The European Patent Office's Enlarged Board of Appeal (EBoA) has now had a second look and issued its decisions on the so-called 'Broccoli' and 'Tomato' cases. In its decisions, the EBoA considered whether the claimed subject-matter relating to plants or plant parts produced by essentially biological processes was contrary to Article 53(b) EPC. Article 53(b) EPC states that: "European patents shall not be granted in respect of...plant or animal varieties or essentially biological processes for the production of plants or animals".
A process for the production of plants or animals is further defined in Rule 26(5) EPC as being "essentially biological" if it consists entirely of natural phenomena such as crossing or selection. As both cases were closely related, the EBoA considered them in consolidated proceedings, and issued its decisions as G 2/12 and G 2/13 on 25 March 2015.
Background to G 2/12 and G 2/13
G 2/12 is the result of a second referral to the EBoA from T 1242/06 and G 2/13 is the result of a second referral to the EBoA from T 83/05.
As explained in detail in edition 21 of this newsletter, February 2011 (see note 1), the first referrals from T 1242/06 and T 83/05 resulted in the EBoA decisions of G 1/08 and G 2/07 which held that:
- A process which contains or consists of sexually crossing whole genomes of plants and of subsequently selecting plants is "essentially biological" and excluded from patentability.
- A process does not escape the exclusion just because it includes a further technical step.
- Unless the further technical step 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 mixing the genes of the plant chosen for sexual crossing.
T 1242/06 concerned European patent number 1211926 which related to a method for breeding tomato plants that produce tomatoes with a reduced fruit water content. T 83/05 concerned European patent number 1069819 which related to a method for the production of Brassica oleracea with elevated levels of 4-methylsulfinylbutyl glucosinolates and/or 3-methylsulfinylpropyl glucosinolates. After G 2/07 and G 1/08, the cases were remitted back to the respective Technical Boards of Appeal, and the method claims were deleted. The patentees instead sought protection for the plants per se or the plants claimed in "product-by-process" claims.
The further question that arose in both T 1242/06 and T 83/08 was then whether the claimed subject-matter was excluded from patentability pursuant to Article 53(b) EPC. This issue in the context of product and/or product-by-process claims had not been covered by the first referrals to the EBoA. It therefore resulted in the further questions being referred to the EBoA as G 2/12 and G 2/13. The specific questions which were referred to the EBoA and their respective answers are set out on our website article of April 2015 (see note 2).
Decision of the EBoA in G 2/12 and G 2/13
Both of the patent proprietors and the opponent in T 83/05 made submissions in writing and at the oral proceedings before the EBoA. The opponent in T 1242/06 had withdrawn its appeal and did not file any submissions during the proceedings before the EBoA. The President of the EPO commented in writing and at the oral proceedings on both referrals. Various third parties also filed amici curiae briefs including plant breeders and plant breeders' associations. The interaction between patents and plant breeders' rights is discussed below.
One of the arguments presented by the opponent was that the product-by-process claims should not be allowed because the patent proprietor could describe the alleged invention by structural features. The referring Technical Boards of Appeal also questioned whether such an allowance could be seen as circumvention of the process exclusion in Article 53(b) EPC.
The EBoA has, however, decided that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material such as fruit or plant parts.
The EBoA held further that the allowability of such a product claim applies even if the only method available at the filing date of the patent application for generating the claimed plants or plant material is an essentially biological process. It was also deemed irrelevant whether the claimed product is defined as a product per se or in terms of a product-by-process claim referring to the excluded essentially biological process. An example of a product-by-process claim is in the form "Plant X obtainable from process Y".
The EBoA also decided that it is irrelevant that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process.
The EBoA reasoned that a reading of Article 53(b) EPC to the effect that a product obtained by an essentially biological process is excluded from patentability would require that the method applied would be traceable in the product. The EBoA concluded, however, that Article 53(b) EPC does not imply or even permit a broad reading of the process exclusion based on specific process elements that may or may not be traceable in the claimed product. Broadening the scope of the process exclusion would also introduce an inconsistency in the system of the EPC, as plants and plant material other than plant varieties are generally eligible for patent protection.
Further, the EBoA held that the fact that an applicant or patent proprietor chooses a product claim or product-by-process claim instead of a method claim directed to an essentially biological process for the production of a plant is not a circumvention of legal hurdles, but a legitimate choice to obtain patent protection for the claimed subject-matter.
Interaction with the protection of plant varieties
It can be seen from Article 53(b) EPC cited above that plant varieties are excluded from patentability in Europe. Even after G 2/12 and G 2/13, product claims or product-by-process claims directed to plants or plant material must not therefore claim a plant variety per se. New plant varieties are instead protectable under a sui generis system laid down in national and EU legislation based on the UPOV (see note 3) convention.
This sui generis system provides plant breeders' rights (PBR), also known as plant variety rights (PVR), to the breeder of a new variety of plant. The rights give the breeder exclusive control over the commercial exploitation of propagating material, such as seeds, cuttings, divisions and tissue cultures, and, under certain limitations, the harvested material of a protected variety.
There exists, however, a degree of tension as to how the PBR/PVR overlap and interact with patent rights. In particular, some exemptions from infringement of a PBR/PVR do not correspond to exemptions from infringement of the patents covering the same plants. The most important exemption of a PBR is the so-called breeders' exemption allowing breeders to use material of a protected variety to create a new variety. A similar exemption does not exist in patent law. A limited number of European countries, namely France, Germany, Switzerland and the Netherlands have introduced a form of breeders' exemption in their patent law. But their example has until now not been followed by other European countries
The overlap between PBR/PVR and patent rights has been the subject of litigation worldwide. In the decision of the US Supreme Court in JEM AG Supply, Inc v Pioneer Hi-Bred International, Inc (2001) 534 US 124, it was held that newly developed plant breeds are patentable subject-matter (under the remit of 35 USC §101), and the creation of a sui generis right (eg, the US Plant Variety Protection Act, 1970) does not limit the scope of patent protection. This decision has as a consequence that plant varieties as such in the US be protected by different types of intellectual property rights, utility patents, plant patents and plant breeders' rights UPOV type.
Although this is not the case in Europe where plant varieties per se are still only protectable with a PBR/PVR, G 2/12 and G 2/13 make clear that it is possible to patent new traits or characteristics of non-GM plants in a broad conceptual manner, whilst also maintaining the potential for a PBR/PVR to encompass a specific variety containing patented traits or characteristics. Article 12 of the so-called Biotech Directive holds a provision to solve conflicts between the holder of a patent and the holder of a PVR in a situation where the same subject matter is partly protected by a PVR as well as a patent.
What does this mean for applicants?
These decisions from the EBoA are good news for applicants seeking protection for non-GM plants in Europe. They mean that claims – whether in the form of product or product-by-process claims – will not be excluded from patentability just because they relate to a plant or plant materials. Applicants should, however, also consider how such patent protection can interact and overlap with PBR/PVR available for new plant varieties.