The Enlarged Board of Appeal (EBA) of the EPO has confirmed in decision G3/19 that plants, plant material or animals exclusively obtained by essentially biological processes are not patentable. This decision represents a change from earlier EBA decisions G2/12 and G2/13 (“Tomatoes II” and “Broccoli II”). In this regard, it has been confirmed that the exclusion does not apply to European patents granted before 1 July 2017 and European patent applications filed before that date and that are still pending.
Article 53(b) EPC excludes from patentability “essentially biological processes for the production of plants or animals”. This provision was previously construed narrowly by EBA decisions G2/12 and G2/13, such that plants or animals obtained by essentially biological processes did not form part of the exclusion.
However, in November 2016, the European Commission issued a Notice of interpretation of the EU Biotech Directive 98/44/EC, which directly conflicted with these EBA decisions. In 2017, the Administrative Council of the EPO responded by implementing an amendment to Rule 28 EPC to recite:
“Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.”
This disagreement between the EBA decisions and Rule 28(2) EPC as amended was considered by the EPO’s Technical Board of Appeal (TBA) in decision T1063/18. In this decision, the TBA determined that, in view of Article 164(2) EPC, where provisions and implementing regulations conflict, the provisions of the European Patent Convention prevail. Therefore, following the interpretation of Article 53(b) EPC as given in G2/12 and G2/13, products obtained by essentially biological processes were held patentable. This TBA decision prompted the President of the EPO to refer questions to the Enlarged Board of Appeal concerning the interpretation of Article 53(b) EPC (see our previous bulletin titled: The patentability of plants and animals obtained by essentially biological processes).
The Enlarged Board’s decision
The President referred two questions to the EPO. The first of these questions sought to address the relationship between Article 53 EPC and the implementing regulations (i.e. the rules), particularly whether the earlier EBA decisions limited the clarification of Article 53 by any subsequent changes to the rules. The second question directly addressed the interpretation of Article 53(b) EPC. The EBA considered that the first question extended beyond the ultimate aim of the President’s referral and thus provided an amended question to reflect the true purpose of the referral:
“Taking into account developments that occurred after a decision by the Enlarged Board of Appeal giving an interpretation of the scope of the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC, could this exception have a negative effect on the allowability of product claims or product-by-process claims directed to plants, plant materials or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process feature define an essentially biological process?”
Under this rephrased question, the EBA considered the interpretation of Article 53(b) EPC in light of the developments since G2/12 and G2/13.
Regarding the EU Commission’s Notice of interpretation of the Biotech Directive, the EBA affirmed that this was not itself legally binding. However, it was considered noteworthy that around a quarter of the EPC Contracting States had national legislation excluding from patentability products of essentially biological processes.
The EBA disagreed with the TBA’s approach in T1063/18, in particular, the notion that in G2/12 and G2/13, the EBA had given a conclusive interpretation of Article 53(b) EPC, to the extent that it could only be overturned by an amendment to the Article itself.
The EBA considered that an interpretation of an EPC Article cannot be treated as definitive, since meanings of provisions may change over time. Rather, the EBA favoured a “dynamic interpretation” of the law, where developments since the signing of the EPC could be taken into account so as not to conflict with the legislator’s aims.
The EBA considered the introduction of Rule 28(2) EPC to represent such a development. Introduced after the decisions in G2/12 and G2/13, the EBA stated that this new rule provided a new legal and factual context in which Article 53(b) EPC should be considered. In light of these developments, it was held that a strict literal interpretation of the wording of Article 53(b) EPC was not appropriate.
The EBA thus concluded that the introduction of Rule 28(2) EPC established a new interpretation of Article 53(b) EPC, i.e. extending the exclusion to plants and animals obtained exclusively by essentially biological processes.
What does this mean?
For European patent applications filed from 1 July 2017, this decision means that claims to plants, plant material or animals obtained by means of essentially biological processes are not permitted. As noted in the EPO President’s referral, the application of Rule 28(2) EPC was relevant to >250 cases pending before the EPO. Hence the outcome of this decision is relevant to many parties in this sector.
If you wish to know more about this decision or would like further advice, please contact Joanna Peak or your usual Boult Wade Tennant LLP advisor.