Canada: À Vos Marques, Prêts, CRISPRez! Ou Comment Les Brevets S'invitent Dans Une Révolution Biotechnologique

Il n'y a pas si longtemps, la manipulation génétique était réservée à une poignée d'élu(e)s qui avait fait ou était en train de faire sa maîtrise ou son doctorat. Le processus était long, dans certains cas inexact et habituellement onéreux. Mais depuis les trois dernières années, la communauté scientifique utilise un nouvel outil (le système Clustered Regularly lnterspaced Short Palindromic Repeats (CRISPR)/Cas9)), élégamment simple et facilement programmable, pour modifier de manière infiniment précise le génome de n'importe quelle cellule, de la bactérie primitive à la cellule humaine.

Le système CRISPR/Cas9 a été développé à partir d'un mécanisme de défense bactérien contre les infections virales. Il contient deux modules : un système de guidage (CRISPR) et une paire de ciseaux moléculaire (Cas9). Le système de guidage amène la paire de ciseaux moléculaire à un endroit très précis dans le génome, sur le double brin d'acide deoxyribonucleique (ADN). Une fois arrimé sur le double brin d'ADN, la paire de ciseaux coupe les deux brins d'ADN. Cette scission permet d'insérer une mutation ou un nouveau brin d'ADN (un nouveau gène, par exemple). La seule information nécessaire afin de programmer l'endroit de la coupe du double brin d'ADN est la séquence en acides nucléiques de la cible qui est, grâce aux nombreux projets de séquençage maintenant terminés, un jeu d'enfant. Ce qui différencie le système CRISPR/Cas9 des autres systèmes de manipulation génétique est qu'il est facilement programmable et ultra-précis.

Et les multinationales en sciences de la vie s'arrachent cette technologie. Nombreuses sont celles qui, en 2015, ont acquis des compagnies en biotechnologie ayant développées des solutions basées sur la technologie CRISPR/Cas9. À quoi la technologie CRISPR/Cas9 peut-elle servir? Pour les compagnies pharmaceutiques, à accélérer la découverte de médicaments en permettant de générer des modèles animaux plus précis, des systèmes de criblage à haut débit et des lignées cellulaires modifiées. Pour les compagnies Suvrant dans le domaine de l'agriculture, obtenir des plantes génétiquement modifiées plus rapidement. Évidemment, cette technologie pourrait également être utilisée afin de traiter ou prévenir des maladies génétiques et même à extirper des virus de cellules infectées (par le VIHb, par exemple).

La technologie CRISPR/Cas9 a été découverte dans le cadre de recherches universitaires. Vraisemblablement à cause de son potentiel commercial immense, des demandes de brevets ont été déposées par deux équipes différentes. L'équipe de Jennifer Doudna (University of California /Berkeley) a déposé une demande de brevet le 15 mars 2013. Quelques mois plus tard, le 15 octobre 2013, l'équipe de Feng Zhang (Broad Institute/Massachussetts Institute of Technology) a déposé un demande sur la technologie CRISPR/Cas9.

Dans toutes les juridictions à l'extérieur des États-Unis, le brevet sera accordé à l'équipe Doudna car sa demande de brevet a été déposée avant celle de l'équipe Zhang. C'est ce que l'on appelle le système de premier déposant (i.e., « first to file », dans lequel on accorde un brevet à l'équipe ayant déposée la demande de brevet le plus « tôt »). Mais aux États-Unis, pour les demandes de brevets déposées avant le 16 mars 2013, un autre système s'applique : celui du premier inventeur (i.e., « first to invent » dans lequel on accorde un brevet au demandeur capable de prouver qu'il a inventé le plus « tôt »).

Puisque l'équipe Doudna a déposé sa demande de brevet le 15 mars 2013, le système du premier inventeur s'applique. Le 11 janvier 2016, le United States Patent and Trademark Office (USPTO) a déclaré une interférence entre les deux groupes, c.-à-d. qu'une analyse sera faite afin de déterminer l'équipe ayant inventé la technologie CRISPR/Cas9 le plus tôt. Durant ces procédures, les deux équipes devront démontrer quand chacune d'elle a « conçu » et « mis en pratique » l'invention en soumettant, par exemple, des extraits de cahiers de laboratoire. Loin d'être banale, cette bataille déterminera qui, de l'équipe de Doudna ou de l'équipe Zhang aura une position dominante dans le marché CRISPR/Cas9 (du moins aux États-Unis). Pour la petite histoire, rappelons-nous que les interférences ont été utilisées dans le passé afin de déterminer quelle partie a inventé le téléphone, la machine à coudre et la télévision (des inventions commercialement très importantes).

Peu importe l'équipe qui obtiendra son(ses) brevet(s) américain(s) sur la technologie CRISPR/Cas9, il est inévitable qu'un panoplie de brevets sur la technologie CRISPR/Cas9 sera détenue soit par l'équipe Doudna ou par l'équipe Zhang. Il est même prévisible qu'une deuxième (et même une troisième) couche de brevets sera détenue par divers groupes qui amélioreront la technologie CRISPR/Cas9. Les entités n'ayant pas obtenu une approbation (c.-à-d. un une ou des licence(s)) auprès du(des) groupe(s) détenteur(s) de droits par brevet(s) sur la technologie CRISPR/Cas9 seront susceptibles d'être poursuivies pour contrefaçon de brevet(s). Pour la technologie CRISPR/Cas9, les brevets donneront une position dominante sur le marché.

Ce qui est particulier dans cette histoire est, comme je l'ai mentionné plus haut, que la technologie a été développée dans le milieu universitaire, vraisemblablement en partie financée par des deniers publiques. Par conséquent, quelle stratégie de commercialisation le groupe qui détiendra des brevets sur la technologie CRISPR/Cas9 utilisera-t-il? Sera-t-il agressif en tentant d'empêcher toute utilisation non licenciée de la technologie? Créera-t-il un pool de brevets auquel les utilisateurs pourront souscrire? Adoptera-t-il une approche différente pour les utilisateurs académiques et les utilisateurs industriels? Pour l'instant, ces questions restent sans réponse ce qui freine, en partie, l'utilisation de la technologie de manière très répandue.

La technologie CRISPR/Cas9 est trop simple, trop efficace et trop facilement adaptable pour s'en passer. Il sera donc crucial pour les compagnies désireuses d'utiliser ce nouvel outil révolutionnaire de déterminer leur tolérance au risque à la contrefaçon de brevets et, si nécessaire, d'obtenir une(des) licence(s) nécessaire(s) pour l'exploiter.

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