The European Patent Office (EPO) has stayed all examination and
opposition proceedings relating to plants and animals obtained by
essentially biological processes. This pause will give the EPO time
to consider a Notice of the European Commission relating to the
relevant provisions of Biotech Directive (98/44/EC). Search
proceedings are not affected.
The Enlarged Board of Appeal (EBA) has previously held in the
Broccoli II (G2/13) and Tomatoes II (G2/12)
decisions of March 2015 that Article 53(b) EPC excludes from
patentability essentially biological processes for the production
of a plant or animal but that the plant or animal produced by this
process may be patentable. It was decided, in effect, that the
exclusion was directed to the process, not the products of that
process as exclusions under the EPC must be interpreted narrowly.
Our previous article discusses this in more detail.
On 3 November 2016, the European Commission adopted a Notice on
the corresponding articles of the Biotech Directive which
correspond to these exclusions and how it considers the Directive
should be applied. The Commission disagrees with the EBA's
position on this subject matter and believes that the preparatory
work by the EU Parliament should be taken into account. In
particular, the Notice quotes the Parliament's report:
procedures', i.e. crossing and selection of the whole genome
[...] do not meet the general conditions for patentability, as they
are neither inventive nor reproducible. Breeding is a reiterative
process, in which a genetically stable end-product with the
required characteristics is attained only after much crossing and
selection. This process is so strongly marked by the individuality
of the initial and intermediate material that an identical result
will not be obtained upon its repetition. Patent protection
is not appropriate for such procedures and their
(Explanatory statement to the ROTHLEY
report, 25 June 1997 (A4-0222/97), p. 38, footnote 5)(emphasis
The Notice raises a further argument that certain provisions of
the Directive are only consistent if the products of essentially
biological processes are excluded from patentability, in particular
Articles 3(2) and 4 of the Directive. These articles of the
Directive dictate the patentability of biological material, and
plant and animal varieties under EU law.
As such, the Commission concludes that it was the
legislator's intent when adopting the Biotech Directive to
exclude from patentability products of essentially biological
processes. However, this Notice has no binding effect. "Only
the Court of Justice of the European Union is competent to
interpret EU law" and the Notice is officially intended only
to assist in the application of the Directive. In any case, the EPO
is not an EU institution and is not subject to the Commission.
Nonetheless, it is evident that the EPO is taking the time to
consider the Commission's position carefully. The EPO notice
confirming the stay of proceedings, states that EPO examination
practice is under discussion with the representatives of the member
states of the European Patent Organisation, presumably via the
For now, on applications relating to this subject matter, the
Examining and Opposition divisions will withdraw communications
setting deadlines for applicants to respond. No further
communications will issue for these applications until proceedings
are permitted to resume.
1.The trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent.
The UK government has not yet invoked Article 50 of the Treaty on European Union (this is likely to happen by the end of March), and the UK's actual exit from the European Union is at least two years away.
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