Canada: La Singularité De La Protection Supplémentaire

Le 26 septembre 2014, le premier ministre canadien Stephen Harper ainsi que le président de la Commission européenne José Manuel Barroso ont signé les textes de l'entente de libre-échange Canada-Union Européenne. Cette signature couronne de succès les longues négociations qui ont duré plus de cinq ans et qui ont mené à la ratification de l'entente.

L'entente de libre-échange Canada-Union Européenne (officiellement nommée Accord Économique et Commercial Global Canada/Union Européenne ou AECG) aura des répercussions importantes sur la mobilité des résidents dans la zone euro-canadienne, l'exportation du sirop d'étable, de bSuf et de porc, l'importation de fromages ainsi que sur la protection par brevet couvrant des médicaments commercialisés au Canada.

En effet, l'entente prévoit que les brevets couvrant les médicaments pourront bénéficier d'une protection supplémentaire d'un maximum de 2 ans. Cette protection supplémentaire sera ajoutée à la fin du terme légal de 20 ans octroyé pour les brevets canadiens. Dans les textes de l'entente, cette protection a été libellée sui generis et ce libelle indique une situation juridique dont la singularité prévient tout classement dans une catégorie déjà répertoriée. Donc, exceptionnelle cette protection supplémentaire? Hum, pas vraiment... En fait le Canada faisait cavalier seul car il était le seul pays du G7 à ne pas offrir une telle protection pour les brevets couvrant les médicaments.

Pourquoi donc les autres pays du G7 (États-Unis, Japon, Allemagne, France, Royaume-Uni et Italie) offrent-ils une protection supplémentaire sur les brevets couvrant les médicaments? La réponse n'est pas simple et pour y répondre, il faut (un peu) connaître le cycle de développement d'un médicament.

Il en prend habituellement entre 10 et 14 ans pour qu'un médicament qui a été identifié comme étant prometteur dans les confins d'un laboratoire puisse être approuvé pour être vendu au Canada. Le développement d'un médicament est donc long et risqué. Pour préserver les droits de propriété intellectuelle sur les médicaments qu'elles développent, les compagnies pharmaceutiques déposent habituellement tôt dans le cycle de vie d'un médicament une demande de brevet couvrant ce médicament (habituellement avant que le médicament ait été testé chez les humains). Ce qui est également particulier à l'industrie pharmaceutique, c'est que la commercialisation d'un médicament ne peut être faite qu'à la suite de nombreux essais pré-cliniques et cliniques démontrant l'innocuité et l'efficacité de ce dernier. Durant la période où l'innocuité et l'efficacité du médicament sont évaluées, la compagnie qui développe le médicament (habituellement le propriétaire du brevet) ne peut pas jouir du monopole conféré par le brevet puisqu'il ne peut commercialiser son médicament. La protection supplémentaire vise donc à pallier en partie le délai causé par les essais cliniques dans la commercialisation du médicament.

Dans les négociations menant à la signature de l'entente de libre-échange, l'Europe demandait au Canada d'octroyer une protection supplémentaire maximale de 5 ans, ce qui est couramment en vigueur dans la zone euro. Le Canada a toutefois décider de couper la poire en deux en octroyant une protection supplémentaire maximale de 2 ans.

Dès la ratification des textes de l'entente du libre-échange dans la loi canadienne, la protection supplémentaire sera accordée si les conditions suivantes sont remplies :

  • Une autorisation pour la mise en marché du médicament a été octroyée;
  • Aucune autre protection supplémentaire n'a été octroyée pour médicament dans le passé; et
  • La requête pour l'obtention de la protection supplémentaire a été déposée dans les 60 jours suivant la date de l'autorisation de la mise en marché du médicament ou la date d'octroi du brevet (la plus antérieure des deux).

La protection supplémentaire ne sera être accordée sur un seul brevet couvrant le médicament. Le brevet peut couvrir le médicament lui-même, le procédé pour fabriquer ce médicament ou l'utilisation thérapeutique du médicament. Si plusieurs brevets couvrent un même médicament, le propriétaire des brevets devra choisir le brevet auquel la protection supplémentaire s'appliquera.

La protection supplémentaire sera calculée comme suit :

calculprotsupp

Tel qu'indiqué plus haut, la protection supplémentaire ne pourra être de plus de 2 ans et pourra même être réduite davantage si des délais jugés comme étant « injustifiées » ou « non-raisonnables » ont été causés par la partie qui demande la protection supplémentaire. Aucun détails sur la nature de ces délais n'ont été divulgué pour l'instant. Pour les parties intéressées à obtenir une protection supplémentaire, il est donc recommandé d'éviter autant que possible les délais pouvant être encourus durant l'approbation de mise ne marché du médicament ou durant la poursuite des brevets couvrant ce médicament.

Ce qui est intéressant dans cette provision de l'entente de libre-échange est que la protection supplémentaire est applicable aux brevets couvrant les médicaments produits par des compagnies canadiennes et européennes ainsi que par toutes autres Suvrant partout dans le reste du monde commercialisant des médicaments brevetés au Canada.

Norton Rose Fulbright Canada LLP

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Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

Norton Rose Fulbright LLP, Norton Rose Fulbright Australia, Norton Rose Fulbright Canada LLP, Norton Rose Fulbright South Africa (incorporated as Deneys Reitz Inc) and Fulbright & Jaworski LLP, each of which is a separate legal entity, are members ('the Norton Rose Fulbright members') of Norton Rose Fulbright Verein, a Swiss Verein. Norton Rose Fulbright Verein helps coordinate the activities of the Norton Rose Fulbright members but does not itself provide legal services to clients.

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