On 5 December 2018 the Technical Board of Appeal of the European Patent Office (EPO) issued a remarkable decision in case T 1063/18 to overturn a recently implemented amendment to Rule 28(2) EPC, thereby undoing what was effectively an amendment to the Implementing Regulations to the Convention on the Grant of European Patents initiated by the European Union (EU). This decision can be seen as underlining the independence of the EPO’s Boards of Appeal from the EU, an important and timely reminder for everyone grappling with the impact of Brexit on IP in Europe.
The amendment to Rule 28(2) EPC, which entered into force in July 2017, was held to be in conflict with Article 53(b) EPC as interpreted by the Enlarged Board of Appeal. According to Article 164(2) EPC, in case of conflict, the Articles prevail, thus rendering the amendment to Rule 28(2) EPC void.
The decision issued in T 1063/18 was an appeal against an Examining Division objection under amended Rule 28(2) EPC. The amendment to Rule 28(2) EPC was deemed void and the application, relating to pepper plants with improved nutritional value, has been remitted to the Examining Division for further prosecution. The EPO issued a statement (click here to read in full) confirming the facts of the decision on 7 December 2018.
The case represents the latest twist in a long running legal saga concerning the patentability of plant products produced by essentially biological processes.
In 1999 the EPO implemented the “Biotech” Directive (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions), with the purpose of harmonising national law on the patentability of inventions relating to biological material.
As a result of the Biotech Directive, essentially biological processes for producing plants and animals are excluded from patentability, and this is implemented by Article 53(b) EPC. A process for the production of plants and animals is considered to be essentially biological if it consists entirely of natural phenomena such as crossing or selection. However, biotechnological methods of producing transgenic plants and tools such as genetic markers for use in such methods can be patented.
The exclusions to patentability provided by the Biotech Directive have been confirmed by numerous decisions of the EPO Boards of Appeal, for example, in the related cases Broccoli II (G2/13) and Tomato II (G2/12). In G2/12 and G2/13 it was found that Article 53(b) EPC should be interpreted narrowly and should not prevent claims directed to plants or plant products produced by essentially biological processes.
In G2/13 and G2/12, the Enlarged Board of Appeal referred to the official background documents for the negotiation leading to the EPC in 1973, which indicated that exclusions from the general principle of patentability must be narrowly interpreted. In view of this, the Enlarged Board decided that claims to products derived from an essentially biological process are not excluded from patentability, even if the process used to obtain the products is essentially biological and thus not patentable.
However, these decisions of the Enlarged Board of Appeal were not received favourably by some groups, especially plant breeders’ associations.
Having come under pressure from such lobbying groups, and certain national governments, to limit the extent of patent protection available in this area, in December 2015, the European Parliament adopted a resolution asking the European Commission to review the patentability of products of essentially biological processes.
This resulted, in November 2016, in the Commission adopting a Notice on certain articles of the Biotech Directive (Notice 2016/C 411/03). In the Notice it was considered that in trying to assess the intentions of the EU legislator when adopting the Directive, the relevant preparatory work to be taken into consideration was not the work which preceded the signature of the EPC in 1973, but that which relates to the adoption of the Biotech Directive. The European Commission concluded that the EU legislator’s intention when adopting the Biotech Directive was to exclude from patentability products that are obtained by means of essentially biological processes. Thus, the rulings in G2/13 and G2/12 by the EPO’s Enlarged Board of Appeal to allow claims to products obtained from an essentially biological process were considered contrary to the intentions of the Biotech Directive.
The Commission’s Notice was highly controversial, and although it was not binding on the EPO, Decision (CA/D 6/17) was issued by the EPO’s Administrative Council to amend Rules 27(b) and 28(2) EPC in light of the Notice. Rule 28(2) EPC was thus amended to state that European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process. The Decision to amend Rule 28(2) EPC was unprecedented because it was in direct contradiction to the previous decisions of the EPO’s Enlarged Board of Appeal.
The amendment to Rule 28(2) EPC was considered to be a setback to companies that filed European patent applications based on the G2/12 and G2/13 decisions, and generally to patent applicants in the European agricultural sector. Therefore, the decision of T 1063/18 is likely to be very warmly received by applicants in this field.
Whilst this may not be the end of the story, the EPO’s Board of Appeal decision sends a clear signal that it is the EPO’s Boards of Appeal that decide how to interpret the European Patent Convention for the purpose of granting patents, rather than the EU or individual national governments.