On 3 November 2016, the European Commission (the
"Commission") adopted a 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
The Notice follows a decision from the Enlarged Board of Appeal
of the European Patent Office (the "Enlarged Board") of
March 2015 which held that although it follows from Directive
98/44/EC (the "Directive") that an essentially biological
process for the production of a plant or animal is not patentable,
a patent may nonetheless be granted for plants/plant material or
animals resulting from this process. The Enlarged Board reached
this decision after stating that exclusions from the general
principle of patentability have to be interpreted narrowly. Article
4 of the Directive specifically excludes from the scope of
patentable subject-matter "essentially biological
processes for the production of plants and animal", such
as crossing and selection, but leaves unaddressed the issue of
patentability for products obtained from these processes.
Following this decision, the European Parliament asked the
Commission in December 2015 to look into the patentability of these
In the Notice, the Commission diverges from the Enlarged
Board's decision as it believes that the European
legislator's intention when adopting the Directive was to
exclude from patentability products that are obtained by
essentially biological processes. The Commission emphasises that
this interpretation stems from the preparatory works and from
recital 32 of the Directive which states that "if an
invention consists only in genetically modifying a particular plant
variety, and if a new plant variety is bred, it will still be
excluded from patentability even if the genetic modification is the
result not of an essentially biological process but of a
biotechnological process". The Commission adds that
specific provisions of the Directive will only form a consistent
framework if plants/animals obtained by essentially biological
processes are understood as excluded from the scope of the
In addition, the Commission addresses two further issues
relating to the Directive following a request from the European
Parliament that an access to, and use of, material obtained from
essentially biological processes for plant breeding be
First, the Commission calls for further analysis of the
compulsory cross-licensing system under the Directive which enables
a breeder who cannot acquire or exploit a plant variety right
without infringing a prior patent to apply for a compulsory licence
for non-exclusive use of the invention protected by the patent if
the licence is necessary for the exploitation of the plant variety
under protection, subject to payment of an appropriate royalty. The
Commission believes that this further analysis should focus on the
conditions triggering access to such cross-licensing system
(i.e., Article 12(3)(b) of the Directive).
Second, the Commission examines Article 13(3) of the Directive
which regulates the access to and deposit of biological material
for the purpose of patent procedures. It takes the view that the
wording of this provision offers balanced access to patented
material of biological origin.
Although the Notice is not binding on the European Patent Office
(the "EPO"), the EPO announced in a Notice of 24 November
2016 that, in view of the potential impact of the Notice, all
proceedings before it relating to the patentability of a plant or
animal obtained by an essentially biological process will be stayed
while the concrete effects of the Notice are under discussion with
the EPO members.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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