Report of the Committee on Biotechnological Inventions
A. De Clercq (BE), Chair
1. Patentability of plants and animals - T1063/18 and G 3/19
Our committee reported T 1063/18 in epi information 1/2019. This decision 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).
The 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 Enlarged Board of Appeal (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.
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 earlier 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.
The Biotech Committee analyzed and agrees with the well-founded decision in T 1063/18 and believes that it is actually the only one that could reasonably be reached. 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. Also in another plant case under appeal as T 2734/18 (EP 2 825 024), Board 3.3.04 issued a preliminary opinion on 29 March 2019 with the same conclusion as in T 1063/18
In the meanwhile with G 3/19, a referral to the EBA is now pending. 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 the EBA to clarify 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. Also it is mentioned that, the possibility of a referral to the EBA was presented end of March 2019 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 in G3/19:
- 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?
The epi Biotech Committee together with EPPC will prepare an amicus brief in name of epi for G 3/19. A short presentation was given at the council meeting to highlight the issues at stake in this referral
Further, an EPO Notice dated 9 April 2019 announces the staying of proceedings due to the referral G3/19 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 Biotech Committee will keep on following up this topic and provide its comments.
2. Overview of patentability of plants in the Member States
The Biotech Committee is following further national developments and will soon report an updated overview of the patentability of plants in the member states.
3. Guidelines for Examination - biotech issues
The Biotech Committee was represented in a discussion of the Guidelines for Examination at the SACEPO Working Party on Guidelines on 22 February 2019. The biotech committee also presented its comments on Rule 28(2) EPC and relating disclaimer parts of the Guidelines. The EPO is requesting whether the biotech committee wishes to propose further examples now or for the next version of the GL amendments. The Biotech committee will make suggestions if deemed appropriate. Given T 1063/18, our committee submitted 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.
4. Meetings with attendance of the Biotech Committee
On 8 January 2019 the epi Biotech Committee held a web meeting to prepare for the SACEPO meeting WP on Guidelines reported here below. All biotech passages in the guidelines were assembled and the recommendations were passed on for discussion in the meeting.
On 22 February 2019 the epi Biotech Committee was represented in a discussion of the Guidelines for Examination at the SACEPO Working Party on Guidelines (Jan Desomer, Gabrielle-Leissler-Gerstl and Martin Wilming attended this meeting).
On 19-20 February 2019 Gabrielle Leissler-Gerstl, a legal adviser of the epi secretariat and Francis Leyder attended the CPL meeting during which the patentability of plants produced by essentially biological methods was discussed.
On 2 May 2019, Ann De Clercq attended an epi delegation meeting with new VP1 Stephen Rowan and Razik Menidjel wherein amongst others it was discussed to continue holding the meetings with the DG1 Biotech Directors.
5. Next meeting
The Biotech Committee will continue to deal with all questions relating to biotech and related life sciences inventions as well as topics referred to it by EPPC or other channels. The next meeting 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.