C-110/95

YAMANOUCHI PHARMACEUTICAL v COMPTROLLER-GENERAL OF PATENTS, DESIGNS A N D TRADE MARKS

OPINION OF ADVOCATE GENERAL FENNELLY delivered on 6 February 1997

I — Introduction provisions of the same Regulation were the subject of a request for a preliminary ruling in Biogen,3 in which the Court delivered judgment on 23 January 1997.

1. The present request for a preliminary rul- ing raises the question of whether Article 19 of Council Regulation (EEC) N o 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for 3. In Spain v Councã, the Court explained medicinal products (hereinafter 'the [SPC] the factual situation, as described in the pre- Regulation') ' derogates from the substantive amble to the Regulation, which led the conditions for the granting of a supplemen- Council to adopt the Regulation, in the fol- tary protection certificate (hereinafter 'SPC' lowing terms: or 'certificate'), or whether the derogation is merely temporal in character.

II — Facts and legislative background 'medicinal products, especially those that are the result of long, costly research, will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research ... at (a) The SPC ReguUtion the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorization to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. That situa- 2. The Court is already familiar with the tion leads to a lack of protection which SPC Regulation, which survived a challenge penalizes pharmaceutical research.' 4 to its validity in Spain v Council; 2 certain

In the case of certificates to be granted in Denmark and in Germany, the date of 1 January 1985 shall be replaced by that of (c) the product has not already been the 1 January 1988. subject of a certificate;

In the case of certificates to be granted in (d) the authorization referred to in (b) is the Belgium and in Italy, the date of 1 January first authorization to place the product 1985 shall be replaced by that of 1 January on the market as a medicinal product.' 1982.

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2. An application for a certificate as referred (b) Article 19(1) shall be replaced by the to in paragraph 1 shall be submitted within following: six months of the date on which this Regu- lation enters into force.'

" 1 . Any product which on 2 January 7. In accordance with Article 23, the Regu- 1993 is protected by a valid patent and lation entered into force on 2 January 1993. for which the first authorization to place it on the market as a medicinal product within the territories of the Contracting Parties was obtained after 1 January 1985 may be granted a certifi- cate. 8. Paragraph 5 of Annex 15 to Decision N o 7/94 of the EEA Joint Committee 5 pro- vides for the following adaptations of the Regulation in the context of the Agreement on the European Economic Area of 2 May 1992 (hereinafter 'the [EEA] Agreement'): 6 ... (omissis)."

10. On 18January 1973, Yamanouchi Phar- maceutical Co. Ltd (hereinafter 'the appli- cants') obtained United Kingdom Patent N o 1415256 in respect of a-aminomethyl- 5. A certificate applied for in accordance benzyl alcohol derivatives, referred to here- with paragraph 3 shall not prevent any third inafter for convenience as 'eformoterol'. In party 'who, between the lapse of the basic 1982 the applicants licensed the patent to patent and the publication of the application Ciba-Geigy, which has sought to develop for a certificate, in good faith has commer- eformoterol in tablet and aerosol form for cially used the invention or made serious use in the treatment of asthma. O n 29 June preparations for such use, to continue such 1990, Ciba-Geigy was granted an authoriza- use. », tion to market a solution aerosol formulation of eformoterol in France, the first such mar- keting authorization in the Community. Authorization to market both a solution aerosol formulation and a tablet formulation in the United Kingdom submitted in June 1989 was refused; authorization for a dry powder formulation was, however, granted 9. Council Directive 65/65/EEC of 26 Janu- by the United Kingdom authorities on ary 1965 on the approximation of provisions 17 August 1995. laid down by law, regulation or administra- tive action relating to proprietary medicinal products 7 to which Article 3(b) refers, does not provide for a Community authorization procedure for the marketing of proprietary medicinal products. Article 3 of the Directive establishes that no such product may be placed on the market without an authoriza- 11. O n 15 January 1993, two days before the tion issued by the competent Member State United Kingdom patent was due to expire, authority, -while subsequent provisions lay Ciba-Geigy lodged an application, on the down the rules governing the grant, suspen- applicants' behalf, for an SPC in respect of sion and revocation of market authoriza- an eformoterol-based product, Formoterol tions. Council Directive 81/851/EEC relates Fumarate (hereinafter 'the product'). This to veterinary medicinal products and is was refused by the United Kingdom Patent therefore not relevant to the present pro- Office on 8 September 1993, essentially on ceedings. the ground that no valid authorization to place the product on the market as a medici- nal product had been granted in the United 7 _ OJ, English Special EHidon 1965-66 (I), p. 20. Kingdom.

HI — Analysis — at the date of submission of such applica- tion, marketing authorization in the Member State had still to be obtained;

14. In the applicants' view, Article 19 of the — application for a certificate as referred to Regulation provides for the (obligatory) in paragraph 1 of Article 19 was submit- grant of a transitional SPC when three con- ted to the relevant national authority (viz. ditions are satisfied, to wit, that the product the UK Patent Office) within 6 months be protected by a valid basic patent on the of 2nd January 1993, as laid down in date on which the Regulation enters into paragraph 2 of Article 19; force, that the first authorization to place the

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17. The applicants identify two purposes of the Regulation: a general purpose, that new 16. The applicants contend that it is clear medicinal products should not be deprived from the wording of the Regulation that of adequate patent protection (or its equiva- Article 19(1) does not incorporate expressly lent) as a result of the length of time taken to the ordinary provisions of the Regulation; process applications for marketing authori- had this been the Council's intention, there zations, and a more specific purpose (of the would have been an explicit reference back transitional provisions), to allow the to Article 3 and the necessity to fulfil the Community pharmaceutical industry to conditions it lays down. N o r is such a refer- catch up, to some extent, with its main non- ence implicit, as Article 19(1) 'can operate Community competitors while taking sensibly and effectively so as to achieve the account of other legitimate objectives in the objectives of the Regulation without refer- area of public health. The refusal of the SPC ence to Article 3'. In their view, the Regu- •would, in their view, conflict with each of lation draws a very clear distinction between these purposes, in that no protection would

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19. The only matter of substance raised by the present request for a preliminary ruling 8 — The situation of products for which a marketing authoriza- is the interpretation of Article 19(1) of the tion was issued in the period after the Regulation was Regulation, and in particular whether the adopted and before the expiry of the transitional period fixed by Article 19(2) is considered at paragraph 27, below. phrase 'the first authorization to place 9 — On the equivalent provisions of the EEA version of the [a product] on the market as a medicinal Regulation, which in certain circumstances allow the grant of an SPC for a product whose basic patent has expired, sec product in the Community' replaces the paragraphs 30 to 33, below.

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24. Articles 8(l)(a)(iv),8(l)(b), 9(1), 9(2)(d), and ll(l)(d), concerning, respectively, the content, notification and publication of an application, each require information 22. N o r does the wording of the Regulation support the applicants' view. Unlike Article 3, Article 19(1) does not define the 10 — COM(90) 101 final —SYN 255, 11 April 1990, comments on draft Article 3, explanatory memorandum, paragraph 32, conditions of eligibility for an SPC but p. 18.

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27. Furthermore, where a national market- ing authorization was delivered in the period after the adoption of the Regulation and the expiry of the transitional period fixed by Article 19(2), the applicant for an SPC could choose between the more restrictive 'ordi- nary provisions' of the Regulation (Articles 2 25. The anomalies to which the applicants' to 18) and the free-for-all provisions of interpretation gives rise do not stop at the Article 19 as interpreted by the applicants in impossibility of applying most of the proce- the present case. Thus, for example, where dural provisions of the Regulation. As the the marketing authorization was granted on, United Kingdom has pointed out, under this say, 1 October 1992, an application lodged view the holder of a basic patent valid any- on 1 February 1993 would comply with both where in the Community on 2 January 1993 Articles 7(1) and 19(2); the same is true of could apply in any Member State for an SPC for a product which has received a marketing authorization anywhere in the Community after the date set by Article 19(1). Faced with 11 — 'It occurs very often that one and the same product is suc- cessfully granted several authorizations to be placed o n the this striking anomaly, the applicants, at the market, namely each time a modification is made affecting the pharmaceutical form, dose, composition, indications, oral hearing, departed from a literal interpre- etc. In such a case, only the first authorization ... is taken tation and sought a common-sense one, into account' (Commission proposal, cited in preceding footnote, explanatory memorandum, p a r a g r a p h s , p. 19, based on Articles 4 and 5, which would emphasis added).

28. While it is true that the Regulation draws a distinction between, on the one hand, the first marketing authorization in the Community and, on the other hand, the first marketing authorization in an individual 30. The applicants have sought to rely on Member State, and that the former is used as the EEA version of the Regulation set out in the basis for calculating the duration of the paragraph 5 of Annex 15 to Decision SPC in accordance with Article 13, I do not No 7/94 of the EEA Joint Committee. 12 see how this can afford any assistance to the None of the parties to the present proceed- applicants; indeed, it is clear from Articles 13 ings addressed the issue of •whether it is and 19(1) that the function of the first mar- appropriate to interpret a measure based on keting authorization in the Community is the E E C / E C Treaty in the light of a later temporal in character. Their affirmation that measure which was based on an international 'Article 19(1) operates by reference to the agreement concluded by the Community, the first marketing authorization granted in the Member States and a number of third coun- Community' assumes that Article 19(1) tries. In my view, resort to such a technique defines a substantive criterion of eligibility of interpretation should be approached with for an SPC, rather than identifying the caution; even if the provisions in question category of products which can benefit from had been identical, the differences in charac- the temporal derogation it provides. The ter between the EEC/EC Treaty and the difference in wording in Articles 3 and 19(1) EEA Agreement are notorious. 1 3 reflects the differences in their function in the system set up by the Regulation, and not the imposition of different criteria of 12 — Cited at paragraph 8 of the present Opinion, above. eligibility for an SPC under the transitional 13 — Opinion 1/91 Draft Agreement relating to the creation of arrangements. the European Economic Area [1991] ECR1-6079, para- graphs 13 to 22.

33. The applicants' submission that Article 19 of the EEA Regulation operates independently of Article 3 of the same Regu- lation is therefore, in my view, completely unfounded, and their suggested interpreta- 32. This argument seems to be based on a tion of the EEC Regulation in the light of misunderstanding of the legal effect and these provisions must be rejected. function of the amendments in question. Article 19(1) of the EEA Regulation pro- vides in effect that an SPC may be granted in the EFTA States for products protected by a valid patent on 2 January 1993 and for which a marketing authorization has been granted after 1 January 1985. Under Article 19(2), applications for such transitional EFTA- SPCs must be made within six months of the coming into force of the EEA Regulation, on 34. The interpretation of Article 19 put for- 1 July 1994 (Article 3 of Decision N o 7/94 of ward by the applicants would not, in my the EEA Joint Committee). Article 19(3) view, advance the purposes of the transi- provides for the special situation of products tional provisions. These were outlined in the in respect of which the basic patent has tenth recital in the preamble as being to expired between the coming into force of the 'enable the Community pharmaceutical EEC Regulation and that of the EEA Regu- industry to catch up to some extent with its lation; an SPC may be granted for such main competitors who, for a number of products, in accordance with Article 19(1), years, have been covered by laws guarantee- but only with effect from the date of publi- ing them more adequate protection, while cation of the application for the certificate making sure that the arrangements d o not (Article 19(3)) and only if the application is compromise the achievement of other made within rwo months of the entry into legitimate objectives concerning the health force of the EEA Regulation (Article 19(4)). policies pursued both at national and

Community level'. It seems to me that the latter briefly, should this be of assistance to interpretation of Article 19 as a temporal the Court. derogation to Article 7 of the Regulation corresponds perfectly well with the objec- tives of the former provision set out in this recital. N o r is there any indication in the Regulation that the balance between the interests of the pharmaceutical industry and those promoted by Community and national health policies should be so vastly different under the transitional, as compared to the definitive, regime. Furthermore, the net effect of the applicants' thesis would be to extend SPC protection to patent-holders in 36. It would take a remarkably eclectic read- Member States where they have not obtained ing of the Commission proposal to derive a marketing authorization; I do not see how any support for the applicants' thesis. In such an interpretation could be said to foster describing the 'Details and characteristics of research and innovation in the pharmaceuti- the proposed system' at page 7 of the cal sector, which the applicants identified as explanatory memorandum, 14 the Commis- the underlying purpose of the Regulation. sion notes that the SPC 'will be granted by the patent office in each Member State ... relating to a product authorized to be mar- keted in the State concerned'; as neither Article 3 nor Article 19 is mentioned, the statement was presumably intended to cover both. In discussing the duration of the certificate, the purpose of the cut-off point (established by Article 13(2) of the Regulation) is identified as being 'to penalize against authorizations obtained at a very late date (more than 15 years after the filing of the patent)'. In its commentary on the conditions established by Article 3, the Commission states that as the certificate is 'a 35. Given the overwhelming evidence that national document, compliance with these Article 19 of the Regulation should be conditions must be examined with respect to treated as a temporal derogation only, it does the Member State in which the certificate not seem necessary or appropriate to refer to application is submitted'; no exception is its legislative history, which the applicants made for transitional SPCs, either here or in take to comprise only a preliminary draft the comments on the draft of those proposal considered by a group of govern- provisions. In commenting on Article 4, the ment experts in September 1989 and the Commission describes the SPC as being Commission proposal of April 1990. The 'linked to ... an authorization to place the first I would exclude in this case, as any con- product on the market (the first chronologi- tribution the experts made to the preparation of the proposal was superseded by the pro- posal itself which, furthermore, originated in a Community institution. I shall examine the 14 — Cited in footnote 10 above.

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