You certainly remember this case concerning a patent covering a process for breeding tomato plants as well as the fruit resulting from the process.
The Opposition Division (OD) had maintained the patent in amended form, which triggered appeals of both the patent proprietor and the opponent.
In an interlocutory decision issued on 4 April 2008, the board referred three questions of law to the Enlarged Board of Appeal (EBA). All questions related to the interpretation of the process exclusion contained in A 53(b), namely to the circumstances under which processes for the production of plants have to be regarded as “essentially biological”. The EBA answered the referred questions in its decision G 1/08.
The patent proprietor then dropped the process claims.
The patent proprietor then dropped the process claims.
The Board found the main request before it not to comply with A 123(3) and then dealt with the first auxiliary request, claims 1 and 2 of which read:
1. A raisin-type tomato fruit of the species Lycopersicon esculentum which is naturally dehydrated, wherein natural dehydration is defined as wrinkling of skin of the tomato fruit when the fruit is allowed to remain on the plant after a normal ripe harvest stage, said natural dehydration being generally unaccompanied by microbial spoilage.2. A raisin-type tomato fruit of the species Lycopersicon esculentum characterized by an untreated skin, dehydration of the fruit and wrinkling of the skin, said dehydration being generally unaccompanied by microbial spoilage.
These were claims that had been filed during oral proceedings (OPs) before the OD and found allowable by the latter.
The Board found this request to be admissible and to comply with the requirements of R 80 and A 123 as well as A84. It then examined the allowability of the request in view of A 53(b).
This led the Board to make a second referral to the EBA. The questions the EBA is asked to answer are as follows:
1. Can the exclusion of essentially biological processes for the production of plants in A 53(b) have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit?2. In particular, is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application?3. Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under A 53(b)?
If you would like to know why the Board found this referral necessary, please read on:
General
[19] With respect to the area of plant breeding, A 53(b) contains two exceptions from patentability. It prohibits the patenting of, on the one hand, plant varieties and, on the other hand, essentially biological processes for the production of plants. When this board handed down its first interlocutory decision, both the proprietor’s main request and auxiliary request I then on file contained process claims directed to methods for breeding tomato plants as well as product claims directed to tomato fruits and tomato plants. Since the board considered that the interpretation of the process exclusion contained in A 53(b) needed clarification in the light of R 26(5), it referred corresponding questions to the EBA.
[20] In view of the responses given by the EBA in G 1/08, [the patent proprietor] deleted the process claims so that the claim requests now on file are restricted to product claims directed to tomato fruits or tomato fruit products […]. Nevertheless, [the opponent] is of the opinion that the remaining product claims are still directed to subject-matter excluded from patentability by A 53(b). Its main lines of argument are firstly that the claims are directed to plant varieties which are excluded from patentability, and secondly that allowing these claims would counteract the process exclusion of A 53(b) as interpreted in G 1/08, thereby frustrating the legislator’s aim not to provide patent protection for the excluded plant breeding processes.
Procedural aspects
[21] When filing its notice of opposition, [the opponent] challenged both process and product claims of the granted patent as not complying with A 53(b) EPC 1973. In particular, it argued that the claimed tomato fruit had to be regarded as concerning an excluded plant variety. Thus, as also noted by [the patent proprietor] in its response to the notice of opposition, the ground for opposition under A 100(a) EPC 1973 in connection with the product exclusion under A 53(b) EPC 1973 was specifically raised already at the beginning of the opposition procedure.
[22] During the OPs before the OD, [the opponent] did not maintain this objection when confronted with the newly introduced auxiliary requests II and IIIb then on file (which contained only product claims directed to tomato fruits). Nevertheless, the OD dealt with the objection in substance […] by stating that claims 1 and 2 of auxiliary request II were not limited to a single plant variety and were therefore allowable under A 53(b) and R 23b(4) EPC 1973.
[23] Under these circumstances the objection under A 100(a) in conjunction with A 53(b) against product claims relating to tomato fruits cannot be regarded as a fresh ground of opposition which may be introduced in the appeal proceedings only with the proprietor’s consent according to G 10/91 and G 1/95 (see also T 275/05 [1]).
[24] Although [the opponent] did not pursue the above objection in its grounds of appeal or in the response to the [the patent proprietor’s] grounds of appeal, it raised the objection again in the course of the first OPs before this board (which took place more than four years before the second OPs) and requested that questions of law relating to the interpretation of the product exclusion contained in A 53(b) be referred to the EBA. Furthermore, in its written submissions in the aftermath of the EBA’s decision G 1/08, [the opponent] presented several arguments as to why the product claims contained in [the patent proprietor’s] requests should be regarded as non-patentable under A 53(b). Since [the patent proprietor] therefore had ample opportunity to consider this objection and the supporting arguments brought forward by [the opponent], the board, using its discretion under Article 13(1) RBPA, admits and examines the objection in the present appeal procedure.
The concept of plant varieties
[25] Both the European legislator (see Article 2(3) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ EPO 1999, 101, hereinafter “Biotech Directive”, and R 26(4)) as well as the EBA in its decision G 1/98 have contributed to clarifying the meaning of the term “plant varieties” contained in A 53(b). According to the definition provided by R 26(4), “plant variety” means any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be (a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes, (b) distinguished from any other plant grouping by the expression of at least one of the said characteristics, and (c) considered as a unit with regard to its suitability for being propagated unchanged. Identical or very similar definitions are contained in the international and European legislative framework for the protection of plant breeders’ rights (see Article 5(2) Council Regulation (EC) No. 2100/94 of 27 July 1994 on Community Plant Variety Rights, hereinafter “CPVR Regulation”) and Article 1(vi) UPOV Convention 1991).
[26] In accordance with the decision G 1/98 [3.1; 3.8], the reference in R 26(4)(a) to the expression of the characteristics that results from a given genotype or combination of genotypes is to be understood as a reference to the entire constitution of a plant or a set of genetic information. The concept of plant variety requires plant groupings defined by their whole genome, not merely by individual characteristics. The EBA has therefore held that a claim to transgenic plants that are characterised merely by specific recombinant DNA sequences is not directed to a plant variety. The relevant passages in decision G 1/98 read as follows:
“In contrast, a plant defined by single recombinant DNA sequences is not an individual plant grouping to which an entire constitution can be attributed […]. It is not a concrete living being or grouping of concrete living beings but an abstract and open definition embracing an indefinite number of individual entities defined by a part of its genotype or by a property bestowed on it by that part. As described in more detail in the referring decision, the claimed transgenic plants in the application in suit are defined by certain characteristics allowing the plants to inhibit the growth of plant pathogens […]. The taxonomic category within the traditional classification of the plant kingdom to which the claimed plants belong is not specified, let alone the further characteristics necessary to assess the homogeneity and stability of varieties within a given species. Hence, it would appear that the claimed invention neither expressly nor implicitly defines a single variety, whether according to the definition of ‘plant variety’ in Article 1(vi) of the UPOV Convention 1991, or according to any of the other definitions of ‘plant variety’ mentioned above. This also means that it does not define a multiplicity of varieties which necessarily consists of several individual varieties. In the absence of the identification of specific varieties in the product claims, the subject-matter of the claimed invention is neither limited nor even directed to a variety or varieties.”
[27] In the present case, the subject-matter of the claims of auxiliary request I is not directed to whole tomato plants, but to dehydrated tomato fruits. The question thus arises whether for that reason alone the claimed subject-matter might escape the exclusion of plant varieties. However, a plant variety may be represented not only by whole plants but also by propagating material such as seeds and by parts of plants. It is noted that Article 5(3) CPVR Regulation defines “variety constituents” as “entire plants or parts of plants as far as such parts are capable of producing entire plants”. In addition, Article 13(2) CPVR Regulation defines the rights of the holder of a Community plant variety right as covering specific acts in respect of variety constituents or harvested material of the protected variety. The UPOV Convention 1991 defines the scope of the breeders’ right primarily by enumerating certain acts in respect of the propagating material of the protected variety, but extends these rights under certain conditions also to acts relating to harvested material (see Article 14(1) and (2) UPOV Convention 1991). The board therefore concludes that claims which, as in the present case, are directed to plant fruits which contain seeds and which are therefore to be regarded as plant parts capable of producing entire plants may well in general fall under the patent exclusion of plant varieties contained in A 53(b).
[28] The plant grouping to which the claimed tomatoes belong is restricted to plants belonging to the species Lycopersicon esculentum. Thus it is not as broad and generic as the plant grouping in the case underlying the decision G 1/98 where the claimed subject-matter was transgenic plants that, while being characterised by specific recombinant DNA sequences, could belong to completely different taxonomic categories within the traditional classification of the plant kingdom.
[29] However, even a plant grouping of which the members all belong to a single plant species such as Lycopersicon esculentum is not necessarily a plant variety. There are currently several thousands of tomato varieties grown for various purposes, each tomato variety being based on an entire set of genetic information and having a number of specific features e.g. with respect to leaf type, plant type, plant height, plant size, season, fruit shape, skin colour, flesh colour, taste and resistance to plant diseases and pests. In contrast, in the present case the claimed tomatoes are not defined by a multitude of characteristics resulting in a given genotype, but only by one particular trait, i.e. (natural) dehydration.
[30] The board is aware that a single trait may be sufficient to make a given plant grouping distinguishable from another very similar plant grouping not having that trait and thus provide a basis for the grant of a plant breeders’ right for that specific plant grouping if it qualifies as a new variety (which may be an essentially derived variety, see Article 14(5)(b) UPOV 1991 and Article 13(6) CPVR Regulation). Nevertheless, a single trait is in general not sufficient to define a plant variety without providing, apart from an indication of the species, any other indication about the actual genotype of the plant grouping. As already pointed out (point [26], above), the concept of plant variety requires plant groupings to be defined by their whole genome and not merely by a particular individual characteristic. It is therefore not sufficient that, as maintained by [the opponent] in the present case, the specific trait is inserted into the tomato plants in a stable manner so that it can be inherited by future generations.
[31] The board acknowledges that the description of the patent in suit uses at some places the term “tomato varieties”, e.g. by stating that the development of tomato varieties with the trait of natural dehydration is highly valuable to the tomato industry […] or that selected plants may be crossed with other Lycopersicon esculentum cultivars to create varieties that incorporate characteristics other than reduced fruit water content […]. Furthermore, as described in Examples 1 and 2, specific Lycopersicon esculentum breeding lines were used in the breeding programme for developing naturally dehydrated tomatoes. Nevertheless, the subject-matter of the claims under consideration is not restricted to tomatoes of any of those specific varieties or breeding lines. The claims leave completely open what further characteristics the claimed naturally dehydrated tomato fruits and the plants on which they grow may have.
[32] According to the patent description, the tomato fruits of the invention were developed by crossing and selection, i.e. “classical” plant breeding methods. However, this does not have the automatic consequence that they have to be regarded as a plant variety. The question as to whether a plant grouping constitutes a plant variety does not depend on how it was obtained, i.e. whether it was produced by genetic engineering technology or by more traditional breeding techniques based on crossing and selection. This was made clear by the EBA in the following passage of its decision G 1/98 [5.3] (see also T 1854/07 [10.4]):
“As already emphasised by the referring Board, it does not make any difference for the requirements under the UPOV Convention or under the Regulation on Plant Variety Rights, how a variety was obtained. Whether a plant variety is the result of traditional breeding techniques, or whether genetic engineering was used to obtain a distinct plant grouping, does not matter for the criteria of distinctness, homogeneity and stability and the examination thereof. This means that the term ‘plant variety’ is appropriate for defining the borderline between patent protection and plant breeders’ rights protection irrespectively of the origin of the variety.”
No extension of the exclusion of plant varieties to plants in general
[33] Having ascertained that the claimed invention at issue was neither limited nor even directed to a variety or varieties, the EBA in its decision G 1/98 carefully considered in great depth the further issue as to whether the exclusion of plant varieties negatively affected the allowability of claims which included plant varieties as possible embodiments, i.e. whether it prohibited the patenting of subject-matter which, whilst not directed to a plant variety, embraced plant varieties.
[34] The EBA found that there was no general principle according to which a claim would become automatically non-patentable if it encompassed an embodiment which did not comply with the requirements of the EPC. This principle applied only in certain contexts, in particular when examining novelty or inventive step, but not in others (e.g. when examining the requirement of sufficiency of disclosure or the exception to patentability pursuant to A 53(a) EPC 1973).
[35] The EBA furthermore considered that the legislative reason for excluding plant varieties in A 53(b) EPC 1973 was to delimit patents and plant breeders’ rights as the two forms of protection for plant innovation, taking into account the ban on dual protection in the UPOV Convention in its version of 1961. It had been the legislator’s intention to consider plant breeders’ rights and patents as a single comprehensive system, so that the two forms of protection together permitted neither overlapping nor gaps in the protection of eligible subject-matter. Inventions ineligible under the plant breeders’ rights system were thus intended to be patentable under the EPC provided they fulfilled the other requirements of patentability. The extent of the exclusion for patents was the obverse of the availability of plant variety rights.
[36] The EBA concluded that it was not sufficient, for the exclusion of A 53(b) EPC 1973 to apply, that one or more plant varieties were embraced by the claims. Thus, a claim wherein specific plant varieties are not individually claimed is not excluded from patentability under A 53(b), even though it may embrace plant varieties. The EBA’s conclusion is corroborated by R 27(b) which was introduced into European patent law as R 23c(b) EPC 1973 in the course of implementation of the Biotech Directive and which states that biotechnological inventions shall also be patentable if they concern plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety.
[37] The EBA underpinned its legal analysis by emphasising that the broadly claimed subject-matter in the case underlying the referral, i.e. transgenic plants characterised by specific recombinant DNA sequences, could not be protected by a plant breeders’ right and that the inventor in the genetic engineering field would not obtain appropriate protection if he were restricted to specific varieties. Notwithstanding these particular arguments made in view of the specific technology involved, the EBA did not limit its above conclusion to situations where inventions based on genetic engineering are claimed.
[38] Rather, the core of its reasoning was the consideration that the exclusion of plant varieties serves only to exclude from patentability those plant inventions which can be protected by plant breeders’ rights. To extend the product exclusion contained in A 53(b) generally to a plant invention which is not directed to a plant variety would be difficult to reconcile with this legislative purpose and could lead to undesirable gaps of protection. Whether the invention is in the area of genetic engineering (as in the case underlying decision G 1/98) or in the field of more traditional plant breeding, as in the present case, should therefore not make any difference when considering the effect of the exclusion of plant varieties on the patentability of the claimed subject-matter (see also T 1854/07 [10.4]).
[39] The present board therefore takes the view that, if it only had to consider the exclusion of plant varieties in A 53(b), the subject-matter of the claims of auxiliary request I would not be excluded from patentability.
Impact of the process exclusion on claimed subject-matter
[40] However, the above conclusion does not yet terminate the analysis of the objections raised by [the opponent] under A 53(b) (see point [20] above). The board still has to address the further argument that, irrespective of the interpretation of the exclusion of plant varieties, it would be wrong to allow the claimed subject-matter to be patented, since this would render the exclusion of essentially biological processes for the production of plants completely ineffective, thereby frustrating the legislative purpose behind the process exclusion in A 53(b).
[41] The meaning and the scope of this process exclusion were considered in detail in G 1/08 on referral in the present case. Although R 26(5) (which was introduced into European patent law as R 23b(5) EPC 1973 in the framework of implementation of the Biotech Directive) attempts to define the term “essentially biological process for the production of plants”, the EBA considered this provision as unclear and self-contradictory. Since R 26(5) did not provide any useful guidance on the interpretation of the above term, the latter had to be interpreted on its own authority.
[42] The EBA came to the conclusion that any non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genome of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of A 53(b). Excluded processes are characterised by the fact that the traits of the plants resulting from the crossing are determined by the underlying natural phenomenon of meiosis which is responsible for the genetic make-up of the plants produced (see G 1/08 [6.4.2.3]). A process does not escape the exclusion of A 53(b) merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genome of plants or of subsequently selecting plants. An exception has to be made only with respect to processes which contain within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces or modifies a trait in the genome.
[43] In view of the above ruling, the deletion of all the method claims in [the patent proprietor’s] present claim requests […] did not come as a surprise. It follows from the principles stated in G 1/08 that the method claims in the patent as granted and in [the patent proprietor’s] claim requests at the time when the case was before the EBA fell under the process exclusion of A 53(b). For they were based on and contained steps of sexually crossing the whole genome of plants and of subsequently selecting plants by screening for reduced fruit water content, and none of them appeared to contain an additional step of a technical nature which by itself introduced or modified a trait in the genome.
[44] [The opponent] took the view, however, that the deletion of the method claims was not sufficient to escape the process exclusion of A 53(b). Its line of argument can be summarised as follows. As a matter of legislative policy, it would not make any sense to exclude, on the one hand, essentially biological processes for the production of plants from patentability and to allow, on the other hand, patents on plants which, according to the disclosure of the invention, are produced by an excluded process. The legislator’s reasons for excluding these processes had to be respected and necessarily implied the exclusion of plants or plant parts that are produced by essentially biological processes. To hold otherwise would lead to an inconsistent legal framework. The EPC should not be interpreted in such a self-contradictory way even in the absence of an explicit provision excluding the products of essentially biological plant production processes.
[45] The argument that allowing the product claims in the present case would be inconsistent with the legislator’s decision to exclude the processes specified in A 53(b) may, in the board’s view, be underpinned by considering the respective scope of protection conferred by product and process claims. According to established principles of patent law, the protection conferred by a product claim is absolute (see G 2/88 [5]) and the patent proprietor has in particular the right to exclude others from making or using the patented product (see decision G 2/06 [25]; Article 28.1(a) TRIPS Agreement and the corresponding provisions of the national laws of the contracting states). In contrast, the protection conferred by a process claim for making a product is narrower since it basically covers only the use of the process and the products directly obtained by it (see A 64(2), Article 28.1(b) TRIPS Agreement). Hence, a claim to a product provides the patent proprietor with protection that generally encompasses the protection provided by a patent claim for the process of making the product.
[46] If in the present case the product claims of auxiliary request I were allowed, any act of making and using the claimed dehydrated tomato fruits would in principle fall under the prerogative of the patent proprietor. This would have the consequence that the proprietor could prevent others from using the essentially biological plant breeding method which is taught in the description of the patent and which was the subject-matter of the deleted method claims. In fact, if one takes into account the features of the breeding method as defined in claim 1 as granted (“breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: crossing […]; growing plants from the first generation of hybrid seeds; […] growing plants from the seeds of the most recent hybrid generation; allowing plants [sic] to remain on the vine past the point of normal ripening; and screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin”), it appears that this method cannot be performed without producing and using the tomato fruits claimed in auxiliary request I.
[47] In view of the above considerations, the question arises whether allowing the product claims in the present case would effectively negate the legislator’s intention as identified in G 1/08 [6.4.2.3] “to exclude from patentability the kind of plant breeding processes which were the conventional methods for the breeding of plant varieties”. Disregarding the process exclusion in the examination of product claims altogether would have the general consequence that for many plant breeding inventions patent applicants and proprietors could easily overcome the process exclusion of A 53(b) by relying on product claims providing a broad protection which encompasses that which would have been provided by an excluded process claim. At least prima facie this would appear to be at odds with a purposive construction of A 53(b).
Issue not settled by decision G 1/98 and R 27(b)
[48] In the board’s view, decision G 1/98 did not deal with this line of argumentation, either explicitly or implicitly. It is true that the EBA came to the conclusion that a claim wherein specific plant varieties are not individually claimed is not excluded from patentability under A 53(b) EPC 1973, even though it may embrace plant varieties (see point [36] above). However, the reasons underlying this conclusion only concerned the meaning and the scope of the exclusion of plant varieties. The issue of a possible impact of the process exclusion in A 53(b) EPC 1973 on claims for plants or plant material was not addressed. This can be explained by the fact that the case underlying the referral leading up to decision G 1/98 concerned transgenic plants that were produced by modern genetic technology, rather than by a breeding method based on crossing and selection.
[49] In a similar vein, R 27(b) is understood by the board as aiming at restricting the scope of the product exclusion in A 53(b), not of the process exclusion. If the legislator had intended to clarify that products obtained by essentially biological plant production processes, other than a plant variety, should not be excluded from patentability, then this could have been expected to be expressed in R 27(c) (according to this provision, products obtained by means of a microbiological or other technical process other than a plant or animal variety are to be regarded as patentable). However, this was not done. The board furthermore considers that, in the light of A 164(2), it appears questionable whether a provision of the Implementing Regulations could mitigate an effect which a provision of the Convention would have if interpreted on its own authority.
Interpretation of other process exclusions - the example of R 28(c)
[50] The case law shows that there are situations where an exclusionary provision referring to specific processes or uses may have an impact on the allowability of product claims. According to R 28(c), European patents shall not be granted in respect of biotechnological inventions which concern the uses of human embryos for industrial or commercial purposes. In its decision G 2/06 the EBA concluded that this provision forbids the patenting of claims directed to products which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which said products are derived, even if the said method is not part of the claims. The patent applicant’s counter-argument that, in order to fall under the prohibition of R 28(c), the use of human embryos must be claimed was dealt with in point [22] of the reasons for the decision as follows:
“However, this Rule (as well as the corresponding provision of the Directive) does not mention claims, but refers to ‘invention’ in the context of its exploitation. What needs to be looked at is not just the explicit wording of the claims but the technical teaching of the application as a whole as to how the invention is to be performed. Before human embryonic stem cell cultures can be used they have to be made. Since in the case referred to the EBA the only teaching of how to perform the invention to make human embryonic stem cell cultures is the use (involving their destruction) of human embryos, this invention falls under the prohibition of Rule 28(c) […]. To restrict the application of Rule 28(c) […] to what an applicant chooses explicitly to put in his claim would have the undesirable consequence of making avoidance of the patenting prohibition merely a matter of clever and skilful drafting of such claim.”
[51] The corresponding provision of the Biotech Directive was interpreted in a similar manner by the European Court of Justice (ECJ) in its decision C-34/10 of 18 October 2011 (Oliver Brüstle v. Greenpeace e.V.). In response to the third question referred to it by the German Federal Supreme Court, the ECJ concluded that Article 6(2)(c) Biotech Directive excluded an invention from patentability where the technical teaching which was the subject-matter of the patent application required the prior destruction of human embryos or their use as base material, whatever the stage at which that took place and even if the description of the technical teaching claimed did not refer to the use of human embryos. In the ECJ’s view, not to include in the scope of the exclusion technical teaching claimed, on the ground that it does not refer to the use of human embryos, would make the provision concerned redundant by allowing a patent applicant to avoid its application by skilful drafting of the claim.
[52] The board is aware that, due to the different legislative purposes of the patentability exceptions under A 53(a) and (b), the above considerations do not necessarily apply mutatis mutandis to the interpretation of the process exclusion of A 53(b). Nevertheless, they demonstrate that situations exist where an exclusion referring to specific processes (according to the EBA’s case law “uses” are regarded as a sub-class of processes, see e.g. decision G 5/83 [11]) may negatively affect the allowability of product claims.
Arguments against a negative effect of the process exclusion on product claims
[53] The board considers that the following interrelated lines of argument against extending the effect of the process exclusion in A 53(b) to product claims need to be addressed:
- Issues of patentability (including the applicability of an exclusionary provision) should be determined strictly in relation to the subject-matter of the claim to be examined.
- The subject-matter of product claims is different from that of process claims, so that it is justified to treat them differently when determining what is patentable and what is not.
- The difference in subject-matter should not be smoothed out by taking into account the scope of protection or the proprietor’s prerogatives conferred by the claims, since this would amount to an impermissible mixing of two bodies of rules, i.e. those concerned with the patentability of inventions and those concerned with patent infringement.
The following considerations are of relevance for addressing these lines of arguments.
[54] As pointed out in the EBA’s decision G 2/88 ([2.2; 2.6], the subject-matter of a claimed invention involves two aspects: first, the category or type of the claim, and second, the technical features, which constitute its technical subject-matter. Basically two types of claim have to be distinguished, namely claims to a physical entity (e.g. product, apparatus) and claims to a physical activity (e.g. method, process, use), although there are no rigid demarcation lines between the various possible forms of claims. Consequently, the subject-matter of a process claim for the production of plants (which relates to a physical activity) and that of a product claim for plants or plant parts (which relates to physical entities) are not identical.
[55] The difference of subject-matter between product and process claims is inter alia of importance when the patentability requirements of novelty and inventive steps are examined. While a product claim can only be allowed when the claimed product is new and inventive, a claim to a manufacturing process for a product may comply with the requirements of novelty and inventive step even where the product to be manufactured does not fulfil these requirements itself. Since an invention underlying a product claim therefore has to have an “inventive quality” which is not the same as that of an invention underlying a process claim, it may be argued that, when framing the exclusionary provision of A 53(b), the legislator made a deliberate differentiation by excluding only certain plant breeding processes, but not all the products produced by those processes.
[56] However, the process exclusion itself does not distinguish between processes which lead to new and inventive plants and those processes which do not. Rather, it excludes them all. This uniform approach is reflected in the legislative history, during which it was explained that the (essentially) biological processes for the production of plants or animals should include those which may produce known varieties as well as those which may produce new ones (see G 1/08 [6.4.2.2]). It appears furthermore that, when new and inventive subject-matter is developed in the context of a plant breeding invention based on the natural phenomenon of meiosis, it will very often be possible to formulate process and product claims which both comply with the requirements of novelty and inventive step. The argument of a distinctive inventive quality of product inventions justifying their general allowability notwithstanding the general non-allowability of process claims therefore does not seem to be convincing in the present context.
[57] In decision G 1/98 […]the EBA dealt with an issue which may be considered to be the obverse of the present core issue: it analysed a possible impact of the product exclusion in A 53(b) EPC 1973 on the examination of process claims, namely the question as to whether, in view of A 64(2) EPC 1973, the exclusion of plant varieties should be a bar to process claims when the products directly obtained by such processes were or covered plant varieties. The EBA gave a negative answer to this question and pointed out that the protection of the product obtained by a patented process was of particular importance in situations where product protection was not available. Thus, when a claim to a process for the production of a plant variety is examined, A 64(2) EPC 1973 should not be taken into consideration.
[58] It is apparent that the protection conferred by A 64(2) on any process for the production of a plant variety is limited to the variety directly obtained by the process and thus considerably narrower than the protection which would be conferred by a product claim to the variety. As emphasised by the EBA in decision G 1/98 [4], the protection of the product obtained by a patented process has nothing to do with product-by-process claims, which belong to the category of product claims. It may be inferred from this that a legal framework does not lack consistency if it disallows the broader protection conferred by product claims while allowing the narrower protection conferred by process claims.
[59] The core issue of the present case, however, is quite different, since not taking into account the process exclusion of A 53(b) when examining product claims may lead to a situation where the legal framework disallows the narrower protection conferred by claims on essentially biological plant production processes while allowing the generally broader protection conferred by product claims. The EBA’s above-mentioned finding in decision G 1/98 can therefore not simply be extrapolated to the present case.
[60] European patent law clearly distinguishes between issues of patentability, which are governed by the EPC, and issues of infringement, which are a matter for the legislation of the contracting states. The process exclusion of A 53(b) belongs to those provisions which determine what can be patented under the EPC. It is not a provision exempting specific activities from the rights conferred by patents and therefore does not completely shield those who use an essentially biological process for the production of plants from infringing patent rights.
[61] Already at an early stage in the legislative history of Article 2(b) Strasbourg Convention (on the Unification of Certain Points of Substantive Law on Patents for Invention) and A 53(b) it was recognised and accepted that technical devices used in an excluded process (e.g. a particular type of instrument for use in a grafting process or a special greenhouse for growing a plant) may perfectly well be patented themselves (see in particular document EXP/Brev 61(8), pages 4-5, as cited in decision T 83/05 [40], and summarised in G 1/08 [6.4.2.2]). The legislator apparently did not see any inconsistency in allowing patent protection for these devices, notwithstanding the consequence that the proprietor’s prerogatives may then encompass the use of the patented devices in an excluded process.
[62] A similar approach appears to underlie A 53(c) which, on the one hand, excludes certain surgical, therapeutic and diagnostic methods from patentability and, on the other hand, stipulates that products, in particular substances or compositions, for use in any of these methods are patentable. This has the consequence that, although the exclusion of medical methods by A 53(c) is commonly explained by the legislator’s aim to free the medical profession from possible constraints imposed on them by patents (see e.g. decision G 1/07 [3.2.3.2]), medical practitioners who use such products in a medical method excluded per se may well infringe patents (see decision G 2/08 [6.5] in the context of dosage regimes).
[63] It follows from the above that a process exclusion cannot have the general effect of precluding patents on any product that can be used in the excluded process. This also appears to be justified from the point of view of legal policy. As there will normally be a market for lawfully produced and commercialised products to be used in excluded processes (e.g. plant greenhouses or medicaments), those who want to use these products in their professional activities (e.g. plant breeders or medical practitioners) will be able to acquire them. Using these products put on the market with the consent of the patent proprietor will then be exempted from patent infringement pursuant to the doctrine of exhaustion.
[64] In the present case, however, a product is claimed which is being made (i.e. not only used) when an excluded process is performed. The breeding method disclosed in the patent necessarily implies the production of the claimed tomatoes (see point [46] above). Plant breeders who perform this essentially biological process would fall into the scope of protection of [the patent proprietor’s] patent without being able to invoke the doctrine of exhaustion. They would also be prevented from commercializing the tomatoes obtained through the breeding method. If [the patent proprietor’s] product claims were allowed, then plant breeders would be more severely restricted in performing essentially biological processes than in the above-mentioned situation where (merely) a product to be used in the course of this activity was patented.
[65] Summing up, the board is not fully convinced by the arguments reviewed above against considering the process exclusion of A 53(b) in the examination of claims for plants or plant material. Serious concerns remain that allowing claims to plant material which, according to the disclosure of the patent, is obtained by means of an essentially biological breeding process would de facto frustrate the legislator’s intentions in framing the process exclusion, which were emphasised in G 1/08, and make the circumvention of the exclusion in many cases a matter of skilful claim drafting, thereby diminishing the consistency and persuasiveness of the legislative framework of the EPC as regards patentable subject-matter.
[66] In the board’s view, these concerns can equally not be overcome by pointing out that national legislators, insofar as this is permitted under the Biotech Directive, might be able to introduce specific exemptions for plant breeding activities into their national infringement provisions (see e.g. Article L 613-5-3 French Intellectual Property Code and § 11 No. 2a German Patent Law). Courts should aim at interpreting the EPC provisions on patentable subject-matter in a consistent manner, wherever possible. To rely on the possibility that inconsistencies might be partially remedied by national infringement provisions appears to the board to be the second-best solution.
Referral under A 112(1)
[67] The board is of the opinion that the issues analysed above under points [40] to [66] raise points of law of fundamental importance and that a decision of the EBA on them is required in order to dispose of the present appeals on a correct legal basis.
[68] While there are further grounds of opposition in the present appeal procedure which the board has not yet fully examined, the issue as to whether the claimed subject-matter is excluded from patentability conceptually precedes the assessment of other substantive requirements such as novelty or inventive step and is therefore normally determined first. This has also been noted in decision T 1384/06 [5] (“[…] it must be investigated whether such subject-matter falls within the category of exceptions to patentability. Obviously, this should be done as the first step in the examination because there is absolutely no point in assessing whether or not a subject-matter which is decided to be an exception to patentability fulfils the requirements for patentability.”).
[69] Similarly, it was found in decisions G 1/03 [1.2] and G 2/10 [1] that a referral concerning the conditions under which a disclaimer complies with A 123(2) is justified since formal allowability is normally examined before substantive requirements.
[70] The board notes in addition that the issue of a possible impact of the process exclusion in A 53(b) on the allowability of product claims does not only arise in view of auxiliary request I; it is also highly relevant for all other pending requests of [the patent proprietor].
[71] The board has therefore not followed [the patent proprietor’s] suggestion that it proceed with the examination of these other requirements before referring questions of law to the EBA.
[72] The questions of law referred by the board with its first interlocutory decision were limited to the issue as to whether certain plant production processes fall under the process exclusion of A 53(b). The EBA was therefore not provided with the opportunity to address the further issue now at stake.
[73] Indeed, when the board took that first interlocutory decision, the current issue had not yet emerged, at least not clearly. Insofar as the decision under appeal and the submissions of the parties dealt with the allowability of the product claims under A 53(b), they focused only on the scope of the exclusion of plant varieties. Since the board was - and still is (see point 39, above) - of the opinion that the EBA had already sufficiently clarified the interpretation of the exclusion of plant varieties in its decision G 1/98, it refrained from following the suggestion made by [the opponent] in the first OPs to refer an additional question concerning that interpretation.
[74] The issue now at stake, i.e. a possible negative effect of the process exclusion contained in A 53(b) on the allowability of [the patent proprietor’s] product claims, differs from the issues considered by the board in its first interlocutory decision. It has come up as a result of the EBA’s decision G 1/08 which, as summarised above (points [41] and [42]), has given the process exclusion a broad reading, and of the parties’ submissions made in the aftermath of that decision. Fully aware of the unusual character of such a course of action, the board therefore decides to refer again questions of law to the EBA. In formulating them, the board has taken into account the suggestions made by [the opponent] […], while submissions by third parties after the closure of the debate on this issue at the end of the OPs have been disregarded. […]
The following questions are referred to the EBA for decision:
1. Can the exclusion of essentially biological processes for the production of plants in A 53(b) have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit?
2. In particular, is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application?
3. Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under A 53(b)?
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