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”.
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.
[Edited by Nathalie Weatherald]
