Europe: EU interpretation of Biotech Directive
The patentability of biotechnological inventions in Europe is governed by the EU Directive on the protection of biotechnological inventions (98/44/EG, the Biotech Directive). The Directive is implemented in the national patent laws, but has also been used to amend the European Patent Convention.
In the recent past, the EPO Enlarged Board of Appeal had a few cases in which they had to interpret the wording of the EPC that was driven by the Directive. The most discussed cases are the so-called tomato and broccoli cases, in which the metes and bounds of the exclusion of "essentially biological processes" were discussed (G 2/07, G 1/08, G 2/12 and G 2/13). In essence, the EBoA ruled that excluded essentially biological processes are those processes that involve normal crosses between plants or animals, but that the products of such crosses would be patentable if not confined to one specific variety.
The latter decisions on the products-by-process claims were heavily criticised by the plant breeding community. In June 2016 an expert committee of the EU advised the EU Commission to issue a clear statement on the interpretation of the Directive on this topic (instead of opening negotiations on an amendment of the directive). This was done in November, when the Commission explained that the exclusion should be understood to also include products obtained by essentially biological processes.
On basis of this, the EPO has announced (OJ EPO, 2016, A104) that all proceedings before the EPO examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by essentially biological processes, will be stayed ex officio.
On February 20 2017 the EU Council (the meeting of the ministers of all member states) adopted the proposal of the Commission and urged the member states, in their capacity as members of the European Patent Organisation, to advocate that the practice of the European Patent Organisation is in line with these conclusions.
This had not yet led to any proposal for amending the EPC, but on a national level the new interpretation has already been provided for in the Dutch patent law, where products obtained by essentially biological processes are excluded from patentability.
Bart van Wezenbeek
Johan de Wittlaan 7
2517 JR The Hague
Tel: +31 70 416 67 11
Fax: +31 70 416 67 99