Arbitral Digest

Matter

Halozyme Inc v National Institute of Industrial Property (Paris Court of Appeal 20/17731)

Halozyme challenged refusal of a protection certificate for rituximab and hyaluronidase; the Paris Court of Appeal upheld the refusal under EU law on appeal.

  • Other
Industry type
Manufacturing

Procedural record

  1. 27 January 2020Arbitration

    27 January 2020Arbitration

    Decision of the Director General of the National Institute of Industrial Property on CCP application 16C0030 dated 27 January 2020

    Decision summary
    The National Institute of Industrial Property rejected Halozyme Inc's application for a supplementary protection certificate for rituximab and recombinant human hyaluronidase.

    Participants

    HALOZYME INC
    National Institute of Industrial Property

    1 year, 11 months and 22 days later · 722 days

  2. 18 January 2022France

    18 January 2022France

    Judgment of the Paris Court of Appeal in case 20/17731 dated 18 January 2022

    Paris Court of Appeal

    Case no.
    20/17731
    Citation
    n°017/2022
    Decision summary
    The Paris Court of Appeal rejected Halozyme Inc's appeal against the National Institute of Industrial Property's refusal of supplementary protection certificate application 16C0030. It held that recombinant human hyaluronidase was an excipient rather than an active ingredient, so the combination with rituximab was not a product under Article 1(b) of Regulation (EC) No 469/2009; it also held that rituximab had earlier marketing authorisations and the invoked authorisation was not the first for that product.

    Participants

    HALOZYME INC
    Representative
    [O] [H] (For: HALOZYME INC)
    Representative
    [P] [D] (For: HALOZYME INC)
    Representative
    Pauline DEBRÉ (For: HALOZYME INC)
    Representative
    LINKLATERS LLP (For: HALOZYME INC)
    National Institute of Industrial Property
    Representative
    Virginie LANDAIS (For: National Institute of Industrial Property)
    Paris Court of Appeal
    Judge
    Isabelle DOUILLET
    Judge
    Françoise BARUTEL
    Judge
    Déborah BOHEE
    Advocate General
    Muriel FUSINA
    Other
    Court Reporter
    Karine ABELKALON
    Institutional administrator
    Public Prosecutor's Office

    Authorities cited

    10
    • Regulation (EC) No 469/2009
      statute
    • MIT C-431/04 (CJEU, C-431/04, 4 May 2006)
      case law
    • GlaxoSmithKline C-210/13 (CJEU, C-210/13, 14 November 2013)
      case law
    • Bayer C-11/13 (CJEU, C-11/13, 19 June 2014)
      case law
    • Forsgren C-631/13 (CJEU, C-631/13, 15 January 2015)
      case law
    • Directive 2011/62/EU
      statute
    • Directive 2001/83/EC
      statute
    • Directive 2003/63/EC
      statute
    • Regulation (EC) No 1610/96
      statute
    • French Code of Civil Procedure
      statute

Matter record

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Halozyme Inc v National Institute of Industrial Property (Paris Court of Appeal 20/17731) · Matter