C-181/95

OPINION OF MR FENNELLY — CASE C-181/95

OPINION OF ADVOCATE GENERAL FENNELLY delivered on 3 October 1996

1. The Court is asked here to provide for a N o 1768/92 of 18 June 1992 concerning the situation which was not foreseen by the creation of a supplementary protection cer- Community legislator and could not have tificate for medicinal products (hereinafter been foreseen by private parties and was not 'the Regulation'). 1 The legal basis of the expressly provided for. The 1992 Council Regulation is Article 100a of the Treaty Regulation establishing the supplementary establishing the European Community protection certificate for medicinal products (hereinafter 'the Treaty'). took no account of the contingency that the basic patent and the marketing authorization for a medicinal product based upon it should be in different hands. In relation to any one medicinal product, can a certificate be granted for more than one patent? Is the holder of the marketing authorization obliged to furnish a copy to the patent holder so that he can obtain a certificate? Alternatively, must the public authority 3. The third and fourth recitals in the pre- responsible for granting the authorization amble to the Regulation state that the period furnish a copy to the patent holder or to the that elapses between the filing of an applica- public authority responsible for granting the tion for a patent for a new medicinal product certificate? The Regulation is silent on these and the authorization to place the medicinal points. product on the market makes the period of effective protection under the patent insuffi- cient to cover the investment put into phar- maceutical research, a situation which penal- izes such research. 2 The sixth recital states Legal context that 'a uniform solution at Community level should be provided for, thereby preventing the heterogenous development of national laws leading to further disparities which would be likely to create obstacles to the free (a) The Regulation movement of medicinal products within the Community and thus directly affect the

establishment and the functioning of the the procedure for grant of a [supplementary internal market'. The seventh recital states protection] certificate' (hereinafter 'certifi- that it is necessary that the supplementary cate'). protection certificate be granted under the same conditions by each of the Member States, thereby justifying legislation by way of a regulation. The eighth recital envisages that 'the holder of both a patent and a cer- tificate should be able to enjoy an overall maximum of fifteen years of exclusivity from 5. Article 2 of the Regulation states that the time the medicinal product in question '[a]ny product protected by a patent in the first obtains authorization to be placed on territory of a Member State and subject, the market in the Community'. The ninth prior to being placed on the market as a recital states that 'the protection granted medicinal product, to an administrative should ... be strictly confined to the product authorization procedure as laid down which obtained authorization to be placed in Council Directive 65/65/EEC or on the market as a medicinal product'. Directive 81/851/EEC 4 may, under the terms and conditions provided for in this Regulation, be the subject of a certificate'.

'(b) a copy of the authorization to place the product on the market, as referred to in (d) the authorization referred to in (b) is the Article 3(b), in which the product is first authorization to place the product identified, containing in particular the on the market as a medicinal product.' number and date of the authorization and the summary of the product characteristics listed in Article 4a of Directive 65/65/EEC or Article 5a of Directive 81/851/EEC; 7. Article 6 of the Regulation states that the certificate shall be granted to the holder of the basic patent or his successor in title. Article 4 of the Regulation, reflecting the ninth recital in the preamble, provides that (c) if the authorization referred to in (b) is ' [w]ithin the limits of the protection con- not the first authorization for placing ferred by the basic patent, the protection the product on the market as a medici- conferred by a certificate shall extend only to nal product in the Community, infor- the product covered by the authorization to mation regarding the identity of the place the corresponding medicinal product product thus authorized and the legal on the market and for any use of the product provision under which the authoriza- as a medicinal product that has been autho- tion procedure took place, together rized before the expiry of the certificate'. with a copy of the notice publishing the Article 5 of the Regulation states that, sub- authorization in the appropriate official ject to Article 4, 'the certificate shall confer publication.' the same rights as are conferred by the basic patent, and shall be subject to the same limi- tations and the same obligations'. 9. Article 10 of the Regulation states, in rel- evant part:

(4) If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the 12. Article 3 of the Directive states that '[n]o application.' proprietary medicinal product may be placed on the market in a Member State unless an authorization has been issued by the compe- tent authority of that Member State'.

10. Article 13 of the Regulation provides that a certificate 'shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed 13. Article 4(9) of the Directive 6 requires between the date on which the application applications for the grant of an authorization

5 — '[T]he competent industrial property office of the Member State which granted the basic patent or on whose behalf it 6 — As amended by Council Directive 83/570/EEC of 26 Octo- was granted and in which the authorization referred to in ber 1983 amending Directives 65/65/EEC, 75/318/EEC and Article 3(b) to place the product on the market was obtained, 75/319/EEC on the approximation of provisions laid down unless the Member State designates another authority for the by law, regulation or administrative action relating to propri- purpose.' etary medicinal products, OJ 1983 L 332, p. 1.

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(iii) ... that the proprietary medicinal 15. Article 4(8) of the Directive 7 requires product is essentially similar to a applications for the grant of a marketing product which has been authorized within the Community, in accord­ ance with Community provisions in force, for not less than six years and 7 — As amended by Council Directive 87/21/EEC of 22 Decem­ is marketed in the Member State for ber 1986 amending Directive 65/65/EEC on the approxima­ tion of provisions laid down by law, regulation or adminis­ which the application is made; this trative action relating to proprietary medicinal products, OJ 1987 L 15, p. 36. period shall be extended to 10 years

Ι-364

BIOGEN v SMITHKLINE BEECHAM BIOLOGICALS

9 — B-013 828 and B- 182 442, respectively. 8 — OJ 1987 L 15, p. 38. 10 — Deoxyribo nucleic acid.

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OPINION OF MR FENNELLY — CASE C-181/95

11 — Marketing authorization N o 18 S 354 F 17. 12 — The plaintiff states that two earlier applications deposited on 23 February 1993 were rejected by the Office of Indus- trial Property of the Belgian Ministry of Economic Affairs because they did not include copies of the relevant market- ing authorization. '1. In the event that the holder of the basic 13 — Moniteur Beige/Belgisch Staatsblad, 29 August 1991. patent or his successor in title is a

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BIOGEN v SMITHKLINE BEECHAM BIOLOGICALS

person other than the holder of the original or a copy of the said authoriza­ authorization to place the medicinal tion refuse to supply a copy to the product concerned on the market, is the holder of the basic patent or patents latter obliged to provide to the patent concerned or to his successor in title or holder on request, or, where appropri­ may it decide, arbitrarily or subject to ate, several patent holders when certain conditions, whether it is advis­ they so request, the "copy" of that able to provide or communicate such authorization which is referred to in copy with a view to its being used to Article 8(1 )(b) of Council Regulation support an application for a supplemen­ (EEC) N o 1768/92 of 18 June 1992 con­ tary protection certificate under the cerning the creation of a supplementary provisions of Council Regulation (EEC) protection certificate for medicinal N o 1768/92 of 18 June 1992?' products?

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research. The defendant argues that the cer- authorization to the patent holder, the latter tificate regime aims, primarily, to compensate would be in a position to withdraw his those responsible for developing and market- licence at the end of the patent term or to ing medicinal products for the effort, charge exorbitantly for its extension, con- expense and time devoted to seeking a mar- trary to Community competition rules. The keting authorization, rather than uniformly defendant points out that the licensing agree- to benefit all pharmaceutical research. It also ment between it and the plaintiff was relies on references to the certificate in the concluded before even the Commission's singular throughout the text of the Regu- proposal for a partially retrospective supple- lation. mentary protection regime and so did not provide for it.

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BIOGEN v SMITHKLINE BEECHAM BIOLOGICALS

the alternative, the defendant submits, con- himself had a patent the protection of which sistently with its argument that the market- he wished to prolong, or to contract to sup- ing authorization as such constitutes a dis- ply a copy to one of the other interested tinct property interest for the purposes of patent holders on the best available terms. In the supplementary protection regime, that the event of a positive response to the second the provision of copies of the authorization question, it would not assist matters if the to third parties would unjustly affect income competent public authorities were to supply which it would otherwise earn to compen- copies of the marketing authorization to all sate it for its effort and that this should not comers, to enable them to apply for certifi- be permitted. cates. Those authorities would then have to find a different criterion by which to allocate the sole possible certificate. There is no pro- vision in the Regulation for any qualitative preference of some patents over others, according, for example, to their relative importance to the marketed medicinal prod- uct; any such process of selection would be Analysis difficult, if not impossible. The alternative approach, that of 'first come, first served', is equally unconvincing, not least because it would sit ill with the general principle of legal equality.

31. This assumption becomes more impor­ tant in Article 3(c) of the Regulation, which requires, as one of the conditions for obtain­ ing a certificate, that 'the product has not already been the subject of a certificate'. As 29. The text of the Regulation applies simply there is only one 'product' corresponding to to a simple situation, in which basic research, any one medicinal product, this implies that product development, production and mar­ there can be only one certificate for any one keting are vertically integrated: where the marketing authorization for a medicinal holder of the patent or patents relating to a product. It could therefore be argued that medicinal product, the marketing of which Article 3(c) is designed to permit a certificate has been authorized in a Member State, is in respect of only one patent, viz. the basic also the holder of the relevant marketing patent chosen by its holder. This, however, authorization. The Regulation was evidently does not appear to be its purpose. In my drafted on the basis of this 'classic' model. view, the purpose of the provision is to However, the facts of the instant case do not ensure that the right exclusively to market a correspond to this model. medicinal product is not multiply extended over time by obtaining a number of certifi­ cates in succession. Otherwise, there could be attempts to bypass the calculation of the period of supplementary protection, includ­ ing the maximum of five years, which repre­ sents a key compromise between a number 30. The concept of 'the product' is central to of competing political, social and economic the legislative scheme. A 'product' is defined 15 interests. This could occur, in the absence in Article 1 (b) as 'the active ingredient or combination of active ingredients of a medicinal product' (emphasis added), indi­ cating that there will be only one 'product' 14 — This is evident from paragraph 33 of the Explanatory Memorandum. corresponding to any one preventative, 15 — See, to this effect, Case C-350/92 Spain ν Council [1995] therapeutic, diagnostic or other medicinal ECR I-1985, paragraphs 38 and 39 of the judgment. See also the ninth recital in the preamble to the Regulation and product. Article 1(c) may be thought to paragraphs 34 to 36 of the Explanatory Memorandum.

'Suppose the application for patent protec- tion was lodged in 1990 in Member State A, and in 1991 in Member State B, patent pro- tection expiring respectively in 2010 and in 2011. The authorization to market the prod- uct is first given in Member State C, in 1998. That leads to the following calculation of the duration of the certificate. In Member State A that duration is eight (1990-1998) minus 32. The assumption that for every product, five years, the certificate taking effect in 2010 there will be — and there need be — only and expiring in 2013. In Member State B the one corresponding basic patent, designated duration is seven (1991-1998) minus five by its holder, thus entailing the award of a single certificate, underlies the approach adopted in Article 3(c) of the Regulation, but is in no way necessary to the achievement of 16 — Cited in footnote 15 above, paragraph 44 of his Opinion.

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33. A number of problems would arise if Article 3(c) of the Regulation were inter- preted as permitting only one patent to be given the benefit of supplementary protec- tion on the basis of any one product autho- rized to be marketed as a medicinal product. First of all, contradictions would arise in the 35. As regards the first objective, the first text of the Regulation. As was stated above, recital in the preamble to the Regulation Article 1(c) appears to provide that the states that 'pharmaceutical research plays a holder of a number of patents shall designate decisive role in the continuing improvement one as his basic patent for the purposes of of public health'. Article 1(c) refers the award of a certificate. Where there is a number of patent holders, this choice cannot take place unless each is free to designate a 17 — Sec the Commission's remark in paragraph 37 of the patent for supplementary protection. If the Explanatory Memorandum, relative to the equivalent in the other legislative conditions were satisfied, proposal or Article 6 of the Regulation, that the decision as to whether it was opportune to apply for a certificate each patent holder could then be granted a should be reserved to the patent holder.

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36. Secondly, a limit of one certificate per product would undermine the objective of the Regulation of achieving greater unifor- mity of patent protection throughout the 37. The problems posed by such fragmenta- Community in order to reduce the obstacles tion are illustrated by the decision in EMI to intra-Community trade in medicinal Electrola v Patricia Im-und Export & Oth- products. 19 The sixth recital in the preamble ers, 21 in the related field of copyright protec- to the Regulation attests to this concern to tion. Where exclusive rights to market a achieve 'a uniform solution at Community product persist under the industrial property level'. Article 100a of the Treaty is the legal law of one Member State and where the fact basis of the Regulation because of the signifi- that the product is lawfully marketed in cance of the measure to this aspect of the another Member State is due not to an act or establishment of the internal market. In the consent of the holder of the industrial Spain v Council, the Court adverted to the property interest or his licensee but to the trend towards the heterogenous development expiry of the protection period provided for by the legislation of the second Member State, Article 36 of the Treaty permits the interest holder in the first Member State to 18 — The fact that the Regulation applies to all levels of pharma- ceutical research, without discrimination, and not just those final stages in which a marketable medicinal product is developed, is also evidenced by statements by the Commis- sion to that effect in the Explanatory Memorandum, para- graphs 12 and 29. 20 — Cited in footnote 15 above, paragraph 36 of the judgment. 19 — Greater uniformity in patent protection would also assist in 21 — Case 341/87 [1989] ECR 79; the case is referred to by harmonizing the conditions of competition in the various Advocate General Jacobs at paragraph 44 of his Opinion in Member States. Spain v Council, cited in footnote 15 above.

39. In the circumstances just described, the holder of a certificate in respect of patent X 38. As Advocate General Jacobs pointed out in Member State A could then oppose, on in Spain ν Council, the means by which the the same grounds as in EMI Electrola, the period of supplementary protection under import into that Member State of the medici­ the Regulation is calculated in each Member nal product in question from Member State State should result, in the case of any given B, where patent Y benefits from supplemen­ product, in a uniform point of termination, tary protection and the equivalent of pat­ throughout the Community, of the protec­ ent X has expired. The fact that the medici­ tion of associated patents which are covered nal product is marketed in Member State Β by a certificate (subject to the caveat outlined by or with the consent of the company above about the effect of the five-year maxi­ which holds a licence for patent X in Mem­ mum). H e continued, that this should lead to ber State A could hardly permit the invoca­ the free movement of medicinal products tion of the doctrine of exhaustion against the which are subject to patent protection. 22 Of holder of patent X: 23 he could not be course, because patent protection is not fully deemed to have consented to marketing in a harmonized or centralized in the Commu­ Member State where he does not himself nity, obstacles to free movement would market the medicinal product and where, his remain if equivalent patents associated with a patent having expired, he cannot control the medicinal product were held by different use of his invention in that product. As far as undertakings in different Member States. he is concerned, the imported medicinal However, even in a situation in which a product is a generic copy rather than a paral­ number of undertakings hold patents associ­ lel import. While the Court warned in EMI ated with a product, and each such patent is Electrola against the use of such disparities in held by the same undertaking throughout national periods of protection as a means of the Community, the restriction of supple­ arbitrary discrimination or as a disguised mentary protection to just one patent in each measure to restrict trade, 2 4 it could prove Member State would almost certainly result difficult in practice to detect or prevent the in the fragmentation of the market. As cer­ award of certificates, with precisely this end, tificates are awarded on a country-by- to different patent holders in different Mem­ country basis, different patent holders could ber States, either by public authorities or succeed in winning supplementary protec­ tion in different Member States, depending,

through the good offices of the holder of the be a valid marketing authorization in respect relevant marketing authorization. 25 Even if of the product, that no other marketing not deliberately exploited in order to parti- authorization relating to that product have tion the Community market, it is clear that been used as the basis for supplementary such a system would result in market frag- protection of its associated patents and that mentation. the marketing authorization to be used as the basis of such protection be the first granted in respect of the product in that Member State. Such an interpretation would ensure that the stated purpose of Article 3(c) is 40. The Regulation is a legislative enactment achieved, viz. the avoidance of multiple of general application, adopted to achieve extensions of the period of supplementary certain objectives. The text of the Regulation protection, while the objectives of the Regu- should be interpreted, as far as possible, to lation as a whole could then be pursued facilitate the achievement of those objectives. without impediment. The holder of any Where a provision gives rise to more than patent associated with the product could one possible interpretation, the alternatives designate that patent as a basic patent and, should be examined when the most obvious, subject to compliance with the conditions literal interpretation fails fully to serve the prescribed in the Regulation, could be objective of the Regulation because it is granted a certificate in order to compensate based on partially inaccurate assumptions more fully his research activities. about the pattern of economic relations in the field addressed by the Regulation and gives rise to contradictions in the legislative text. 26 In my view, Article 3(c) of the Regu- lation should be read as requiring that the product has not already been the subject of a certificate procured on the basis of a different marketing authorization. This implicit con- dition, unspoken because of the assumptions 41. I conclude, therefore, that the second which guided the draughtsman, is consistent question referred by the national court with the structure of Article 3: paragraphs should be answered in the negative. (b) to (d) would then be interpreted as requiring, in logical progression, that there

43. The Regulation is silent on the relation- ship between the holder of a basic patent and the holder of a related marketing authoriza- tion for the Member State in question, due again, I imagine, to the implicit assumption on the part of the draughtsman that they would be concentrated in the hands of a single undertaking. It is, in effect, the legisla- 44. The invocation by the plaintiff of Com- tive failure to advert to the possible diver- munity rules against abuse of a dominant gent ownership of patents and marketing position to support its argument for compul- authorizations that creates the problem in sory provision by its holder of a copy of the the present case. None the less, I would marketing authorization can only be rel- accept the argument that additional obliga- evant, if at all, if an actual copy of the rel- tions should not be imposed on private indi- evant marketing authorization is required for viduals or bodies by mere implication from the purposes of an application for a certifi- the functional needs of legislation which has cate and such a copy is not available from failed to provide for an unforeseen situation. any other source. Demand in the 'market' Thus, in the absence of a contractual obliga- for such copies would be likely speedily to tion to that effect (the parties would have collapse if they were not necessary, while the had to be gifted with remarkable prescience holder of the marketing authorization would to have provided for the event which has hardly enjoy a dominant position in supply- arisen under the Regulation), the Regulation ing that market if copies, or an acceptable should not be interpreted as requiring an substitute, were readily available elsewhere. undertaking in the position of the defendant Moreover, a teleological argument for an to hand over to an undertaking in the pos- obligation on private holders of marketing ition of the plaintiff a copy of the relevant authorizations to supply copies to patent national marketing authorization for the pur- holders, such as that considered and rejected pose of compliance with Article 8(1 )(b). It is above, would be further weakened if those impossible even to identify the provision of two conditions of necessity and non- the Regulation from which such an obliga- availability were not satisfied. The import of tion might be inferred; the most likely con- these remarks will become clearer when I tender, Article 6, establishes, at most, the come to deal with the substantive nature of

47. The defendant's contention that the patent and the marketing authorization con- stitute twin poles and distinct property inter- ests in the scheme of the Regulation is 46. The defendant argued, on related unconvincing, for a number of reasons. First, grounds, that the applicant for a certificate the certificate is granted to the holder of a must have a copy of the pertinent national basic patent and extends the rights held marketing authorization and that this could under the patent. The enjoyment of rights be provided only by the holder, on the basis granted by Community law is not normally of a contractual arrangement. As the placed at the discretion of private third par- substance of its contentions in respect of the ties. 28 Just as I cannot read the Regulation so first and third questions touches on the free- dom of public authorities to undermine the purported property interest of the holder of 27 — See, for example, Case C-186/90 Durighello [1991] a marketing authorization by releasing cop- ECR 1-5773, paragraphs 8 and 9 of the judgment; Case C-415/93 Union Royale Belge des Sociétés de Football Asso- ies of the authorization to patent holders, or ciation and Others v Bosman and Others [1995] by accepting alternative documents, the ECR I-4921, paragraph 59. 28 — See, for example, Case 61/81 Commission v United King- issues raised by the fourth question need to dom [1982] ECR 2601, paragraphs 6 to 9 of the judgment.

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48. Secondly, the marketing authorization performs some important but, none the less, merely ancillary functions in the scheme of the Regulation. The first authorization granted in the Community determines the period of supplementary protection; the first granted in a particular Member State deter- mines the time-limit for applications for a certificate (six months after the grant of the authorization); 29 the requirement under Article 8(1 )(b) of the Regulation that a copy 50. Fourthly, there is nothing to support the of that national marketing authorization be defendant's contention that the Regulation provided with the application for a certificate was designed primarily to reward the serves the further purpose of identifying the expense and effort involved in developing product and of assisting the verification of marketable medicinal products, rather than the first two conditions. For that reason, I pharmaceutical research in general, the take the view that it is not necessary to pro- results of much of which may require further vide a copy of the actual marketing authori- development before marketing. While it is zation mentioned in that Article, if the infor- essential under the scheme of the Regulation mation specified therein can be reliably that research ultimately result in a market- provided from another source — a point able medicinal product, the recitals in the upon which I will expand below. preamble to the Regulation (such as the first, second and fourth) speak of pharmaceutical research in general, while Article 1(c) of the Regulation suggests that any patent, includ- 29 — Article 7(1) of the Regulation, read in conjunction with ing one based on the most elementary Article 3(b) and (d); see further paragraph 35 of the Explanatory Memorandum. research, may be designated as a basic patent

for the purposes of applying for a certifi- limited to the medicinal product governed cate. 30 by the marketing authorization, the defen- dant contended that other vaccines against Hepatitis-B could be devised and authorized, with an active ingredient slightly different from Engerix-B but none the less using tech- nology covered by patents such as those of the plaintiff, which would fall outside the scope of the certificate. Thus, it would lose its right exclusively to market vaccines based 51. Fifthly, I would raise again the objective on those patents, but would be the only of avoiding, where possible, the fragmenta- undertaking obliged to pay royalties to the tion of the Community market in medicinal holder of the certificate. products. While the Regulation cannot entirely remedy this problem, it should not be interpreted so as to create new means of raising obstacles to free movement of such products. If the holder of marketing authori- zations for a medicinal product in a number of Member States were in a position to deter- mine whether undertakings which held any relevant patents in those countries could obtain certificates and could adopt a different approach in each country dependent on the terms offered, partitioning of the market could ensue even if more than one certificate could, in principle, be granted in respect of the product in each Member State. 53. If the defendant were correct, a variant of this problem would arise even if the cer- tificate and the marketing authorization were held by the same undertaking. Other under- takings could develop slightly different prod- ucts which, once authorized, they could mar- ket without regard to the supplementary period of protection accorded by the certifi- cate. Although this danger may be more 52. Finally, I would reject the defendant's apparent than real (because of the five-year argument that it could be unfairly penalized, maximum period of supplementary protec- by virtue of Article 4 of the Regulation, if it tion, the delay involved in obtaining an did not have a degree of control over the authorization in most cases and the protec- award of certificates. Because the protection tion afforded by Article 4(8)(a)(iii) of the conferred by a certificate is stated to be Directive), such a situation, whereby the extension of patent protection under the cer- tificate would lose much of its useful effect, would be inconsistent with the objectives of 30 — The Commission remarked, furthermore, in paragraph 2 of the Explanatory Memorandum, that, while the obtaining of the Regulation. This potential problem could a marketing authorization requires considerable scientific, be countered by permitting the holder of a technical and financial efforts, it was primarily the ever- lengthening delays involved in the procedure which patent either to acquire new certificates in resulted in an effective diminution of the period of protec- tion under a patent — delays which affect all patent holders. respect of new products which rely on its

54. However, of these two possibilities, only the second would be consistent with the objective of Article 3(c) of the Regulation: a certificate the material scope of which had been extended by reference to other medici- nal products authorized before its expiry would retain its original temporal scope, determined by reference to the date of the 55. The defendant also submitted an argu- first authorization in the Community to ment, based on the partially retrospective market the product initially relied upon in terms of the Regulation, that its interests the application for the certificate. Thus, no could be severely prejudiced if the Court did undue extra advantage would accrue to the not accept that the holder of a marketing holder of the certificate. Furthermore, per- authorization should have a privileged pos- mitting the material extension of the certifi- ition under the supplementary protection cate to other authorized medicinal products regime. It contended that, if the plaintiff would reflect and expand the policy underly- patent holder secured a certificate, it would ing the provision in Article 4 of the Regu- possess, at the end of the existing period of lation for the extension of the protection of patent protection, when the licensing agree- the certificate to any further use of the initial ment was due to expire, greatly increased product as a medicinal product that has been bargaining power. 31 It could either deny a authorized before the expiry of the certifi- further licence to the defendant, thus causing cate. While such a development would its factories, distribution networks and so on reduce the central role in the legislative to lie idle, or, in the light of that bleak alter- scheme, as set out above, of the concept of native and of the established position of the product, it would better secure the ben- Engerix-B on the market, charge an exorbi- efits of the Regulation for the holder of the tant royalty for a new licence. The Regu- marketing authorization for the product in lation, it concluded, should be interpreted in relation to which the certificate was first granted, against the competition of fast- followers. Thus, just as every product should 31 — It is, of course, for the national court to interpret the terms be able to give rise, where necessary, to cer- of the original licensing agreement. It appears from the order for reference that the national court concluded that tificates in relation to a number of associated the provision for prolongation of a patent in the 1988 patents in different hands, the material scope licensing agreement does not apply to the period of supple- mentary protection under a certificate.

57. If, in the light of the foregoing, the holder of a national marketing authorization for a medicinal product is not entitled effec­ tively to control the application for certifi­ cates by patent holders, public authorities 56. I do not accept this argument. First of must, at the very least, be free, as a matter of all, the evidence before the Court is not suf­ Community law, to provide copies of the ficient to establish that the plaintiff's bar­ marketing authorization to the patent holder gaining power would be greatly enhanced for the purposes of that application. 33 relative to that of the defendant if a certifi­ France, Sweden and the Commission argue cate were granted. For example, the plaintiff that whether they do so should depend upon would have little choice but to license its national rules relating to such disclosures, as patent to the defendant, if it wished to draw the matter is not provided for in the Regu­ any benefit from its period of supplementary lation. I do not agree. First, however, I will protection under the certificate and if no examine whether the provision of such a other company had a marketing authoriza­ copy of the marketing certificate is necessary tion for a product involving the patent. Sec­ for the grant of a certificate. ondly, and more importantly, if, upon grant of a certificate, a sufficiently narrow product market were found to exist — a market for Hepatitis-B antigens, for example — on which the plaintiff enjoyed a dominant pos­ ition, established remedies exist under the Community competition rules to forestall or rectify an abuse of that position. If, on the other hand, the behaviour of the holder of a 58. As I have already briefly outlined, the certificate were found not to constitute an purpose of the requirement that a copy of abuse of a dominant position, within the the marketing authorization be contained in meaning of that term in Community law, 3 2 an application for a certificate is to assist in the identification of the product and in veri­ fying compliance with Article 3(b) and (d) of 32 — The behaviour would presumably have to fall within one of the Regulation: that it is the first such autho­ the exceptions, identified in Case 238/87 Volvo v Veng rization for the marketing of the product in [1988] ECR 6211, to the general rule that the exercise of exclusive industrial property rights does not constitute, in itself, an abuse of a dominant position. For an elaboration of these exceptions, sec Joined Cases C-241/91 Ρ and C-242/91 Ρ RTE and ITP ν Commission [1995] ECR I-743. On the charging of patent licence fees greatly in excess of 33 — The exercise of such a freedom might remain subject to cer­ the norm, see also Case T-30/89 Hilti ν Commission [1991] tain conditions, imposed, for example, by the need to pro­ ECR II-1439. tect confidential information, discussed further below.

that Member State (which is important in information held by the body responsible for determining the time-limit for application) granting marketing authorizations. In those and, where applicable, that it is the first such circumstances, the conditions referred to in authorization in the Community (the date of Article 10(1) of the Regulation should be which will determine the period of supple- deemed to be satisfied, and the certificate mentary protection under the certificate). should be granted as a matter of right. These functions are evident from the stated requirement in Article 8(1 )(b) of the Regu- lation that the copy of the authorization sup- plied should identify the product and should contain 'in particular the number and date of the authorization and the summary of the product characteristics listed in Article 4a of Directive 65/65/EEC or Article 5a of Directive 81/851/EEC'. 34 60. I would reject a contrary textual argu- ment made by the defendant. It pointed out that Article 8(1 )(b) of the Regulation refers to a copy of the marketing authorization, while Article 8(1 )(c) requires only that the applicant provide a copy of the notice pub- lishing the authorization in the appropriate official publication, together with infor- mation regarding the identity of the product thus authorized, in cases where the first authorization in the Community was 59. For that reason, it is my view that the granted in a Member State other than that in requirement that a copy of the national mar- which the application is being made. This keting authorization be produced is not a distinction is all the more important, it con- further substantive condition of award of a tends, because the initial Commission pro- certificate; it establishes, rather, a require- posal referred to a copy of the authorization ment that the applicant be able to show com- in both cases. 35 According to the defendant, pliance with the actual substantive condi- the amendment was thus introduced by the tions, set out, chiefly, in Article 3 of the Council to preserve the position of the Regulation. A copy of the marketing autho- holder of the marketing authorization in the rization probably constitutes the easiest Member State of application and the reason means of proof. However, if an applicant given by the Commission in the Explanatory who does not possess a copy of the market- Memorandum is no longer valid. Further- ing authorization can none the less provide more, the fact that the information required the information specified from a reliable will normally be in the public domain shows, source, which is the real purpose of in its view, that the requirement of a copy of Article 8(l)(b) of the Regulation, a certificate the marketing authorization itself had a should not be refused. The competent public greater purpose, that of making the award of authority will, in any event, be in a position the certificate dependent on the patent hold- to verify that information by reference to er's actual possession of the authorization or

61. I do not find this argument convincing. The fact that the Council amended the equivalent of paragraph (c) of Article 8(1) of the present Regulation before enactment of the proposal need not in itself determine the 62. The evidence before the Court suggests interpretation of paragraph (b). Furthermore, that a patent holder will normally be able the objective of paragraph (b) in the original to supply the information required by proposal, viz. the obtaining of information Article 8(1 )(b) of the Regulation from about the identity of the product in question, sources in the public domain. Both of the was reinforced by the Council, which added parties to the main proceedings seem to the requirement that a summary of product accept, either expressly or implicitly, that all characteristics be included. 36 The require- of the pertinent information in the instant ment in Article 8(1 )(c) that a copy of the case is available to the plaintiff. This, of notice of the authorization in the appropriate course, is a matter of fact for the competent official publication of another Member State national industrial property office and, in the be provided, rather than a copy of the autho- case of a dispute, the national court to rization itself, probably reflects a realization decide. Thus, in order to answer in full the on the part of the Council that such an fourth question referred by the national authorization to market the product in a dif- court, and to provide for all possible circum- ferent country would not necessarily be held stances, I will now turn to the residual issue by the applicant patent holder. The fact that of those cases, if any, where the necessary it failed to realize that the same might be information is not publicly available. In such true within a single Member State should not cases, it is my view that the relevant public be held, on its own, to raise a simple proce- authorities should assist the applicant. The dural requirement into a substantive con- public body responsible for awarding mar- dition for obtaining a certificate, any more keting authorizations should either supply a copy of the authorization to the applicant or directly to the competent industrial property office of the Member State in question, 36 — This was originally a separate requirement, under Article 6(3)(e) of the Commission proposal. depending on practical considerations and on

63. The Commission envisaged, in its Explanatory Memorandum, that the admin- istration of the supplementary protection regime might require coordination between national health and industrial property 39 — Paragraph 16. 40 — See, for example, the remarks of Advocate General Van Gerven in Case 362/89 D'Urso and Others [1991] 37 — Article 12(4) of Council Regulation (EEC) N o 2309/93 of ECR I-4105, paragraphs 33 and 34 of his Opinion, that the 22 July 1993 laying down Community procedures for the useful effect of Council Directive 77/187/EEC on the safe- authorization and supervision of medicinal products for guarding of employees' rights in the event of transfers of human and veterinary use and establishing a European undertakings would be undermined if third parties could Agency for the Evaluation of Medicinal Products, OJ 1993 determine who benefited from it. Advocate General Mischo L 214, p. 1, provides a precedent for such precautions. It concluded, in Case 22/86 Rindone v Allgemeine Ortskran- states that '[u]pon request from any interested person, the kenkasse Bad Urach-Münsingen [1987] ECR 1339, p. 1354, Agency shall make available the assessment report of the that the need to give useful effect to Council Regulation medicinal product by the Committee for Proprietary (EEC) N o 574/72 required Member State authorities, in Medicinal Products and the reasons for its opinion in certain circumstances, to accept the conclusions of an exam- favour of granting authorization, after deletion of any ining doctor in the country of residence of a worker regard- information of a commercially confidential nature'. The ing his incapacity for work, even if their own national rules need for such measures would be reduced, of course, if did not impose such an obligation. documents were provided directly by one public body to 41 — See Article 5 of the Treaty, as applied, for example, in Case another. 93/71 Leonesio v Italian Ministry for Agriculture and For- 38 — See also paragraph 9 of the Explanatory Memorandum. estry [1972] ECR 287, paragraph 21 of the judgment.

(3) The competent national industrial property office shall deem Article 8(1 )(b) of Council Regulation (EEC) N o 1768/92 to have been complied with where an applicant for a supplementary protection certificate who is unable to produce a copy of the authorization to place the medicinal product concerned on the market provides with his application, from a reliable source, the information which is specified in that provision.

(4) Where the applicant for a supplementary protection certificate is unable to produce a copy of the authorization to place the medicinal product concerned on the market and the information which is specified in Article 8(l)(b) of Regulation (EEC) N o 1768/92 is not in the public domain, the national public body responsible for the grant of the authorization to place the medicinal product on the market must provide a copy of that authorization, or, in the alternative, of the information in question, either to the applicant or to the competent national industrial property office, as the case may be. Whether the relevant material is provided to the applicant or directly to the competent industrial property office, and the manner in which it is provided, will depend on considerations of practicality and on the need to safeguard confidential information.

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