Frustrating news for the biotech industry, the European Patent Office (EPO) has decided to suspend all examination and opposition proceedings for patents concerning plants/animals that are obtained by means of essentially biological processes. This follows a recent non-binding Notice from the European Commission (EC) regarding the interpretation of certain aspects of Directive 98/44/EC (the so called “Biotech Directive”).
On 3 November 2016, the EC issued a Notice regarding the patentability of plants/animals that are obtained by means of essentially biological processes. This Notice expressed the view that “the EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes”.
The Notice specifically relates to recent decisions by the EPO Enlarged Boards of Appeal in the combined “Tomato I” and “Broccoli I” cases (G2/07 and G1/08) and the combined “Tomato II” and “Broccoli II” cases (G2/12 and G2/13). These decisions respectively found that while essentially biological processes making use of gene markers for selection do not concern patentable subject matter, plants/plant material obtained from essentially biological processes are patentable. Although these decisions are in line with the intended scope of the European Patent Convention (EPC), the Notice questions whether they would be in line with the Biotech Directive.
Directive 98/44/EC was adopted July 6, 1998, and arose from efforts to harmonize patent eligibility standards for biotechnological inventions among the different member states of the European Union. The Directive provides that the following inventions are not patentable:
- Plant and animal varieties (Article 4);
- Essentially biological processes for the production of plants or animals (Article 4);
- Human body and its elements (e.g., gene sequences) (Article 5); and
- Inventions whose commercial use contrary to ordre public or morality (e.g., processes of cloning human being, and processes for modifying the germ line genetic identity of human beings, uses of human embryos) (Article 6).
With respect to (2), Article 2 of the Directive defines essentially biological processes as processes consisting “entirely of natural phenomena, such as crossing or selection.” The Directive lays out a few examples of patentable subject matter, which appear to include microbiological products and processes (Article 4), biological materials possessing specific characteristics as the result of the invention and processes for the production of such biological materials (Article 8), and products containing genetic information (Article 9). However, the Directive does not specifically address the patentability of products made by essentially biological processes.
EPO Enlarged Board of Appeal Decisions
The recent attention to this issue was sparked by March 25, 2015 decisions from the EPO Enlarged Board of Appeal addressing the patentability of plants and plant parts produced by conventional breeding methods. The decisions were rendered in G 2/12 (“Tomato II”) and G2/13 (“Broccoli II”).
Tomato II involved EP Patent No. EP 1211926, which included the following exemplary product claims:
- A tomato fruit characterized by a capability of natural dehydration while on a tomato plant, natural dehydration being defined as wrinkling of skin of the tomato fruit when the fruit is allowed to remain on the plant after a normal ripe harvest stage, said natural dehydration being generally unaccompanied by microbial spoilage.
- A tomato fruit characterized by an untreated skin which permits dehydration of the fruit so as to obtain wrinkling of the skin, said dehydration being generally unaccompanied by microbial spoilage.
Broccoli II involved EP Patent No. EP1069819, which included the following exemplary product claim:
- A broccoli inflorescence having elevated levels of 3-methylsulfinylpropyl glucosinolates, or 4-methylsulfinylbutyl glucosinolates, or both; wherein the broccoli inflorescence is obtained from a hybrid plant following crossing of broccoli breeding lines with wild species and, the levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, are elevated above that initially found in broccoli breeding lines.
The Enlarged Board of Appeal rendered its decisions under Article 53(b) of the European Patent Convention (EPC), which prohibits patenting “plant or animal varieties or essentially biological processes for the production of plants or animals” with the exception of microbiological processes and products, and EPC Rule 27, which provides that plants or animals are patentable if the “technical feasibility of the invention is not confined to a particular plant or animal variety” (Rule 27(b)) or a product obtained by means of a technical process other than a plant or animal variety (Rule 27(c)).
After the Patentees canceled process claims reciting breeding methods, the Enlarged Board of Appeal upheld the patents with the product claims, explaining:
The exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allow-ability of a product claim directed to plants or plant material such as plant parts.
The fact that 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 does not render a claim directed to plants or plant material other than a plant variety unallowable.
Notably, the combined “Tomato II” and “Broccoli II” cases have led to divergent stances in the national laws of several individual European member states. For instance, in contrast to the EPO’s position, Germany, the Netherlands and France have each tabled changes to their national laws to exclude from patentability products which are made by essentially biological processes. The Notice may therefore be aimed at trying to bring some harmony to this area of law across all European member states.
It is important to note that the Notice by the EC has no legal effect over the EPO, since the EC does not have any legislative or other power over the EPC. It is interesting, therefore, that the EPO has decided to suspend all examination and opposition proceedings (For full statements refer to notes). In particular, the EPO has stated that:
“in view of the potential impact of the Commission Notice, all proceedings before EPO examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process will be stayed ex officio. This concerns cases in which the subject-matter of the invention is a plant or animal obtained by an essentially biological process for the production of plants or animals. Search proceedings will not be affected.
If proceedings are stayed, the examining or opposition division concerned will inform the parties accordingly. At the same time, it will withdraw any communications setting those time limits to react, and will despatch no further such communications until the resumption of proceedings.”
More Uncertainty for Life Sciences
While the EC Decision makes clear that products made by genetic engineering are patentable, the EPO’s decision to stay proceedings involving a subset of applications and patents relating to plant and animal products creates more uncertainty for the life sciences industry. The EPO’s notice states that “the effect of the Commission Notice for the EPO’s examination practice including any necessary follow-up measures is currently under discussion with the representatives of the member states of the European Patent Organization.” Thus, it seems likely that the stay will remain in effect until “the representatives” reach agreement on the impact of the Notice.
In the meantime, it is not even clear when a proceeding will be deemed to depend “entirely” on the patentability of a plant or animal obtained by an essentially biological process so as to be subject to the stay. If an application or patent includes some such claims, could the stay be avoided by cancelling them?