Friday, February 01, 2019 T 2435/13 - More Broccoli: the meaning of "sexually crossing the whole genomes of plants"

In the present case, the proprietor gave his interpretation of the decisions in consolidated cases G 2/07 and G 1/08, which dealt with the question of whether conventional methods for the breeding of plant varieties should be excluded from patentability under Article 53(b) EPC. The proprietor referred to the third paragraph of point "6.4.2.3 Conclusions" that "These conventional methods included in particular those (relevant for the present referrals) based on the sexual crossing of plants (i.e. of their whole genomes) deemed suitable for the purpose pursued and on the subsequent selection of the plants having the desired traits", and the sexual crossing of whole genomes was subsequently said to be "characterized by the fact that the traits of the plants resulting from the crossing were determined by the underlying natural phenomenon of meiosis". The proprietor argued that the decisions consistently referred to "sexually crossing the whole genomes of plants" as being the key criteria for determining whether a process for the production of plants was "essentially biological" and thus excluded from patentability or not. The proprietor argued that txpression "sexually crossing the whole genomes of plants" emphasised that the conventional breeding processes referred to in the two decisions of the EBA were construed as being those involving meiotic recombination events throughout the whole genome during the pairing of homologous chromosomes. The proprietor argued that the meiosis in the claimed regenerated F1 plant (grown from a rescued embryo) which preceded a back-crossing step of the claimed method was distorted; Indeed, since the A- and C-chromosomes were not homologous and did not pair with each other, only very few homologous recombination events took place over only very limited parts of their respective genomes (one being the required transfer of the clubroot resistance trait from A-genome to C-genome). Furthermore, he argued that the genomes of the first generation of back-crossed plants (BC1 plants) produced in steps f) to h) of the claimed method could range from a CC-genome (2n=18, i.e. no Brassica rapa A-chromosome derived from the F1 plant present in the BC1 progeny) to an ACC-genome (2n=28, i.e. all Brassica rapa A-chromosomes derived from the F1 plant present in the progeny); In the former case, it was literally impossible to state that the whole genomes had been sexually crossed since no A-chromosomes were retained in the produced plant. The proprietor concluded that, accordingly, since only partial homologous recombination on limited portions of the respective genomes took place, the claimed method was not directed to a process for the production of plants involving sexually crossing the whole genomes of plants as referred to decisions G 2/07 and G 1/08, and that, consequently, decisions G 2/07 and G 1/08 did not apply and the claimed subject-matter did not fall within the exceptions of Article 53(b) EPC. The Board did not agree: its conclusion is given in reasons 12-13 and the substantiation of the conclusion in the reasons just before.

Monday, December 19, 2016 Broccoli and Tomatoes followup: staying of proceedings due to the Commission Notice on certain articles of Directive 98/44/EC

 

In G 2/12 and G 2/13 (decision, blog), the Enlarged Board of Appeal concluded that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts. The decision led to a successful maintenance in amended form in the Broccoli case (decision, blog, register) as well as in the Tomatoes case (decision, blog, register).
The decision also led to a discussion in the European Commission. On 3 November 2016 ,the European Commission adopted a notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions ("the (Biotech Directive"/ "The Directive"). With regard to the patentability of plants and animals obtained by means of essentially biological processes, the Commission takes the view that in accordance with the EU legislator's intention such plants and animals are not patentable under the Directive.
The effect of the Commission Notice for the EPO's examination practice including any necessary follow-up measures is currently under discussion with the representatives of the member states of the European Patent Organisation.
The President of the EPO has decided that, in view of the potential impact of the Commission Notice, all proceedings before EPO examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process will be stayed ex officio. The details are given in the Notice that is reproduced below, together with parts of the Commission Notice.

Tuesday, October 06, 2015 T 0083/05 - Broccoli III the final

This decision concerns the patent application directed to a broccoli plant with elevated levels of anticarcinogenic glucosinolate derivatives, that was the result of crossing different known broccoli plants and using genetic markers that indicated elevated levels of such glucosinolate derivatives. It is the final of a long lasting case going through two rounds of Enlarged Board of Appeal decisions: Broccoli I (G2/07) and Broccoli II (G2/13, case law blog: here). See also the Tomatoes I and II decisions that concerned similar issues and that were co-decided by the Enlarged Board. 
In this particular decision (which was named Broccoli III) the Board of Appeal reacts to the ruling of the Enlarged Board in G2/13 and of course adapted to that ruling by finding that the claims directed to 'an edible Brassica plant produced according to a method for the production of Brassica oleracea with... etc.'  fulfills the requirements of the EPC. The exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts. There is nothing unexpected about this particular decision, but it is important because it generated such important case law.

Smmary of Facts and Submissions

I. Both opponent 01 (appellant I) and opponent 02 (appellant II) filed appeals against the interlocutory decision of the opposition division maintaining European patent No. 1 069 819 in amended form.

II. The appellants submitted that the patent as amended and the invention to which it related did not meet the requirements of the EPC. They relied in particular on the opposition grounds of added subject-matter, lack of enabling disclosure, lack of novelty, lack of inventive step and that the subject-matter of the method claims was not patentable pursuant to Article 53(b) EPC.

III. During the first oral proceedings before this board (albeit in a different composition), the patent proprietor (respondent) submitted a new main and auxiliary request. Claims 1 to 4 of the main request were directed to a method for the production of Brassica oleracea with elevated levels of particular glucosinolates comprising a number of steps of crossing, selecting and backcrossing.

The other claims of the main request were all independent and read as follows:

"5. An edible Brassica plant produced according to the method of any one of claims 1 to 4.

Friday, March 27, 2015 G 2/12 and G 2/13 - Fruit and veggies

On 25 March 2015 the Enlarged Board of Appeal published the consolidated decisions G 2/12 (Tomatoes II) and G 2/13 (Broccoli II). Whereas the EBoA decided in G 1/08 (Tomatoes I) and G 2/07 (Broccoli I) that the processes as claimed in the respective patents at stake were not allowable under Article 53(b) EPC (that indicates that plants and plant varieties or essentially biological processes for the production of plants are unpatentable), the EBoA now came to the (not unexpected) conclusion that this article in the EPC does not prevent patenting the plant products (e.g. fruit and edible parts of the plant) that may be obtained by such processes. Interestingly, all parties involved (patent proprietors, opponents as well as the President of the EPO) agreed with this notion, before the EBoA confirmed it.
The EBoA once again stresses the difference between a product claim, a process claim and a product-by-process claim, the latter being a product claim that should be addressed for patentability separate from the process that is used to produce it.

The EBoA concluded earlier in G 2/07 and G 1/08 that the legislator's intention (Article 53(b) EPC) had been to exclude from patentability those plant breeding processes which were the conventional methods of plant-variety breeding at the time. 
Article 53(b) EPC is about an essentially biological process that cannot be patented. But if one claims a product (not a plant or a plant variety) that may be obtained by such excluded process, such product may very well be patentable and is explicitly not excluded from patentability under Article 53(b) EPC, solely because it was obtained by the unpatentable process.  

Notably, and the EBoA admits this, in some EPC contracting states, including Germany and the Netherlands, the patent law deviates from the EPC by explicitly excluding patentability of products obtained by essentially biological processes (e.g. see Art. 3(1)(d) ROW 1995). The EBoA indicates that such is not the case in the EPC.

Ergo: not all is lost for parties pursuing European patent protection for commercial plant products (like fruit) when the process leading to such products falls under the exclusion of Article 53(b) EPC, at least not in all contracting states of the EPC.