EPO Enlarged Board of Appeal Decision G 3/19 and the patentability of plant and animal products in Europe

EPO Enlarged Board of Appeal Decision G 3/19 and the patentability of plant and animal products in E

Last week the EPO issued another decision (G 3/19, “Pepper”) from the Enlarged Board of Appeal (EBA) regarding the patentability of plant and animal products. The decision is from the “extreme dark and bulky peppers” application and is the latest decision in over 2 decades of EPO case law relating to “essentially biological processes” for the production of plants and animals.

The decision sets out detailed and fundamental principles for interpretation of the European Patent Convention (EPC) in the context of changing political and legislative circumstances. It is notable because it essentially overturns a previous decision of the EBA, uses a form of legal interpretation not previously adopted by the EBA, and discusses the powers of the Administrative Council (AC) of the EPO to amend the European Patent Convention (EPC).

In this article of two halves, we first set out the practical consequences for the Agri-Tech sector, before summarising how we got here and examining some of the relevant legal principles in detail.

Part 1: What this decision means for patent applicants

Following new decision G 3/19, plants or animals exclusively obtained by means of an essentially biological process are no longer patentable in Europe. Significantly, G 3/19 reverses the conclusion reached by the EBA in earlier combined EBA decisions G 2/12 and G 2/13 (“Tomatoes II” and “Broccoli II”).

The EBA has affirmed the earlier Enlarged Board decisions, but have stated the situation is different now than in 2015 when G 2/12 and G 2/13 were decided, because of a decision from the Administrative Council (AC) in July 2017 to amend Rule 28 EPC to explicitly exclude plants or animals exclusively obtained by means of an essentially biological process.

To allow for continued legal certainty for patent applicants and third parties, G 3/19 will only be relevant to patent applications filed on or after 1 July 2017, i.e. the date of entry into force of the AC decision. 

This can be considered a “win” for bodies advocating for farmers and the plant-breeding sector in Europe, but may serve as a frustration for those in the Agricultural Technology sector, who might legitimately wish to obtain patent protection for their products. 

From a practical perspective, this decision serves as a reminder for those in the field to draft applications so that any plant products are not claimed in such a way as to define them solely according to an “essentially biological process” (i.e. as a result of sexual crossing). This can be avoided by including a step of a “technical nature” in the step of crossing, which introduces a trait into the genome or modifies a trait in the genome of the plant produced, whether that technical step is relevant to the invention or not. Basically, provided your process does not comprise simple sexual crossing of plants, it should be possible to avoid the exclusion.

For a more detailed analysis of the decision, read on…

Part 2: A deep dive into the decision

The referred point of law is directly relevant to more than 250 cases before the Examining Divisions and Opposition Divisions. The questions posed and decisions reached are of significant legal importance, not only to those cases but others as well in view of the potentially wider ramifications of the decision.

The background

Our article from 2019 discusses the decision set out in T 1063/18 and can be found here. As a quick recap(sicum), here’s how the protection of plant and animal varieties has evolved over the years:

Article 53(b) EPC states European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals.

1999 – EBA decision G 1/98 was published and confirmed a claim directed to plant varieties was excluded from patentability, but “a claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC even though it may embrace plant varieties”.

2010 – Combined EBA decisions G 2/07 and G 1/08 (“Tomatoes” and “Broccoli”) were published. They related to the patentability of claims relating to essentially biological processes (not products), and stated the exclusion to patentability set out in Article 53(b) EPC extended to “essentially biological processes for the production of plants”, as literally stated, and not just essentially biological processes for the production of plant varieties. Among other things, the decision confirmed processes that “contain or consist” of the steps of sexually crossing the whole genomes of plants are not patentable.

2015 – The EBA published combined decisions G 2/12 and G 2/13 (“Broccoli II” and “Tomato II”, respectively), which related to the relevance of Article 53(b) EPC to the patentability of plant products obtained by the excluded “essentially biological processes”. In that decision, the EBA stated Article 53(b) EPC did not exclude such products from patentability, other than plant varieties specifically. 

July 2017Rule 28 EPC was amended by a decision of the Administrative Council (AC) to include an interpretation of Article 53(b) EPC under new Rule 28(2) EPC. The amended rule states, under Article 53(b) EPC, European patents shall not be granted in respect of “plants or animals exclusively obtained by means of an essentially biological process”. This clearly conflicts with the EBA’s interpretation of Article 53(b) EPC in G 2/12 and G 2/13.

February 2019 – EPO Technical Board of Appeal (TBA) decision T 1063/18 was published. In that decision, the TBA concluded that Rule 28(2) EPC was in conflict with Article 53(b) EPC as earlier interpreted in G 2/12 and G 2/13. The TBA therefore disregarded Rule 28(2) EPC pursuant to Article 164(2) EPC, which states in the situation where any conflict arises between the Articles and Rules of the EPC, it is the Articles that prevail over the Rules. It seemed then the amendment to Rule 28 EPC by the AC was null and void.

April 2019 – In light of legal developments since G 2/12 and G 2/13, namely interpretations and statements of the European Commission, the EU Council, the European Parliament and the EPO's AC (all of which concluded there should be no patentability in the case of plants or animals obtained as a direct product of essentially biological processes), the President of the European Patent Office referred a point of law to the EBA. The questions posed aimed to clarify whether Rule 28(2) EPC as amended by the AC should be followed or not, with the President arguing it should be followed as written. The referral was not without controversy, and the proceedings relating to G 3/19 attracted no fewer than 41 amicus curiae briefs arguing both sides of the case.

May 2020 – The present decision G 3/19 is published, and addresses that last question. In short, the answer is: yes, Rule 28(2) EPC as amended by the AC decision should be followed.

How the EBA reached its conclusion in this case

Issues addressed in the decision included: admissibility of the referral from the President, competence of the AC to interpret the EPC, and finally the correct interpretation of Article 53(b) EPC itself. We discuss each of these below.

Admissibility of the referral

Under Article 112 EPC, referrals to the Enlarged Board of Appeal from the President are only permitted where “two Boards of Appeal” have given “different decisions”. Several of the amicus curiae briefs argued the referral was inadmissible on this basis, since in its view there were no two different decisions from two Boards of Appeal that conflicted. Rather, T 1063/18 confirmed the approach taken in G 2/12 and G 2/13.

However, in G 3/19, the EBA decided the referral complied with the requirement of “two Boards of Appeal” and “different decisions”. Specifically, the EBA was of the view T 1063/18 conflicted with earlier Board of Appeal decisions on how it addressed an apparent contradiction between the amended Implementing Regulations (i.e. Rules of the EPC) and earlier Board of Appeal interpretations of the law that were reached before those Implementing Regulations were amended.

On that basis, the referral was deemed admissible.

However, the EBA did take the opportunity to re-phrase the referred questions, since the Board was of the view the President’s original questions were too general and reached “well beyond the ultimate object of the referral”. The EBA also thought the referred questions inherently included within them the President’s own view on what the answers to the questions should be (a pointer to the solution, one might say). The EBA did agree it was necessary to examine the AC’s competence to adopt secondary legislation, and that formed part of its analysis, but the EBA wanted to limit the analysis to the case in hand. The re-phrased questions were thus:

  1. With regard to the exception to patentability of “essentially biological processes for the production of plants and animals”, does Article 53(b) EPC permit only a single interpretation or could it bear a wider scope of interpretation?

  2. Does Article 53(b) EPC allow a dynamic interpretation in the sense that its meaning may change over time?

  3. And if so, can an amendment to the Implementing Regulations give effect to a change of meaning resulting from a dynamic interpretation of Article 53(b) EPC?


Competence of the Administrative Council

The AC’s alleged “incompetence” to amend the Rules as it did, contrary to an interpretation of the related Article of the EPC already laid out by the EBA, was argued by some in the amicus curiae briefs. Lines of argument included the suggestion that the AC had “breached its duty of loyalty to the judiciary, i.e. the Boards of Appeal” and that an amendment to establish a certain interpretation “requires a formal amendment of the Article itself”. These are in line with the separation of powers doctrine, in which branches of an organisation (in this case the EPO) are separated such that the powers of one branch are not in conflict with another. Further arguments were based on the “essentiality” theory, which argues decisions of fundamental or essential importance are reserved for the legislature (i.e. Parliament).

Neither line of argument was found to be convincing by the EBA. On the separation of powers doctrine, the EBA did not see how this would or could prevent the adoption of secondary legislation (the Rules) by one branch of the EPO, since the EBA as another branch is still able to interpret the secondary legislation as the competent independent judiciary. As for the “essentiality” theory, the EPO has no parliament, and besides, the EBA was of the view the AC already has the power to amend the Articles of the EPC (under Articles 33(1)(b) and 35(3) EPC).

Now that the EBA had established the AC is competent to amend the Rules, it turned to what the amendment to Rule 28 EPC meant for the interpretation of Article 53(b) EPC.

Interpretation of Article 53(b) EPC

The EBA extensively examined “grammatical, systematic and teleological interpretations” of Article 53(b) EPC, as well as subsequent agreement and practice, an historical interpretation and, importantly, a “dynamic interpretation in the light of Rule 28(2) EPC”, now explicitly mentioned in the re-phrased questions. To assist in its analysis, the EBA made reference to the Vienna Convention of the Law of Treaties, an international agreement the EBA often references in its decisions when conducting in-depth analyses of law interpretation. 

On the first of these considerations (grammatical, systematic and teleological interpretations), the EBA in G 3/19 referred to the detailed reasoning already set out in G 2/12 and G2/13. The conclusions of the EBA in that earlier decision were endorsed and the EBA concluded at paragraph XIV.6 of G 3/19:

It follows that none of the various methods of interpretation provided for in Article 31(1) Vienna Convention leads to the conclusion that the term “essentially biological processes for the production of plants” clearly extends beyond processes to products defined or obtained by such processes”

Moving on, the EBA examined subsequent agreement and practice, in particular for those member states of the EU that are also member states of the EPC. This included reference to an EU Commission Notice of Interpretation of Rule 28 EPC, issued in reaction to the EBA’s decision in G 2/12, stating the EU legislator’s intention on adopting the Biotech Directive was to exclude from patentability products obtained by means of essentially biological processes. The President also argued that, in a number of EPC Contracting States (10 out of 38), Article 53(b) EPC is already interpreted to exclude plant and animal products from patentability in the national legislation. Further, all contracting states which are also EU member states have apparently declared their national law practice is in line with the EU Commission’s Notice of Interpretation.

However, the relevant Article of the Vienna Convention requires subsequent agreement between “the” – interpreted by the EBA in G 3/19 to mean “all” – of the contracting parties, which the EBA found to be lacking (since there are EPC contracting states that are not members of the EU). So, no luck for the President on this line of argument, either.

Turning to a historical interpretation, the EBA was of the opinion there was no evidence in the travaux préparatoires of the EPC that a product characterised by the method of its manufacture but claims protection regardless of that (or any other) method was meant to be excluded. This was confirmation of the assessment made already in all of the earlier decisions G 1/98, G 2/07, G 1/08, G 2/12 and G 2/13.

Nevertheless, and turning to the final assessment of Article 53(b) EPC under a “dynamic” interpretation, the EBA conceded:

This is not to say that…the meaning of the exception to patentability under Article 53(b) EPC has been settled once and for all, for it may emerge at a later point that there are aspects or developments which were unknown at the time the decision was issued or irrelevant to the case, or were otherwise not taken into consideration” (Para XVIII of G 3/19)

Under a “dynamic interpretation”, it is accepted that considerations may arise after a treaty is signed that might give reason to believe a literal interpretation of the provision’s wording would conflict with the legislator’s aims. We believe this is the first time the EBA has used this approach to law interpretation.

The TBA in T 1063/18 concluded the adoption of Rule 28(2) EPC was not a new development that should be taken into account for adopting Article 53(b) EPC because, in its view, the AC lacked competence to “amend” that Article by means of the Rules. This appeared to consider the interpretation of Article 53(b) EPC in G 2/12 and G 2/13 to be definitive and of higher importance than the AC decision. Many of the amicus curiae briefs agreed with this argument. 

Conversely, the EBA in G 3/19 acknowledged it “cannot ignore the AC’s decision to introduce a new paragraph 2 in Rule 28 EPC”. Looking at the travaux préparatoires for that rule, the EBA also accepted it was the legislator’s intent to exclude, by means of this rule, plants or animals exclusively obtained by means of an essentially biological process from patentability. The amendment of Rule 28 EPC means “the legal and factual situation underlying decision G 2/12 has substantially changed” (para XXVI.4 of G 3/19). The very fact that this Rule was amended “allows and indeed calls for a dynamic interpretation of Article 53(b) EPC” (para XXVI.7 of G 3/19).

Thus, the interpretation of Article 53(b) EPC chosen by the EBA in G 2/12 and G 2/13 was abandoned, in favour of the literal interpretation of Rule 28(2) EPC as amended by the AC.

The wider impact of G 3/19

Whilst this decision provides clarity for future applications in this particular field, removing some of the grey area around plant and animal products, the decision poses new challenges for those applications already pending but filed on or after 1 July 2017. These applications have (rather frustratingly for applicants) been filed under one, more lenient, interpretation of the law, and will subsequently be prosecuted under another, stricter, interpretation. 

On the amendment of the EPC by the AC, we note the EBA did not take into account the fact a decision of the AC to amend the Articles of the EPC requires a unanimous decision from the member states, whereas amendment to the Rules only requires a three-quarters majority (see Articles 33(b) and 35(3) EPC). Does the AC now have the power to amend the Articles of the EPC by introducing new Rules that fundamentally change or at least direct the interpretation of those Articles? It seems the answer might be “yes”. Is this a big deal? It will depend how (or if) that power is used.

How far will the “dynamic interpretation” approach to the reading of the Articles of the Convention take us? It is hard to say, but it clearly paves the way for the potential use of such an interpretation of the EPC in other situations. The EBA has said itself:

A particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time” (paragraph XX of G 3/19)

What worms might attempt to wriggle out of that can, we wonder?

For more information, please contact Tom Leonard or Harriet Folland, or your usual Kilburn & Strode advisor.

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