Report of the Committee on Biotechnological Inventions
A. De Clercq (BE), Chair
1. Patentability of plants and animals – T1063/18
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 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 Enlarged Board of Appeal in decisions G 2/12 and G 2/13. In these decisions, the Enlarged Board of Appeal 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 Board 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 Enlarged Board of Appeal, 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 Enlarged Board. The Board concluded that, in view of Article 164(2) EPC, the provisions 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.
Our committee agrees with the well-founded decision in T 1063/18 and believes that it is actually the only one that could reasonably be reached. Given this decision our committee submits 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. This decision should be mentioned in the Guidelines and we are of the opinion that it should be applied consistently by the examining divisions as soon as possible.
The Biotech Committee is of the opinion that 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 Enlarged Board of Appeal or of a revision of the European Patent Convention, e.g. Article 53(b) EPC.
The Biotech Committee will present its analysis to the epi members attending the CPL meeting on 19-20 February 2019.
2. Overview of patentability of plants in the Member States
Already before the decisions of the Enlarged Board of Appeal, a few countries had adapted their legislation in order to exclude from patentability product claims where the claimed products have been generated by an essentially biological process for the production of plants. Our committee has in the past published an overview of the national laws of the EPC Contracting States based on input of its members. This overview has now been updated and is published in this issue of epi Information.
3. Guidelines for Examination – biotech issues
The Biotech Committee has offered a proposal for discussion of the Guidelines for Examination at the SACEPO Working Party on Guidelines on 22 February 2019 (delegates of the Biotech Committee will be present at said meeting). Amongst these are also comments to the Rule 28(2) EPC disclaimer parts of the Guidelines.
4. Next meeting
The Biotech Committee will continue to deal with all questions relating to biotech and related life sciences inventions. The Biotech Committee will also be involved in any other topics that come up for discussion related to biotech or referred to it by EPPC or other channels.
The next meeting date of our committee is still to be scheduled in 2019. A meeting with the EPO Biotech Directors will also be scheduled for this or next year.