Whereas in the U.S. the patentability of micro-organisms has been questioned before SCOTUS in Chakrabarty, the European Patent Office (“EPO”) had not faced major challenges related to this issue, in the same years. Whilst in the U.S. the Chakrabarty judgment attracted public attention, in 1976 the British Patent Office had already granted the corresponding British patent, but the fact went unnoticed.738 This shows, however, how much the patentability of microorganisms, as such, was not a controversial matter for legal scholars, NGOs and citizens at the time.
733 Tallacchini (n 31) 164-165; Tallacchini (n 596) 8.
734 Tallacchini (n 596) 8. Translation mine.
735 ibid.Translation mine.
736 U.S.OTA (n 640), 19.
737Tallacchini (n 31) 166.
738 UK Patent No. 1,436,573, published on 19 June 1976. See Graham Dutfield, ‘Claiming Life: are Organisms Inherently Unpatentable’ in Catherine Ng, Lionel Bently and Giuseppina D’Agostino (eds), The Common Law of Intellectual Property: Essays in Honour of Professor David Vaver (Hart Publishing 2010) 161, 162.
141 The European Patent Convention (“EPC”), which is a multinational treaty in operation since 1978,739 lacks any explicit rule allowing the patentability of microorganisms as such, as Art.
53(b) and Rule 31 EPC do not refer to microorganisms as such.740 Rule 26(3) EPC defines
“biological material” as “any material containing genetic information and capable of reproducing itself or being reproduced in a biological system”. Microorganisms are encompassed in the definition.
The term "microorganism", according to EPO Guidelines, G-II, 5.5.1, “includes bacteria and other generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory, including plasmids and viruses and unicellular fungi (including yeasts), algae, protozoa and, moreover, human, animal and plant cells.741
Article 53(b) EPC sets out the patentability exception of plants or animal varieties or essentially biological processes for the production of plants or animals, but it clarifies that the provision “shall not apply to microbiological processes or the products thereof”. Therefore, if a product resulting from a microbiological process other than a plant or animal variety is a microorganism, it may be patentable.742
Moreover, Art. 52(2) EPC sets out subject matter and activities which shall not be regarded as inventions within the meaning of paragraph 1, and includes “(a) discoveries, scientific theories and mathematical methods”.
However, the patentability of micro-organisms as discoveries has never been at the core of a major judicial challenge and European social debate, in 1970s and 1980s.
At present, Section G-II, 3.1 of the Guidelines, specifies the threshold of patentability for micro-organisms, which is characterized as the “production of a technical effect”.743
Although the EPC does not provide a definition of what “invention” is, the standard established in Section G-II, 3.1 of the Guidelines is consistent with the technical nature of the invention. As Huys, Van Overwalle and Matthijs pointed out the implementing regulations
739 Sigrid Sterckx and Julian Cockbain, Exclusions from Patentability. How Far Has the European Patent Office Eroded Boundaries? (Cambridge University Press 2012) vii, 17.
740 Franz-Josef Zimmer, Steven M Zeman, Jens Hammer, Klara Goldbach, Bernard Allekotte, Protecting and Enforcing Life Science Inventions in Europe (C.H. Beck-Hart 2015) Protecting and Enforcing Life Science Inventions in Europe , 219-220.
741 EPO Guidelines for Examination, G-II, 5.5.1. Zimmer, et al. (n 740) 219.
742 EPO Guidelines for Examination, G-II, 5.5.1, clarifies that microorganisms may be obtained as products of a microbiological processes: “The product of a microbiological process may also be patentable per se (product claim). Propagation of the microorganisms itself is to be construed as microbiological process for the purposes of Art. 53(b). Consequently, the microorganism can be protected per se as is a product obtained by a microbiological process (see Guidelines at section G-II, 3.1)”. EPO Guidelines for Examination, G-II, 5.5.1.
Zimmer, et al. (n 740) 220.
743 Section G-II, 3.1, EPO Guidelines for Examination.
142 clarify that “the invention must have technical features (Rule 43(1)), which is related to a technical field (Rule 42(1)(a)) and concerned with a technical problem (Rule 42(1)(c))”.744 Under the EPC system, the “technical” character of the invention and the “production of a technical effect” as a threshold of patent eligibility have proved to be central for the settlement of the patent eligibility of genetically modified microorganisms and organisms.
Issues regarding the patent eligibility of microorganisms have been raised, in the 1990s, when the NGO Greenpeace opposed European Patent No. 0 242 235, granted to Plant Genetic Systems on 10 October 1990, entitled “plant cells resistant to glutamine synthetase inhibitors, made by genetic engineering” (which made them resistant to herbicides inhibiting glutamine synthetase).
The patent, according to the specification, regarded a process “for producing plants and reproduction material of said plants including a heterologous material stably integrated therein”,745 but also “plant cells, reproduction material, particularly seeds, as well as plants containing a foreign or heterologous DNA fragment stably integrated in their respective genomic DNAs, said fragments being transferred throughout generations of such plant cells, reproduction material, seeds and plants”.746
Greenpeace opposed the patent on several grounds and argued that the claims concerned non patentable subject matter under Art.53(a) and (b). In particular, Greenpeace maintained that the grant of a patent for plant life forms and its exploitation was contrary to morality and ordre public; that the claims related to plants and the processes for their production were not patentable under Art. 53(b) EPC and plant products from any generation beyond the first one did not constitute an invention under Art. 52 EPC.
The Technical Board of Appeal (“TBA”) of the EPO decided, finally, on the case, T 356/93 Plant cells/Plant Genetic Systems, on 21 February 1995.
The TBA drew on a technical approach to the kind of claims involved, refraining from engaging in any discussion of the nature and risks of genetically engineered microorganisms and organisms. The Board relied on the narrative of naturalization and normalization of contemporary biotechnology which has been illustrated in chapter two: rDNA biotechnology should not be considered differently from the previous biotechnology, as it only entails a better control over the patented products.
744 Huys, Van Overwalle and Matthijs (n 26) 1104.
745 Jan Leemans, Johan Botterman, Marc de Block, Charles Thomson and Rao Maoura, Plant cells resistant to glutamine synthetase inhibitors, made by genetic engineering, European Patent No. 242236, Munich: EPO, at 7, in Sigrid Sterckx and Julian Cockbain, Exclusions from Patentability. How Far Has the European Patent Office Eroded Boundaries? (Cambridge University Press 2012) vii, 201.
746 ibid.
143 As far as claim 14 was concerned, which regarded plant cells (which fall within the definition of microorganisms), Greenpeace argued that the grant of a patent on plant cells contravened Article 53(a) and (b).
The Board pointed out that “plant cells were considered to be microbiological products under the current practice of the EPO”747 and addressed whether any of the claimed subject matter constituted an exception to patentability under Art. 53(a) and (b). Art. 53(a) EPC 1973 excluded from patentability “inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States”.
The Board clarified that there was no European definition of morality and ordre public and that the meaning of these concepts “must be defined by way of interpretation”.748
Ordre public was considered to cover the protection of public security and the physical integrity of individuals as part of society, which also encompasses the environment.
Therefore, the inventions whose exploitation is likely to breach public peace, social order, or seriously prejudice the environment can be considered contrary to ordre public. The TBA construed “morality” as “related to the belief that some behavior is right and acceptable, whereas other behavior is wrong”749 on the basis of the “totality of accepted norms which are deeply rooted in a particular culture”.750
It, then, affirmed that, according to the historical documentation relating to the EPC the concept of patentability must be as wide as possible, pinpointing that the exceptions to patentability should be narrowly construed.751
The Board maintained the opposed patent claims, as it deemed that no challenged claim included subject-matter contrary to the clause, 752 as Greenpeace failed to prove a sufficiently substantiated threat to the environment linked to the invention and its contrariety to morality, as no misuse or destructive use of the invention could be devised “in light of the conventionally accepted standards of conduct of European culture”.753 Moreover, the Board
747 Technical Board of Appeal of the European Patent Office, Decision of 21 February 1995, T 356/93 Plant cells/Plant Genetic Systems, 13.
748 ibid 15.
749 ibid 16.
750 ibid.
751 ibid 17.
752 Zimmer, et al. (n 740) 221.
753 T 356/93 (n 747) 24.
144 affirmed that the processes involved were not essentially biological, but technical, and microbiological and, thus, did not fall within the patent exceptions set out in Art. 53(b).754 The case was finally remitted to the Opposition Division, which maintained it in an amended form in 1996.755 However, the claims to transgenic seeds and plants had already been deleted, following the decision of the Opposition Division in 1993 and the TBA affirmed its decision.
It has been illustrated that patents became “socially sensitive” institutions in Europe in the 1990s, when growing awareness of NGOs and groups about the social impact and effects of IPRs emerged and, in the process of political integration towards the future European Union, ethics was increasingly considered and devised as a relevant means to build the European identity.756
As Tallacchini explained, the institutionalization of ethics in the European Community began when “the European Commission decided to incorporate ethics into the decision-making process for Community research and technological development policies by setting up the Group of Advisers on Ethical Implications of Biotechnology (GAEIB)”,757 in November 1991. This incorporation concerned, first, biotechnology and, then, from 1997, when the GAEIB was replaced by the European Group on Ethics on Science and New Technologies (EGE), all the areas of science and technology, as the Group’s mandate was extended to cover all areas of application of science and technology.758 This integration, Tallacchini noticed, was deemed as a fundamental political factor in the transition from Rome Treaties to the Unique Market, up until the Maastricht Treaty.759 However, this process of integration turned to be particularly difficult and the efforts of constructing a European ethical shared view went amiss also within the EPC system as no settled vision emerged from patent case law, as chapter six will show.