The Breeding Exception to Patent Rights: Analysis of Compliance with Article 30 of the TRIPS Agreement

Prifti, Viola

doi:10.1007/978-3-319-15771-9_6

Viola Prifti⁸

Part of the book series: International Law and Economics ((ILEC))

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Abstract

This chapter analyzes the compliance of both a narrow and a broad version of the breeder’s exception to patent rights with article 30 of the TRIPS Agreement. The interpretation of the vague rule contained in this article mainly relies on the panels’ decision in the EC-Canada pharmaceuticals case, but the analysis goes beyond the panel’s opinion. It enriches the understanding of article 30 through a review of legal and economic studies on the incentive to innovate and elaborates a reasonableness test in relation to a possible conflict with the interests of the patent owner. It also introduces human rights concerns on food security issues and finds a linkage between the breeding exception, food security, and countries’ obligations under the International Treaty on Plant Genetic Resources for Food and Agricultural. These considerations combined with an infield research with stakeholders in plant breeding offer a method for an accurate assessment of the compliance test in article 30.

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Notes

1.
Note that although TRIPS membership coincides with WTO membership, not all WTO countries are members of TRIPS since least developed countries have been granted a grace period.
2.
See Article 3.2 of the Understanding on rules and procedures governing the settlement of disputes (Dispute Settlement Understanding or DSU), Annex 2 of the WTO Agreement, 1869 UNTS 401; 33 ILM 1226 (1994).
3.
The legal basis for the application of the Understanding to TRIPS is found in article 1.1 of the Understanding.
4.
For more see Van Damme (2009), pp. 32–55.
5.
Panizzon (2006), p. 20.
6.
Van Damme (2009), p. 263.
7.
Please compare with article 38 of the Statute of the International Court of Justice, 3 Bevans 1179; 59 Stat. 1031; T.S. 993; 39 AJIL Supp. 215 (1945). For more see Cattaneo (2000), pp. 627 and 673.
8.
Van Damme (2009), pp. 52–56.
9.
This principle was first defined in US – Gasoline (WT/DS2/AB/R) and recalled in Korea-Dairy (WT/DS98/AB/R), para. 80. For more on the principle of effectiveness in the WTO dispute settlement see Cameron and Gray (2001), pp. 248–298; WTO Analytical Index (2007), p. 1118.
10.
Section 271-e-1 of the Drug Price Competition and Patent Term Restoration Act, informally known as the “Hatch-Waxman Act” [Public Law 98-417] after a court case Roche Products v Bolar Pharmaceutical, 733 F.2d 858 (Fed. Cir. 1984).
11.
Correa (2005), pp. 10–16.
12.
Ibidem, 14.
13.
Ibidem; Kur (2011), pp. 239–240; Rodrigues (2012).
14.
Prof. Kur argues that this might be particularly the case if the three conditions of article 30 must be cumulatively satisfied. See Kur (2011).
15.
For more on the interests of different parties on weakening the TRIPS Agreement see Cattaneo (2000). In interpretative terms, the interests of parties on weakening or strengthening the TRIPS provisions can be reflected in the scholarly debate between ‘activists’ and ‘strict constructivists’. See Cattaneo (2000), p. 657, note 118.
16.
Para. 7.20 WT/DS114/R.
17.
WTO panels play a significant role in shaping interpretation of the DSU. For a comprehensive analysis of the interpretative function of the WTO see Van Damme (2009).
18.
Para 7.30 WT/DS114/R.
19.
Para. 7.32 WT/DS114/R. In another dispute on copyright exceptions, the panel established a maximum requirement of narrowness in a quantitative as well as qualitative sense. See WT/DS160/R (para. 6.109). This has been interpreted by an author as a leeway for determining whether these thresholds are decisive. See Senftleben (2006), p. 407. The considerations of the copyright panel can be relevant for the interpretation of article 30, given that both patent and copyright exceptions are inspired by article 9 (2) of the Berne Convention.
20.
Dictionaries have become an essential research tool in WTO TRIPS litigation. See Dinwoodie (2002), p. 993; Van Damme (2009), pp. 22–223.
21.
See the online Oxford dictionary, available at http://oxforddictionaries.com/definition/english/limited?q=limited, accessed 12 March 2014.
22.
See the online Merriam Webster dictionary, available at http://www.merriam-webster.com/dictionary/limited, accessed 12 March 2014.
23.
For more see Correa (2007), p. 307. On the practice of countries on patent exceptions see also UNCTAD-ICTSD (2005), p. 437.
24.
Please note that paragraph one of Article 28 provides for rights on both products and processes, but only patented products are relevant for examining the breeding exception.
25.
Para. 7.59 WT/DS114/R.
26.
Senftleben (2006), pp. 407 and 428.
27.
Para. 7.55, emphasis added WT/DS114/R.
28.
Correa (2005), p. 12.
29.
Note that the definition of genetic distance is a controversial point. See better Chap. 4.
30.
Geiger (2007).
31.
See article 28 of TRIPS.
32.
For an overview of the fees in these countries see: http://www.patentvista.nl/kosten_taksen_overzicht_en.php, accessed 16 March 2014.
33.
Fewer than 5 % of German patents remain in force during their entire term. See Cooter and Ulen (2011), p. 123.
34.
Para. 7.56 WT/DS114/R, emphasis added.
35.
Para. 7.57 WT/DS114/R, emphasis added.
36.
British Society of Plant Breeders (2000).
37.
The European Food Safety Authority (EFSA) is the competent authority within the EU, http://www.efsa.europa.eu/en/topics/topic/gmo.htm. For recent developments on this topic see Gillam (2012).
38.
Please, note that new varieties do not necessarily contain patented elements. Patented genes are often crossed out in the breeding process.
39.
For a better explanation see Chap. 4.
40.
For further argumentation see Langinier and Moschini (2002).
41.
See better the article from Nobel economist, Becker (2013).
42.
This argument rejects suggestions to introduce supplementary protection certificates in order to compensate the ‘loss’ from reduced patent length. For more on this suggestion see Kock (2009), pp. 167 and 172–173.
43.
Para. 7.68, WT/DS114/R.
44.
Para. 7.69, WT/DS114/R.
45.
For further discussion see Kanwar and Evenson (2003), pp. 235–264; Machlup and Penrose (1950), p. 1; Landes and Posner (2003); Pugatch (2006).
46.
Arora et al. (2003); Hall and Harhoff (2012), pp. 541–565.
47.
Wang (2010), pp. 103–116.
48.
See Chap. 4, Part 2 for further argumentation.
49.
Scherer (2009), pp. 167–216.
50.
Boldrin and Levine (2008).
51.
See Annex for a list of the interviewees.
52.
It is worth noting that the International Community of Ornamental and Plant Fruits Breeders (CIOPORA) has a diverging opinion. This category of breeders is concerned only with vegetatively propagated ornamentals and fruits. Only a few multinationals operate in this sector and the number of patents is very low. Thus, the breeding exception in patent law does not affect the sector of vegetatively reproduced ornamentals and fruits. Nevertheless, these breeders call for stronger rights and for a weakening of the breeder’s exception in the UPOV Convention.
53.
The recognition of the legitimate interests of third parties redimensions the view on patent law. The latter, indeed, is shifting from its original narrow definition of private law towards a more social approach. See Schneider (2009), pp. 129 and 131.
54.
Note that the WTO system does not explicitly take social and cultural rights into account. Exceptionally, related arguments were brought up in the case of access to patented knowledge for pharmaceuticals. However, the WTO does not impede member states to consider social and cultural aspects. For more see Herstemeyer (2012), pp. 71–105.
55.
See arts. 5.2 and 6 of the ITPGRFA and arts. 1, 15.2, 16 of the CBD.
56.
Moser (2013), pp. 3–22.
57.
Article 26.3 of the Implementing Regulations of the European Patent Convention and paragraph 2403 of the US Manual of Patenting Examining Procedure.
58.
Para 7.98, WT/DS114/R.
59.
Para 7.98, WT/DS114/R.
60.
Para 7.101, WT/DS114/R.
61.
Para 7.92, WT/DS114/R. See also UNCTAD-ICTSD (2005), p. 370.
62.
Para 7.100, WT/DS114/R.
63.
See the online Oxford and Merriam Webster dictionary.
64.
‘Sui generis’ is a Latin phrase that means ‘of its own kind’, thus it denotes the particularity of a system.
65.
Para 7.92, WT/DS114/R.
66.
See UNCTAD-ICTSD (2005), p. 374.
67.
For a better explanation see Food Security, FAO Policy Brief, June 2006, Issue 2.
68.
For more see the FAO (2005).
69.
Fujisaka et al. (2011). For the role of human action on GRFA interdependence see Hufler and Lefber, pp. 237–248.
70.
For a further discussion of the role of IP in food security, see Tansey (2012).
71.
Para. 7.59, WT/DS114R.
72.
For the need to interpret the three-step test in the light of the proportionality principle see Kur (2011), p. 246.
73.
In accordance with article 31.2 of the VCLT. See also UNCTAD-ICTSD (2005), p. 2.
74.
For more see Correa (2007), p. 92; Stoll et al. (2009), p. 180. Moreover, articles 7 and 8 have been identified as relevant in interpreting the TRIPS Agreement by the Doha WTO Ministerial 2001.
75.
Para. 7.26, WT/DS114/R.
76.
Correa (2007), p. 309.
77.
Correa (2007), p. 309; Kur (2011), p. 246.
78.
For more on this issue see Yu (2009), p. 12.
79.
Correa (2007), Stoll et al. (2009), and UNCTAD-ICTSD (2005).
80.
Pires de Carvalho sustains that this article does not indicate the objectives of TRIPS, but those of the protection and enforcement of some IPRs. He admits though the relevance of article 7 in interpreting the Agreement. See de Carvalho (2006), p. 172.
81.
Keßler in Stoll et al. (2009), p. 182 citing Machlup (1958) and Demaret (1978). The distinction between ‘innovation’ and ‘invention’ was first recognized in the theory of economic development by Schumpeter.
82.
Correa (2007), p. 91.
83.
Keßler in Stoll et al. (2009), p. 184.
84.
Wechsler (2009), p. 2.
85.
Ibidem.
86.
See Correa (2007), p. 108; Gervais (2008), p. 209; de Carvalho (2006); UNCTAD-ICTSD (2005), p. 127.
87.
Para. 7.26 WT/DS114/R.
88.
The definition of sectors of vital importance in socio-economic and technological development is, however, a matter of national policy.
89.
For more on this issue see WTO (2003).
90.
Correa (2007), p. 105.
91.
Stoll et al. (2009), p. 198.
92.
For an explanation of the general and specific exceptions provided by TRIPS, see Gervais (2008), pp. 380–381.
93.
Correa (2005) and Bently et al. (2010).
94.
‘Desiring to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade.’ Compare with the preamble of the 1947 General Agreement on Trade and Tariffs (GATT), which purpose is ‘the substantial reduction of tariffs and other trade barriers and the elimination of preferences, on a reciprocal and mutual advantageous basis’ (emphasis added).
95.
WTO (2011), p. 39.
96.
Note that there are additional factors that contribute to trade tensions. For more see Reichman (1995), pp. 345 and 346.
97.
Developed countries accounted for more than 90 % of global R&D expenditures in the 1990s. See Correa (2011), p. 154.
98.
For a better explanation, see supra note, pp. 154–156.
99.
Saggi (2008), pp. 329–355. See also Saggi (1999).
100.
Prasetyo et al. (2013). Moreover, this study found that IPR protection has either had a negative impact on trade or no impact at all for the year 2011.
101.
On the contrary, a recent empirical study has found that the tightening of IPRs after the adoption of the TRIPS Agreement in 60 developed and developing countries, has negatively effected trade in these countries. See Campi and Duenas (2014).
102.
This information is based on some of the interviews conducted for the purpose of this research. See Annex for a list of the interviewees.
103.
See the two letters of Ms Sharon A.M. Dijksma, Dutch Minister of Agriculture, dated 27 June 2013, Vergaderjaar 2012–2013, 33 365 (R1987) Nr. 6 and 28 June 2013, Vergaderjaar 2012–2013, 33 365 (R1987) Nr. 8.
104.
Para. 7.35, WT/DS114/R.
105.
Kur (2011), p. 228. This view is supported by the European Board of Appeal (EBA) judgment on restrictions to patentability. In G01/07, Treatment by Surgery/Medi-Physics of 15 February, 2010, the EBA affirmed that exceptions to patentability are to be interpreted in a way that gives effect to their purposes.
106.
Rodrigues (2012).
107.
Senftleben (2006).
108.
See article 11.1 of the ITPGRFA.
109.
Hall and Harhoff (2012), pp. 541–565.
110.
For an understanding see Louwaars et al. (2009), Nr. 14, p. 10.
111.
Bessen and Meurer (2008), p. 89.
112.
Bessen (2003), p. 8.
113.
Levin et al. (1987), pp. 783–820.
114.
Please, note that the reproductive nature of the biological material makes it very unlikely to protect inventions with trade secrets. If secrets were used in the biotechnological sector, they would give only a few years of lead time advantage.
115.
Please, note that if a comprehensive exception were limited to the 64 crops listed in Annex I of the ITPGRFA there would be no concerns in this regard since the exception would allow breeding of plant varieties for the sole purpose of food and agricultural use.
116.
See, for example, the letter of Monsanto to the concerned Dutch ministries: http://vorige.nrc.nl/multimedia/archive/00242/Patentrecht_09-07-0_242612a.pdf, accessed 24 October 2013.
117.
Andersen and Konzelmann (2008); Bessen and Meurer (2008); Boldrin and Levine (2008); Greenspoon and Cottle (2011); Moser (2013), pp. 3–22.
118.
For an overview of the economic literature and for the impact of IPRs in the US market see Dhar and Foltz (2007).
119.
Allred and Park (2007), pp. 91–109; Hall and Harhoff (2012), pp. 541–565; Harabi (1996). Mansfield, in particular, concluded that 60 % of inventions in the pharmaceutical industry would not have been developed without patent protection and 38 % would not have been developed in the chemical industry. See Mansfield (1986), p. 173.
120.
Evenson and Kislev (1975). In particular, Evenson and Kislev found that the absorption of foreign-generated technology depends on domestic research capacities. On the role of national systems in innovation see also Freeman (1995), pp. 5–24.
121.
Kur (2011), p. 246; Rodrigues (2012).
122.
Conflicts may arise when patents contribute to the concentration of the market and push local varieties out of the market. For a better explanation see Evangelic Church in Germany ‘Biopatents and Food Security from a Christian Perspective’, a study of the Evangelical Church in Germany’s Advisory Commission on Sustainable Development, April 2013. For the possible influence of patents on food security and genetic diversity see De Schutter (2009).
123.
For the development of the right to food, see Wernaart (2010), pp. 43–81.
124.
E/C.12/1999/5, 12 May 1999.
125.
The reasons are related to the importance of plant breeding as depicted in Chap. 3.
126.
For more on this point see Hospes et al. (2010), pp. 19–38.
127.
Please, note that food security incorporates both an international dimension and an important local dimension. For this reason, it is named as a ‘glocal’ problem.
128.
Reichman (2000), pp. 1743 and 1784.
129.
This phenomenon might lead to a the so-called ‘Tragedy of anti-commons’. For more details refer to second part in Chap. 5 of this thesis.
130.
See arts. 10–12 of the ITPGRFA.
131.
See art. 13 of the ITPGRFA.
132.
For more see the ‘Open Letter Regarding the Vegetable Licensing Platform’ elaborated by the Berne Declaration. Available at http://www.evb.ch/en/p25021548.html, accessed 9 March 2014. See also De Schutter (2014). In page 22 of the Report, the UN special rapporteur on the right to food recommends not to ‘…allow patents on plants and establish research exceptions in legislation protecting plant breeders’ rights’. Please, note that Germany amended in 2013 its Patent Act in order to exclude plants bred from essentially biological processes from patentability. See section 2(a) 1.1 of the German Patent Act and German Parliamentary resolution nr. 17/10308.

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Max Planck Institute for Innovation and Competition, Munich, Germany
Viola Prifti

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Viola Prifti
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Prifti, V. (2015). The Breeding Exception to Patent Rights: Analysis of Compliance with Article 30 of the TRIPS Agreement. In: The Breeder's Exception to Patent Rights. International Law and Economics. Springer, Cham. https://doi.org/10.1007/978-3-319-15771-9_6

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DOI: https://doi.org/10.1007/978-3-319-15771-9_6
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