http://ipkitten.blogspot.com/2024/02/european-parliament-votes-to-exclude.html
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.
| 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)
Content reproduced from The IPKat as permitted under the Creative Commons Licence (UK).