Case C-297/15, Ferring Lægemidler – artificially segmenting the market in laxatives?

Can multi-packs of trademarked medicine be repackaged in an exporting country where this is necessary to be able to sell single packs of those goods in an importing EU country? And if so, then what are the criteria for determining ‘necessity’ for the purposes of the EU’s trade mark Directive 2008/95/EC?

Background
Ferring Lægemidler is part of the Swiss-based bio-pharmaceutical giant, Ferring. Since 1959, it has been making and selling a laxative under the trademark ‘Klyx’. This medicinal product is sold in volumes of 120 ml and 240 ml; and either in individual packs or packs of ten. These are not only sold in the EU Member States of Finland and Sweden but also in the EEA Member State of Norway.

Orifarm is company which has been buying up 10-pack Klyx in Norway. It has then been repackaging them into individual packs of Klyx. In the course of doing this, it has been reapplying the trademarks which were on the 10-pack Klyx onto the single packs. These single doses have then been imported into Denmark and marketed for sale there.

The question here is whether Ferring can use EU trade mark law to stop Orifarm from parallel importing Klyx in this way.

The answer turns on the correct interpretation being given to the EU’s trade mark Directive 2008/95/EC to approximate the laws of the Member States relating to trade marks (Codified version) (Text with EEA relevance) OJ [2008] L 299/25.

The starting point is Article 5 of the Directive which provides:

Rights conferred by a trade mark
1.   The registered trade mark shall confer on the proprietor exclusive rights therein. The proprietor shall be entitled to prevent all third parties not having his consent from using in the course of trade:
(a) any sign which is identical with the trade mark in relation to goods or services which are identical with those for which the trade mark is registered;
(b) any sign where, because of its identity with, or similarity to, the trade mark and the identity or similarity of the goods or services covered by the trade mark and the sign, there exists a likelihood of confusion on the part of the public; the likelihood of confusion includes the likelihood of association between the sign and the trade mark.

2.   Any Member State may also provide that the proprietor shall be entitled to prevent all third parties not having his consent from using in the course of trade any sign which is identical with, or similar to, the trade mark in relation to goods or services which are not similar to those for which the trade mark is registered, where the latter has a reputation in the Member State and where use of that sign without due cause takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the trade mark.

3.   The following, inter alia, may be prohibited under paragraphs 1 and 2:
(a) affixing the sign to the goods or to the packaging thereof;
(b) offering the goods, or putting them on the market or stocking them for these purposes under that sign, or offering or supplying services thereunder;
(c) importing or exporting the goods under the sign;
(d) using the sign on business papers and in advertising.

4.   Where, under the law of the Member State, the use of a sign under the conditions referred to in paragraph 1(b) or paragraph 2 could not be prohibited before the date of entry into force of the provisions necessary to comply with Directive 89/104/EEC in the Member State concerned, the rights conferred by the trade mark may not be relied on to prevent the continued use of the sign.

5.   Paragraphs 1 to 4 shall not affect provisions in any Member State relating to the protection against the use of a sign other than for the purposes of distinguishing goods or services, where use of that sign without due cause takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the trade mark.

However, Article 5 needs to be read together with Article 7, and in particular, Article 7(2):

Exhaustion of the rights conferred by a trade mark
1.   The trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent.

2.   Paragraph 1 shall not apply where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market.

Yet these provisions of EU legislation have also been subject to extensive interpretation by the ECJ (as it then was).

Thus, in the repackaging of trade-marked goods dispute in Case 102/77, Hoffmann-La Roche v Centrafarm the ECJ reasoned:

8 It is accordingly justified under the first sentence of article 36 to recognize that the proprietor of a trade-mark is entitled to prevent an importer of a trade-marked product , following repackaging of that product, from affixing the trade-mark to the new packaging without the authorization of the proprietor.

And

14 The first question must therefore be answered to the effect that :
(a) the proprietor of a trade-mark right which is protected in two member states at the same time is justified pursuant to the first sentence of article 36 of the EEC Treaty in preventing a product to which the trade-mark has lawfully been applied in one of those states from being marketed in the other member state after it has been repacked in new packaging to which the trade-mark has been affixed by a third party.
(b) however , such prevention of marketing constitutes a disguised restriction on trade between member states within the meaning of the second sentence of article 36 where :
– it is established that the use of the trade-mark right by the proprietor , having regard to the marketing system which he has adopted , will contribute to the artificial partitioning of the markets between member states ;
– it is shown that the repackaging cannot adversely affect the original condition of the product ;
– the proprietor of the mark receives prior notice of the marketing of the repackaged product ; and
– it is stated on the new packaging by whom the product has been repackaged.

This reasoning was subsequently elaborated upon in C-427/93 Bristol-Myers Squibb v Paranova, another case about the repackaging of trade-marked products. The ECJ reasoned:

46 Trade mark rights are not intended to allow their owners to partition national markets and thus promote the retention of price differences which may exist between Member States. Whilst, in the pharmaceutical market especially, such price differences may result from factors over which trade mark owners have no control, such as divergent rules between the Member States on the fixing of maximum prices, the profit margins of pharmaceutical wholesalers and pharmacies, or the maximum amount of medical expenses which may be reimbursed under sickness insurance schemes, distortions caused by divergent pricing rules in one Member State must be remedied by measures of the Community authorities and not by another Member State introducing measures which are incompatible with the rules on the free movement of goods (see, in particular, Winthrop, paragraphs 16 and 17).

47 In answering the question whether a trade mark owner’ s exclusive rights include the power to oppose the use of the trade mark by a third party after the product has been repackaged, account must be taken of the essential function of the trade mark, which is to guarantee to the consumer or end user the identity of the trade- marked product’ s origin by enabling him to distinguish it without any risk of confusion from products of different origin. That guarantee of origin means that the consumer or end user can be certain that a trade-marked product offered to him has not been subject at a previous stage of marketing to interference by a third person, without the authorization of the trade mark owner, in such a way as to affect the original condition of the product (Hoffmann-La Roche, paragraph 7; Pfizer, paragraph 8).

The ECJ went on to say:

Artificial partitioning of the markets between Member States

52 Reliance on trade mark rights by their owner in order to oppose marketing under that trade mark of products repackaged by a third party would contribute to the partitioning of markets between Member States in particular where the owner has placed an identical pharmaceutical product on the market in several Member States in various forms of packaging, and the product may not, in the condition in which it has been marketed by the trade mark owner in one Member State, be imported and put on the market in another Member State by a parallel importer.

53 The trade mark owner cannot therefore oppose the repackaging of the product in new external packaging when the size of packet used by the owner in the Member State where the importer purchased the product cannot be marketed in the Member State of importation by reason, in particular, of a rule authorizing packaging only of a certain size or a national practice to the same effect, sickness insurance rules making the reimbursement of medical expenses depend on the size of the packaging, or well-established medical prescription practices based, inter alia, on standard sizes recommended by professional groups and sickness insurance institutions.

54 Where, in accordance with the rules and practices in force in the Member State of importation, the trade mark owner uses many different sizes of packaging in that State, the finding that one of those sizes is also marketed in the Member State of exportation is not enough to justify the conclusion that repackaging is unnecessary. Partitioning of the markets would exist if the importer were able to sell the product in only part of his market.

55 The owner may, on the other hand, oppose the repackaging of the product in new external packaging where the importer is able to achieve packaging which may be marketed in the Member State of importation by, for example, affixing to the original external or inner packaging new labels in the language of the Member State of importation, or by adding new user instructions or information in the language of the Member State of importation, or by replacing an additional article not capable of gaining approval in the Member State of importation with a similar article that has obtained such approval.

56 The power of the owner of trade mark rights protected in a Member State to oppose the marketing of repackaged products under the trade mark should be limited only in so far as the repackaging undertaken by the importer is necessary in order to market the product in the Member State of importation.

However, this reasoning of the ECJ has also been refined in Case C-348/04, Boehringer Ingelheim. In that judgment, the ECJ explained:

14. It must be borne in mind that the specific subject-matter of a mark is to guarantee the origin of the product bearing that mark and that repackaging of that product by a third party without the authorisation of the proprietor is likely to create real risks for that guarantee of origin (see Boehringer Ingelheim and Others , paragraph 29).

15. According to the case-law of the Court, it is the repackaging of the trade-marked pharmaceutical products in itself which is prejudicial to the specific subject-matter of the mark, and it is not necessary in that context to assess the actual effects of the repackaging by the parallel importer (see Boehringer Ingelheim and Others , paragraph 30).

Nevertheless, the ECJ also said:

18. A trade mark proprietor’s opposition to repackaging of pharmaceutical products contributes to artificial partitioning of the markets between Member States where the repackaging is necessary in order to enable the product imported in parallel to be marketed in the importing State ( Boehringer Ingelheim and Others , paragraph 33).
19. Thus it is clear from settled case-law that the change brought about by any repackaging of a trade-marked pharmaceutical product – creating by its very nature the risk of interference with the original condition of the product – may be prohibited by the trade mark proprietor unless the repackaging is necessary in order to enable the marketing of the products imported in parallel and the legitimate interests of the proprietor are also safeguarded ( Bristol-Myers Squibb and Others , paragraph 57, and Boehringer Ingelheim and Others , paragraph 34).

36. That condition that repackaging be necessary is fulfilled if the rules or practices in the importing Member State prevent the product in question from being marketed in that State in the same packaging as that in which those products are marketed in the exporting Member State (see, to that effect, Upjohn , paragraphs 37 to 39 and 43).

37. Conversely, the condition that it be necessary is not fulfilled if repackaging of the product is explicable solely by the parallel importer’s attempt to secure a commercial advantage (see Upjohn , paragraph 44).

While the ECJ has been building up this body of case law to regulate parallel imports, the German Supreme Court has also recently handed down a judgment on the same area concerning the importation of tablets into Germany from France. When discussing the notion of ‘necessity’ of the repackaging, the German Supreme Court reasoned:

Der maßgebliche Sachverhalt bei diesem Arzneimittel unterscheidet sich von dem zuvor behandelten Fall der Einfuhr von ʺMicardisPlus” allein dadurch, dass die in Deutschland weit überwiegend nachgefragte Packungsgröße mit 100 Tabletten auch in Frankreich verkehrsfähig und in für Zwecke des Parallel- imports ausreichenden Mengen zu beschaffen ist. Für die Frage der Erforderlichkeit des Umpackens ist aber nur auf das konkrete im Europäischen Wirtschaftsraum in Verkehr gebrachte Warenexemplar abzustellen (BGH, Urteil vom 12. Juli 2007 – I ZR 148/04, BGHZ 173, 230 Rn. 33 – CORDARONE unter Hinweis auf EuGH, Urteil vom 1. Juli 1999 – C-173/98, Slg. 1999, I-4103 = GRUR Int. 1999, 870 Rn. 19 f. – Sebago). Wie das Berufungsgericht zu Recht angenommen hat, ist ein Umpacken dann zulässig, wenn die konkret importierte Ware andernfalls vom Vertrieb auf einem Teilmarkt des Einfuhrmitgliedstaats ausgeschlossen wäre. Dementsprechend darf der Parallelimporteur nicht darauf verwiesen werden, die (auch) durch die Packungsgröße bestimmten Teilmärkte des Einfuhrmitgliedstaats durch den Ankauf passender Packungen in den Ausfuhrmitgliedstaaten zu bedienen.

Folglich steht der Klägerin auch kein Unterlassungsanspruch gegen das Umpacken aus Frankreich eingeführter “Sifrol”-Tabletten der Packungsgröße 30 Tabletten in die Packungsgröße 100 Tabletten für den deutschen Markt zu.

It is the German Supreme Court’s reasoning about necessity, and whether this complies with the CJEU’s case law, which is disputed by the parties in the present Danish case.

On the one hand, Ferring maintains that in light of the criteria mentioned in the ECJ’s judgments, Orifarm’s repackaging cannot be deemed to be necessary. Ferring’s drug is offered for sale in all the markets under the same name and in the same volume sizes and in the same pack-sizes. Consequently, Orifarm’s repackaging of Klyx in new exterior packaging is illegal. In so far as the German Supreme Court’s judgment is concerned, it is difficult to square with this with the existing requirements of EU law. The general rule in EU law is that the proprietor can oppose any repackaging of the goods. The exception to this rule is where the proprietor relies on a sales system that uses different pack-sizes and forbids repackaging with the result that the market is artificially segmented. But that is not the case here.

The force of Ferring’s submissions is denied by Orifarm, who point out that it is objectively necessary for them to repackage the goods for the company to have effective access to the Danish market. What they are doing complies with the EU courts’ case law. And since Ferring opposes Orifarm purchasing packs of 10 and repackaging them into single packs for sale on the Danish market, Ferring are artificially segmenting the market.

Orifarm adds that, in its view, the German Supreme Court’s judgment is in accordance with the CJEU’s case law. Namely, the German court explained that repackaging was permitted where imported goods would otherwise be excluded from the segment of the market in the importing Member State. Concomitantly, the German court had also said that the parallel importer could not be required to buy packaging in the Member State of export that matched the use of package sizes that were specific to that segment of the market in the importing Member State.

The different interpretations of the law in this area prompted the Sø- og Handelsretten to make a preliminary reference to the CJEU.

Questions Referred
According to the website of the UK’s Intellectual Property Office, the Sø- og Handelsretten has asked:

1. Must Article 7(2) of Directive 2008/95/EC […] and the related case-law be interpreted as meaning that a trade mark proprietor may lawfully object to the continued marketing of a medicinal product by a parallel importer, where the importer has repackaged the medicinal product in a new, outer packaging and reaffixed the trade mark in a situation where the trade mark proprietor has marketed the medicinal product in the same volume and packet sizes in all EEA countries where the medicinal product is sold?

2. Will the answer to the first question be different if the trade mark proprietor in both the country of export and the country of import has marketed the medicinal product in two different packet sizes (10-piece packets and 1-piece packets) and the importer has purchased 10-piece packets in the country of export and repackaged them in 1-piece packets, on which the trade mark has been reaffixed before the products are marketed in the country of import?

Comment
This EU Law Radar report has been compiled on the basis of the Danish court’s referring order and a translation put into English by a machine. Consequently, the report may be replete with errors and omissions.

For accuracy, the quotation from the German Supreme Court does not come from the Danish referring court’s judgment but from the original judgment of the German Supreme Court.

Curiously, the paragraph of the German Supreme Court’s judgment refers to a different judgment from the ECJ, namely that in Sebago.

Update – 16 August 2015
The parallel trade in medical products can also be hindered by the need for an importer to provide an accurate translation of the wording on a manufacturer’s labelling and packaging. In that context, there is a preliminary reference from the German Supreme Court; see further, Case C-277/15, Servoprax – challenging language obstacles to parallel imported medical products.

The parallel trade in medical products can also be made more difficult by a country’s rules on the pricing and advertising of medicines. Readers may be interested to learn that there is another preliminary reference from the German Supreme Court in respect of medicines that have been supplied to German patients by a Dutch online pharmacy; see further, Case C-148/15, Deutsche Parkinson Vereinigung – bonuses for buying Dutch mail order medicines.

There is also a parallel trade in veterinary medicinal products, and the principle of parallel trade is at stake in a preliminary reference that has been made from a French court; see further, Case C-114/15, AUDACE – audacious French farmers buy Spanish veterinary medicinal products.

Update – 16 October 2016
There does not appear to have been an oral hearing of the parties or an Opinion from Advocate General Wathelet, and the judgment of the Fifth Chamber is due on 10 November 2016.
 
Update – 10 November 2016
Judgment

A version of the CJEU’s judgment in Case C-297/15, Ferring Lægemidler ECLI:EU:C:2016:857 is reproduced below. The reproduction is not authentic. Only the versions of the document published in the ‘Reports of Cases’ or the ‘Official Journal of the European Union’ are authentic. The source of the reproduction is the Eur-Lex Europa web site. The information on that site is subject to a disclaimer and a copyright notice.
 

JUDGMENT OF THE COURT (Fifth Chamber)

10 November 2016 ( )

(Reference for a preliminary ruling — Trade marks — Directive 2008/95/EC — Article 7(2) — Medicinal products — Parallel import — Partitioning of the markets — Need for the repackaging of the product bearing the mark — Medicinal product placed on the exporting market and importing market by the trade mark proprietor with the same kind of packaging)

In Case C‑297/15,

REQUEST for a preliminary ruling under Article 267 TFEU from the Sø- og Handelsretten (Maritime and Commercial Court, Denmark), made by decision of 10 June 2015, received at the Court on 18 June 2015, in the proceedings

Ferring Lægemidler A/S, acting on behalf of Ferring BV

v

Orifarm A/S,

THE COURT (Fifth Chamber),

composed of J.L. da Cruz Vilaça (Rapporteur), President of the Chamber, M. Berger, A. Borg Barthet, E. Levits and F. Biltgen, Judges,

Advocate General: M. Wathelet,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

–        Ferring Lægemidler A/S, acting on behalf of Ferring BV, by T. Ryhl, advokat,

–        Orifarm A/S, by K. Jensen, advokat,

–        the European Commission, by H. Støvlbæk, T. Scharf and J. Samnadda, acting as Agents,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

1        This request for a preliminary ruling concerns the interpretation of Article 7(2) of Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks (OJ 2008 L 299, p. 25).

2        The request has been made in proceedings between Ferring Lægemidler A/S, acting on behalf of Ferring BV (‘Ferring’), and Orifarm A/S in respect of Ferring’s opposition to the marketing in Denmark of one of its medicinal products, as repackaged by Orifarm, in the context of parallel imports originating in Norway carried out by that company.

 Legal context

 The EEA Agreement

3        Article 13 of the Agreement on the European Economic Area of 2 May 1992 (OJ 1994 L 1, p. 3, ‘the EEA Agreement’) reproduces the content of Article 36 TFEU.

4        Directive 2008/95 was incorporated into the EEA Agreement by Decision No 146/2009 of the EEA Joint Committee of 4 December 2009, amending Annex XVII (Intellectual Property) of the EEA Agreement (OJ 2010 L 62, p. 43).

 European Union legislation

5        Article 7 of Directive 2008/95 provides:

‘1.      The trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent.

2.      Paragraph 1 shall not apply where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market.’

 Danish law

6        It is apparent from the request for a preliminary ruling that Article 6 of the varemærkeloven (Law on trade marks), implementing Directive 2008/95 in Denmark, is essentially identical to Article 7 of Directive 2008/95.

 The dispute in the main proceedings and the questions referred for a preliminary ruling

7        Ferring markets a medicinal product under the trade mark Klyx, of which it is the proprietor, in Denmark, Finland, Sweden and Norway. In all those States, Klyx is sold in identical packaging, namely containers of 120 ml or 240 ml, as well as in packets containing 1 or 10 such containers.

8        In the course of its parallel import business, Orifarm purchases Klyx in Norway in packets of 10 and sells that product on the Danish market, after having repackaged it in new packets of 1, upon which the mark Klyx is reaffixed (‘the contested repackaging’).

9        Before the referring court, Ferring claims that it can legitimately oppose the contested repackaging in that, in the first place, that repackaging is not necessary to market the product imported in parallel and, in the second place, that repackaging is justified only by the importer’s attempt to secure a commercial advantage.

10      Orifarm, for its part, contends that the repackaging is necessary to gain access to the segment of the Danish market for Klyx packaged in packets of one.

11      The referring court observes that it follows from the case-law of the Court that the trade mark proprietor cannot oppose the repackaging if that opposition contributes to the partitioning of the markets. That would be the case where the opposition prevents a repackaging which is necessary to market the medicinal product in the importing State. In those circumstances, the referring court questions whether the contested repackaging can be considered ‘necessary’, given that Klyx is available in packets of 1 or packets of 10 in all the States party to the EEA Agreement in which the medicinal product is placed on the market, including in the States in question in the main proceedings.

12      In those circumstances, the Sø- og Handelsretten (Maritime and Commercial Court, Denmark) decided to stay the proceedings and refer the following questions to the Court for a preliminary ruling:

‘(1)       Must Article 7(2) of Directive 2008/95/EC and the related case-law be interpreted as meaning that a trade mark proprietor may lawfully object to the continued marketing of a medicinal product by a parallel importer, where the importer has repackaged the medicinal product in a new, outer packaging and reaffixed the trade mark in a situation where the trade mark proprietor has marketed the medicinal product in the same volume and packet sizes in all EEA countries where the medicinal product is sold?

(2)       Will the answer to the first question be different if the trade mark proprietor in both the country of export and the country of import has marketed the medicinal product in two different packet sizes (10-piece packets and 1-piece packets) and the importer has purchased 10-piece packets in the country of export and repackaged them in 1-piece packets, on which the trade mark has been reaffixed before the products are marketed in the country of import?’

 The questions referred

13      By these questions, which must be examined together, the referring court asks, in essence, whether Article 7(2) of Directive 2008/95 must be interpreted as meaning that a trade mark proprietor may oppose the continued marketing of a medicinal product by a parallel importer, where that importer has repackaged the medicinal product in a new, outer packaging and reaffixed the trade mark.

14      In this respect, it must be noted, first, that the specific purpose of a mark is to guarantee the origin of the product bearing that mark and that a repackaging of that product carried out by a third party without the authorisation of the proprietor is likely to create real risks for that guarantee of origin (see, by analogy, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 14 and the case-law cited).

15      Second, it must be noted that under Article 7(2) of Directive 2008/95, the trade mark proprietor’s opposition to the repackaging, in so far as it constitutes a derogation from free movement of goods, cannot be accepted if the proprietor’s exercise of that right constitutes a disguised restriction on trade between States party to the EEA Agreement within the meaning of the second sentence of Article 13 of that agreement (see, by analogy, with regard to the second sentence of Article 36 TFEU, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 16 and the case-law cited).

16      A disguised restriction within the meaning of that latter provision will exist where the exercise, by the trade mark proprietor, of his right to oppose repackaging contributes to artificial partitioning of the markets between the States party to the EEA Agreement, where the repackaging is done in such a way that the legitimate interests of the proprietor are respected (see, by analogy, with regard to the second sentence of Article 36 TFEU, judgments of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 17, and of 28 July 2011, Orifarm and Others, C‑400/09 and C‑207/10, EU:C:2011:519, paragraph 24 and the case-law cited).

17      A trade mark proprietor’s opposition to repackaging contributes to the artificial partitioning of the markets between the States party to the EEA Agreement where the repackaging is necessary to enable the product imported in parallel to be marketed in the importing State (see, by analogy, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 18 and the case law cited).

18      As is apparent from the case-law of the Court, the power of the proprietor of trade mark rights protected in a Member State to oppose the marketing of repackaged products under the trade mark should be limited only in so far as the repackaging undertaken by the importer is necessary in order to market the product in the Member State of importation (see, by analogy, judgment of 11 July 1996, Bristol-Myers Squibb and Others, C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282, paragraph 56).

19      It follows from those considerations that the change brought about by any repackaging of a trade-marked medicinal product — creating by its very nature the risk of interference with the original condition of the product — may be prohibited by the trade mark proprietor unless the repackaging is necessary in order to enable the marketing of the products imported in parallel and the legitimate interests of the proprietor are also safeguarded (see, by analogy, judgments of 23 April 2002, Boehringer Ingelheim and Others, C‑143/00, EU:C:2002:246, paragraph 34, and of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 19).

20      As regards in particular the criterion of the necessity of the repackaging, the circumstances prevailing at the time of marketing in the importing State, which render repackaging objectively necessary for the medicinal product to be placed on the market in that State by the parallel importer, must be taken into account in the assessment. A trade mark proprietor’s opposition to repackaging is not justified if it hinders effective access to the importing market (see, by analogy, judgments of 12 October 1999, Upjohn, C‑379/97, EU:C:1999:494, paragraph 43, and of 23 April 2002, Boehringer Ingelheim and Others, C‑143/00, EU:C:2002:246, paragraph 46).

21      In particular, it should be noted, first of all, that the trade mark proprietor cannot oppose the repackaging of the product in new external packaging, when the packet size used by that proprietor in the State party to the EEA Agreement where the importer purchased the product, cannot be marketed in the importing State because of, in particular, a rule authorising packaging only of a certain size or a national practice to the same effect, sickness insurance rules making the reimbursement of medical expenses depend on the size of the packaging, or well-established medical prescription practices based, inter alia, on standard sizes recommended by professional groups and sickness insurance institutions (see, by analogy, judgment of 11 July 1996, Bristol-Myers Squibb and Others, C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282, paragraph 53).

22      Then, where, in accordance with the rules and practices in force in the importing State, the proprietor uses several different sizes of packaging in that State, the finding that one of those sizes is also marketed in the importing State party to the EEA Agreement is not enough to justify the conclusion that repackaging is unnecessary. Partitioning of the markets would exist if the importer were able to sell the product in only part of his market (see, by analogy, judgment of 11 July 1996, Bristol-Myers Squibb and Others, C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282, paragraph 54).

23      Finally, it is for the parallel importer to prove the existence of the conditions preventing the trade mark proprietor from lawfully opposing further marketing of those medicinal products (see, by analogy, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 52).

24      In this case, it is apparent from the request for a preliminary ruling that, in all the States party to the EEA Agreement in which it is placed on the market, including in the States in question in the main proceedings, Klyx is marketed by Ferring in the same packaging.

25      Conversely, it is not apparent from the information available to the Court that one of the situations set out in paragraph 21 of the present judgment existed in the present case or that, because of the specific circumstances prevailing at the time of the marketing, effective access to the Danish market for Klyx was hindered.

26      It is for the referring court to determine whether one or several of the situations referred to in paragraph 21 of the present judgment are in existence in the main proceedings. If this is not the case, the trade mark proprietor can oppose the contested repackaging, as long as the product imported in parallel can be marketed in Denmark in the same packaging as that in which that product is marketed in Norway.

27      Orifarm, in its written observations, contends that the partitioning of markets is an inherent consequence of the opposition to the repackaging, in that the importer can only penetrate the Danish sub-market of packets of one container of Klyx by importing the product in the same packaging from Norway. Thus, without the contested repackaging, the imported product could only be marketed in a limited part of the Danish market.

28      In this regard, it must be stated that the documents before the Court do not contain any information making it possible to state that the market for Klyx in packets of 10 represents only a limited part of the market of the importing State, namely Denmark. It is, in any event, for the referring court to determine if such a condition is met in the main proceedings.

29      In these circumstances, the answer to the questions referred is that Article 7(2) of Directive 2008/95 must be interpreted as meaning that a trade mark proprietor may object to the continued marketing of a medicinal product by a parallel importer, where that importer has repackaged that medicinal product in a new, outer packaging and reaffixed the trade mark, where, first, the medicinal product at issue can be marketed in the importing State party to the EEA Agreement in the same packaging as that in which it is marketed in the exporting State party to the EEA Agreement and, second, the importer has not demonstrated that the imported product can only be marketed in a limited part of the importing State’s market, and those are matters which it is for the referring court to determine.

 Costs

30      Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Fifth Chamber) hereby rules:

Article 7(2) of Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks must be interpreted as meaning that a trade mark proprietor may object to the continued marketing of a medicinal product by a parallel importer, where that importer has repackaged that medicinal product in a new, outer packaging and reaffixed the trade mark, where, first, the medicinal product at issue can be marketed in the importing State party to the EEA Agreement, of 2 May 1992, in the same packaging as that in which it is marketed in the exporting State party to the EEA Agreement and, second, the importer has not demonstrated that the imported product can only be marketed in a limited part of the importing State’s market, and those are matters which it is for the referring court to determine.

[Signatures]


Language of the case: Danish.