14 April 2019

President’s Referral to Enlarged Board of Appeal – Patentability of Plants and Plant Products

The President of the European Patent Office (EPO) has submitted questions to the Enlarged Board of Appeal (EBA) which relate to the patentability of plants exclusively obtained by essentially biological processes and to T1063/18, a Technical Board of Appeal decision of December 2018.

In T1063/18, the Appeal Board disregarded an 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 has been widely 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 President’s decision to refer the matter to the EBA is highly controversial and has been widely criticised. The referral is described by the President as being necessary to restore legal certainty, but commentators have argued that rather than alleviating uncertainty, the President is adding to it by asking the EBA to revisit a question that they have already considered.

The decision issued in T1063/18 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, was remitted to the Examining Division for further prosecution.

The President’s EBA referral represents the latest twist in a long running legal and political 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 the grant of patent claims directed to plants or plant products produced by essentially biological processes.

In G2/13 and G2/12, the EBA 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 EBA 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 EBA 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 EBA.

Indeed, in the written decision of T1063/18, the Appeal Board clearly states that the amendment to Rule 28(2) EPC reverses the meaning of Article 53(b) EPC, as interpreted by the EBA, and it is not possible to interpret Rule 28(2) EPC in such a way that no contradiction exists. According to Article 164(2) EPC, in case of conflict the Articles prevail, thus rendering the amendment to Rule 28(2) EPC void.

The Appeal Board also found that the interpretation of the Biotech Directive as put forward in the Notice had not been confirmed in a legally binding way. Specifically, the Board highlighted that within the legal framework of the European Union (EU), only the Court of Justice of the European Union (CJEU) was competent to issue a binding interpretation of the Biotech Directive. This point was specifically recognised in the Notice itself, and since the CJEU has not decided on the matter the Notice does not have any legal authority.

The Appeal Board also addressed the question of whether an interpretation of Article 53(b) EPC, different from that given in decisions G 2/12 and G 2/13, is necessary in view of Article 31(3)(a) of the Vienna Convention. This was not found to be necessary, however. The Appeal Board found that such an interpretation would imply the amendment of an Article of the EPC by the Administrative Council (i.e. Art. 53(b) EPC), but this is beyond the competency of the Administrative Council, which has the authority to amend the Implementing Regulations, but not the Articles, of the EPC.

For these reasons, the Board found that it was not necessary to deviate from the interpretation of Article 53(b) EPC given by the EBA in decisions G 2/12 and G 2/13, and in addition, a referral to the EBA was also unnecessary.

Nevertheless, at a recent meeting of the Administrative Council, the EPO President, António Campinos, discussed the possibility of referring T1063/18 to the Enlarged Board of Appeal, arguing that the referral was “justified and necessary”.

Prior to the publication of the President’s referral, commentators were quick to question its admissibility. According to Article 112 EPC “the President of the European Patent Office may refer a point of law to the Enlarged Board of Appeal where two Boards of Appeal have given different decisions on that question”. However, there have not been two conflicting Boards of Appeal decisions on the question of the patentability of plant products produced by essentially biological processes.

CIPA, the professional body for patent attorneys in the United Kingdom, issued a position paper on the issue, arguing that there are no valid grounds for the EBA to accept another referral on the interpretation of Article 53(b) EPC in the absence of conflicting decisions.

Nevertheless, the President has referred two questions to the EBA:

  1. Having regard to Article 164(2) EPC, can the meaning and scope of Article 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal?
  2. If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to Rule 28(2) EPC in conformity with Article 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?

The President argued that Question 1 is admissible on the basis that T1063/18 is in conflict with previous decisions on how to resolve a conflict between the interpretation of an Article by the EBA (or BA) and a subsequent interpretation of the same Article by the Administrative Council.

In relation to the admissibility of Question 2, the President argued that a conflict between a Rule and a single BA decision is equivalent to a situation where two Appeal Boards have given different decisions.

This argument presupposes that Rule 28(2) EPC is in conflict with only a single Appeal Board decision (T1063/18). However, as stated by the BA in T1063/18, Rule 28(2) EPC in fact conflicts with a number of decisions of the EBA, which is the EPO’s highest judicial authority. Indeed, many commentators believe that the legal situation was made clear by the EBA in G 2/12, that plants produced by essentially biological processes are patentable.

It is expected that the referral will either be deemed inadmissible, or that the EBA will consider the questions, only to reiterate their previous view, that plants produced by essentially biological processes are patentable under Article 53(c) EPC.

Nevertheless, the decision of T1063/18 was very warmly received by applicants in this field and news of the President’s referral will be of concern 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. In the meantime, however, the EPO has returned to granting patents in respect of plants or animals exclusively obtained by means of an essentially biological process. It is also worth emphasising that plants and plant material obtained by a technical process are unquestionably patentable.

It is not clear when the EBA will decide on the President’s referral, but in the meantime it is worth noting that the decision in T1063/18, and the President’s subsequent referral to the EPO’s Enlarged Board of Appeal, sends a clear signal that it is the EPO’s Appeal Boards that decide how to interpret the European Patent Convention for the purpose of granting patents, and not the EU or individual national governments.