Patents on life?

First, a brief history and background of the topic “Patents on life” – or, more specifically, on plants – are they possible?

Traditionally, plants (and other patents “on life”) have been seen as excluded from patentability, both in national legislation and under the European Patent Convention (EPC).

EPC article 53 (b) states that European patents should not be granted in respect of […] plant varieties […] or essentially biological processes for the production of plants.

This position was confirmed by the EPO Enlarged Board of Appeal in the decision G 1/98,  in which the EPO examines the meaning of “plant varieties”. The decision stated:

• A product claim identifying a specific “plant variety” is not patentable but…
• A product claim merely embracing plant varieties, but not claiming any individual varieties, is not excluded from patentability.
   

In the later decisions, G 2/07 (Tomato I) and G 1/08 (Broccoli I), in which the EPO examines the meaning of “essentially biological processes,” the EPO’s position was further elaborated on:

• Genetic engineering, such as GMO, is patentable since it is considered to be technical (as opposed to a “biological process”).
• Crossing and selection of plants is however a biological process and thus cannot be patented.
• “The middle way” – Crossing and selection in combination with technical methods is not patentable if the technical nature solely “enables or assists the performance of the crossing”. If the technical “feature” by itself introduces or modifies a trait in the genome it is however patentable.

So far, so good. And the industry adapted. But moving on to the present, the tides have turned. Or have they?

In two more recent decisions, decided on 25 March 2015, the EPO allowed two patents on plants, even though the plants were the results of essentially biological processes. In the cases G 2/12 (Tomato II) and G 2/13 (Broccoli II), the EPO stated that:

• Article 53 (b) does not exclude product or product-by-process claims, even though they are the result of essentially biological processes.

The EPO thus stated that the exclusion from patentability according to article 53(b) consists of (i) Plant varieties and (ii) Biological processes for the production of plants.

There is, according to the EPO, no exclusion of the plant (or fruit etc.), as such from patentability – only on varieties of plants and/or processes to produce plants. This provoked considerable reactions, and the EU Commission issued an interpretative notice stating that products that are a result of essentially biological processes should be excluded from patentability. Since the EPO is not a European Union body, and is therefore not obligated to obey a notice from the Commission, the content of the notice was incorporated into the implementing regulations for the EPC (not incorporated into the EPC itself).

This effort on clarity was then “torpedoed” by the EPO in the case of T 1063/18, decided on 5 December 2018. Now the EPO stated that one cannot change the meaning of the convention simply by changing the implementing regulations for the EPC. Hence, the interpretation of article 53(b) that was made in the two previous cases is contrary to the implementing regulations, and in accordance with article 164(2) EPC, the provisions of the Convention prevailed. The patent in question was, however, remitted back to the examining division, since the decision in the case merely regarded the position of the implemented notice and the earlier interpretation of article 53(b) EPC.

So here we are. Or, rather, were.

Looking forward, the question seems to remain – are plants patentable? The EU has, as evidenced by the interpretative notice, adopted a sceptical attitude. Furthermore, national legislation in Germany, France, Sweden and the Netherlands does not allow patents on product or on product-by-process claims that are the result of essentially biological processes.

The EPO may have given a “loophole” for patenting plants, but is this the given outcome for the foreseeable future? It is notable that the EPO may alter its opinion since they are not formally bound by their own practice. Hence, the EPO boards are free to alter their approach.

One may also ask if the recent development is to be seen as legal erosion of the exclusion of plants from patentability. The issue may be defined as whether the exclusion for “essentially biological processes” from patentability is rendered useless following the decisions in Tomato II and Broccoli II. The EPO also states in the Tomato II decision that their decisions do not constitute legal erosion, as they conclude that they interpret the article according to its wording and the intent of the signees of the EPC. 

Even so, the question of this article may be tweaked as to whether plants should be patentable. This raises further issues, such as whether the legal landscape is dependent on social, economic and moral arguments. Of course it is, to an extent. In the Tomato II decision, the EPO does however state in relation to such arguments that the Board’s mandate is only in the interpretation of the EPC, and the Board is not mandated to exercise any “legislative powers”, i.e. the EPO does not have the mandate to alter the meaning of the EPC through interpretation. Only the legislative bodies have that mandate.

This actualizes the question of dynamic interpretation of the EPC, e.g. an interpretation of a legal document that takes on issues not present at the time of drafting, contrary to a literal interpretation of the document. The EPO discusses dynamic interpretation of the EPC in the Tomato II judgement, and states that the judgement at hand is not the result of a dynamic interpretation of the EPC. However, they do not close the door to a dynamic interpretation of the EPC with regard to plants.

A comparison of the discussion and development regarding patents on plants may be made with the historic discussions on product claims on pharmaceuticals. At first they were considered immoral, and were therefore excluded from patentability. However, as the legal landscape and perhaps public opinion changed, product claims on pharmaceuticals are as common as any other type of patent.

In our humble opinion, with regard to patents on plants, the EPO has failed to respect the fundamental reasons behind the wording of the EPC and made a technical interpretation of a political issue. But they are acting on their mandate and the national authorities are – if they consider the EPO’s interpretation of the EPC not to be contrary to national law – obligated to respect and follow the EPO. Will they? We do not think so. But honestly, we do not know.

If we want clarity – reform and further clarify the EPC…