Biotechnology has been identified as one of the key technologies with a significant potential to boost Europe’s competitiveness whilst providing solutions that contribute to reaching the EU’s sustainability ambitions.
A new regulation for plants produced by certain new genomic techniques (NGT), such as targeted gene editing, would represent an important milestone in fostering and therewith creating a growing economy and more employment in the biotechnology sector of Europe.
It was therefore highly welcomed that on Wednesday, February 7, the European Parliament voted in favor of a new regulatory framework to regulate the release and use of NGT plants in argriculture.
However, at the same time, Members of the European Parliament (MEPs) amended the European Commission’s proposal to introduce a new full exclusion from patentability for all NGT plants (plants obtained by new genomics techniques such as targeted mutagenesis and cisgenesis) and further even for plants obtained by random mutagenesis techniques or cell fusion.
This caused quite some criticism.
Without adequate patent protection, companies in Europe will not be able to invest in NGTs, the pace of innovation will slow down, and the EU’s goal of fostering competitiveness with stronger biotechnology contributions will be put at risk.
For a successful introduction of NGTs, both adequate regulatory requirements and patent protection are crucial.
Patent and regulatory law fulfil different tasks.
The regulatory framework serves to protect health and the environment, whereas the patent system is designed to stimulate innovation and the economy.
New technologies such as gene editing and NGTs offer new opportunities. With these innovations, scientists can make very specific changes in a plant to develop new varieties with targeted desirable characteristics.
However, they require significant R&D investments to develop such varieties.
The ability to protect newly created traits with patents is an essential component to secure sustainable investments into R&D for the successful breeding of innovative crops that help farmers keep up productivity in times of climate change and help introduce more sustainable cropping systems.
Fatal signal
Patent bans are therefore a fatal signal.
In the European parliament, it was said that the ban may help to avoid new dependencies of farmers and breeders from patent holding companies. Patent bans are often misperceived to be a solution, but rather end up being detrimental to further innovation.
A patentability ban could result in less to no further developments specific to agricultural conditions in Europe as there would be no adequate compensation for the efforts.
Plant breeding is a highly regional business. For example, seeds produced in the mid-west of the US, might not be well-suited for Europe or Latin America.
Should there be no adequate patent protection, it is hard to see who would develop and work on specific regional solutions for Europe using these new techniques.
Plant variety protection alone falls too short. Patents are the only legally available tool to protect new traits.
The general research exemption and the breeders’ exemptions already implemented by many EU member states, and being part of the new unitary patent system enable free experimentation, breeding and development of new plants.
Together with an equitable and fair licensing policy, enabling the commercialisation of new plants patents does not block access but stimulates innovation.
Enabling the dissemination of innovation to many breeders, provides more choice and value-added solutions for farmers.
Patent protection secures a level playing field between competing companies, and fair licensing is prone to doing the same for small market players and larger cooperations.
Over the last year or so, several voluntary initiatives have been launched across the crop sector intending to facilitate access to patented materials.
In addition, under the EU's Biotech Directive, farmers are entitled to save seeds under the same conditions as for plant variety protection. Small farmers do not have to pay anything.
A solution should be reached that acknowledges the importance for small market participants to gain access to genetic material while respecting the importance of patent protection for trait innovators.
This would, in our view, be the only option to give NGT technology a chance to deliver on its promises in Europe for the benefit of all. We should first wait for publication of a much-needed fact-based study into NGTS that has been announced by the commission.
Excluding these technologies from patentability is surely not the solution.
