2019 saw a further twist in the long-running saga on the provisions in the Biotech Directive (Directive 98/44/ EC) and European Patent Convention (EPC) regarding patentability of the products of “essentially biological processes”. By way of reminder, Article 4 of the Biotech Directive states that “essentially biological processes for the production of plants or animals” shall not be patentable and the exclusion thus applies in all EU signatory states to the EPC. Following introduction of the Biotech Directive, the EPC was modified to include the same exception to patentability in Article 53(b) (brought in with the changes to EPC 2000). Both provisions are silent as to the plant (or animal) products of those processes. Notwithstanding the virtually identical wording, and the fact that the EPC was specifically modified so as to be aligned with the changes introduced in the majority of its signatory states as a result of the Biotech Directive, there has been some divergence as to the correct interpretation of the provision.
A short history lesson is required to understand the current situation. In 2015, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) was required to consider the scope of the exception in the Tomato II and Broccoli II cases (G2/12 and G2/13). The EBA concluded that a narrow interpretation of Article 53(b) EPC was appropriate and as a result plants and animals derived from essentially biological processes were in principle patentable, even if they were inevitably derived from such processes.
Nevertheless, the European Parliament asked the EU Commission to consider various issues relating to the Biotech Directive, including the exclusion to patentability in question. The Commission reviewed the context and provisions of the Biotech Directive and published a notice on 3 November 2016 concluding that the intention of the EU legislators when adopting the Biotech Directive was to exclude such products from patentability.
In response to the Commission’s Notice, which diverged from the conclusions of the EBA in G 2/12 and G 2/13, the EPO published its own notice from the EPC Administrative Council clarifying that plants and animals exclusively obtained by means of an essentially biological process will no longer be patentable given the need to safeguard uniformity in harmonised European patent law. The Administrative Council also amended Rules 27 and 28 of the Implementing Regulations to the EPC, which came into force on 1 July 2017 and which applied to all (as then) pending and future patent applications. Rule 28(2) now reads: “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 appeared to have laid the matter to rest. However, in a subsequent case one of the EPO Technical Boards of Appeal (TBA) held that modified Rule 28(2) was void because it contradicted the interpretation of Article 53(b) EPC in 2015 by the EBA in the Broccoli/Tomato II cases. The TBA was also of the view that the EBA had already decided on the question and therefore a further reference to the EBA was not required.
This led to a referral in March 2019 by the President of the EPO to the EBA, purportedly under Article 112(1)(b) EPC, which allows the EPO President to refer a point of law to the EBA where two Boards of Appeal have given different decisions on that question.
The President has referred two questions to the EBA, as follows:
Question 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?”
Question 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?”
There is some uncertainty as to whether the EPO President’s referral is admissible, given that previous decisions of the Boards of Appeal appear to be aligned. On this, and in relation to the first question, the President has sought to rely on previous TBA decisions which suggest that the Administrative Council can issue Rules on interpretation of the EPC that are contrary to an earlier decision of a Board of Appeal (albeit that the previous decisions in the earlier cases were not those of the EBA). The referral by the President has attracted widespread comment, as well as over 40 amicus curiae from interested parties, including a number of Governments from member states to both the EU and EPC as well as the European Commission itself. At present, although the referral has been given a case number (G 3/19), no decision has been made on admissibility or the merits of the questions themselves. We await to see what 2020 brings by way of developments in this area. In the meantime, whilst the referral remains pending, examination and opposition proceedings at the EPO relating to products produced by essentially biological processes have been stayed.