WORKING SESSION
Recent case law on patenting biotechnological inventions
Manfred WIESER - Chairman of EPO board of appeal (DG 3) - Essentially biological processes and their products
According to Article 53(b) EPC, "European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants and animals". This wording is almost identical to that of Article 2(b) of the Strasbourg Patent Convention signed in 1963. Indeed, the working groups of the European Economic Community and of the Council of Europe which framed the two provisions, respectively, in the early 1960s heavily influenced each other. The legislative history of Article 53(b) EPC, the wording of which was amended several times, shows that its drafters regarded "biological" as the opposite of "technical", and that they deliberately chose the adverb "essentially" to replace the narrower "purely".
The EPO boards of appeal have considered the exclusionary provision in Article 53(b) EPC on several occasions. The board in T 320/87 ("Lubrizol"), a landmark decision relating to the production of hybrid plants, held that its applicability had to be judged on the basis of the invention's essence, taking into account the totality of human intervention and its impact on the result achieved. Although it considered that the exclusion had to be construed narrowly, it did not regard the need for human intervention as sufficient by itself to find that a process was not essentially biological, observing that such "interference may only mean that the process is not … purely 'biological'," without making any more than a trivial contribution.
The case at issue was decided in favour of the appealing applicant on the basis that the claimed processes for the preparation of hybrid plants were an essential modification of known biological and classic breeding processes, while the efficiency and high yield associated with the product pointed to a highly technological character.
In T 19/90 ("Onco-Mouse"), a five-member board considered that the equivalent exclusion of essentially biological processes for the production of animals did not apply to process claims for the production of transgenic non-human mammals through chromosomal incorporation of an activated oncogene sequence into the genome of the mammal. Given that the oncogene was inserted by technical means into a vector, which was then micro-injected at an early embryonic stage, the board held that claimed processes were not "essentially biological processes".
The decision T 356/93 ("Plant cells"; PGS) concerned, among other things, a process claim for producing a plant or its reproduction material. The process comprised transforming plant cells or tissue with a recombinant DNA containing a certain heterologous DNA, regenerating plants or reproduction material from the transformed plant cells and tissue and, optionally, biologically replicating the plants or the reproduction material. The board, considering that the "genetic engineering" step of transforming the plant cells or tissue with a recombinant DNA was an essential technical step which had a decisive impact on the desired final result and could not occur without human intervention, concluded that the claimed plant production process as a whole was not essentially biological.
In decision T 1054/96 ("Anti-pathogenic compositions"; Novartis), a technical board referred several questions of law relating to the interpretation of Article 53(b) EPC to the Enlarged Board of Appeal. These included a broadly framed question as to how the term "essentially biological processes for the production of plants" was to be construed.
In this context, the referring board had identified three different approaches to arriving at the required "value judgment". The first of these approaches was analogous to that used under Article 53(c) EPC in relation to methods of treatment by surgery and therapy, and its result was that the inclusion in a claimed process of one step of an essentially biological nature would not be allowable. The second approach was that adopted in decision T 320/87. The third approach was to require, in order to escape the Article 53(b) EPC prohibition, at least one clearly identified "non-biological" process step but allow any number of additional "essentially biological steps", these being rendered allowable by the "non-biological" process step. It was noted that this approach, which had been adopted in Article 2(2) of the (then) draft EU Biotech Directive, would be that most favourable to applicants, but was not that so far adopted by the boards of appeal.
In decision G 1/98, the Enlarged Board of Appeal answered the questions of law referred, but refrained from addressing the substantive aspects of interpreting the process exclusion under Article 53(b) EPC since the appealing applicant had in the meantime filed new amendments excluding essentially biological processes.
By a decision which entered into force on 1 September 1999, the Administrative Council of the EPO implemented Directive 98/44/EC of the European Parliament and the Council on the legal protection of biotechnological inventions (the Biotech Directive). Article 2(2) of the Biotech Directive, transposed verbatim in Rule 26(5) EPC (Rule 23b(5) EPC 1973), reads: "A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing and selection."
Thus, under Rule 26(5) EPC, a process which, in addition to "natural phenomena such as crossing and selection", includes a feature of a technical nature would be outside the ambit of the process exclusion. However, this was not the approach adopted by the boards of appeal before the introduction of Rule 26(5) EPC, when the applicability of the exclusion was judged on the basis of the invention's essence, taking into account the totality of human intervention and its impact on the result achieved.
It was not until T 83/05 ("Broccoli") and T 1242/06 ("Tomatoes") that the boards of appeal were faced with a situation in which the outcome hinged on the question which of these two approaches to interpreting Article 53(b) EPC should prevail. In these two cases, however, this question was decisive, since the two approaches would lead to different results. Both patents contained claims referring to a method for the production of plants which, besides the steps of crossing and selection, encompassed additional features. In the "Broccoli" case, these additional features were the use of molecular markers in the selection steps following the crossing and backcrossing steps, the use of a non-natural starting material, i.e. a double haploid strain, and the fact that the strains used in the claimed process grew in remote geographical locations and were unlikely to hybridise with broccoli breeding lines unless specifically brought into contact with them by human intervention. In the "Tomatoes" case, it was argued that the need for an interspecific cross, the choice of an unusual selection criterion and the weighing and drying steps took the claimed method outside the realm of classic plant breeding technology.
Thus, following the approach adopted in Rule 26(5) EPC, the boards would have to conclude that the claimed processes escaped the exclusionary provision in Article 53(b) EPC. If, however, the approach adopted by the boards of appeal in their previous decisions (see T 320/87) were still the correct one, the claimed processes would fall foul of that exclusion, as none of the additional features could be considered to make any more than a trivial contribution.
In view of the above, the boards decided to refer questions of law to the Enlarged Board of Appeal in accordance with Article 112(1)(a) EPC. Question 1 in case T 83/05 (largely corresponding to question 2 in case T 1242/06) read:
"Does a non-microbiological process for the production of plants which contains the steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, an additional feature of a technical nature?"
The Enlarged Board of Appeal answered this question as follows (see G 2/07 and G 1/08):
"1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being 'essentially biological' within the meaning of Article 53(b) EPC.
2. Such a process does not escape the exclusion of Article 53(b) EPC 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 genomes of plants or of subsequently selecting plants."
Having established that the wording of Rule 26(5) EPC, which is identical to Article 2(2) of the Biotech Directive, could not be of assistance in interpreting Article 53(b) EPC, the Enlarged Board turned to interpreting the exclusion of "essentially biological processes for the production of plants" in Article 53(b) EPC on its own authority.
It ruled out that the term "plants" could, contrary to its wording, be interpreted as meaning "plant varieties" only, as there was no indication in the legislative history that such a meaning had been intended. The exception of "essentially biological processes for the production of plants" thus could not be read as being limited to processes for the production of plant varieties. Since any attempt to determine a reliable literal meaning of the term "essentially biological" process appeared futile, it considered whether the approach adopted in earlier case law held good. It found that, in the context of examining whether such a process was excluded from patentability as "essentially biological", it was irrelevant whether a step of a technical nature was a new or known measure, whether it was trivial or a fundamental alteration of a known process or whether the essence of the invention lay in it.
Earlier case law had suggested that another criterion for delimiting non-patentable essentially biological processes from patentable processes was the totality of human intervention in the process and its impact on the results achieved. The Enlarged Board considered that, as essentially biological processes for the production of plants were excluded from patentability by Article 53(b) EPC even though they were inventions and as such characterised by human intervention, the board in T 320/87 had been fundamentally correct in its starting point that not just any kind of human intervention could suffice to make an invention in this field escape the exclusion. To determine more precisely how the excluded kinds of processes involving human intervention were to be properly delimited from the patentable ones, the Enlarged Board turned to the legislative history of the Strasbourg Patent Convention and the EPC 1973. It concluded that the legislator's intention had been to exclude from patentability those plant breeding processes which had been the conventional methods for breeding plant varieties at that time. These conventional methods included, in particular, those based on the sexual crossing of plants (i.e. of their whole genomes) deemed suitable for the purpose pursued and on the subsequent selection of the plants having the desired trait(s).
Another teaching which the Enlarged Board was able to discern from the legislative history was that the word "purely" had been deliberately replaced by "essentially" and that this reflected the legislative intention that the mere fact of using a technical device in a breeding process should not be sufficient to give the process as such a technical character and should not have the effect that such process was no longer excluded from patentability. The legislator had not wanted breeding processes to be patented in which the technical measures used were only means serving to bring about processes for the production of plants which were otherwise based on biological forces. Thus, the provision of a technical step, be it explicit or implicit, in a process based on the sexual crossing of plants and on subsequent selection did not cause the claimed invention to escape the exclusion if that technical step only served to perform the process step of the breeding process.
However, if a process of sexual crossing and selection included within it an additional step of a technical nature, which step by itself introduced a trait into the genome or modified a trait in the genome of the plant produced, so that the introduction or modification of that trait was not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process left the realm of plant breeding which the legislator had wanted to exclude from patentability. Therefore, such a process was not excluded from patentability under Article 53(b) EPC.
The above applied only where such additional step was performed within the steps of sexual crossing and selection, regardless how often they were repeated. Otherwise the exclusion of sexual crossing and selection processes from patentability under Article 53(b) EPC could be circumvented simply by adding steps which did not properly pertain to the crossing and selection process, whether they be upstream steps dealing with the preparation of the plant(s) to be crossed or downstream steps dealing with the further treatment of the plant resulting from such crossing and selection process. Any such additional technical steps performed either before or after the process of crossing and selection should therefore be ignored when determining whether or not the process was excluded from patentability under Article 53(b) EPC.
Patent protection is available for such previous or subsequent steps per se. This is the case, for example, for genetic engineering techniques applied to plants, which techniques differ profoundly from conventional breeding techniques in that they work primarily through the purposeful insertion and/or modification of one or more genes in a plant (T 356/93). However, in such cases, the claims should not, explicitly or implicitly, include the sexual crossing and selection process.
Consequently, while the presence in a claim of one feature which could be characterised as biological does not necessarily result in the claimed process as a whole being excluded from patentability under Article 53(b) EPC, this does not apply where the process includes sexual crossing and selection.
In case T 83/05 the respondent (patent proprietor) filed amended claims from which all process claims had been deleted, so that only product claims containing the features of the method for their production ("product-by-process" claims) were maintained. Both appellants (opponents) informed the board that they had no further objections as all issues with regard to the patentability had already been settled by the board.
In case T 1242/06 the patent proprietor (appellant I) likewise filed new claims which no longer included method claims. The claims directed to products were defined by functional features or by product-by-process features. However, the board in T 1242/06 had not yet ruled on the patentability of the product claims and the opponent (appellant II) had not signalled its agreement to the amended sets of claims.
In its earlier decision G 1/98, the Enlarged Board of Appeal had looked at the patentability of plants and observed that "whereas the exclusion for processes is related to the production of plants, the exclusion for products is related to plant varieties. The use of the more specific term 'variety' within the same half-sentence of the provision relating to products is supposed to have some meaning. If it was the intention of the legislator to exclude plants as a group embracing in general varieties as products, the provision would use the more general term plants as used for the processes."
It went on its decision to find "that Article 53(b) EPC defines the borderline between patent protection and plant variety protection. … The latter [is] only granted for specific plant varieties and not for technical teachings which can be implemented in an indefinite number of plant varieties." It held that a plant variety, which both the UPOV Convention and Rule 26(4) EPC define as a plant grouping within a single botanical taxon of the lowest known rank which can be defined by the expression of the characteristics resulting from a given genotype, distinguished from any other plant grouping by the expression of at least one of said characteristics and propagated unchanged, could not be defined by a single characteristic or by a limited number of genes coding for it. Although the case underlying decision G 1/98 concerned a transgenic plant, the Enlarged Board explicitly stated that the prohibition on patenting plant varieties under Article 53(b) EPC applied irrespective of the variety's origin, i.e. irrespective of the process for its production.
The second question referred to the Enlarged Board of Appeal in G 1/98 read:
"Does a claim which relates to plants but wherein specific plant varieties are not individually claimed ipso facto avoid the prohibition on patenting in Article 53(b) EPC even though it embraces plant varieties?"
It answered this question as follows:
"A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC, even though it may embrace plant varieties."
In assessing the situation in case T 1242/06, it has to be borne in mind that a claim directed to a product provides broad protection encompassing its production and use, and that, according to Article 64(2) EPC, the protection conferred by a process claim extends to the directly obtained products. In G 1/98, the Enlarged Board had decided that not claims to plants per se, but only claims referring to individual plant varieties irrespective of their origin were excluded from patentability, while in G 1/08, it had decided that all processes relying on crossing and selection were excluded from patentability (including such processes as did not result in an individual plant variety as defined in Rule 26(4) EPC).
At fresh oral proceedings in case T 1242/06 on 8 November 2011, the board decided to close the debate on Article 53(b) EPC and continue the procedure in writing.
The opponent (appellant) had argued that, "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."
The board agreed that "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 decision G 1/08 … '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 Article 53(b) EPC 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 Article 53(b) EPC."
In a further interlocutory decision ("Tomatoes II"), it referred the following questions to the Enlarged Board of Appeal:
"1. Can the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC 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 Article 53(b) EPC?"
The opponent withdrew its appeal by letter dated 28 June 2012. There has as yet been no reaction from the appealing patent proprietor, but the Enlarged Board has received a plethora of amicus curiae briefs from interested circles.
In the meantime, the Civil Law Division of the Hague District Court in the Netherlands gave judgment on 31 January 2012 in the summary proceedings in case No. 408315/KG ZA 11-414 (Taste of Nature v Cresco). The case concerned a patent for a Raphanus sativa plant defined in claim 1 as the product of a process relying on crossing and selection.
The court considered it plausible that, under Article 53(b) EPC, "not only an essentially biological method is unpatentable, such as the 'classical breeding' in this case, but also a product directly obtained by using that method … (see Article 64(2) of the EPC). If it were to be ruled that a product-by-process claim is admissible for the directly obtained product of an unpatentable essentially biological method, that would render the exclusion in Article 53, opening lines and (b), of the EPC as interpreted by the [Enlarged Board of Appeal] in G 1/08 pointless because in that case the same situation would be involved as if the [Enlarged Board] had considered the process claims admissible, which is not the case."
Taste of Nature has appealed against this judgment to the Hague Regional Court of Appeal.
Finally, on 10 May 2012, the European Parliament adopted a resolution on the patenting of essentially biological processes. Whilst welcoming the Enlarged Board of Appeal's interpretation of essentially biological processes in the "Broccoli" and "Tomatoes" decisions, the Parliament calls on the EPO also to exclude from patentability the products derived from conventional plant and animal breeding techniques, including SMART breeding.