Another twist in the discussion on patentability of plants: are they really not patentable?
Yesterday, the Board of Appeal of the European Patent Office (EPO) decided, in case T 1063, that plants produced by essentially biological processes should be considered patentable. This decision comes only one year after the EPO amended its regulations stating the contrary.
The discussion started many years ago, when Israel’s Ministry of Agriculture and the biotech company Plant Bioscience Limited (PLB) filed applications covering processes for producing, respectively, tomatoes and broccoli involving crossing and selection steps completed by a further step of technical nature.
Both applications were granted by the EPO and opposed by third parties on grounds including exclusion from patentability of “essentially biological processes” under Art. 53(b) EPC. Referrals were made to the Enlarged Board of Appeals, EBA (G1/08, also known as Tomato I, and G2/07, also known as Broccoli I) in order to clarify how broadly the definition of “essentially biological process” should be construed. The EBA concluded that a process for the production of plants, which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, is excluded under Art. 53(b) EPC, even if it includes a step of technical nature which serves to enable or assist the steps of crossing and selection.
The question which was left unanswered in Tomato I and Broccoli I was whether claims directed to products resulting from such processes were also excluded from patentability. Thus, after the claims of the two applications were amended to cover the tomato and broccoli plants, the Tomato II and Broccoli II (G2/12 and G2/13) referrals were made to the EBA.
Various interested parties, among which breeder’s groups, seed industries and NGOs, filed Amicus Briefs. After much debate, on 26 March 2015, the EBA decided that plants may be patentable even if methods of producing them are not. This applies even if the only method available at the filing date for generating the claimed product is an essentially biological process. Of course, such products must meet all other requirements for patentability.
After that, the matter was reopened to discussion in November 2016, when the European Commission issued a Notice related to certain articles in the EU Biopatent Directive (98/44/EC)[1], clarifying that the European legislator’s intention was to exclude not only essentially biological processes but also products obtained by such processes.
The Administrative Council of the EPO decided to amend its regulations in order to exclude from patentability plants and animals exclusively obtained by an essentially biological breeding process, thus complying with the Notice of the Commission. The new provisions applied starting from 1 July 2017. More specifically, Rules 27 and 28 EPC were amended to clarify the interpretation of Art. 53(b) EPC, which excludes essentially biological processes from patentability, but does not specify an exclusion for the products thereof. The Administrative Council considered that this interpretation should be applied to pending cases and to granted patents in opposition.
After the matter appeared to have been solved, yesterday’s decision came as a surprise.
The patent application at issue here is EP 2753168 in the name of Syngenta Participations AG and relates to new pepper plants and fruits with improved nutritional value. The application was rejected by the EPO since the subject-matter of the claims was found to be within the exceptions to patentability as set out in Art. 53(b) and new Rule 28(2) EPC. The Applicant filed an appeal against this rejection and oral proceedings were held yesterday.
In the grounds of appeal, Syngenta challenged the amendment to Rule 28 EPC made by the Administrative Council and held that new Rule 28(2) EPC would create legal uncertainty and misalign the EPC with Directive 98/44/EC. Syngenta highlighted that the Notice of the Commission is not legally binding as only the Court of Justice of the EU is competent to issue a binding interpretation of the Directive. The Commission’s Notice can therefore not overrule the interpretation provided by the EBA of the EPO in its decisions G2/12 and G2/13. Syngenta also requested for a referral to the EBA.
According to information provided by Kluwer patent blog (the minutes of yesterday’s oral proceeding are not available yet), the Board of Appeal (BoA) accepted Syngenta’s line of argumentation, but did not refer the question to the EBA. Further, it remitted the case back to the Examining Division to consider the requirements of inventive step (Art. 56 EPC) and clarity (Art. 83 EPC). According to the BoA the correct interpretation of Art. 53(b) would have already been provided by the EBA in cases G2/07 and G1/08 and this should prevail over any amendment to the rules.
This decision revives the debate on the patentability of plants produced by essentially biological processes. It has to be said that, at the time the Notice of the European Commission was issued, many stakeholders already held that amending the Rules would not be sufficient and that an amendment of Art. 53(b) EPC would be necessary. Apparently, they were right and a conference of the contracting states according to Art. 172 EPC will be necessary to finally solve the issue.
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[1] EU Directive 98/44/CE on the legal protection of biotechnological inventions entered into force on 30.07.1998. Its aim was to harmonize the protection of biotech inventions within the EU. The Directive was in theory addressed only to EU member states, but the EPO (which is independent of the EU) voluntarily incorporated the Directive’s rules in the EPC Implementing Regulations.
ALESSANDRA BOSIA
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