What are the patentability implications of deregulating gene editing in plants in the EU?

The European Parliament has recently adopted its negotiating position on the European Commission's proposal for a less stringent approach to the regulation of plants produced by new genomic techniques (NGTs) and products, food and feed containing or consisting of NGT plants.

Its most surprising (and controversial) amendment to the proposal is to ban patents for NGT plants. Whether the proposal (and amendments) will or could be enacted in their current form remains to be seen.

New genomic techniques

NGTs refer to a wide range of techniques that alter the genetic material of a plant but which, crucially, do not involve the insertion of genetic material from another species. The techniques are therefore considered to be safer. Sometimes NGT plants cannot be differentiated from plants bred using conventional methods.

The techniques have been developed to create plant varieties that are more climate resilient, pest resistant, and that have higher yields or require fewer fertilisers and pesticides.

Proposal to ease regulatory process

In the EU, at present, all plants obtained through NGTs are subject to the same rules as genetically modified organisms (GMOs), with its regime being one of the strictest in the world.

As a consequence, few NGT plants are approved in Europe. This has led to the Commission proposing to make the regulatory process easier for (some) NGT plants to be placed on the market. In adopting its negotiating position, the European Parliament has made amendments to the proposal, including proposing a ban of patents for all NGT plants.

It is important to emphasise that this proposal has not been enacted and therefore does not yet have an impact on the regulation and patentability of NGT plants. Indeed, it is not clear how the proposed ban on patents for NGT plants would work in practice.

Two categories of NGT plants

Under the Commission's proposal, NGT plants refer to genetically modified plants that have been obtained by targeted mutagenesis or cisgenesis (or a combination).

Within this, two categories of plants are proposed – NGT 1 plants and NGT 2 plants – with different rules and levels of regulatory scrutiny for each. This approach has been endorsed by the European Parliament.

NGT 1 plants

The first category of plants would be considered "equivalent" to conventional plants and would fall outside the more stringent requirements that apply to GMOs. Under the Commission's proposal this would be when they have no more than 20 specific types of genetic modifications.

However, the European Parliament has proposed an amendment to reduce the size and number of permissible modifications, thus seeking to limit the number of NGT plants that fall into this category.

For NGT 1 plants, deliberate release and placing on the market would require a simplified verification procedure, including that the equivalency criteria have been met. The European Parliament is supportive of there being a public online list of all NGT 1 plants to ensure greater transparency in this more flexible process.

The simplified procedure is designed to reduce the administrative burden and cost for businesses seeking to place NGT 1 plants on the market.

NGT 2 plants

The second category encompasses all other NGT plants.

The European Parliament agrees with the Commission that NGT 2 plants should still have to adhere to most of the requirements outlined in the GMO legislation, including the authorisation procedure and an environmental risk assessment.

Under the Commission's proposal, a monitoring plan for environmental effects is required when initially granting consent for NGT 2 plants. To encourage NGT 2 plants to be placed on the market, the European Parliament has proposed accelerating the risk assessment procedure for the monitoring requirements.

The Parliament has also proposed an amendment to add a possibility of waiving the monitoring requirement during consent renewal, if it can be demonstrated that the plant poses no risks (such as indirect or unforeseen effects on human health or the environment) in line with the precautionary principle.

Prohibition in organic production

Both the Commission and the European Parliament agree that all NGT plants should remain prohibited in organic production, with their compatibility with organic farming methods requiring further consideration.

The Parliament has added an amendment to oblige the Commission to report on the evolving perception of NGTs among consumers and producers seven years after the implementation of the proposed regulation.

Mandatory labelling

The European Parliament went further than the Commission's proposal in advocating for mandatory labelling for all NGT plants. The Commission's proposal required mandatory labelling for NGT 2 plants but, for NGT 1 plants, mandatory labelling would be only required for products intended for plant reproduction.

However, the European Parliament has proposed that mandatory labelling be required for products derived from both NGT 1 and NGT 2 plants, which could potentially increase costs for businesses if enacted.

Ban on patents for NGT plants

Undoubtedly, the most controversial amendment by the European Parliament is its proposal to ban patents for all NGT plants, plant material, parts thereof, genetic information and process features they contain.

This is surprising given that European patent law is largely governed by the European Patent Convention (EPC), which is an intergovernmental treaty that includes signatories outside of the EU, such as the UK. The EPC sets out a framework for the grant of European patents and, at present, it does not prohibit patents for NGT plants.

Besides the EPC, there is an EU directive that deals with the protection of biotechnological inventions. The provisions of the Biotech Directive have been inserted into the EPC's implementing regulations (as opposed to the EPC itself). The directive does not presently prohibit patents for NGT plants.

However, the European Parliament proposal seeks to amend the directive to include a ban. An amendment of this nature would not be straightforward. There are likely to be prolonged negotiations between Member States on the issue, and whether agreement could be reached is not clear.

EU v EPO – past history

Even if agreement could be reached between Member States, the desired ban still would not be achieved without change at the European Patent Office (EPO) – whether that would be via amendment to the EPC or "dynamic interpretation" of the EPC by the EPO's Enlarged Board of Appeal (EBA). This, again, would be highly controversial and not easily (or quickly) achieved, if it is possible at all.

There is a complex relationship between the EU and the EPO, but the EPO has ceded to political pressure from the EU with respect to the Biotech Directive previously.

The EPO had held that plants produced by "essentially biological processes" were patentable. In response, the European Commission released a non-binding notice stating that it was the EU legislator's intention to exclude plants obtained by essentially biological processes from patentability in the Biotech Directive.

Despite the non-binding nature of the Commission's notice and in conflict with the EPO's own previous case law, the Administrative Council of the EPO introduced a new rule explicitly excluding plants produced by essentially biological processes from patentability.

In a subsequent case, the EPO's EBA held that the introduction of the new rule called for a "dynamic interpretation" of the EPC, abandoned its previous case law and held that the EPC is to be understood as prohibiting the patenting of plants obtained by essentially biological processes.

Explicit amendment required?

Nonetheless, the EPO ceding to political pressure in the context of NGT plants would be even more controversial because, unlike the past scenario, the Biotech Directive would need to be explicitly amended to introduce a ban. This means that a similarly explicit amendment of the EPC would probably be needed (rather than dynamic interpretation of it).

Moreover, certain non-EU EPC states, such as the UK, have already introduced deregulatory measures without introducing a patent ban. Introducing a ban poses significant political issues given that the EPO is not an EU institution, the EPC is not EU law and the UK has chosen a different deregulatory path post-Brexit that does not affect the current patent position.

Any amendment to the EPC would require a three-quarters majority of a conference of the contracting states, which, given the controversial nature of the proposal, would be difficult to achieve.

Osborne Clarke comment

This proposal is not yet enacted and therefore does not yet have an impact on the regulation and patentability of NGT plants. The European Parliament will soon begin negotiations with EU Member States and agreement would also need to be obtained from the European Council. It is not clear whether the proposal will be approved in its current form, particularly given the practical and political issues that surround the European Parliament's controversial proposal to ban patents for NGT plants.

Businesses seeking to place NGT plants on the EU market should keep on top of the progress of this legislation. The simplified regulatory approach to placing NGT 1 plants on the market would be a welcome change for businesses operating in this area. However, if, as the European Parliament has proposed, the scope of the NGT 1 plant category is reduced, this could have a dramatic impact on the practical utility of these deregulatory measures.

While it seems unlikely that a patent ban would be agreed upon at an EU level, it seems even less likely that such a ban would be introduced by the EPO. The text of this regulation is not final and the remaining legislative process should be carefully monitored to properly assess its potential impact. The controversial nature of this proposal and the scope of the European Parliament's amendments are likely to mean that the legislative progress is slow, which will not be helped by the upcoming European elections in June 2024.

This Insight is the first in a two-part series on gene-edited plants. Our next Insight will consider the UK's approach to regulation.