Patenting Plant Innovations at the EPO
In Europe, ‘plant or animal varieties or essentially biological processes for the production of plants or animals’ are excluded from patentability. The Enlarged Board of Appeal decision G1/98 attempted to clarify the distinction between a ‘plant’ and a ‘plant variety’. Plants which are not plant varieties have to date been patentable before the EPO. However, if the claims related to a plant variety per se then these would be considered excluded from patentability. Therefore claims to plants per se in Europe which may cover plant varieties but where the plant varieties are not specifically claimed are patentable in Europe.
Recent Enlarged Board of Appeal decisions (G2/07 and G1/08)1 have concluded that:
a non-microbiological process for the production of plants which contains the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being ‘essentially biological.
In order for a process of plant production to be patentable an additional step of a technical nature is necessary, which step ‘by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced’ so that the introduction or modification of that trait is not the result of mixing of the genes of the plant chosen for sexual crossing.
Claims in Europe for inventions directed to methods of producing plants should therefore ideally be formulated to exclude any sexual crossing and selection steps. For example a method claim may be formulated as a method of identifying a plant with elevated levels of a compound of interest which method comprises steps of a technical nature only.
Whether plants obtained solely by an excluded method will be patentable in Europe is still under review. Technical Boards of Appeal (such as in T-1854/07)2 had previously confirmed that such ‘product-by-process’ claims remain a product claim (i.e. a claim to the plant per se) irrespective of the process it refers to and therefore the claim to the plant was not excluded from patentability even if the method by which it was produced was. However, very recently the Technical Board of Appeal in T-1242/06 (the Board that originally referred questions in G1/08 to the Enlarged Board of Appeal) has attempted to refer further questions to the Enlarged Board of Appeal to seek clarification on whether plant claims are patentable when they are solely produced by an excluded method.
The questions that have been referred at the time of writing have not been finalised and the Enlarged Board of Appeal has not yet formally accepted the referral. However, any decision from such a referral may change the landscape for plant patenting in Europe. The reaction of one of the opponents in T-83/05 (which resulted in the parallel Enlarged Board of Appeal decision G2/07) has been to ask for proceedings in that case to be stayed until the outcome of T-1242/06 is clearer.
The questions tentatively proposed by the opponent in T-1242/06:
- Is a claim which is not directed to an essentially biological process as defined in Art. 53(b) EPC and G1/08 patentable if such claim would render inoperative the exclusion from patentability as defined in G1/08?
- Is a claim patentable if such claim is directed to a plant, fruit, seed or any other part of an essentially biological process as defined in G1/08 if such a claim would render inoperative the exclusion from patentability as defined in G1/08?
- If such claim is patentable which other requirements are there to be met?
- If such claim is unpatentable which other requirements need to be met to escape the exclusion from patentability as defined in G1/08?”
For the avoidance of doubt, plants produced by recombinant gene technology are not part of this review and assuming they are novel, inventive, industrially applicable and enabled will continue to be patentable in Europe. The EPO is clearly conscious of the public debate surrounding their decisions in plant cases. In an attempt to put the debate into context, the EPO has recently published some statistics indicating that although around 800 applications are filed per year in the plant arena, fewer than 100 patent applications claiming non-GM [non-genetically modified] plants are filed every year. Furthermore, of the 13,848 patent applications relating to plants published by the EPO since 1990, 1,690 ended with the grant of a European patent. Of these, only 88 are patents for non-GM plants, while 1,602 relate to GM plants. The EPO press release also attempts to put into context the recent opposition of EP1962578B to closterovirus-resistant melon plants.
Claim 1 of this patent states:
A CYSDV-resistant plant of the species Cucumis melo, said plant comprising an introgression from a plant of melon accession PI313970, which introgression comprises a CYSDV-resistance-conferring QTL or a CYSDV-resistance-conferring part thereof linked to at least one marker located on the chromosome equivalent to linkage group 6 of melon accession no PI313970, wherein said marker is E11/M49-239, and wherein said QTL or said part thereof is present in homozygous form.
There are no method claims.
The argument of one of the opponents is that such a claim as drafted includes plants that are obtainable by crossing techniques, and that merely to direct a claim to products and not to the process of breeding should not be a way of ‘avoiding’ G1/08. Whilst we do not know at this time, this argument may increase pressure on the Enlarged Board of Appeal to consider the questions pending before them.
In addition there has been a Court ruling in The Hague in January 2012 in a patent case between Taste of Nature (Koppert Cress) and Cresco on the patentability of a plant (Raphanus sativa) obtained by an essentially biological process. This was the first time that a Dutch Court had examined such a case. According to the Dutch Court in summary proceedings, allowing the protection of a plant obtained solely by a non-patentable, essentially biological method, is contradictory to the EPC and would render the regulations of the EPC in this particular field void. Taste of Nature’s plant claims were therefore dismissed.
This sort of decision is certainly not binding on the Enlarged Board of Appeal, but again may be seen as pressure from contracting states of the EPC to consider this matter further.
Considering that the EPO’s own data show that this would affect only a small minority of patents in the field of plant patenting (eg, the non-GM plant patents) – this may not overall affect business’ commitment to Europe. It is important for companies embarking on plant patenting in Europe to seek professional advice from experienced patent attorneys in this field so as to not fall foul of the EPC’s provisions in this technology.
If you have any questions with regard to plant patenting in Europe – please contact the authors.