The judgment that crops modified by CRISPR-Cas9 technologies
are genetically modified organisms has halted efforts to
establish a European CRISPR patent pool in the agricultural
sector, according to in-house sources.
Agricultural businesses had started working together to
establish a licensing platform for must-have, gene-editing
technologies until the European Court of Justice
ruled that organisms obtained by mutagenesis must be
governed by the restrictive provisions of the EU
"Having this licensing platform was a high priority before
the ECJ ruling, but due to the uncertainties on
commercialisation of plant varieties with genome editing under
this new ruling in Europe, the urgency has decreased somewhat,"
says Claudia Hallebach, head of legal affairs and IP at seed
"Having this licensing platform was a high
priority before the ECJ ruling, but due to the
uncertainties on commercialisation of plant
varieties with genome editing under this new
ruling in Europe, the urgency has decreased
Claudia Hallebach, KWS
She adds that her firm was actively promoting the idea with
other CRISPR players in the agricultural space to enable
unrestricted innovation for gene-edited crops. Although there
are companies with larger portfolios of CRISPR-Cas9 patents,
she says, even they would need access to patents surrounding
the technology from both the agricultural and pharmaceutical
The pool would have operated in a similar manner to the
sector’s International Licensing Platform, which
offers licences for agricultural patents under fair, reasonable
and non-discriminatory terms.
But the uncertainty and limitations that the ruling has
imposed on CRISPR crop development has stifled the industry in
Europe. It is not clear what the next steps are and whether the
regulations in Europe will be lifted.
Hallebach says the concept of the licensing platform will
remain relevant because genome editing technologies are not
considered as 'essentially biological processes’
and so are not prohibited by European patent law.
"Nevertheless it needs to be ensured that access to breeding
material will not be blocked by patented genome-editing traits
contained in plant varieties. Therefore a licensing platform,
coming with a contractual breeder’s exemption,
could provide a balanced solution in future," she says.
The European Commission’s Scientific Advice
Mechanism (SAM) Group of Chief Scientific Advisors mirrored
Hallebach’s position on decreased CRISPR
innovation as a result of this ruling, contending in a
published statement that the EU must improve the regulatory
environment for products of gene-editing or Europe would be
left behind in the field.
GMO Directive governance stands to limit CRISPR crop
commercialisation because products regulated by its provisions
can only be released into the environment or put on the market
after an environmental risk assessment and public
The directive also contains a safeguard clause in Article 23
that allows member states to restrict the use and sale of GMOs
previously approved by the EU – and so even if a GMO
product is authorised, states can opt out and restrict or ban a
This opt-out provision has been used before, and it means
the use of the older, random methods of mutagenesis is likely
to be a safer bet than using CRISPR.
The ECJ went against the opinion given by Advocate General
Bobek in January 2018, which said that organisms obtained by
mutagenesis should be exempted from the GMO Directive.
European patents nipped in the bud
Part of the reason that a European CRISPR patent pool is
less important is that because the ECJ ruling has stifled
CRISPR innovation in agriculture, patents for the technology
and derived products are less valuable, and fewer will be filed
than previously expected.
The head of IP at a Netherlands-based food technology
company says that European CRISPR patents will be less valuable
because GMO classification will inevitably reduce demand for
gene-edited products in certain jurisdictions.
"If a product is GMO, that rules out some customers and
countries entirely, and that will affect the IP behind
"Demand for a food product is obviously very much dependant
on what the final customer wants, which is why some things are
marketed as natural or organic, for example. If a product is
GMO, that rules out some customers and countries entirely, and
that will affect the IP behind it."
The IP director of a food tech business agrees with this
view, and adds that her company is now on the fence on how
involved it want to be in the technology.
"Many of the ingredients we make are sourced through natural
strains but we are also investigating genetic engineering of
strains because we see advantages in manipulating properties,"
she says. "Depending on how this all turns out, we may want to
change our level of activity in that space."
Sources also explain that European vegetable seed companies
traditionally have not used GMOs because the profit margins for
modified vegetables is relatively low compared to the
regulatory costs of producing them. One source says his company
would have entered the CRISPR space had the ECJ not ruled the
way it did, but is now very unlikely to.
"I do not know why you would patent something that you
cannot bring to the market anyway," he adds.
But the regulatory regime for CRISPR products is going down
a more permissive path in places such as the US. Sources say
they will likely seek appropriate global protection and patent
designations, despite the regulatory decision.
"Although based in Europe, our business is a worldwide one,"
the head of IP at a global seeds company points out. "We are
still analysing the situation, but that fact will have a large
bearing on our strategy."
Jeroen Rouppe van der Voort, IP research manager at Enza
Zaden, adds that companies developing CRISPR agricultural
products elsewhere in the world would also likely have little
difficulty selling them in Europe.
"Products developed in the US, for example, will go the
European market and if they are declared non-GMO, they would be
treated as a non-GMO because of treaties between the EU and
He points out that the ruling ultimately cannot be enforced
because the types of mutations generated by CRISPR also occur
in nature, which means the technology does not leave a trace
like those solutions traditionally used to produce GMOs.
As such, the ruling only stands to have the effect of
limiting innovation and will likely fail to effectively
regulate the distribution of CRISPR derived food products in
Europe as it intended.
The ruling from the ECJ does not affect patentability of
CRISPR technologies or products because the GMO Directive is
separate from the Biotech Directive and Article 53 of the
European Patent Convention that provide exceptions to
patentability in Europe.
The permanent working group on IP rights for the ALLEA
(European Federation of Academies of Sciences and Humanities)
considered whether there should be changes to the EU Biotech
Directive in view of CRISPR-Cas9 technology in 2016.
"I do not know why you would patent something that you
cannot bring to the market anyway"
It concluded that European patent law provided the necessary
incentives for the successful development of CRISPR-Cas9
technologies while the EU Biotech Directive gave the necessary
safeguards, and as such changes to patent law were not
According to most in-house sources, the laws governing
CRISPR patentability are likely to stay as they are –
but not everyone is convinced. The IP director of a food tech
business says she has doubts over the assertion that the
ECJ’s ruling will not one day affect
"It may not happen in the next few years because we have
just had this giant discussion around it – but I would
not be surprised if it did affect patentability to some extent
in the future," she says.
She adds that she cannot imagine that EU lawmakers will
leave patent law surrounding CRISPR intact if the situation
stays as it is.