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G 1/08 - Decision of the Enlarged Board of the Appeal of the EPO of December 9, 2010

In a Nutshell In decision G 1/08, the Enlarged Board of Appeal clarified the meaning of the provision of Art. 53 b) EPC stating that European patents are not granted for "essentially biological processes for the production of plants or animals". This exception of patentability concerns in basic terms processes of crossing and selection used by plant breeders. In very short, the Enlarged Board specified that processes containing the steps of sexually crossing whole genomes and subsequently selecting plants are generally excluded from patentability. It was made clear that the presence of a step of technical nature in such a process does not allow a claim to escape the exclusion, since certain steps in breeding processes, being based on human intervention, can also be regarded as having a technical character. Furthermore, the contribution of a technical feature of the process to the state of the art did not have any impact on the question whether or not a method was excluded, contrary to the approach developed in previous case law (T 320/87).

Further below, the headnotes, the referring questions and the claims at the origin of this decision are reproduced.

Background on of the Decision

At the origin of the referrals G 2/07 and G 1/08 is the discrepancy between:

  • the interpretation of the expression "essentially biological processes for the production of plants" in Art. 53)(b) EPC as developed by the boards of appeal (T 320/87 and subsequent case law), and

  • the wording Rule 26(5) EPC, which tries to define exactly this expression. Rule 26(5) EPC corresponds to the wording of Art. 2(2) of the Directive 98/44/EC and corresponds to Rule 23b(5) EPC 1973, which was introduced into the implementing 1 regulations with effect of September 9, 1999, in order to assure the harmonization of European patent law (OJ 7/1999, 437-440 and OJ 8-9/199, 573-582.)

Under T 320/87, for deciding whether or not a (non-microbiological) process is "essentially biological" within the meaning of Art. 53(b) EPC one had to judge "the essence of the invention taking into account the totality of human intervention and its impact on the result achieved". Human intervention alone was not considered sufficient to render a process different from essentially biological process, because human intervention could be trivial. Under this case law, the question if a process for the production of plants is an "essentially biological process" depended also on the state of the art. T 320/87 also used criteria such as if a feature is trivial, bis part of "classical" plant breeding processes or if it alters the character of a known process in a fundamental way. Only by considering the state of the art one could thus determine if a method escapes the exclusion.

On the other hand, Rule 26(5) EPC states that "[a] process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing and selection". The patentees in the procedures T 1242/06 and T 83/05 of the referring boards argued that the presence of any technical step, which could not be implemented without human intervention, had the consequence that the process was no longer an "essentially biological process".

In other words, at the origin of G 2/07 and G 1/08 was the question whether Rule 26(5) EPC reduced the scope of the exclusion under Art. 53(b) EPC and thus rendered plant breeding processes patentable if they contained any technical feature, contrary to T 320/87, which put specific requirements with respect to the technical step, such as the fact that it should not be a "classical" plant breeding step or needed human intervention and had to have a decisive impact on the final result.

The Decision and Conclusion of the Decision

Rule 26(5) EPC and the Biotech directive 98/44/EC

The Enlarged Board of Appeal discussed in detail the legislative history of Article 2(2) of the biotech directive - and thus indirectly of Rule 26(5) EPC - and came to the deflating conclusion that not only are these provisions contradictory in themselves, but that even the legislative history did not allow determining what the legislator intended to say by the wording.
Without going into much detail, one can say that the analysis of the Enlarged Board of the Appeal casts an unflattering light on the legislative processes of the EU, as it seems that amendments voted for by the European parliament were repeatedly dampened if not undone by amendments introduced by the Commission which repeatedly introduced back previously proposed concepts in subsequently presented versions. What was obtained in the end was a definition of "essentially biological processes" that combined two elements of different concepts (processes existing in nature vs. crossing of whole genomes in general and subsequent selection) and cites one concept as an example of the other.

The Enlarged Board concluded understandingly that Rule 26(5) EPC could not give any usefully guidance on how to interpret the expression "essentially biological process for the production of plants". The Enlarged Board thus had to interpret the expression on its own authority.

Criteria referring to the state of the art

The Enlarged Board set in particular out that criteria for deciding whether a process is essentially biological were not the good if they were linked to the state of the art. This applies to questions whether features do or do not correspond to the "classical breeders' processes", and whether a technical feature is "trivial" or "alters the nature of a known process in a fundamental way", for example. Such criteria mixed up the criteria of patentability in general with those of novelty and inventive step and were thus detrimental to legal certainty, because new prior art could change the outcome. There was also no logic found in saying that the decision whether a process is technical or essentially biological depends on what was already known in the art or how far the claimed subject-matter went beyond that.

What is a technical feature? - "Human intervention and its impact"

Also the criterion of the "totality of human intervention and its impact on the result achieved" (T 320/87; and similar T 356/93) was discussed and dismissed on the basis of the purpose of Art. 53(b) EPC and its legislative history, going back to the origins of the Strasbourg Patent Convention (SPC).

From the legislative history, the enlarged Board deduced that at that time the legislator was concerned with excluding from patentability the processes applied by plant breeders, for which a special property right was going to be introduced under the UPOV convention. The use of technical means or other forms of human intervention in such processes was already common at that time. The breeder's processes were characterized in that the traits of the plants resulting from the crossing were determined by the underlying natural phenomenon of meiosis, which determined the genetic make-up of the plant produced, and the breeding result was achieved by the selection of plants having the desired traits.

In the legislative history, an originally proposed, narrow expression "purely biological processes" was replaced by the finally accepted wording "essentially biological processes". This reflected the legislative intention that the mere fact of using a technical device in a breeding process as such based on the sexual crossing of plants and subsequent selection should not be sufficient to give the process a technical character and should not have the effect that such process is no longer excluded from patentability.

"Human intervention" using the forces of nature, even if no technical means strictu sensu are applied are to be considered as technical. The steps of "leaving tomatoes on the vine past ripening and selecting the ones that are less wrinkled" are considered as technical. Human intervention in a process in order to achieve a desired result is the essence of what an invention is, and breeding processes by their nature involve human intervention.

On the other hand, processes for introducing into the genome, or changing a trait of the genome of a plant in another way than by mixing genomes by sexual crossing of chosen plants, for example changing the genome of plants by technical means, such as irradiation or genetic 4 engineering techniques, were not intended to be excluded from patentability. In such cases, the claims should not, explicitly or implicitly, include the sexual crossing and selection process. Also technical devices that can be used in breeding processes remain patentable.

Conclusions by the Author

Processes, which comprise the steps of producing genotypic variation by sexually crossing organisms ("whole genomes") and subsequently selecting plants are not patentable. Art. 53(b) EPC is interpreted so as to exclude processes in which the natural phenomenon of meiosis is used as the unique means to produce variation that subsequently enables a selection.

Headnote 2 makes clear that the use of technical means that assist in either the crossing step or the selection step (for example molecular markers for checking the presence of specific genes) does not help escaping the exclusion in processes of crossing and selection.

Headnote 3 seems to be less clear at first sight, mentioning that "such processes" (thus the excluded ones) can be patentable if they comprise a step which introduces a trait into the genome, so that the trait is not the result of mixing the genes of the plants chosen for sexual crossing. This is not totally clear, because genetic engineering techniques, which are generally used to introduce genetic traits, are seen to be something different from sexual crossing and selection. Genetic engineering techniques are said to be patentable per se, and claims directed to these techniques should not be recited so as to include the sexual crossing and selection process (last but one paragraph of the reasons). In the end, headnote 3 can be seen as an attempt to limit the exclusion as defined in headnotes 1 and 2. If processes are found, which comprise the steps of crossing and selection, but at the same time introduce additional traits during this very process, which traits are not the direct or only result of meiosis, but due to a (further) technical feature, then the process could be patentable, even though being a process of crossing and selection.

Headnote 4 is again very clear and has the purpose of separating criteria of relative exclusion grounds (novelty and inventive step) from a subject that is generally not patentable, independently from novelty or inventive step. Thus, it is not relevant if a process goes beyond a trivial process or if it fundamentally alters a known process as was argued in T 320/87. 5 The case law based on T 320/87 is overruled in that the scope of the exclusion under Art. 53(b) EPC has been extended. The scope of patentable subject matter has thus been reduced. The two patents at the origin of the referrals contain the steps of crossing whole genomes and selecting plants with specific traits and will thus need to be revoked as being unpatentable under Art. 53(b) EPC.

All in all, IP Advice appreciates the decision and is in particular impressed by the sharp-eyed manner of the Enlarged Board of Appeal when discerning the key issues within the bunch of legal provisions and arguments that were involved in the underlying proceedings.

Several points that came up in the decision are, however, regrettable. It is in particular disappointing that the EU Biotech directive turned out to be completely unsuitable to give any guidance with respect to the decision making process.

In the end, the legislative history of Art. 2(b) of the Strasbourg Patent Convention (SPC), which is the predecessor of Art. 53(b) EPC, had to be consulted. The documents that were adduced by the Enlarged Board of the Appeal for identifying the intention behind Art. 53(b) EPC date back to the early nineteen-sixties.

The Enlarged Board stated itself that the explanations that can be found in the legislative history of the SPC in this regard are "rather rudimentary". Apparently, the legislator wanted to avoid any conflict with the UPOV agreement for the protection of new plant varieties. That agreement was, however, not yet created at the time when the SPC was drafted. Art. 2(b) SPC was thus created as kind of a precautionary measure. We know today that the UPOV agreement does not allow the protection of any breeding processes, but only of new plant varieties. Such breeding processes, even if they represent important innovations, can thus not be protected by any intellectual property right today, and there is no apparent logic why this should be so.

Furthermore, there is no agreement that is concerned with the protection of new animal varieties and breeders can thus not get any protection on new animal varieties on the basis of the current intellectual property laws.

Taking this into account, and further considering the enormous progresses that have been made in the area of biological sciences within the last few decades, it appears that Art. 53(b) EPC should be limited to new plant varieties obtained by crossing and selection processes. The general exclusion of "essentially biological processes for the production of plants and animals" under Art. 53(b) EPC does not seem to make any sense in this form.

Further Issues

EPC 1973 vs. EPC 2000. On the basis of the transitional provisions (see Special edition 4 OJ 2001, 130-140 concerning Art. 53 EPC and Special Edition OJ 2007, 89-90, concerning the Implementing regulations) it was decided that the EPC 2000 and Rule 26(5) EPC 2000 (current versions) applied to both patents underlying the referring appeal procedures. The patents underlying both referrals were granted before the entry into force of the EPC 2000.

Applicability of Rule 23b EPC 1973. In case T 83/05, the patent application was filed before entry into force of Rule 23b EPC1973, and the question came up if Rule 26(5) EPC 2000 (Rule 23b EPC 1973) was applicable. The answer was already given in decision G 2/06 (no. 13 of the reasons), where it was found that the fact that no transitional provisions were presented when introducing Rules 23b to Rules 23e EPC1973 on the basis of the EU biotech directive could only be interpreted as meaning that these rules applied to all pending applications. The referring board in T 83/05 found that the competence of the Administrative Council did not extend to core issues of substantive patent law. The introduction of Rules 23b to Rules 23e EPC1973 by the Administrative council, implementing the EU biotech directive 98/44/EC could thus be regarded as null and void ultra vires. According to the Enlarged Board, the function of the Implementing regulations was to determine in detail how the articles should be applied and there was nothing in the Convention allowing the conclusion that this would not also apply in the case of Articles governing substantive patent law. The limits to the Administrative Council's law- 7 making powers by means of the Implementing regulations can only be inferred from Art. 164(29 EPC.

Legitimate expectations. It was argued that Rule 23b EPC 1973 (Rule 16(5) EPC 2000) narrowed the exclusion scope under Art. 53(b) EPC 2000, which means expanded the area of patentable subject matter. The questions was raised if there should not be a protection of "legitimate expectations" in case an applicant filed an application expecting that the claimed subject matter was acceptable under the new rules, while this had not been the case on the basis of previous case law. According to the Enlarged Board, "letigimate expectations" have never been acknowledged for issues before the Enlarged Board concerning the correct interpretation of law. In the present case, "Legitimate expectations" could only be considered if the Enlarged Board's conclusion was that the introduction of Rule 23b(5) EPC 1973 indeed changed the scope of the process exclusion contained in Art. 53(b) EPC 1973, but not if the Enlarged Board solely made corrections to the approach in jurisprudence hitherto, as established by T 320/87 (which is what the Enlarged Board did).

Headnotes, Questions Referred to the Enlarged Board of Appeal and Claims at Issue

Headnotes of 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.

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 Article 53(b) EPC.

4. In the context of examining whether such a process is excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC, 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.

Legal background

Art. 53 EPC: European patents shall not be granted in respect of:
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
(c) ….

Rule 26(5) EPC 2000: A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.

Questions and claims of T 83/05 (G 2/07)

1. 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?

2. If question 1 is answered in the negative, what are the relevant criteria for distinguishing nonmicrobiological plant production processes excluded from patent protection under Article 53(b) EPC 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?

Claim 1: A method for the production of Brassica oleracea with elevated levels of 4- methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, which comprises:

a) crossing wild Brassica oleracea species selected from the group consisting of Brassica villosa and Brassica drepanensis with broccoli double haploid breeding lines;

b) selecting hybrids with levels of 4-methylsulfinylbutyl glucosinolates, or 3- methylsulfinylpropyl glucosinolates, or both, elevated above that initially found in broccoli double haploid breeding lines;

c) backcrossing and selecting plants with the genetic combination encoding the expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both; and

d) selecting a broccoli line with elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3- methylsulfinylpropyl glucosinlates [sic], or both, capable of causing a strong induction of phase II enzymes, wherein molecular markers are used in steps (b) and (c) to select hybrids with genetic combination encoding expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, capable of causing a strong induction of phase II enzymes.

Claim 1 of the auxiliary request differs from claim 1 of the main request by the addition of the step of "deriving broccoli double haploid breeding lines" as the first step of the claimed method. Questions and claims of T 1243/06 (G 1/08)

1. Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of Article 53(b) EPC only if these steps reflect and correspond to phenomena which could occur in nature without human intervention? 10

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

3. If question 2 is answered in the negative, what are the relevant criteria for distinguishing nonmicrobiological plant production processes excluded from patent protection under Article 53(b) EPC 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?

Claim 1: A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed; collecting the first generation of hybrid seeds; growing plants from the first generation of hybrid seeds; pollinating the plants of the most recent hybrid generation; collecting the seeds produced by the most recent hybrid generation; growing plants from the seeds of the most recent hybrid generation; allowing fruit 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."

Claim 1 of auxiliary request I contains inter alia the additional feature of "selecting plants with tomato fruits having an increased dry weight percentage". 11

 

Intellectual property