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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
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”.
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- Case Commentaries
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- 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
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- © Cambridge University Press 2019
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.