as expected .. but now made explizit
-------- Weitergeleitete Nachricht --------
https://www.euractiv.com/section/agriculture-food/news/europe-patent-office-gene-edited-plants-will-be-patented-under-gmo-rules/
Europe Patent Office: Gene-edited plants will be patented under
GMO rules
By Gerardo Fortuna | EURACTIV.com
Est. 4min 22 Aug 2023 (updated: 8:05)
Patent applications for new genomic techniques (NGTs) will be
examined under the same criteria genetically modified organisms
(GMOs) have been assessed so far, according to the European Patent
Office.
The recent European Commission proposal to boost the marketing
uptake of gene-edited crops will not affect how patents for these
innovative technologies are granted, according to the organisation
protecting inventions across Europe.
A new legislative initiative presented by the EU executive in
early July aims to loosen rules on certain new genomic techniques
(NGTs) used to genetically engineer certain traits into plants,
including drought and pest resistance.
However, the Commission decided not to deal with intellectual
property (IP) rights, leaving the issues of patentability for
plants obtained by these new methods unanswered.
For the European Patent Office (EPO), this means that, in
practice, patent applications for NGTs will be examined under the
same criteria genetically modified organisms (GMOs) have been
assessed so far.
“NGTs is not a term for us. What is relevant for us is whether
there is a question of technical invention or not,” Heli
Pihlajamaa, EPO’s principal director for patent law and
procedures, told EURACTIV in an interview.
The relevant framework for the assessment of a patent application
is the 1998 directive on the legal protection of biotechnological
interventions which was incorporated already in 1999 in the set of
rules on which EPO’s practice is based.
“The EPO was the first one to implement that directive, way before
the contracting states,” she said, adding that only in case there
are modifications in the 1998 directive, this will have an impact
on the legal framework used by the EPO to grant patents.
She mentioned that, for instance, in 2017 the Commission put
forward a new interpretative notice about the Biotech directive
that immediately led to a change in EPO’s implementing
regulations.
But despite the proposed new rules for NGTs, the overarching legal
framework for biotechnologies has remained unchanged.
“The Biotech directive remains as it is, so the European Patent
Convention and the implementing regulations of this directive stay
as they are,” explained Pihlajamaa.
An EU official already confirmed to EURACTIV at the time of the
proposal’s presentation that NGTs still fall under the definition
of GMOs and that the new rules “largely rel[ies] on the current
architecture of the GMO framework”.
EU Commission takes more time on patentability of gene-edited
plants
The newest European Commission proposal on new genomic techniques
(NGTs) leaves the issue of patentability for plants obtained by
these new methods unanswered, with the EU executive pushing back
possible actions to 2026.
Conventional v. technical breeding innovation
The Munich-based European Patent Office is a body of the
organisation set up by 39 contracting states to grant patents in
Europe after having assessed the applications for intellectual
protections on inventions.
Although all 27 EU member states are also signatories of the
European Patent Convention, the EPO is independent from the EU and
its cooperation with the Commission, in particular, is regulated
by a memorandum of understanding.
“When we look at plant related to patent applications, we can see
that a very large majority [since the 1998 Biotech directive] have
been filed for genetically modified plants, products or
processes,” she said.
Precisely, for roughly 9,000 patent applications for GMOs, about
3,000 patents have been granted. “That means about one-third of
these applications have led to a grant of a patent,” she
continued.
The reason why only applications for GMOs are de facto filed to
the EPO is that conventionally-bred plants are excluded from
patentability.
In 2015, the EPO opened to the possibility of registering plants
obtained by essentially biological processes but after a
longstanding legal saga which drew the ire of both the Commission
and the European Parliament the office excluded this ‘dynamic
interpretation’ of the exception of patentability.
“We moved on from this. The whole situation has been solved with
the case law that has followed since then,” said an EPO
spokesperson.
The first task of the EPO is then to check if the invention is
actually patentable, meaning that it is not a plant variety
obtained by conventional breeding.
“Then we look at whether it’s ‘inventive’ and whether it fulfils
the other requirements of patentability,” explained Pihlajamaa.
Novelty is one of these patentability requirements. “If it’s a
known trait, then it’s not new. One has to see all these
patentability requirements in one and cannot just single out the
question of whether is a technical or a conventional breeding
method,” she concluded.
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