UK: MEPs Sow Seeds Of Change For Gene-edited Plant Patentability: Will It Bear Bad Fruit For The Biotechnology Industry?

Members of the European Parliament (MEPs) have backed a recent proposal from the European Commission (EC) intended to simplify the regulation of certain gene-edited plants to create a more sustainable and robust food system. The inadvertent effects of the proposal on gene-edited plant patentability could have drastic impacts on the biotechnology industry.

Background

Genetically modified plants are plants which have had alterations made to their DNA. This can be achieved using "established genomic techniques" developed pre-2001 (e.g., transposon insertions) or more widely used "new genomic techniques" (NGTs) developed post-2001 (e.g., CRISPR/Cas systems). Genetic modification can alter the plant's characteristics, for example by enhancing pest or disease resistance. Understandably, this is an extremely attractive prospect given the pressing need for increased food production to match the rise in global population.

At present, an established and strict legal framework is in place in the EU to ensure the safety of genetically modified organisms (GMOs), irrespective of whether they were produced by established genomic techniques or NGTs. Approval from the relevant regulatory authorities must be obtained before GM crops can be grown. The assessment for approval may consider the type of GM method used, the specific alterations made, and results from animal feeding trials. Consequently, the barrier to approval for GMO plants is high, somewhat thwarting NGT plants' ability to maximise their potential positive impact on crop production. By contrast, conventionally bred plants, produced by techniques including crossing or selection, are subject to far less stringent regulations.

The European Commission's proposal

In order to simplify the regulatory process for certain NGT plants, the EC have proposed to split NGT plants into two categories: NGT 1 and NGT 2. Of particular relevance are NGT 1 plants. Provided certain criteria are met, relating to the size and number of modifications made to the genome, NGT 1 plants will be treated as if they are conventionally bred plants. Consequently, they will be exempt from the legal framework associated with GMOs and face lower regulation. NGT 2 plants, which encompass plants produced by NGT techniques that do not meet the criteria for NGT 1 status, will remain subject to the majority of the existing GMO legislation.

Early positivity within the biotechnology industry surrounding decreased regulation of NGTs was swiftly smothered by an amendment posed by MEPs to ban patents for all NGT plants (both category 1 and 2), plant material, parts thereof, genetic information, and process features they contain. Patent protection at the European Patent Office (EPO) is currently afforded to GMOs (including NGT plants), in contrast to conventionally bred plants which are not patentable at the EPO.

The commission's proposal, including the suggestion to ban all patents for NGT plants, was voted through the EU Parliament by a margin of 307 votes to 263 (with 41 abstentions).

Impact of the vote

The decision in support of the exclusion to patentability is one of particular concern to the biotechnology industry. Arguments in favour of the exclusion appear to rest almost exclusively with farmers and breeders, who would enjoy full access to genetic material of NGT plants at reduced costs attributable to the absence of royalties and licenses that would have previously been paid.

It is difficult to extract any positives from the exclusion for biotechnology businesses. If the exclusion is introduced, patent protection will only be obtainable for plants produced by the established genomic techniques developed pre-2001. This appears entirely counter intuitive, as businesses could be discouraged from innovating NGT plant technologies in the absence of a reward for their investment, rather favouring more primitive methods instead. As such, this provision would likely counteract any benefit obtained from simplifying the regulatory process for certain NGT plants, as fewer businesses will be expected to develop them.

It should be noted that this result does not mark the end of the discussion. EU member states will now negotiate with the EU parliament to determine the final framework of the law. In addition, the Institute of Professional Representatives before the European Patent Office (epi) has requested that MEPs reconsider the exclusion to patentability. However, it appears clear that although the new rules may make the process of regulatory approval for NGT plants more streamlined, they almost entirely remove any incentive for companies to utilise it.

For now, MEPs appear drawn towards increased access to genetic material of NGT plants at reduced cost to farmers and breeders. This approach could backfire significantly. To develop advantageous crops using NGTs, substantial investment in gene editing technologies is required. Without the incentive to do so, developments in the field may simply freeze. Therefore, a significant weapon used to battle the pressing need for increased food production risks being lost.

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