From 1 July 2017, the EPO will no longer grant patents for plants and animals exclusively obtained by means of an “essentially biological process”. This follows a European Commission Notice dated 8 November 2016 (please click here for the full text of the Commission Notice) clarifying that the EU legislator had intended to exclude such plants and animals (either in whole or in part) from patentability when adopting the EU Directive on biotechnological inventions (Directive 98/44/EC) (the “Directive“).
Background and legal framework
The Directive was adopted in 1998 in order to harmonise national law on the patentability of inventions relating to biological material. Article 4(1) of the Directive states that (a) plant and animal varieties, and (b) essentially biological processes for the production of plants and animals shall not be patentable. However, the Directive is silent on the “products” (ie, the plants and animals, or their material, such as fruits or seeds) obtained from such essentially biological processes, defined in the Directive as consisting entirely of natural phenomena such as crossing or selection. Although the EPO is an autonomous body unconnected to the EU decision-making bodies, this uncertainty in the Directive is also present in Article 53(b) of the European Patent Convention 2000 (the “EPC“) and Rules 27-28 of the Implementing Regulations to the EPC pursuant to subsequent amendments. Furthermore, the provisions of the Directive have been incorporated into domestic law in the UK under section 76A of the Patents Act 1977 and the accompanying Schedule A2.
EPO Board of Appeal decisions have tended to apply exclusions to patentability narrowly in relation to products from biological processes. In T19/90 Onco-mouse/HARVARD, an early decision from the EPO Technical Board of Appeal which pre-dated the Directive, the claim whose validity was in issue (claim 19) was a product-by-process claim that covered transgenic animals whose cells contained an activated oncogene produced by a technical process (claimed separately) and the descendants of such animals. The Board held the claim to be a product claim and therefore not caught by the exclusion in Article 53(b) of the European Patent Convention 1973.
More recently, the Enlarged Board of Appeal of the EPO has held that although non-microbiological processes for the production of plants which are “essentially biological” (ie, containing steps of sexually crossing the whole genomes of plants and subsequently selecting plants) cannot be patented under Article 53(b) (G2/07 Broccoli/PLANT BIOSCIENCE; G1/08 Tomatoes/STATE OF ISRAEL, also referred to as Tomatoes I/Broccoli I), the products derived from using essentially biological processes, more controversially, could be patentable (G2/12; G2/13, also referred to as Tomatoes II/Broccoli II).
Following these decisions, the European Parliament asked the European Commission to review the patentability of plants and animals derived from essentially biological processes, the result of which was the Commission’s Notice of 8 November 2016. In its Notice, the Commission sets out its reasoned view as to why the EU legislator’s intentions while drafting the Directive could not have been to provide for the patentability of such plants and animals.
Even though the EPO is not expressly bound by the European Commission’s Notice, it stayed all patent applications seeking protection for plants and animals derived from essentially biological processes following the Commission’s Notice. The present decision of the Administrative Council clarifies EPO practice and keeps it aligned with the Notice at least for the time being.
Commentators believe that the issue is far from being truly resolved. Key to understanding the extent of the exclusion would be to have further interpretative clarity from the EPO on what would constitute “essentially biological processes” and similarly, which plants or animals (or their products) would be “exclusively obtained” by such processes (Rule 28 of the Implementing Regulations to the EPC).
In this regard, the Notice considers the preparatory work relating to the Directive and attempts to construe Article 4(1) consistent with the other provisions and recitals in the Directive. There is some indication of the Commission’s view in this paragraph in the Notice:
“Article 4(2) states that inventions which concern plants or animals are patentable if the technical feasibility of the invention is not confined to a particular plant variety (i.e. a plant grouping larger than a plant variety). This exception does not nullify the exclusion in paragraph one of this Article. An example of Article 4(2) is the case of a gene which is inserted into the genome of plants and leads to the creation of a new plant grouping characterised by this specific gene (i.e. genetic engineering). By contrast, the crossing of the whole genome of plant varieties corresponding to an essential biological process would be excluded from patentability.”
The Commission Notice appears to view biological processes as either being “essentially” biological or microbiological/technical and provides no guidance on products obtained from processes which are essentially biological, but contain additional step(s) introducing or modifying traits of the genome, with such introduction or modification of the trait not being a result of the mixing of genes of the plants or animals chosen for the sexual crossing. If such enhanced processes can be patented pursuant to the decisions in Tomatoes I/Broccoli I, then there is no reason why products obtained by such processes cannot be patented. Moreover, if the practical reality in the industry is that genetic engineering processes are invariably used in obtaining new plant or animal varieties, then the Commission Notice does little more than express a point of principle that may have minimal practical significance.
It is therefore clear that further EPO and national jurisprudence (note that the UK currently already has these provisions transposed into UK law) would be required to understand and define the extent of this patentability exclusion. Guidance from the CJEU on interpreting and applying the Directive provisions would also be helpful.