Europe: EU interpretation of Biotech Directive
Managing IP is part of the Delinian Group, Delinian Limited, 4 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2024

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

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

The Netherlands

Tel: +31 70 416 67 11

Fax: +31 70 416 67 99

more from across site and ros bottom lb

More from across our site

Malisheia Douglas, who spent six years at Eaton Corporation, said she was attracted by the firm's global footprint
The European Parliament has voted in favour of overhauling the SEP framework, a proposal that has sparked deep division among patent owners and implementers
Daniel Poh talks about his journey to becoming managing partner and how firms can win new business from Chinese companies
Missing a deadline can have serious consequences but law firms should consider being lenient to those responsible
Each week Managing IP speaks to a different IP practitioner about their life and career
CMS, which was told to respond to a cancellation action by February 12 but filed its response a day later, has rowed back on claims about an IT error
The deal could help Rouse gain a foothold in Australia and New Zealand for the first time
With a team of more than 80 patent lawyers and attorneys across 21 European offices, the firm is acting in some of the most high-profile UPC cases
Lippes Mathias has hired three partners and a counsel from Offit Kurman
External counsel for automotive companies explain how trends such as AI and vehicle connectivity are affecting their practices and reveal what their clients are prioritising
Gift this article