Canada: Le Choix d’Angelina

Le 14 mai 2013, l'actrice et réalisatrice Angelina Jolie a publié une première tribune intitulée « My Medical Choice » dans le New York Times expliquant son choix de procéder à une double mastectomie1 afin de réduire ses chances de développer un cancer du sein. Angelina avait appris que, comme sa mère, elle était porteuse d'une mutation dans le gène BRCA1 et que cette mutation était associée à un risque élevé de développer un cancer du sein.2 Pour la petite histoire, rappelons que la mère d'Angelina est décédée à l'âge de 56 ans à la suite de complications liées à un cancer du sein.

Le 24 mars dernier, Angelina a publié une seconde tribune intitulée « Angelina Jolie Pitt: Diary of a Surgery » (toujours dans le New York Times) où elle relate son choix d'avoir fait retirer ses ovaires et ses trompes de Fallope afin de réduire son risque de développer un cancer des ovaires. Il est important de mentionner que la mutation du gène BRCA1 que porte Angelina la prédispose non seulement à développer un cancer du sein, mais également un cancer des ovaires.3

Les publications d'Angelina ont causé une onde de choc dans la communauté médicale car elle faisait la promotion de la proactivité afin de prendre en main sa santé et, plus philosophiquement, sa destinée. Moi, cette histoire m'a touchée, non seulement parce que je suis une femme et une maman, mais aussi parce qu'elle démontre l'importance de développer et de commercialiser des outils diagnostiques poussés afin de fournir l'information nécessaire aux médecins, infirmières et patient(e)s et de protéger ces innovations technologiques.

Les nouvelles trousses diagnostiques prennent plusieurs années à être peaufinées avant d'être mises sur le marché. Les compagnies qui les développent prennent des risques et dépensent des millions de dollars pour leur développement et leur validation. De plus, une fois sur mis sur le marché, les outils diagnostiques peuvent souvent être relativement facilement copiés. Les risques associés au développement de nouveaux outils diagnostiques sont en partie mitigés par l'obtention de brevets qui protègent les actifs intangibles des compagnies qui les développent. Je pousserai même le raisonnement en affirmant que le choix d'Angelina n'aurait pu être possible sans la protection par brevets accordée aux méthodes et outils diagnostiques.

Je m'explique.

Angelina a sûrement fait analyser son code génétique par la compagnie Myriad Genetics, un pionnier dans le domaine du diagnostic du cancer du sein qui a découvert (et breveté) le lien entre les mutations dans le gène BRCA1 et le cancer du sein et des ovaires. Myriad Genetics a su, à tort ou à raison, se tailler une place dominante dans le marché nord-américain dans le domaine du diagnostic du cancer du sein, entre autre à cause de ses brevets.

Récemment, aux États-Unis, certains des brevets de Myriad Genetics ont été invalidés. En effet, l'éligibilité à la protection des brevets des méthodes diagnostiques a été mise à rude épreuve dans les trois dernières années. Les méthodes diagnostiques ont été scrutées sous la loupe de la Cour Suprême dans les arrêts de Mayo c. Prometheus4 et de l'AMP c. Myriad.5 Dans ces décisions, les juges ont cru nécessaire de clarifier que de découvrir et revendiquer une corrélation entre un biomarqueur6 et une maladie était tout simplement insuffisant pour obtenir un brevet (même si cette corrélation était nouvelle et non-évidente). De plus, les juges ont également indiqué que la découverte d'un biomarqueur, dans sa forme native ou isolé, n'était pas nécessairement éligible à la protection par brevet.

Ce qui en a surpris plusieurs, c'est que la Cour a conclu que les revendications examinées n'aurait jamais dû être accordées puisque ces dernières ne rencontrent pas la définition d'une « invention » (c.-à-d. qu'elles ne sont pas éligibles à la protection par brevet) selon la loi américaine. Dans le monde des brevets, cette manière de penser était diamétralement opposée aux pratiques existantes du bureau des brevets américain ainsi qu'aux attentes de plusieurs de mes clients.

Tout juste avant Noël, le bureau des brevets américain a publié des lignes directrices pour ses examinateurs réitérant les conclusions de la Cour. Ces lignes directrices présentent, entre autre, comment les examinateurs doivent procéder à l'évaluation de l'éligibilité à la protection par brevet des revendications touchant les méthodes diagnostiques.

Est-ce que tout est perdu pour les innovateurs dans le domaine diagnostique? Pas nécessairement. Souvent la mise en place d'outils diagnostiques sophistiqués nécessite d'autres innovations qui peuvent être considérées comme étant éligibles à la protection par brevet (réactifs, anticorps, logiciels, etc.). De plus, dans d'autres juridictions comme le Canada et l'Europe, il est encore possible d'obtenir une protection par brevet pour les méthodes diagnostiques.

Un des objectif du système des brevets est de favoriser le décloisonnement et l'échange d'informations. Dans un excellent billet de mon collègue Patrice sur ce blogue, il a été prouvé d'ores et déjà que le système des brevets facilite la divulgation d'information qui ultimement nourrit un nouveau cycle d'innovation. Dans le domaine des méthodes diagnostiques, le brevet non seulement protège les innovations mais favorise également la divulgation de données. Les brevets sont donc une source importante d'information qui peuvent permettre la génération de nouveaux outils diagnostiques plus puissants.

Et comme l'écrivait Angelina dans sa deuxième tribune dans le New York Times : « Knowledge is power ».

Footnotes

1 Une ablation des deux seins.

2 Dans le cas d'Angelina, elle avait 87% de risque de développer un cancer du sein.

3 Dans le cas d'Angelina, elle avait 50% de risque de développer un cancer des ovaires.

4 Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289, 1304 (2012).

5 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013).

6 Un biomarqueur est une substance obtenue du corps humain étant liée à un processus biologique normal ou pathologique.

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