{"id":7948,"date":"2022-10-05T16:08:50","date_gmt":"2022-10-05T16:08:50","guid":{"rendered":"https:\/\/www.dhenne-avocat.sea-dev-and-sun.fr\/2022\/10\/05\/blog-dhenne-avocats-2\/"},"modified":"2022-10-05T16:08:50","modified_gmt":"2022-10-05T16:08:50","slug":"avelumab-spc-case","status":"publish","type":"post","link":"https:\/\/www.dhenne-avocats.fr\/en\/avelumab-spc-case\/","title":{"rendered":"AVELUMAB SPC Case\u201d: A key U-turn in French case law"},"content":{"rendered":"<p class=\"translation-block\">25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the \u201cnivolumab\u201d case law on the interpretation of Article 3(a) of Regulation (EC) No 469\/2009 (SPC Regulation).<\/p>\n<p>Dans cette affaire, le Dana-Farber Cancer Institute avait d\u00e9pos\u00e9 une demande de CCP (FR17C1046) 17 novembre 2017, qui \u00e9tait fond\u00e9e sur le <a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/european-patent\/\"><strong>brevet europ\u00e9en<\/strong><\/a> EP 1 210 424 (ci-apr\u00e8s <strong>EP&rsquo;424<\/strong>) d\u00e9pos\u00e9 le 23 ao\u00fbt 2000, et sur l&rsquo;AMM de l&rsquo;avelumab (EU\/1\/17\/1214) accord\u00e9e \u00e0 Merck Europe B.V. le 20 septembre 2017.<\/p>\n<p>L&rsquo;avelumab constitue un anticorps monoclonal anti-PD-L1, principe actif du Bavencio (Pfizer), qui est indiqu\u00e9 dans le traitement du cancer, car il perturbe l&rsquo;interaction PD-1\/PD-L1 in vivo.<\/p>\n<p>Il convient de noter que le brevet EP&rsquo;424 ne concerne pas l&rsquo;avelumab en tant que tel. En effet, l&rsquo;avelumab est revendiqu\u00e9 dans un brevet ult\u00e9rieur EP 2,785,375 (ci-apr\u00e8s EP&rsquo;375) d\u00e9pos\u00e9 le 21 novembre 2012 par Merck Patent GmbH et constitue la base d&rsquo;une autre demande de CCP (FR20C1068). EP&rsquo;424 concerne principalement PD-L1, en tant que polypeptide isol\u00e9 (revendication 12), ainsi que, de mani\u00e8re g\u00e9n\u00e9rale, \u00ab\u00a0<em>un anticorps qui se lie s\u00e9lectivement \u00e0 un polypeptide de la revendication 12<\/em>\u00a0\u00bb (revendication 17) et \u00ab\u00a0<em>un anticorps qui se lie s\u00e9lectivement \u00e0 un polypeptide de la SEQ ID NO : 2 ou 4<\/em> [c&rsquo;est-\u00e0-dire PD-L1]\u00a0\u00bb (<a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/claims\/\">revendication<\/a> 27).<\/p>\n<p>Le 3 f\u00e9vrier 2021, <strong>l&rsquo;INPI a rejet\u00e9 l&rsquo;octroi du CCP conform\u00e9ment \u00e0 l&rsquo;article 3(a) du r\u00e8glement CCP<\/strong>. L&rsquo;office a consid\u00e9r\u00e9, \u00e0 la suite de <a href=\"https:\/\/curia.europa.eu\/juris\/document\/document.jsf?text=&amp;docid=225984&amp;pageIndex=0&amp;doclang=FR&amp;mode=req&amp;dir=&amp;occ=first&amp;part=1&amp;cid=5579861\"><strong>l&rsquo;arr\u00eat Royalty Pharma de la Cour de justice de l&rsquo;Union europ\u00e9enne (CJUE)<\/strong><\/a> dans l&rsquo;affaire C-650\/17, que l&rsquo;avelumab, bien qu&rsquo;implicitement et n\u00e9cessairement couvert par la d\u00e9finition fonctionnelle utilis\u00e9e dans les revendications 17 et 27 du <a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/patent\/\"><strong>patent<\/strong><\/a> de base, n&rsquo;\u00e9tait n\u00e9anmoins pas sp\u00e9cifiquement identifiable dans le brevet, ayant \u00e9t\u00e9 d\u00e9velopp\u00e9 apr\u00e8s la date de d\u00e9p\u00f4t du brevet de base par une <a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/inventive-activity\/\"><strong>activit\u00e9 inventive<\/strong><\/a> ind\u00e9pendante.<\/p>\n<p>La Cour d&rsquo;appel a annul\u00e9 cette d\u00e9cision en consid\u00e9rant que les m\u00e9thodes de g\u00e9n\u00e9ration et d&rsquo;identification d&rsquo;un anticorps dirig\u00e9 contre un antig\u00e8ne donn\u00e9 \u00e9taient des techniques de routine pour l&rsquo;homme du m\u00e9tier \u00e0 la date de priorit\u00e9 et que, par cons\u00e9quent, lorsque l&rsquo;antig\u00e8ne cibl\u00e9 est d\u00e9j\u00e0 connu, la d\u00e9couverte d&rsquo;un anticorps se liant \u00e0 cet anticorps n&rsquo;implique pas d&rsquo;activit\u00e9 inventive. Les juges ont \u00e9galement relev\u00e9 que dans le cas du brevet EP&rsquo;375, d\u00e9pos\u00e9 11 ans apr\u00e8s la date de d\u00e9p\u00f4t du brevet EP&rsquo;424 et accord\u00e9 pour l&rsquo;avelumab, l&rsquo;activit\u00e9 inventive a finalement \u00e9t\u00e9 reconnue par l&rsquo;OEB en raison de la r\u00e9activit\u00e9 inter-esp\u00e8ces de l&rsquo;avelumab, et non en raison de sa capacit\u00e9 \u00e0 se lier \u00e0 PD-L1, la division d&rsquo;examen ayant initialement conclu \u00e0 l&rsquo;absence d&rsquo;activit\u00e9 inventive. <strong>La Cour en\u00a0conclut qu&rsquo;il r\u00e9sulte de ces \u00e9l\u00e9ments, fond\u00e9s sur les connaissances g\u00e9n\u00e9rales de l&rsquo;<a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/man-of-work\/\">person skilled in the art<\/a> et l&rsquo;<a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/technical-status\/\">\u00e9tat de la technique<\/a> \u00e0 la date de priorit\u00e9 du brevet EP&rsquo;464, que l&rsquo;anticorps monoclonal humain avelumab \u00e9tait sp\u00e9cifiquement identifiable par l&rsquo;homme du m\u00e9tier \u00e0 la lumi\u00e8re des enseignements dudit brevet, par des exp\u00e9riences de routine connues et bien ma\u00eetris\u00e9es, qui peuvent \u00eatre longues et fastidieuses, mais n&rsquo;impliquent pas une activit\u00e9 inventive ind\u00e9pendante<\/strong>.<\/p>\n<p>Cet arr\u00eat peut, \u00e0 premi\u00e8re vue, surprendre. En effet, d<strong>ans une affaire r\u00e9cente tr\u00e8s proche, la Cour a confirm\u00e9 la d\u00e9cision de l&rsquo;<a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/inpi\/\">INPI<\/a> par un arr\u00eat du 19 janvier 2021. Dans cette affaire, il s&rsquo;agissait de la confirmation d&rsquo;une d\u00e9cision de l&rsquo;INPI de rejeter une demande de CCP pour le nivolumab<\/strong>, un anticorps monoclonal anti-PD-1. Les juges ont consid\u00e9r\u00e9 que si le nivolumab entrait implicitement et n\u00e9cessairement dans le champ de l&rsquo;invention couverte par le brevet de base, la pr\u00e9paration d&rsquo;anticorps monoclonaux n\u00e9cessitait plus que des op\u00e9rations de routine. Ils ont \u00e9galement soulign\u00e9 qu&rsquo;il a fallu trois ans apr\u00e8s le d\u00e9p\u00f4t du brevet de base pour d\u00e9poser un brevet portant sp\u00e9cifiquement sur le nivolumab, ce qui constitue une indication forte qu&rsquo;une activit\u00e9 inventive ind\u00e9pendante du brevet de base a \u00e9t\u00e9 n\u00e9cessaire pour aboutir au nivolumab.<\/p>\n<p>Deux motifs principaux paraissent expliquer ce revirement de jurisprudence. <strong>Premi\u00e8rement, la prise en compte des crit\u00e8res r\u00e9sultant de la Convention sur le brevet europ\u00e9en (CBE) et des directives et de la jurisprudence de l&rsquo;Office europ\u00e9en des brevets (<a href=\"https:\/\/www.dhenne-avocats.fr\/en\/lexique-propriete-industrielle\/oeb\/\">EPO (European Patent Office)<\/a>), conform\u00e9ment au crit\u00e8re de l'\u00a0\u00bbactivit\u00e9 inventive ind\u00e9pendante\u00a0\u00bb issu de la jurisprudence Royalty Pharma, qui a \u00e9t\u00e9 d\u00e9terminante. Deuxi\u00e8mement, dans l&rsquo;affaire nivolumab, la Cour d&rsquo;appel a \u00e9galement consid\u00e9r\u00e9 que le CCP n&rsquo;\u00e9tait pas conforme \u00e0 l&rsquo;article 3(c) du r\u00e8glement CCP, de sorte que l&rsquo;appr\u00e9ciation de la conformit\u00e9 \u00e0 l&rsquo;article 3(a) est devenue une question secondaire<\/strong>.<\/p>\n<p>En tout \u00e9tat de cause, ce revirement de jurisprudence est fondamental et devrait faciliter le respect des exigences de l&rsquo;article 3(a) du R\u00e8glement CCP en mati\u00e8re d&rsquo;anticorps monoclonaux en France, notamment dans le cadre des affaires <a href=\"https:\/\/curia.europa.eu\/juris\/document\/document.jsf?text=&amp;docid=115209&amp;pageIndex=0&amp;doclang=EN&amp;mode=lst&amp;dir=&amp;occ=first&amp;part=1&amp;cid=3600410\"><strong>Medeva (C-322\/10)<\/strong><\/a> et <a href=\"https:\/\/curia.europa.eu\/juris\/document\/document.jsf?text=&amp;docid=145535&amp;pageIndex=0&amp;doclang=EN&amp;mode=lst&amp;dir=&amp;occ=first&amp;part=1&amp;cid=3600534\"><strong>Eli Lilly (C-493\/12)<\/strong><\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Le 25 mai 2022, la Cour d&rsquo;appel de Paris a annul\u00e9 le refus de l&rsquo;Institut national de la propri\u00e9t\u00e9 industrielle (INPI) d&rsquo;accorder un Certificat Compl\u00e9mentaire de Protection\u00a0(\u00ab\u00a0CCP\u00a0\u00bb) pour l&rsquo;avelumab. Il s&rsquo;agit d&rsquo;un revirement de la jurisprudence \u00ab\u00a0nivolumab\u00a0\u00bb sur l&rsquo;interpr\u00e9tation de l&rsquo;article 3(a) du r\u00e8glement (CE) n\u00b0 469\/2009 (ci-apr\u00e8s le r\u00e8glement CCP). Dans cette affaire, le [&hellip;]<\/p>","protected":false},"author":5,"featured_media":7936,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27,28],"tags":[],"class_list":["post-7948","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-certificat-complementaire-de-protection","category-pharmaceutique"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Affaire &quot;AVELUMAB&quot; : un revirement important dans la jurisprudence fran\u00e7aise relative aux certificats compl\u00e9mentaires de protection - Dhenne Avocats<\/title>\n<meta name=\"description\" content=\"Lisez l&#039;article : Affaire &quot;AVELUMAB&quot; : un revirement important dans la jurisprudence fran\u00e7aise relative aux certificats compl\u00e9mentaires de protection du blog Dhenne Avocats\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dhenne-avocats.fr\/en\/avelumab-spc-case\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Affaire &quot;AVELUMAB&quot; : un revirement important dans la jurisprudence fran\u00e7aise relative aux certificats compl\u00e9mentaires de protection - 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