At the end of June the EPO published a notice (see here) stating from 1 July 2017 plants and animals exclusively obtained by means of an essentially biological process will no longer be patentable.
As many readers will be aware, this represents a U-turn for the EPO following the decisions of the Enlarged Board of Appeal (EBA) in 2015 in the Tomato II and Broccoli II cases (G2/12 and G2/13). Here the EBA conducted a lengthy and in-depth legal analysis leading to the conclusion that a narrow interpretation of Art 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.
The law seemed settled until the European Parliament asked the EU Commission to consider various issues concerning the Biotech Directive (Directive 98/44/EC). The exclusion to patentability in the Biotech Directive is framed much like that in Article 53(b) EPC i.e. it expressly excludes from patentability essentially biological processes for the production of plants and animals but does not mention products derived from such processes. The Commission reviewed the context and provisions of the Biotech Directive and published a notice on 3 November 2016 (Notice 2016/C 411/03) concluding that the European Union legislators’ intention when adopting the Biotech Directive was to exclude such products from patentability.
In response to the Commission Notice in November last year the EPO stayed all proceedings in relevant examination and opposition cases ex officio. This remained the situation until the EPO notice published at the end of last month.
The Commission’s Notice states that it is intended only as guidance and, in any event, the EPO is not bound by the views of the Commission nor any decision of the Court of Justice of the European Union (CJEU) on interpretation of these provisions. So why the change in position by the EPO? The EPO notice states that the decision has been taken by the Administrative Council to safeguard uniformity in harmonised European patent law. It seems the EPO wanted to avoid future divergent decisions on this issue around Europe for example between EU member states and between these member states and the EPO. In addition, the Biotech Directive itself is relevant to the EPO when considering patentability. The EPC Implementing Regulations were amended to include its main provisions and it is used as a supplementary means of interpretation (see Rule 26(1) EPC). In these circumstances the possibility of legal disharmony seemed inevitable.
Following the EPO notice the Administrative Council has amended Rules 27 and 28 of the Implementing Regulations to the EPC and these changes came into force on 1 July and apply to European patent applications filed on or after this date, as well as European patent applications pending at that time. The key provision in Rule 28(2) now reads:
“(2) 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 may at first sight appear to be the end of the saga but is it? The Commission Notice is clear that it is a guideline document only, merely to assist in the application of the Biotech Directive, and only the CJEU is competent to rule on the interpretation of EU law. Hence there could still be a reference to the CJEU in the future.