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Following a Notice of the European Commission related to certain parts of the EU Biotech Directive (98/44/EC), the EPO has decided to stay all examination and opposition proceedings in which the invention is a plant or animal obtained by an essentially biological process.

The Commission Notice appears to be in direct response to decisions of the EPO’s Enlarged Board of Appeal in the “Tomato II” and “Broccoli II” cases (G 2/12 and G 2/13). These decisions related to the patentability of products which could be obtained by an essentially biological process. Such essentially biological processes are excluded from patentability by Article 53(b) EPC. However, the Enlarged Board decided that the exclusion of essentially biological processes for the production of plants by Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material. Therefore, such product claims are potentially allowable under the EPC.

Following these decisions, the European Parliament adopted a Resolution which asked the Commission to look at the patentability of plants and animals obtained by means of essentially biological processes. Surprisingly, we understand that the Commission undertook this review without consulting its own expert working group on biotech patents. The resulting notice sets out the Commission’s view of the intention of the legislator when adopting the EU Biotech Directive 98/44/EC, Article 4(1) of which contains an exclusion drafted in identical terms to Article 53(b) EPC. Their conclusion is that such plants and animals are not patentable under the Directive.

Interestingly, even before this Notice, German and Dutch national laws had been amended to exclude from patentability plants and animals obtained by essentially biological processes (see Patentability of Plants in epi information 4/15:156-168). Moreover, French law was amended last August to include an even broader exclusion of “products obtained from such processes, as well as their parts and genetic components”. Thus, this Notice adds to uncertainty across Europe with regard to the patentability of plants and animals obtained by means of essentially biological processes.

It is important to note that the EPO is not legally bound by the Commission’s view. However, there is common interest in avoiding possible divergences in practice between the IPOs of EU member states, many of which are also EPO member states, and the EPO. For example, the IPOs of EU member states may feel under pressure to adopt the Commission’s view whilst the EPO must follow the Enlarged Board. This could result in a situation whereby patents containing claims to animals or plants which could be obtained by an essentially biological process are obtainable via the EPO (following the Enlarged Board) but not via the national IPOs (following the Commission). It could even mean that such patents granted by the EPO would then be liable to revocation by the national courts.

This issue had already been discussed earlier last year by the EPO’s Committee on Patent Law and, more recently, the EPO has itself issued a notice explaining that the President of the EPO has decided 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.”

We understand that within the EPO, alternative options are being considered. One option may be amendment of the Implementing Regulations (the Rules accompanying the EPC) within the framework of the Commission’s Notice and the Biotech Directive. The Committee on Patent Law will meet at end of April to discuss these options with a view to making a recommendation to the EPO’s Administrative Council. The Administrative Council then has the authority to make a decision on how to proceed.

Thus, it is unclear for how long the stay of proceedings will be in place; however, it is likely to remain for a least several months yet. However, there does seem to be a desire within the EPO to resolve this issue, to minimise damage to applicants, patentees and the public.

For additional details, please see the links on this page or contact us.

Meet the team
Helen Brearley
Helen has over 15 years of experience in the field of intellectual property. Helen's background is in the life sciences.
Glyn Truscott
Glyn's practice spans a wide range of biotechnology subject-matter, from combination immunotherapies to PCR-based diagnostic assays.