C-377/98

OPINION OF MR JACOBS — CASE C-377/98

OPINION OF ADVOCATE GENERAL JACOBS delivered on 14 June 2001 1

Table of contents

The Directive I-7085

The action for annulment I-7087

The context of the Directive — patent law I - 7089

The argument that the Directive creates a new intellectual property right I-7105

The argument as to subsidiarity I-7108

The argument as to legal certainty I-7109

The arguments as to Article 6 I-7111

The relevant recitals and provisions of the Directive I-7111

Are ordre public and morality sufficiently clear concepts? I-7112

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The argument as to Articles 8 and 9 I - 7121 The argument that 'animal varieties' is not defined I - 7123 The arguments as to recitals 31 and 32 and Article 4(1)(a) and 4(2) I-7124 The argument as to the infringement of international obligations I-7126 Infringement of the TRIPs Agreement I - 7128 Incompatibility with the Agreement on Technical Barriers to Trade I-7129 Incompatibility with the European Patent Convention I-7131 Incompatibility with the Convention on Biological Diversity I-7132 The argument as to fundamental rights I-7137 Does Article 5(2) infringe fundamental rights? I - 7140 Does the failure to provide for consent infringe fundamental rights? I-7142 The argument that the correct procedure was not followed I - 7145 Conclusion I - 7147

1. In this case the Netherlands has brought 3. The Directive requires Member States to an action under Article 173 of the EC protect biotechnological inventions under Treaty (now, after amendment, Article 230 national patent law. 3 Although there is no EC) seeking a n n u l m e n t of Directive definition of 'biotechnological inventions', 98/44/EC on the legal protection of bio- it is clear that the concept essentially technological inventions. 2 comprises inventions concerning 'a product consisting of or containing biological mate- rial or a process by means of which biological material is produced, processed or used' 4 or inventions concerning 'a microbiological or other technical process or a product obtained by means of such a The Directive process'. 5 'Microbiological process' is defined as 'any process involving or per- formed upon or resulting in microbiologi-

4. The Directive provides that the follow- ing may not be patented: (i) plant and animal varieties; 10 (ii) essentially biological processes for the production of plants or animals; 11 (iii) the human body, at the 6. The Directive has a relatively long various stages of its formation and devel- history, although the version finally opment, and the simple discovery of one of adopted went through the legislative pro- its elements, including the sequence or cess with impressive speed. partial sequence of a gene; 12 and (iv) inventions the commercial exploitation of which would be contrary to ordre public or morality. 13 Examples of the latter are (a) processes for cloning human beings; (b) processes for modifying the germ line 7. In 1988 the Commission presented its genetic identity of human beings; (c) uses first proposal for a Council Directive on the of human embryos for industrial or com- legal protection of biotechnological inven- tions. 16 The proposed Directive started from the premiss that a 'subject matter of 6 — Article 2(1)(b). an invention shall not be considered unpa- 7 — Article 2(1)(a). 8 — Article 3(2). tentable for the reason only that it is 9 — Article 5(2). 10 — Article 4(1)(a). 11 —Article 4(1)(b). 14 — Article 6(2). 12 — Article 5(1). 15 — See note 139. 13 — Article 6(1). 16 — COM(88) 496 of 17 October 1988; OJ 1989 C 10, p. 3.

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11. The grounds invoked for the annul- ment of the Directive are that it (i) is incorrectly based on Article 100a of the Treaty; (ii) is contrary to the principle of subsidiarity; (iii) infringes the principle of 9. There are 56 recitals in the preamble to legal certainty; (iv) is incompatible with the Directive as adopted, 20 in contrast to a international obligations; (v) breaches fun- mere 18 articles, not all substantive. Many damental rights; and (vi) was not properly of the recitals are clearly designed to adopted since the definitive version of the counter objections raised by the Parlia- proposal submitted to the Parliament and ment, both to the 1996 proposal and to the the Council was not decided on by the 1988 proposal. Not all the recitals are college of Commissioners. reflected in the articles of the Directive. The recitals and the substantive provisions of the Directive are considered further below in the context of the various heads of the Netherlands' claims. 12. As will be seen, some of the above grounds concern the interpretation and 17 — Article2. effect of the Directive in technical areas: 18 — Proposal for a European Parliament and Council Directive thus for example the second head of the on the legal protection of biotechnological inventions, COM(95) 661 of 13 December 1995; OJ 1996 C 296, p. 4. third ground questions the scope of the 19 —Article 15(1). exclusion from patentability of plant and 20 — Some of the more relevant recitals are set out in paragraphs 42, 91, 113, 149, 167 and 186 below. animal varieties. Other grounds raise sub-

16. Second, the Council and the Parliament 13. The Netherlands is supported by Italy submit as a preliminary point that Nor- (whose written observations in intervention way's statement in intervention is inadmis- focus on the first and third grounds for sible. Article 37 of the Statute of the Court annulment) and Norway (whose observa- of Justice requires an application to inter- tions focus on the first, third and fourth vene by a State which is party to the grounds). The Parliament and Council are Agreement on the European Economic supported by the Commission (whose Area to be limited to supporting the form observations are limited to the sixth of order sought by one of the parties. ground). Article 93(5)(a) of the Rules of Procedure of the Court similarly requires that the statement in intervention contain a state- ment of the form of order sought by the intervener in support of or opposing, in whole or in part, the form of order sought by one of the parties. In the present case, 14. Two procedural matters should be the Netherlands seeks the annulment of the mentioned at this point. Directive. In the introduction to its state- ment in intervention, Norway states that the Netherlands 'raises several questions which may have a bearing on whether or not the Directive falls within the area covered by the EEA Agreement, and on the implementation of the Directive into 15. First, on 6 July 2000 the Netherlands the EEA Agreement'. It is nowhere stated lodged an application for interim measures, that Norway is intervening in support of principally seeking suspension of operation the form of order sought by the Nether-

17. The Council adds that in any event Norway's observations in intervention have The context of the Directive — patent law been largely overtaken by events, since Article 3(4) of Protocol 28 to the EEA Agreement requires the EFTA States to comply in their law with the substantive provisions of the European Patent Conven- tion and since those provisions now include the provisions of the Directive (see further below). 19. A patent is a legal right conferred on an inventor in respect of a specific invention and entitling him to prevent others from making, using or selling the invention for the duration of the patent. Most developed legal systems have had a system of patent law for some time. The earliest known 18. I do not agree with the Council and the English patent, for example, was granted Parliament that Norway's statement in by Henry VI to Flemish-born John of intervention is inadmissible. Norway expli- Utynam in 1449. The patent conferred a citly stated in its application to intervene 20-year monopoly for a method of making that it wished to intervene in support of the stained glass, required for the windows of Netherlands. It is apparent from its state- Eton college, that had not been previously ment in intervention, even if it is not known in England.

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20. Modern patent systems tend to impose which involve an inventive step. 25 A Eur- more or less uniform requirements for the opean patent is not however to be granted grant of a patent. Those requirements may in respect of: be illustrated by the European Patent Convention, which came into force in 1978. Although not a Community instru- ment, 21 since all Member States of the Union are parties to the Convention it in effect unifies the conditions for the grant of a patent throughout the Union. '(a) inventions the publication or exploita- tion 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;

23. The same criteria are used to define 22. A European patent is to be granted for patentable subject-matter in the TRIPs any inventions which are susceptible of industrial application, which are new and 25 — Article 52(1), reproducing verbatim the first sentence of Article 1 of the 1963 Strasbourg Convention on the unification of certain points of substantive law on patents for invention. That Convention drew extensively upon the 21 — The Contracting States are currently the 15 EU Member preparatory work (dating back to 1950) undertaken by the States plus Switzerland, Liechtenstein, Monaco, Cyprus Scandinavian countries on a Nordic patent law (subse- and Turkey. quently superseded by the European Patent Convention) 22 —Article 1. and on the work of the six original EEC Member States on a common European patent law. 23 — The applicant must specify at least one Contracting State. 26 — Article 53, reproducing verbatim Article 2 of the Stras- 24 — Article 2. bourg Convention.

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Agreement, 27 although the exclusions from he makes, uses or sells his invention. 31 He patentability are there set out as options. may for example need to obtain a licence or authorisation; he may even patent an invention (a type of weapon for example) the making, use or sale of which is prohib- ited by national law.

25. Once conferred, a patent merely enti- tles the holder to prevent others from making, using or selling the patented invention in the territory in which the patent has effect. It confers no right of 27. Normally, only exploitation for indus- ownership as such, nor any absolute right trial and commercial purposes constitutes to manufacture or otherwise exploit the infringement of a patent, and patent laws invention. Thus the holder of a patent will specify that certain acts do not constitute still need to comply with national law when infringement. Experimental use is one such exception: experiments aimed at perfecting, improving or further developing protected 27 — Article 27 of the Agreement on Trade-Related Aspects or inventions do not infringe the patent. Intellectual Property Rights (the TRIPs Agreement), OJ 1994 L 336, p. 213. 28 — European Patent Convention, Article 83; TRIPs Agree- ment, Article 29(1). 31 — Sec generally recital 14 in the preamble to the Directive, set 29 — Rule 27(1)(e) and (f) or the Implementing Regulations to out in paragrapli 42 below. the Convention on the grant of European patents. 32 — See Guidelines for examination in the European Patent 30 — See for example Article 93 of the European Patent Office, as last amended in February 2001, Part C, Chapter Convention. IV, paragraph 3.3.

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The context of the Directive — biotech- such as processes using yeasts and fermen- nology tation 36 were typically regarded as paten- table: 37 there was thus no general prohibi- tion on patents involving such basic types of living matter although more sophisti- cated living matter was normally excluded from patentability by express provision or case-law.

36 — The discovery that yeasts were living cells was first made by a French and a German scientist (independently) in 1836 and 1837; it was initially ridiculed but subsequently accepted when described in 1858 by Pasteur. In 1871 two 29. Biotechnology in that broad sense is as applications for patents were made to the UK Patent Office old as bread, wine, beer and cheese. for a formula for self-raising flour comprising flour and dried yeast. In 1873 the US Patent Office granted Pasteur a Historically, biotechnological inventions patent on 'yeast, free from organic germs of disease, as an article of manufacture'. In 1883 Hansen, then director of the Carlsberg brewery in Copenhagen, who had succeeded in growing pure cultures of yeast from single cells, used one of his cultures to ferment a batch of beer after the 33 — It had no entry in the previous edition. original yeast used had spoiled. The owner of the brewery 34 — Signed by the Community and all the Member States at the refused to patent the culture process; it was accordingly United Nations Conference on Environment and Develop- published and used by most breweries in Europe and ment in Rio de Janeiro on 5 June 1992; Annex A to America. Council Decision 93/626/EEC of 25 October 1993 con- 37 — Although Australia granted its first patent for a living cerning the conclusion of the Convention on Biological organism, a yeast strain having improved properties for Diversity, OJ 1993 L 309, p. 1. bread making, only in 1976. 35 — Article 2. 38 — Deoxyribonucleic acid.

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39 — So called because they target a restricted segment of DNA. 40 — And indeed to animals, since several vaccines have been engineered, for example against foot and month disease and cattle ticks. Creations of broader environmental benefit include bacteria used to biodegrade oil spills and 32. In the 1970s a method was discovered toxic waste. of extracting specific genes and parts of 41 — Developed in 19S2.

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into embryonic cells. The new gene will be statutory subject matter to 'include any- present in the adult organism and will be thing under the sun that is made by man'. 44 inherited by some descendants of that organism.

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Clearly technology which enables the in Member States which have as their genetic make-up of animals and humans object the establishment and functioning to be modified and which has the potential of the internal market. to create human clones calls for careful regulation. Much of the understandable anxiety about the consequences of insuffi- ciently regulated research in the field has been directed against legislation — such as the Directive — which governs the patent- ability of such inventions. Many commen- 41. The Netherlands, supported by Italy, tators start from the assumption that such submits that Article 100a is not the correct legislation means that any gene or gene legal basis for the Directive on several sequence, or even the entire human gen- grounds and that, if it was considered ome, can now automatically be patented. necessary to regulate biotechnological That assumption is incorrect. The Directive inventions, Article 235 of the EC Treaty leaves untouched the classic requirements (now Article 308 EC), which requires for a patent of novelty, inventive step and unanimity, should have been used. industrial application.47 The mere discov- ery of a gene or gene sequence is no more patentable under the Directive than it was before.

The relevant recitals and provisions of the Directive

The arguments as to legal basis

42. The preamble to the Directive includes the following recitals: 40. The Directive is based on Article 100a of the Treaty (now, after amendment, Article 95 EC), paragraph 1 of which requires the Council to adopt, by qualified majority and in accordance with the code- cision procedure laid down in Article 189b (now Article 251 EC), measures for the approximation of the provisions laid down '(1) Whereas biotechnology and genetic by law, regulation or administrative action engineering are playing an increasingly important role in a broad range of industries and the protection of bio- 47 — See Article 3(1), set out in paragraph 187 below. Arti- technological inventions will certainly cle 5(3) further provides that the 'ndustrial application of be of fundamental importance for the a sequence or partial sequence of a gene must be disclosed in the patent application'. Community's industrial development;

(9) Whereas in certain cases, such as the exclusion from patentability of plant and animal varieties and of essentially (6) Whereas such differences could well biological processes for the production become greater as Member States of plants and animals, certain concepts adopt new and different legislation in national laws based upon interna- and administrative practices, or [as] tional patent and plant variety conven-

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tions have created uncertainty regard- law. They shall, if necessary, adjust their ing the protection of biotechnological national patent law to take account of the and certain microbiological inventions; provisions of the Directive. whereas harmonisation is necessary to clarify the said uncertainty;

2. This Directive shall be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the TRIPs Agreement and the Convention on Biological Diversity.'

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pursuing his agricultural activity but not recourse to Article 100a is justified where sale within the framework or for the 'harmonising measures are necessary to purpose of a commercial reproduction deal with disparities between the laws of activity. the Member States in areas where such disparities are liable to create or maintain distorted conditions of competition [or] in so far as such disparities are liable to hinder the free movement of goods within the 3. The extent and the conditions of the Community'. In that case, the Court con- derogation provided for in paragraph 2 firmed the validity of a regulation concern- shall be determined by national laws, ing the creation of a supplementary protec- regulations and practices.' tion certificate for medicinal products 49 adopted on the basis of Article 100a. The Court noted that, according to the Council, at the time the contested regulation was adopted provisions concerning the creation of a supplementary protection certificate for medicinal products existed in two The arguments that obstacles to trade have Member States and were at the draft stage not been shown in another State. The regulation was inten- ded to establish a uniform Community approach. 50 It thus aimed 'to prevent the heterogeneous development of national 45. First, the Netherlands submits that, laws leading to further disparities which even if it is assumed that, as stated in would be likely to create obstacles to the recitals five and six in the preamble, there free movement of medicinal products are actual or potential differences in within the Community and thus directly national laws on the patenting of biotech- affect the establishment and functioning of nological inventions, it has not been proved the internal market'. 51 that such differences in fact hinder or can hinder trade. Even if they did, the obstacles would be to trade with the United States and Japan, where the manufacture and patenting of biotechnological inventions is more advanced, and not within the internal market. In the absence of any evidence of differences in national laws or of effect on trade, harmonisation by way of a directive cannot be justified.

Germany v Parliament and Council. 52 In protection of industrial property and the that case the Court stated that, while variations between the different legislative recourse to Article 100a as a legal basis systems are capable of creating obstacles was possible if the aim was to prevent the both to the free movement of patented emergence of future obstacles to trade products and to competition within the resulting from multifarious development common market. 59 It has moreover con- of national laws, the emergence of such sistently recognised that the specific subject obstacles must be likely and the measure in matter of a patent is the guarantee that the question must be designed to prevent patentee, to reward the creative effort of them. 53 With regard to the measure's effect the inventor, has the exclusive right to use on competition, the Court stated that it was an invention with a view to manufacturing required to verify whether the distortion of industrial products and putting them into competition which the measure purported circulation for the first time, as well as the to eliminate was 'appreciable' 54 and thus right to oppose infringements. 60 Patents whether the measure actually contributed thus promote competition through innova- to eliminating appreciable distortions of tion. Indeed the Netherlands implicitly competition. 5 5With regard to the mea- recognises this, noting that the manufacture sure's effect on the free movement of goods, of biotechnological inventions is more the Court appears to have been less exact- advanced in the United States and Japan ing: it is sufficient that obstacles to free where, as mentioned above, biotechnologi- movement 'may well arise'. 56 Although it cal inventions have been readily patentable had been demonstrated that no obstacle since 1980 and 1981 respectively. 61 Het- existed at the material time, the Court erogeneous and potentially or actually accepted that 'in view of the trend in divergent national laws on legal protection, national legislation... it is probable that patentability, the extent of protection, obstacles to the free movement of... pro- ducts will arise in the future' 57 and that in derogations and limitations are clearly principle a harmonising measure could be liable to distort competition within the adopted on the basis of Article 100a. 58 Community and moreover to hinder the free movement of goods. Different levels of protection for an identical product would lead to fragmentation of the market into national markets where the product would be protected and others where it would not; the common market would not be a single environment for the economic activities of undertakings. The Court has explicitly recognised this in the context of intellectual 48. The Court has made it clear since an property rights. 62 early stage that, in the absence of harmo- nisation, the national character of the

50. With regard to the Netherlands' argu- ment that the Directive seeks in particular to make European industry more competi- tive vis-à-vis the United States and Japan, I agree with the Parliament that it is consis- 51. The Netherlands' second argument is tent with Article 100a that the harmonisa- based on the fact that recital 9 in the tion sought should improve the competitive preamble refers to uncertainty deriving position of European undertakings on the from international patent and plant variety world market. Although that objective conventions as a justification for harmoni- could be seen as an industrial policy sation. The Netherlands submits that it is objective, I have no doubt that it can not for the European Union to undertake lawfully guide the Community's action. such harmonisation. It would have been Some would argue that similar considera- preferable on several grounds to harmonise tions underlie the entire internal market by amending the European Patent Conven- programme, as it was conceived in 1985, tion, which would have effected more and competition in world markets has often extensive harmonisation since States other been said to motivate that programme. I than the Member States of the European would also point out that the EC Treaty Union are Contracting Parties. 64 As it is, now 63 contains a title on industry, accord- that convention now incorporates the ing to which the action of the Community Directive (by way of implementing regula- and of the Member States shall also be tions made by the Administrative Council aimed at 'fostering better exploitation of of the European Patent Office 65 ), which is the industrial potential of policies of inno- thus imposed on those Contracting Parties vation, research and technological develop- who are not Member States. Such a proce- ment' (Article 130(1), now Article 157(1) EC). In Article 130(3) of the EC Treaty (now Article 157(3) EC) it is further stated 64 — See note 21. 65 — The decision of the Administrative Council of 16 June that the Community 'shall contribute to the 1999 amended the Implementing Regulations to the European Patent Convention by inserting a new Chapter VI entitled 'Biotechnological inventions' containing provi- sions essentially identical to Articles 2, 3, 4(2) and (31, 5 and 6(2) of the Directive and providing that the Directive 63 — Since the entry into force of the Treaty on European Union. shall be used as a supplementary means of interpretation.

54. As for the fact — criticised by the Netherlands — that the European Patent Convention now incorporates certain pro- 53. Moreover I agree with the Parliament visions of the Directive by means of a that in any event amendment of the Con- decision of the Administrative Council amending the Implementing Regulations, 70 which are thus imposed on those contract- 66 — First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to ing parties who are not Member States, it is trade marks, OJ 1989 L 40. p. 1. not for the Court to rule on the manner in 67 — Of 20 March 1883, as revised at Brussels on 14 December 1900, at Washington on 2 June 1911, at The Hague on which the European Patent Office has 6 November 1925, at London on 2 June 1934, at Lisbon chosen to reflect the Directive in its law on 31 October 1958, and at Stockholm on 14 July 1967. 68 — Of 14 April 1891, as revised at Brussels on 14 December 1900, at Washington on 2 June 1911, at The Hague on 6 November 1925, at London on 2 June 1934, at Nice on 15 June 1957, and at Stockholm on 14 July 1967, and as 69 — Article 172 of the Convention. amended on 28 September 1979. 70 — See note 65.

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and practice. It may however be thought importance of the principle of the free that that choice suggests that the Patent movement of goods in limiting the exercise Office, which has considerable experience of national patent rights. Nor indeed does in handling applications for patents for it mean that Community legislation for the biotechnological inventions, does not harmonisation of national laws relating to anticipate major problems in the interpre- supplementary protection certificates, tation or application of the provisions of which confer protection akin to patent the Directive concerning the grant of such protection, is misconceived, ineffective or patents. unlawful. 73

71 — See recital 14, set out in paragraph 42 above. 72 — See paragraph 25 above. 73 — Spain v Council, cited in note 48.

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for legislation in the sectors of industry and proper functioning of the internal market. research respectively, in conjunction with Recital 7 in particular states that disincen- Article 235. The functioning of the internal tives to trade flowing from the uncoordi- market is a secondary objective of the nated development of national law would Directive, which should therefore not have be 'to the detriment of the industrial been based on Article 100a. 74 development of such inventions and of the smooth operation of the internal market', thus linking the two aims. Recitals 8 and 9 make further reference to the harmonising aim of the Directive.

58. The Court has made it clear that the choice of the legal basis for a measure must be based on objective factors which are amenable to judicial review, including in particular the aim and content of the measure as they appear from its actual wording. 75 Where moreover a measure pursues more than one objective, its prin- cipal objective is decisive for determining the correct legal basis. 76

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Parliament gives other examples of diver- 63. In the present case, I consider that gences in national law and practice the harmonisation is not an incidental or existence of which is not disputed by the ancillary aim or effect of the Directive but Netherlands. is its essence and that Article 100a was accordingly the correct legal basis. Arti- cle 235 could not therefore have been used as the legal basis of the Directive, whether alone or in conjunction with other provi- sions, since it applies only where the Treaty has not elsewhere provided the necessary powers to legislate.

61. That harmonisation is the principal aim of the Directive is moreover borne out by its content: indeed Article 1(1) unequivo- cally requires Member States to adjust their national patent law to take account of its provisions. The extent to which the provi- sions of the Directive will affect industrial development in the Community and scien- tific research in the genetic engineering sector is more difficult to assess. What The argument that the Directive infringes seems clear however is that the impact of Article 100a(3) the Directive on those areas is indissociably linked with its harmonising effect.

66. The Netherlands submits that the Directive creates a specific right so that it cannot be said simply to harmonise national principles of patent law. The Directive requires Member States to protect biotechnological inventions under national 65. In my view the Directive does not fall patent law. A patent for biotechnological within the scope of Article 100a(3). That inventions is a patent on life. Biological paragraph applies to 'proposals... concern- matter, in particular living animals or ing health, safety, environmental protection plants, cannot be compared to dead matter and consumer protection'. A proposal for a which until a few years ago could alone be directive on the legal protection of biotech- patented. The fact that biological matter nological inventions is not covered by that can reproduce without human intervention paragraph. While it is indisputable that means that protecting it by way of patents both the conduct of research culminating in is different in kind from so protecting dead biotechnological inventions and the use to matter. which such inventions are put may have significant implications for health, safety and environmental protection in particular, the proposed measure did not seek to regulate such research or use from the standpoint of health, safety or environmen- tal or consumer protection (in contrast to, for example, the Community legislation on 67. It seems to me, however, as submitted the release into the environment of geneti- by the Parliament, that the patentability of cally modified organisms 81): indeed recital living material is not an innovation intro- 14 expressly states that 'substantive patent duced by the Directive but the recognition law cannot serve to replace or render of what is actually happening in conformity superfluous national, European or interna- with national law: the Member States have tional law which may impose restrictions long recognised the patentability of certain or prohibitions or which concerns the inventions concerning a living material. monitoring of research and of the use or commercialisation of its results, notably from the point of view of the requirements of public health, safety, environmental protection...'.

in 1833 and 1843 respectively.82 More depositary. Applications for such patents recently, in Germany the Bundesgerichtshof have thus for more than 20 years been held in 1975 that new micro-organisms per recognised and regulated at international se were susceptible to patent protection 83 level. and in 1993 acknowledged the patentabil- ity of plants. 84 Patents for biotechnological inventions involving transgenic animals have, as already mentioned, been granted in France and Italy in 1991 and 1996 respectively. 8 5 Numerous European patents for biotechnological inventions have been granted since the early 1980s and recognised in the Member States to 70. The notion of a 'patent on life' further- which they extend. 86 more appears to me to be unhelpful and unclear. As discussed above, 88 a patent does not give rights of ownership or unfettered rights to exploit. It merely entitles the patent-holder to prevent others manufacturing, using or selling the inven- tion without his consent. The patent-holder however is not absolved from compliance with national regulatory requirements in 69. Moreover the Budapest Treaty on the areas such as public health, safety, animal international recognition of the deposit of welfare and compliance with ethical stan- micro-organisms for the purposes of patent dards. The Directive explicitly recognises procedure, which was signed in 1977 and this in recital 14. The Directive also which came into force in 1980, 87 sought to explicitly recognises numerous limits to address the problem of providing, with patentability in line with national laws regard to applications for patents for living and international conventions, as will be organisms such as yeasts and other self- discussed in some detail in the context of replicating organisms, a written description the third ground for annulment. in sufficient detail to satisfy the require- ment in most patent law systems for sufficiency of disclosure. That Treaty per- mitted a specification in a patent applica- tion to be supplemented by the deposit of a sample of the organism at an authorised

73. First, Article 11(1) permits a farmer to use the seed saved from a crop he has grown from patented seed sold to him for agricultural use in order to grow another crop. That derogation is similar in kind to that in Article 14(1) of Council Regulation No 2100/94 on Community plant variety rights 89 (in turn based on provisions of the UPOV Convention 1961 and 1991), 90 75. In my view it is clear that Article 11 although it is more extensive since Arti- does not create a new right since it is solely cle 14(1) of the Regulation is limited to concerned with limiting the scope of pro- specified plant species of fodder plants, tection conferred by a patent granted cereals, potatoes and oil and fibre plants. pursuant to the Directive. For further The extent and conditions of the deroga- discussion of the protection from which tion are to correspond to those under Article 11 derogates, and the rationale for Article 14 of the Regulation, which pro- that protection, see the discussion of Arti- vides in particular that farmers other than cles 8 and 9 in paragraph 121 et seq. below. small farmers are to pay 'an equitable remuneration' to the holder.

74. Second, Article 11(2) provides an ana- logous privilege for breeding livestock. In other words, a farmer may use for an agricultural purpose (but not for commer- 76. I accordingly conclude that the argu- ment that the Directive was incorrectly based on Article 100a and should therefore 89 — OJ 1994 L 227, p. 1. be annulled must be rejected. 90 — The International Convention for the protection of new varieties of plants (UPOV being the acronym for Union internationale pour la protection des obtentions végétales, the French name of the Union established by the Conven- tion). 91 — See note 18.

78. Article 190 of the EC Treaty (now Article 253 EC) provides:

'Regulations, directives and decisions 80. In the alternative, the Netherlands adopted jointly by the European Parliament submits that it is not clear from the recitals

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that the second paragraph of Article 3b It is clear from the case-law of the Court was taken into account as required by that in such circumstances it is not neces- Article 190 and Germany v Parliament and sary for the legislation to make express Council. 92 reference to the principle of subsidiarity. 93

93 — See Gcrnnuty v Parliament and Council, cited in note 92, 92 — Case C-233/94 [1997] ECR I-2405, paragraph 28 of the paragraph 28 of the judgment. judgment. 94 — Recital 9, set out in paragraph 42 above.

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tions; moreover it creates further uncer- 88. Even where a provision of a directive is tainty since the precise meaning and scope open to different interpretations, as the of Articles 4, 6, 8 and 9 are not clear. The Netherlands alleges in the present case, I do Directive accordingly infringes the princi- not consider that that in itself is grounds for ple of legal certainty. annulment. In recent cases in which the Court has held that a Member State, in incorrectly implementing an imprecisely drafted provision of a directive, gave the provision a meaning which it was reason- ably capable of bearing, there has been no suggestion that the directive (or even the provision) should be regarded as invalid merely because it was imprecise and hence open to more than one interpretation.95 86. Before looking more closely at the Similarly the Court in formulating the substance of those arguments, the effect of principle that only those provisions of uncertainty in a Community act such as a directives which are clear and unambiguous directive must be considered. The Nether- may have direct effect has not to my lands has cited no authority for its apparent knowledge suggested that all provisions view that, if the meaning of one or two not so precise and unconditional are provisions of the Directive is not entirely thereby invalid. and exhaustively clear, the Directive should be annulled; nor has Italy or Norway. Nor indeed has the Court ever to my knowledge endorsed such a principle

'(36) Whereas the TRIPs Agreement pro- vides for the possibility that members of the World Trade Organisation may (39) Whereas ordre public and morality exclude from patentability inven- correspond in particular to ethical and tions, the prevention within their moral principles recognised in a Mem- territory of the commercial exploita- ber State, respect for which is parti- tion of which is necessary to protect cularly important in the field of bio- ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to 96 — See paragraph 111 below for an explanation of sonic of the the environment, provided that such terms used in tins recital.

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technology in view of the potential (b) processes for modifying the germ line scope of inventions in this field and genetic identity of human beings; their inherent relationship to living matter; whereas such ethical or moral principles supplement the standard legal examinations under patent law regardless of the technical field of the invention'. (c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to 92. Article 6 of the Directive provides: cause them suffering without any sub- stantial medical benefit to man or animal, and also animals resulting from such processes.' 97

'(1) Inventions shall be considered unpa- tentable where their commercial exploita- 93. The Netherlands and Italy put forward tion would be contrary to ordre public or four arguments to the effect that Article 6 morality; however, exploitation shall not be infringes the principle of legal certainty. I deemed to be so contrary merely because it propose to deal separately with each of is prohibited by law or regulation. those arguments.

96. Community intellectual property legis- lation continues this pattern. The Commu- nity Trade Mark Regulation 103 and the 95. I would note at the outset that the Trade Marks Directive 104 both provide for concepts of ordre public and morality have the refusal of registration or invalidity of a a long and distinguished history as criteria mark which is 'contrary to public policy or for the lawfulness of the grant or exercise to accepted principles of morality' ('contra- of intellectual property rights. In relation to ire à l'ordre public ou aux bonnes trade marks, for example, Article 6 quin- moeurs'). 105 The Community Plant Variety quies (A)(3) of the Paris Convention, dating Rights Regulation 106 provides that there is from the 1911 Washington revision, pro- an impediment to the designation of a vides for an exception to the general variety denomination where 'it is liable to prohibition on denying registration or give offence in one of the Member States or invalidating a trade mark where it is is contrary to public policy' ('est susceptible 'contrary to morality or public order'. In de contrevenir aux bonnes moeurs dans un relation to patents, Article 6(1) of the Directive is, as indicated above, 98 to essen- tially similar effect as Article 53(a) of the 100 — Cited in note 25. European Patent Convention, although the 101 — Presumably to accommodate the US and Japan, where as Convention also prohibits the patenting of indicated (note 44) there is apparently no general ethical exclusion from patentability. inventions the publication of which would 102 — M. Van Empel, The Granting of European Patents be contrary to ordre public or morality. 99 (1975), p. 68, citing an international survey of 10 European countries published in GRUR Int. 1960, p. 105. Article 53 itself reproduces almost verba- 103 — Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade mark, OJ 1994 L 11, p. 1. 104 — Cited in note 66. 105 — Article 7(1)(f) of the Regulation and Article 3(1)(f) of the 98 — See paragraph 22. Directive. It may be noted that i nhis Opinion delivered 99 — It appears however that the Standing Advisory Committee on 23 January 2001 in Case C-299/99 Philips Electro- heforc the European Patent Office proposed m Septcmhcr nics, at paragraph 18, Advocate General Ruiz-Jarabo 1998 that Article 53(a) should be modified so as to refer to Colomer gave as an example of a trade mark registration exploitation only: see Deryck Beyleveld, 'Why Recital 26 of which would be barred because it was contrary to of the EC Directive on the Legal Protection of Biotechno- public policy the mark 'Babykiller' for a pharmaceutical logical Inventions Should Be Implemented in National abortifacient. Law' [2000] I.P.Q. 1. 106 — Cited in note 89.

98. The Community legislature has also resorted to the concept of ordre public in numerous harmonising measures, thus apparently seeing no contradiction in con- ferring a degree of discretion on national authorities in an area subject to harmoni- sation. 114 97. The concept of ordre public in particu- lar also has wider significance in Commu- 113 — Case 41/74 Van Duyn [1974] ECR 1337, paragraph 18 nity law. It is for example used in the of the judgment. 114 — Article 11(2)(b) of First Council Directive 68/151/EEC of French text of the Treaty, although it is 9 March 1968 on co-ordination of safeguards which, for usually rendered 'public policy' in Eng- the protection of the interests of members and others, are required by Member States of companies within the lish. 1 1 2 Articles 30, 39(3), 46(1) and meaning of the second paragraph of Article 58 of the Treaty, with a view to making such safeguards equivalent 58(1)(b) (formerly Articles 36, 48(3), throughout the Community, OJ English Special Edition 56(1) and 73d(1)(b)) all refer (as grounds 1968 (I), p. 41 (translated as public policy); Arti- cle 10(2)(a) of Council Directive 89/592/EEC of for permitted restrictions of the free move- 13 November 1989 coordinating regulations on insider dealing, OJ 1989 L 334, p. 30 (public policy); Arti- ment of goods, the freedom of movement cle 14(5) of Council Directive 90/619/EEC of 8 Novem- of workers, the freedom of establishment ber 1990 on the coordination of laws, regulations and administrative provisions relating to direct fife assurance, and the free movement of capital respec- laying down provisions to facilitate the effective exercise of freedom to provide services and amending Directive tively) to ordre public ('public policy' in the 79/267/EEC, OJ 1990 L 330, p. 50 (public policy); English). The Court has recognised that the Article 5(b) of Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons, OJ 1991 L 256, p. 51 (public order); Arti- cle 15(6) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ 1993 L 169, p. 1 (public policy); Article 6(2) of Directive 94/22/EC of the 107 — Article 63(3)(e). European Parliament and of the Council of 30 May 1994 108 — Directive 98/71/EC of the European Parliament and of on the conditions for granting and using authorisations the Council of 13 October 1998, OJ 1998 L 289, p. 28. for the prospection, exploration and production of hydrocarbons, OJ 1994 L 164, p. 3 (public safety); and 109 — Article 8. Article 9(7) of Directive 98/34/EC of the European 110 — OJ 2000 C 248E, p. 56. Parliament and of the Council of 22 June 1998 laying 111 —Article4(a). down a procedure for the provision of information in the field of technical standards and regulations, OJ 1998 112 — See the Opinion of Advocate General Warner in Case L 204, p. 37, as amended by Directive 98/48/EC of the 30/77 Bouchereau [1977] ECR 1999, pages 2023 to European Parliament and of the Council of 20 July 1998, 2026, for a discussion of the concepts of public policy OJ 1998 L 217, p. 18 (public policy). and ordre public.

100. Thus the statement in recital 39 of the Directive that 'ordre public and morality correspond in particular to ethical or moral principles recognised in a Member State' closely reflects the Court's interpretation and application of those concepts in the context of the Treaty. It cannot therefore in 102. It may be added that the discretion of my view be argued that the approach of the a Member State to determine the scope of Directive infringes the principle of legal the concept of public morality in accor- certainty. dance with its own scale of values, so

118 — Bouchereau, cited in note 112, paragraph 35 of the 115 — Case 34/79 [979] ECU 3795. judgment. 116 — Case 121/85 [1986] ECR 1007. 119 — Guidelines for examination i n the European Patent 117 — Paragraph 15 or the judgment. See further the Opinion or Office, as last amended in February 2001, Part C, Advocate General Warner. Chapter IV, paragraph 3.1.

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What is the meaning and purpose of the proviso in Article 6(1)?

'The grant of a patent shall not be refused and a patent shall not be invalidated on the 103. Second, the Netherlands and Italy ground that the sale of the patented pro- submit that the meaning and purpose of duct or a product obtained by means of a

120 — In Herat and Darby, cited in note 115. 122 — Set out in paragraph 42 above. 121 — T 356/93 Plant Genetic Systems/Flam cells [1995] EPOR 123 — Article 27(2) of the TRIPs Agreement contains a similar 357, paragraph 6 of the decision. proviso.

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patented process is subject to restrictions or facture an invention in a Member State limitations resulting from the domestic where the exploitation (but not the manu- law'. facture) of the invention is prohibited, with a view to exporting it to States in which its exploitation is not prohibited.

106. It is moreover not correct to assert that it would be purposeless to grant a patent for an invention the exploitation of which is prohibited. As suggested above, the inventor may wish to obtain protection in anticipation of a change in the regulatory Does ordre public encompass prejudice to structure enabling him to exploit his inven- the environment? tion in the future. A good topical example is genetically modified organisms — there is a general moratorium on the use of these in the European Union at the moment, but it will not necessarily be indefinite. Simi- 108. Third, the Netherlands and Italy refei- larly at national level an inventor may to recital 36, which notes that the TRIPs anticipate a change of government. Alter- Agreement recognises in the context of natively, an inventor may wish to manu- ordre public and morality the grounds of protection of human, animal or plant life or 124 — Bureau international de la propriété intellectuelle, Co- vention de Paris - LA PRotection tie h propriété indus¬ trielle de 1883 à 1983 (1983). 125 — See paragraph 25 above.

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health and the avoidance of serious pre- What is the status of recital 38? judice to the environment. That raises the question whether, for the purpose of Arti- cle 6(1), serious prejudice to the environ- ment, or the risk thereof, may fall within the concept of ordre public.

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totipotent cell is a cell having unlimited The argument as to plant and animal capability. 129 The production of chimeras varieties from germ cells or from totipotent cells of humans and animals will inevitably modify the germ line genetic identity of human beings.

The relevant recitals and provisions of the Directive

113. Recitals 31 and 32 in the preamble 112. Even if that were not so, I cannot see read as follows: that a legislative measure should be annulled for lack of legal certainty merely because an example of conduct excluded from the scope of that measure appears in its preamble but not in its substantive provisions. 130 It is not moreover an unpre- cedented legislative technique to give an illustrative, non-exhaustive list of examples '(31) Whereas a plant grouping which is of situations where an ordre public excep- characterised by a particular gene tion will apply: see for example Article 9(7) (and not its whole genome) is not of Directive 98/34 laying down a procedure covered by the protection of new for the provision of information in the field varieties and is therefore not exclu- of technical standards and regulations 131 ded from patentability even if it as amended by Directive 98/48 132 and comprises new varieties of plants; Article 3(4)(a)(i) of the Directive on elec- tronic commerce. 133

2. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific charac- (b) essentially biological processes for the teristics as a result of the invention shall production of plants or animals. extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and posses- sing those same characteristics.' 2. Inventions which concern plants or ani- mals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.'

117. Article 9 provides:

115. 'Plant variety' is defined for the pur- pose of the Directive134 by reference to the 'The protection conferred by a patent on a definition in Article 5 of Regulation product containing or consisting of genetic No 2100/94. 135 information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which 134 — By Article 2(3). the genetic information is contained and 135 —Cited in note 89. performs its function.' I - 7120

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122. Article 8(2) similarly adapts a well- known principle of traditional patent law to the exigencies of biotechnological inven- 120. In my view there is no conflict between Article 4(l)(a) on the one hand and Articles 8 and 9 on the other. 136 — Sec paragraph 73.

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tions. Where the subject-matter of a patent 124. Article 9 caters for the situation is a process, the protection conferred by the where a patent confers protection on a patent extends to the products directly product containing or consisting of genetic obtained by such a process. That principle information, such as a particular DNA has been incorporated in international sequence, or a particular gene. It extends patent legislation since at least 1958, when the protection conferred by such a patent to Article 5 quater was inserted into the Paris all material, subject to the exception in Convention. 137 It finds expression in Arti- Article 5(1), 138 in which the product is cle 64(2) of the European Patent Conven- incorporated and in which the genetic tion, which provides: information is contained and performs its function. Thus where the DNA sequence or gene is incorporated into a host micro- organism which may be multiplied, the patent protection enjoyed by it will extend to that micro-organism.

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that use of the gene will infringe the patent. where in such circumstances the holder of If the original patent for the gene did not the plant variety right has applied unsuc- protect against such use, it would clearly be cessfully to the patent-holder for a licence of very little value. That does not mean, and where the plant variety constitutes however, that the plant variety will itself be significant technical progress of consider- patentable. An example from the field of able economic interest compared with the traditional technology may help to make invention claimed in the patent. 140 this clear. Historically, many countries prohibited the patenting of pharmaceutical products. If an unpatentable pharmaceuti- cal product were manufactured which incorporated a specific chemical compound which had been patented, clearly that 128. There is thus no conflict between patent would be infringed by the manufac- Article 4(1 )(a) on the one hand and Arti- ture of the pharmaceutical product, not- cles 8 and 9 on the other. withstanding that the latter product could not itself benefit from patent protection.

The argument that 'animal varieties' is not defined

The arguments as to recitals 31 and 32 and 131. Admittedly, there is no generally Article 4(1)(a) and 4(2) recognised taxonomie definition for 'vari- ety' as there is for 'species' or 'genus', 141 although it may be noted that the Shorter Oxford English Dictionary 142 gives as the biological definition of 'variety': 132. The Netherlands, supported by Nor- way, puts forward two arguments to the effect that the above provisions are contra- dictory and hence infringe the principle of legal certainty.

tal 31. However, recital 32 is not logical, 136. In 1961, and hence even before the since the appearance of a new plant variety Strasbourg Convention was signed, the must be irrelevant from the point of view of majority of the States which would subse­ patentability: no patent may be obtained quently sign the two later conventions 147 for a plant variety as such. signed the UPOV Convention. The UPOV Convention in its original version provided that members could confer either special plant variety protection or patent protection (in either case under national law) on plant varieties within the scope of the Convention, but not both types of protection. Article 2(b) of the Strasbourg Convention and Article 53(b) of the later 134. Second, Article 4 is also illogical: European Patent Convention exclude Article 4(1)(a) excludes from patentability patent protection for plant varieties in plant and animal varieties in the plural recognition of this internationally accepted while under Article 4(2) only inventions approach. 148 concerning one single variety are unpaten­ table. It is unthinkable in scientific terms that an invention should be technically applicable to one plant or animal variety alone: any invention linked to a genetic modification of a plant or animal will be applicable to several varieties. Article 4(2) is thus meaningless. 137. It is helpful to bear in mind that, at the time the Directive was being drafted and going through the legislative process, the scope of the exception for plant vari­ eties in Article 53(b) was unclear.

140. It may be noted that the above interpretation of recitals 31 and 32 and Article 4(2) is in accordance with the current case-law of the European Patent Office following the decision in December 1999 of the Enlarged Board of Appeal in the Novartis case. 151 139. Clearly that ruling, the effect of which was that any genetically modified plant was regarded as a plant variety and hence unpatentable, would have seriously under- mined one of the principal objectives of the Directive. The Council and the Parliament 141. I accordingly conclude that all the have confirmed in their written observa- arguments to the effect that the Directive tions to the Court that that case-law of the should be annulled on the ground that it European Patent Office explains the word- infringes the principle of legal certainty ing of the relevant provisions of the Direc- should be rejected. tive, which were drafted so as to ensure that they did not lead to the same result. Recital 31 states that a plant grouping characterised by a particular gene is not covered by the protection of new varieties even if it comprises new varieties. That situation however must be distinguished from an invention which consists only in The argument as to the infringement of genetically modifying a particular plant international obligations variety which itself results in a new variety: in such a case, recital 32 states that the exception to patentability will apply. Arti- cle 4(2) in effect reverses the decision in Plant Genetic Systems: an invention — 142. The Netherlands submits that, in such as the genetic modification of a plant adopting the Directive, the Parliament and Council infringed Article 228(7) of the EC

146. I do not however consider that, on the assumption that the provisions of the international agreements referred to do 'Agreements concluded under the condi- not have direct effect, that necessarily tions set out in this Article shall be binding supports the conclusion which the Council on the institutions of the Community and draws. In Germany v Council, 153 relied on on Member States.' by the Council as authority for its submis- sion, the Court stated that it could review the lawfulness of a Community act from the point of view of international obliga- tions (the GATT rules) which did not have direct effect if the Community intended to 144. The international obligations invoked implement a particular obligation entered by the Netherlands arise under the TRIPs into within the framework of those rules or Agreement, the Agreement on Technical if the Community act expressly referred to Barriers to Trade, the European Patent specific provisions thereof. 154 It is that Convention and the Convention on Biolo- criterion rather than direct effect which gical Diversity. seems appropriate in this context.

145. The Council submits as a preliminary point that the question whether a Commu- nity act is unlawful because it infringes 147. More generally, it might be thought provisions of an international agreement to that it is in any event desirable as a matter which the Community is a party arises only of policy for the Court to be able to review if those provisions have direct effect. 152 the legality of Community legislation in the The Council considers that the provisions light of treaties binding the Community. There is no other court which is in a

149. Recitals 12 and 36 in the preamble to the Directive read as follows: ISO. Article 1(2) of the Directive provides:

'(12) Whereas the Agreement on Trade- Related Aspects of Intellectual Prop- erty Rights (TRIPs)... signed by the European Community and the Mem- 'This Directive shall be without prejudice ber States, has entered into force and to the obligations of the Member States provides that patent protection must pursuant to international agreements, and be guaranteed for products and pro- in particular the TRIPs Agreement and the cesses in all areas of technology; Convention on Biological Diversity.' I - 7128

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151. Article 27(3)(b) of the TRIPs Agree- Member, has chosen, in Article 4(1) of the ment permits members to exclude from Directive, to exclude only part of that range patentability: from patentability. The Community was thereby exercising the option in accordance with Article 27(3). The fact that that option is no longer available to the Nether- lands is a consequence not of any infringe- ment of the TRIPs Agreement but of the 'plants and animals other than micro- harmonising effect of the Directive. organisms, and essentially biological pro- cesses for the production of plants or animals other than non-biological and microbiological processes...'.

155. Moreover the Netherlands cannot rely on Article 1(2) of the Directive. That 152. The Netherlands submits that the provision states that the Directive is to be Directive prevents Member States from without prejudice to Member States' obli- choosing whether to use that option since gations pursuant to the TRIPs Agreement. it provides for a system of patentability The Netherlands' obligations under that which extends to plants and animals other Agreement are however not affected by than plant and animal varieties. The Direc- Article 4(1) of the Directive, which simply tive is accordingly incompatible with the exercises a right (of option) and does not TRIPs Agreement. affect such obligations.

Technical Barriers to Trade, 155 Article 2 of of publication and notification with regard which regulates the adoption of such reg- to technical regulations which may have a ulations. Moreover notice of draft technical significant effect on trade of other Mem- regulations must be published and notified bers. 158 'Technical regulation' is defined as to the Secretariat of the World Trade follows: Organisation in accordance with Arti- cle 2.9 of the Agreement. The Netherlands is not aware that the prescribed procedure has been followed; in any event, it is not apparent from the Directive itself so that the Court cannot monitor compliance. 'Document which lays down product char- acteristics or their related processes and production methods, including the applic- able administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminol- ogy, symbols, packaging, marking or label- ling requirements as they apply to a pro- duct, process or production method.' 159

155 — As far as the Community is concerned, the WTO Agreement and the other agteements concluded in that connection, including the Agreement on Technical Bar- 159. I cannot in any event see any argu- riers to Trade, were approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclu- ment to support the assertion that the sion on behalf of the European Community, as regards Directive is a technical regulation as matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986- 1994) (OJ 1994 L 336, p. 1). Those agreements are defined by the Agreement and hence within published as annexes to the Decision; the Agreement on Technical Barriers to Trade is published in OJ 1994 L 336, p. 86. They entered into force on 1 January 1996 for the Community and its Member States. 158 — Article 2.9. 156 — See recital five in the preamble. 159 — Point 1 of Annex 1. 157 — Article 2.2. 160 — See Germany v Council, cited in note 152.

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the scope of the Agreement. It does not lay use which are in particular to be considered down product characteristics within the unpatentable. 161 meaning of the Agreement, nor does it create obstacles to international trade. I accordingly consider that the Netherlands' submission on this head should be dis- missed.

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164. In any event, any differences between 166. I accordingly consider that the Neth- the substantive requirements of the two erlands' submission on this head should be instruments are to my mind marginal. As dismissed. demonstrated in the context of the Nether- lands' third ground of annulment, and in particular in discussing the scope of the ordre public exception, there is no reason to consider that the concept of ordre public falls to be interpreted differently in the Convention and in the Directive. Any risk that national courts will, when applying Incompatibility with the Convention on national law implementing the Directive, Biological Diversity interpret the concept differently from the European Patent Office when applying the Convention is now moreover even further reduced since the entire text of the Direc- tive has (since the present case was lodged) 167. Recitals 55 and 56 in the preamble to been incorporated in the Implementing the Directive state: Regulations to the Convention, which state that the Directive 'shall be used as a supplementary means of interpretation'. 162

the Convention on Biological Diver- approved by the Community on 25 Octo- sity, in particular on issues relating to ber 1993, 164 seeks to ensure the sustain- technology transfer and conservation able conservation and use of biological and sustainable use of biological diversity.165 An important aspect is the fair diversity and the fair and equitable and equitable sharing of the benefits arising sharing of benefits arising out of the out of the utilisation of genetic resources, use of genetic resources, including the including by appropriate access to genetic protection of knowledge, innovations resources and by appropriate transfer of and practices of indigenous and local relevant technologies, taking into account communities embodying traditional all rights over those resources and to lifestyles relevant for the conservation technologies.166 Norway, as a member of and sustainable use of biological the European Economic Area, is also a diversity".' party to the Convention.

170. Genetic resources are defined as 'genetic material of actual or potential value'. Genetic material is defined as 'any 168. Article 1(2) of the Directive provides: material of plant, animal, microbial or other origin containing functional units of heredity'. Technology includes biotechnol- ogy. 167

171. Article 3 of the Convention provides: 'This Directive shall be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the TRIPs Agreement and the Convention on Biological Diversity.' 'States have, in accordance with the Char- ter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental policies, and the

173. Article 16(2) of the Convention requires the provision and/or facilitation of access to and transfer of technology, including biotechnology, to developing 175. Moreover, although the Directive countries under fair and most favourable draws a clear distinction between inven- terms. The second sentence of Article 16(2) tions, which are patentable, and discover- states that, in the case of biotechnology ies, which are not, there is a risk that subject to patents, such access and transfer traditional products and processes originat- are to be provided on terms which recog- ing in developing countries may be mista- nise and are consistent with the adequate kenly granted a patent even though they are and effective protection of intellectual discoveries rather than inventions: it is in property rights. Article 16(5) states that practice difficult to determine whether patents may have an influence on imple- living material is a discovery or an inven- mentation of the Convention and requires tion, precisely because not all traditional the Contracting Parties to ensure that such products and processes are known. In that rights are supportive of and do not run case, the income from such patents would counter to its objectives. benefit not the developing country con-

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cerned but the (Western) patent-holder. The few highly specific obligations on the developing country would have to launch Member States in that narrow context. lengthy and costly legal proceedings to Patents conferred in accordance with the challenge a patent once granted, which Directive will of course, as with all patents, would conflict with the requirement in the be territorial in effect. Convention that knowledge and the benefit of genetic resources in the developing countries should be justly shared.

177. In my view, the arguments that the 180. It is axiomatic that nothing in the Directive is incompatible with the Conven- Directive could require States which are not tion on Biological Diversity betray a failure Member States of the European Union (or to appreciate the respective objectives and Contracting Parties to the Agreement on spheres of application of the two instru- the European Economic Area) to confer ments. patent protection on biotechnological inventions (although of course other inter- national instruments, including the TRIPs Agreement, may have precisely that effect). Thus the approach of developing coun- tries — where, as the Netherlands and 178. The Directive, as is clear from the Norway suggest, much genetic richness is analysis in the context of the earlier concentrated — to the patent protection of grounds for annulment, requires the Mem- biotechnological inventions remains unaf- ber States of the European Union to ensure fected by the Directive. that their national law provides patent protection for biotechnological inventions as there defined. To that effect it imposes a 168 — Articles 5, 6(b), 7, 8, 9, 10, 11 and 14.

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182. I do not understand how, as the Netherlands submits, traditional products and processes originating in developing countries may be patented in accordance with the Directive even though they are discoveries not inventions. As the Directive makes explicit,171in order to be patentable an invention must be new, must involve an inventive step and must be susceptible of industrial application. Those requirements, 184. I accordingly reject the arguments that which have been part of patent legislation the Directive and the Convention on Bio- logical Diversity are incompatible, without therefore needing to consider what the 169 — See paragraph 25 above and paragraphs 211-214 below. implications of any such incompatibility 170 — The Philippines, for example, requires bio-prospectors to would be. obtain prior informed consent from both the government and local peoples; Costa Rica's National Institute of Biodiversity has signed an agreement with a major drug company to receive funds and share in benefits from biological materials that are commercialised; countries of 172 — 'any new ingenious contrivance... reduced to perfection, the Andean Pact require bio-prospectors to meet certain so that it can be used and exercised'. See S.P. Ladas conditions (Convention on Biological Diversity website). Patents, Trademarks, and Related Rights — National 171 — In Article 3(1), set out in paragraph 187 below. and International Protection (1975), pp. 6 and 7.

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The argument as to fundamental rights sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented; 185. Article F(2) of the Treaty on European Union states:

(26) Whereas if an invention is based on biological material of human origin or 188. Article 5 provides: if it uses such material, where a patent application is filed, the person from whose body the material is taken must have an opportunity of expressing free and informed consent thereto, in '1. The human body, at the various stages accordance with national law; of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a (43) Whereas pursuant to Article F(2) of patentable invention, even if the structure the Treaty on European Union, the of that element is identical to that of a Union is to respect fundamental natural element. rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms signed in Rome on 4 November 1950 and as they result from the constitutional traditions 3. The industrial application of a sequence common to the Member States, as or a partial sequence of a gene must be general principles of Community law'. disclosed in the patent application.'

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189. The Netherlands, citing X v Commis- must at the very least have some control sion, 173 submits that any Community act over the fate of his body, or a part thereof. which infringes any fundamental right is Only in recital 26 however does the Direc- unlawful. In its view, the Directive infringes tive mention the donor's right. Recitals fundamental rights both by commission have no binding legal force. The fact that and by omission. there is nothing in the body of the Directive ensuring that human matter is managed carefully must be considered to be contrary to fundamental rights.

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the necessary guarantees that its applica- respected and protected. The right to free tion will protect those rights cannot be and informed consent both of donors of valid. elements of the human body and of reci- pients of medical treatment can also prop- erly be regarded as fundamental; it is also now reflected in Article 3(2) of the EU Charter which requires in the fields of medicine and biology respect for 'the free 195. Thus the Netherlands considers that and informed consent of the person con- the Directive violates fundamental rights in cerned, according to procedures laid down two ways: it contains a provision (Arti- by law'. It must be accepted that any cle 5(2)) which is contrary to human dig- Community instrument infringing those nity and it fails to provide for the respect of rights would be unlawful. donors' right of control over donated matter and of medical patients' right of consent to treatment. It is helpful in my view to deal with these arguments sepa- rately.

198. In my view, however, the Directive does not infringe fundamental rights as alleged by the Netherlands and Italy.

196. I would note that the arguments presented to the Court on the compatibility of the Directive with fundamental rights focus on the abovementioned specific issues alone. I must therefore restrict my analysis of the alleged incompatibility of the Direc- tive with fundamental rights to those issues. Does Article 5(2) infringe fundamental rights?

nor the simple discovery of one of its 201. None the less, circumstances in which elements may be patented. 175 As a matter the grant of a patent for an element isolated of general patent law, which is made from the human body offends against explicit in Article 3(1) of the Directive, human dignity may perhaps be imagined; only inventions which are new, which moreover future developments in biotech- involve an inventive step and which are nology may make feasible products or susceptible of industrial application are processes which are unimaginable now patentable. 176 The discovery of an element but which would similarly offend against of the human body, such as a gene, thus human dignity. Such inventions would cannot be patented; only when the gene has however unquestionably be unpatentable been isolated from its natural state by, for under the Directive by virtue of the exclu- example, processing through purifying sion from patentability in Article 6(1) of steps that separate it from other molecules inventions whose commercial exploitation naturally associated with it, can it be would be contrary to morality. The Direc- patented, and then only if its industrial tive thus provides an essential safeguard application, for example the production of against the issue of such a patent. That new drugs, is disclosed in the patent safeguard is moreover so framed as to application in accordance with Article 5(3) accommodate future developments: the of the Directive. The patent will therefore generality of the standard ensures that it not cover the gene as it occurs in the human can be applied to inventions in this fast body, since genes in the body are not in the evolving field the detail of which cannot at isolated and purified form which is the present be foreseen. It is no doubt for that subject of the patent. 177 reason also that the legislature chose not to lay down in Article 6(2) an exhaustive list of examples of inventions which are to be considered unpatentable by virtue of Arti- cle 6(1). A case-by-case evaluation of patent applications in the light of moral consensus is the surest guarantee that the right to human dignity will be respected, and that is the framework established by the Directive.

205. It is not however sufficient to say that the provisions of the Directive do not in themselves infringe fundamental rights. The complaint of the Netherlands and Italy 203. The Directive also reflects the conclu- is also that the Directive fails to contain sions of the Group of Advisers to the certain provisions necessary to protect such European Commission on the ethical impli- rights and thereby infringes those rights. In cations of biotechnology. In its report on particular it fails to ensure that such rights the ethical aspects of patenting inventions are respected when patents are initially involving elements of human origin, 178 the granted for biotechnological products and Group of Advisers does not recommend processes and when such patented products excluding the patentability of such inven- and processes are subsequently exploited tions as a matter of principle, but considers and used. that it should be subject to certain ethical principles, with the result that fundamental human rights are respected. Thus it says: 'Whatever is the nature of the biotechno- logical invention involving elements of human origin, the Directive must give 206. The Netherlands submits first that the sufficient guarantee so that refusal to grant Directive should provide for the donor of a patent on an invention in so far as it elements isolated from the human body infringes the rights of the person and the which are patented to have control over the respect of human dignity should be legally fate of his body or a part thereof. founded.' That guarantee is to be found in the exclusion from patentability on the ground of morality in Article 6(1) of the Directive.

209. It is not clear from the wording of recital 26 in the various language versions whether the consent must relate to the 211. In my view, however, although the filing of the patent application or to the requirement of consent to all potential uses taking of the material from the donor. of human material may be regarded as Recital 26 therefore may not go as far as fundamental, patent law is not the appro- recommended by the Group of Advisers to priate framework for the imposition and the Commission, 180 which stated: monitoring of such a requirement. A patent, as discussed above, 184 simply con- fers the right to prevent others from using or otherwise exploiting the patented inven- tion; how the grantee of the patent uses or exploits that invention is regulated not by patent law but by national law and practice governing the field concerned. 'The ethical principle of informed and free consent of the person from whom retrievals are performed, must be respected. This principle includes that the information of this person is complete and specific, in particular on the potential patent applica- tion on the invention which could be made from the use of this element. An invention 212. Moreover to make evidence of such based on the use of elements of human consent a condition of granting a biotech- origin, having been retrieved without respecting the principle of consent will 181 — See paragraph 197 above. not fulfil the ethical requirements.' 182 — Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine signed at Oviedo on 4 April 1997; European Treaty Series No 164. 179 — Amendment 76/rev. in the legislative resolution embody- 183 — The Convention has been in force since I December ing the Parliament's opinion on the proposal for the 1999, although of EU Member States only Denmark, Directive, OJ 1997 C 286, p. 87. Greece and Spain have both signed and ratified it. 180 —See note 178. 184 — See paragraph 25 above.

215. I therefore reach the conclusion that the Directive does not, either by what it provides or by what it fails to provide, 213. Thus in my view the Directive is not infringe, in itself, fundamental rights recog- the proper place for rules governing the nised in Community law. The possibility consent of the donor or of the recipient of cannot of course be excluded that a parti- elements of human origin. Indeed such cular application of the Directive within a questions of consent arise more generally Member State may infringe fundamental with regard to any use of human sub- rights, although it contains provisions stances, such as transplants, organ dona- designed to avoid that consequence. But tion, etc. That supports the view that the the conclusion is clear in my view that the issues are not to be resolved by patent law, and in particular by patent law as it applies in this specific sector. 185 — See paragraph 25 above.

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220. With regard to the argument as to the 218. Article 190 (now Article 253 EC) principle of collegiality, it appears from its provides: reply that the Netherlands is not alleging that that principle was in fact infringed, but merely that the Commission did not verify compliance therewith, or at least that there is no trace of such verification in the preamble to the Directive. 'Regulations, directives and decisions adopted jointly by the European Parliament and the Council... shall state the reasons on 186 —Case C-137/92 P Commission v BASF [1994] ECR which they are based and shall refer to any I-2555, paragraph 62 of the judgment. proposals or opinions which were required 187 — BASP, paragraph 63 of the judgment. to be obtained pursuant to this Treaty.' 188 —Case C-191/95 Commission v Germany [1998] ECR I-5449, paragraph 41 of the judgment.

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223. With regard to the argument that the proposal should have been made available to all the members of the college in all the official languages when it was adopted by the Commission, it must be borne in mind that a Commission proposal is not a decision taking the form of one of the acts referred to in Article 189 of the EC Treaty and is not therefore required by the Treaty to be adopted in authentic versions in all 225. I would accordingly reject the argu- languages. I accept the Commission's sub- ment that the Directive was not properly mission that it would be inappropriate, and adopted since it was based on an unlawful is not necessary in order to respect the proposal by the Commission. principle of collegiality, to require a pro- posal to be adopted by the college in all languages. 189 — OJ, English Special Edition I (1952-58), p. 59.

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Conclusion

226. It follows, for the reasons I have given, that this action must, in my opinion, fail. But the action may not have been fruitless. It is clear, I think, that it was prompted by understandable concerns, reflecting a general awareness that the irresponsible pursuit of biotechnological research may have consequences which are ethically unacceptable. Although some of the grounds of challenge were of a purely technical character, those concerns were central. The action may not have been fruitless in that it may have shown that those concerns can and should be allayed.

227. Thus the Directive is concerned in particular with the patentability of biotechnological inventions and not with their use. Within that framework, there are adequate moral safeguards going in some respects beyond mere application of the existing criteria for patentability. The fact that the ethical criteria for patentability are not exhaustively defined, far from undermining the moral safeguard, enhances it since future developments will continue to be governed by those criteria even if not currently foreseeable. Biotechnological inventions which are contrary to human dignity consequently neither are now nor can in the future be patentable in accordance with the Directive.

(3) The interveners should bear their own costs.

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