EPO bows to EU Commission on patentability of products of essentially biological processes

This Kat is grateful to his colleague Andrew Sharples, head of  practice group EIP Life, for preparing this report of recent news from the European Patent Office about the patentability of products of essentially biological processes.  Over to Andy...

The EPO announced on 12 December that it has stayed all examination and opposition proceedings relating to plants and animals obtained by an essentially biological process. This is because of a notice of the European Commission questioning the availability of patents in these fields.

Following the Broccoli and Tomato cases (G2/12 Tomatoes II and G3/12 Broccoli II, discussed on the IPKat here), the Enlarged Board of the EPO ruled that even where an essentially biological process for the production of a plant or animal is not patentable, the resultant animal or plant may itself be patentable. This was on the basis that, effectively, the exclusion under Art. 54(3) EPC was an exclusion of a process, and there was no basis for giving this Article a broader interpretation.

This decision did not go unnoticed by the powers of the EU, and in December 2015, the European Parliament adopted a resolution asking the European Commission to look into the patentability of products of essentially biological processes. This resulted, on 3 November, in the Commission adopting a Notice on certain articles of the Biotech Directive (2016/C 411/03), in which the Commission took a different view from that of the Enlarged Board.

In particular, the Commission found that the preparatory work to the Biotech Directive (Directive 98/44/EC Of The European Parliament And Of The Council)  should have been taken into consideration. Notably, the Commission refers to the Rapporteur's report that

“‘Essentially biological procedures’, i.e. crossing and selection of the whole genome […] do not meet the general conditions for patentability, as they are neither inventive nor reproducible. Breeding is a reiterative process, in which a genetically stable end-product with the required characteristics is attained only after much crossing and selection. This process is so strongly marked by the individuality of the initial and intermediate material that an identical result will not be obtained upon its repetition. Patent protection is not appropriate for such procedures and their products” (Explanatory statement to the ROTHLEY report, 25 June 1997 (A4-0222/97), p. 38, footnote 5)

Certainly the reference to “and their products” seems to support the Commission’s view. However, the Commission’s Notice goes on to state that certain provisions of the Biotech Directive are only consistent if understood as excluding the products of essentially biological process from patentability. To this reader, these aspects of the Commission’s reasoning do not sit well with the fact that there is a specific exclusion in the legislation on plant and animal varieties, and that

“Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety” (Art. 4(2) of the Biotech Directive).

Nevertheless, the Commission has concluded that animals and plants derived from essentially biological processes should not be patentable.

The Commission’s view is not binding on the EPO. It’s not even binding on the EU, as the Notice makes clear, and instead it only provides guidance as to the application of the Directive. Even though  EU law is not binding upon the EPO, the EPO does in practice apply the Biotech Directive, and decisions of the CJEU are certainly persuasive, as was seen in the Brüstle decision, where EPO practice was changed to follow a CJEU decision. Whilst this notice does not have the force of a CJEU decision, it clearly warrants consideration. The EPO Notice states that the effect the Commission’s Notice should have is currently being discussed by the EPO Contracting States.  This is presumably within the forum of the Administrative Council, which has the power to amend the Implementing Regulations of the EPC and hence effectively override G2/12 and G3/12, if it so wishes. This author is not aware of any timescale for this, and in the meantime the EPO has decided to suspend examination and opposition proceedings relating to this subject matter, although searches will continue unaffected. Any communications setting time limits will be withdrawn by the EPO. This is effective immediately.