While Art. 53(b) European Patent Convention (EPC) clearly excludes essentially biological processes for the production of plants and animals from patentability, it is currently a highly controversial issue whether plants which are obtained by such a process are also excluded from patentability. The Enlarged Board of Appeal held in the well-known “Tomato I” (G 1/08) and “Broccoli I” (G 2/07) decisions that genetically modified plants are indeed patentable under the EPC. In the subsequent decisions “Tomato II” (G 2/12) and “Broccoli II” (G 2/13), the Enlarged Board of Appeal affirmed that plants obtained by an essentially biological process are also patentable, even if the claim is formulated as a product-by-process claim. However, this interpretation of the EPC was regarded as not being in line with the EU Biotechnology Directive 98/44/EC of July 1998, as well as a European Commission Notice, which contradict the Enlarged Board of Appeal’s “Tomato II” and “Broccoli II” decisions. Triggered by the initiative of the former President of the European Patent Office, the Administrative Council amended the EPC Implementing Regulations in June 2017 with the aim to explicitly exclude plants or animals obtained by an essentially biological process from patentability. In the present case, the applicant of a European patent application directed to a pepper plant obtained by an essentially biological process appealed the decision of the Examining Division to reject the application based on the newly implemented Rule 28(2) EPC, which excludes the claimed subject-matter from patentability. The Board of Appeal granted the appeal and set aside the first instance decision, because the newly implemented Rule 28(2) EPC is in strict conflict with Art. 53(b) EPC and its corresponding interpretation provided by the Enlarged Board of Appeal in “Tomato II” and “Broccoli II”. The Board in its role as a judiciary body sided with the EPC and Enlarged Board of Appeal jurisdiction and disregarded the European Commission, national governments and the EPO’s President and Administrative Council. The decision has triggered a heated debate. President Campinos referred T 1063/18 to the Enlarged Board of Appeal (pending Referral G 3/19) and the EPO announced a stay of all proceedings relating to plants obtained by an essentially biological process.
Obwohl Art. 53(b) des Europäischen Patentübereinkommens (EPÜ) im Wesentlichen biologische Verfahren zur Züchtung von Pflanzen und Tieren von der Patentierbarkeit ausschliesst, ist es momentan eine hochgradig strittige Frage, ob durch ein solches Verfahren hergestellte Pflanzen und Tiere patentierbar sind. Die Grosse Beschwerdekammer hielt in den allseits bekannten Entscheiden «Tomate I» (G 1/08) und «Brokkoli I» (G 2 /07) fest, dass unter dem EPÜ genetisch veränderte Pflanzen tatsächlich patentierbar sind. In den Folgeentscheiden «Tomate II» (G 2/12) und «Brokkoli II» (G 2/13) bestätigte die Grosse Beschwerdekammer zudem, dass mittels eines im Wesentlichen biologischen Verfahrens hergestellte Pflanzen patentierbar sind, sogar wenn der Anspruch als ein sogenannter «product-by-process»-Anspruch formuliert ist. Diese Auslegung des EPÜ wurde jedoch als nicht konform mit der EU Biotechnologie-Richtlinie 98/44/EG vom Juli 1998 und mit der Mitteilung der Europäischen Kommission angesehen, welche im Widerspruch zu den Entscheiden «Tomate II» und «Brokkoli II» stehen. Auf Initiative des früheren Präsidenten des Europäischen Patentamts hin hat der Verwaltungsrat die Ausführungsordnung zum EPÜ im Juni 2017 mit dem Ziel geändert, Pflanzen und Tiere, welche durch ein im Wesentlichen biologisches Verfahren hergestellt wurden, vom Patentschutz auszuschliessen. Im vorliegenden Fall hat der Anmelder einer europäischen Patentanmeldung, welche sich auf eine durch ein im Wesentlichen biologisches Verfahren hergestellte Paprikapflanze bezieht, gegen die Entscheidung der Prüfungsabteilung, die Anmeldung aufgrund der neu eingeführten Regel 28(2) EPÜ zurückzuweisen, Beschwerde eingelegt. Die Beschwerdekammer hat der Beschwerde stattgegeben und die Entscheidung der ersten Instanz mit der Begründung zurückgewiesen, dass die neu eingeführte Regel 28(2) EPÜ im genauen Widerspruch zu Art. 53(b) EPÜ und dessen Interpretation durch die Grosse Beschwerde- | kammer in den Entscheiden «Tomate II» und «Brokkoli II» steht. In ihrer Rolle als Judikative stellte sich die Kammer auf die Seite des EPÜ und der Rechtsprechung der Grossen Beschwerdekammer und liess die Europäische Kommission, nationale Regierungen sowie den Präsidenten und den Verwaltungsrat des EPA ausser Acht. Diese Entscheidung löste in der Folge eine hitzige Debatte aus. Präsident Campinos hat die Entscheidung T 1063/18 an die Grosse Beschwerdekammer verwiesen (anhängige Vorlage G 3/19), und das EPA hat angekündigt, sämtliche Verfahren, welche sich auf durch im Wesentlichen biologische Verfahren hergestellte Pflanzen und Tiere beziehen, auszusetzen.
Bien que l’art. 53(b) de la Convention sur le brevet européen (CBE) exclue les procédés essentiellement biologiques d’élevage de plantes et d’animaux de la brevetabilité, la question de savoir si les plantes et les animaux ainsi obtenus sont brevetables est extrêmement controversée. La Grande Chambre de recours a estimé, dans ses décisions bien connues, «Tomato I» (G 1/08) et «Brocoli I» (G 2/07), que les plantes génétiquement modifiées de la CBE étaient en réalité brevetables. Dans les décisions ultérieures «Tomato II» (G 2/12) et «Brocoli II» (G 2/13), la Grande Chambre de recours a également confirmé que les plantes produites selon un procédé essentiellement biologique sont brevetables, même si la revendication est formulée sous la forme d’un «product-by-process». Toutefois, cette interprétation de la CBE a été jugée non conforme à la directive européenne sur la biotechnologie no 98/44/CE de juillet 1998 et à la communication de la Commission européenne qui contredisent les décisions «Tomato II» et «Brocoli II». À l’initiative de l’ancien président de l’Office européen des brevets, le Conseil d’administration a modifié le règlement d’exécution de la CBE en juin 2017 dans le but d’exclure de la brevetabilité les végétaux et les animaux produits selon un procédé essentiellement biologique. En l’espèce, le déposant d’une demande de brevet européen concernant une plante de paprika produite par un procédé essentiellement biologique a formé un recours contre la décision de la division d’examen qui avait rejeté la demande en vertu de la règle 28(2) CBE, qui venait d’être introduite. La chambre de recours a admis le recours et rejeté la décision de première instance au motif que la règle 28(2) CBE introduite récemment était en totale contradiction avec l’art. 53(b) CBE et son interprétation par la Grande Chambre de recours dans les décisions «Tomate II» et «Brocoli II». En tant que pouvoir judiciaire, la Chambre s’est rangée du côté de la CBE et de la jurisprudence de la Grande Chambre de recours en ignorant la Commission européenne, les gouvernements nationaux ainsi que le président et le conseil d’administration de l’OEB. Cette décision a déclenché un débat houleux. Le président Campinos a déféré la décision T 1063/18 à la Grande Chambre de recours (G 3/19, pendante) et l’OEB a annoncé qu’il suspendrait toutes les procédures relatives aux plantes et aux animaux produits par des procédés essentiellement biologiques.
“I’m president,” so no more Broccoli!
This famous New York Times headline was dedicated to a president who was fed up with certain vegetables and who used his powerful position to ban broccoli from the menu. The president was George H.W. Bush, the 41st president of the USA. As the following article shows, other presidents have also had issues with broccoli.
Starting early in the century, the patentability of fruits, seeds and parts of plants obtained by conventional breeding methods became a hotly debated issue in Europe. Two patents granted in 2003 by the European Patent Office (EPO) for tomatoes with reduced fruit water content and for broccoli with a high content of anti-carcinogenic glucosinolates triggered the second chapter of the tomato and broccoli saga at the EPO.
Previously, it had been established in the “Tomato I” and “Broccoli I” decisions, that genetically modified plants are patentable in view of Art. 53(b) European Patent Convention (EPC). However, in the “Tomato II” and “Broccoli II” decisions, the plants were not genetically modified but obtained by conven- | tional breeding. The question now was whether Art. 53(b) EPC excluded not only the patentability of essentially biological breeding processes, but also the patentability of products obtained by said processes.
The EPO’s Enlarged Board of Appeal decided this highly controversial issue in “Tomato II” (G 2/12) and “Broccoli II” (G 2/13) leaving no doubt that plants, fruits or seeds obtained by such essentially biological processes are indeed patentable, even if they are claimed in a product-by-process format.
This decision was regarded as not conforming with the EU Biotechnology Directive dated July 6, 1998, and was not received well in several EPO member states. Consequently, the European Commission (EC) contradicted the Enlarged Board of Appeal in an Interpretative Notice in November 2016, stating that products obtained by essentially biological processes should not be patentable. Noteworthy, the EC has no authority over the EPO, neither the first instance nor the Board of Appeal.
However, the former President of the EPO, Benoît Batistelli, took this EC Notice very seriously and stayed ex officio all pending cases which depended entirely on the patentability of a plant or animal obtained by an essentially biological process. In addition, the Administrative Council also acted quite fast and amended Rules 27 and 28 of the Implementing Regulation in June 2017.
New R. 28(2) EPC clearly states that under Art. 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 new rule left no room for doubt and – like it or not – most of the interested parties thought that the matter was settled and patentability for plants and animals in Europe was limited to those which are genetically modified.
Next, the Technical Board of Appeal 3.3.04 (with a Swiss member) took a step back, looked at the relevant provision in the EPC, and issued a quite “peppery” decision.
In February 2014, Syngenta requested entry into the European phase with respect to international application WO 2013 034 747, which is directed to a pepper plant exhibiting a characteristic extreme dark green color at an immature stage in order to increase the quality and freshness perception of the consumer. This is achieved by increasing the amounts of various selected pigments, such as chlorophyll A and B as well as lutein. During substantive examination, the Examining Division of the EPO objected to the corresponding European patent application Nº 12756468.0 as being neither novel nor clear. In response, Syngenta filed an amended set of claims, for which novelty and inventive step were acknowledged by the Examining Division. Further, the applicant was invited to adapt the description to the submitted amended claims. On January 19, 2017, the applicant was informed that proceedings would be stayed according to the Notice from the European Patent Office, because the subject-matter would relate to plants of an essentially biological process. According to this, pending examination and opposition proceedings in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process are interrupted until the impact of the Commission Notice on certain articles if EU Directive 98/44/EC on the EPO’s practice has been clarified.
In March 2018, the Examining Division of the EPO decided to refuse Syngenta’s European patent application. The refusal was based on the fact that the subject-matter of claim 1 would be excluded from patentability under Art. 53(b) EPC and recently introduced R. 28(2) EPC. The wording of refused claim 1 is as follows:
“A cultivated blocky fruit type pepper plant, bearing extreme dark green color fruit at immature harvestable stage, said plant comprising two genetic determinants directing or controlling expression of said extreme dark green color in the pepper fruit of the pepper plant, wherein said two genetic determinants are represented by two QTL, wherein said genetic determinants are obtainable from Capsium annum 8728C, seed of which has been deposited under Deposit Number NCIMB 41 858 on July 29th 2011; and wherein the first QTL, QTL1 is genetically linked to markers loci SP436 and SP626, and the second QTL, QTL2, is linked to markers loci SP693 and SP694; and wherein the ‹dark green color› is associated with the following characteristics of the pepper fruits at immature harvestable stage:
Importantly, the description of the patent application in suit makes it explicitly clear on page 31 that the claimed pepper plant is the product of a breeding process.
In its decision, the Examining Division justified the amendment to R. 28(2) EPC, by explaining in detail that the interpretation of EU patent law by the provisions of the EU Biotechnology Directive (hereinafter “the Directive”) would be a fundamental principle under the EPC. By including Rules 26 to 29 into the EPC, the legislator would have demonstrated its intent to ensure consistency between the EPC and the Directive. Despite not being entitled to rule on legal issues of the EPC, the Examining Division further argued that R. 28(2) EPC would represent a “lawful clarification of the scope of Article 53(b) EPC”, because the EU Commission in its Notice of November 3, 2016, clarified that it was the legislator’s intent behind the exclusion of essentially biological processes contained in Art. 4 of the Directive to also exclude products obtained by such a process. The Examining Division thus neglected the interpretation of Art. 53(b) EPC provided by the Enlarged Board of Appeal in G 2/12, “Tomato II” and G 2/13, “Broccoli II”, and decided to prioritize the newly introduced R. 28(2) EPC.
In response to this refusal, Syngenta filed an appeal against the decision of the Examining Division. In the grounds for appeal, the appellant argued that the sole reason for refusal of the application at hand was the newly introduced R. 28(2) EPC, which according to the appellant was in strict conflict with Art. 53(b) EPC and its interpretation provided by the Enlarged Board of Appeal in decisions G 2/12, “Tomato II” and G 2/13, “Broccoli II”. Syngenta argued that according to these decisions, it is unambiguously clear that Art. 53(b) EPC does not exclude plants from patentability, even if they are obtained by an essentially biological process.
In regard of the interpretation of Art. 53(b) EPC by the Enlarged Board of Appeal, the appellant further pointed out that according to Art. 164(2) EPC, the provisions of the EPC prevail over the Implementing Regulations if these are in conflict with each other. As G 2/12 and G 2/13 simply provide the guidance on how Art. 53(b) is to be interpreted, R. 28(2) EPC conflicts with the provisions of the EPC. As a consequence, the Examining Division violated Art. 164(2) EPC.
With respect to the statement of the Examining Division that R. 28(2) EPC would be a lawful clarification as the legislator would have intended to ensure consistency between the EPC and the EU, Syngenta pointed out a crucial issue: the Notice solely represents the opinion of the European Commission, as is clearly stated in its Introduction: “[…] this notice sets out the Commission’s views on the patentability of products emanating from essentially biological processes (addressed in Article 4 of the Directive).”
Syngenta argued that the opinion provided in the Notice is by no means legally binding, as only the Court of Justice of the European Union (CJEU) is competent to issue a legally binding interpretation of Art. 53(b) EPC and the associated issue of the patentability of plants obtained by an essentially biological process.
A further argument brought forward by the appellant is the strikingly different interpretation of the term “essentially biological process”. The Directive adopted a relatively narrow interpretation, according to which only non-technical processes are categorized as essentially biological processes. In addition, the Directive essentially defines that a non-technical process is in general not reproducible, i.e. relies on coincidence, while technical processes are reproducible. In contrast, the Enlarged Board of Appeal applied a much broader definition, according to which an essentially biological process is a process relating to sexual crossing and selection, i.e. processes in which the genome is not changed by technical means. Syngenta argued that if the Examining Division was correct and the EPC thus in alignment with the Directive, the Directive’s interpretation of an essentially biological process has to be employed and not the broader interpretation of the Enlarged Board of Appeal. Importantly, many technical breeding processes are indeed reproducible despite that fact that these involve sexual crossing.
As was already the case with the “Broccoli / Tomato I” and “Broccoli / Tomato II” decisions of the Enlarged Board of Appeal, the decision at hand T 1063/18 also raised the interest of the public and certain interest groups. Therefore, several third-party observations under Art. 115 EPC were submitted. The majority of the observations shared the appellant’s arguments. For example, it was submitted that by amending R. 28 EPC, i.e. the exclusive competence of the Enlarged Board of Appeal to interpret the convention, the fundamental principle of separation of powers was violated. Another third party went even further by stating that the introduction of R. 28(2) EPC was not an alleged clarification, but clearly politically motivated – an allegation, which is seemingly comprehensible in view of the recent events at the EPO.
A single third party, namely the European Seed Association (ESA), argued in favor of the decision of the Examining Division. The ESA emphasized the importance of the principle of free | access to all genetic resources for breeders and further mentioned the importance of harmonization between the EPC and the EU Directive. However, these arguments overlooked the essence of the appealed decision. The critical issue is not whether or not plants and animals should be patentable in general, but rather whether the way of implementing this exclusion chosen by the Administrative Council severely violates the law. As a further argument, the ESA stated that the Enlarged Board of Appeal would have arrived at a different opinion in decisions G 2/12 and G 2/13 if the EU Commission’s interpretation of the Directive would have already existed at that time. In particular, the ESA argued that in these decisions the Enlarged Board of Appeal referred to Arts. 3 and 4 of the Directive, which would not suggest that products obtained by an essentially biological process were to be excluded from patentability:
“Thus the Biotech Derivative, to which Rule 26(1) EPC refers as a supplementary means for interpreting the EPC in relation to biotechnological inventions, does not provide a basis for extending the process exclusion under Article 4(1) Biotech Directive and Article 53(b) EPC to products of such processes.”
Interestingly, the ESA argued that R. 28(2) EPC would provide legal certainty, while third parties in favor of the appellant raised their concerns with respect to the legal certainty of applicants due to the retroactive effect of the new R. 28(2) EPC.
In its decision, the Board of Appeal in T 1063/18 (hereinafter “the Board”) initially provided a detailed summary of the most crucial points of decisions G 2/12 and G 2/13. Therein, the Board emphasized the methodical interpretation of Art. 53(b) EPC in line with the Vienna Convention, which led to the conclusion that the exclusion of essentially biological processes for the production of plants cannot be extended to plants obtained by such a process, as long as it is not directed to a plant variety. In addition, in its decision, the Board discussed the consideration of the Enlarged Board of whether a dynamic interpretation of Art. 53(b) would be necessary. For example, a dynamic interpretation would be suitable if factors had arisen, which would provide grounds for assuming a restrictive interpretation. An example for such a ground would be “legal erosion”, i.e. if all Contracting States had explicitly excluded plants and animals obtained by an essentially biological process, then the provided interpretation of Art. 53(b) would be meaningless. In this respect, however, the Enlarged Board of Appeal saw no such ground, because while some Contracting States exclude such products from patentability, others refrained from doing so. Therefore, the Enlarged Board of Appeal assumed its intended role, namely to interpret the EPC according to the generally accepted principles of interpretation of international treaties. It further declared that it is not mandated to engage in any legislative policy.
With respect to the Notice, the Board generally shared the opinion of the appellant and the majority of the third parties in that the Notice solely represents a legally non-binding opinion of the EU Commission and that the competence of interpreting the Directive lies solely in the competence of the CJEU.
Next, the Board assessed whether the newly implemented R. 28(2) EPC is in conflict with Art. 53(b) EPC, and if so, whether this conflict can be resolved by means of interpretation. According to Art. 22(1) EPC, the Enlarged Board of Appeal is responsible for deciding or giving an opinion on points of law referred to it. Thus, the Enlarged Board of Appeal is the judicial body within the EPO with the obligation to ensure uniform application of the law. Furthermore, while Art. 112(3) EPC holds that a decision of the Enlarged Board of Appeal shall be binding for the Board of Appeal in respect of the appeal in question, it follows from Art. 21 Rules of Procedure of the Boards of Appeal (RPBA), that these decisions have a de facto binding effect for all Boards up to the point at which they consider it necessary to deviate from the decision:
“Should a Board consider it necessary to deviate from an interpretation or explanation of the Convention contained in an earlier opinion or decision of the Enlarged Board of Appeal, the question shall be referred to the Enlarged Board of Appeal.”
Thus, in view of the interpretation of Art. 53(b) EPC of the Enlarged Board of Appeal in G 2/12 and G 2/13, which does not exclude plants and animals obtained by an essentially biological process from patentability, the Board comes to the conclusion that the newly introduced R. 28(2) EPC is in strict conflict with Art. 53(b) EPC. Furthermore, due to the fact that R. 28(2) EPC implements the exact opposite of these decisions of the Enlarged Board of Appeal, this conflict between the Convention and the Implementing Regulations cannot be solved by way of interpretation.
While decision G 2/07, “Broccoli I”, recognized the Administrative Council’s power to lay down provisions concerning the law in the Implementing Regulations, the Board in T 1063/18 further emphasized point 2.2 of this decision, according to which the Administrative Council’s power is limited by Art. 164(2) EPC. Therein, it is explicitly held that in case of a conflict between the provisions of the Convention and the Implementing Regulations, the provisions shall prevail. In its decision, the Board cites T 39/83 according to which “the meaning of an Article of the EPC […], on its true interpretation as established by the Enlarged Board of Appeal cannot, […], be overturned by a newly drafted Rule of the Implement- | ing Regulations, the effect of which is to conflict with this interpretation.”
Therefore, the Board concluded that it had no other choice than to apply G 2/12 and G 2/13, unless it would be willing to refer this issue to the Enlarged Board of Appeal. According to the Board, referring the same issue again to the Enlarged Board of Appeal is only required if the Board of Appeal deems it necessary to deviate from the former ruling of the Enlarged Board of Appeal. However, in the present case, the Board saw no rea-sons to deviate from G 2/12 and G 2/13. A major reason for this conclusion is the fact that the Notice was found to have no legally binding effect. The whole issue would be different, if the CJEU was in fact to provide a legally binding interpretation of the Directive. However, the opinion provided by the EU Commission has by no means any legally binding authority.
The Board further addressed the question, whether the amendment of R. 28(2) EPC could represent a subsequent agreement or a subsequent practice between the parties to the agreement, i.e. the Contracting States of the EPC, under Art. 31(3) of the Vienna Convention. According to this provision, such a subsequent agreement shall be taken into account for interpreting the treaty. Thus, if the amendment of R. 28(2) EPC was indeed to be regarded as a subsequent agreement between the Contracting States, the meaning of Art. 53(b) EPC would be reversed. As a result, the Board would have to deviate from the previous decisions G 2/12 and G 2/13, and the issue would have to be referred to the Enlarged Board of Appeal again. According to Art. 33(1)(b) and (c) EPC, the Administrative Council is competent to amend Parts I to VIII and Part X of the Convention to bring them in line with an international treaty relating to patents or European Community legislation on patents, as well as to amend the Implementing Regulations. However, in the present case, the Administrative Council tried to amend the provisions of the Convention (i.e. Art. 53(b) EPC) by amending the Implementing Regulations (i.e.R. 28(2) EPC). Article 33(1) EPC does, however, not entitle the Administrative Council to do so. The Board therefore came to the conclusion that implementing the new R. 28(2) EPC cannot be regarded as a subsequent agreement between the Contracting States of the EPC under Art. 31(3) of the Vienna Convention. Obviously, the Notice can also not be regarded as such an agreement, as the EU Commission is not a Contracting State of the EPC and is therefore not a party to the treaty. In light of the above, the Board came to the conclusion that it is not necessary to deviate from the previous decisions of the Enlarged Board of Appeal and therefore considered a referral unnecessary and not justified under Art. 112(1)(a) EPC.
The Board also addressed the arguments submitted by the European Seed Association. In particular, the Board stated that while it is well aware of the interest of breeders to freely perform crossing and selection, it also has to consider the legal certainty of inventors, who published their invention under the assumption of benefiting from patent protection. In fact, the Board explicitly held that balancing these interests is a matter for the legislative body. Therefore, these considerations cannot play a role in the legal assessment of the raised issue in the case at hand. With respect to the argument that R. 28(2) EPC achieves harmonization between the EPC and the EU Directive, the Board emphasized that this presumption is only valid if one assumes that the Notice indeed reflects the valid interpretation of the Directive. However, as the CJEU has not decided on this issue, R. 28(2) EPC imposes the risk of aligning the EPC with an interpretation which may ultimately not be held legally binding. In conclusion, such harmonization of the EPC with the Directive should only be pursued after the CJEU has provided a legally binding interpretation of the Directive.
As a result, the Board held that the decision under appeal to exclude the subject-matter of claims 1 and 2 from patentability under Art. 53(b) EPC is to be set aside. However, as the Board was of the preliminary opinion that the claims lack clarity and do not involve an inventive step, it decided to remit the case to the Examining Division.
During the 159th meeting of the Administrative Council, the representatives of the 38 EPO Contracting States together with the EPO expressed their concerns with regard to the legal uncertainty caused by decision T 1063/18 and discussed the need to find a solution in the short term following this decision.
The current EPO President António Campinos declared that in his opinion, a President’s referral of the case to the Enlarged Board of Appeal is justified and necessary:
“The EPO endeavours to restore legal certainty fully and speedily in the interest of the users of the European patent system and the general public.”
Only recently has the referral by President Campinos been published on the EPO’s homepage under G 3/19. The particular questions raised are as follows:
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1.Having regard to Article 164(2) EPC, can the meaning and scope | of Article 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal Board or the Enlarged Board of Appeal?
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2.If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to Rule 28(2) EPC in conformity with Article 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?
As a result of this referral, the President of the EPO decided with respect to the potential impact of the referral that all proceedings before the EPO in which the decision depends entirely on the outcome of the Enlarged Board of Appeal’s decision will be stayed ex officio. While the legal situation is more than unclear, the question is whether the President’s referral has a legal basis. According to Art. 112(1)(b) EPC, “the President of the European Patent Office may refer a point of law to the Enlarged Board of Appeal where two Boards of Appeal have given different decisions on this question.” However, at a first glance, there seems to be no such differing decisions and therefore, it will be interesting to see whether the EBA will even admit the referral. It would not be the first time that a President’s referral is found inadmissible due to a lack of conflicting decisions. In G 3/95, the Enlarged Board of Appeal decided that the referral of the question: “Does a claim which relates to plants or animals but wherein specific plant or animal varieties are not individually claimed contravene the prohibition on patenting in Article 53(b) EPC if it embraces plant or animal varieties?” by the President of the EPO was inadmissible under Art. 112(1)(b) EPC.
In the referral, President Campinos argues that the criterion of different decisions in Art. 112(1) EPC would be fulfilled, as there would be conflicting case law with regard to how the Board of Appeals have assessed the EPC rules which implement Art. 53 EPC under Art. 164(2) EPC. In other words, the President tries to justify the referral by arguing that in contrast to the Board in T 1063/18, other Boards would have come to the conclusion that the Administrative Council may interpret an article even after the Enlarged Board of Appeal has already provided an interpretation. President Campinos comes to the conclusion that the approach adopted by the Board in T 1063/18 for assessing whether R. 28(2) EPC is in conflict with Art. 53(b) EPC according to Art. 164(2) EPC is wrong. According to the President, the Board equated the literal meaning of an article with an interpretation of this article by the Enlarged Board of Appeal. As Art. 53(b) does not explicitly exclude certain subject-matter, but leaves this issue open to interpretation, all relevant elements have to be considered for interpreting this article. The President further emphasizes that it is not only the case law which belongs to these relevant elements, but also the Administrative Council’s interpretation provided in a specific rule. Only then it can be assessed whether or not a rule is in conflict with an article and thus violates Art. 164(2) EPC. The existence of the criterion of different decisions is justified by citing several decisions, which in contrast to T 1063/18 allegedly did not consider that an earlier interpretation of an article would impose an absolute bar on its implementation. Reference is made to T 272/95, in which the Board concluded that a new rule (in this case R. 29[1] EPC) was applicable for interpreting the Convention and that the Administrative Council is competent to provide a more detailed interpretation of the articles. To support his argumentation, the President mentions further T-decisions which allegedly stand in contrast to T 1063/18. However, it is noted that several of the cited decisions are not comparable to the issue at hand. For example, T 272/95 did not consider the case in which an interpretation of an article by the Enlarged Board of Appeal is in conflict with a newly implemented rule, but a case in which there was no conflict between the more detailed interpretation provided by the Administrative Council and the interpretation of the Enlarged Board of Appeal. Furthermore, T 315/03, which is also addressed by the President to support his argumentation, only held that a previous interpretation by a different Board of Appeal – and thus not of an Enlarged Board of Appeal – prevents the Administrative Council from providing a different interpretation by amending a rule.
Additionally, the referral emphasizes G 2/07 in which the Enlarged Board of Appeal would not have endorsed the reasoning of T 39/93, according to which a previous interpretation of an article by the Enlarged Board of Appeal would a priori preclude its clarification by means of a newly drafted rule of the Implementing Regulations. However, a closer look to the exact wording of G 2/07 seems to reveal that the Enlarged Board of Appeal in G 2/07 does solely not endorse the existence of a conflict between the Enlarged Board of Appeal and the newly implemented rule:
“As will be set out below, this reasoning is based on assumptions which are not endorsed by the Enlarged Board, so that a problem of conflict between Rule 26(5) EPC and Article 53(b) EPC in the sense described by the referring Board does not arise.”
In light of the above, the conclusion of the President according to which the Enlarged Board of appeal would have “not endorsed the reasoning underlying decision T 39/93” seems incorrect.
Furthermore, the President argues that the referral is indeed admissible, as there would not be a general principle according to which the criterion “different decisions” must necessarily be interpreted in a restrictive manner. For example, in G 4/98, the need for a broad interpretation of Art. 112(1) EPC is emphasized to not unduly restrict the presidential right of referral.
If the present referral is admitted, it will be interesting to see whether the Enlarged Board of Appeal will disregard its earlier case law, i.e. decisions G 2/12, “Tomato II”, and G 2/13, “Broccoli II” ,and “harmonize” the patentability question according to the Directive. So far, the Enlarged Board of Appeal has disregarded its own case law only a single time in G 9/91 and G 10/91, which held that in contrast to G 1/84, self-opposition is unlawful.
Harmonization is an often used argument for amending an established practice. In Switzerland, the Federal Supreme Court only recently abandoned the well-established “Fosinopril” practice for granting supplementary protection certificates (SPC) (BGE 124 III 375) and “harmonized” the national practice with CJEU decisions (4 A_576/2017, “Tenofovir”). The Swiss Supreme Court noted that the aim of the Swiss legislators was to “harmonize” the level of SPC protection with the protection in neighboring countries.
It remains to be seen whether the EBA is as keen to harmonize the level of protection for conventionally bred plants with the EU Biotechnology Directive and the wishes of the European Commission and several EU Member States, or whether they will not budge unless Art. 53(b) EPC is amended.