30 April 2019
The patentability of plants or animals exclusively obtained by means of an essentially biological process at the EPO remains uncertain following a recent referral from the President of the EPO to the Enlarged Board of Appeal (EBA) seeking clarification of the applicable legal framework. All proceedings before the EPO examining and opposition divisions concerning patent applications or patents which claim subject-matter encompassing plants or animals exclusively obtained by means of an essentially biological process, and in which the decision depends entirely on the outcome of the EBA's decision, will be stayed ex officio until the EBA issues its decision.
T 1063/18 concerns the appeal by the applicant against the decision of the Examining Division to refuse European patent application no. 12 756 468.0 (publication no. EP 2 753 168 A1) for the sole reason that the claimed subject-matter was "found to be within the exception to patentability according to Article 53(b) EPC and Rule 28(2)" (here: plants exclusively obtained by means of an essentially biological process).
At the oral proceedings in T 1063/18, which took place on 5 December 2018, Technical Board of Appeal (TBA) 3.3.04, in an enlarged composition consisting of three technically and two legally qualified members, held that Rule 28(2) EPC (see OJ 2017, A56) is in conflict with Article 53(b) EPC as interpreted by the EBA in decisions G 2/12 and G 2/13. In these decisions, the EBA had concluded that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC did not have a negative effect on the allowability of a product claim directed to plants or plant material.
In the reasoned decision dated 5 February 2019, the TBA 3.3.04 stated that Rule 28(2) EPC could not be interpreted in such a way that it was not in conflict with Art. 53(b) EPC as interpreted by the EBA, i.e. the conflict could not be resolved by way of interpretation. The Board also saw no reason to deviate from the interpretation of the EBA. The Board concluded that, in view of Article 164(2) EPC, the articles of the Convention prevailed and decided to set aside the decision under appeal and to remit the case to the Examining Division for further prosecution.
Biotech practitioners agree with the well-founded decision in T 1063/18 and believe that it is actually the only one that could reasonably be reached. Given this decision, it is evident that the need to remove subject-matter as referred to in Rule 28(2) EPC - by disclaimer or otherwise – de facto no longer has any legal basis and should be removed from the Guidelines for Examination, and that this decision should be mentioned in the Guidelines for Examination.
In particular, one aspect is made clear by decision T 1063/18: the exclusion of product claims directed to plants or plant material directly obtained and/or defined by an essentially biological process in the sense of Article 53(b) EPC cannot be achieved by amending the Regulations to the Convention. Such an exclusion could only be the consequence of a further development in the jurisprudence of the EBA or of a revision of the European Patent Convention, e.g. Article 53(b) EPC, by a Conference of the Contracting States.
In the meanwhile with G 3/19, a referral before the EBA is now pending. In particular, pursuant to Article 112(1)(b) EPC, the President of the EPO has submitted questions to the EBA which relate to the patentability of plants exclusively obtained by essentially biological processes and to the above-mentioned decision T 1063/18. In the referral the President of the EPO seeks that the EBA clarifies the applicable legal framework.
The EPO in its press release regarding G 3/19 of April 5, 2019 mentions that it reacts to the concerns expressed by the Contracting States, the user community and representatives of civil society who are worried about legal uncertainty resulting from decision T 1063/18.
It is also mentioned that the President of the EPO considers the referral to the EBA as an important step on the way to restore legal certainty in the interest of the users of the European patent system and the general public. It is also mentioned that the possibility of a referral to the EBA was presented at the end of March at a meeting of the Administrative Council and met with broad support.
The following points of law have been referred to the EBA by the President of the EPO:
- 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?
- 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?
It is expected that many parties will be submitting an amicus brief for G 3/19.
Further, an EPO Notice dated 9 April 2019 announces the staying of proceedings due to the referral G 3/19 as the President of the EPO has decided that, having regard to the potential impact of the referral, all proceedings before the EPO examining and opposition divisions in which the decision depends entirely on the outcome of the EBA's decision will be stayed ex officio until the EBA issues its decision. Search proceedings will not be affected. This concerns patent applications or patents in which the claimed subject-matter encompasses a plant or animal exclusively obtained by means of an essentially biological process. Patent applications or patents claiming other plant-related inventions will not be affected. If proceedings are stayed, the responsible examining or opposition division concerned will inform the party or parties thereof. At the same time, communications setting time limits for the party/parties to react will be withdrawn by the examining or opposition division, and no further communications to this effect will be dispatched. Once the EBA has given its decision, a further communication will be issued concerning the resumption of proceedings. This notice is immediately applicable.
The team of plant patent experts at De Clercq & Partners will keep on following up this topic and provide its comments at your request.