C-433/00

I - 7763

OPINION OF MR JACOBS — CASE C-433/00

5. Aventis appears to accept that the usual No 2309/93 to provide scientific advice in package size in Germany is ten cartridges the context of the authorisation and super- and that the defendants are accordingly vision of medicinal products — is also of entitled to adapt the imported packages in the view that a double pack of two five- some way so as to be able to sell Insuman in cartridge packages in not covered by a Germany in units of ten cartridges. It central marketing authorisation. However considers however that the defendants the Landgericht Köln notes that the opinion could produce 'double packs', namely retail of the EMEA is not legally binding. packs consisting of two imported five-car- tridge packages not repackaged but over- stickered as appropriate. Aventis submits that it is for that reason unnecessary to create new external packaging for units of ten cartridges and that to do so therefore infringes its trade mark rights. It has 8. It appears from the documents before accordingly sought an order before the the Court that the EMEA expressed the Landgericht Köln that the defendants above view in a letter sent to the first refrain from importing, stocking, offering defendant in response to the latter's notifi- for sale and marketing the product in new cation of the proposed parallel import. The external packaging holding ten cartridges EMEA stated in that letter: each containing 3 ml suspension.

10. The Landgericht Köln has accordingly cases of the kind referred to in referred the following questions for a pre- Question 1, is directed against "re- liminary ruling: packaging" on the ground, derived from national trademark law, that the possibility of creating a double pack, which, moreover, exists de facto and de jure, constitutes a less intrusive inter- ference with the rights of the trade- '1. Do the provisions governing the central mark holder?' authorisation of medicinal products in the European Union — in particular t h o s e of R e g u l a t i o n (EEC) No 2309/93 — preclude the legal possibility of "bundling" (that is to say, the joining together of several packages, each bearing the necessary labelling, in order to form a new retail 11. Written observations have been sub- unit) of packages of medicinal products mitted by Aventis, the defendants, the following importation into one Norwegian Government 5and the Com- Member State from another Member mission. Aventis, the defendants and the State, so that "repackaging" of medici- Commission were represented at the hear- nal products (that is to say, the produc- ing. tion of new external packaging to which the importer affixes the foreign trademark without the authorisation of the trademark holder) is "necessary" within the meaning of the decision of the European Court of Justice in Case C-232/94 MPA Pharma v Rhône-Pou- lenc Pharma [1996] ECR I-3671 and the trademark holder for that reason cannot prohibit such repackaging? The relevant Community legislation

2. In the event that Question 1 should be answered in the negative: 12. Since 1 January 1995 it has been poss- ible to obtain centralised Community-wide authorisation for the marketing of medici- nal products. Once such an authorisation has been granted, products covered by the authorisation may be marketed in any part of the Community. Do the rules on the free movement of goods within the Common Market or other rules of Community law stand in 5 — Pursuant to Article 20 of the Statute of the Court of Justice the way of a prohibition which, in of the EC.

15. Article 8(3) of Directive 2001/83 8 17. Article 11 of Directive 2001/83 10 requires the application for authorisation requires the summary of product char- to be accompanied by listed particulars and acteristics to contain specified information including at 6.4 'nature and contents of the immediate packaging'. 6 — Cited in note 3. 7 — The reference was originally to Articles 4 and 4a of Council Directive 65/65/EEC of 26 January 1965 on the approxi- mation of provisions laid down by law, regulation or administrative action relating to medicinal products, OJ, English Special Edition, Second Series 1965-66, p. 20. Directive 65/65, together with numerous other directives on medicinal products, was repealed with effect from 18 De- cember 2001 by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311, p. 67, Article 128 of which provides 18. Annex I to Directive 2001/83 requires that references to the repealed directives are to be construed as references to that directive in accordance with the the particulars and documents accompany- correlation table in Annex III thereto. ing an application for marketing authori- 8 — Directive 2001/83 is cited in note 7. Article 8(3) re-enacts the third paragraph of Article 4 of Directive 65/65, cited in note 7, as replaced by Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of 9 — Article 1(23) and (24) of Directive 2001/83, re-enacting the provisions laid down by law, regulation or administrative definitions in Article 1(2) of Directive 92/27 of 31 March action relating to proprietary medicinal products, OJ 1983 1992 on the labelling of medicinal products for human use L 332, p. 1. Point 9 under the third paragraph of Article 4 and on package leaflets, OJ 1992 L 113, p. 8. read: 'A summary, in accordance with Article 4a, of the 10 — Re-enacting Article 4a of Directive 65/65, cited in note 7, product characteristics, one or more specimens or mock-ups inserted by Directive 83/570, cited in note 8. The of the sales presentation of the proprietary product, together information prescribed by Article 4a included under with a package leaflet where one is to be enclosed'. point 6.4 'nature and contents of container'.

U—Established by Article 8 of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, 01 1975 L 147, p. 13. 12 — Article 5 of Regulation No 2309/93, cited in note 3. In addition the applicant shall provide 13—The reference was originally to Council Directive 92/27/ĽEC, cited in note 9. Directive 92/27 was also samples or mock-ups of the packaging, repealed with effect from 18 December 2001 by Directive 2001/83, cited in note 7. labels and package leaflets for the medici­ 14 — Re-enacting Article 2(1) of Directive 92/27, winch nal product concerned.' included identical items under (c) and (I).

I - 7767

OPINION OF MR JACOBS — CASE C-433/00

maceutical form and the contents by doses of the product, in the case of each weight, by volume or by number of doses presentation of the product'. 18 of the product' and at (1) 'the number of the authorisation for placing the medicinal products on the market'.

2 5 . A r t i c l e 10(1) of Regulation No 2309/93 provides:

22. Article 56 of Directive 2001/83 15 requires the particulars referred to in Article 54 to be 'easily legible, clearly comprehensible and indelible'. 'Within 30 days of receipt of the opinion [of the Committee for Proprietary Medici- nal Products], the Commission shall pre- pare a draft of the decision to be taken in respect of the application, taking account of Community law. 23. Article 58 of Directive 2001/83 16 pro- vides that the inclusion in the packaging of all medicinal products of a package leaflet is to be obligatory unless all the infor- mation required by Articles 59 and 62 is directly conveyed on the outer packaging or In the event of a draft decision which on the immediate packaging. envisages the granting of marketing auth- orisation, the documents referred to in Article 9(3)(a), (b) and (c) shall be annexed.

2 7 . A r t i c l e 12( 1 ) of Regulation No 2309/93 provides: 29. Article 51 of the Regulation provides, in so far as is relevant:

'... a marketing authorisation which has been granted in accordance with the pro- cedure laid down in this Regulation shall be 'In order to promote the protection of valid throughout the Community. It shall human... health and of consumers of confer the same rights and obligations in medicinal products throughout the Com- each of the Member States as a marketing munity... the Agency shall undertake the authorisation granted by that Member following tasks within its Committees: State in accordance with Article 3 of Direc- tive 65/65/EEC.

The authorised medicinal products shall be entered in the Community Register of Medicinal Products and shall be given a number which must appear on the packag- ing.' (c) the coordination of the supervision... of 20 — The reference was originally to Directive 92/27, cited in medicinal products which have been note 9. authorised within the Community.'

I - 7769

OPINION OF MR JACOBS — CASE C-433/00

The first question referred orisation to submit specific packaging with the application. The authorisation, if granted, relates to packages of the size proposed. Multiple packages are not pro- vided for and are hence not authorised.

32. The defendants, the Norwegian Gov- 35. In particular, it is apparent from the ernment and the Commission submit that legislation that the legislature regards it as the question should be answered in the important that information concerning the negative on the basis that each authori- precise quantity of medicinal products in a sation is limited to the package size to package for which a central marketing which the application for that authori- sation related. The legislation requires the applicant for a central marketing auth- 21 — Article 4 of Directive 65/65, cited in note 7.

I - 7770

AVENTIS

authorisation has been granted should be acteristics 27 which must specify the con- clearly indicated both on the outer packag- tents of the immediate packaging. 28 The ing and in the package leaflet. Again, the outer packaging must show the contents by requirement as to outer packaging has a weight, by volume or by number of doses long history, dating back to 1965. 22 of the product 29 and the package leaflet must specify the contents by weight, by volume or by number of doses of each presentation of the product. 30

36. The pertinent requirements of the cur- rent legislation may be summarised as follows.

I - 7771

OPINION OF MR JACOBS — CASE C-433/00

40. The importance of the information the size of package specified. The product which the legislation requires to be shown cannot therefore lawfully be marketed in a on the outer packaging and included in the double pack consisting of two packages of package leaflet is underlined by the facts five units. that (i) a central marketing authorisation is to be refused if the labelling and package leaflets proposed by the applicant are not in accordance with that legislation 34 and (ii) the person responsible for placing the product on the market is required to apply to the Agency if he proposes to make any 43. That proposition appears to me, as I alteration to that information. 35 have indicated, to follow ineluctably from the scheme, objectives and wording of the legislation. In particular, as the Commis- sion argued at the hearing, there is an obvious risk inherent in the type of 'bund- ling' envisaged by the referring court that the consumer will be confused and public 41. Third, the outer packaging must show health thereby jeopardised: there may be the number of the central marketing auth- inconsistencies in the package leaflets orisation. 36 Given the points made above, inserted in packages so bundled together the conclusion appears inescapable that since the leaflets will have been designed that number must be the number of the for — and should specify 37 — the quan- authorisation which was sought and tities to be marketed in the original pack- granted on the basis of the packaging and ages. package leaflet submitted with the appli- cation. That authorisation in my view relates only to the 'retail unit' consisting of packaging of that size and described in that package leaflet.

48. Regulation No 2309/93 requires the 45. Aventis relies on Article 12(1) of Regu- Agency to undertake the coordination of lation No 2309/93, 39 which provides that the supervision of medicinal products a central marketing authorisation is to be which have been authorised within the valid throughout the Community, and Community. 41 submits on that basis that an importer can market a medicinal product which is ident- ical to that for which the authorisation was granted. However, it is clear to me that, for the reasons given above, a central market- ing authorisation relates to more than the constituents of the medicinal product con- cerned, and in particular requires that that 49. In a communication issued in 1998 42 product be marketed in packaging of the 'to clarify its position on certain aspects size submitted with the application. relating to the implementation of the cen- tralised and mutual recognition pro- cedures', 43 the Commission states, under the head 'Parallel distribution of Commu- nity authorised medicines':

50. In 1999 the EMEA issued its 'Pro- suggested by Aventis, seeking to impose a cedure for notifications of parallel distribu- requirement on the parallel importer and it tion of centrally authorised medicinal prod- is therefore not necessary to determine ucts' 'to provide guidance and assist paral- whether it had the power to do so. As the lel distributors to fulfil their obligations, Commission points out, the answer to the without prejudice to the interpretation of first question referred by the Landgericht Community Directives and Regulations by Köln depends on the correct interpretation the European Commission and/or Euro- of Regulation No 2309/93. pean Court of Justice'. That document refers to the Commission's Communication and notes that 'the EMEA is the Authority designated to check compliance of a prod- uct distributed in parallel with the terms of the Community Marketing Authorisation 53. I accordingly conclude that the first for the concerned centrally authorised question — essentially whether Regulation medicinal product'. It requires parallel (EEC) No 2309/93 precludes the marketing importers of centrally authorised medicinal in double packs of medicinal products products to notify the EMEA of proposed imported into one Member State from imports. another Member State — should be answered in the affirmative.

51. There is nothing to suggest that the system described by the Commission goes The second question referred beyond the role of the EMEA as envisaged by Regulation No 2309/93.

of Community law preclude a national rule pharmaceutical product where the importer which prohibits repackaging on the ground has repackaged it and reaffixed the trade that creating a double pack constitutes a mark provided that certain conditions are less intrusive interference with the rights of met, namely: (i) reliance on trade mark the trademark holder. rights by the owner would contribute to the artificial partitioning of the markets between Member States; (ii) the repackag- ing cannot affect the original condition of the product inside the packaging; (iii) the new packaging clearly states who re- packaged the product and the name of the 56. That question concerns the trade mark manufacturer; (iv) the presentation of the aspects of the defendants' conduct. A repackaged product is not such as to be parallel importer who repackages trade- liable to damage the reputation of the trade marked goods necessarily re-apposes the mark and of its owner; and (v) the importer trade mark, and in so doing prima facie gives notice to the trade mark owner before infringes the trade mark owner's rights. the repackaged product is put on sale, and, However, by virtue of the principle of on demand, supplies him with a specimen Community-wide exhaustion of rights, first thereof. The first condition will be regarded articulated by the Court of Justice and as satisfied where the trade mark owner has subsequently enshrined in Article 7(1) of put an identical pharmaceutical product on the Trade Marks Directive,44 the trade the market in several Member States in mark does not entitle the proprietor to various forms of packaging and the re- prohibit its use in relation to goods which packaging carried out by the importer is have been put on the market in the necessary in order to market the product in Community under that trade mark by the the Member State of importation. 45 proprietor or with his consent. By way of exception to that principle, Article 7(2) provides that Article 7(1) 'shall not apply where there exist legitimate reasons for the proprietor to oppose further commercial- isation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the 58. The referring court's second question in market'. the present case is concerned with that condition, and in particular with the con- sequence that a parallel importer of trade- marked products may repackage such products if it is necessary to do so in order to market the product in the State of importation.46 It appears from the order for reference that 'repackaging' in the 57. Article 7(2) has been interpreted by the Court to mean that a trade mark owner may not oppose the further marketing of a 45 — See Joined Cases C-427/93, C-429/93 and C-436/93 Bristol-Myers Squibb and Others (1996) ECR I-3457, operative part of the judgment. 46 — See in particular Bristol-Myers Squibb, cited in note 45, 44 — First Council Directive 89/104/EEC of 21 December 1988 and Case C-379/97 Upiohn |1999| ECR I-6927; see also to approximate the laws of the Member States relating to my Opinion in Merck, Sharp &' Dohme and Boehringer trade marks, OJ 1989 L 40, p. 1. Ingelheim anedOthers, cited in note 2.

62. As the Commission pointed out at the hearing, those are not, however, the only possible 'retail units': the Insuman car- tridges can lawfully be sold in Germany in the five-cartridge packages in which they 60. I have explained above why I consider are imported, subject to necessary linguistic that marketing a double pack of two changes. That follows from the fact that five-unit packages is not in accordance five-cartridge packages are the subject of a with either the central marketing auth- central marketing authorisation —• which orisation for five-unit packages or that for is valid throughout the Community. ten-unit packages. Marketing a newly packaged ten-unit package however will — as all parties appear to accept — be within the terms of the central market- ing authorisation for ten-unit packages, provided that the information given on the outer packaging and in the package leaflet is the same (apart from necessary linguistic changes) as that on the basis of which the authorisation was granted. 63. It is not clear however from the docu- ments before the Court whether there is a market in Germany for Insuman in five- cartridge packages. The defendants state in their written observations that the product is marketed in France in a package size which is not marketable in Germany; at the 61. If therefore the only possible 'retail hearing however the defendants' counsel units' in which the Insuman cartridges at appeared to state that both sizes could be

I - 7776

AVENTIS

sold there. If that is the case, the German such as the regulatory requirements of the market is not closed to the defendants if importing Member State — but also of they cannot repackage in ten-unit packages. obstacles which exist in fact, including The Commission concludes from that that resistance of consumers, for example to such repackaging is not necessary. over-stickered boxes, which is such as to affect prescription or dispensing prac- tice.' 48

I - 7777

OPINION OF MR JACOBS — CASE C-433/00

Conclusion

68. I am accordingly of the view that the questions referred by the Landgericht Köln should be answered as follows:

(1) A central marketing authorisation granted pursuant to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products authorises the marketing of a medicinal product only in the size of packaging specified in the authorisation. Where a medicinal product is the subject of two separate central marketing authorisations granted pursuant to Regulation (EEC) No 2309/93 (i) for packages of ten items and (ii) for packages of five items, the product cannot therefore lawfully be marketed in a 'bundle' of two packages of five units.

(2) Repackaging is necessary if it is reasonably required to enable the importer to obtain effective access to the market of the importing Member State and in so far as other, less intrusive, methods of repackaging will not enable him to obtain effective access to that market; for that purpose account must be taken not only of obstacles which exist in law — such as the regulatory requirements of the importing Member State — but also of obstacles which exist in fact, including resistance of consumers, for example to over-stickered boxes, which is such as to affect prescription or dispensing practice.