CA Paris 14/04/2016 : Un médicament ne peut bénéficier d’un certificat complémentaire de protection (CCP) sur la base d’un brevet et d’une AMM, lorsque un premier CCP a été délivré sur la base de ce même brevet et d’une autre AMM et qu’il couvre ce médicament .

Cet article a été initialement publié sur le blog Patentmyfrench tenu par Renaud Fulconis.

The decision we discuss today was rendered by the Cour d’Appel de Paris on April 12, 2016 and deals with the appeal lodged by the Government of the United States of America against the decision of the Director of the INPI (French patent and trademark office) to reject SPC application No.08C0003 covering Cervarix® (GlaxoSmithKline Biologicals).

As a side note, we will first remind our readers that appeals against decisions of the Director of the INPI, such as rejections of patent applications or SPCs, are to be lodged directly to the Cour d’Appel de Paris, i.e. the second instance court, and not to the first instance Tribunal de Grande Instance de Paris.

Back to the case at hand, Cervarix® is a vaccine intended for use in women and girls from nine years old to protect against cancer of the cervix (neck of the womb) and precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina) caused by certain types of the human papillomavirus (HPV). Cervarix® HPV-16/18 L1 AS04 vaccine contains recombinant C-terminally truncated major capsid L1 proteins of HPV types 16 and 18 as active ingredients. The L1 proteins of HPV-16 and HPV-18 are separately produced using a recombinantBaculovirus expression system and the insect cell line Hi-5 Rix4446 derived from Trichoplusia ni.

For those not versed in the biological arts, this basically means that the antigens contained in the vaccine are shortened versions of viral proteins from two different viruses (HPV-16 and HPV-18), which proteins have been produced in vitro in insect cells.

The SPC application was filed on January 18, 2008 on the basis of European patent EP 0662132 filed on September 3, 1993 and of the Marketing Authorization (MA) No.EU/1/07/49/001 of September 20, 2007. It was rejected on March 16, 2015 by the INPI.

The decision of the INPI was essentially based on the Actavis judgment C-443/12 of December 12, 2013 by the CJEU (following a reference for a preliminary ruling from the High Court of Justice of England and Wales), and more particularly on points 40 and 42 of this judgement:

40. Bearing in mind the objective of Regulation No. 469/2009 [i.e. the SPC regulation] […] – namely, to compensate the patent holder for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity – first, the grant of the first SPC in respect of the single active ingredient irbesartan [i.e. the drug at stake in the judgment] has already afforded the holder such compensation and, second, the objective of that regulation is not to compensate the holder fully for the delay to the marketing of his invention or to compensate for such delay in connection with the marketing of that invention in all its possible forms, including in the form of combinations based on that active ingredient. […] (emphasis added)

42. It follows that, in such a situation, Article 3(c) of Regulation No. 469/2009 precludes a patent holder from obtaining, on the basis of one and the same basic patent, more than one SPC in connection with irbesartan, since such SPCs would in fact be connected, wholly or in part, with the same product […]”

Indeed, another SPC No.07C0020 covering Gardasil® (GlaxoSmithKline Biologicals) was granted earlier on the basis of the same patent in regard of a L1 protein from HPV16. The INPI thus considered that this previous SPC also protected the C-terminally truncated form of the L1 protein, purported to be obtained by production from insect cells, and that the product for which SPC No.08C0003 was applied for had already been the subject-matter of a certificate.

As it appears from the ruling, the main argument of the appellant against the decision of the INPI was that the HPV16 L1 protein obtained from insect cells, which forms the subject-matter of SPC No.08C0003, is a different product from the HPV16 L1 protein obtained from yeast cells, which forms the subject-matter of SPC No.07C0020, because of the differences in the glycosylation pattern and amino acid chains depending on the cell type (yeast or insect) in which the protein is produced. Accordingly, the MAs of Gardasil® and Cervarix® relate to medicinal products having different active ingredients and SPC No.07C0020 and SPC application No.08C0003 relate to different products. In addition, pursuant to Articles 4 and 5 of Regulation (EC) No 1768/92 (i.e. the previous version of the SPC regulation), an SPC may not confer a protection extending to a product which is not the one related to the marketing authorization.

However the Court ruled that:

As is rightly pointed by the Director of the INPI, firstly, the basic patent claims (claim 1) “an isolated HPV16 capsomer structure comprising L1 capsid protein” which is not characterized by its manufacturing process and the patent does not explain the differences between the proteins asserted by the appellant, [the patent] referring to various manufacturing processes (insect cells such as for Cervarix, yeast cells such as for Gardasil, and even mammalian cells (cf. page 20 of the patent)), secondly, the asserted differences are not mentioned either in the MAs provided with the two SPC applications which relate secondarily to the manufacturing process without drawing any conclusion regarding the protein structure, and finally, SPC application No.08C0003 initially related – before the amendments brought by the applicant in relation with the forms and production methods in response to the objections from the INPI during the examination procedure of the application – to a product defined as “L1 proteins from type 16 human papillomavirus”, this definition being precisely that mentioned in SPC application No.07C0020 filed on March 20, 2007;

Article 1 of the previously cited Regulation defines the product as “the active ingredient or combination of active ingredients of a medicinal product”, without any reference to the manufacturing process of the active ingredient;

Accordingly, the HPV16 L1 protein comprised in Cervarix and that comprised in Gardasil constitute one and the same product within the meaning of the previously cited Regulation, regardless of their possible differences regarding their forms and their manufacturing processes;

It results from Articles 4 and 5 of the Regulation that the protection and the rights conferred by an SPC are framed by the basic patent and that the MA is used to determine the product forming the subject-matter of the protection; it is thus irrelevant, for assessing the regularity of the rejection of SPC application No.08C0003, whether this application is based on an MA specially obtained for Cervarix, which, even though it aims at treating the same pathologies, is different from Gardasil, which has a different MA, since the HPV16 L1 protein comprised in the two drugs is the same;

Under these conditions, the Director [of the INPI] was right in considering that SPC No.07C0020 granted on July 23, 202 also applied to the HPV16 L1 protein comprised in Cervarix, even if obtained from insect cells, and in rejecting SCP application No.08C0003 filed on June 18, 2008 by the Government of the United States of America.

Accordingly, the decision of rejection of SPC application No.08C0003 was upheld.

This decision is interesting in that the Court decided, following the INPI, that the protection conferred by an SPC extends beyond the physical product which can be found in the marketed medicinal product to encompass all products falling within the definition of the product in the SPC or SPC application.

This construction of Articles 4 and 5 of the SPC Regulation may not give rise to too much discussion for chemical medicinal products, as in addition to C-443/12 (Actavis) it could also be considered to be an application of the previous ruling of the CJEU in C-392/97 (Farmitalia) (“where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent”). But it may give rise to more concerns as regards biological medicinal products, as in the present case.

In fact, it can be regretted that the present decision was not taken as an opportunity to discuss – and why not to request a preliminary ruling on – the question of knowing if the same standard is to be applied to chemical and biological medicinal products when applying Articles 4 and 5 of the SPC Regulation.

Indeed, the specificity of biological medicinal products has been recognized by European Union law. By way of example, Article 10 of Directive 2001/83/EC notably provides that where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

Accordingly, in view of the objective of the SPC Regulation which is, as was recalled above, to compensate the patent holder for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity, it could be questioned whether biological products obtained by different manufacturing processes could not be considered as truly different products and not merely as different forms of a same product.

As a final side note, we would like to add that the above-mentioned Actavis decision of the CJEU is only one of numerous rulings following from references from the High Court of Justice of England and Wales. It is with some sadness that the commentator in us sees the Brexit taking away the most active Case Law provider in SPC matters.

CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 1, April 12, 2016,The Government of the United States of America v. Directeur Général de l’INPI, RG No. 15/12234.

Le printemps est également la saison où fleurissent les classements de dépôts de demandes de brevet. C’est ainsi que le 3 mars 2016 l’Office Européen des Brevets (OEB) a publié son rapport annuel pour l’année 2015 et que le 5 avril 2016, l’Institut national de la propriété industrielle (INPI) a publié son palmarès 2015 des principaux déposants.

Quels enseignements en tirer pour les sciences de la vie et de la santé ?

On observe qu’alors que les dépôts en biotechnologie, en pharmacie et en chimie organique sont relativement stables sur les dix dernières années, les technologies médicales (medtech) sont en forte croissance (+11% entre 2014 et 2015), jusqu’à représenter le premier domaine technique en termes de dépôts de demandes de brevet européen (7,8% du nombre total de dépôt), ce qui explique d’ailleurs la vague récente de recrutements d’examinateurs par l’OEB dans ce domaine technique.

Ce fait relativement méconnu mérite quelques approfondissements.

L’étude de l’origine géographique des dépôts en medtech montre que ce sont les sociétés américaines qui dominent le secteur avec plus de 5000 demandes déposées en 2015. Parmi les Etats européens, l’Allemagne arrive en tête avec 1456 dépôts, suivie des Pays-Bas (792 dépôts) et de la Suisse (539 dépôts), la France ne se classant qu’en quatrième position avec 493 dépôts.

La place de la France dans ce classement est plutôt étonnante car cela ne correspond pas à l’importance de son marché. En effet, on estime le marché européen des medtech à 100 milliards d’euros/an, la France représentant 16% de ce marché, derrière l’Allemagne (28%) mais devant le Royaume-Uni (13%), l’Italie (10%), l’Espagne (5%), les Pays-Bas (4%) ou la Suisse (3%).

Quelles conséquences ?

Si la taille du marché, le nombre de salariés employés dans les medtech, ou encore la balance commerciale des medtech ne semblent pas être corrélés au nombre de dépôts de demandes de brevet européen par pays, on observe en revanche une relation linéaire (dont le haut niveau de corrélation est plutôt inattendu) entre le nombre de dépôts de demandes de brevet européen dans le domaine des medtech et les exportations.

Il apparaît à la lecture de ce graphique qu’il y a un lien étroit entre le succès à l’exportation d’un pays européen, en ce qui concerne les medtech, et le nombre de dépôts de demandes de brevet européen, qui est lui-même probablement une conséquence du niveau des investissements de R&D.

On note que la Belgique et l’Irlande semblent ne pas suivre cette règle, les exportations étant supérieures à ce qui serait attendu au vu de leurs dépôts de demandes de brevet européen. Ceci pourrait s’expliquer par le fait que ces pays accueillent des filiales de sociétés étrangères qui ne sont pas déposantes de demandes de brevet, les dépôts étant faits aux noms des sociétés mères dont les sièges sociaux se trouvent dans d’autres pays, par exemple aux Etats-Unis.

Il semble donc bien que les entreprises exportatrices de medtech sont également celles qui investissent dans le couple innovation/brevet et il est tentant d’établir un lien de causalité entre les deux.

Sources :

• Données économiques : The European Medical Technology Industry in Figures (MedTech Europe)
• Données PI : Statistiques de l’Office Européen des Brevets

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A l’heure actuelle, seules les juridictions nationales des Etats parties à la Convention sur le brevet européen (CBE) sont compétentes pour statuer sur le contentieux (contrefaçon et validité) des brevets européens.

Ce fonctionnement soulève un certain nombre de problèmes : des coûts élevés, notamment liés à la multiplicité des juridictions, de longs délais (deux ans environ en France) ou encore une application non uniforme du droit et son corolaire, le forum shopping.

Pour pallier à ces difficultés, un Accord a été signé le 19 février 2013 par 25 Etats membres de l’Union européenne sur 28 (à noter l’absence de l’Espagne) afin de mettre en place une Juridiction Unifiée du Brevet (JUB), sous réserve de ratification par au moins 13 Etats signataires de l’Accord (dont la France, l’Allemagne et le Royaume-Uni). Cette dernière aura compétence exclusive concernant les litiges relatifs aux brevets européens et aux brevets européens à effet unitaire.

A ce jour, 9 Etats signataires ont ratifié l’Accord (dont la France). Il ne reste donc plus que la ratification de 4 Etats, Allemagne et Royaume-Uni inclus. Ces ratifications manquantes sont attendues courant 2016 et on peut s’attendre à une entrée en vigueur de la JUB en 2017. Toutefois, le référendum sur le Brexit organisé le 24 juin 2016 pourrait remettre en cause ces prévisions.

La future JUB aura pour objectifs d’unifier la jurisprudence, de rendre rapidement des décisions et de favoriser la négociation à l’amiable entre les parties, tout en ayant pour contrainte de s’autofinancer à travers les parties au litige.

Ainsi, le Règlement de procédure de la JUB adopté par le Comité Préparatoire le 19 octobre 2015 (après 6 ans de discussion et 18 projets !) devrait normalement permettre la tenue de l’audience finale de première instance sur les questions de contrefaçon et de validité sous un an.

Par ailleurs, les règles relatives aux frais de justice de la JUB ont été arrêtées le 25 février 2016. Les frais se composent de la façon suivante : des frais fixes en fonction de l’action intentée devant la JUB, accompagnés de frais additionnels en fonction de la valeur estimée du litige. Ces frais additionnels ne s’appliqueront cependant qu’aux litiges ayant une valeur supérieure à 500.000 €. Ils varient entre 2.500 € et 250.000 € pour des litiges estimés entre 750.000 € et 50.000.000 €. Pour les litiges ayant une valeur supérieure à 50.000.000 €, les frais additionnels s’élèvent à 325.000 €.

La JUB est consciente de l’effet dissuasif que ces frais pourraient avoir sur les PME. Aussi, il prévu que leurs frais de justice soient réduits de 40%, sous certaines conditions (voir l’Article 8 des règles relatives aux frais de justice de la JUB).

Des frais fixes en fonction de l’action intentée devant la JUB, accompagnés de frais additionnels en fonction de la valeur estimée du litige.

Voici pour conclure un résumé graphique de la procédure d’action en contrefaçon de brevet devant la JUB telle qu’elle est prévue :

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T719/12 : Un composé chimique dont la synthèse est décrite dans un document n’est pas mis à la disposition du public, dès lors que ce document indique que le procédé de synthèse n’aboutit pas au composé – quand bien même ce procédé pourrait effectivement permettre d’obtenir le composé – car l’homme du métier n’aurait aucune incitation à mettre en oeuvre le procédé de synthèse.

Cet article a été initialement publié sur le blog Patentmyfrench tenu par Renaud Fulconis.

The decision we will discuss today relates to the difficult question of knowing under which conditions the chemical composition of a product is made available to the public.

Decision T 719/12 was rendered on October 29, 2015 on an appeal formed by the proprietor (appellant) of European patent No. 1539673 against the decision of the opposition division to revoke the patent. The decision of the opposition division was based on the lack of novelty of the subject-matter of claims 9 and 10 in view of the disclosure of document (1) (Blicke et al. (1942) J. Am. Chem. Soc. 64:451 to 454).

Claims 9 and 10 respectively claimed the compounds of formulae II and VI:

wherein R¹ can be a thienyl (i.e. the cycle shown in formula VI), R²can be a C1-8 alkyl (i.e. a -C_nH_2n+1 group where 1 ≤ n ≤ 8) and R⁴ is methyl (-CH₃), ethyl (-CH₂CH₃), isobutyl (-CH₂CH(CH₃)₂) or tert-butyl (-C(CH₃)₃).

Document (1) identified the compound methyl-2-(α-thenoyl)-ethylamine by its chemical name. For those not versed in the chemical arts, here is what it looks like:

methyl-2-(α-thenoyl)-ethylamine

It can readily be seen that this compound falls within formulae II and VI of the opposed patent.

Indeed, this fact was contested by neither of the parties as is noted by the Board in point 2 of the reasons for the decision and the question was rather whether methyl-2-(α-thenoyl)-ethylamine had been made available to the public.

There the Board recalled that:

It is the established jurisprudence of the Boards of Appeal that the subject-matter described in a document can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Article 54(1) EPC, if the information given therein is sufficient to enable the skilled person, at the relevant date of the the [sic] document, to practise the technical teaching which is the subject of the document, taking into account also the general knowledge at the time in the field to be expected of him (see T 206/83, OJ EPO 1987, 5) (point 2.2. of the Reasons).

However, even though document (1) aimed at synthesizing methyl-2-(α-thenoyl)-ethylamine through a Mannich reaction or the steam distillation of the corresponding tertiary amine, the authors of the document could neither isolate it nor obtain it when the reactions were actually carried out, in spite of the use of conditions which were considered favorable for its formation. The Board thus went on to consider that document (1) alone did not make the compound methyl-2-(α-thenoyl)-ethylamine available to the public, since the specific attempts to prepare it, which are described in said document, failed (see point 2.2 of the Reasons).

The opponent (Respondent) replied by arguing that document (1) did nonetheless make the compound methyl-2-(α-thenoyl)-ethylamine available to the public, since on repeating the preparation of the tertiary amine methyl[di-2-(α-thenoyl)-ethyl]amine 5 of document (1) in experimental report V1 it submitted, the compound methyl-2-(α-thenoyl)-ethylamine was indeed produced (but went unnoticed by the authors of document (1)).

This did not convince the Board:

[…] the Board holds that in view of the categorical statement in document (1) that despite attempts to synthesise it, the secondary amine could be neither isolated nor obtained, the skilled person, at the date of publication of document (1), would not have seriously contemplated repeating its teaching in order to undertake further investigations as to whether the secondary amine was formed after all. Thus, regardless of whether the report V1 repeats the method of document (1) exactly, the Appellant contesting this fact (see point IV above), the skilled person had no motivation to perform the steps in the experimental report V1 which are not disclosed in document (1), namely of analysing the product mixture obtained or of recrystallising from the mother liquor (point 2.3 of the Reasons, emphasis added).

Hence, even if methyl-2-(α-thenoyl)-ethylamine were inevitably produced by a method described in document (1), since its presence remained undetected by the skilled person, it had not been made available to the public (point 2.3 of the Reasons, emphasis added).

Well so long for the astute novelty attack, but doesn’t that ring a bell? G 1/92 of course:

The chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition (emphasis added).

Except that the Board appeared to favor an opposite view to that of the Enlarged board of appeal. Unfortunately, the Board did not discuss the particulars of this case with respect to G 1/92, leaving us in uncertainty as to the interpretation of this decision: is it to be understood as going against G 1/92 or can it be reconciled with it?

Let’s try to see by ourselves.

A reminder of the case behind G 1/92 might be useful at this stage.

G 1/92 followed from a question referred to the Enlarged board of appeal by the President of the EPO pursuant to Article 112(1)(b) EPC which arose as consequence of decision T 93/89. It was held in this latter decision that if the composition of a commercially available product (e.g. aqueous polyvinyl ester dispersion) can be established only by a chemical analysis, the ingredients of the product (e.g.polyvinyl acetate, native starch, polyvinyl alcohol) have not been made available to the public unless there was a reason for experts to investigate it (see Headnote and point 8.2 of the Reasons).

The case at hand thus differs from the case at the origin of G 1/92 in that the product is not “directly” available to the public since it has to be manufactured before it can submitted to a chemical analysis (as opposed to a commercially available product). As such, decision T 719/12 could be interpreted as meaning that when a product is not commonly available to the public and needs to be manufactured to become so, then it would become relevant that one of skill in the art should have a special motivation to perform the manufacture and the analysis of the product.

However, this point of view is not totally satisfying as this would amount to making a distinction between the different means by which any information is made available to the public under Article 54(1) EPC, i.e. public use vs. written description, which is something G 1/92 specifically warned against (see point 1.2 of the Reasons).

Accordingly, even though the Board in decision T 719/12 does not explicitly take position against G 1/92, one might wonder whether after more than 23 years of good service the latter has not been silently euthanized.

CASE REFERENCE: Board of Appeal 3.3.10, T 719/12, Lonza AG v. Merck Patent GmbH, October 29, 2015.

Longtemps attendue et désirée, c’est le 15 mars 2016 que l’Office Européen des Brevets (OEB) a finalement débloqué la fonctionnalité de recherche dans le texte intégral sur Espacenet.

En effet, il était jusqu’alors uniquement possible d’effectuer des recherches par mots-clés dans le titre et l’abrégé des demandes de brevet et des brevets de la base de données phare et gratuite de l’OEB, ce qui était frustrant pour beaucoup d’utilisateurs.

Voici comment faire.

Par défaut, le masque de recherche en plein texte n’est pas visible sur la page d’accueil de la recherche avancée. Pour le faire apparaître, il convient de sélectionner l’une des trois langues (EN, FR ou DE) dans le menu déroulant de la collection à interroger :

Le masque de recherche en plein texte apparaît alors :

Pour information : il est nécessaire de retourner à la collection de base (Worldwide sans mention de la langue) pour effectuer une recherche n’impliquant pas le champ de recherche « Mot(s)-clé(s) dans le titre, l’abrégé et le texte intégral ».

La recherche Smart Search permet quant à elle de limiter la recherche dans le texte intégral aux revendications ou à la description. Pour ceci, il convient tout d’abord d’effectuer une recherche Smart Search puis de sélectionner « Reformuler votre recherche » sur l’écran de résultat.

Il faut alors à nouveau sélectionner l’une des trois langues (EN, FR ou DE) dans le menu déroulant de la collection à interroger et éventuellement, faire précéder le mot-clé de :

• « claims = » pour une recherche dans les revendications ;
• « desc = » pour une recherche dans la description ;
• ou « ftxt = » pour une recherche dans tout le document.

Pour plus d’informations, suivez ce lien (voir page 6).

Bonnes recherches !

Introduite par le biais d’une décision rendue par le directeur général de l’INPI le 18 décembre 2015, une procédure dite « accélérée » a été mise en place concernant les demandes de brevets français.

Cette procédure a été ouverte au public le 22 décembre 2015. Elle s’effectue en ligne à travers le service « E-PROCEDURES » de l’INPI et ne nécessite pas de paiement de taxe supplémentaire.

Elle peut être demandée au moment du dépôt d’une demande de brevet ou bien dans un délai de 10 mois à compter de son dépôt.

Le délai de délivrance accélérée d’un brevet ou d’un certificat d’utilité est de 20 mois à compter de son dépôt, à condition bien entendu que ce dernier ne fasse pas l’objet d’irrégularités et sous certaines réserves (voir l’article 5 de la décision).

Le délai de délivrance accélérée d’un brevet ou d’un certificat d’utilité est de 20 mois à compter de son dépôt.

Par ailleurs, au-delà des formalités classiques à accomplir, une demande de publication anticipée de la demande de brevet ou de certificat d’utilité devra accompagner la demande de brevet.

Ainsi, la publication s’effectuera dans un délai de 10 mois à compter du dépôt (voir l’article 2 de la décision).

La publication s’effectuera dans un délai de 10 mois à compter du dépôt de la demande de brevet.

De par notre expérience, le délai moyen pour obtenir un brevet en France peut être estimé à 28 mois environ. Dès lors, pour une utilisation de la procédure accélérée, le gain de temps est de l’ordre de 8 mois en moyenne par rapport à la procédure classique, ce qui est plutôt appréciable.

Toutefois, dans le cas fréquent où le dépôt de demande de brevet français sert à établir une date de priorité, revendiquée par une demande ultérieure dans un délai de 12 mois, il conviendra d’être particulièrement vigilant à la publication anticipée à 10 mois.

En effet, la demande publiée pourra constituer une antériorité opposable au titre de la nouveauté et de l’activité inventive aux éléments de la demande ultérieure qui ne bénéficient pas de la priorité, dans la mesure où cette dernière sera déposée après la publication à 10 mois.

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T528/11 : Pour une revendication de produit contenant une caractéristique d’effet technique introduite par une expression du type « adapté pour« , il faut qu’il soit établi que l’effet technique peut être atteint pour que la condition de suffisance de l’exposé soit remplie.

Cet article a été initialement publié sur le blog Patentmyfrench tenu par Renaud Fulconis.

In our previous post regarding the sufficiency of disclosure requirement applied to therapeutic purpose-limited product claims when there is a doubt that the therapeutic effect is attained, Renaud wondered if the bar had been raised.

Well, the decision discussed today might be just another hint that there is indeed a trend towards a wider application of the requirement of achievement of the claimed technical effect by the Boards of appeal of the EPO in regard of sufficiency of disclosure.

Decision T 528/11 was rendered on November 19, 2015 on an appeal formed by the opponent (appellant) against the decision of the opposition division to uphold European patent No. EP 1427808.

Claim 1 of the main request filed during the appeal proceedings read:

An isolated bacterial strain of the genus Lactobacillus characterized by that it is selected from the group consisting of the strain of Lactobacillus casei subsp rhamnosus, LN 113, deposited under number LMG P-20562, and the strain of Lactobacillus fermentum, LN 99, deposited under number LMG P-20561, and having the ability to colonise and become established in a human vagina, displaying a disturbed vaginal flora of microorganisms, upon vaginal administration, even during menstrual discharge, wherein said bacterial strain or strains is/are considered established if the bacterial strain or strains is/are still present in the vagina after at least two menstrual cycles from the time of administration, said strains were deposited at Belgian Coordinated Collections of Microorganisms on 14 June 2001 (emphasis added).

Among other arguments, the appellant submitted that although the deposit of strains LN 99 and LN 113 ensured their availability, this did not guarantee that they fulfilled the functional feature required by claim 1 (underlined above). None of the examples of the patent showed that the deposited strains indeed had this feature, which was necessary in order to meet the requirements of Article 83 EPC. The in vivo assay, required to reliably determine whether the strains had the alleged feature, was not described in the prior art. Post-published document D13 could not be used to prove sufficiency of disclosure. The functional feature that strains LN 99 and LN 113 were required to exhibit was not reproducible. Thus, according to decision G 1/03 (OJ EPO 2004, page 413), there was a lack of sufficiency of disclosure (see point XI of the Summary of Facts and Submissions).

If the Board did not share the same appreciation of the facts and arrived at the conclusion that the claimed invention was sufficiently disclosed (see points 10-14 of the Reasons), it nevertheless followed the appellant’s view as to the application of the requirement of sufficiency of disclosure to the feature at stake:

According to decision G 1/03 (supra), “(i)f an effect is expressed in a claim [and is not achieved by the claimed subject-matter; added by the board], there is lack of sufficient disclosure. Otherwise, i.e. if the effect is not expressed in a claim but is part of the problem to be solved, there is a problem of inventive step” (cf. G 1/03, supra, point 2.5.2 of the Reasons).

In line therewith, the claimed strains LN 99 and LN 113 must have the functional feature cited in claim 1. Otherwise, there is lack of sufficient disclosure (point 9 of the Reasons).

This famous obiter dictum of the Enlarged Board of Appeal is an enlightening reminder of the principles underlying the interplay between insufficiency of disclosure (as in decision T 609/02) and lack of inventive step (as in decision T 939/92) when there is a doubt that an effect is achieved.

However, in our opinion the present decision marks an evolution in the application of this sufficiency of disclosure principle to product claims.

Indeed, following decision T 609/02, this principle was mainly applied to a particular subset of product claims, the therapeutic purpose-limited product claims (“Product X for use in the treatment of Y”), i.e. so-called medical use claims, which are in fact hybrid between product and use claims. For these claims, attaining the claimed therapeutic effect is a functional technical feature of the claim.

In the present case, what the board refers to as a functional feature (underlined above) is generally considered to merely define a suitable use of the claimed bacterial strain, as can be construed from the tell-tale expression “having the ability to”. In fact, it is clear, e.g. from the Guidelines for Examination in the EPO (F-IV, 4.13) that such features are usually not considered as true functional features like those of medical use claims:

Similarly, a claim to a substance or composition for a particular use should be construed as meaning a substance or composition which is in fact suitable for the stated use; a known product which prima facie is the same as the substance or composition defined in the claim, but which is in a form which would render it unsuitable for the stated use, would not deprive the claim of novelty. However, if the known product is in a form in which it is in fact suitable for the stated use, though it has never been described for that use, it would deprive the claim of novelty. An exception to this general principle of interpretation is where the claim is to a known substance or composition for use in a surgical, therapeutic or diagnostic method (see G‑II, 4.2).

In contrast to an apparatus or product claim, in case of a method claim commencing with such words as: “Method for remelting galvanic layers” the part “for remelting …” should not be understood as meaning that the process is merely suitable for remelting galvanic layers, but rather as a functional feature concerning the remelting of galvanic layers and, hence, defining one of the method steps of the claimed method (see T 848/93).

Accordingly, the Board’s finding extends the scope of application of this sufficiency of disclosure requirement for product claims outside the field of medical use claims to which it was confined. Should this decision be followed, the requirement of achievement of the recited technical effect could thus expand to just about any technical field provided the product claim considered recites that a feature is suitable for attaining an effect.

Given the feeble gain in terms of patentability offered by “suitable for” features, in contrast to non-functional features, their usefulness could in the future very well be outweighed by the risk they impart to the claims containing them. Accordingly, drafters should be cautious when incorporating them in a claim. As for opponents, well, it is a promising new field to explore.

CASE REFERENCE: Board of Appeal 3.3.08, T 528/11, SCA Hygiene Products AB v. Ellen Aktienbolag, November 19, 2015.

T2059/13 : Pour établir qu’un composé convient pour le traitement d’une maladie dans le cadre de l’examen de la suffisance de l’exposé, il faut que les expériences présentées dans la demande de brevet ou le brevet permette à l’homme du métier de conclure directement et sans ambiguïté, à l’aide de ses seules connaissance générale et de la description, que le composé est utile pour le traitement de la maladie.

Cet article a été initialement publié sur le blog Patentmyfrench tenu par Renaud Fulconis.

Renaud’s previous post related to the French way of dealing with the sufficiency of disclosure requirement regarding therapeutic purpose-limited product claims (compound X for use the treatment of Y) when there is a doubt that the therapeutic technical effect has been attained. But how does the EPO deal with it nowadays?

Decision T 2059/13 of December 7, 2015 was rendered on the appeal lodged by patentee Otsuka Pharmaceutical against the decision of the opposition division to revoke European patent No. 1712225.

The patent was revoked under the ground of Article 100(b) EPC (i.e.insufficiency of disclosure) by applying the landmark decision T 609/02of October 27, 2004, which was discussed in Renaud’s previous post. As a reminder, the catchword of this decision is that:

If the description of a patent specification provides no more than a vague indication of a possible medical use for a chemical compound yet to be identified, later more detailed evidence cannot be used to remedy the fundamental insufficiency of disclosure of such subject-matter (emphasis added).

Claim 1 of the main request in the appeal proceedings at hand read:

A compound which is a pharmaceutically acceptable acid-addition salt or solvate of a carbostyril compound of the formula (1):

wherein the dotted line represents a single or a double bond, for use in the treatment of disorders of the central nervous system associated with 5-HT1A receptor subtype, selected from

(i) bipolar I disorder with most recent hypomanic, manic, mixed, depressed or unspecific episode, and

(ii) bipolar II disorder with recurrent major depressive episodes with hypomanic episodes, and cyclothymic disorder.

The other claims also related to the compounds of formula (1) for a further medical use and it was not contested by the parties that in such cases, for the requirement of sufficiency of disclosure to be fulfilled, the suitability of these compounds for the claimed therapeutic application must be disclosed (point 4.1 of the Reasons).

The patentee argued that the facts and circumstances of the present case differed from those underlying T 609/02 in which the chemical structure of the compounds was not identified (point 4.2.2 of the Reasons). Indeed, the above claims are restricted to a group of only two, well identified, compounds.

The Board only partly concurred with the patentee and explained that the usefulness of case law is not confined to similar or identical facts, but lies in the principles or guidance which can be extracted from earlier cases (point 4.2.3 of the Reasons).

In accordance with these considerations the Board then offered the following statement:

Therefore, for a patent claiming a compound for use in therapy, grounds under Article 100(b) EPC will prejudice the maintenance if the application does not disclose the suitability of the product for the claimed therapeutic application to the skilled person using its common general knowledge. Only once this evidence is available from the patent application, may postpublished evidence be taken into account when assessing sufficiency of disclosure (point 4.2.4 of the Reasons, emphasis added).

Going back to the particulars of the case at hand, the patent in suit properly disclosed and proved that the claimed compounds bind to a receptor called 5-HT1A, or in other terms were 5-HT1A agonists – this was not challenged by the respondents. But the real issue was the link between this biochemical property and the treatment of bipolar disorders.

In this respect, the Board found that the patent as disclosed at its filing date did not render the suitability of either of the compounds of formula (1) for the treatment of any type of bipolar disorder plausible; nor did it provide the information that there is a clear relationship between 5-HT1A receptor agonism and the suitability for the treatment of bipolar disorder (point 4.4.5 of the Reasons).

The Board went on to consider that there was no evidence on file showing that the person skilled in the art was in the possession of common general knowledge at the filing date of the patent in suit (only represented by basic handbooks and textbooks on the subject in question, see points 4.5.1 and 2 of the Reasons) which, together with the disclosure of the application as filed, led to the direct and unambiguous conclusion that 5-HT1A agonists in general, or either of the compounds of formula (1) in particular, were useful in the treatment of any type of bipolar disorder (point 4.5.3 of the Reasons).

Eventually, the Board concluded that the application as filed in combination with common knowledge at the filing date did not disclose the suitability of either of the compounds of formula (1) in the treatment of any type of bipolar disorder. Consequently, the minimum requirements set out in T 609/02 for taking into account post-published evidence were not met (point 4.5.3 of the Reasons).

The present decision follows the jurisprudence set by T 609/02 (point 9 of the Reasons) and confirmed inter alia by T 433/05 of June 14, 2007 (point 28 of the Reasons), T 801/06 of March 4, 2009 (point 25 of the Reasons), T 1437/07 of October 26, 2009 (point 37 of the Reasons), T 866/08 of September 16, 2010 (point 2 of the Reasons) (kindly brought to our attention by our reader Raoul), T 1685/10 of June 6, 2011 (point 3.1 of the Reasons), and T 801/10 of July 8, 2014 (point 4.1 of the Reasons).

However, it adds a twist to the existing case law by requiring that the skilled person can only rely on common general knowledge, represented by basic handbooks and textbooks, and excluding patent literature and scientific articles, to determine if the experimental data presented in a patent is representative of a metabolic mechanism specifically involved in the disease purported to be treated according to the claimed invention.

This was not expressly mentioned in T 609/02, which although it stated that:

As a consequence, under Article 83 EPC, unless this is already known to the skilled person at the priority date, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application (point 9 of the Reasons for the Decision, emphasis added),

also considered that:

It is required that the patent provides some information in the form of, for example, experimental tests, to the avail that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art [i.e. not only from the common general knowledge of the skilled person] or demonstrated in the patent per se. Showing a pharmaceutical effect in vitro may be sufficient if for the skilled person this observed effect directly and unambiguously reflects such a therapeutic application […] (point 9 of the Reasons for the Decision, emphasis added).

In fact, it is not clear if the skilled person mentioned in T 609/02 should be akin to the one of Article 100(a) EPC, who has access to all the prior art, or to the one of Article 100(b) or of Article 100(c) EPC, who has only access to the contents of the patent and common technical knowledge.

The present decision appears to have decided for the latter solution, while previous decisions did not seem to set restrictions on the type of prior art that should be relied on for assessing the suitability of a product for a claimed therapeutic application (see for example T 433/05, point 29 of the Reasons and T 801/06, point 29 of the Reasons – even though in the latter case the prior art documents used were cited in the opposed patent, but this was not mentioned by the Board).

We cannot foresee if this decision will set a new trend in applying the teachings of T 609/02, but it is surely advisable for applicants to strengthen the description of the in vitro or in vivo disease models relied on in applications containing therapeutic purpose-limited claims, in particular by fully citing the scientific literature on which such models are based.

We would also like to add that even though this decision seems to add a further burden on applicants in regard of the sufficiency of disclosure requirement, it may conversely be a benefit to them when considering the novelty requirement. Indeed, as is clearly expressed in the above-mentioned decision T 1437/07:

A disclosure in a prior art document is novelty-destroying only if the teaching it contains is reproducible. This need for an enabling disclosure is in conformity with the principle expressed in Article 83 EPC. Thus, the requirements of sufficiency of disclosure are identical for a prior art document and a patent (point 25 of the Reasons, emphasis added).

CASE REFERENCE: Board of Appeal 3.3.01, T 2059/13, Otsuka Pharmaceutical Co. Ltd. v. Stada Arzneimittel AG et al., December 7, 2015

CA Paris, 03/11/2015 : Une revendication de type suisse doit être considérée comme couvrant une méthode de traitement, et donc être annulée, si elle ne vise pas une substance ou une composition déterminée et si elle vise un mode d’action plutôt qu’une utilisation thérapeutique.

Cet article a été initialement publié sur le blog Patentmyfrench tenu par Renaud Fulconis.

It is often tempting to rule out of hand seemingly makeshift arguments but the decision we discuss today is a reminder of why it is always a bad idea to do so. It is also yet another reminder that it is not easy to be Swiss in France nowadays.

The decision in question was rendered by the Cour d’appel de Paris on November 3, 2015 (Ethypharm SA v. Alkermes Pharma Ireland Ltd.). It notably dealt with the appeal of Ethypharm against the decision of the Tribunal de Grande Instance (TGI) de Paris of December 21, 2012 to uphold claim 9 of European patent EP 0644755 (the ‘755 patent), which Ethypharm was found to infringe.

The ‘755 patent was filed on June 1, 1993 and was granted on March 19, 1997, i.e. well before the entry into force of EPC 2000. Accordingly, claim 9 is under the form of a so-called Swiss-type claim (i.e. “use of a substance or composition X for the manufacture of a medicament for therapeutic application Y”). It reads as follows:

The use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

It can be seen that the scope of the claim is rather extensive as it basically covers any process of manufacture of a medicament with particles of a drug substance (different from naproxen or indomethacin) having an average size of less than 400 nm, thanks to the use of a surface modifier which adsorbs onto the drug substance, for increasing the speed with which the substance will exert its activity upon administration.

While all the arguments set forth against the validity of the claim had failed in the first instance, in the course of the second instance Ethypharm found a new motive to be opposed to the validity of claim 9, namely that the claim would cover a method of treatment of the human or animal body and that it would be therefore excluded from patentability.

According to Ethypharm, this would be because claim 9 does not relate to a specified substance or composition but relates to all existing active substances without specifying their therapeutic use, since it covers the use of nanoparticles of any medicament for treating any disease, any patient, by any administration route and with any dosage.

The patentee, Alkermes, made the mistake of not offering any counter argumentation.

In this regard the Court first notes, somehow ironically, that Alkermes apparently intended to respond to the argument, in view of the following statement in their written submissions:

To conclude, we will say a word on the argument of “revocation of claim 9 because it relates to a method of treatment” a last resort makeshift which replaced the equally exotic argument of “nullity of the further medical use claim”.

However, nothing of the sort could be found by the Court in the rest of these written submissions.

This proved to be fatal in the present case, because the argument surfed on the French courts’ supercilious approach to claims liable to cover methods of treatment (see our previous posts here and there) and was thus found to be persuasive by the Court:

[…] In application of that text [i.e. EPC 1973] a European patent can be granted for any further medical use of a known substance or composition, provided the claim is drafted under the so-called “Swiss-type” form, of the use of a product for obtaining a medicament used in a novel therapeutic application;

[…] It is thus necessary that a determined specific substance has a new therapeutic use which is distinct from the state of the art, since a simple claim to a method relating to a therapeutic treatment is not patentable;

[…] In the present case claim 9 of the patent at stake relates to any drug substance, with the only exceptions of naproxen and indomethacin, already taught in the state of the art, with the sole aim of hastening the onset of its action upon its administration to a mammal;

[…] When reading the claim, it appears that it relates to no known determined substance or composition with the view of obtaining a medicament for a novel and determined therapeutic use;

[…] Indeed the claimed hastening of the onset of the action of the medicament is only a mode of action of a medicament, which is by the way undefined, and cannot be considered as a therapeutic use of this medicament;

[…] Accordingly claim 9 only teaches a hastened mode of therapeutic treatment applying to any drug substance (naproxen and indomethacin being excluded) for treating any disease and applying to any patient, whatever the mode of administration of the drug and its dosage;

[…] As a consequence the claim will be revoked […].

The Court thus considered that although it was in the form of a Swiss-type claim, the fact that neither (i) the drug substance nor (ii) the therapeutic use were specified meant that claim 9 was to be considered as covering a method of treatment.

However, with this reasoning it appears that the Court merely assimilates Swiss-type claims to further medical use claims according to Article 54(5) EPC 2000, thereby casting aside the literal sense of Swiss-type claims, which is to cover a process for the manufacture of a medicament. As a reminder, in decision G 5/83, the Enlarged Board of Appeal of the EPO ruled that it is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient.

Accordingly, the sanction for a Swiss-type claim which is found not to benefit from the special approach of novelty defined in decision G 5/83, for instance because the claim does not relate to a specified therapeutic application, should rather be to consider that the intended therapeutic use is not limiting. This approach is notably illustrated by decision T 1758/07 (see paragraph 3.4.3).

Applied to the present case, the finding of the Court according to which the hastening of the onset of the action of the medicament cannot be considered as a therapeutic use could thus have led to reformulating claim 9 as the use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament suitable for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

Incidentally, this would also have had the valuable advantage of doing without the rather confusing notion that a claim found not to relate to a therapeutic use could be considered at the same time to cover a method of treatment.

CASE REFERENCE: Cour d’appel de Paris, pôle 5, 1ère chambre, 3 novembre 2015, Ethypharm SA v. Alkermes Pharma Ireland Ltd., RG No. 2012/23743.