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Settling the Patentability of Products Obtained from Essentially Biological Processes: The EPO President’s Referral to the Enlarged Board of Appeal in the Aftermath of “the Pepper Case”

Published online by Cambridge University Press:  27 September 2019

Emanuela GAMBINI Open the ORCID record for Emanuela GAMBINI [Opens in a new window]
Emanuela GAMBINI*
Affiliation:
Centre for Commercial Law Studies, Queen Mary University of London, email: e.s.d.gambini@qmul.ac.uk.
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Abstract

In the aftermath of the Technical Board of Appeal’s decision T 1063/18 of 5 December 2018 (“the Pepper case”), the President of the EPO has referred, in G 3/19, two questions to the Enlarged Board of Appeal pursuant to Article 112(1)(b) of the European Patent Convention concerning the patentability of products obtained from essentially biological processes under Article 53(b) EPC. The Technical Board of Appeals in T 1063/18 upheld that the new Rule 28(2) of the Implementing Regulations to the European Patent Convention conflicts with Article 53(b) EPC, as it has been interpreted by the Enlarged Board of Appeal in G 2/12 and G 2/13 (the “Tomato II” and “Broccoli II” cases), namely that “the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plants material such as fruit”. Moreover, the TBA concluded that Article 58(b) EPC should prevail over Rule 28(2) EPC-IR. Since this ruling challenges the Administrative Council’s amendment to Rule 28 EPC-IR, the President deemed it necessary to refer the conflict to the EBA in order to “restore legal certainty”.

Type
Case Commentaries
Information
European Journal of Risk Regulation , Volume 10 , Issue 3: Symposium on Institutional Innovations in the Enforcement of EU Law and Policies , September 2019 , pp. 587 - 601
Copyright
© Cambridge University Press 2019 

I. The background of the referral concerning the patent exclusion of products obtained from essentially biological processes

On 5 April 2019 the President of the European Patent Office, António Campinos, submitted a referralFootnote 1 to the Enlarged Board of Appeal (EBA) pursuant to Article 112(1)(b) of the European Patent Convention (EPC) regarding the patentability of products obtained from essentially biological processes, in order “to restore legal certainty in the interest of the users of the European patent system and the general public”.Footnote 2

Article 112(1)(b) EPC, which concerns the decision or opinion of the EBA, provides that “(1) In order to ensure uniform application of the law, or if a point of law of fundamental importance arises: […] (b) 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 that question”.Footnote 3

The referral follows decision T 1063/18 of Technical Board of Appeal (TBA) 3.3.04 of 5 December 2018Footnote 4 in the so called “Pepper case”, which upheld that the new Rule 28(2) of the Implementing Regulations to the European Patent Convention conflicts with Article 53(b) EPC, as it has been interpreted by the EBA in G 2/12 and G 2/13 (“the Tomato II and Broccoli II cases”),Footnote 5 and that Article 53(b) EPC should prevail over the aforementioned rule.Footnote 6

In decisions G 2/12 and G 2/13Footnote 7 of 25 March 2015, the EBA concluded that “the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plants material such as fruit”.Footnote 8

However, in the aftermath of this decision, the European Commission expressed a diverging interpretation of the patent exclusion of “essentially biological processes for the production of plants or animals”, which is set out likewise in Article 4(1)(b) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (the Biotech Directive).Footnote 9

In the Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions,Footnote 10 the Commission pointed out that it took “the view that the EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes”.Footnote 11

In this respect, both the European Commission and ParliamentFootnote 12 have expressed the same view about the scope of the patent exclusion concerning essentially biological processes and the resulting plants. Some scholars have highlighted, however, that in light of Articles 53(b) EPC and 4(3)Footnote 13 of the Biotech Directive only non-technical processes are covered by the exclusion.Footnote 14

On 29 June 2017 the Administrative Council of the EPO decidedFootnote 15 to endorse the Commission’s view and amend Rules 27 and 28 of the Implementing Regulations to the EPC (EPC-IR), which entered into force on 1 July 2017.Footnote 16 These amendments provide a statutory interpretation of Article 53(b) EPC in order to harmonise EPO’s interpretation and rules with the Biotech Directive. New Rule 28(2) EPC-IR sets forth that: “(2) Under Article 53(b), European patents shall not be granted in respect of plants and animals exclusively obtained by means of an essentially biological process”.Footnote 17

However, as the EU Commission’s Notice is not legally binding because it has been issued by a non-judicial body,Footnote 18 several scholars raised doubts about the effectiveness of these amendments.Footnote 19

The Pepper case has been decided in the aftermath of the amendment to Rule 28 EPC-IR and regards an appeal by Syngenta Participations AG against the rejection of patent application no 12756468.0 entitled “New pepper plants and fruits with improved nutritional value” by the EPO’s Examining Division (posted on 22 March 2018), which involved marker-assisted selection.Footnote 20 In particular, the Examining Division considered the subject matter of claims 1Footnote 21 and 2 of the patent application as falling within the exception to patentability under Article 53(b) EPC and the related Rule 28(2) EPC-IR.Footnote 22

Syngenta claimed before the TBA the patentability of the invention, arguing that Rule 28(2) EPC-IR was in contradiction with Article 53(b) EPC according to the interpretation provided by the EBA in the Tomato II and Broccoli II cases,Footnote 23 namely that Article 53(b) EPC does not exclude plants resulting from essentially biological processes from patentability.Footnote 24 It questioned, moreover, the legally binding nature of the Commission’s Notice with regard to its authority to provide binding interpretations of the Biotech Directive, pointing out that the competence of issuing binding interpretations lies only with the Court of Justice of the European Union (CJEU).

Syngenta, in addition, challenged “the competence of the EPO’s Administrative Council to combine Rule 28(2) EPC-IR with the broad definition of essentially biological processes”Footnote 25 affirmed by the EBA in G 2/07Footnote 26 and G 1/08Footnote 27 (Broccoli I and Tomato I cases), which deviated from the narrower definition of this exception under the Biotech Directive, as falling “outside the legislative power delegated to the Administrative Council”.Footnote 28

In the decision, the TBA upheld the EBA’s narrow interpretation of the exception under Article 53(b) EPC in G 2/12 and G 2/13 (see Reasons point IX. (1)), and deemed that the term “essentially biological processes for the production of plants”, in Article 53(b) EPC, should be interpreted as not excluding from patentability “product inventions where the claimed subject matter is directed to plants or plants materials, such as a fruit or plant parts other than a plant variety”.Footnote 29

The TBA challenged the applicability of Rule 28(2) EPC-IR in relation to the exception under Article 53(b) EPC on the grounds of the separation of judicial power of the EBA as the “judicial body entrusted with deciding and giving opinions on points of law referred to it under Article 112(1)(a) and (b) EPC in order to ensure uniform application of the law”.Footnote 30 Accordingly, the TBA deemed that the EBA’s answers to the interpretation of Article 53(b) EPC should be given due consideration, pointing out the binding effect of its decision in Broccoli II and Tomato II cases on the Boards of Appeal.Footnote 31

Moreover, the TBA considered the conflict between Article 53(b) EPC and Rule 28(2) EPC-IR insoluble by way of interpretation,Footnote 32 as the latter reverses the meaning of the former according to the EBA’s interpretation.Footnote 33 The Board, therefore, argued that in this case the provisions of the Convention should prevail over the Implementing Regulations.Footnote 34

Finally, the Board examined whether there could be reasons to deviate from the conclusions formulated in G 2/12 and G 2/13. By recalling G 2/07, it acknowledged the Administrative Council’s power to set out provisions regarding substantive law in the Implementing Regulations,Footnote 35 but pointed out the limits of the Administrative Council’s law-making powers under Article 164(2) EPC. According to the Board, although the Administrative Council is competent to amend articles of the EPC under Articles 33(1)(b) and 35(3) EPC in order “to bring them in line with an international treaty relating to patents or European Community legislation relating to patents”,Footnote 36 its competence does not extend to amending an article of the Convention, namely Article 53(b) EPC.Footnote 37

In this respect, the TBA questioned the binding nature of the interpretation of Article 4 of the Biotech Directive offered in the Notice, highlighting that only the CJEU’s judgments constitute binding interpretations of EU law pursuant to Article 267(b) TFEU.Footnote 38

Since the decision to adopt Rule 28(2) EPC-IR could be not deemed a subsequent agreement among the parties to be considered in light of Article 31(3)(a) of the Vienna Convention, the TBA maintained that there was no need to deviate from the EBA’s interpretation of the exception in the Tomato II and Broccoli II decisions.

As a result, the TBA set aside the decision under appeal, namely the rejection of patent application no 12756468.0 by the EPO’s Examining Division posted on 22 March 2018.

II. The arguments of the referral

The President of the EPO raised two questions in his referral:

  • “1. Having regard to Article 164(2) EPC,Footnote 39 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 or the Enlarged Board of Appeal?

  • 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?”Footnote 40

In addressing these questions, the President first engaged in explaining the grounds of admissibility of the referral under Article 112(1)(b) EPC. He then set forth the substantive arguments which supported a positive answer to the first question and bolstered the conformity of Rule 28(2) EPC-IR with Article 53(b) EPC.Footnote 41

As far as admissibility is concerned, he illustrated the requirements set out for the referral in Article 112(1)(b) EPC, which provides that “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 that question”.

He noted on the terms “different decisions” that the TBA’s decision in the Pepper case differed from earlier decisions of the Boards on how the assessment of an EPC rule elucidating the meaning of Article 53 EPC should be made under Article 164(2) EPC.Footnote 42

In particular, he pointed out that the TBA, in the Pepper case, found a conflict between Article 53(b) EPC and Rule 28(2) EPC-IR and that applying the rule “would reverse the meaning of Article 53(b) EPC as interpreted by the EBA” and would constitute an amendment of an article to the Convention.Footnote 43 The TBA drew this conclusion by relying on T 39/93,Footnote 44 which stated that “the meaning of an Article of the EPC […], on its true interpretation as established by a ruling of the Enlarged Board of Appeal cannot, […] be overturned by a newly drafted Rule of the Implementing Regulations, the effect of which is to conflict with this interpretation”.Footnote 45

Moreover, he clarified that, in assessing the conformity between the two provisions, the TBA equated law (the provisions of the EPC) under Article 164(2) EPC with case law (the interpretation of Article 53(b) EPC in an earlier decision of the EBA)Footnote 46 and dismissed the fact that the EBA’s decisions in the Tomato II and Broccoli II cases, could not consider the Administrative Council’s implementation of Article 53(b) EPC.Footnote 47

However, he pointed out that in several decisions involving the implementation of the Biotech Directive the Board fully acknowledged the Administrative Council’s competence to interpret Article 53(a) EPC by amending the Implementing Regulations. He referred, in particular to T 315/03, T 272/95 and G 2/07, in which the EBA rejected the argument endorsed in T 39/93 that “under Article 164(2) EPC a previous interpretation of Article 53 EPC would a priori preclude its clarification by means of a newly drafted Rule of the Implementing Regulations”.Footnote 48

He allowed nevertheless that, under Article 112(1)(b) EPC, the Board of Appeal is not the EBA to which the article refers. Still he arguedFootnote 49 that different decisions between a Board of Appeal and the EBA cannot normally occur, as the Board shall refer a matter to the EBA if it deems necessary to provide a diverging interpretation of the EPC from one set forth in an earlier decision of the EBA.Footnote 50 The TBA, however, in the Pepper case, did not consider it necessary to refer the matter of conflict to the EBA, even though the decision contrasted with the interpretation of Article 164(2) EPC in G 2/07, which dismissed the argument in T 39/93.Footnote 51

He pinpointed that there is a substantial difference between the Pepper case and former decisions, as in none of these had an earlier interpretation of Article 53 EPC been held to require “an absolute bar on its implementation”Footnote 52 by a new EPC rule.

He noted, furthermore, that this difference is substantial and, since Article 53 EPC does not exclude explicitly particular subject matter and, therefore, leaves open different interpretations, there cannot be an a priori conflict between the rule excluding such subject matter and the Article.Footnote 53 He, consequently, concluded that on these grounds both questions of referral should be considered admissible.Footnote 54

The President then illustrated that, in any case, the application of Article 112(1)(b) EPC by analogy Footnote 55 should be considered admissible,Footnote 56 as the general rules of interpretation followed by the Boards of Appeal do not rule out the possibility of an analogical application.Footnote 57

He pointed out that in G 1/97 and G 2/02 the EBA acknowledged the occasional need for the judge to fill lacunae in the law, in a codified legal system such as the EPC, especially when he has to deal with situations “for which the legislator has omitted to provide”.Footnote 58 He, therefore, observed that there are no reasons to interpret Article 112(1)(b) EPC in a restrictive manner, as the case lawFootnote 59 has rejected its interpretation in a way that could “unduly restrict its effect and the presidential right of referral”.Footnote 60

The President has claimed his right of referral under Article 112(1)(b) EPC in order to “establish uniformity of law and legal certainty within the European Patent system”Footnote 61 and clarified that the reference to “different decisions” was set out, in particular, to avoid referrals to address abstract points of law.Footnote 62

By reasoning a fortiori, he maintained that if the presidential right of referral exists when two Boards of Appeal provide diverging interpretations of the EPC in decisions with inter partes effects, “it must all the more exist in the case of a divergence between the interpretation of an EPC article in a single Board of Appeal decision and its implementation (ie interpretation) with erga omnes effect”Footnote 63 set out in a Rule of the Implementing Regulations to the EPC, which has been adopted by the Administrative Council.Footnote 64

He highlighted, furthermore, that the issue of the validity of Rule 28(2) EPC-IR, raised in the Pepper case, is a fundamental point of law that should be settled by the EBA as the highest judicial authority of the EPO in order to solve pivotal questions of legal interpretation concerning a large number of similar cases,Footnote 65 ensure legal uniformity and the alignment of the EPC to the Biotech Directive.Footnote 66

The President, subsequently, addressed the substantial considerations related to the two questions.

As far as Question 1 is concerned, his referral emphasises the competence of the Administrative Council to implement Article 53 EPC and amend the Implementing Regulations, pursuant to Article 33(1)(c) EPC. He argued that this competence has been endorsed by significant case law of the EBA, which pointed out that the Implementing Regulations aim at determining in more detail how the EPC articles shall be applied even when the articles govern issues of substantive patent law.Footnote 67

Furthermore, the referral argues that the Administrative Council competence (and power) is “limited only by the hierarchy of laws laid down in Article 164(2) EPC”Footnote 68 and not by an interpretation of the article in an earlier decision of the EBA. This interpretation, according to the President, is confirmed by the wording of Article 164(2) which refers to the “provisions of this Convention” and not to the earlier interpretation of case law.Footnote 69 Moreover, it is sustained by the context and telos of the provision that has been inserted in Part XII of the EPC, which concerns the relationship between the articles adopted by the Diplomatic Conference and the Implementing Regulations by the Administrative Council.

Whereas the referral acknowledges the Boards’ interpretative judicial supremacy on the EPC, it observes that the case lawFootnote 70 clarified that their judicial function is bound by the EPC and the Implementing Regulations, which set out an authentic interpretation of the Convention. As a result, the Boards’ jurisdiction is limited.Footnote 71 It, furthermore, highlights that this interpretation of Article 164(2) EPC has been deemed consistent with the role and function of the EBA, which is not a constitutional court and whose holdings, albeit de facto binding (under Article 21 of the Rules of Procedure of the EBA), do not have the force of law and do not bar the evolution of the law or its interpretation.Footnote 72

In particular, by drawing on T 315/03, it maintains that their jurisdiction does not imply “any power, express or necessarily implied, to prevent the operation of correctly enacted legislation and, as regards the passage of legislation, the choice between articles and Implementing Regulations is one exclusively for the legislator”.Footnote 73

As far as the second question is concerned, namely the conformity of Rule 28(2) EPC-IR with Article 53(b) EPC, the referral argues that several considerations confirm it.

The President, first, noted that in decisions G2/12 and G 2/13, the EBA allowed that Article 53(b) EPC is open to different interpretations and did not consider it “to be sufficiently clear, to provide explicit support or a solid basis to extend the process exclusion also to the products obtained by such processes”.Footnote 74

Conversely, the EBA referred to the need for a legislative clarification regarding the exclusion of essentially biological processes for the production of plants or animals from patentability.Footnote 75 As Article 53(b) EPC does not expressly allow the patentability of plants “exclusively obtained by essentially biological processes”Footnote 76 and the other means of interpretation applied by the EBA did not offer a clear result, the President concluded that Rule 28(2) of EPC-IR constitutes a “permissible clarification” of Article 53(b) EPC.Footnote 77

Moreover, he maintained that in any case the article itself shall be interpreted as excluding the subject matter mentioned in Rule 28(2) EPC-IR. He, pointed out that, whilst the legislative intent of this provision, namely the ratio legis for the patent exclusion of essentially biological processes for the production of plants and animals, was not sufficiently clear,Footnote 78 the intention of the EPC legislator “to ensure the uniformity of harmonised patent law” and align the EPC with the Biotech Directive is clearFootnote 79 from the travaux préparatoires of the Directive and its incorporation into the EPC rules.Footnote 80

In addition, he observed that this intention has been expressed in Rule 26(1) EPC-IR, which establishes that the Directive shall be applied as a supplementary means of interpretation of the relevant provisions of the EPC.Footnote 81

The President then dealt with the intention of the EU legislator behind Article 4(1)(b) of the Biotech Directive. In contrast with the TBA decision in the Pepper case, which pointed out that the European Commission’s Notice “has no legal authority”, he argued that its endorsement by the EU Council of MinistersFootnote 82 and the European ParliamentFootnote 83 should count and assist in the interpretation of the Directive.Footnote 84 He, therefore, pointed out that a consensus on the interpretation of this patent exception has been expressed by the same three institutions competent for the legislative procedure which resulted in the adoption of the Biotech DirectiveFootnote 85 in order to support the democratic legitimacy.

In the referral, the interpretation of Article 53(b) EPC by the EBA in G 2/12 Broccoli II and G 2/13 Tomato II has been affirmed not to conflict with the views of the EU institutions expressed in the Notice, as the EBA did not draw any conclusion regarding the EU legislator’s intent related to Article 4(1)(b).Footnote 86 Since the grammatical, systematic and teleological interpretations of Article 53(b) EPC did not assist the EBA in establishing in a distinctive way the meaning of this patent exception, as much as the travaux préparatoires, the EPO’s President argued that Rule 28 (2) should be considered fully in line with Article 53(b) EPC and a conflict under Article 164(2) EPC did not arise.Footnote 87

Finally, he noted that, in the aftermath of the publication of the European Commission’s Notice, the agreement and practice of the Contracting States of the EPC has resulted in the alignment of the interpretation of Article 53(b) EPC. Whereas the 28 EPC Contracting States that are members of the EU affirmed their national law aligned with the interpretation of Article 4(1)(b) of the Biotech Directive, the 10 Contracting States not members of the EU voted in favour of the introduction of Rule 28(2) EPC-IR to align their practices and legislation.Footnote 88

III. Unsettled settlements: future lessons for the European Patent Governance

The outcome of this referral is uncertain and rests on whether the EBA will endorse the argument a fortiori set forth by the EPO’s President and/or the analogical interpretation of his power of referral under Article 112(1)(b) EPC (see supra).

However, it is likely that the EBA will fully address these questions in order to settle, finally, the patentability of products obtained from essentially biological processes and the boundaries of powers of the European Patent Organisation (EPOrg) institutions, which are crucial to support their legitimacy.

The referral, following the TBA’s decision in the Pepper case, highlights a clear conflict of powers within the EPOrg in establishing the meaning and scope of the patent exception under Article 53(b) EPC.

The EPO’s President claimed the legislative (albeit limited) power of the Administrative CouncilFootnote 89 to amend the rules of the Implementing Regulations to the EPC to clarify the meaning of the EPC and promote its harmonisation with the Biotech Directive.

The TBA, conversely, championed the EBA’s supreme judicial power to interpret the articles of the EPC. In particular, the TBA pointed out that the adoption of Rule 28(2) EPC-IR by the Administrative Council, following the publication of the European Commission’s Notice, amounted to amending the EPC, beyond its competence pursuant to Articles 33(1)(b) and 35(3) EPC.Footnote 90

Moreover, it questioned the legitimacy of the Council’s action,Footnote 91 which provided an authentic interpretation of Article 53(b) EPC in light of the Notice’s non-binding interpretation of the exception under Recital 32Footnote 92 and Article 4(1)(b) of the Biotech Directive, which sets out that essentially biological processes for the production of plants and animals shall not be patentable.

The referral and the emergence of a clear conflict of powers between EPO’s Administrative Council and the Boards can hopefully be taken on by the EBA as an opportunity to improve the democratic legitimacy of EPOrg institutions, foster a better harmonisation of European patent law and engage in building a more “reflective”Footnote 93 European patent governance.

Several scholarsFootnote 94 have pointed out that, although EPOrg institutions exercise powers in ways that should express the principle of the separation of powers which informs modern representative democracies, they are nevertheless characterised by features that make them differ from democratic national institutions. As Ingrid Schneider illustrated, the EPOrg is a unique politico-legal set of institutions, whose powers do not fall within the strict division which is the hallmark of national constitutional powersFootnote 95 and, according to Aerts, under the EPC system “there appears to be no functional separation of powers”.Footnote 96

The EPO’s Boards of Appeal enjoy a power which is not entirely judicial and jurisdictional,Footnote 97 but quasi-jurisdictional, and the Administrative Council exercises a legislative power (together with executive power),Footnote 98 which is significantly limited because substantial patent law should ensue only from a Diplomatic Conference of the Contracting States. Moreover, there is no possibility of judicial review of the adopted legislation.Footnote 99

In addition, the unique character of the EBA in comparison to an ordinary judicial body has been pointed out in the travaux préparatoires of Article 112(1)(b) EPC, at the second meeting of the Inter-governmental Conference for the setting up of a European Patent system for the grant of patents. At the time, several delegations questioned whether the EBA had to be allowed to decide on abstract points of law, which entailed the risk of granting it a very broad power (almost legislative), and remarked that the EBA, “notwithstanding the rules governing its composition”, could not “be totally likened to a judicial body”.Footnote 100

Moreover, part of the scholarshipFootnote 101 has illustrated that the EPOrg lacks an adequate system of balances of powers that could insure and improve the legitimacy of the decisions of its institutions that the fragmentation and expansion of the European patent system has even made more “structurally weak”.Footnote 102

In this respect the EBA’s decision could possibly clarify several significant issues related to the separation of powers within the EPOrg.

As the EBA pointed out in Referral G 3/08, considerations regarding democracy are pivotal in the interpretation of Article 112(1)(b) EPC, since EPOrg is “an international, intergovernmental organisation, modelled on a modern state order and based on the separation of powers principle, which the sovereign contracting states have entrusted with the exercise of some of their national powers in the field of patents”.Footnote 103

As Pila has illustrated, in that referral, which concerned the patent exclusion of computer programs under Article 52(2)(c) and (3), the EBA inferred a duty on EPOrg “to ensure ‘the predictability and verifiability’ of its actions, and to protect ‘the separation of powers, the rule of law and respect for human rights including fundamental procedural rights’”.Footnote 104 Nevertheless, she pointed out that in that EBA’s Opinion these constitutional arguments have been drawn upon to maintain a restrictive interpretation of Article 112(1)(b) EPC, claiming the Boards’ authority to interpret the EPC, so that the President’s referral could “only be justified in extremis”.Footnote 105

On the substance of the referral, it should be noted that the exclusion of Article 53(b) EPC has finally come to the forefront of the EPO’s and EU’s institutions debate on its meaning and application, after being long overlooked.Footnote 106 The EBA is asked to decide on whether the introduction of Rule 28(2) EPC-IR constitutes a lawful clarification of the scope of Article 53(b) and the Administrative Council has the power to settle the meaning of this exception, following a non-binding initiative of the EU Commission.

Sterckx and Cockbain have shown that, since the 1980s, the history of patent exceptions and exclusions set out in the EPC has been marked by the erosion of their scope, which has been consistently brought about by the jurisprudence of the EPO’s Boards of Appeal and has concerned also the exception under Article 53(b) EPC.Footnote 107

Moreover, in particular as far as plant-related patent law is concerned, Godt has explained that it has “evolved primarily through internal review procedures of the European Patent Office [...], which focused on patentability exclusions, relied on a narrow interpretation of those, and allowed a broad patent claims language”.Footnote 108

However, just over the last decade, the EBA has shownFootnote 109 its commitment to re-establish the boundaries and scope of patent exceptions,Footnote 110 which has also involved Article 53(b) EPC in the Broccoli I and Tomato I cases.Footnote 111

According to the EBA’s decisions in the Tomato II and Broccoli II cases the rationale for the exclusion under Article 53(b) EPC is partially unclear, as the travaux préparatoires do not provide decisive elements regarding products obtained from essentially biological processes. The wording of Article 53(b) EPC was drawn from Article 2(b) of the Strasbourg Patent Convention (SPC)Footnote 112 and only the UK delegation, at the time of their drafting, remarked that the wording of this exception in the SPCFootnote 113 and EPC was ambiguous.Footnote 114

The approval of the Biotech Directive, in 1998, has fostered patent eligibility in several areas of biotechnology and set forth the patent exclusion under Article 4(1)(b) on “essentially biological processesFootnote 115 for the production of plants or animals”, which mirrors the exclusion under Article 53(b) EPC.

However, part of the scholarship has pinpointed that the harmonisation between the EPC and the Biotech Directive has been brought about in a controversial way by the Administrative Council for “pragmatic reasons”Footnote 116 and instantiates a democratic gap in the European patent governance.Footnote 117

Although the EU and EPOrg are formally independent supranational institutions, on 16 June 1999, a resolution of the EPOrg’s Administrative Council made the articles of the Biotech Directive effective as Rules 23(d)–(e) of the EPC-IR, on 1 September 1999. The implementation of the Directive has been justified in order to insure a uniform and harmonised European approach to biotech patenting,Footnote 118 but has raised criticism since it should have resulted from a Diplomatic Conference.Footnote 119

Although this defective implementation was legitimised a posteriori by the EPC 2000 Diplomatic Conference, which led to the revision of several articles of the Convention in order to improve its harmonisation with the Biotech Directive,Footnote 120 still some questions persist on how the governance of European patent law should be pursued.

Borrás has noticed that the legitimacy of the European patent system cannot be detached from its effectiveness Footnote 121 and it relies on establishing mechanisms of checks and balances among the network of organisations which set out the formal governance of the European patent system. As she pointed out, these checks and balances, namely “a set of formal power structures in the politico-administrative system established by the formal independency among the organisations”, could improve the formal interactions within the patent system.Footnote 122

Notwithstanding the Notice is not binding for EPOrg, the adoption of Rule 28(2) EPC-IR has been endorsed by the consensus of the Contracting Members of the EPC, by the existence of analogous provisions in the national patent law of some Contracting MembersFootnote 123 and by the further harmonisation of the national patent law of several other Members in the aftermath of the Administrative Council’s decision to implement the EU Commission’s Notice.

However, the Rule has been censured by scholars and professionals,Footnote 124 as it undermines the possibility for agri-biotech companies to be granted IPRs on product and product-by-process claims involving marker-assisted selection and could affect the patentability of native traits and inventions concerning plant genome editing.Footnote 125

Moreover, it has been pointed outFootnote 126 as a paradox that the amendment set out in Rule 28(2) EPC-IR affects the patentability of products involving marker-assisted selection and breeding,Footnote 127 which is an area of innovation considered more favourably by European civil society than the production (and patenting) of GMOs.

This apparently contradictory outcome, nevertheless, pinpoints the urgent need for more inclusive European patent governance that could address more efficiently the democratic deficits of the European patent system and achieve a co-evolution between the EPC system and EU patent policy. Part of the scholarship has suggested that a formalisation of the links between the EU and EPO should contribute to attain these goals.Footnote 128

Schneider has, moreover, illustrated that patent law is undergoing a significant shift “from a narrow definition of inventors and economic competitors by legal entitlements towards a regulatory law mediating different rights and entitlements, taking several ‘third parties’, stakeholders and public interests into account, as well as providing foresight on the socio-economic impact and political dimensions of patent granting”.Footnote 129

In the face of this shift, as part of the scholarship has pointed out, one of the major challenges that the EPOrg has to address in the near future is how to devise its role in broader and more democratic terms as a regulatory agency that deals with innovation and technology rather than just a major patent office organisation dealing with the examination of patent applications and possible granting of IPRs over inventions.Footnote 130

Although several significant initiatives in this direction have been set out,Footnote 131 establishing a sustainableFootnote 132 patent social contractFootnote 133 between the inventor and the European civil society should be a priority for the EPO. The promotion of institutional legitimacy within EPOrg and an increased democratic participation in view of devising a co-ordinated European patent governance can make the patenting of biotechnological inventions less unpredictable in the future.

References

1 G 3/19, Referral of a point of law to the Enlarged Board of Appeal by the President of the European Patent Office (Art 112(1)(b) EPC), <documents.epo.org/projects/babylon/eponet.nsf/0/4F62ECCAF1B2F2F5C12584020026796E/$File/Referral%20under%20Art.%20112(1)(b)%20EPC-%20G%203-19.pdf> accessed 15 August 2019.+accessed+15+August+2019.>Google Scholar

2 See EPO’s news release “Referral to the Enlarged Board of Appeal related to plant patentability”, <www.epo.org/news-issues/news/2019/20190405.html> accessed 15 August 2019.

3 Art 112(b) EPC, <www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar112.html>, accessed 19 August 2019. Emphasis added.

4 Decision T 1063/18 (Extreme dark green, blocky peppers/SYNGENTA) of Technical Board of Appeal 3.3.04 of 5 December 2018 (unpublished), <documents.epo.org/projects/babylon/eponet.nsf/0/426B74FD32463ACEC1258398003EA3F4/$File/T_1063-18_en.pdf> accessed 19 August 2019.

5 Neither the Broccoli nor Tomato case concerned transgenic process and products (seeds, plants, and fruits). The Broccoli patent involved a biotechnological step, as it referred to marker-assisted selection in step (b) and (c) of method claim 1, whereas the Tomato patent involved a more conventional process of crossing and selecting.

6 Decision T 1063/18, supra, note 4, p 25.

7 EPO Enlarged Board of Appeal, 25 March 2015, G 2/12 and G 2/13, OJ EPO 2016, A27 and A28.

8 Decision of the Enlarged Board of Appeal dated 25 March 2015 G 2/12, <www.epo.org/law-practice/legal-texts/official-journal/2016/03/a27/2016-a27.pdf>, p 2. Decision of the Enlarged Board of Appeal dated 25 March 2015 G 2/13, <www.epo.org/law-practice/legal-texts/official-journal/2016/03/a28/2016-a28.pdf>, p 3.

9 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L213/13.

10 Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions, 8 November 2016, OJ C411/3.

11 ibid, C411/7.

12 European Parliament Resolution of 17 December 2015 on patents and plant breeders’ rights.

13 Art 4(3) of the Biotech Directive sets out that “3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process”, supra, note 9.

14 MA Kock and G Morgan, “Broccoli and Tomato: A Never Ending Story?” (2017) 16(3) Bio-Science Law Review 123.

15 Decision of the Administrative Council of 29 June 2017 amending Rule 27 and 28 of the Implementing Regulations of the European Patent Convention (CA/D 6/17) (2017) OJ EPO A56.

16 M Snodin, “Patentability of Plants under the EPC: Act in Haste, Repent at Leisure?” (2017) 16(3) Bio-Science Law Review 115.

17 Decision of the Administrative Council of 29 June 2017 amending Rule 27 and 28 of the Implementing Regulations of the European Patent Convention (n 15).

18 Snodin, supra, note 16, p 119.

19 Snodin, supra, note 16, pp 119–120.

20 Molecular marker-assisted selection (MAS) has been applied to improve the efficiency of plant selection in comparison with conventional plant breeding (which draws only on phenotypic selection) and relies on the study and use of molecular marker genotypes, which “are either within genes or tightly linked to QTL influencing traits under selection”. Molecular marker genotypes are relied on “as a supplement to phenotypic observations in a selection index”. As Moose and Mumm explain, “In cases where genetic correlations are high, further efficiencies can be gained by substituting genotypic for phenotypic selection during some selection cycles, which can reduce phenotyping efforts and cycle times by permitting the use of off-season nurseries”: SP Moose and RH Mumm, “Molecular Plant Breeding as the Foundation for 21st Century Crop Improvement” (2008) 147 Plant Physiology 969 at p 974.

21 Claim 1 of the main request regarded “1. A cultivated blocky fruit type pepper plant, bearing extreme dark green colour fruit at immature harvestable stage, said plant comprising two genetic determinants directing or controlling expression of said extreme dark green colour in the pepper fruit of the pepper plant wherein said two genetic determinants are represented by two QTL” and the two QTL 1 and 2 were then stated as genetically linked to two specific markers loci (SP436 and SP626) of Capsicum annuum 8728C: T 1063/18, supra, note 4, pp 1–2.

22 T 1063/18, supra, note 4, p 1.

23 ibid.

24 ibid, p 5.

25 ibid, p 6.

26 G 2/07, Decision of the Enlarged Board of Appeal dated 9 December 2010, OJ EPO 3/2012, 130.

27 G 1/08, Decision of the Enlarged Board of Appeal dated 9 December 2010, OJ EPO 3/2012, 206.

28 T 1063/18, supra, note 4, p 6.

29 ibid, p 14.

30 ibid, p 17.

31 ibid, p 18.

32 ibid, p 20.

33 ibid, p 19.

34 ibid, p 20.

35 ibid.

36 ibid, p 22.

37 ibid.

38 ibid, p 21.

39 Art 164 EPC regards implementing regulations and protocols to the EPC. In particular, Art 164(2) EPC sets out that “In case of conflict between the provisions of this Convention and those of the Implementing Regulations, the provisions of this Convention shall prevail”. See Art 164 EPC, <www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar164.html> accessed 19 August 2019.

40 G 3/19, supra, note 1, p 1.

41 ibid, pp 16 and 25.

42 ibid, p 2.

43 ibid.

44 ibid.

45 ibid. See T 39/93, Decision of the Technical Board of Appeal of 14 February 1996, OJ EPO 4/1997, p 134, point 3.2 of the Reasons for the decision.

46 G 3/19, supra, note 1, p 2.

47 ibid, pp 1–2.

48 ibid, p 3.

49 ibid, p 4.

50 See Art 21 of the Rules of Procedure of the Boards of Appeal.

51 ibid.

52 ibid.

53 G 3/19, supra, note 1, p 5.

54 ibid.

55 Legal analogy (analogia legis) is a form of reasoning which aims at filling legal gaps, in Latin lacunae, which is allowed to be drawn upon by judges when a particular concrete case (species facti) cannot be solved by subsuming it under one or more legal provisions. The logical structure of analogical reasoning, as Bobbio illustrated, is the following: “S is similar to M; M is P: S is P”. See N Bobbio, “‘Analogia’ Contributi ad un dizionario giuridico (Giappichelli 1994) p 1 at p 3. Canale and Tuzet explained that the legal gap “is filled by arguing analogically from a source case to a target case” and the scheme of analogy is: “C1 falls under N1. C2 does not fall under any actual norm of the system (there is a gap in the law). There is relevant similarity between C1 and C2. C2 falls under N2 obtained by analogical reasoning (filling the gap)”. See D Canale and G Tuzet, “Analogical Reasoning and Extensive Interpretation” in H Kaptein and B van der Velden (eds), Analogy and Exemplary Reasoning in Legal Discourse (Amsterdam University Press, 2018) pp 66, 69. In analogical reasoning, therefore, the regulation of the source case C1 is extended to the target case C2, by creating analogically a new norm N2 from N1.

56 G 3/19, supra, note 1, p 6.

57 ibid.

58 ibid.

59 G 4/98, Opinion of the Enlarged Board of Appeal dated 27 November 2000, OJ EPO 3/2001, point 1.2 of the Reasons for the Decision.

60 G 3/19, supra, note 1, p 6.

61 ibid, p 7.

62 ibid.

63 ibid, p 8.

64 ibid.

65 ibid, pp 9–10.

66 ibid, p 10.

67 The EPO’s President referred, in particular, to G2/07, G 2/12, G 2/13, G2/06, T 315/03, T 272/95. He cited and commented also on J 20/84 and T 991/04, in which he pointed out that the Board acknowledged that the Administrative Council can adopt EPC Rules to the effect that “the Implementing Regulations to the Convention stipulate an authentic interpretation within the framework set out by the Convention”. See G 3/19, supra, note 1, p 13.

68 ibid.

69 ibid.

70 In particular decision T 991/04, Interlocutory Decision of the Technical Board of Appeal of 22 November 2005 (unpublished), <www.epo.org/law-practice/case-law-appeals/pdf/t040991eu1.pdf> accessed 19 August 2019, point 6 of the Reasons for the Decision.

71 In particular, T 315/03, OJ EPO 1/2006, 15, point 5.8 of the Reasons for the Decision.

72 G 3/19, supra, note 1, p 14.

73 In particular, T 315/03, Decision of Technical Board of Appeal dated 6 July 2004, OJ EPO 1/2006, 15, point 5.8 of the Reasons for the Decision.

74 G 3/19, supra, note 1, p 17

75 ibid.

76 ibid.

77 ibid, pp 17–18.

78 See G 2/12, Decision of the Enlarged Board of Appeal of 25 March 2015 and G 2/13, point vii.3 (3) of the Reasons for the Decision.

79 G 3/19, supra, note 1, p 18.

80 ibid, pp 18–19.

81 ibid, p 19.

82 Point 4 of the Council Conclusions on the Commission Notice on certain Articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions, OJ C65, 1 March 2017, pp 2–3.

83 European Parliament Resolution of 17 December 2015 on patents and plant breeders’ rights, 2015/2981 (2015/2981 (RSP)).

84 G 3/19, supra, note 1, p 20.

85 ibid.

86 ibid, p 21.

87 ibid, p 22.

88 ibid, p 23.

89 The adoption of the EPC 2000 has increased the legislative power of the EPO’s Administrative Council to harmonise the EPC with EU legislation and international treaties. See RJ Aerts, “The Legitimacy of Patent Law-Making in Europe and the U.S. – A Tentative Comparison” (2007) 28(2) IIC 165 at p 169.

90 Decision T 1063/18, supra, note 4, p 22.

91 ibid, p 21.

92 Recital 32 of the Biotech Directive sets out that: “Whereas, however, if an invention consists only in genetically modifying a particular plant variety, and if a new plant variety is bred, it will still be excluded from patentability even if the genetic modification is the result not of an essentially biological process but of a biotechnological process”.

93 On the concept of reflective mode of patent governance see I Schneider, “Governing the Patent System in Europe: The EPO’s Supranational Autonomy and Its Need for a Regulatory Perspective” (2009) 36(8) Science and Public Policy 619 at p 620.

94 See Schneider, supra, note 93, p 623; Aerts, supra, note 89, pp 173–180; S Thambisetty, “The Construction of Legitimacy in European Patent Law” (2017) 21 Intellectual Property Quarterly 221 at pp 241–242.

95 Schneider, supra, note 93, p 623.

96 Aerts, supra, note 89, p 174.

97 Schneider has noticed that “there is no institutional separation of power between the executive branch (examination departments) and the quasi-jurisdictional branch” and that “both branches enact tacit policy-making processes concerning substantial patent law in new technological fields for which there is hardly any accountability vis-à-vis the EPO Council, and no accountability at all with respect to national parliaments and the European public”. These flaws in the separation of powers of the EPOrg constitute, furthermore, democratic deficits in its structure: Schneider, supra, note 93, p 623. See also Aerts, supra, note 89, p 179.

98 Aerts, supra, note 89, p 174.

99 Aerts, supra, note 89, pp 173–174.

100 Inter-Governmental Conference for the setting up of a European System for the grant of patents, Minutes of the 2nd Meeting held at Luxembourg 13–16 January 1970 (BR/26 e/70 kel/PA7mk), at point 36.

101 Thambisetty, supra, note 94, p 221.

102 S Borrás, “The Governance of the European Patent System: Effective and Legitimate?” (2007) 35(4) Economy and Society 594 at p 601.

103 G 3/08 (President’s Reference/Computer Program Exclusions) [2010] EPOR 36, at point 7.2.1.

104 J Pila, “Software Patents, Separation of Powers, and Failed Syllogisms: A Cornucopia from the Enlarged Board of Appeal of the European Patent Office” (2011) 71(1) Cambridge Law Journal 203 at p 215.

105 ibid. She is referring, in particular, to G 3/08, supra, note 103, at point 7.2.5.

106 I Schneider, “Exclusions and Exceptions to Patent Eligibility Revisited: Examining the Political Functions of the ‘Discovery’ and ‘Ordre Public’ Clauses in the European Patent Convention and the Arenas of Negotiation” in I de Miguel Berian and CM Romeo Casabona (eds), Synbio and Human Health: A Challenge to the Current IP Framework (Springer 2014) pp 145, 153.

107 S Sterckx and J Cockbain, Exclusions from Patentability: How far Has the European Patent Office Eroded the Boundaries? (Cambridge University Press 2012) pp vii, 172–241 (chs 6 and 7). See also P Drahos, “Biotechnology Patents, Markets and Morality” (1999) 21(9) EIPR 441 at p 445.

108 C Godt, “Technology, Patents and Markets: The Implied Lessons of the EU Commission’s Intervention in the Broccoli/Tomatoes Case of 2016 for Modern (Plant) Genome Editing” (2018) 49 IIC 512 at pp 516–517.

109 Eg G 2/12 and G 2/13 and G2/06 (Use of embryos/WARF) of 25 November 2008.

110 Sterckx and Cockbain, supra, note 107, p 322.

111 G 2/12 and G 2/13, supra, note 7.

112 Council of Europe, Convention on the Unification of Certain Points of Substantive Law on Patents for Invention, 27 November 1963, European Treaty Series No 47, <www.coe.int/en/web/conventions/full-list/-/conventions/rms/090000168006b65d> accessed 19 August 2019. Sterckx and Cockbain have clarified that the travaux préparatoires of the SPC point out that the term “production” of plants and animals was meant to include breeding and farming: Sterckx and Cockbain, supra, note 107, p 182.

113 Board of Trade, United Kingdom Patent Law: The Effects of the Strasbourg Convention of 1963, Report on the legislative changes which would be involved in the proposed ratification by the United Kingdom of the Strasbourg Convention on the unification of certain points of substantive law on patents for invention by the Patents Liaison Group, at point 41.

114 The UK delegation during the travaux préparatoires regarding Art 53 EPC “proposed that subparagraph (b) [of Art 10 Exceptions to patentability, in the draft] should be amended on the grounds that the meaning of ‘essentially biological processes’ was not clear”. Minutes of the 4th Meeting of the Inter-Governmental Conference for the setting up of a European System for the grant of patents, 20–28 April 1971 (BR/135 e/71 prk), point 99.

115 Art 2(2) Biotech Directive defines “essentially biological process” as “A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection”.

116 Schneider, supra, note 93, p 623.

117 ibid.

118 ibid.

119 C Godt, Eigentum an Information (Mohr Siebeck 2007) pp V, 23; RJ Aerts, “The European Commission’s Notice on Directive 98/44 and the European Patent Organization’s Response: The Unpredictable Interaction of EU and EPC Law” (2018) 13(10) Journal of Intellectual Property Law & Practice 800 at p 801; O Bossung, “A Union Patent Instead of the Community Patent” (2003) 34(1) IIC 1 at p 14.

120 Arts 32 and 33 EPC were amended for this purpose. See on the point Schneider, supra, note 93, p 623.

121 Borrás, supra, note 102, p 598.

122 Borrás, supra, note 102, p 600.

123 Eg §2a(1) No 1 German Patent Act §2a(1) and Art 3(1)(d) Dutch Patent Act of 15 December 1994.

124 For example the Position paper “Patenting of Plants in Europe” by the Chartered Institute of Patent Attorneys (CIPA) of the UK, <www.cipa.org.uk/policy-and-news/briefing-papers/position-paper-on-patenting-of-plants-in-europe/> accessed 19 August 2019.

125 C Godt, “Technology, patents and markets: the implied lessons of the EU Commission’s intervention in the Broccoli/Tomatoes Case of 2016 for modern (plant) genome editing” (2018) 49 IIC 512.

126 Kock and Morgan, supra, note 14, p 127.

127 Molecular markers are “DNA sequences that vary among individuals (DNA polymorphisms) of the same species and are useful in genetic linkage studies”: H Lodish et al, Molecular Cell Biology (Macmillan 2013) p G-15.

128 Borrás, supra, note 102, p 607.

129 I Schneider, “Can Patent Legislation Make a Difference? Bringing Parliaments and Civil Society into Patent Governance” in S Haunss and KC Shadlen (eds), Politics of Intellectual Property: Contestation over the Ownership, Use and Control of Knowledge and Information (Edward Elgar 2009) p 129 at p 131.

130 See on this point, Schneider, supra, note 93, p 627; Godt, supra, note 119; I Schneider, Das Europäische Patentsystem: Wandel von Governance durch Parlamente und Zivilgesellschaft (Campus Verlag 2010) p 6.

131 See Schneider, supra, note 93, pp 625–627.

132 Susana Borrás pointed out that, since most economists acknowledge the social nature of the process of innovation, the sustainability of the social contract results pivotal for the legitimacy of the patent system: Borrás, supra, note 102, p 595.

133 The social contract justification for the existence of patent institutions is centred on the idea that “The patent system is a social contract in which society induces the inventor to make public for the use of others what he might have otherwise kept secret by offering him a monopoly for a limited period of time”: P Drahos, The Global Governance of Knowledge: Patent Offices and Their Clients (Cambridge University Press 2010) pp vii, 27.