UK: Stay On EPO Proceedings Involving Plants Or Animals Obtained By Essentially Biological Processes

If your European patent/patent application involves products of essentially biological processes, such as crossing of whole plant or animal genomes, proceedings may be stayed.

The European Patent Office (EPO) has issued a Notice¹ advising that proceedings before its examining and opposition divisions will be stayed if they depend entirely on the patentability of plants/animals, or plant/animal parts (eg seeds, fruit) obtained by "essentially biological processes". This is because directly opposing views have been reached by the EPO's Enlarged Board of Appeal (EBoA), (its highest level of review) in a 2015 decision, versus the view set out by the European Commission in a Notice² issued on 3 November 2016 on whether this type of product should be patentable in Europe. The EPO want time for discussion and consideration of the effect of this divergence.

The EU's Biotech Directive³ from 1998 aimed to harmonise member states' laws and clarify what is or is not patentable in Europe in the field of biotechnology. In 1999 the provisions of this Directive were adopted directly into European patent rules⁴.

The directive affirmed, for example, that isolated biological material is patentable even if it has occurred previously in nature⁵ It also confirmed that plants or animals are patentable if the technical feasibility of the invention (e.g. a genetic modification) is not confined to a particular plant or animal variety⁶ However, "essentially biological processes" for the production of plants and animals⁷, i.e. classical breeding comprising crossing and selection are not patentable, nor are individual plant or animal varieties.

In 2010⁸ the EPO's EBoA considered whether a process for sexually crossing the whole genomes of plants – that being an essentially biological process excluded from patentability – became patentable if the process is enhanced by a technical means (for example, by use of certain markers) to enable or assist the crossing and subsequent selection of plants. The EBoA concluded such processes remain unpatentable.

In 2015⁹ the EPO's EBoA was asked to consider whether products (e.g. plants/animals or plant/animal parts such as seeds, fruit) obtained by the unpatentable processes considered in 2010 could themselves be patentable. It was identified that the European Patent Rules did not state that such products were unpatentable and consequently the EPO's EBoA decided they must be patentable products. This decision was intended to give legal certainty but has led to queries on how patents for such products might affect plant breeders and the European Parliament asked the European Commission to clarify the interpretation of the Biotech Directive.

The Biotech Directive does not contain a provision on the patentability of products obtained through essentially biological processes. However, the European Commission considered the preparatory work for and legislator's intent in drafting the Biotech Directive to reach the conclusion that consistent application of the Directive's provisions only occurs if plants/animals and plant/animal parts obtained by essentially biological processes are understood as being excluded from patentability.

It is unclear what legal weight the Commission's Notice has on European patent practice. However, it is interesting to consider the reasons behind its creation. There appears to be pressure from some plant breeders, who consider that patents are extending too far into their field and could hamper their activities. Innovative plant breeders can obtain plant breeders rights (PBRs) for a new plant variety (as noted above a plant variety is not patentable). PBRs have a so-called breeder's exemption that is more generous that the exemptions from patent infringement and include a provision for compulsory licensing in certain situations. Therefore tensions can exist between patent rights and PBRs. Perhaps the EPO may need to alter its stance and/or the Biotech Directive may need to be modified.

Footnotes

1. Notice from the European Patent Office dated 24 November 2016 concerning the staying or proceedings due to the Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. NB the official text will be that published in the December 2017 EPO OJ

2. 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)

3. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

4. See Rules 26 to 29 of the Implementing Regulations to the EPC. See also Article 53(b) EPC

5. Rule 27(a) EPC

6. Rule 27(b) EPC

7. Art. 53(b) EPC

8. Decisions G2/07 and G1/08

9. Decisions G2/12 and G2/13

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