The European Parliament supports the introduction of a full ban on patents for all plants produced by certain New Genomic Techniques (NGT), plant material, parts thereof, genetic information and process features they contain. The ban, part of a proposal to introduce two different categories of NGT plants, got support in a vote today. The provision on a patent ban has been criticized as ‘wishful thinking’ and ‘not the right arena’.
According to the European Parliament, the ban avoids ’legal uncertainties, increased costs and new dependencies for farmers and breeders.’ MEPs also request a report by June 2025 on the impact of patents on breeders’ and farmers’ access to varied plant reproductive material as well as a legislative proposal to update EU rules on intellectual property rights accordingly.
MEPs introduced the ban on patents by amending a proposal of the European Commission to have two different categories and two sets of rules for NGT plants. NGT plants considered equivalent to conventional ones (NGT 1 plants) would be exempted from the requirements of the GMO legislation, whereas for NGT 2 plants with more complex modifications this legislation adapts the GMO framework to those NGT plants.
The proposal has to be discussed with the member states before it can be adopted. Whether this will be possible before the European elections of June is uncertain.
Criticism
The proposed ban has been criticized by both industry and environmentalists. In a press release issued two weeks ago, when the Committee on Environment, Public Health and Food of the EP had adopted the proposal, the lobby group IFOAM Organics Europe wrote: ‘This rushed legislative process to deregulate NGTs goes against the interest of European breeders, farmers and citizens. Today’s vote by MEPs in the Environment committee leaves too many issues about risks, patents and the right of farmers and consumers to avoid NGTs, unsolved. (…) Claiming to address the patent issue with an amendment and a report is wishful thinking, but far behind reality.’ IFOAM called for the plenary 6 February vote to be delayed.
In Science Business, Garlich von Essen, secretary general of seed industry association Euroseeds, said an amendment to the NGT regulation is not the right arena to strike a balance between firms which develop technologies and the use of these by small companies. ‘It will not be done with two or three trilogue meetings.’
Last week, the epi wrote on its website: ‘epi, together with other associations and companies has called upon MEPs to reconsider the proposed amendment to ban patents on NGT plants, because without adequate 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.
New technologies such as gene editing (e.g. CRIPR-Cas9) and NGTs offer new opportunities. However, they require significant investments. The ability to protect newly created traits with patents is therefore an essential component to secure sustainable investments in the creation of innovative crops that help farmers to keep up productivity in times of climate change and help to introduce more sustainable cropping systems.
The MEPs seem to be motivated by concerns that patents may limit breeder´s and farmer´s access to these novel plant materials. It is important to note in this connection that already today, the scope of the patent protection is limited by the general research exemption in European patent law and by the breeders’ exemptions implemented also by many EU Member States as well as in the recently implemented EU unitary patent system.
Moreover, the Biotech Patent Directive, the EU Plant Variety Regulation as well as the Unified Patent Court Agreement all contain provisions allowing farmers to save protected seeds for using it in a next cultivation cycle on their own farm. Small farmers do not have to pay anything.
Finally, over the last years, the Administrative Council of the European Patent Organisation has introduced provisions into the European Patent Convention to exclude from patentability plants or plant material, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process.
A solution should be reached that acknowledges the importance to gain access on fair licensing terms to genetic material especially for small market players whilst respecting the importance of patent protection for trait innovators.’
_____________________________
To make sure you do not miss out on regular updates from the Kluwer Patent Blog, please subscribe here.
Kluwer IP Law
The 2022 Future Ready Lawyer survey showed that 79% of lawyers think that the importance of legal technology will increase for next year. With Kluwer IP Law you can navigate the increasingly global practice of IP law with specialized, local and cross-border information and tools from every preferred location. Are you, as an IP professional, ready for the future?
Learn how Kluwer IP Law can support you.
The following section of proposed Recital (45a) makes for interesting reading:
“in order to avoid patents being granted or patent applications being submitted between the date of the entry into force of this Regulation and the application of its provisions, it should be ensured that plant material is excluded from patentability from the day of entry into force of this Regulation. For patents already granted or pending patent applications covering plant material, the effects of patents should be further limited”.
By seeking to apply the ban to existing patents and patent applications, it would appear that MEPs are seriously considering giving RETROACTIVE effect to the ban on patent rights. If I am not mistaken, that would represent a clear violation of European Human Rights Law, including Article 1 of Protocol 1 to the ECHR (a provision relating to rights in property which, as clarified in ECtHR case law, also includes intellectual property).
How the EPO and the European courts would deal with any retroactive ban is an interesting question, to say the least.
The EP calls for “a ban on patents for all plants obtained by New Genome Techniques (NGT plants), plant material, parts thereof, genetic information and process features they contain”. I am still puzzled as to what exactly this description means, but it seems that the exclusion from patentability called for is much broader than NGT plants.
Importantly, the EP proposes to open the EU Biotech Directive 98/44/EC, to not only ban patents on NGT plants, but also patents on plants obtained by (classical) mutagenesis or cisgenesis, with retroactive effect as already highlighted in a previous comment.
The proposal to open up the Biotech directive, combined with the notion that a ban on patents would be beneficial for affordable prices and innovation, leading to opportunities for small and medium enterprises, should be very worrying for the entire biotechnology sector.
Proposed Recital (45a) also contains some interesting reasoning from the Parliament. That is, it indicates that “NGT plants should NOT be subject to patent legislation, but SHOULD for the protection of intellectual property SOLELY be subject to the Community Plant Variety Rights (CPVR) system”. The reasons given are:
– “to safeguard the freedom to operate and the breeders’ exemption for varieties”;
– “It should be ensured that breeders have full access to the genetic material of NGT plants”;
– “Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder’s exemption)”; and
– the CPVR system “allows the use of the breeder’s exemption”.
As I understand it, the reasoning is that patents should not pose a FTO issue for any plant breeder that wishes to create and then commercialise a new variety that embodies a potentially patentable characteristic of a marketed (NGT) plant.
For me, this reasoning poses a question: other than potentially serving the commercial interests of plant breeders, what other purpose(s) will be served by the proposed patent ban?
In common with patents, CPV rights are intellectual property that serve a commercial purpose and can prevent commercialisation of certain plants (or seeds) without the consent of the rights holder. We can therefore conclude that the purpose of the patent ban is not to remove all FTO barriers for breeders.
In addition to the various plant-related exemptions in the UPCA (and national patent laws), we should remember that it is the EPO’s practice (in view of Rule 28(2) EPC) to require the insertion of disclaimers to plants that can be produced by conventional means. This should mean that plant breeders need not fear being sued for infringement for selling plants that they have obtained by conventional means from plants that are not subject to patent protection.
With the above in mind, it seems to me that the principal effect (if not the underlying intention) of the proposed patent ban will be to provide plant breeders with the freedom to COMMERCIALISE new varieties derived from NGT plants. Thus, in essence, the patent ban appears to aim to transfer commercial profits from those producing new NGT plants to those using such plants to produce new varieties.
I am all for helping small companies to thrive and compete. But I have to ask: if CPV rights become the only IP protection available, will that be sufficient to encourage companies to invest in creating new NGT plants that address current challenges (eg relating to climate change and/or the spread of pests or diseases)? If not, then does this mean that banning patents on NGT plants means that everyone loses? Whilst I do not know the answer to this question, I think it might be wise to apply the precautionary principle and to find out the answer before implementing the proposed ban.
Can the European Parliament have a say on the patentability in the non-EU member states of the EPC?
Rule 28 EPC is a clear example on how the European Parliament can impose its wishes also to non-EU member states.
The EP doesn’t impose anything on the non-EU countries, it decides what should apply in the EU countries, it doesn’t care how the EPO then complies with its directives, it can do whatever it wants, the important thing is that it complies for the EU countries, how it does it and how it treats the non-EU countries is the EPO’s problem alone.
The link with R 28 EPC is interesting, especially when one looks at G 3/19.
Some of the new seeds obtained by NGT are meant to correspond to seeds obtained in the “standard” way of selection, simply that the selection is achieved quicker with the help of gene scissors.
It is clear that for “standard” selections there is no patent protection available, cf. R 28(2) EPC and G 3/19.
Why should then those seeds obtained by NGT get patent protection if the aim is simply to do what nature and normal selection can achieve?
I do not disguise having some sympathy with the ban on patents for all types of NGT seeds.
It will be interesting to see which lobby will prevail.
That in Europe only recognised seeds are allowed is already a scandal on its own. No need to add more.
As seeds obtained by NGT are meant to correspond to seeds obtained in the standard way, those seeds should be protected under the UPOV and not with patents.