On 5 December 2018 the Boards of Appeal decided that Rule 28(2) EPC is in conflict with Article 53(b) EPC and that the article prevails over the Rule under Article 164(2) EPC. As a result, Rule 28(2) EPC is to be considered void and to be ignored. This means that plants (or animals) obtained via essentially biological processes are not excluded from patentability – despite Rule 28(2) explicitly saying so.

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 Board of Appeal, in a composition enlarged to five members, considered that this matter had already been settled by the Enlarged Board of Appeal (EBoA) in 2015, and that no new referral was required.

WHEN THE SEED OF DISCORD WAS SOWN

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.


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, plants can be patented, even if they were the result of traditional breeding, as long as the usual criteria for patentability are met and the technical feasibility of the invention is not confined to a particular variety. These decisions caused some commotion, leading up to the short-lived implementation of Rule 28(2) EPC.

Plants are patentable even if they are obtained through essentially biological breeding methods involving crossing and selection.

LEGAL PERSPECTIVE

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.


The Administrative Council, while being competent to amend the Rules of the EPC (See Art. 33(1)(c)), is not competent to amend the Articles without meeting further requirements. In this light, the Board in the present case T 1063/18 reasoned that the Administrative Council overstepped its competence by implementing this new Rule. The fact that Rule 28(2) would indirectly amend the scope of Article 53 could be seen as an indirect amendment of an Article – one that was already clarified by authoritative EBoA decisions in the Broccoli and Tomato cases G 2/12 and G 2/13.


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.

ROOTING THROUGH THE DECISION

The following are some relevant excerpts from the written decision, which illustrate the discussion above:

23. *In the decision under appeal, the examining division reasoned that Rule 28(2) EPC constitutes a “clarification of the scope of Article 53(b) EPC”. The board however cannot deduce from decisions G 2/12 and G 2/13 any other interpretation of Article 53(b) EPC than that plants are not excluded from patentability, even if they can only be obtained by an essentially biological process. Since Rule 28(2) EPC excludes plants or animals exclusively obtained by means of an essentially biological process from patentability, its meaning is in conflict with the meaning of Article 53(b) EPC as interpreted by the EBA.


24. (…) in the present case, Rule 28(2) EPC in fact reverses the meaning of Article 53(b) EPC, as interpreted by the EBA. In view of this direct contradiction, interpreting Rule 28(2) EPC in such a way that no contradiction exists is not possible.


25. The Board therefore concurs with the appellant’s view, (…), that Rule 28(2) EPC is in conflict with Article 53(b) EPC as interpreted by the EBA.


34. (…) the Administrative Council is not (…) competent to amend the Convention, here Article 53(b) EPC, by amendment of the Implementing Regulations, here Rule 28(2) EPC.


43. The view that Rule 28(2) EPC served to ensure consistency between the Biotech Directive and the EPC and with that legal certainty, is based on the presumption that the Biotech Directive has to be interpreted as set out in the Notice. As explained under point 29 above, such a presumption is not valid unless the CJEU has decided on the matter, which it has not. In fact, adopting the interpretation of the Notice in the absence of a decision of the CJEU on the matter, creates a risk of misaligning the provisions of the EPC with the Biotech Directive, should the CJEU later concur with the analysis of the EBA.


46. Having established that Rule 28(2) EPC is in conflict with Article 53(b) EPC as interpreted by the EBA and in view of Article 164(2) EPC, it must be concluded that the provisions of the Convention prevail.

CULTURING THE FUTURE

If it is still the intention of the legislature that plants obtained by means of an essentially biological process are to be excluded from patentability, then a few possibilities remain.


One option is that Article 53(b) of the Convention could be changed via a direct process. However, this would not be a short-term exercise because it requires the 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 creates additional 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 G 2/12 and G 2/13. 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 G 2/12 and G 2/13 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 merely 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.


Third, the EBoA could come to a new point of view on Article 53. This, however, is not very likely, for multiple reasons – the first of which is that G 2/12 and G 2/13 themselves already are a second consideration of the subject matter, confirming the earlier point of view. A third consideration would therefore be very unlikely. Additionally, to even bring a case before the EBoA, certain conditions need to be met. For example, a Board of Appeal needs to make a referral. This is virtually out of the question, as the only board who deals with this subject matter has just explicitly stated that referral to EBoA is not required. Referral can also be made by the president of the EPO, but this can only be done when conflicting decisions from the Board of Appeal exist; this is not the case, at least explicitly. The president might try and find a conflicting opinion to justify a new referral to the enlarged board. For example, in decision T 297/88 the Board found that a Board of Appeal should refer a question that has already been decided by the Enlarged Board of Appeal to that Enlarged Board again if, weighing all circumstances, it considers that legal developments which have occurred since the earlier decision let it appear desirable in the public interest to have the issue re-assessed by the Enlarged Board of Appeal. It remains to be seen whether this can be construed as actually conflicting with the present decision. Also, it is not a given that T 297/88 also applies when a case has already been decided more than once with consistent outcome.


Fourth, the European Commission could amend those provisions of the biotech directive corresponding to the relevant EPC Articles. Article 33(1)(b) allows the Administrative Council to amend the Articles of the EPC if the amendment brings the articles in line with an international treaty relating to patents, or with European Community legislation relating to patents. Faced with changed international law, the competency of the Administrative Council would in such a case expand to direct amendment of Article 53. If the article itself were to be amended, the Boards of Appeal would not be able to rely on its present argumentation that the Rule conflicts with an Article. Moreover, the G 2/12 and G 2/13 EboA decisions would no longer apply to the latest wording of Article 53, meriting new consideration from the EBoA as well. Thus far it appears as if the Commission has been reluctant to open up the biotech directive as this may well open up a can of worms that can also affect the patentability of biotechnological inventions outside the realm of plant breeding. If nonetheless the Commission does go forward with amending the biotech directive, good governance, as well as the European Convention on Human Rights, would require the Commission to legislate proper transitional provisions to take account of existing rights of patentees and applicants.


A final consideration is that the decision formally only binds other cases “where the facts are the same”. This technicality does not seem very hopeful for limiting the reach of this decision: when Rule 28(2) would ever become relevant, then one cannot expect anything else than the facts relating to patentability being substantially the same.

WHICH PLANS MIGHT BEAR FRUIT?

In a 20 February 2019 meeting of the Committee on Patent Law, the EPO and representatives of all the Contracting States discussed this decision T 1063/18. This discussion was also attended by representatives from the European Commission, as observers. The Committee addressed different potential options for the way forward, and were particularly interested in options for obtaining a new opinion from the Enlarged Board of Appeal. However, in light of the third point discussed above, this would require an unconventional approach at the least, because the EPC does not allow for a referral to the EboA in the present circumstances. Moreover, one can seriously doubt whether the EboA at present has any reason to deviate from their well-reasoned earlier decision in G 2/12 and G 2/13. All parties present at the Committee meeting expressed the intention to find a solution in the short term, which could be construed as also excluding the first option, as a diplomatic conference between 38 states is not generally seen as a short term undertaking.


Judging by point 43 of the decision, quoted above, it can be concluded that the Board itself might expect consideration of the situation by the CJEU. This, or amendment of the biotech directive, might be the only ways forward for those wishing to reinstate Rule 28(2) (or its effect) to its short-lived glory. Then again, the president might try to refer the case based on the allegedly conflicting decisions. The one thing that is sure is that there is not much certainty at the moment.

THE LITTLE PLANT THAT PERSISTED

If it is still the intention of the legislature that plants obtained by means of an essentially biological process are to be excluded from patentability, then a few possibilities remain.


One option is that Article 53(b) of the Convention could be changed via a direct process. However, this would not be a short-term exercise because it requires the 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 creates additional legal uncertainty because such plants are nowadays no longer clearly distinguishable from plants produced by new gene-editing technologies such as CRISPR-Cas.

NOTE: these articles and rules can of course be omitted, but they might be handy reference material given how much of the discussion revolves around them.

ARTICLE 53

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;

Rule 28

(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.

ARTICLE 164

(2) In case of conflict between the provisions of this Convention and those of the Implementing Regulations, the provisions of this Convention shall prevail.