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
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
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.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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