# C_2023015EN.01000401.xml

| 16.1.2023 | EN | Official Journal of the European Union | C 15/4 |
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16.1.2023

EN

Official Journal of the European Union

C 15/4

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Judgment of the Court (Fifth Chamber) of 17 November 2022 (request for a preliminary ruling from the Sø- og Handelsretten — Denmark) — Merck Sharp & Dohme BV, Merck Sharp & Dohme Corp., MSD Danmark ApS v Abacus Medicine A/S, and Novartis AG v Abacus Medicine A/S, and Novartis AG v Abacus Medicine A/S, and Novartis AG v Paranova Danmark A/S, and H. Lundbeck A/S v Paranova Danmark A/S, and MSD Danmark ApS, MSD Sharp & Dohme GmbH, Merck Sharp & Dohme Corp. v 2CARE4 ApS, and Ferring Lægemidler A/S v Paranova Danmark A/S

(Case C-224/20) (1)

(Reference for a preliminary ruling - Articles 34 and 36 TFEU - Free movement of goods - Intellectual property - Trade marks - Regulation (EU) 2017/1001 - EU trade mark - Article 9(2) - Article 15 - Directive (EU) 2015/2436 - Approximation of the laws of the Member States relating to trade marks - Article 10(2) - Article 15 - Rights conferred by a trade mark - Exhaustion of the rights conferred by a trade mark - Parallel import of medicinal products - Repackaging of the product bearing the mark - New outer packaging - Replacement of the trade mark appearing on the original outer packaging by another product name - Reaffixing of the trade mark of the proprietor specific to the product, to the exclusion of the other distinctive marks or signs appearing on that original outer packaging - Opposition by the proprietor of the mark - Artificial partitioning of the markets between Member States - Medicinal products for human use - Directive 2001/83/EC - Article 47a - Safety features - Replacement - Equivalent features - Delegated Regulation (EU) 2016/161 - Article 3(2) - Anti-tampering device)

(2023/C 15/04)

Language of the case: Danish

Referring court

Sø- og Handelsretten

Parties to the main proceedings

Applicants: Merck Sharp & Dohme BV, Merck Sharp & Dohme Corp., MSD Danmark ApS, Novartis AG, H. Lundbeck A/S, Ferring Lægemidler A/S

Defendants: Abacus Medicine A/S, Paranova Danmark A/S, 2CARE4 ApS

Operative part of the judgment

| 1. | Article 9(2) and Article 15 of Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark, and Article 10(2) and Article 15 of 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, read in conjunction with Articles 34 and 36 TFEU,
  must be interpreted as meaning that the proprietor of a trade mark is entitled to oppose the marketing, by a parallel importer, of a medicinal product repackaged in new outer packaging to which that trade mark is affixed where the replacement of the anti-tampering device of the original outer packaging, carried out in accordance with Article 47a(1) of 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, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, would leave visible or tangible traces of that original outer packaging having been opened, provided that:






  — | there is no doubt that those traces of opening are attributable to the repackaging of that medicinal product by that parallel importer and |
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1.

Article 9(2) and Article 15 of Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark, and Article 10(2) and Article 15 of 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, read in conjunction with Articles 34 and 36 TFEU,

must be interpreted as meaning that the proprietor of a trade mark is entitled to oppose the marketing, by a parallel importer, of a medicinal product repackaged in new outer packaging to which that trade mark is affixed where the replacement of the anti-tampering device of the original outer packaging, carried out in accordance with Article 47a(1) of 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, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, would leave visible or tangible traces of that original outer packaging having been opened, provided that:

—

there is no doubt that those traces of opening are attributable to the repackaging of that medicinal product by that parallel importer and

| — | those traces do not cause, on the market of the Member State of importation or on a substantial part of it, such strong resistance from a significant proportion of consumers to the medicinal products repackaged in that way that it would constitute a barrier to effective access to that market. |
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those traces do not cause, on the market of the Member State of importation or on a substantial part of it, such strong resistance from a significant proportion of consumers to the medicinal products repackaged in that way that it would constitute a barrier to effective access to that market.

| 2. | Directive 2001/83, as amended by Directive 2012/26, and Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83,
  must be interpreted as precluding a Member State from requiring that medicinal products imported in parallel must, in principle, be repackaged in new packaging and that recourse may be had to relabelling and to the affixing of new safety features to the original outer packaging of those medicinal products only on application and in exceptional circumstances, such as, inter alia, a risk of disruption to the supply of the medicinal product concerned. |
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2.

Directive 2001/83, as amended by Directive 2012/26, and Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83,

must be interpreted as precluding a Member State from requiring that medicinal products imported in parallel must, in principle, be repackaged in new packaging and that recourse may be had to relabelling and to the affixing of new safety features to the original outer packaging of those medicinal products only on application and in exceptional circumstances, such as, inter alia, a risk of disruption to the supply of the medicinal product concerned.

| 3. | Article 9(2) and Article 15 of Regulation 2017/1001 and Article 10(2) and Article 15 of Directive 2015/2436, read in conjunction with Articles 34 and 36 TFEU,
  must be interpreted as meaning that a Member State rule which requires that medicinal products imported in parallel must, in principle, be repackaged in new packaging and that recourse may be had to relabelling and to the affixing of new safety features to the original outer packaging of those medicinal products only on application and in exceptional circumstances does not impede the exercise by a trade mark proprietor of his or her right to oppose the marketing by a parallel importer of a medicinal product repackaged in new outer packaging to which that mark is affixed. |
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3.

Article 9(2) and Article 15 of Regulation 2017/1001 and Article 10(2) and Article 15 of Directive 2015/2436, read in conjunction with Articles 34 and 36 TFEU,

must be interpreted as meaning that a Member State rule which requires that medicinal products imported in parallel must, in principle, be repackaged in new packaging and that recourse may be had to relabelling and to the affixing of new safety features to the original outer packaging of those medicinal products only on application and in exceptional circumstances does not impede the exercise by a trade mark proprietor of his or her right to oppose the marketing by a parallel importer of a medicinal product repackaged in new outer packaging to which that mark is affixed.

| 4. | Article 9(2) and Article 15(2) of Regulation 2017/1001 and Article 10(2) and Article 15(2) of Directive 2015/2436, read in conjunction with Articles 34 and 36 TFEU,
  must be interpreted as meaning that the first of the five conditions set out in paragraph 79 of the judgment of 11 July 1996, Bristol-Myers Squibb and Others (C-427/93, C-429/93 and C-436/93, EU:C:1996:282) — according to which the proprietor of a trade mark may legitimately oppose the further marketing in a Member State of a medicinal product bearing that mark and imported from another Member State, where the importer of that medicinal product has repackaged that product and reaffixed that trade mark to the packaging and where such repackaging of that medicinal product in new outer packaging is not objectively necessary for the purposes of its being marketed in the Member State of importation — must be satisfied where the trade mark which appeared on the original outer packaging of the medicinal product concerned has been replaced by a different product name on the new outer packaging of that medicinal product, provided that the immediate packaging of that product bears that trade mark and/or that new outer packaging refers to that mark. |
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4.

Article 9(2) and Article 15(2) of Regulation 2017/1001 and Article 10(2) and Article 15(2) of Directive 2015/2436, read in conjunction with Articles 34 and 36 TFEU,

must be interpreted as meaning that the first of the five conditions set out in paragraph 79 of the judgment of 11 July 1996, Bristol-Myers Squibb and Others (C-427/93, C-429/93 and C-436/93, EU:C:1996:282) — according to which the proprietor of a trade mark may legitimately oppose the further marketing in a Member State of a medicinal product bearing that mark and imported from another Member State, where the importer of that medicinal product has repackaged that product and reaffixed that trade mark to the packaging and where such repackaging of that medicinal product in new outer packaging is not objectively necessary for the purposes of its being marketed in the Member State of importation — must be satisfied where the trade mark which appeared on the original outer packaging of the medicinal product concerned has been replaced by a different product name on the new outer packaging of that medicinal product, provided that the immediate packaging of that product bears that trade mark and/or that new outer packaging refers to that mark.

| 5. | Article 9(2) and Article 15(2) of Regulation 2017/1001 and Article 10(2) and Article 15(2) of Directive 2015/2436
  must be interpreted as meaning that the proprietor of a trade mark may oppose the marketing in a Member State by a parallel importer of a medicinal product imported from another Member State which that importer has repackaged in new outer packaging to which he or she has reaffixed the trade mark of the proprietor specific to that product, but not the other trade marks and/or other distinctive signs which appeared on the original outer packaging of that medicinal product, where the presentation of that new outer packaging is in fact liable to damage the reputation of the trade mark or where that presentation does not enable normally informed and reasonably attentive consumers, or enables them only with difficulty, to ascertain whether that medicinal product originates from the proprietor of the trade mark or an undertaking economically linked to him or her or, on the contrary, originates from a third party, thus adversely affecting the function of indicating the origin of the mark. |
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5.

Article 9(2) and Article 15(2) of Regulation 2017/1001 and Article 10(2) and Article 15(2) of Directive 2015/2436

must be interpreted as meaning that the proprietor of a trade mark may oppose the marketing in a Member State by a parallel importer of a medicinal product imported from another Member State which that importer has repackaged in new outer packaging to which he or she has reaffixed the trade mark of the proprietor specific to that product, but not the other trade marks and/or other distinctive signs which appeared on the original outer packaging of that medicinal product, where the presentation of that new outer packaging is in fact liable to damage the reputation of the trade mark or where that presentation does not enable normally informed and reasonably attentive consumers, or enables them only with difficulty, to ascertain whether that medicinal product originates from the proprietor of the trade mark or an undertaking economically linked to him or her or, on the contrary, originates from a third party, thus adversely affecting the function of indicating the origin of the mark.

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(1)  OJ C 279, 24.8.2020.

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