3.2.4 Public prior use
T 438/19 × View decision
Catchword:
The following questions are referred to the Enlarged Board of Appeal for decision:
1. Is a product put on the market before the date of filing of a European patent application to be excluded from the state of the art within the meaning of Article 54(2) EPC for the sole reason that its composition or internal structure could not be analysed and reproduced without undue burden by the skilled person before that date? 2. If the answer to question 1 is no, is technical information about said product which was made available to the public before the filing date (e.g. by publication of technical brochure, non-patent or patent literature) state of the art within the meaning of Article 54(2) EPC, irrespective of whether the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person before that date? 3. If the answer to question 1 is yes or the answer to question 2 is no, which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed and reproduced without undue burden within the meaning of opinion G 1/92? In particular, is it required that the composition and internal structure of the product be fully analysable and identically reproducible?
T 2510/18 × View decision
Abstract
Dans l'affaire T 2510/18 la chambre a considéré comme nouvelles par rapport aux documents D2, D3 et D5 les revendications 1 à 6 du brevet en cause qui a pour objet une molécule, la Simalikalactone E (ci-après la SkE), qui peut être extraite de la plante Quassia amara, ainsi que son utilisation comme médicament dans la prévention et le traitement du paludisme.
D2 est un article qui décrit une étude sur les remèdes antipaludiques utilisés en Guyane française. Il ressort de l'étude que l'espèce la plus utilisée est Quassia amara seule ou en combinaison avec d'autres espèces végétales. D2 décrit que cette plante est utilisée sous forme de décoctions administrée par voie orale ou est appliquée sur le corps du patient.
D3 est un article qui concerne l'évaluation de l'activité antipaludique de 23 espèces différentes de plantes utilisées en Guyane française dont la Quassia amara. D3 décrit que la décoction préparée avec les feuilles fraîches de Quassia amara n'est pas toxique à 1000 mg/jour et peut être administrée sans problème pendant plusieurs jours, quel que soit le principe actif. La décoction de feuilles de Quassia amara est donc présentée comme un remède antipaludique intéressant.
D5 est un article qui concerne l'effet de l'âge des feuilles de Quassia amara et l'état de dessication sur l'activité antipaludique d'infusions traditionnelles préparées à partir des feuilles à différents états de maturité et de fraîcheur. Dans une étude antérieure, la molécule Simalikalactone D "SkD" avait été identifiée comme le composé actif. Quatre infusions avaient été préparées avec des feuilles. Les concentrations de la SkD dans chaque préparation et leur activité antipaludique y sont comparées. Il est également indiqué dans D5 que l'infusion de jeunes feuilles séchées possède une activité in vivo très puissante qui ne semble pas provenir uniquement de la molécule SkD. Selon la chambre, aucun de ces documents D2, D3 et D5 ne décrivait explicitement la molécule active SkE. Ces documents divulguent plutôt des remèdes traditionnels antipaludiques, c.-à-d. des préparations dérivées des feuilles ou des tiges d'une plante particulière, Quassia amara.
La chambre a interprété la revendication 1 comme couvrant toutes les compositions contenant la molécule SkE y compris les extraits de D2, D3 et D5, dans la mesure où ils contiennent la molécule SkE. Cependant, la question de savoir si les extraits de D2, D3 ou D5 entrent dans la portée de la revendication 1 n'était pas le critère correct pour évaluer si l'objet de cette revendication est nouveau. Pour évaluer si l'objet d'une revendication a été rendu accessible au public et donc manque de nouveauté, la "norme de référence" est le seul critère à appliquer.
Le fait que la molécule SkE puisse être contenue dans les extraits de D2, D3 et D5 n'équivalait pas non plus à une divulgation implicite. Selon G 2/88 (points 10 et 10.1 des motifs), la question qui se pose est de savoir ce qui a été rendu accessible au public, et non pas ce qui pouvait y être contenu intrinsèquement. Il n'y avait pas non plus de divulgation implicite de l'objet de la revendication 1 au regard de G 1/92: il aurait été nécessaire que la personne du métier identifie la SkE dans les extraits de D2, D3 ou D5. Étant donné que l'identification de la SkE aurait représenté un effort excessif et donc impliqué une activité inventive, la chambre a décidé que SkE ne faisait pas partie de l'état de la technique accessible au public.
La chambre a également relevé que la question en l'espèce était différente de celle dans la saisine T 438/19. Il ne pouvait ici y avoir de divulgation implicite de la SkE dans lesdits extraits, à tout le moins parce que leur identification aurait impliqué un effort excessif pour la personne du métier.
La chambre n'a pas non plus été convaincue par l'argument des requérants qui avaient fait valoir que l'objet d'une revendication ne pouvait pas être considéré comme nouveau s'il était contrefait par une utilisation existante, par exemple, par les extraits de D2, D3 ou D5. En d'autres termes, la protection conférée par le brevet donnerait à l'intimé le droit d'interdire aux populations autochtones d'utiliser les feuilles de Quassia amara pour la préparation de leurs remèdes traditionnels. Par analogie avec G 2/88, la chambre a expliqué qu'en vertu de l'art. 54(2) CBE, la question était de savoir ce qui a été "rendu accessible" au public, et non pas ce qui pouvait être "contenu intrinsèquement" dans ce qui a été rendu accessible. En conséquence, la question du "contenu intrinsèque" ne se posait pas en tant que telle dans le cadre de l'art. 54 CBE.
In many cases the ability to recognise a technical teaching such as the internal structure or composition of a product in prior use presupposes analysis of the product embodying this technical teaching. Whether it is technically feasible to analyse a product that is available on the open market is an issue that the boards have considered on a number of occasions.
In T 952/92 (OJ 1995, 755) the board stated that information as to the composition or internal structure of a prior sold product is made available to the public and becomes part of the state of the art if direct and unambiguous access to such information is possible by means of known analytical techniques which were available for use by a skilled person before the relevant filing date (see also T 2/09). The board also stated that the likelihood or otherwise of a skilled person analysing such a prior sold product, and the degree of burden (i.e. the amount of work and time involved in carrying out such an analysis), is in principle irrelevant to the determination of what constitutes the state of the art. The novelty of a claimed invention is destroyed by the prior disclosure (by any means) of an embodiment which falls within the claim. The possibility of a complete analysis of a prior sold product is not necessary. The novelty of a claim is destroyed if an analysis of a prior sold product is such as to inform the skilled person of an embodiment of the product which falls within the claim.
In G 1/92 (OJ 1993, 277) the Enlarged Board of Appeal held that the chemical composition of a product forms part of the 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. The same principle applies mutatis mutandis to any other product. It also stated that "[a]n essential purpose of any technical teaching is to enable the person skilled in the art to manufacture or use a given product by applying such teaching. Where such teaching results from a product put on the market, the person skilled in the art will have to rely on his general technical knowledge to gather all information enabling him to prepare the said product. Where it is possible for the skilled person to discover the composition or the internal structure of the product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art". However, the Enlarged Board added that "a commercially available product per se does not implicitly disclose anything beyond its composition or internal structure. Extrinsic characteristics, which are only revealed when the product is exposed to interaction with specifically chosen outside conditions, e.g., reactants or the like, in order to provide a particular effect or result or to discover potential results or capabilities, therefore point beyond the product per se as they are dependent on deliberate choices being made. Typical examples are the application as a pharmaceutical product of a known substance or composition (cf. Article 54(5) EPC) and the use of a known compound for a particular purpose, based on a new technical effect (cf. G 2/88, OJ 1990, 93). Thus, such characteristics cannot be considered as already having been made available to the public". See below on T 472/92, T 834/15, T 1409/16 and T 1666/16 which (among other things) discuss the issue of extrinsic characteristics.
(i) Structure or composition made available to the public
In T 390/88 a photographic film had been made available to the public by announcement at a press conference three weeks before the priority date. The board held that this relatively short time interval was sufficient to enable interested parties to become fully aware of the film's composition.
In T 969/90 and T 953/90 the board ruled that the internal structure of a product in prior use had been made available to the public because a skilled person relying on the normal means of investigation available to them would have been able to analyse the product.
In T 301/94 the board decided that the skilled person would have been able to reproduce the green glass without undue burden and that this was sufficient to meet the requirement of reproducibility set out in G 1/92. A skilled person must be able to prepare the product without undue burden on the basis of his general technical knowledge and knowing the composition or internal structure of the product, whatever the scale of production (laboratory, pilot or industrial scale). The board held that when a commercially available product could be analysed by the analytical methods known on the priority date and could also be reproduced, its chemical composition formed part of the state of the art even if a skilled person could not have recognised a priori (i.e. before performing an analysis), on the basis of the common general knowledge on the priority date that at least one component was present in the product, or was present in an "unusual small" amount (referring to T 952/92, OJ 1995, 755; T 406/86 OJ 1989, 302; T 390/88; G 1/92; see also T 370/02).
In T 947/99 the alleged public prior use concerned a visit to an ice-cream factory. Although it had not been established that a feature of the manufacturing process had been explicitly explained to the visitors, the board decided that information about the procedure had been publicly disclosed. The board observed that, in accordance with the principles set out in G 1/92, it was the fact that direct, unlimited and unambiguous access to any particular information regarding the manufacturing processes known per se was possible which made these processes available to the public within the meaning of Art. 54(2) EPC 1973, whether or not there was any reason to look or ask for such information.
In T 2068/15 (chemical composition – analysability), the board considered in the case at issue that the skilled person analysing the film with the techniques known at that time (electron microscopy) would not have overlooked the first top layer. And the board stated also that it was common practice at the priority date of the patent to apply more than one analytical method in order to obtain information about the composition of a material.
In T 1409/16 the board decided that commercial composition only accessible by subjecting said prior art composition to a kind of reverse engineering (by fractionation) based on hindsight revealed "extrinsic characteristic" within the meaning of G 1/92 (see also similar case T 834/15).
In T 1452/16 (alleged prior use of Amano lactase) the board stated that in order to assess whether a prior-art product falls within the terms of the claim, one obviously has to assess the claimed parameters, even if these have never been used before. Furthermore, the board explained in detail why the present cases differed from T 946/04, T 1457/09, T 2048/12 and T 2068/15. Contrary to the patent proprietor's arguments, the board noted firstly that T 952/92 did not stipulate that structural assays had to be used, and second that the skilled person did not have to test for all possible impurities. As to reproducibility, T 952/92 also clarified that no complete reproducibility was needed. The board came to the conclusion that the evidence on file convincingly demonstrated that a lactase preparation fulfilling the parameters (given ratio) recited in claim 1 of the main request was publicly available, that an enzyme with the characteristics as claimed was commercially available in the prior art and that its use in a process as claimed had also been made available to a member of the public, and hence was state of the art.
(ii) Structure or composition not made available to the public
In T 461/88 (OJ 1993, 295) the board ruled that a control program stored on a microchip had not been made available to the public if the analysis of the program would require an expenditure of effort on a scale which could only be reckoned in man-years and if, for economic reasons, it was highly improbable that the sole purchaser of the machine controlled by the program had carried out such an analysis (see obiter dictum in T 969/90, see also T 212/99).
In T 472/92 (OJ 1998, 161) the board referred to G 1/92 and concluded that the printability characteristic of the material was not a property that became available to the public by their mere delivery, since this was clearly an extrinsic characteristic requiring interaction with specifically chosen outside conditions. Thus, such characteristic could not be considered as already having been made available to the public (see also T 267/92).
The board in T 1217/01 found that, since the perming product allegedly in prior use was a fast-moving consumer good, it could be presumed that it had gone on sale, and so been publicly available, soon after payment of the invoice the appellant (opponent) had adduced as supporting evidence. For the board, the case turned on the composition of the oxidising agent (fixer) in the invoiced product. But, as no product or even packaging dating from the time was available, its exact composition could be deduced only by "reverse reasoning", working back from the process of its elaboration and production. The board ultimately found that the evidence was not conclusive enough; owing especially to changes in the product names and numbers, it had not been shown that the sold product had also been made of the claimed composition.
In T 2048/12 the board stated that opinion G 1/92 did not imply that in each and every case the commercial availability of a chemical product as such necessarily amounted to a disclosure of (also) all the impurities contained therein merely because it was possible to identify and quantify these impurities by analytical means. Conclusion 1 of G 1/92 was to be read by attributing a technically reasonable meaning to the technical expression "chemical composition". In the present case there was no direct or indirect pointer to the possible technical relevance of further impurities (besides water) in the commercial product.
T 1833/14 dealt with the condition of reproducibility laid down in G 1/92. It could not be concluded that the skilled person was able to reproduce the product Rigidex®P450xHP60 without undue burden. In order to be part of the prior art pursuant to Art. 54(2) EPC, a public prior use must amount to an enabling disclosure (T 977/93, OJ 2001, 84; T 370/02, T 2045/09, T 23/11 and T 301/94). It is generally known in the field of polymers that the nature of the catalyst system, the type of reacting system and the process conditions significantly affect the properties of the produced polymer. In the polymer field, in which products and compositions are often defined by means of parameters, the requirements of sufficiency of disclosure is analysed with particular care and the same criteria must apply to the reproducibility without undue burden of a product on the market. In order for the product to be state of the art, the question was whether or not the skilled person would have been in a position to prepare the product as such, i.e. a sample identical to Rigidex®P450xHP60 in all its properties (not only those specified in claim 1). This was however not shown by the appellant (opponent). To the contrary, the appellant stated that "what may be more difficult (if the catalyst used for the original product is not known) is obtaining the same mechanical properties as the Rigidex product". T 1833/14 cited by T 842/14 in connection with Art. 83 EPC.
In T 1666/16 (powders – angle of repose), the board could not conclude that the skilled person was able to determine the internal structure of the sold products and to reproduce them without undue burden at the date of their sale; the internal structure of these products did not form part of the prior art. The issue of extrinsic characteristics in view of G 1/92 was also at stake.