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15 December 2016
In frustrating news for the biotech industry, we can report that the European Patent Office (EPO) has decided to suspend all examination and opposition proceedings for inventions concerning plants/animals that are obtained by means of essentially biological processes. This follows a recent non-binding Notice from the European Commission (EC) regarding the interpretation of certain aspects of Directive 98/44/EC (the so called “Biotech Directive”).
On 3 November 2016, the EC issued a Notice regarding the patentability of plants/animals that are obtained by means of essentially biological processes. This Notice expressed the view that “the EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes” (emphasis added).
The Notice specifically relates to recent decisions by the EPO Enlarged Boards of Appeal in the combined “Tomato I” and “Broccoli I” cases (G2/07 and G1/08) and the combined “Tomato II” and “Broccoli II” cases (G2/12 and G2/13), which we have previously reported. These decisions respectively found that while essentially biological processes making use of gene markers for selection do not concern patentable subject matter, plants/plant material obtained from essentially biological processes are patentable. Although these decisions are in line with the intended scope of the European Patent Convention (EPC), the Notice questions whether they would be in line with the Biotech Directive.
Notably, the combined “Tomato II” and “Broccoli II” cases have led to divergent stances in the national laws of several individual European member states, which we have also previously reported. For instance, in contrast to the EPO’s position, Germany, the Netherlands and France have each tabled changes to their national laws to exclude from patentability products which are made by essentially biological processes. The Notice may therefore be aimed at trying to bring some harmony to this area of law across all European member states.
It is important to note that the Notice by the EC has no legal effect over the EPO, since the EC does not have any legislative or other power over the EPC. It is interesting, therefore, that the EPO has decided to suspend all examination and opposition proceedings (see full statement here). In particular, the EPO has stated that:
“in view of the potential impact of the Commission Notice, all proceedings before EPO examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process will be stayed ex officio. This concerns cases in which the subject-matter of the invention is a plant or animal obtained by an essentially biological process for the production of plants or animals. Search proceedings will not be affected.
If proceedings are stayed, the examining or opposition division concerned will inform the parties accordingly. At the same time, it will withdraw any communications setting them time limits to react, and will despatch no further such communications until the resumption of proceedings.”
Unfortunately, there is no indication of how long the stay of proceedings will be in place. It is also unclear what types of discussions are in place to consider the implications of the Notice and how the EPO might react, if at all. This therefore leaves the biotech industry in a great deal of uncertainty in Europe for the foreseeable future.
We will, of course, provide further updates as soon as additional information becomes available.
Life Sciences & Chemistry group
If you require further information on anything covered in this briefing, please contact Jon Elsworth (email@example.com; +44 207 940 3600) or your usual contact at the firm. This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP, December 2016