An EPO Board of Appeal has found that Article 53(b) EPC prevails over Rule 28(2) EPC as introduced by the Administrative Council of the EPO last year. Thus, the Board of Appeal found that plants exclusively obtained by essentially biological processes are in principle patentable at the EPO.
Background
As we reported earlier this year [1], the patent-eligibility of plants has long been unsettled in Europe. This uncertainty largely stems from Article 53(b) EPC, which specifies:
"European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof."
Patents are not granted if the claimed subject matter is directed to a specific plant variety, regardless if the plant variety is produced by recombinant gene technology or by classical breeding. Rule 26(4) EPC defines a plant variety as follows:
"Plant variety" means any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be:
(a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes,
(b) distinguished from any other plant grouping by the expression of at least one of the said characteristics, and
(c) considered as a unit with regard to its suitability for being propagated unchanged."
Instead of patents, protection for individual plant varieties is available via plant variety rights (PVR). PVRs can be sought via a central EU system (Community Plant Variety Rights) or via national routes (e.g. via the Plant Variety Rights Office in the UK).
However, a claim where specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC [2]. For example, patent claims may be granted to transgenic or genome-edited plants even though such claims embrace plant varieties. Some examples of claims deemed by the EPO to meet the requirements of Article 53(b) EPC are shown below:
"A transgenic plant comprising transgene X"
"A mutant plant comprising heritable exchange in a nucleotide sequence effected by technical means, e.g. UV mutagenesis or CRISPR/Cas."
Thus, the patent system in Europe does provide an incentive to innovate in GM crops and gene-editing. However, the commercialization of such crops is subject to strict regulatory requirements in Europe.
To avoid such issues raised by genetic engineering, marker-assisted selection has also been developed for plant breeding. Such selection may involve the use of genetic markers linked to desirable traits to inform plant breeding decisions. Whether or not Article 53(b) EPC should exclude marker-assisted selection has been (and remains) a contentious issue at the EPO.
Following referral to the Enlarged Board of Appeal (the highest judicial body of the EPO), it was found that methods encompassing steps of sexually crossing the whole genome and subsequently selecting plants are excluded by Article 53(b) EPC even if they include any further technical steps serving to enable or assist performance of the crossing and selection steps (G1/08, G2/07) [3].
However, follow-up referrals to the Enlarged Board of Appeal (G2/12 and G2/13) [4] found that plants obtained by such methods are not excluded by Article 53(b) EPC. Thus, plants produced by essentially biological processes are in principle patentable even if the process used to obtain the product (i.e. selecting and crossing of plants) is not.
The law in this area therefore appeared to be finally settled. However, following G2/12 and G2/13, the European Commission reviewed the “Biotech Directive” 98/44/EC. This Directive was created over twenty years ago to try to harmonize European laws relating to the protection of biotechnological inventions. The European Commission is concerned that patenting of plants obtained by essentially biological processes is in conflict with the legal protection provided to plant varieties under Community Plant Variety Rights.
The Commission took the view that the EU legislator’s intention when adopting the Biotech Directive was to exclude from patentability plants exclusively obtained by essentially biological processes. In view of the Commission’s intervention, the Administrative Council of the EPO amended Rule 28 EPC to include:
"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 new Rule came into effect on 1 July 2017. As a result, the EPO Examination Guidelines (which are not binding but influential) were updated to indicate that patent applications directed to plants exclusively obtained by essentially biological processes should not be granted [5]. For example, the EPO Examination Guidelines currently indicate that whilst transgenic plants and technically induced mutants are patentable, products of conventional breeding are not.
However, it remains uncertain whether new Rule 28(2) EPC can be enforced because it is in direct conflict with the earlier Enlarged Board of Appeal decisions G2/12 and G2/13. Article 164(2) EPC states:
"In case of conflict between the provisions of this Convention and those of the Implementing Regulations, the provisions of this Convention shall prevail."
Following Article 164(2) EPC, the interpretation of Article 53(b) EPC by the Enlarged Board of Appeal in G2/12 and G2/13 should therefore prevail over the later amendment to Rule 28 EPC made by the Administrative Council of the EPO.
Decision in case T 1063/18
The Technical Board of Appeal, in an enlarged composition consisting of three technically and two legally qualified members, have held that Rule 28(2) EPC is in conflict with Article 53(b) as interpreted in decisions G2/12 and G2/13 [6]. Thus, plants obtained by essentially biological processes are in principle patentable at the EPO, even if the process used to obtain the product (i.e. selecting and crossing of plants) is not.
This decision may help resolve Article 53(b) patentability issues for other pending cases at the EPO. This decision is favorable for patentees developing plants by marker-assisted selection but is only the latest chapter in this story and how the decision may effect other similar pending cases remains to be seen. The written decision containing the Board’s full reasons is expected to be issued early next year. We will provide further commentary once the implications of this decision on EPO practice are more clear. If you would like any further information, please contact Huw Jenkins (hjenkins@secerna.com).
[1] https://secerna.co.uk/news/navigating-the-maize-developing-innovative-crops-in-europe
[2] G1/98
[5] https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_5_4.htm
[6] https://www.epo.org/law-practice/case-law-appeals/communications/2018/20181207.html