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Published online by Cambridge University Press: 20 January 2017
Nowadays, biotechnologies are among the most interesting areas of science. Their development, fostered by intellectual property (IP) rights’ protection, leads to useful progress. Nonetheless, when, as with biotech inventions, environmental protection is at stake, this progress is not without controversy. The present contribution aims at examining the interferences between IP and environmental protection, as emerging in the framework of the European Patent Convention. To this extent, it will focus on the function and on the limits of the ordre public exception clause, with the purpose of suggesting a new role for science in disputes for revocation of biotech patents.
1 Plant cells/Plant Genetic Systems, T 356/93, Decision of the Technical Board of Appeal of the European Patent Office, 21 February 1995, para. 18.3. See Paterson, Gerald (ed.), The European Patent System. The Law and Practice of the European Patent Convention, 2 nd ed. (London: Sweet & Maxwell, 2001), at p. 436 Google Scholar; Singer, Margaret and Stauder, Dieter (eds.), European Patent Convention. A Commentary, v. 1, 3 rd ed. (London: Sweet & Maxwell, 2003), at p. 88 Google Scholar; Visser, Derk and Forsyth, Neil, The Annotated European Patent Convention, 16 th ed. (Veldhoven: Tel, 2008) at p. 63Google Scholar. The decisions adopted by the EPO are available on the Internet at <http://www.epo.org> (last accessed on 16 January 2012).
2 Convention on the Grant of European Patents (European Patent Convention), adopted by the EPO in Munich on 5 October 1973, revised by the Act revising Article 63 EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000. The text is available on the Internet at <http://www.epo.org> (last accessed on 16 January 2012).
3 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, OJ 1998 L 213/13, Art. 3.1 (hereinafter, “Directive 98/44/EC”). On it, see Jean-Pierre Berlan, “La directive européenne 98/44 de brevetabilité des inventions biotechnologiques”, in Michel Vivant (sous la dir. de), Propriété intellectuelle et mondialisation: la propriété intellectuelle est-elle une marchandise? (Paris: Dalloz, 2004), at p. 151; Kamstra, Gerald, Döring, Mark, Scott-Ram, Nick, Sheard, Andrew, and Wixon, Henry, Patents on Biotechnological Inventions: The E.C. Directive (London: Sweet & Maxwell, 2001)Google Scholar; Schertenleib, Denis, “The Patentability and Protection of Living Organisms in the European Union”, European Intellectual Property Review (2004), at p. 25 Google Scholar.
4 Directive 98/44/EC, supra note 3, Art. 1(a).
5 The list of techniques is alleged as Annex I A to Directive 2001/18/ EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ 2001 L106/1 (hereinafter, “Directive 2001/18/EC”).
6 See Bera, Rajendra K., “Patentable Subject Matter Under the US Patent Act, 1952: Cases”, 95 Current Science (2008), at p. 1421 Google Scholar.
7 Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, 447 U.S. 303, 100 S.Ct. 2204, U.S., 1980, June 16, 1980, at 309. The conclusion reached in Diamond v. Chakrabarty was confirmed in 2001 in J.E.M. AG Supply, DBA Farm Advantage v. Pioneer Hi- Bred International, on occasion of which the Supreme Court stated that the relevant distinction is not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions. See, J.E.M. AG Supply, Inc., DBA Farm Advantage, Inc., et al. v. Pioneer Hi-Bred International, Inc, 534 U.S. 124, 122 S. Ct. 593, U.S. Iowa, 2001, December 10, 2001, at 134. The rationale was recently followed by the District Court for the Southern District of New York in Association for Molecular Pathology v. United States Patent and Trademark Office, according to which the patents for the BRCA1 and BRCA2 genes, granted to Myriad Genetics, are invalid because of their incompatibility with the “product of nature” exception. See Association for Molecular Pathology et. Al. v. United States Patent and Trademark Office et al., 702 F. Supp. 2d 181, S.D.N.Y., 2010, March 29, 2010.
8 US Patent no. 4.736.866, “Transgenic non-human mammals” (1998). On this point, see Bera, “Patentable Subject Matter Under the US Patent Act, 1952: Cases”, supra note 6, at p. 1422; Gold, Edward Richard, “The Ethics of Biotechnological Intellectual Property”, in Gold, Edward Richard and Knoppers, Bartha Maria (eds.), Biotechnology, IP & Ethics (Ontario: LexisNexis, 2009), pp. 22–23 Google Scholar; Rao, M.B. and Guru, Manjula, Biotechnology, IPRs and Biodiversity (Pearson: Delhi, 2007), p. 53 Google Scholar; Westerlund, Li, Biotech Patents. Equivalent and Exclusions under European and U.S. Patent Law (The Hague: Kluwer Law International, 2002), pp. 39–40 Google Scholar.
9 President Battistelli's Keynote Speech on Clean Energy Technologies and IP (Munich, 22 July 2010) is available on the Internet at <http://www.epo.org> (last accessed on 16 January 2012).
10 Plant cells / Plant Genetic Systems, supra note 1, paras. 5–6. On the notion of ordre public in biotech issues, see Beyleveld, Deryck, Brownsword, Roger, and Llewelyn, Margaret, “The Morality Clause of the Directive on the Legal Protection of Biotechnological Inventions: Conflict, Compromise and the Patent Community,” in Goldberg, Richard and Lonbay, Julian (eds.), Pharmaceutical Medicine, Biotechnology and European Law (Cambridge: Cambridge University Press, 2000), pp. 157 et sqq Google Scholar; Boschiero, Nerina, “Le biotecnologie tra etica e principi generali del diritto internazionale”, in Boschiero, Nerina (ed.), Bioetica e biotecnologie nel diritto internazionale e comunitario. Questioni generali e tutela della proprietà intellettuale (Torino: Giappichelli, 2006), pp. 1 et sqq., at p. 84Google Scholar; Mills, Oliver, Biotechnological Inventions: Moral Restraints and Patent Law (Farnham: Ashgate, 2010)Google Scholar; Singer and Stauder, European Patent Convention, supra note 1, pp. 88-89; Zimmer, Franz-Josef and Sethmann, Svenja, “The immoral Gene: Does it really exist?”, in 11 Science and Engineering Ethics (2005), at p. 97 Google ScholarPubMed.
11 Plant cells / Plant Genetic Systems, supra note 1, paras. 5–6.
12 Singer and Stauder, European Patent Convention, supra note 1, at p. 89.
13 Dupuy, Pierre-Marie, “L’Unité de l’ordre juridique international. Cours general de droit international public (2000)”, in Recueil des cours. Collected Courses of the Hague Academy of International Law, v. 207 (Leiden/Boston: Martinus Nijhoff Publishers, 2003), at p. 282 Google Scholar.
14 Relaxin / Howard Florey Institute, V 8/94, Decision of the Opposition Division of the European Patent Office, 8 December 1994, para. 6.6.2. On this point, see Singer and Stauder, European Patent Convention, supra note 1, at p. 87.
15 Implementing Regulations to the Convention on the Grant of European Patents of 5 October 1973, adopted by decision of the Administrative Council of the European Patent Organisation of 7 December 2006 (hereinafter “Implementing Regulations”). Implementing Regulations were last amended with Decision of the Administrative Council of 26 October 2010 amending Rule 36, entering into force on 1 January 2011. Their text is available at <http://www.epo.org> (last accessed on 16 January 2012). For a comment on Rule 28, see Visser and Forsyth, The Annotated European Patent Convention, supra note 1, at p. 401. Pursuant to the previous version of the Implementing Regulations, as last amended by Decision of the Administrative Council of the European Patent Organisation of 9 December 2004, Rule 28 was numbered Rule 23d. From now on, it will be indicated as “Rule 28”.
16 Implementing Regulations, Rule 28.d. See Beyleveld, Brownsword, and Llewelyn, “The Morality Clause of the Directive on the Legal Protection of Biotechnological Inventions”, supra note 10, pp. 167–169; Cristina Campiglio, “I brevetti biotecnologici nel diritto comunitario”, in 13 Diritto del commercio internazionale (1999), pp. 849 et. sqq., pp. 890–899; Kamstra, Döring, Scott-Ram, Sheard, and Wixon, Patents on Biotechnological Inventions: The E.C. Directive, supra note 3, at p. 41.
17 Onco-mouse / Harvard, V 6/92, Decision of the Examining Division of the European Patent Office, 3 April 2002, para. 3. See Mills, Biotechnological Inventions: Moral Restraints and Patent Law, supra note 10, at. p. 57; Thomas, David and Richards, Georgina, “The Importance of the Morality Exception under the European Patent Convention: The Oncomouse Case Continues”, 26 European Intellectual Property Review (2004), at p. 97 Google Scholar.
18 Cullet, Philippe, “Liability and Redress for Modern Biotechnology”, in 15 Yearbook of International Environmental Law (2006), pp. 165 et sqq., pp. 172-174CrossRefGoogle Scholar; Grosko, Brett, “Genetic Engineering and International Law: Conflict or Harmony? An Analysis of the Biosafety Protocol, GATT, and the WTO Sanitary and Phytosanitary Agreement”, 20 Virginia Environmental Law Journal (2001), at p. 295 Google Scholar; Mackenzie, Ruth, “Environmental Damage and Genetically Modified Organisms”, in Bowman, Michael and Boyle, Alan (eds.), Environmental Damage in International and Comparative Law (Oxford: Oxford University Press, 2002), pp. 66 et sqq.Google Scholar; Murphy, Sean D., “Biotechnology and International Law”, 42 Harvard International Law Journal (2001), at p. 47 Google Scholar.
19 Method for producing transgenic animals / The President and Fellows of Harvard College, T 315/03, Decision of the Board of Appeal of the European Patent Office, 6 July 2004, para. 5 et sqq.
20 Decision of the Administrative Council of 16 June 1999 Amending the Implementing Regulations to the European Patent Convention, available on the Internet at <http://www.epo.org> (last accessed 16 January 2012).
21 Onco-mouse / Harvard, T 19/90, Decision of the Board of Appeal of the European Patent Office, 3 October 1990, para. 5. See Mills, supra note 10, pp. 55–59.
22 Method for producing transgenic animals / The President and Fellows of Harvard College, supra note 19, paras. 6.3 and 10.1.
23 Ibid., para. 6.3 and 10.1.
24 Ibid., para. 9.3.
25 Ibid., para. 13.2.9.
26 Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted by the Conference of the Parties to the Convention on Biological Diversity on 29 January 2000 and entered into force on 11 September 2003 (hereinafter, “Cartagena Protocol”), 39 International Legal Materials (2000), pp. 1027 et sqq.
27 Marquard, Helen, “Scope”, in Bail, Christoph, Falkner, Robert, and Marquard, Helen (eds.), The Cartagena Protocol on Biosafety. Reconciling Trade an Biotechnology with Environment and Development? (London: Earthscan, 2002), at p. 291–293 Google Scholar; Pavoni, Riccardo, “Biosicurezza e commercio di prodotti biotecnologici nel diritto internazionale e comunitario: quale reale portata innovativa per il principio di precauzione?”, in Bianchi, Andrea and Gestri, Marco (eds.), Il principio precauzionale nel diritto internazionale e comunitario (Milan: Giuffrè, 2006), pp. 81 et sqq., at. p. 92Google Scholar; Id., “Assessing and Managing Biotechnology Risk under the Cartagena Protocol on Biosafety”, in 10 The Italian Yearbook of International Law (2000), pp. 113 et sqq., at p. 124 and at p. 126.
28 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the Contained Use of Genetically Modified Micro-Organisms, OJ 2009 L 125/75, para. 9 of the Preamble.
29 Directive 2001/18/EC, supra note 5, para. 23 of the Preamble. On Directive 2001/18/EC see Lee, Maria, EU Regulation of GMOs. Law and Decision Making for a New Technology (Cheltenham: Edward Elgar, 2008), pp. 64 et sqq Google Scholar.
30 Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on Transboundary Movements of Genetically Modified Organisms, in OJ 2003 L287/1, Art. 11.2.
31 Redgwell, Catherine, “Biotechnology, Biodiversity and Sustainable Development: Conflict or Congruence?”, in Francioni, Francesco, and Scovazzi, Tullio (eds.), Biotechnology and International Law (Oxford: Hart, 2006), pp. 61 et sqq., pp. 68–69Google Scholar.
32 Plant Cells / Plant Genetic Systems, supra note 1, para. 18.2
33 Diamond, Commissioner of Patents and Trademarks v. Chakrabarty, supra note 7, at p. 317. On the decision, Rao and Guru, Biotechnology, IPRs and Biodiversity, supra note 8, at p. 52–53; Westerlund, Biotech Patents, supra note 8, pp. 39–40.
34 Gold, Edward Richard, “The Reach of Patent Law and Institutional Competence”, in 1 University of Ottawa Law & Technology Journal (2003–2004), at p. 272 Google Scholar.
35 Directive 98/44/EC, supra note 3, para. 14 of the Preamble.
36 van Overwalle, Geertrui, “Reshaping Bio-Patents: Measures to Restore Trust in Patent System”, in Somsen, Han (ed.), The Regulatory Challenge of Bio-Technology. Human Genetics, Food and Patents (Cheltenham: Edward Elgar, 2007) at p. 246 Google Scholar.
37 Method for producing transgenic animals / The President and Fellows of Harvard College, supra note 19, para. 4.2.
38 On this issue, see Beyleveld, Brownsword, and Llewelyn, supra note 10, pp. 164–167; Riccardo Pavoni, “Brevettabilità genetica e protezione della biodiversità: la giurisprudenza dell’Ufficio europeo dei brevetti”, in 83 Rivista di diritto internazionale (2000), pp. 429 et sqq. See also Adam Inch, “The European Patent Convention: A Moral Roadblock to Biotechnological Innovation in Europe”, in 30 Houston Journal of International Law (2007), pp. 203 et sqq.
39 Primate Embryonic Stem Cells / Wisconsin Alumni Research Foundation, T 1374/04, Decision of the Enlarged Board of Appeal, 25 November 2008, para. 25.
40 David A. Wirth, “The Role of Science in the Uruguay Round and NAFTA Trade Disciplines,” in 27 Cornell International Law Journal (1994), pp. 817 et sqq, at p. 845.
41 Plant Cells / Plant Genetic Systems, supra note 1, para. 18.6.
42 Ibid., para. 18.7.
43 Pavoni, Riccardo, Biodiversità e biotecnologie nel diritto internazionale e comunitario (Milan: Giuffre, 2004), at p. 479 Google Scholar.
44 Vienna Convention on the Law of Treaties, Vienna, 23 May 1969, in force 27 January 1980, in United Nations Treaty Series, vol. 1155, p. 331 et sqq.
45 Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law, Report of the Study Group of the International Law Commission finalized by Martti Koskenniemi, UN doc. A/CN.4/L.682, 13 April 2006, para. 423.
46 This expression is generally referred to the WTO legal system. See United States – Standards for reformulated and conventional gasoline, WT/DS2/AB/R, 29 April 1996, para. 14. On this issue, see Fragmentation of International Law, supra note 45, para. 165. See also Van Damme, Isabelle, “Some Observations About the ILC Study Group Report on the Fragmentation of International Law: WTO Treaty Interpretation Against the Background of Other International Law”, 17 The Finnish Yearbook of International Law (2006), at p. 21 Google Scholar; Young, Margaret A., “The WTO's Use of Relevant Rules of International Law: An Analysis of the Biotech Case”, 56 International and Comparative Law Quarterly (2007), pp. 907 et sqq., at p. 911Google Scholar.
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48 Communication on the Precautionary Principle, Commission of the European Communities, 2 February 2000, COM (2000)1, pp. 11 et sqq.
49 Theofanis Christoforou, “The Origins, Content and Role of the Precautionary Principle in European Community Law”, in Charles Leben and Joe Verhoeven (sous la dir. de), Le principe de précaution: aspects de droit international et communautaire (Paris: L.G.D.J., 2002), p. 205; Daniele Franzone, “Il principio di precauzione in diritto comunitario”, in Bianchi, Gestri, Il principio precauzionale, supra note 27, pp. 3 et sqq.
50 Directive 98/44/EC, supra note 3, para. 55 of the Preamble.
51 Convention on Biological Diversity, signed at Rio de Janeiro on 5 June 1992, entered into force on 29 December 1993, 31 International Legal Materials (1992), pp. 818 et sqq. See Birnie, Boyle and Redgwell, International Law and the Environment, supra note 47, at p. 612.
52 Rio Declaration on Environment and Development, 13 June 1992, UN Doc. A/CONF.151/26 (vol. I), 31 International Legal Materials (1992), pp. 874 et sqq.
53 Agreement on the Application of Sanitary and Phytosanitary Measures, GATT Doc. MTN/FA Ii-A1A-4, 1867 United Nations Treaty Series, pp. 493 et sqq. (hereinafter, “SPS Agreement”).
54 On the limited fields of application ratione materiae of both the instruments, Stoll, Peter-Tobias, “Controlling the Risk of Genetically Modified Organisms: The Cartagena Protocol on Biosafety and the SPS Agreement”, 10 Yearbook of International Environmental Law (1999), pp. 82 et sqq., pp. 102–103CrossRefGoogle Scholar.
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57 For the WTO, see Art. 3.2 of the Understanding on Rules and Procedures Governing the Settlement of Disputes; for the EPO, Art. 99 EPC et sqq.
58 European Communities – Measures affecting the approval and marketing of biotech products, Report of the Panel, 29 September 2006, WT/DS291/R, WT/DS292/R, WT/DS293/R, para. 7.68. See Fragmentation of International Law, supra note 45, para. 448; Steve Charnovitz, “The WTO's Environmental Progress”, in Journal of International Economic Law (2007), at 685 et sqq.; Cheyne, “Gateways to the Precautionary Principle”, supra note 55, at 157; Young, “The WTO's Use”, supra note 46, at. 907 and at 914; Antonia Eliason, “Science Versus Law in WTO Jurisprudence: The (Mis)Interpretation of the Scientific Process and the (In) Sufficiency of Scientific Evidence in EC-Biotech”, in 41 New York University Journal of International Law and Politics (2009), pp. 341 et sqq.; Marceau, Gabrielle, “Conflict of Norms and Conflicts of Jurisdiction: The Relationship between the WTO Agreement and MEAs and Other Treaties”, 35 Journal of World Trade Law (2001), pp. 1081 et sqq., at p. 1086CrossRefGoogle Scholar; Pollack, Mark J. and Shaffer, Gregory, When Cooperation Fails. The International Law and Politics of Genetically Modified Foods (Oxford: Oxford University Press, 2009), at p. 177 CrossRefGoogle Scholar; Andrew Thomison, “A New Controversial Mandate for the SPS Agreement: The WTO Panel's Interim Report in the E. C. – Biotech Dispute”, in 32 Columbia Journal of Environmental Law (2007), pp. 287 et sqq. On the case, see also Struss, Debra M., “Feast or Famine: The Impact of the WTO Decision Favoring the U.S. Biotechnology Industry in the EU Ban of Genetically Modified Foods”, 45 American Business Law Journal (2008), at p. 775 CrossRefGoogle Scholar.
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60 European Communities – Measures affecting the approval and marketing of biotech products, supra note 58, paras. 7.74–7.75.
61 Ibid., para. 7.74.
62 On this point, see Duncan French, “Treaty Interpretation and the Incorporation of Extraneous Legal Rules”, in 55 International and Comparative Law Quarterly (2006), p. 281 et sqq., pp. 305–307; Ulf Linderfalk, “Who are ‘The Parties’? Article 31, paragraph 3(c) of the 1969 Vienna Convention and the ‘Principle of Systemic Integration” Revisited’, in 55 Netherlands International Law Review (2008), p. 343 et sqq.; Gabrielle Marceau, “The WTO Dispute Settlement and Human Rights”, in 13 European Journal of International Law (2002), p. 754 et sqq., pp. 780–783; Pauwelyn, Joost, Conflicts of Norms in Public International Law (Cambridge: Cambridge University Press, 2003), at p. 261CrossRefGoogle Scholar.
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