A decision less green – but is it sweet yet?, Comment to Tomato II and Broccoli II by Hanna Kompagne, Danubia Patent and Law Office
The much awaited twins, G 2/12 (Tomato II) and G 2/13 (Broccoli II) are out (one may read them here). The Enlarged Board of Appeal (EBoA) of the EPO has decided that patents for plants and plant material can be granted even if the process of production contains or consists of essentially biological steps.
Although the ruling was not unexpected, in view of the public interest, it is a comforting feeling for IP professionals to learn that Article 53(b) EPC (exclusion on the patentability of essentially biological processes for the production of plants) “does not have a negative effect on the allowability of a product claim directed to plants or plant material”.
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The EBoA made a clear difference between a product claim, a process claim and a product by process claim, stating that the intention of the legislator was the exclusion of processes and not of products. The national patent law of some contracting states explicitly excludes products produced by essentially biological processes as well as the processes themselves. There is no chance to get a patent on tomatoes produced by essentially biological processes in Germany or The Netherlands for example – two countries conventionally active in the fields.
Although differences between national laws and the EPC make the life of applicants difficult in Europe, the practical value of an unambiguous ruling is undeniable. As mentioned previously, the current decision was not entirely unexpected: the President of the EPO commented on the referrals leading to G 2/12 and G 2/13 and came to essentially the same conclusion.
The Rechtbank Den Haag (the District Court of The Hague) has decided in a very similar case, Cresco vs Taste of Nature, that plants, such as the one in dispute before the court (a Raphanus sativa plant with a certain minimum level of anthocyanins, produced by an essentially biological process) are not excluded from patentability under Article 53(b) EPC.
The amendment of the German Patent Act of June 27, 2013, excluding plants and animals exclusively obtained by essentially biological processes along with the already excluded essentially biological processes could also have been read as a hint that at least some legislators found that Article 53(b) EPC did not unambiguously exclude products of essentially biological processes.
In decisions G 1/08 and G 2/07, the EboA, analyzing the meaning of “essentially biological process” and the legislative history of the relevant law in detail, interpreted the exclusion under Article 53(b) EPC broadly and held that “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”.
It also stated that “it must be concluded that the provision of a technical step, be it explicit or implicit, in a process which is based on the sexual crossing of plants and on subsequent selection does not cause the claimed invention to escape the exclusion if that technical step only serves to perform the process steps of the breeding process”.
This broad interpretation has created a certain degree of uncertainty regarding the future of the European plant industry. In an amicus curiae brief the epi (for one) pointed out the possible effects of such an approach on genetically engineered plants: “Should the notion prevail that products of an excluded essentially biological process for the production of plants in the sense of G 2/07 are also not patentable, genetically engineered plants may also not be patentable under Article 53(b) EPC. Of particular concern are for instance mixed processes comprising both technical (i.e. non-biological) and biological steps. Presumably, there is no example of a transgenic plant that was marketed without having undergone at least one round of crossing and selection after the genetic engineering.”
This leads us to another interesting issue: how to design research in a laboratory – and not only in botany labs. Genetically modified animals as disease models, for example, are widely used, but there is always room for improvement. It is thus perfectly possible to make a GM animal with multiple added traits, whereas the animal is not new or does not involve an inventive step per se, although the process leading to the animal contains new and inventive technical steps (and crossing of course).
It is usually easier, safer, cheaper and more reasonable to cross two different GM animals, knowing hoping that the offspring will have both desired features than to introduce both features into the same animal by technical means. However, scientists may be forced to make such animals without crossing, if they wish to obtain protection for their invention in Europe.
A situation very similar to that of the GM plants mentioned by the epi or, indeed, to the tomato fruits of G 2/12. Consequently, making GM animals or plants with crossing and selection included, may easily become a fruitless effort in the green and flourishing European IP field.