The proceedings in case T 1063/18 by board 3.3.04 concerned the appeal of a patent applicant (Syngenta) against the decision of an examining division to refuse a European patent application (publication number EP 2 753 168) for the sole reason that the claimed subject-matter falls within the exception to patentability according to Article 53(b) and Rule 28(2) EPC (here: plants exclusively obtained by means of an essentially biological process). Public oral proceedings were arranged for 5 December 2018, where the Rule was determined to conflict with Article 53(b), and was ruled to not be enforceable.
The Rule 28(2) at the center of the issue is rather new. On 29 June 2017, the Administrative Council (AC) of the European Patent Office (EPO) amended the Regulations pertaining to the patentability of plants. In the new Rule, plants and animals exclusively obtained by an essentially biological breeding process were explicitly excluded from patentability. These rules originally came into being as an implementation into the EPC of the “EU Directive on biotechnological inventions (98/44/EC)”. This EU directive was issued to harmonize European law in a field that was newly emerging at the time.
The decision by the Administrative Council to change the rules was taken after a proposal of the EPO, which in turn was made after a Notice of the European Commission was issued in November 2016. In this notice, the European Commission clarified that in their view, it was never the intention of the legislators of the original Directive, to allow patents on biological processes or on products obtained by such processes. Delving further back in time, this Notice of the European Commission was triggered by the so-called Tomato-II and Broccoli-II cases from the EPO’s Enlarged Board of Appeal (EBoA).
In 2015, these Tomato-II and Broccoli-II cases (G 2/12 and G 2/13) reached decisions which held that ‘plants are patentable even if they are obtained through essentially biological breeding methods involving crossing and selection.’ In other words, individual plants could be patented, even if they were the result of traditional breeding. These decisions caused some commotion, leading up to the short-lived implementation of Rule 28(2) EPC.
The boards of appeal, who issued the Broccoli and Tomato decisions, are not formally bound by an amendment of the EPC Implementing Regulations if they perceive the rule to be in conflict with an article. This is because articles trump rules. Therefore, the Boards can declare a rule invalid and non-enforceable under Article 164(2) EPC (which the EBoA in G 2/07 already did with Rule 26(5) EPC, which deals with a sort of definition of what essentially biological processes would be). This prerogative of the Boards also applies when there is a conflict of an EPC rule with the interpretation of an EPC article, wherein the interpretation is established by a ruling of the EBoA (See e.g. T 315/03, point 5.7). In the present case a board of appeal once again exercised this discretion by voiding Rule 28(2) EPC.
Thus, even though the rule change looked pretty clear-cut when it was implemented, it actually did not achieve its intended effect. The patentability of plants obtained by means of an essentially biological process is still a fact, as decided in the Broccoli and Tomato cases G2/12 and G2/13.
If it still is the legislator’s intention that plants obtained by means of an essentially biological process are to be excluded from patentability, then Article 53(b) of the Convention should be changed. However, this would not be a short-term exercise because it requires unanimity of all the Contracting States at a diplomatic conference. Moreover, such a change in law would require appropriate transitional provisions to take account of existing rights of patentees and applicants. A further point that would need to be considered is that the exclusion of plants produced by essentially biological processes additionally creates legal uncertainty because such plants are nowadays no longer clearly distinguishable from plants produced by new gene-editing technologies such as CRISPR-Cas.
Another possibility is that the European Court of Justice would have to deal with the patentability of plants obtained by means of an essentially biological process under EU Biotech Directive. While the ECJ is not formally bound by decisions of the EPO’s Enlarged Board of Appeal (and vice versa), the Court would be wise not to ignore such well-reasoned and authoritative decisions as the Broccoli and Tomato cases G2/12 and G2/13. After all, not only does the EBoA have final competence in interpretation of the EPC, its decisions are reached only after exhaustively applying established international provisions on the interpretation of treaties, and after considering facts from all available sources. In G2/12 and G2/13 the EBoA already considered the relevant provisions of the EU Biotech Directive, being its Articles 2, 3, and 4, and it came to the conclusion that an exception of plants (and animals) is not supported by the Directive. The more recent notice of the European Commission is not legally binding and could be seen as reflecting the current political climate. The notice itself mentions its own non-binding nature. In light of this, it would not be unexpected if the ECJ were to come to a conclusion in line with that of the EBoA.
The patent application at issue related to “a cultivated blocky fruit type pepper plant” wherein several genetic markers associated with an extreme dark green color in the fruit were to be present. The refusal by the Examining Division has been overturned in appeal, and the Examining Division is now bound by this decision. The appeal was not a solitary affair – there were various third party observations and interested members of the public present at the oral proceedings. Given this interest, it’s probably a safe bet that Notices of Opposition are already being drafted.
Exceptions to patentability
European patents shall not be granted in respect of:
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
(2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
(2) In case of conflict between the provisions of this Convention and those of the Implementing Regulations, the provisions of this Convention shall prevail.