The European Parliament has voted to ban patents for gene-edited plants. The vote related to an amendment of the European Commission's proposed legislation seeking to relax the regulatory rules on gene edited plants. The EU parliamentary vote is not legally binding, and has no immediate effect on the patentability of gene editing plants. Nonetheless, the EU Parliament's stance is likely to unnerve an already embattled European agritech industry and will do nothing to encourage innovation into new plant products in Europe.
Making new plants
New types of plants may be produced by natural breeding methods ("essentially biological process") which select for genes of interest. New types of plant may also be produced by genetic modification, which involves inserting genetic material (transgenes) from another species into a plant's genome. However, genetic modification of plants is mired in safety concerns that it might produce dangerous mutant plants. Plants produced by genetic modification are thus subject to stringent EU regulation.
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| Too many transgenes? |
However, the last decade has seen the rise of a new type of technique for genetic manipulation that doesn't use transgenes: gene editing. Gene editing technologies (NGTs), such as CRISPR/Cas9, act like molecule scissors to precisely modify an organism's own DNA (mutagenesis). Gene editing is considered safer than introducing foreign DNA, and is free from the Frankenstein-like connotations of genetic modification. Gene edited plants may in some cases be indistinguishable from plants produced by traditional breeding methods. Gene edited plants are considered important tools for bolstering global food security in the face of climate change. Plants may be modified by gene editing to increase yield, improve resistance of pests, lengthen shelf life and improve drought resistance. Outside of the EU, a number of gene editing plant products are already on the market.
In Europe, however, gene edited plant products still face a challenging regulatory environment. A hard blow to Europe's agritech industry came in the form of the 2018 CJEU ruling that organisms obtained by gene editing techniques should also be considered "genetically modified organisms (GMOs)" and subject to the same strict obligations laid down by the GMO Directive (IPKat).
Giving with one and taking with the other
In recent years, there has been growing pressure for the EU to relax its strict provisions for gene edited plant products. There is increasing evidence for the safety of gene editing techniques and the stifling impact of the current regulatory environment on the EU agritech industry. In the UK, the laws on the commercialisation of gene editing plants have already been relaxed.
Last year the European Commission (EC) issued a proposal to relax the rules on gene-edited plants. The EC proposed that plants produced by gene editing which do not contain genetic material from another plant species should be considered equivalent to plants produced by traditional breeding methods.
However, the proposal from the EC to classify gene edited plants as equivalent to plants produced by natural breeding methods, has now resulted in a new threat for the industry, namely the exclusion of gene edited plant products from patentability. Plants produced by natural breeding methods ("essentially biological processes") are excluded from patentability in Europe following G 3/19, Pepper (IPKat). Currently, however, these are no exclusions to the patentability of genetically modified or gene edited plants. The original EC proposal on relaxing the regulation on gene edited plants also did not mention patents. However, when considering the EC proposal this month, the MEPs in the EU Parliament introduced amendments that would exclude all gene edited and genetically modified plants from patentability. According to the European Parliament's summary: "MEPs want a full ban on patents for all NGT plants, plant material, parts thereof, genetic information and process features they contain, to avoid legal uncertainties, increased costs and new dependencies for farmers and breeders.".
The proposed legislation, including the MEP's amendments, was then passed with the narrow margin of 307 to 263 votes, with 41 members abstaining.
The EPO versus EU on the patentability of plants produced by essentially biological processes
The complicated relationship between the EU and the European Patent Office was infamously highlighted in the Broccoli/Tomato (G 2/21) and Pepper (G 3/19.) cases. In G 2/12 (Broccoli/Tomato II) the EBA found that the EPC did not exclude plant and animal products produced by essentially biological (i.e. natural) processes from patentability. However, subsequent to Broccoli/Tomato II (G 2/12) the EU Commission issued a (non-legally binding) opinion that the EU Biotech Directive excludes products produced by natural processes from patentability. The Administrative Counsel (AC) of the EPO then introduced a new Rule explicitly excluding products produced by natural processes from patentability. The new Rule was thus in conflict with the EBA's interpretation of the EPC in Broccoli/Tomato II (G 2/12). This conflict eventually led to another referral EBA asking essentially the same question as in G 2/12 (Broccoli/Tomato II), namely are products produced by essentially biological processes excluded from patentability?
In a remarkable demonstration of legal fudge, the EBA in Pepper (G3/19) found that a "dynamic interpretation" of the Articles could be adopted in view of the new Rule introduced by the AC. The EBA concluded that the new Rule changed the correct interpretation of the Articles such that plants produced by essentially biological processes were now excluded from patentability.
The agritech industry thus faces challenges on multiple sides. On the one hand, plants produced by essentially biological processes are excluded from patentability. On the other hand, plants produced by gene editing and genetic modification are subject to very strict EU regulation. Were it to come into force, the most recent EC proposal might encourage innovation by producing a more permissible regulatory environment. However, the European Parliament's amendments might then simultaneously stifle innovation by removing critical IP protections.
Final thoughts
The EU parliamentary vote is not legally binding, and has no immediate effect on the patentability of gene editing plants. The European Commission's proposal and the European Parliament's amendments would still have to be agreed by the European Council. The Council may adopt the proposal, propose its own amendments and/or send it back to the European Parliament. Neither the EPC nor the EU Biotech Directive as they currently stand exclude gene edited plants from patentability. Changing EU legislation to exclude gene editing plants from patentability would likely take many years and a great deal of protracted negotiation between member states. It would also require amendments to the EPC (absent more dynamic interpretation). It therefore seems unlikely that the European Parliament's amendments would ever be adopted. However, as we saw with G 3/19, the EPO is not immune from political influence in the form of non-binding legal opinions from the EU. As the EU parliament begins negotiations with EU member states on the proposal, the lobbyists on both sides have already come out in force. The vote in the European Parliament is only the first shot in the fight to maintain patent rights for gene edited plants.
Further reading
- CJEU rules that mutated organisms are covered by the GMO Directive (Aug 2018)
- Has the EU lost its way on gene-editing? (Sep 2019)
- Lessons in legal fudge from the EBA in Pepper (G3/19) (May 2020)
Reviewed by Rose Hughes
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Sunday, February 11, 2024
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To say that G 3/19 provides a "remarkable demonstration of legal fudge" is an understatement. This is because that decision was based upon the demonstrably false premise that a "legislative intent" can be demonstrated by a body (the AC) that was not the legislator for the provision in question. Personally, I view G 3/19 as instead providing a remarkable demonstration of the power of political will to override the rule of law.
ReplyDeleteTurning to current events, I would not assume that it will necessarily take a long time to change EU legislation to exclude NGT plants from patentability. All that would be required is for the NGT Regulation to pass into law including the patent ban proposed by the European Parliament. This would then make the AC competent (under Art 33(1)(b) EPC) to bring the EPC "into line with ... European Community legislation relating to patents". The voting rule of Art 35(3) EPC means that a unanimous vote at the AC would be required to effect that change. However, I would be surprised if any AC delegation would be prepared to vote against alignment of the EPC with EU law. Also, the Regulation will have direct effect in EU Member States, and will likely (eventually) be incorporated into the EEA Agreement.
Perhaps a more interesting question is whether the UK will align its national laws with any NGT Plants Regulation that includes a ban on patents for those plants (as well as plants produced by random mutagenesis or cisgenesis). The Genetic Technology (Precision Breeding) Act 2023 means that the UK has chosen to diverge from the EU on the regulatory rules for NGT plants. It would therefore make perfect sense for the UK to also diverge on the patentability rules for such plants. Indeed, even if the EPC were amended to include a patent ban on NGT plants, there would be no obligation on the UK to introduce such a ban into the Patents Act. This is because neither Section 76(A) nor Schedule A2 is mentioned (in Section 130(7)) as being "framed as to have, as nearly as practicable, the same effects in the United Kingdom as" the corresponding provision of the EPC, i.e. Article 53 EPC.
Another interesting point to watch is whether any ban, if passed into law, has the retroactive effect (against pending applications and granted patents) that the European Parliament has set out in their proposed Recital (45a). I would hope not, as that would contravene Article 1 of Protocol 1 of the ECHR. It would also cause major headaches for the AC, as even the EBA in G 3/19 was not prepared to accept a retroactive ban.
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. I would thus assimilate those seeds to seeds obtained in the standard way.
ReplyDeleteIt is clear that for “standard” selections of seeds, there is no patent protection available, cf. R 28(2) EPC and G 3/19.
Whether one approves or not G 3/19 is not really relevant. It does however exists and cannot be ignored. I personally do not like G 3/19 as "dynamic interpretations" are too dependent from the zeitgeist.
The real question to ask is thus why should those seeds obtained by NGT with the help of gene scissors get patent protection if the aim is simply to do what nature and normal selection can achieve?
As seeds obtained by such NGT are meant to correspond to seeds obtained in the standard way, those seeds should be protected under the UPOV and not by patents.
That seeds obtained not just by accelerating selection with the help of gene scissors, are open to patent protection is disturbing to say the least.
The position of the European Parliament banning patenting of seeds obtained by NGT is thus fully understandable and is to be approved.
If patenting is maintained, the information of the consumers about the treatment by NGT is a must.
Furthermore, that in Europe only recognised seeds are allowed is already a scandal on its own.
No need to add more.
Why is it disturbing that some (but not all) gene editing research on plants might lead to an invention that can be protected by a patent?
DeleteBy drawing an equivalence between the seeds of an individual NGT plant and the seeds of a "conventional" plant, I think that you are missing the point that patents are granted for (technical) inventions and not for individual plant varieties. That distinction was the subject of G 1/98, where the EBA decided that "A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC, even though it may embrace plant varieties". For the reasoning behind that conclusion, see the EBA's discussion of Question 2.
In essence, it is a case of horses for courses. If you have developed a new plant variety, then UPOV protection will be appropriate. However, patents become appropriate (and indeed necessary) if you have done far more than that, such as identifying a new way of editing genes that is broadly applicable to a wide range of plants and that provides (unexpected) advantageous technical effects.
The aim of gene editing, is to my knowledge, to create new varieties, more resistant for instance to drought, the action of herbicides or other illnesses which can affect plants.
DeleteI am thus not missing anything. Identifying a new way of editing genes has been patented. I remain weary of gene edited plants, even if I am told that editing certain genes is not dangerous as it only does what classical selection achieves but not as quick. Who knows? Neither you, nor myself.
I also maintain that the ban on patenting wished by the European Parliament is to be supported. The problem of plant patenting is a societal problem and the best forum to decide upon is indeed a parliament, be it national or European. That lobbyists want patenting of plants is a fact. But should patents be granted for gene edited plants is the real question.
If patents cannot be banned, at least information of the public on gene edited plants is an absolute necessity. But the lobbies behing gene editing plants, want this question to be swept under the carpet. One wonders why?
Last but not least, don’t you think that G 1/98 has been superseded by G 3/19, in spite of all the defects of the latter.
If a genetic modification / editing invention can be implemented in many different plants (and/or many different ways), then only patents will be capable of providing the inventor with a reasonable reward for their disclosure of the invention.
DeleteIn any event, it is highly doubtful that UPOV protection alone will provide sufficient incentive for companies, whether large or small, to invest in the research required to identify gene edits providing plants having the characteristics that Europe will need to address current (climate-related) challenges. This means that introducing a ban on patents for NGT plants is likely to make it much harder for European agriculture to adapt to climate change. In other words, this is a case of being careful what you wish for.
Regarding G 1/98, that addressed a completely different question (and point of law) to G 3/19. So no, G 1/98 has not been "superseded by G 3/19".
You carefully avoided to reply to the question about the information of the public about plants which are genetically modified.
DeleteIf every type of gene engineering would be as inocuitous as you claim, there should be no harm in making this clear. Why the constant plea not to inform the public? There must be reasons.
The problem is societal and its solution should not be dictated by private interests.
One way for lobbies to push their ideas through is to claim that what is good for them is good for society at large. There are enough examples in recent history to show that the contrary is true. The blackmail with jobs and investments has to stop. The seed breeder also gets its reward for disclosing its improvements to plants by selection.
In the absence of patents on genetically modified plants why should it be more difficult for Europe to adapt to climate change? I claim the contrary is true. It might not be allowed to export plants protected elsewhere by patents, but as far as agriculture is concerned, Europe is anyway a net importer of agricultural goods.
To reassure you, I am not a dangerous leftist wanting to bereave inventors and their employers from the benefits of the patent system. I simply want to have the assurance that what ends up in my plate is not dangerous for my health.
Could you explain what is different between G 1/98 and G 3/19. They both deal with Art 53(b).
I would not read anything into my silence on the question about the information of the public about plants which are genetically modified. This is because my reason for not saying anything is that I feel that I do not (yet) know enough about that topic to make any kind of informed comment. Perhaps you could help me here by explaining the main arguments for and against providing information to the public?
DeleteThe difference between the two EBA decisions is that they interpret two different exclusions that are both covered by Article 53(b) EPC. That is:
- G 1/98 interprets the meaning of "plant or animal varieties"; whereas
- G 3/19 interprets the meaning of "essentially biological processes for the production of plants or animals", in the light of new Rule 28(2) EPC, which states that "Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process".
Thus, the ruling in G 3/19 does not affect all of the "plant or animal varieties" that were the subject of G 1/98, but instead only those plants or animals that are "exclusively obtained by means of an essentially biological process".
For a more complete explanation of the different roles of UPOV and patent protection, I would recommend reading the position paper produced by AIPPI:
https://www.aippi.org/news/aippi-position-paper-on-new-genomic-technique-ngt-plant-patenting-proposal-of-the-european-parliament/
I have to admit that I do not understand the relevance of your comment that "Europe is anyway a net importer of agricultural goods". This suggests to me that you did not understand the point that I was trying to make, which is that the absence of patent protection is likely to disincentivise the production of gene-edited plants in Europe and/or for the European market.
It is unclear whether the absence of patent protection will incentivise (the marketing of) plants obtained by "traditional" breeding. There is simply no evidence to suggest that this would happen. In any event, any gain in plants obtained by "traditional" breeding will not make up for the loss of NGT plants. This is because, combined with research into the roles of various plant genes, gene editing can be a very powerful (and fast) technique for identifying plants having advantageous characteristics.
Perhaps you are happy with European agriculture moving into the slow lane, i.e. sticking with traditional breeding only. Personally, I think that our response to the climate emergency should be to use our most powerful (and fastest) techniques to help our agriculture to adapt.