Following the publication of Directive 98/44/EC (July 1998) and Decision G1/98 (December 1999) the eligibility for plants to patent protection in Europe had raised no particular difficulties and nothing but the patentability of essentially biological processes managed to generate passionate discussions which resulted in an interpretation by the Enlarged Board of Appeal of the European Patent Office (EPO) via Decisions G1/08 and G2/07 (December 2010).
However these decisions, which excluded the processes based on sexual crossing of whole genomes of plants followed by selection, have recently provided an opportunity to reopen the debate on the patentability of plants per se, when obtained by such methods.
The Enlarged Board of Appeal was again referred to by the same parties. This was the start of a new wave of passionate amicus curiae and of various parliament initiatives that also encouraged the Chairman of the EPO to order the suspension of all the proceedings affected by the outcome of the current decision.
Under the European Patent Convention (EPC), patent protection is possible for inventions in all technological fields, including agriculture.
Article 53(b) EPC excludes “plant or animal varieties or essentially biological processes for the production of plant or animals” from patent protection. The reason for such exclusion, as provided by the legislator, is to avoid dual protection of plant varieties by means of a patent and by means of the sui generis Plant Breeders’ Rights (PBR) system.
In Decision G1/98, the Enlarged Board of Appeal of the EPO had to answer the question of whether a claim directed to a plant is acceptable if it embraces plant varieties.
The Enlarged Board of Appeal had considered that such a claim does not fall within the provisions of Article 53 (b) EPC, although plant varieties are included within the scope of protection afforded by the claim with the proviso that the technical teachings of the invention can be implemented in an indefinite number of plant varieties.
This notion also appears in Article 4.2. of Directive 98/44/EC of 6 July 1998 relating to legal protection of biotechnological inventions, in Rule 27 (b) EPC and in Article L611-19, II) of the Intellectual Property Code (IPC) which state that “Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.”
With regard to the exclusion of essentially biological processes for the production of plants, the phrase «essentially biological» in Article 53 (b) EPC has been subject to interpretation. Indeed, Article 2.2 of Directive 98/44/EC Rule 26(5) EPC and Article L611-19, 3°) IPC define – and therefore interpret – an essentially biological process as a «process that consists entirely of (or using exclusively) natural phenomena».
Questions relating to the interpretation of this notion of an essentially biological process have been addressed in Decisions G1/08 and G2/07 known as the “Tomato patent case” and “Broccoli patent case”. The Enlarged Board of Appeal of the EPO decided to ignore Rule 26(5) EPC and chose to render its own interpretation.
It concluded as follows: “any process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being ‘essentially biological.’”
Furthermore, the Enlarged Board decided that such processes do not escape exclusion merely because they contain a step of a technical nature which only serves to enable or assist the performance of the steps of sexually crossing or selecting plants; for example, this is the case for processes in which molecular markers are used.
Following this decision, both cases were referred to their respective Boards of Appeal in order to continue the procedure based on the claims directed to plants since the technical feasibility of the claimed plants was not confined to a particular plant variety. Consequently, one could expect that the granting of patents would be limited to product claims directed to the plants per se.
However, the opponent in the “Tomato patent case” raised the question of the acceptability of product claims – directed to plants – which are produced by processes which have just been excluded from patentability. The opponent argued that in accepting such product claims they would escape the exclusion and would thus deprive the decision of all substance.
The Board of Appeal decided to further refer this case to the Enlarged Board of Appeal.
In this second referral, G2/12, the question asked was whether the exclusion of essentially biological processes for the production of plants in view of the provision of Article 53(b) EPC can have an adverse effect on the acceptability of a product claim directed to plants which have been produced by such processes. The Board of Appeal in charge of the “Broccoli patent case” had delivered and referred similar questions to the Enlarged Board of Appeal under number G2/13.
The opponents to patentability argue that claims directed to plants, which are the result of essentially biological processes, make the provision relating to the exclusion of said processes completely irrelevant. This is because product claim authorizes the patentee to prohibit third parties from exploiting the (essentially biological) process for the production of the product, provided that said claimed product can only be obtained from such a process.
Conversely, according to the patentees and defenders of plant patentability and the Chairman of the EPO, the EPC establishes a clear distinction between the patentability requirements on the one hand and the scope of protection afforded by a patent on the other.
Furthermore, according to same, the EPC recognizes other situations where methods are excluded from patentability, while the claims directed to the products used in the methods are acceptable. Thus, a patented drug gives indirect protection over non patentable methods for treatment of the human or animal body in which the drug is used.
The ruling by the Enlarged Board of Appeal is not expected for some time and it is important to remember that these questions have already inflamed public opinion as well as legislators at various national and community levels throughout Europe.
Indeed, the European parliament has adopted a resolution inviting the EPO to exclude plants obtained by essentially biological processes from patentability (Resolution of the European parliament of 10 May 2012 on the patentability of essentially biological processes).
Similarly, the German parliament has recently modified its national law by introducing an amendment specifying that plants obtained from essentially biological processes are excluded from patentability.
Furthermore in the case Cresco vs. Taste of Nature, a Dutch jurisdiction was faced with the same questions. In that case, the question was based on the validity of the product claims directed to radish plants with particularly high levels of anthocyanin and which were obtained by conventional crossing and selection, i.e. by an essentially biological process (EP1290938).
At summary proceedings, in the first-instance jurisdiction, on 31 January 2012, the judge of the District Court of The Hague considered that the claims directed to plants are not eligible when the plants are obtained by an essentially biological process which is excluded from patentability.
Conversely, in the substantive proceedings, in May 2013, the same Court ruled that the claimed radish plants shall are patentable under Article 53 (b) EPC. According to the Court, and taking into account the distinction made by the EPC between processes and products, the use of the word “process” in Article 53 (b) EPC shows that the legislator deliberately chose not to include the products in the scope of this part of the Article.
In the summary appeal proceedings in May 2013, The Hague Court of Appeal also considered that the exclusion relating to processes should not apply to the product since only the subject matter as defined by the claims should satisfy patentability requirements.
Thus, according to the Dutch jurisdictions, in Article 53(b) EPC essentially biological processes for the production of plants are excluded from patentability, but this provision does not apply to products, taken as such, obtained therefrom.
In the EPO’s press release of October 2013 (OJ EPO 10/2013, page 449), the Chairman of the EPO decided that all substantive proceedings before the EPO First-Instance departments (examining and opposition divisions) relating to patent applications or patents that have claims directed to plants obtained by an essentially biological process and where the outcome depends entirely on the Enlarged Board of Appeal’s decision will be suspended ex officio until the Enlarged Board of Appeal issues its decision; nevertheless search procedure will not be affected.
It is however still possible on the one hand to file patent applications directed to plants obtained by essentially biological processes and on the other hand to file oppositions to patents relating to such plants. However such applications or opposition will not be examined until a decision is given by the Enlarged Board of Appeal.
As suspected, the Enlarged Board of Appeal’s decision is under the spotlight and already eagerly awaited by all the stakeholders, i.e. supporters or opponents of patents directed to plants. In any event, and regardless of the decision, it will have a major impact on practices and filing strategies for patent applications directed to plants in Europe and almost certainly beyond.
