13 July 2017
The EPO has announced a change of the rules that govern patentable subject matter: plants and animals exclusively obtained by an essentially biological process are now excluded from patentability.
The decision comes after years of controversy leading to the seminal cases Broccoli II (G2/13) and Tomato II (G2/12) of the Enlarged Board of Appeal at the European Patent Office (EPO) in March 2015.
In the area of plant breeding and genetic engineering, plants, parts or products thereof are patentable under the European Patent Convention (EPC) as long as the feasibility of the invention is not restricted to a particular plant variety. Plant varieties on the other hand are specifically excluded from patentability (Art. 53(b) and Rule 27(b) EPC) and protectable through separate plant breeders rights. Art 53(b) EPC also prohibits claims directed to an essentially biological process for the production of plants.
In G2/13 and G2/12, the Board decided that claims to products derived from an essentially biological process are allowable as long as the other criteria for patentability are fulfilled, even if the process used to obtain the products (i.e. selecting and crossing the plants) is essentially biological and thus not patentable. The main rationale for the decision was that exclusions from the general principle of patentability have to be narrowly interpreted in law. Therefore, the exclusion of claims directed to an essentially biological process for the production of plants did not extend to products derived therefrom.
This ruling was seen by the European Parliament as in potential conflict with the legal protection provided to plant varieties under EU plant variety right legislation. In December 2015, the European Parliament asked the European Commission to look into the patentability of products derived from essentially biological processes, the issue of cross-licensing between patents and plant variety right as well as access to deposited biological material. In particular, the Commission referred to the principles set out in Directive 98/44/EC on the legal protection of biotechnological inventions (‘the Biotechnology Directive’) which was implemented by the EPO into the EPC in 1999 to harmonise national law on the patentability of inventions relating to biological material.
In November 2016, the European Commission concluded that the EU legislator's intention when adopting the Biotechnology Directive was to exclude from patentability products that are obtained by means of essentially biological processes.1 Thus, the rulings in G2/13 and G2/12 by the EPO’s Enlarged Board of Appeal to allow claims to products obtained from an essentially biological process went contrary to the intentions of the Biotechnology Directive.
Following the Commission’s view, on 24 November 2016, the President of the EPO decided to stay all proceedings before the EPO’s examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process. 2
The EPO has now concluded that plants and animals exclusively obtained by essentially biological processes are excluded from patentability. Rules 27 and 28 EPC have been amended to state that “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”. 3
This decision of the Administrative Council of the EPO entered into force on 1 July 2017. Amended Rules 27 and 28 EPC apply to European patent applications filed on or after this date, as well as to European patent applications and European patents pending at that time. Any EPO proceedings that have been stayed will now be gradually resumed. 4
The EPO’s decision comes at a time of change in the plant science industry. Mergers and acquisitions are changing the industry landscape and new developments in the technology, in particular genome editing, are becoming increasingly important in manipulating plant genomes to improve crop performance. These new technologies may help to increase consumer acceptance of plants with improved traits generated in this way, in particular in Europe where transgenic plants have met with criticism.
Some groups have welcomed the EPO’s decision as re-establishing the balance between the two IP systems that are available for breeders to protect their inventions, plant breeder’s rights on the one hand, and patents on the other. Others may fear that curtailing the possibility of obtaining patent rights for inventions that have until now been patentable will impact innovation in the field. However, it is clear that not all plant related inventions will be affected by amended Rules 27 and 28. Claims to transgenic plants as well as plants modified by genome editing should remain patentable. On the other hand, claims to plants that are generated using marker assisted breeding may fall within the exclusion. The full impact of the rule changes on the industry remains to be seen.
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