The patentability of newly created varieties of plants has been a much debated subject for years. According to the EU Biotech Directive and the European Patent Convention (EPC), plant varieties and essentially biological processes for the production of plants are excluded from patentability. However, neither regulation mentions the patentability of products derived from such processes. The uncertainty as to whether these products are also excluded from patentability has sparked numerous discussions over the years.
In 2015, the European Patent Office’s Enlarged Board of Appeal (EBA) – which decides on points of law under the EPC – finally shed some light on the issue in the “Broccoli/Tomatoes II” cases (decisions G 2/07 and G 2/08). The EBA decided that Article 53(b) EPC (which contains the patentability exclusion) did not extend to novel and inventive plants (or plant material) which were derived from essentially biological processes.
Following the EBA’s decision, the European Commission issued a notice on the interpretation of Article 4 of the Biotech Directive, indicating that, in its view, it had been the EU legislatures’ intention to exclude products obtained by essentially biological processes from patentability. The notice has led the European Patents Office (EPO) to change its regulations so that they align with the Commission’s position. The EPO’s Administrative Council added a second sub-section to Rule 28 of the Implementing Regulations to the EPC, explicitly stating that patents will not be granted for plants obtained through essentially biological processes. Although this amendment seems to put an end to the patent protection of plant products, the saga does not end here. For more information, please see our earlier articles about the Commission’s notice and the amendment.
The TBA’s decision
It was against this backdrop that in December last year, the EPO’s Technical Board of Appeal (TBA) issued its landmark decision on the patentability of plant varieties obtained by essentially biological processes. The case related to a patent application for pepper plants with improved nutritional value, which the EPO’s Examining Division refused. The refusal was based on the ground that the claimed subject matter fell within the patentability exception of article 53(b) in conjunction with the recently amended Rule 28(2).
However, when the TBA reviewed the Examining Division’s decision, it concluded that such plants should be held patentable, despite Rule 28(2).
As the main reason for its decision, the TBA held that Rule 28(2) conflicts with Article 53(b) as it is interpreted by the EBA. According to the TBA, the scope of Article 53(b) has already been defined by the EBA in Broccoli/Tomatoes II and there was no reason to deviate from the EBA’s interpretation as set out in existing case law. Since EPC provisions prevail over those of the Implementing Regulations, the meaning of Article 53(b) – and its interpretation as established by the EBA – cannot be overruled by the newly drafted Rule 28(2). Furthermore, the adoption of Rule 28(2) cannot be considered an amendment of the EPC because the Administrative Council cannot amend the EPC by means of Implementing Regulations.
The TBA concluded that it must apply Broccoli/Tomatoes II and saw no reason to refer to the EBA for reconsideration on the interpretation of Article 53(b). In light of this, the TBA set aside the appealed decision and referred the case back to the EPO’s Examining Division.
This decision has undoubtedly led agrochemical companies and other holders of plant-related patents to breathe an interim sigh of relief. However, it does not end the long-running legal uncertainty around this particular issue; a definitive solution to this debate remains.
Last month, the Committee on Patent Law held a meeting at which the EPO and the representatives from the 38 EPO member states (with the Commission’s representatives attending as observers) discussed next steps in the plant patentability saga. The Committee underlined the need for legal certainty and they exchanged views on potential options moving forward. While discussions continue, patent holders can – temporarily – consider themselves safe. However, we advise clients dealing with these kinds of patents to carefully consider the risks arising from the possible outcome of these discussions, expected in the near future. Business strategies may need to be reassessed accordingly. We will keep you updated on developments.