The patentability of plants in Europe
In March 2015, the Enlarged Board of Appeal at the European Patent Office (EPO) decided in G 2/12 (Broccoli II) and G 2/13 (Tomatoes II) that the exclusion to patentability of essentially biological processes (Art. 53(b) EPC) must be interpreted narrowly and thus the exclusion did not extend to the patentability of any products resulting from such processes per se.
This decision was intended to provide legal certainty for would-be proprietors of such technologies. However, the fact that this opened the possibility for the protection of plants obtained by classical breeding and selection under both patents and the separate rights conferred by Plant Variety Rights (PVRs) has led to much speculation about its potential impact on the plant breeding industry as a whole. In particular, while PVRs are specific to protecting a new variety, the infringement of these rights are limited by what is known as a 'breeders' exemption' (where a plant breeder would not infringe a PVR if the activity is for the creation of a new variety). Such an exemption does not exist in many national laws relating to patents.
On December 2015, the European Parliament adopted a resolution[see note 1 below] for the European Commission to clarify the interpretation of what is commonly known as the 'Biotech Directive'[see note 2 below] as regard the scope of the exclusion to essentially biological processes (Art. 4) and access to biological materials (Art. 12 and 13). It should be noted that while the EPO acts independently from the EU, the Biotech Directive is incorporated into the implementing regulations of the European Patent Convention (EPC)[see note 3 below].
The Commission notice
On 08 November 2016, the European Commission issued its comments on the Biotech Directive[see note 4 below]. In a document longer than the Directive itself, it concluded inter alia the exclusion under Art. 4 to essentially biological processes (the wording of which is mirrored in Art. 53(b) EPC)[see note 5 below]intended to include within its scope products resulting from those processes. Under this interpretation, plants formed from classical breeding and selection would not be patentable in Europe.
The Commission in particular focussed on the legislative history and evolution of what is now Art. 4 of the Directive from its first proposal in 1995, which did include a reference to plants produced by essentially biological processes.
Of interest, the relationship to Art. 3 of the Directive also drew a divergent opinion, compared to that of the EPO in G 2/12. The EPO focussed on Art. 3(1), which essentially allows the patentability of biological products provided they meet the basic requirements of patentability; in the Board's opinion, this necessarily limited the scope of exclusion under Art. 53(b) EPC . The Commission referred instead to Art. 3(2), which specifically recited the patentability of biological material "produced by a technical process", stating that an essentially biological process could not be a technical one.
It should be noted that dissent against the EPO decisions of March 2015 is not new. France, as recently as 08 August 2016, adopted an amendment to its code de la propriété intellectuelle (CPI) to specifically exclude products obtained by essentially biological processes[see note 6 below]. This follows the legal provisions already present in both Germany[see note 7 below]and the Netherlands[see note 8 below]. Thus, it was already questionable if validated European patents directed towards plants produced by crossing and selection (ie, an essentially biological process) would be valid in these countries.
The Chartered Institute of Patent Attorneys (CIPA) in the UK also expressed its opinion in a position paper of July 2016. In particular, it focussed on the fact that legislation which would have come into effect upon introduction of the Unified Patent Court Agreement (UPCA) would have provided a breeders' exemption in UPCA-contracting states[see note 9 below]. Thus, as far as Intellectual Property Rights would still allow breeders to carry on their activity, it was perceived that the UPCA would at least introduce a degree of harmonisation within the European Patent system. In this regard, CIPA saw no reason to alter the present legislation or the precedence set by G 2/12 and G 2/13.
Following the result of the EU Referendum in the UK, there has been a substantial delay in ratification of the UPCA. This would appear to place a higher short-term importance on national laws and how they deal with the conflicting opinions of the EU and the EPO. Time will tell if other EPC-contracting states will follow France and introduce its own exclusion to products derived from biological processes.
As far as the EPO itself is concerned, given that G 2/12 and G 2/13 were decided primarily upon the Enlarged Board's interpretation of the EPC, there is arguably no reason for it to change its tone in light of the Commission's notice – Art. 164(2) EPC provides that the EPC prevails in case of any conflict with its implementing regulations (which includes the Biotech Directive).
If access to plant breeding material is the primary concern, providing a plant breeders' exemption in national laws appears to be a much more convenient solution than casting doubt on the legal fiction of exclusions to patentability. Indeed, it was the UK's intention to directly implement the breeders' exemption once the UPCA came into force. Perhaps linked to the debate over the patentability of plants are the somewhat arduous requirements to obtain a compulsory licence under Art. 12 of the Directive, which the Commission has also noted to merit further analysis.
It remains to be seen how this area develops, and whether the EU will begin the torturous process of amending the Biotech Directive.
- European Parliament resolution of 17 December 2015 on patents and plant breeders' rights (2015/2981(RSP))
- Directive 98/44/EC
- Rule 26(1) EPC; OJ EPO 1999, 101
- Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (2016/C 411/03)
- G 2/12, Reason VII.4(3)
- L. 611-19 CPI
- § 2a Patentgesetz
- Art. 3 Dutch Patent Act
- Art. 27(c)
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