A controversial ruling saw the EPO back the patentability of plants produced by biological processes, with big repercussions for agri-tech. Michael Roberts and Daniel Shaw explain the ruling. This article was originally published in the June edition of Intellectual Property Magazine. Click here to view the article.
In combined decisions G 2/12 and G 2/13, the Enlarged Board of Appeal (“EBA”) of the European Patent Office (“EPO”) has ruled that plants and plant material produced by essentially biological processes are not excluded from patentability under Article 53(b) of the European Patent Convention (“EPC”). We assess here the legal developments that led to these decisions and their relevance to individuals and organisations in the agri-tech sector.
In 2012, the EBA handed down combined decisions G 2/07 (“Broccoli”) and G 1/08 (“Tomato”), which related to the Article 53(b) EPC prohibition of granting European patents for “essentially biological processes for the production of plants”. In those decisions, the EBA stated that a non-microbiological process for the production of plants which contains conventional plant breeding steps of sexually crossing and then selecting plants is excluded from patentability as being “essentially biological”, even if it contains “a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing”. However, a process for the production of plants is not excluded from patentability under Article 53(b) EPC if it “contains within the steps of sexually crossing and selecting an additional step of a technical nature, which by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing”. The effect of G 2/07 and G 1/08 is that innovators cannot obtain European patent protection for plant breeding methods merely involving conventional crossing and selection.
Following G 2/07 and G 1/08, the patentees of the Broccoli and Tomato patents (Israeli Ministry of Agriculture and Plant Bioscience Limited, respectively) amended the granted claims of their patents by limiting to product claims and deleting unallowable process claims.
The claims of the Tomato patent EP1211926, as amended, relate to a tomato fruit which is naturally dehydrated as evidenced by wrinkling of its skin. The claims of the Broccoli patent EP1069819 as amended relate to edible brassica plants having increased levels of anticarcinogenic glucosinolates, where the plants are produced by a defined conventional breeding process.
Under European patent law, protection conferred by a product claim encompasses the production of the product. In view of this, the EPO Boards of Appeal handling the Tomato and Broccoli appeal cases T1242/06 and T83/05, respectively, considered that the patenting of plants generated by essentially biological processes would render the Article 53(b) EPC exclusion “completely ineffective” because such patents would provide broad protection encompassing the generation of the plants by means of essentially biological processes, “thereby frustrating the legislative purpose behind this process exclusion”. These Boards of Appeal therefore referred further questions to the EBA on the interpretation of Article 53(b) EPC.
G 2/12 & G 2/13 Decisions
In G 2/12 (“Tomatoes II”) and G 2/13 (“Broccoli II”), the EBA ruled that the Article 53(b) EPC exclusion on the patentability of essentially biological processes for the production of plants “does not have a negative effect on the allowability of a product claim directed to plants or plant material…[even if] the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application”. Thus, the exception to patentability in Article 53(b) EPC in respect of plants is limited to process or method claims (as well as specific plant varieties).
In response to the concerns of the referring Boards of Appeal, the EBA stated that it is of no relevance that the protection conferred by a product claim encompasses the production of the claimed product by means of an essentially biological process for the production of plants.
In addition, the EBA commented on the patentability of product-by-process claims, as found in the Broccoli patent. According to the EBA, the mere fact that a product-by-process claim includes an essentially biological process for the production of plants does not prevent the EPO from granting a patent for such a claim. However, the patent-eligibility of product-by-process claims depends on whether the products as such fulfil the requirements for patentability (such as novelty, inventive step and industrial applicability) and “the additional (restrictive) conditions established in the case law of the [EPO] boards of appeal”.
Relevance To The Agri-tech Sector
The EPO’s approach to the examination of plant-related European patent applications has been clarified. In particular, the EPO can now resume granting European patents for plants and plant material that have been generated by conventional breeding methods as well as by methods involving technical intervention to introduce or modify a trait, even though essentially biological breeding methods themselves cannot be patented.
Thus, innovators working in the agri-tech sector seeking to obtain protection for their novel and inventive plants should continue to file European patent applications for these plants, even if they have been generated by conventional breeding methods. To be granted, such patent applications will, of course, need to meet all of the requirements of the EPC, the most challenging of which may often be inventive step. The EPO is more likely to accept the inventive step of plants or plant material that have been produced by non-obvious approaches or which demonstrate surprising technical effects. It is therefore important for innovators to catalogue in detail the developments relating to prospective new plant lines. A description of all surprising or non-obvious developments can be helpful for new patent applications.
The EBA’s judgments in the G 2/07, G 1/08, G2/12 and G 2/13 decisions also provide useful guidance on appropriate patent drafting for patent applications relating to agri-tech inventions. In particular, for patent applications relating to plants generated by conventional breeding methods, it is important for applicants to include novel product claims (which may include product-by-process claims), even where the focus of the patent application for non-EPC territories may be on methods for the production of such plants. However, such product claims should not be limited to specific plant varieties owing to the Article 53(b) EPC exclusion on patenting plant varieties per se.
In addition, the EBA’s rulings provide applicants of pending European patent applications with the possibility of overcoming or circumventing Article 53(b) EPC objections by reformulating any claims that are directed to essentially biological processes into product or product-by-process claims. However, the allowability of such reformulated claims will be dependent on the availability of adequate basis in the application as filed.
Agri-tech innovators should also bear in mind that certain countries such as Germany and the Netherlands have amended their national patent law to exclude from patentability products (including plants) that have been produced by essentially biological processes. Thus, it is expected that the German and Dutch patent offices will not follow EPO practice in this field for patent applications filed directly in those countries. It is not clear if the validity of patents granted by the EPO for plants or other products produced by essentially biological processes will be challenged in the Dutch and German courts. Nevertheless, for agri-tech innovators wishing to obtain patent protection for plants and products produced by essentially biological processes, the filing of European patent applications rather than national patent applications is likely to provide broader coverage within EPC states.
Furthermore, the discrepancy between EPO practice and German and Dutch national patent law as noted above may act as an incentive for patentees not to opt out plant-related European patents from the jurisdiction of the Unified Patent Court (“UPC”) when the UPC comes into force (expected in 2016 or 2017). This is because the UPC would not follow German or Dutch national law, but it would instead be expected to follow the EPC and corresponding EPA case law.
Although G 2/12 and G 2/13 in principle allow innovators to obtain patent protection for newly-developed plants, they do not negate the above-mentioned prohibition in Article 53(b) EPC on patenting of specific plant varieties. Instead, plant breeders should continue to seek plant variety rights in order to protect their new plant varieties.
Another implication of G 2/12 and G 2/13 is that third party patents could be used to block the commercialisation of plants or plant material produced by more technical methods as well as traditional breeding methods in Europe. As a consequence, agri-tech companies and organisations will need to ensure that their freedom to operate is not inhibited by third party patents. We recommend that relevant published patent applications and granted patents are reviewed regularly and professional freedom-to-operate patent opinions obtained where appropriate.
The EBA’s decision in G 2/12 and G 2/13 has been criticised by various campaign groups who are against plant patents. Voices within such groups as well as in the European Parliament and in certain European national governments advocate that, in view of the EBA’s decisions, the EPC and European Union patent law should be amended to exclude from patentability plants and plant materials produced by essentially biological processes. It will be prudent for agri-tech innovators who are in favour of the EBA’s decisions to monitor these developments and ensure their own opinions are heard.
The EBA’s answers to the referred questions in G 2/12 and G 2/13 do not relate to the patentability of animals even though Article 53(b) EPC refers to essentially biological processes for the production of animals. It will therefore be interesting to see how G 2/12 and G 2/13 will be applied to European patent applications directed to animals and animal products. We would expect product claims directed to such animals and animal products to escape the Article 53(b) EPC exclusion for the same reasons as provided by the EBA in G 2/12 and G 2/13. Thus, our above advice should be applicable to those working in the animal agri-tech sector as well as those working in the plant agri-tech sector.
In summary, although G 2/12 and G 2/13 may be unpopular among some campaign groups, we consider that they will be warmly received by agri-tech innovators seeking to protect their plant-related intellectual property via European patents.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.