In the February 2011 edition of our Food Law Digest, the so-called 'Broccoli' and 'Tomato' cases were discussed before the Enlarged Board of Appeal of the European Patent Office (EBA). It was explained here on 9 December 2010 that the EBA had announced that no patents can be obtained for plant breeding methods consisting of sexual crossing of plants and subsequent selection, even if technical steps were involved in the breeding method. According to the EBA, if the technical steps merely served to perform the breeding process, such process would still be considered an 'essential biological process' as excluded from patentability under Article 53 (b) of the European Patent Convention (EPC).
The decision of the EBA was eagerly anticipated within the seed and breeding industries, but after the decision was rendered, the exclusion of Article 53 (b) EPC still kept stirring up these industries. In particular, a lot of questions remained both for individual cases (does a given technical step merely serve to enable or assist crossing or selection, or does this step itself introduce a trait into the genome or modify a trait in the genome of the plant produced, which would make the process patentable after all?) as well as questions of a more general and legal nature.
An important debate still remained on whether or not the product of an 'essential biological process', such as a plant or plant material, could also not be patented because of the exclusion of Article 53 (b) EPC. As the 'Broccoli' and 'Tomato' cases were referred back to the Technical Board of Appeal (TBA), this very question came up in the 'Tomato' case. The TBA decided to yet again refer questions to the EBA in order to decide whether the exclusion of Article 53(b) EPC can be held against certain plants or plant materials, in particular where these plants are the result of an essential biological process.The 'Tomato II' case is still pending before the EBA under number G 2/12, but it is uncertain if a decision will ever be rendered by the EBA. The opponent in this particular case has withdrawn himself from the proceedings and it is unsure if the EBA shall decide if the proceedings will continue regardless. In any case, there certainly is no lack of interest within industry as shown by the impressive number of 22 amicus curiae briefs that were filed by or on behalf of interested parties.
Meanwhile, in the Netherlands, a country with a very rich tradition in plant breeding, similar questions as asked in G 2/12 have come up in patent proceedings before the Patent Court in The Hague. This particular case concerned a nullity action against a patent claiming radishes with an increased level of anthocyanins, as well as a counterclaim for infringement. Anthocyanins are pigments that provide the radish sprouts with purple colouring and are suggested to have beneficial health effects. The claimed radish was obtainable by screening and selecting the radishes for their ability to produce sprouts with at least some purple colouring. Such a claim directed at a product, which is defined by the process by which it can be obtained, is called a product-by-process claim. The alleged infringer (Cresco) and the patentee (Taste of Nature) agreed that the method by which the claimed radishes can be obtained was an essentially biological process within the meaning of Article 53 (b) EPC and that there were no technical steps that interfered with this process. Therefore, one of the questions that needed to be answered was if a product-by-process claim is excluded from patentability, where the process is essentially biological (which one at a good game of Scrabble could call a product-by-an-essentially-biological-process claim).
Notwithstanding G 2/12 being still pending, the outcome of which would most likely be highly relevant to the underlying case, the parties requested the court to render judgment and not stay with the proceedings. Not afraid to decide on difficult legal issues and taking into account the uncertainties of when or even whether at all a decision will be rendered in G 2/12, the court did answer the request and ruled on the question at hand.
In its judgment of 8 May 2013 (which can be found in English translation here), the court took the position that the exclusion from Article 53 (b) EPC does not apply to product-by-process claims, even where the process is essentially biological. This means that if the product itself fulfils the criteria for patentability, the fact that the known process to obtain the product is essentially biological does not stand in the way of a valid patent claim.
The court considered that Article 53 (b) EPC does not refer to products, but only to processes, and held that the fact that in this case the claimed products are partly defined on the basis of the production process does not make a difference. Cresco's plea that the granting of patents for plants that are obtainable by essentially biological processes would lead to an ‘erosion’ of the exclusion of Article 53 (b) does not hold according to the court. The court summed up various aspects of product-by-process claims, which make these claims substantially different from mere process claims. An important difference is for instance that product-by-process claims can only be granted if the product itself is novel and has an inventive step. Therefore, certainly not every method claim can be reformulated into a product-by-process claim in order to circumvent the exclusion of Article 53 (b) EPC.
The court has rendered a judgment in which it expressed a firm and clear view, which for the moment acknowledges the patentability of product-by-an-essentially-biological-process claims in the Netherlands (European patents only, the Dutch Patent Act is clearly different in this respect). Patentees should therefore not fear that such claims are likely to be prone to annulment.
However, the fact that the Patent Court in these proceedings on the merits seemed to hold such a strong opinion did come somewhat as a surprise. Earlier this year, in preliminary relief proceedings between the same parties concerning the same patent, a single judge of the Patent Court in The Hague had denied an injunction (PI) against Cresco on the very basis that the product-by-process claims were not patentable because of the exclusion of Article 53 (b) EPC. Taste of Nature lodged an appeal against this decision.
In the proceedings on the merits, the question of infringement is yet to be answered, but on appeal in the PI action a judgment was rendered on 28 May 2013. The Court of Appeal held that in this PI action it is bound by the court's assessment of Article 53 (b) EPC in the proceedings on the merits. Therefore, the Court of Appeal did assume that the patent is valid and also came to a finding of infringement, granting an injunction against Cresco.Still, it can by no means be excluded that an appeal will also be filed in the proceedings on the merits. Even if G 12/2 would be quietly abandoned in the end, it may very well be that higher Dutch courts will get a chance to shed light on this highly debated topic.