Regulation of NGT plants in Europe- Polish Presidency proposes an alternative solution to the Patent ban

In the latest development on the new proposed legislation for the regulation of NGT (gene-edited) plants in the EU, the Polish Presidency have proposed an amendment which removes the proposed patent ban for NGT plants, plant material and plant products.

By way of reminder, in preparing legislation to relax the regulatory process for the marketing of NGT plants, the EU Parliament proposed an amendment which effectively excluded from patentability “NGT plants, parts thereof, genetic information, and the process features they contain”.  The proposal also included restrictions on the scope of protection of existing patents and applications for all NGT plants.  The purpose of the proposed ban was to avoid legal uncertainties, increased costs and dependencies on large agritech companies for farmers and breeders.  This, they argued, was in line with the EU Commission aim to develop sustainable agriculture and increase food security in the region.

Since the proposed amendment, there has been debate over the scope of the exclusion, which could have been interpreted as extending to the genetic tools used for targeted mutagenesis.  There has also been understandable reluctance in having to revise existing legislation such as the EU Biotech Directive, the UPCA and the Trips agreement, as well as questions over the amendments that might be needed to the European Patent Convention.  Despite softening the proposal to be limited to the lower-risk NGT1 plants only by the Belgian Presidency, they were unable to secure a majority vote.

The current Polish presidency have recognised that in order to implement the regulatory legislation, the deadlock between the EU member states on the proposed patent ban has to be promptly addressed.  With the objective of stimulating innovation in the EU whilst enabling free access to varieties by breeders, the Polish Presidency have proposed the following:

• There will be a distinction between patents which protect basic technologies and patents for plants and processes which result in a specific plant trait.
• Reproductive material of an NGT1 plant can be placed on the market without any further restrictions, if it is not protected by a product patent, or a process patent which results in a specific trait of the plant.
• If there are patents which protect the reproductive material, or which protect a process which results in a specific trait, then the reproductive material can still be put on the market, but it may be subject to further restrictions if a Member State wishes. Such restrictions include: a ban on use of the reproductive material for cultivation of reproductive material and a labelling requirement.  These restrictions would aim to protect national farmers and breeders against patents.
• The proposal includes a verification procedure to determine the existence of patents or applications which may be relevant, and this burden will fall to the party putting the reproductive material on the market.

It is notable that the provisions don’t relate to plants per se, or plant products but only to reproductive material.  The requirements are also limited to NGT1 plants, and any other reproductive material will not be subject to the verification procedure.

Many have welcomed the removal of the proposed patent ban, and if the Polish proposal is accepted then the legislation may progress forward, although there are still many non-IP related issues to resolve.

This article was prepared by Partners Punita Shah and Ellie Purnell.