970745W, ISSN 0003-2700, pages 5130 - 5135, XP002922152
INTERNATIONAL-SEARCH-REPORT- SCHWACH G ET AL, "Biodegradable PLGA microparticles for sustained release of a new GnRH antagonist: part II. In vivo performance", EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM, NL, vol. 57, no. 3, ISSN 0939-6411, (20040501), pages 441 - 446, (20040413), XP027111808 [X] 22 * paragraph [02.1] * * paragraph [2.2.1] - paragraph [2.2.2] * [I] 16-21
INTERNATIONAL-SEARCH-REPORT- SCHWACH G ET AL, "Biodegradable microparticles for sustained release of a new GnRH antagonist - part I: screening commercial PLGA and formulation technologies", EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM, NL, (20031101), vol. 56, no. 3, doi:10.1016/S0939-6411(03)00096-1, ISSN 0939-6411, pages 327 - 336, XP004470468 [I] 16 * paragraph [02.1] - paragraph [02.2] *
OPPOSITION- Anonymous, "Australian Public Assessment Report for Degarelix Proprietary Product Name: Firmagon Sponsor: Ferring Pharmaceuticals Pty Ltd", Australian Government Department of Health and Ageing Therapeutic Goods Administration, (20100501), pages 1 - 84, XP093268108
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - FIRMAGON® (degarelix for injection) for subcutaneous use", FDA, FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022201s016lbl.pdf, XP093270644
OPPOSITION- Council of Europe, "2.2.10. Viscosity - Rotating viscometer method", EUROPEAN PHARMACOPOEIA 11.0, FR, Council of Europe, (20080101), pages 33 - 35, ISBN 978-92-871-9096-3, XP009561526
OPPOSITION- D01a: Transmittal letter of March 3, 2016 filed by the patent proprietor’s US representatives during prosecution of US application no. 14/403,775, a family member of EP’813, in which it has been referred to D1 including the (as of today still active) download link
OPPOSITION- D01b: Final Office Action dated April 8, 2016 issued during prosecution of US application no. 14/403,775
OPPOSITION- D01c: Reply to Final Office Action dated July 19, 2016 by the patent proprietor’s US representatives during prosecution of US application no. 14/403,775
OPPOSITION- D01d: US 2015/0141337 A1 (publication of US application no. 14/403,775)
OPPOSITION- D01: Prescribing information for a degarelix drug product for injection submitted to the FDA (Firmagon®) (December 2008); downloaded from www.accessdata.fda.gov/drugsatfda_docs/label/2008/022201lbl.pdf)
OPPOSITION- D8a - Rework of Example 3 of D1
OPPOSITION- D8b -Viscosity determination report from LabAnalysis
OPPOSITION- D8c - Affidavit of Dr. Ivan Guryanov
OPPOSITION- James M. Samanen, "3. Physical Biochemistry of Peptide Drugs: Structure, Properties, and Stabilities of Peptides Compared with Proteins", James M. Samanen, Vincent H.L. Lee, Peptide and Protein Drug Delivery, Marcel Dekker, Inc., (19910101), pages 137 - 167, ISBN 0-8247-7896-0, XP009561525
OPPOSITION- M F Powell, Sanders L M, Rogerson A, Si V, "Parenteral peptide formulations: chemical and physical properties of native luteinizing hormone-releasing hormone (LHRH) and hydrophobic analogues in aqueous solution", Pharmaceutical Research, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (19911001), vol. 8, no. 10, ISSN 0724-8741, pages 1258 - 1263, XP055515891
OPPOSITION- Moulik S P, Khan D P, "Viscosities of Concentrated Solutions of Polyhydroxy Nonelectrolytes, Glucose, Sucrose, Mannitol & Sorbitol in Relation to Solute-Solvent Interaction & a Universal Viscosity Equation", Indian Journal of Chemistry, (19770401), vol. 15A, pages 267 - 272, XP093270642
OPPOSITION- Dathe M., Gast K., Zirwer D., Welfle H., Mehlis B., "Insulin aggregation in solution", INTERNATIONAL JOURNAL OF PEPTIDE AND PROTEIN RESEARCH., MUNKSGAARD, COPENHAGEN., DK, DK , (19901001), vol. 36, no. 4, doi:10.1111/j.1399-3011.1990.tb01292.x, ISSN 0367-8377, pages 344 - 349, XP093270643
OPPOSITION- MAA Y-F, PRESTRELSKI S J, "BIOPHARMACEUTICAL POWDERS: PARTICLE FORMATION AND FORMULATION CONSIDERATIONS", CURRENT PHARMACEUTICAL BIOTECHNOLOGY, BENTHAM SCIENCE PUBLISHERS,, NL, NL , (20001101), vol. 01, no. 03, doi:10.2174/1389201003378898, ISSN 1389-2010, pages 283 - 302, XP001180972

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