Provisional text

delivered on 13 January 2022 (*1)

Joined Cases C-253/20 and C-254/20

Impexeco NV

Novartis AG (C-253/20)

and

PI Pharma NV

Novartis AG, Novartis Pharma NV (C-254/20)

(Requests for a preliminary ruling from the Hof van beroep te Brussel (Court of Appeal, Brussels, Belgium))

( Reference for a preliminary ruling – Industrial and commercial property – Trade mark rights – Parallel imports of medicinal products – Reference medicinal products and generic medicinal products – Opposition by the proprietor of a trade mark to the affixing of the mark on imported generic medicinal products – Artificial partitioning of the markets between Member States )

Introduction

1.In my Opinion in Joined Cases C‑147/20, C‑204/20 and C‑224/20, also delivered today, I examine a series of questions concerning the right of a trade mark proprietor to oppose the use of its mark by a third party in the context of the parallel trade in medicinal products. Those questions relate mainly, but not solely, to the new rules of EU law designed to combat falsified medicinal products.

2.The present Opinion could be seen as an appendix to that Opinion, inasmuch as it, too, concerns the right of a trade mark proprietor to oppose the use of its mark by a third party in the context of the parallel trade in medicinal products.

3.The present case, however, concerns a very specific situation. First of all, the trade marks in question are not those affixed by the proprietor to the products subject to the parallel trade, which are generic medicinal products, but the marks that are used for the reference medicinal products for those generic products. Second, the two types of medicinal product, that is to say, the reference medicinal products and the generic medicinal products, are manufactured by related undertakings, and so it is likely that they are, in reality, the same medicinal product under two different trade marks.

4.The question which arises, therefore, is whether the rules established by the Court in its case-law on the subject, which I analyse at length in my Opinion in Cases C‑147/20, C‑204/20 and C‑224/20, apply also in this specific situation.

Legal framework

5.Article 9(2) and (3) of Council Regulation (EC) No 207/2009 of 26 February 2009 on the European Union trade mark, (*2) as amended by Regulation (EU) 2015/2424 (*3) (‘Regulation No 207/2009’), provided: (*4)

(a) the sign is identical with the EU trade mark and is used in relation to goods or services which are identical with those for which the EU trade mark is registered;

…

(a) affixing the sign to the goods or to the packaging thereof;

(b) offering the goods, putting them on the market, or stocking them for those purposes under the sign, or offering or supplying services thereunder;

…

6.Pursuant to Article 13 of that regulation:

7.Article 5(1) and (3) 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 (*5) provided: (*6)

(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;

…

(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;

…

8.Pursuant to Article 7 of that directive:

The facts of the case in the main proceedings, procedure and the questions referred

9.Novartis AG, a company established under Swiss law, is the parent company of the global Novartis group, which manufactures medicinal products. The Novartis group includes the Novartis Pharmaceuticals and Sandoz divisions, which are respectively responsible for the development of originator medicines (reference medicinal products) and the manufacture of generic medicinal products. The two divisions operate as Novartis Pharma NV and Sandoz NV in the Belgian medicines market and as Novartis Pharma BV and Sandoz BV in the Netherlands market.

10.The cases in the main proceedings concern reference medicinal products, developed and marketed by the Novartis Pharmaceuticals division, and generic medicinal products derived from those reference medicines, marketed by the Sandoz division. Specifically, they concern the medicinal product marketed in Belgium and the Netherlands under the EU trade mark ‘Femara’ and the derived generic ‘Letrozol Sandoz 2.5 mg’ (Case C‑253/20) and the reference medicinal product marketed under the Benelux trade marks ‘Rilatine’ (in Belgium) and ‘Rilatin’ (in the Netherlands) and the derived generic ‘Methylphenidate HCI Sandoz 10 mg’ marketed in the Netherlands (Case C‑254/20).

11.Impexeco NV and PI Pharma NV are companies established under Belgian law which carry on a parallel trade in medicinal products.

12.In Case C‑253/20, by letter of 28 October 2014, Impexeco informed Novartis of its intention to place on the Belgian market, from 1 December 2014 onwards, the medicinal product ‘Femara 2.5 mg x 100 tablets (letrozol)’, imported from the Netherlands. According to the order for reference, Impexeco was actually planning to market the medicinal product ‘Letrozol Sandoz 2.5 mg’ repackaged in a new outer package on which the trade mark ‘Femara’ was to be affixed. Novartis opposed the parallel imports that Impexeco intended to make, arguing that its rights in the mark ‘Femara’ were not exhausted, such that the rebranding of the imported generic product under its trade mark for the reference medicinal product would constitute a clear infringement of those rights and would be misleading for the public.

13.In July 2016, Impexeco proceeded with the marketing in Belgium of the medicinal product ‘Letrozol Sandoz 2.5 mg’ thus repackaged and rebranded. Novartis took the view that this infringed its trade mark rights and, on 16 November 2016, it issued proceedings against Impexeco before the Stakingsrechter te Brussel (Court of Cessations, Brussels, Belgium).

14.In addition to that, by letter of 10 April 2017, Impexeco informed Novartis of its intention to market in Belgium the medicinal product ‘Femara 2.5 mg’ packaged in a pack of 30 tablets imported from the Netherlands and relabelled. According to the order for reference, Impexeco was planning to relabel the medicinal product ‘Letrozol Sandoz 2.5 mg’ by affixing the trade mark ‘Femara’ to it.

15.In Case C‑254/20, by letter of 30 June 2015, PI Pharma informed Novartis Pharma NV of its intention to place on the Belgian market the medicinal product ‘Rilatine 10 mg x 20 tablets’, imported from the Netherlands. It appears from the order for reference that PI Pharma was actually planning to market the medicinal product ‘Methylphenidate Sandoz 10 mg’ repackaged in a new outer package, affixing on it the trade mark ‘Rilatine’. Novartis gave notice of its opposition to the parallel imports that PI Pharma intended to make, arguing that, since its rights in the mark ‘Rilatine’ were not exhausted, the rebranding of the imported generic product under its trade mark for the reference medicinal product constituted a clear infringement of those rights and would be misleading for the public.

16.In October 2016, PI Pharma proceeded with the marketing in Belgium of the repackaged medicinal product thus rebranded. Novartis took the view that such marketing infringed its trade mark rights and, on 28 July 2017, it issued proceedings against PI Pharma before the Stakingsrechter te Brussel (Court of Cessations, Brussels).

17.The referring court states that, although the respective prices of the reference medicinal products and of the generic medicinal products in question are the same or almost the same in Belgium, the prices of those same generic medicinal products are significantly lower in the Netherlands than in Belgium. Those price differences form the basis for the parallel trade in those medicinal products between the two Member States.

18.By two judgments delivered on 12 April 2018, the Stakingsrechter te Brussel (Court of Cessations, Brussels) held the two actions brought by Novartis against Impexeco and PI Pharma to be well founded, in particular for the reason that the rebranding of the generic product by the affixing of the trade mark for the reference medicinal product infringed Novartis’s trade mark rights under Article 9(2)(a) of Regulation No 207/2009 and Article 2.20(1)(a) of the Benelux Convention on Intellectual Property (Trade Marks and Designs), (*7) and it consequently ordered the cessation of that practice. Impexeco and PI Pharma brought appeals against those judgments before the referring court.

19.It is in those circumstances that the Hof van beroep te Brussel (Court of Appeal, Brussels, Belgium) decided to stay the proceedings and to refer the following questions (identical in the two cases) to the Court of Justice for a preliminary ruling:

‘(1) Must Articles 34 to 36 TFEU be interpreted as meaning that, where a branded medicine (reference medicine) and a generic medicine have been put on the market in the [European Economic Area (EEA)] by economically linked undertakings, a trade mark proprietor’s opposition to the further commercialisation of the generic medicine by a parallel importer after the repackaging of that generic medicine by the affixing to it of the trade mark of the branded medicine (reference medicine) in the country of importation may lead to an artificial partitioning of the markets of the Member States?

(2) If the answer to that question is in the affirmative, must the trade mark proprietor’s opposition to that rebranding be assessed by reference to the … conditions [set out in paragraph 79 of the judgment in Bristol-Myers Squibb and Others]? (*8)

(3) Is it relevant to the answer to those questions that the generic medicine and the branded medicine (reference medicine) are identical or have the same therapeutic effect, as referred to in Article 3(2) of the Koninklijk besluit van 19 april 2001 [betreffende de parallelinvoer van geneesmiddelen voor menselijk gebruik en de parallelle distributie van geneesmiddelen voor menselijk en diergeneeskundig gebruik] (Royal Decree of 19 April 2001 on parallel imports of medicinal products for human use and on parallel distribution of medicinal products for human and veterinary use)? (*9)

20.The Court of Justice received the requests for a preliminary ruling on 9 June 2020. Written observations were submitted by the parties in the main proceedings and by the European Commission. No hearing was held. The parties answered in writing the questions put to them by the Court.

Analysis

21.I must observe at the outset that, although the referring court frames its questions from the perspective of the Treaty provisions on the free movement of goods, it seems to me that the answers are to be sought in the European Union’s trade mark laws.

Thus, by its questions, which I propose to address together, the referring court is asking, in essence, whether Article 13 of Regulation No 207/2009 and Article 7 of Directive 2008/95 are to be interpreted as meaning that, where a reference medicinal product and a generic medicinal product have been placed on the market in the EEA by economically linked undertakings, the proprietor of the trade mark for the reference medicinal product loses entitlement to oppose the further commercialisation of the generic medicinal product by a parallel importer after it has been repackaged and the trade mark for the reference medicinal product in the Member State of import has been affixed to it, if, first, the conditions established in the Court’s case-law concerning such opposition are fulfilled and, second, the two medicinal products are identical or have the same therapeutic effects.

23.I shall begin with a brief overview of the Court’s case-law on the subject.

Overview of the Court’s case-law

24.In its judgment in Centrafarm and de Peijper, an early case concerning the parallel importation of medicinal products, the Court established, having regard to the free movement of goods, the principle of the exhaustion of a trade mark proprietor’s right to oppose the marketing by a third party, without the proprietor’s consent, of a product bearing the trade mark that has already been placed on the market in another Member State with the proprietor’s consent.

25.In so far as concerns a trade mark proprietor’s right to oppose the marketing under its trade mark of a product which has been repackaged in new packaging, the Court ruled in Hoffmann-La Roche that, in such a situation, the trade mark proprietor’s opposition is, in principle, justified. According to the Court, to permit the marketing of a product bearing a trade mark after it has been repackaged in new packaging is tantamount to allowing the parallel trader a certain licence which, in normal circumstances, is reserved to the proprietor of the mark, namely, the licence to affix the mark to the new packaging.

26.However, the exercise by the trade mark proprietor of its power of opposition may constitute a disguised restriction of trade between Member States. That would be the case, for example, if the repackaging were done in such a way that neither the identity of origin of the product nor its original condition were affected. The original condition of the product is not affected, inter alia, where it is packed in double packaging and the repackaging affects only the external packaging, or where the repackaging is inspected by a public authority. Indeed, in such circumstances, if a trade mark proprietor used different packaging for the same product in different Member States and then opposed replacement packaging for parallel imports of the product, that would contribute to the artificial partitioning of the markets between Member States.

27.The Court has thus held that the opposition of a trade mark proprietor to the marketing under its trade mark of a product that has been repackaged in new packaging constitutes a disguised restriction of trade between Member States where:

– it is established that the use of the trade mark right by the proprietor, having regard to the marketing system which it 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.

28.The principle of the exhaustion of the trade mark proprietor’s right to oppose the marketing, without its consent, of a product bearing the trade mark that has already been placed on the market with its consent in a different Member State was then enshrined in Article 7 of Directive 89/104/EEC. That provision was subsequently taken up, in essentially identical terms, in Article 13 of Regulation No 207/2009 and Article 7 of Directive 2008/95.

29.The Court nevertheless continues to interpret those two provisions in the light of the free movement of goods, taking the view that they pursue the same objective as the current Article 36 TFEU, such that its case-law in relation to that provision remains relevant.

30.That case-law has, however, been clarified and supplemented on a number of points by subsequent judgments of the Court.

31.Thus, the Court has made clear, in particular, that the proprietor’s opposition to the marketing, under a trade mark belonging to it, of a product that has been repackaged in new packaging contributes to the partitioning of the markets if the repackaging is necessary in order to market the product in the Member State of importation. That need will arise when the product cannot be marketed in its original packaging because of the legislation or practices in the Member State of importation.

32.Moreover, a further condition was added in order for the proprietor of a trade mark to be prohibited from opposing the marketing of a product under its trade mark after it has been repackaged in new packaging, namely that the presentation of the repackaged product must not be such as to be liable to damage the reputation of the trade mark and of its owner, which would be the case if the packaging were defective, of poor quality, or untidy.

33.Lastly, the Court has held that the requirements which must be met in order for the proprietor of a trade mark to lose entitlement to oppose the marketing under its trade mark of a product that has been repackaged, in particular the requirement of necessity, apply not only in the case of repackaging in new packaging, but also in the case of repackaging consisting in the placing of a new label on the original packaging.

Rebranding and the judgment in Upjohn

34.The Court has also been confronted with the problem of the trade mark proprietor’s opposition to the marketing of its product in the situation where the parallel trader has affixed to the product, not the trade mark under which the product was placed on the market, but a different trade mark, also belonging to the same proprietor, under which identical products are marketed with the proprietor’s consent in the Member State of importation.

35.In its judgment in Centrafarm, the Court held that the guarantee of origin of a product, which is the essential function of a trade mark, would be jeopardised if it were permissible for a third party to affix the mark to the product for the first time, even to an original product. Even where the manufacturer is the proprietor of several trade marks for the same product, it is entitled, in the light of the first sentence of Article 36 EEC, to oppose the marketing of the product by a third party under one of those marks if it has not been affixed by the proprietor. The Court nevertheless observed that a manufacturer’s practice of using different marks for the same product in different Member States may be followed with the aim of artificially partitioning the markets. In such a situation, the trade mark proprietor’s opposition to the use of the mark by a third party would constitute a disguised restriction on trade between Member States within the meaning of the second sentence of Article 36 EEC. It is for the court adjudicating on the substance to establish whether the proprietor had that intention.

36.While the case which gave rise to the judgment in Upjohn concerned a similar situation, the legal environment was nevertheless different. Indeed, this case was brought after Directive 89/104 had entered into force and after delivery of the judgment in Bristol-Myers Squibb and Others, in which the Court set out the conditions that must be met in order for a trade mark proprietor to lose entitlement to oppose the marketing under its trade mark of a product that has been repackaged in new packaging by a parallel trader. In Upjohn it was therefore necessary to establish whether the principles identified in Bristol-Myers Squibb and Others should also apply in the situation where a trade mark is replaced by another mark belonging to the same proprietor and whether the application of those principles was conditional on the deliberate intention of the proprietor to partition the markets between Member States.

37.In Upjohn, the Court first of all noted that Article 7 of Directive 89/104, concerning the exhaustion of the rights conferred by the trade mark under which a product has been placed on the market with the proprietor’s consent, did not apply in the case where a parallel trader had replaced that trade mark with a different mark belonging to the same proprietor. The case therefore had to be adjudicated with reference to Articles 30 and 36 EC (now Articles 34 and 36 TFEU).

38.Next, the Court found that there was no objective difference between reaffixing the original trade mark after repackaging the product and replacing it by another trade mark such as might cause the condition of artificial partitioning of the markets to be applied differently, both of those practices representing a use by the parallel importer of a trade mark which does not belong to it.

39.The Court accordingly held that, where trade mark law in the Member State of importation permitted a proprietor to oppose the replacement, by a third party, of a trade mark belonging to it by another mark, and where replacement of the mark was necessary in order for the product to be marketed in the Member State of importation, there were obstacles to trade between Member States giving rise to partitioning of the market, whether or not the proprietor intended such partitioning.

40.The judgment in Upjohn could have served as a starting point for the resolution of the present cases. However, I must express certain reservations about that judgment, in that it dismisses, rather casually, the legislative amendment made by Directive 89/104 and Article 7 thereof.

41.Indeed, first of all, by adjudicating the case which gave rise to that judgment in the light of the provisions of the EC Treaty, the Court departed from its own case-law according to which the issue must be analysed with sole reference to Directive 89/104, Article 7 of which ‘comprehensively [regulated] the question of the exhaustion of trade mark rights for products traded in the [European Union]’.

42.Second, in taking the view that there was no difference between the reaffixing of the original trade mark and its replacement by another mark belonging to the same proprietor, the Court failed to take account of the fact that, once Article 7 of Directive 89/104 had entered into force, in the first of those two situations, the rights in the trade mark are, in principle, exhausted ex lege. The use of that mark by a third party was therefore lawful.

43.Finally, it must be observed that, by holding it to be contrary to the Treaty for a trade mark proprietor to oppose the use of its mark in replacement of another mark, the Court implicitly found Directive 89/104 to be incompatible with the Treaty. Indeed, the ‘trade mark rights in the importing Member State’, mentioned in paragraph 39 of Upjohn, are none other than those which were harmonised by that directive, Article 5(1)(a) of which specifically conferred on the proprietor the right to prevent all third parties from using, without consent and in the course of trade, 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. The EU institutions, however, are also under the same obligation as the Member States to observe the Treaty rules.

44.That said, I do not propose to debate the solution arrived at in Upjohn. Trade mark law must not hinder the free circulation of goods except when that is necessary in order to protect the essential function of a trade mark, which is to guarantee the origin of products. That solution should, on the contrary, be arrived at by means of a more flexible interpretation of the secondary legislation, undertaken in the light of the Treaty as interpreted by the Court of Justice.

A suggested new approach to ‘rebranding’

45.In Bristol-Myers Squibb and Others, the Court held that Article 7 of Directive 89/104 was framed in terms corresponding to those used in its judgments which, in interpreting Articles 30 and 36 EEC, recognised in EU law the principle of the exhaustion of the rights conferred by a trade mark.

46.The Court then pointed out, in response to an argument propounding a narrower scope for Article 7(1) of Directive 89/104 by comparison with the Court’s case-law on Article 36 EEC, that it was clear from that case-law that the proprietor’s exclusive right to affix a trade mark to a product must in certain circumstances be regarded as exhausted in order to allow an importer to market under that trade mark products which have been placed on the market in another Member State by the proprietor or with its consent. Accordingly, a narrower interpretation of Article 7(1) of Directive 89/104 would imply a major alteration to the principles flowing from Articles 30 and 36 EC. Such an effect would not be permissible, however, given the requirement for directives to be in conformity with the Treaty.

As regards Article 7(2) of Directive 89/104, the Court held that, since that article, like Article 36 EEC, was intended to reconcile the interest in protecting trade mark rights with the interest in the free movement of goods, those two provisions had to be interpreted in the same way, on the basis of the Court’s case-law relating to Article 36 EEC. (41) That same principle was reiterated in paragraph 30 of Upjohn, although the Court did not draw the necessary conclusions from it.

48.However, in my view, it is necessary to appreciate all the consequences which flow from the Court’s case-law on the exhaustion of trade mark rights in the context of the free movement of goods within the internal market. If, according to that case-law, the provisions of subsequent acts of EU trade mark law equivalent to Article 7 of Directive 89/104 comprehensively regulate the question of the exhaustion of trade mark rights and must be interpreted in the same way as the relevant provisions of the Treaty, as they in turn have been interpreted by the Court, then it is also its case-law concerning the replacement by a parallel trader of one trade mark by another belonging to the same proprietor that should inform the interpretation of the secondary legislation.

49.Indeed, I must observe that the judgment in Centrafarm was delivered long before Directive 89/104 was adopted. It was therefore already clear by the time of that directive’s adoption that the Treaty provisions on the free movement of goods did not permit a trade mark proprietor to partition the markets between the Member States by using different trade marks for the same product in different Member States and then opposing the replacement, by a parallel trader, of the mark used in the Member State of export by the mark used in the Member State of importation. That case-law was subsequently clarified in Upjohn. On the one hand, the Court abandoned the condition of deliberate intention on the trade mark proprietor’s part to partition the market, posited in Centrafarm. On the other, it applied to the case of the replacement of a trade mark the conditions laid down in Bristol-Myers Squibb and Others in relation to repackaging in new packaging, in particular the condition of necessity, which considerably narrows the scope of exhaustion of the trade mark proprietor’s exclusive rights. (42)

50.Therefore, if the provisions of EU trade mark law concerning the exhaustion of trade mark rights must be interpreted in the same way as follows from the Treaty provisions on the subject, as interpreted by the Court, the aspect concerning the replacement of trade marks must necessarily also be taken into account.

51.Although the wording of Article 13 of Regulation No 207/2009 and of Article 7 of Directive 2008/95, taken literally, may not suggest such a conclusion, it can be arrived at through a teleological and systematic (43) interpretation. That, moreover, is what Advocate General Jacobs had already proposed in his Opinion in Upjohn. (44)

52.Article 13 of Regulation No 207/2009 and Article 7 of Directive 2008/95 should therefore be interpreted as meaning that a trade mark proprietor is precluded from prohibiting the use not only of the trade mark under which the product in question was placed on the market by it or with its consent, but also of the trade mark under which identical products are placed on the market by the same proprietor or with its consent in other Member States.

53.Nonetheless, it must be borne in mind that, in those specific cases where a trade mark is affixed to a product without the proprietor’s consent by a parallel trader after the product has been repackaged, the provisions of EU trade mark law concerning the exhaustion of trade mark rights must be read in the light of the Treaty, as interpreted by the Court. One such case would be where the trade mark used in the Member State of export is replaced by another mark belonging to the same proprietor, because that act of replacement also implies the reaffixing of the mark. The case-law, however, lays down a series of conditions that must be fulfilled in order for a trade mark right to be effectively exhausted, in other words, in order for the proprietor to be unable to rely on it in order to prevent its use by a third party. (45)

54.Indeed, while the reasoning that informs the provisions of EU trade mark law in question is that exhaustion occurs as a matter of principle once the product bearing the trade mark has been placed on the market in the European Union, and that the possibility open to a trade mark proprietor to raise opposition is an exception based on the proprietor’s legitimate interests, the Court of Justice reversed that line of reasoning in its case-law on repackaging. (46) Following the reasoning in that case-law, the scope of exhaustion is confined to situations in which the conditions listed in the case-law are met such as to prevent the proprietor from relying on its trade mark in order to prevent its use by a parallel trader. It is therefore not possible to interpret these two paragraphs of the provisions in question separately, (47) since paragraph 2, as interpreted by the Court, determines the scope of paragraph 1.

55.That renders far less radical my proposal for a broader scope of application of those provisions in the situation where a trade mark is replaced by another mark belonging to the same proprietor. Indeed, while the majority of the conditions identified in the Court’s case-law as preventing a trade mark proprietor from relying on its trade mark to oppose the marketing of a product under that mark are subjective and under the control of the parallel trader, the condition of necessity, for its part, is an objective condition and one that significantly curtails the parallel trader’s freedom.

56.According to the Court, in fact, the condition that repackaging must be necessary is met if the rules or practices in the importing Member State prevent the product in question from being marketed in the original packaging. Conversely, the condition is not fulfilled if repackaging of the product is explicable solely by the parallel importer’s attempt to secure a commercial advantage. (48)

57.With regard to rebranding, the condition of necessity implies that, in order for a trade mark proprietor to be unable to oppose the replacement by a parallel trader of the mark which the proprietor uses in the Member State of export by the mark that it uses for the same products in the Member State of importation, the legislation or practices in the latter Member State must make it impossible for the product in question actually to be marketed in that State under the original trade mark.

58.By contrast, where the parallel trader replaces the original trade mark solely for an economic advantage, for example, to profit from the repute of the mark used in the Member State of importation or to place the product in a more lucrative product category, the condition of necessity is not fulfilled. In such a case, the free movement of goods, which underlies the exhaustion of trade mark rights in trade between Member States, is not in substance threatened and cannot, therefore, override the legitimate interests of the trade mark proprietor.

59.Accordingly, in the case of rebranding, exhaustion of the trade mark right is confined to those cases where the rebranding is objectively necessary in order to ensure that the product has effective access to the market in the Member State of importation.

60.I therefore propose that Article 13 of Regulation No 207/2009 and Article 7 of Directive 2008/95 should be interpreted as meaning that the proprietor of a trade mark may rely on that trade mark to oppose the marketing under that trade mark of a product which has been placed on the market in the European Union by that proprietor or with its consent under another trade mark belonging to it, unless the conditions identified in the Court’s case-law relating to the repackaging of parallel-traded products are fulfilled. Those conditions require, in particular, that effective access for the product to the market of the Member State of importation should render it necessary to replace the original trade mark by the trade mark under which identical products are marketed in that Member State.

Application in the situation where the trade mark for a generic medicinal product is replaced by the trade mark for the reference medicinal product

61.In light of the foregoing considerations, it is necessary to consider whether the interpretation that I suggest can be applied in the situation where, as in the present cases, the parallel importer wishes to replace the trade mark for a generic medicinal product used in the Member State of export with the trade mark for the reference medicinal product used in the Member State of importation. The distinguishing feature of the cases in the main proceedings lies in the fact that the generic medicinal product and the reference medicinal product are marketed by related undertakings and that both trade marks belong to the same proprietor.

62.As has been made clear by the debate conducted in the main proceedings and before the Court, the lawfulness of a parallel trader’s actions may be gauged against two requirements in particular, namely the identical nature of the products and the necessity of rebranding.

The requirement that the products be identical

63.According to the interpretation which I propose, a parallel trader is entitled to replace the trade mark used in the Member State of export with the trade mark used for identical products in the Member State of importation, without the proprietor of the trade mark right being able to oppose that. In the cases in the main proceedings, the parallel-traded product is a generic medicine, while the trade mark affixed by the parallel trader in the Member State of importation is the trade mark for the reference medicine for that generic medicine. The question therefore arises as to whether the generic medicine and the reference medicine may be regarded as identical products for the purposes of exhaustion of trade mark rights.

64.A generic medicinal product is defined in Article 10(2)(b) of Directive 2001/83/EC, (49) as ‘a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies’. Under Article 10(1) of that directive, a generic medicine may undergo a ‘shortened’ marketing authorisation procedure. Indeed, generics are deemed to have the same characteristics as their reference medicines.

65.Nevertheless, the very definition of a generic medicinal product admits of certain variations from the reference medicinal product, both in the chemical form of the active substance, (50) and in the pharmaceutical form of the medicine itself. (51) Moreover, while a generic medicinal product is the bioequivalent of its reference medicinal product in so far as concerns active substances and therapeutic effects, it may differ in its excipients, (52) its physical presentation or other aspects such as taste.

66.Next, in the case of certain medicines, (53) their replacement by other equivalent medicines, whether a generic or a reference product, during a course of treatment is contraindicated on medical grounds. That is in fact the case with one of the medicinal products at issue in the main proceedings, as Impexeco and PI Pharma have confirmed in their answers to the Court’s questions. However, contrary to those parties’ submissions, that fact, far from proving the necessity of rebranding, demonstrates, in my view, that the rebranding of the medical product is not acceptable from a medical perspective. Indeed, if the replacement of one medicine by another during the course of a treatment is precluded for medical reasons, any change in the name of the medicine might be misleading for health professionals and patients, which could have serious consequences for patient health. It is not without good reason that the name of the medicinal product must be specified in any application for a marketing authorisation. Indeed, in the case of medicines, the name of the product plays a broader role than does a trade mark, which merely indicates the origin of the product.

67.While generic medicinal products and their reference medicinal products are therefore equivalents in therapeutic terms, I take the view that they do not, however, constitute, in principle, identical products, because of the differences that may distinguish them.

68.Nonetheless, a generic medicinal product and its reference medical products may, in certain specific situations, and notably when they are manufactured by the same undertaking or by related undertakings, genuinely be the same product, simply marketed differently. That is the position that Impexeco and PI Pharma appear to maintain in the main proceedings. It is for the national authorities and courts to verify the point.

69.In such a case, contrary to what Novartis maintains in its observations, neither the different legal rules applicable to generic medicinal products and reference medicinal products, nor the different perceptions of them in the minds of health professionals and patients are sufficient justification for the proprietor of the trade marks for those products to have the right to oppose the replacement of the mark used in the Member State of export with the mark used in the Member State of importation. Indeed, in a situation where such a replacement is necessary in order for a parallel trader to gain access to the market in the Member State of importation, such a right would enable the proprietor to partition the markets by marketing the same product at one time as a reference medicinal product, at another time as a generic medicine, and then impeding the free movement of the product within the European Union. Whether or not the products are indeed identical, for the purposes of exhaustion of the trade mark right, must therefore be determined solely on the basis of the intrinsic characteristics of the products.

That brings me to the second condition, which is the necessity of replacing the trade mark.

71.As I have already mentioned, (54) the proprietor of a trade mark is precluded from opposing the mark’s use by a parallel trader in replacement of the mark used in the Member State of export, provided, inter alia, that such replacement is objectively necessary in order to ensure that the product has effective access to the market in the Member State of importation. This follows clearly from the judgment in Upjohn. (55) That is because the exhaustion of the trade mark right in the case of the mark’s replacement by another mark belonging to the same proprietor is justified by the requirements of the internal market.

72.However, it seems to me that, in so far as concerns the replacement of the trade mark of a generic medicinal product with the trade mark of a reference medicinal product authorised on the market of the Member State of importation, that condition will be met only exceptionally.

73.Indeed, as Novartis has rightly remarked, the Court has had occasion to hold that a Member State may not, in principle, refuse a parallel import licence for a generic medicinal product for which the reference medical product has been granted a marketing authorisation in that Member State, (56) unless the refusal is justified by considerations relating to the protection of health. (57)

Thus, a parallel trader will normally be able to obtain authorisation to market, under its own name

a generic medicinal product the reference product for which has been authorised in the Member State of importation. The replacement of the trade mark (brand name) of the generic medicinal product with the trade mark (brand name) of the reference medicinal product is therefore unnecessary, whether or not the parallel-traded generic product has also been authorised in the Member State of importation. By contrast, if considerations relating to the protection of health oppose such authorisation, they will oppose all the more the dissimulation of the generic medicinal product behind the name of the reference medicine, and no authorisation will be issued, in accordance with internal market rules, whether or not the proprietor of the trade mark for the reference product has objected.

75.That is sufficient to satisfy the requirements of the free movement of goods. The arguments which Impexeco and PI Pharma make concerning the need for access to the whole of the market on which the proprietor of the trade mark for the reference medicinal product is present and concerning the habit of medical practitioners of prescribing the reference medicine cannot alter that conclusion.

76.First of all, while the free movement of goods ensures that parallel traders have access to the market in the Member State of importation, it does not guarantee them the right to market any product whatsoever under any trade mark whatsoever. Provided that a parallel trader is able to market the generic medicinal product under the trade mark for the generic medicinal product and the reference medicinal product under the trade mark for the reference medicinal product, adapting, where necessary, the packaging to satisfy any market requirements in the Member State of importation, the internal market rules do not require that the parallel trader should be authorised to replace one of those trade marks with the other, thereby encroaching on the rights of the proprietor of those marks.

77.Secondly, every generic medicinal product, whether it is the subject of parallel trade or not, enters by definition into a market already occupied by the reference medicinal product, with all the consequences that this implies in so far as concerns the habits and customs of doctors and patients. It therefore falls to the individual marketing the generic medicinal product to persuade customers to use that product. Any attempt to achieve that result by replacing the trade mark is really an attempt to secure a commercial advantage and is therefore not covered by the exhaustion of the trade mark right.

Interim conclusion

78.The foregoing considerations lead me to the conclusion that, although Article 13 of Regulation No 207/2009 and Article 7 of Directive 2008/95, read in the light of the Treaty as interpreted by the Court, preclude the proprietor of a trade mark from opposing the mark’s use by a parallel trader in order to replace the mark used by the proprietor in the Member State of export with the mark which the proprietor uses for identical products in the Member State of importation, provided that certain conditions arising from the Court’s case-law are met, that will apply only exceptionally in cases where the trade mark for a generic medical product is replaced by the trade mark for a reference medicinal product.

79.In the light of the foregoing considerations, I propose that the questions referred by the Hof van beroep te Brussel (Court of Appeal, Brussels, Belgium) be answered as follows:

Article 13 of Council Regulation (EC) No 207/2009 of 26 February 2009 on the European Union trade mark, as amended by Regulation (EU) 2015/2424 of the European Parliament and of the Council of 16 December 2015, and Article 7 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, read in the light of Articles 34 and 36 TFEU, must be interpreted as meaning that the proprietor of a trade mark for a reference medicinal product may oppose the use of that mark by a third party, in the context of parallel trade, in order to replace the trade mark under which a generic medicinal product is marketed by that proprietor or with its consent in another Member State, unless (i) the two medicinal products are substantively identical and (ii) the conditions identified by the Court of Justice in its judgments of 11 July 1996, Bristol-Myers Squibb and Others (C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282), and of 26 April 2007, Boehringer Ingelheim and Others (C‑348/04, EU:C:2007:249), are met with regard to the replacement of the trade mark.

Original language: French.

OJ 2009 L 78, p. 1.

Regulation of the European Parliament and of the Council of 16 December 2015 (OJ 2015 L 341, p. 21).

Regulation No 207/2009 was repealed by Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ 2017 L 154, p. 1) with effect from 1 October 2017. Given the dates of the facts of the cases in the main proceedings, it is nevertheless with regard to Regulation No 207/2009 that the present cases must be examined.

OJ 2008 L 299, p. 25.

Directive 2008/95 was repealed by Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (OJ 2015 L 336, p. 1) with effect from 15 January 2019. However, given the dates of the facts of the cases in the main proceedings, it is with regard to Directive 2008/95 that the present cases must be examined.

Convention of 25 February 2005, signed in The Hague by the Kingdom of Belgium, the Grand Duchy of Luxembourg and the Kingdom of the Netherlands.

Judgment of 11 July 1996 (C‑427/93, C‑429/93 and C‑436/93, ‘Bristol-Myers Squibb and Others’, EU:C:1996:282).

Belgisch Staatsblad of 30 May 2001, p. 17 954.

Judgment of 31 October 1974 (16/74, EU:C:1974:115). In some earlier case-law of the Court, this judgment is cited as ‘Winthrop’ or as ‘Centrafarm v Winthrop’.

Now the first sentence of Article 36 TFEU.

See paragraph 1 of the operative part of the judgment.

Judgment of 23 May 1978 (102/77, ‘Hoffmann-La Roche’, EU:C:1978:108, point 1(a) of the operative part of the judgment).

Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

all forms of deliberate capture or killing of specimens of these species in the wild;

deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

deliberate destruction or taking of eggs from the wild;

deterioration or destruction of breeding sites or resting places.

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

must be interpreted as meaning that where, in the context of a screening procedure carried out under that provision, a third party has provided the competent authority with objective evidence as regards the potential significant effects of that project on the environment, in particular on a species protected under Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora, as amended by Council Directive 2013/17/EU of 13 May 2013, that authority must ask the developer to provide it with additional information and take that information into account before deciding whether or not an environmental impact assessment is necessary for that project. However, where, despite the observations submitted to that authority by a third party, the competent authority is able to rule out, on the basis of objective evidence, the possibility that the project in question is likely to have significant effects on the environment, that authority may decide that an environmental impact assessment is not necessary, without being required to ask the developer to provide it with additional information.

Gratsias

Passer

Smulders

Delivered in open court in Luxembourg on 6 March 2025.

Registrar

President of the Chamber

ECLI:EU:C:2025:140

15

48Judgment of 26 April 2007, *Boehringer Ingelheim and Others* (C‑348/04, EU:C:2007:249, paragraphs 36 and 37).

49Directive 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), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34).

50‘The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy’.

51‘The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form’.

52That is to say, the ingredients other than the active substances.

53Narrow therapeutic margin medicines.

54See point 60 of this Opinion.

55See paragraphs 42 to 45 of that judgment.

56Judgment of 3 July 2019, *Delfarma* (C‑387/18, EU:C:2019:556, operative part).

57Judgment of 3 July 2019, *Delfarma* (C‑387/18, EU:C:2019:556, paragraph 36).

58*Upjohn* (paragraph 44).