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Wednesday, 6 June 2012

How many EBA Referrals does it take to patent (or not) a tomato?

While the UK was enjoying two national holidays to celebrate the Diamond Jubilee of Queen Elizabeth, the EPO was busy announcing a further referral to the Enlarged Board of Appeal in the case that is generally now known as the “Tomato” case.

This Kat mentioned the case in passing back in February, when the “Melon” case had hit the news section of the EPO website.

The case has already been the subject of a referral to the Enlarged Board in G 1/08, which decided 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 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.
The case relates to dried tomatoes, and at the stage of the Enlarged Board referral, claim 1 of the main request was as follows:
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.
This claim was not sustainable because, in the light of the answers of the Enlarged Board of Appeal in G1/08, it would be regarded as an essentially biological process excluded from patentability under Article 53(b) EPC.  So the patent proprietor (State of Israel) restricted the patent to claims directed towards tomato fruit, for example:
A tomato fruit of the species Lycopersicon esculentem 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.
Was this claim directed to a plant variety, also excluded from patentability under Article 53(b) EPC?  The first referral to the EBA had not answered this question.  Or was it perhaps still excluded under Article 53(b) EPC under “essentially biological processes”, even though it was not a process claim?  The EBA had not considered this point either.

The Board of Appeal held:

[At 27] To be a plant variety, it is not necessary that the whole plant be claimed, so the claim could be excluded under Article 53(b) EPC even if only the tomatoes and not the whole plant are claimed.

[At 28 and 29] Just because it is limited to a single species does not make it a plant variety.

[At 32] Just because classical breeding techniques are involved, rather than microbiological processes, does not make it a plant variety.  Here (and at many other points in the decision) the Board referred to the leading case on plant varieties, G1/98, quoting in particular 5.3 thereof:
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 irrespective of the origin of the variety.
The Board then elaborated on the main finding of G1/98, namely that a claim does not fall foul of Article 53(b) EPC just because it may embrace plant varieties.  It therefore concluded at 39:
The present board therefore takes the view that, if it only had to consider the exclusion of plant varieties in Article 53(b) EPC, the subject matter of the claims [] would not be excluded from patentability.
But the Board then went on to say at 40:
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 Article 53(b) EPC.
This argument, put forward by the opponent (Unilever), was summarised by the Board at 44:
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 plant from patentability and to allow, on the other hand, patent  n 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 EPO 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 of Appeal took the view that this was not settled by G1/98; nor was Rule 27(b) clear with respect to this point.  Having considered the arguments, it decided that a further referral to the Enlarged Board of Appeal was necessary, and referred the following questions:
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 IPKat considers that it is obviously not ideal that a single case results in two referrals to the Enlarged Board of Appeal, but better this than that the law remain unclear, or that the case be wrongly decided.  Multiple referrals by national courts to the Court of Justice of the EU are likewise not ideal, but do happen from time to time.  It would be unkind to suggest that it might have been realised the first time round that this issue needed to be dealt with (product claims having been present in the patent as granted) - such things are often clear in hindsight but require rare perspicacity to see in advance.

In any event, the IPKat very much looks forward to the result of the second EBA proceedings, imaginatively termed Tomatoes II, or, strictly, G 2/12.  Merpel rather likes cases where a country are the proprietor (or even the opponent) but gave up trying to illustrate this with a map when it became clear that the ones turned up by an internet search often had a political point to make.

Let's hope that the answer to the rhetorical question in the title is 2.

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