“Gene-Edited Crops: European Commission Proposal Will Not Impact Patent Granting Process, Says EPO”

European Commission Proposal Unlikely to Impact Patent Granting for Gene-Edited Crops

The European Commission’s recent proposal to enhance the marketability of gene-edited crops will not affect the process of granting patents for these innovative technologies, according to the European Patent Office (EPO), the organisation responsible for protecting inventions across Europe.

The legislative initiative, introduced by the EU executive in early July, seeks to relax regulations on certain new genomic techniques (NGTs). These techniques are used to genetically engineer specific traits into plants, such as resistance to drought and pests. However, the Commission has chosen not to address intellectual property (IP) rights, leaving the question of patentability for plants produced by these new methods unresolved.

For the EPO, this means that patent applications for NGTs will be evaluated using the same criteria as those used for genetically modified organisms (GMOs).

“NGTs is not a term for us. What is relevant for us is whether there is a question of technical invention or not,” said Heli Pihlajamaa, EPO’s principal director for patent law and procedures.

The framework used to assess a patent application is the 1998 directive on the legal protection of biotechnological interventions, which was incorporated into the EPO’s rules in 1999.

Impact of Changes in the Biotech Directive

Pihlajamaa noted that any modifications to the 1998 directive would impact the legal framework the EPO uses to grant patents. For instance, a new interpretative notice about the Biotech directive issued by the Commission in 2017 led to a change in EPO’s implementing regulations.

However, despite the proposed new rules for NGTs, the overarching legal framework for biotechnologies remains the same. “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 confirmed that NGTs still fall under the definition of GMOs and that the new rules largely rely on the current architecture of the GMO framework.

Patent Applications for GMOs and Conventional Breeding

The EPO, based in Munich, is an organisation established by 39 contracting states to grant patents in Europe after assessing applications for intellectual protections on inventions.

Since the 1998 Biotech directive, a large majority of plant-related patent applications have been filed for genetically modified plants, products or processes. Of approximately 9,000 patent applications for GMOs, about 3,000 patents have been granted.

Conventionally-bred plants are excluded from patentability, which is why only applications for GMOs are effectively filed to the EPO. In 2015, the EPO considered registering plants obtained by essentially biological processes, but this was later excluded.

The first task of the EPO is to verify if the invention is patentable, meaning it is not a plant variety obtained by conventional breeding. “Then we look at whether it’s ‘inventive’ and whether it fulfills 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]

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