G 1/08 – Leave Mendel Alone

You might remember that T 83/05 (“Broccoli”) referred the following questions to the Enlarged Board of appeal (EBA):

(1) Does a non-microbiological process for the production of plants which contains the steps of crossing and selecting plants 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, an additional feature of a technical nature?

(2) If question 1 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under A 53(b) from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

and that T 1242/06 (“Tomatoes”) referred a similar set of questions to the EBA:

1) Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of A 53(b) only if these steps reflect and correspond to phenomena which could occur in nature without human intervention? 

(2) If question 1 is answered in the negative, does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants escape the exclusion of A 53(b) merely because it contains, as part of any of the steps of crossing and selection, an additional feature of a technical nature? 

(3) If question 2 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under A 53(b) from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

Well, we just got the answers. If you can, you should study the whole decision, which is well worth reading. There is a link at the end of this post. If you are interested in the answer only, you will find it at the bottom of this post. If you want to know a little bit more but do not wish to read the 72 pages of the decision, here is a short summary:

First the EBA deals with the question of whether the EPC 1973 or the EPC 2000 is to be applied. Based on the transitional provisions, the EBA comes to the conclusion that A 53 as revised and its implementing rule R 26(5) are to be applied.

The discussion then focuses on the question of whether the Administrative Council (AC) is allowed to lay down provisions concerning substantive law in the Implementing Regulations. According to the EBA, there is no reason to believe that it cannot do so.

The Board then deals with the question of legitimate expectations in the context of interpretation of substantive patent law:

“There can be no ‘legitimate expectation’ that an interpretation of a substantive provision governing patentability given in a decision of the Boards of appeal will not be overruled in the future by the EBA, since recognising such an expectation as legitimate would undermine the function of the EBA. This holds particularly true for issues on which there is no solid body of decisions all to the same effect but where instead the relevant jurisprudence consists of a very limited number of individual decisions, as is presently the case.

In the past, the EAB has granted a transitional period in cases in which the EBA’s decision has brought about a change in relation to an established procedural practice which change the parties could not be expected to foresee. By contrast, for the reasons given above, the existence of ‘legitimate expectations’ has never been acknowledged for issues before the EBA concerning the correct application, i.e. interpretation, of substantive patent law.”

After having given an overview of the relevant case law, the EBA then delves into the heart of the matter, starting from the relationship between R 23b(5) EPC 1973 (now R 26(5) EPC) and A 53(b).

The first fundamental question to be answered is whether R 26(5) is meant to provide an exhaustive definition of when a process is “essentially biological.” It is the Biotech Directive (Recital 33), where this rule comes from, that confirms that this is indeed the case.

The EBA then deals with the terms “crossing” and “selection”. Based on the principles of the Vienna Convention (Article 31(1)), the EBA comes to the conclusion that in the context of production of plants, crossing and selection are characterised by the fact that the breeder intervenes in order to achieve a desired result. 

“Hence, in that context, crossing and selection are not natural phenomena but are method steps which generally involve human intervention.”

Based on this result, the EBA finds that “the wording of R 26(5) is ambiguous, if not contradictory.” It nevertheless refuses to jump to the conclusion that the ambit of R 26(5) is to define crossing and selection as natural phenomena by way of a legal fiction.

As the wording of R 26(5) originated in the Biotech Directive, the Board looks for further clarification in the this Directive and in particular in its (eventful) legal history. The EBA notes that 

“mainly as a consequence of the consecutive amendments voted for by the European Parliament – the terms of the definitions in the earlier versions gradually shifted from a very narrow to an at least partially broader construction of the exclusion.”

As a matter of fact, the situation is rather complex because, as the Board finds, 

“the objective meaning of the definition given in Article 2(2) Biotech Directive corresponds neither to the amendments voted for by the European Parliament nor to the substance of the earlier drafts, but rather is definitely something different.”

This difficulty finally leads the Board to abandon its attempt to base its interpretation on the legislative history of the Biotech Directive:

“As a result, the legislative history of the Biotech Directive does not assist in determining what the legislator intended to say by the wording which was eventually adopted for Article 2(2) Biotech Directive. On the contrary, it must be concluded that the contradiction between the terms of the provision cannot be further clarified.”

So even though the EBA admits that the AC can provide for issues of substantive law in the Implementing Regulations, it points out that 

“in order to enable the Article to which a Rule pertains to be interpreted by means of the Rule, such Rule must at least be clear enough to indicate to those applying it in what way the legislator intended the Article to be interpreted by means of that Rule. This is not the case for R 26(5).”

So the EBA comes to the conclusion “that R 26(5) does not give any useful guidance on how to interpret the term “essentially biological process for the production of plants” in A 53(b)” and that the EBA itself has to interpret that term.

When doing so, the EAB first excludes a limitative reading of the expression “for the production of plants”: this expression cannot be read to be limited to the production of plant varieties.

The EBA also points out that the potential differences of meaning between the English, French, and German versions of the EPC appear not to be relevant.

The EBA passes in review several possible approaches of interpretation. It rapidly excludes the analogy to the approach used under A 52(4) EPC 1973 for surgical and therapeutic methods: the mere presence of a biological feature in a process cannot automatically confer an essentially biological character on the process as awhole.

The same holds true for the converse approach based on an analogy to computer related inventions where the existence of a single technical feature confers technicality to the claimed subject matter. The analogy is not convincing, be it only for the very different wording of A 52(2) and A 53b.

The approach (outlined in T 320/87) where some of the criteria for deciding the question depend on the state of the art, is also rejected as flawed “because it conflates the considerations which are relevant for patentability with those relevant for novelty and inventive step.” Moreover, the approach is detrimental to legal certainty because prior art discovered at a late stage might reverse the finding on exclusion from patentability.

The fourth and last approach examined by the EBA is based on “human intervention”. T 320/87 and T 356/93 both have envisaged such an approach.

The EBA undertakes to determine what the purpose of the exclusion in A 53(b) was when the EPC 1973 and the Preliminary Draft (SPC) Convention of the Council of Europe were drafted. An early amendment from “purely biological processes” to “essentially biological processes”:

“According to the explanations given, 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. Selection or hybridization of existing varieties are mentioned as examples of such processes. The replacement of “purely” by “essentially” is explained by the reasoning that it was evident that the exclusion should be extended to cover processes which were fundamentally of this type, even if, as a secondary feature, “technical” devices were involved (use of a particular type of instrument in a grafting process, or of a special greenhouse for growing a plant), it being understood that while such technical devices may perfectly well be patented themselves the biological process in which they are used may not.”

The EBA notes that “the exchange of the word “purely” for “essentially” was deliberate and reflects 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 is no longer excluded from patentability.” This intention is still to be respected.

“Hence, in more general terms, the conclusion to be drawn is that a process for the production of plants which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of A 53(b).

However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in a genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding, which the legislator wanted to exclude from patentability. Therefore, such a process is not excluded from patentability under A 53(b) but qualifies as a potentially patentable technical teaching.

The above applies only where such additional step is performed within the steps of sexually crossing and selection, independently from their number of repetitions. Otherwise the exclusion of sexual crossing and selection processes from patentability under A 53(b) could be circumvented simply by adding steps which do not properly pertain to the crossing and selection process, being either 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 which are performed either before or after the process of crossing and selection should therefore be ignored when determining whether or not the process is excluded from patentability under A 53(b). For the previous or subsequent steps per se patent protection is available. This is the case, for example, for genetic engineering techniques applied to plants which techniques differ profoundly from conventional breeding techniques as they work primarily through the purposeful insertion and/or modification of one or more genes in a plant (cf. T 356/93). However, in such cases the claims should not, explicitly or implicitly, include the sexual crossing and selection process.

As a result this means that, 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 A 53(b), this does not apply where the process includes sexual crossing and selection.

[…] The questions referred to the EBA are answered as follows:

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 A 53(b).

2. Such 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 genomes of plants or of subsequently selecting plants.

3. If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under A 53(b).

4. In the context of examining whether such a process is excluded from patentability as being “essentially biological” within the meaning of A 53(b), it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it. ”

Good reading, well reasoned, and a tangible outcome : I like it. 

You should definitely read the whole decision. Just click here to download it.

Addendum: This decision has created much less of a buzz than the previous EBA decisions: my fellow bloggers appear not to be excited. Tufty the Cat has some interesting comments here. A French summary can be found here.