European Union: Nouvelle question préjudicielle CCP: la France aussi souhaite un éclairage de la CJUE sur 3d) et l'interprétation de Neurim (affaire Santen)

Last Updated: 22 October 2018
Article by Francois Pochart, Mathilde Rauline and Loïc Lemercier
Most Read Contributor in France, October 2018

La France réfère une question préjudicielle à la CJEU sur l'article 3d) du règlement 469/2009 et l'interprétation de Neurim :

  • Où placer la limite de la « nouvelle application » : AMM vétérinaire versus humaine, nouvelle indication médicale, nouveau mode d'action du principe actif, nouvelle posologie, nouveau mode d'administration, nouvelle formulation ?
  • Le critère doit-il être plus strict que celui de la brevetabilité ?
  • La portée du brevet de base doit-elle concorder avec celle de l'AMM ?

L'article 3d) du règlement 469/2009 mentionne qu'un CCP ne peut être délivré que si l'autorisation de mise sur le marché (AMM) dont il bénéficie est « la première autorisation de mise sur le marché du produit, en tant que médicament».

La règle semblait claire : si le principe actif a déjà fait l'objet d'une AMM, le même principe actif ne pourra plus obtenir de CCP, même pour une nouvelle indication thérapeutique. En 2012, la décision Neurim1 a interprété différemment l'article 3d) : un autre CCP peut être délivré pour une « application » différente de celle de la première AMM lorsque le brevet servant de base à la demande de CCP protège cette nouvelle application. Dans Neurim, la première AMM était une AMM vétérinaire, et la seconde était une AMM humaine ; le raisonnement de la CJUE semblait clairement indiquer que la solution aurait été la même avec deux AMM humaines2.

Suite à cette décision, les offices de brevets nationaux ont dû décider de la portée à donner à Neurim. L'INPI mentionne que l'office néerlandais l'a strictement limité au cas d'espèce de l'affaire Neurim (AMM humaine contre AMM vétérinaire), cependant que le juge britannique est allé jusqu'à s'interroger sur la nécessité d'y englober des formulations nouvelles de produits connus. l'INPI entend appliquer Neurim de manière mesurée, mais s'interroge sur la limite à donner à 3d) et à Neurim: une nouvelle indication thérapeutique, le traitement d'une nouvelle espèce (AMM vétérinaire versus AMM humaine), un fonctionnement nouveau d'un principe actif connu, un nouveau mode d'administration, une nouvelle posologie, une nouvelle formulation peuvent-ils donner droit à un CCP ? C'est l'objet de la question référée à la CJEU. La Cour d'Appel de Paris demande également des précisions sur le degré d'exigence : doit-il être plus élevé que celui appliqué à la brevetabilité ? Enfin, la portée du brevet servant de base au CCP doit-elle concorder avec celle de l'AMM ?

Ces interrogations se rapprochent de celles de Mr Arnold J qui a également demandé à la CJUE en janvier 2017 de préciser comment l'article 3d) devait être interprété (Abraxis3).

La Cour d'Appelde Paris a décidé4, après avoir recueilli l'opinion de l'INPI, de référer la décision suivante à la CJUE :

  1. 1 - la notion d'application différente au sens de l'arrêt NEURIM du 19 juillet 2012 CJUE, C-130/11, doit-elle s'entendre de manière stricte, c'est à dire :
  • être limitée au seul cas d'une application humaine faisant suite à une application vétérinaire,
  • ou concerner une indication relevant d'un nouveau champ thérapeutique, au sens d'une nouvelle spécialité médicale, par rapport à l'AMM antérieure, ou un médicament dans lequel le principe actif exerce une action différente de celle qu'il exerce dans le médicament ayant fait l'objet de la première AMM ;
  • ou plus généralement, au regard des objectifs du règlement (CE) n° 469/2009 visant à mettre en place un système équilibré prenant en compte tous les intérêts en jeu, y compris ceux de la santé publique, être appréciée selon des critères plus exigeants que ceux présidant à l'appréciation de la brevetabilité de l'invention ;
  • ou doit-elle au contraire s'entendre de manière extensive, c'est à dire incluant non seulement des indications thérapeutiques et des maladies différentes, mais encore des formulations, posologies et/ou modes d'administration différents.
  1. 2 - la notion d'application entrant dans le champ de protection conféré par le brevet de base au sens de l'arrêt NEURIM du 19 juillet 2012 CJUE, C-130/11, implique-t-elle que la portée du brevet de base devrait concorder avec celle de l'AMM invoquée et, par conséquent, se limiter à la nouvelle utilisation médicale correspondant à l'indication thérapeutique de ladite AMM.

Les faits donnant lieu à cette question préjudicielle sont les suivants :

La ciclosporine était connue, en solution buvable, (médicament Sandimmum®) pour

  • la prévention du rejet de greffes d'organes solides ou de moelle osseuse
  • le traitement de l'uvéite (inflammation de l'uvée : traitement de la partie centrale du globe oculaire)

la nouvelle indication pour laquelle un CCP était demandé était le traitement de la kératite sévère (inflammation de la cornée, partie antérieure du globe oculaire), sous forme de collyre en émulsion administré par une goutte dans l'Sil (médicament Ikervis®)

le dosage et la posologie des deux médicaments diffèrent.

Les raisons de la non délivrance du CCP sont les suivantes : il n'est pas démontré que l'application médicale de l'AMM d'Ikervis constitue une nouvelle application thérapeutique, au sens de Neurim, par rapport à Sandimmun, toutes deux ayant trait au traitement d'inflammations dans le domaine ophtalmologique. De plus, les AMM ont trait toutes deux au traitement d'inflammation de parties de l'Sil chez l'humain, par le même mécanisme d'action anti-inflammatoire de la ciclosporine : une utilisation médicale nouvelle ne serait pas suffisamment démontrée.

L'INPI estime encore que dans la présente affaire, la portée du brevet de base ne concorde pas avec celle de l'AMM, alors que c'était le cas dans Neurim. Le brevet de base couvre le produit (émulsion ophtalmique comprenant la ciclosporine) mais aussi des indications oculaires multiples dont la kératite et l'uvéite.

Footnotes

1 C130/11

2 C130/11 : paragraphes 25, 26 et 30

3 C443/17 – question préjudicielle posée dans Abraxis Bioscience LLC v The Comptroller General of Patents, High Court of England and Wales, (Arnold J), London, UK, 13 January 2017, Neutral Citation Number: [2017] EWHC 14 (Pat)

4 CA Paris, 9 octobre 2018, RG 17/19934, Santen

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