Source: EURLEX
Language: en
Format: md

Case C‑224/20

Merck Sharp & Dohme BV and Others

v

Abacus Medicine A/S and Others

(Request for a preliminary ruling from the Sø- og Handelsretten)

Judgment of the Court (Fifth Chamber) of 17 November 2022

(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)

1. EU trade mark – Effects of the EU trade mark – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products after repackaging and reaffixing of the trade mark – Opposition of the proprietor – Not permissible – Conditions – Artificial partitioning of the markets between Member States – Necessary repackaging of the medicinal product – Criteria for assessment

   (Arts 34 and 36 TFEU; European Parliament and Council Regulation 2017/1001, Arts 15(1) and 15(2); European Parliament and Council Directives 2015/2436, Arts. 15(1) and 15(2))

   (see paragraphs 45, 47-49, 51-56)
2. EU trade mark – Effects of the EU trade mark – Parallel import of medicinal products after repackaging and reaffixing of the trade mark – Repackaging in new packaging and relabelling – Visible traces of opening on the original packaging after replacement of the anti-tampering device – New device that can be considered equivalent – Conditions

   (Commission Regulation 2016/161, Arts 34(4) and 35(4); European Parliament and Council Directives 2001/83, Art. 47a(1), and 2011/62)

   (see paragraphs 63, 64, 66-70, 86)
3. EU trade mark – Effects of the EU trade mark – Exhaustion of the rights conferred by a trade mark – Opposition of the proprietor – Whether permissible – Conditions

   (Arts 34 and 36 TFEU; European Parliament and Council Regulations 2001/83, Art. 47a(1), 2015/2436, Arts 10(2) and 15, and 2017/1001, Arts 9(2) and 15)

   (see paragraphs 71-79, operative part 1)
4. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Parallel import of medicinal products after repackaging and reaffixing of the trade mark – Member State requiring that such medicinal products be repackaged in new packaging – Member State rule allowing relabelling and the affixing of new safety features to the original outer packaging exclusively on application and in exceptional circumstances – Not permissible

   (Commission Regulation 2016/161; European Parliament and Council Directive 2001/83)

   (see paragraphs 95-100, operative part 2)
5. EU trade mark – Effects of the EU trade mark – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products after repackaging and reaffixing of the trade mark – Member State requiring that such medicinal products be repackaged in new packaging – Member State rule allowing relabelling and the affixing of new safety features to the original outer packaging exclusively on application and in exceptional circumstances – No effect on the trade mark proprietor’s right to oppose

   (Arts 34 and 36 TFEU; European Parliament and Council Regulation 2017/1001, Arts 9(2) and 15; European Parliament and Council Directives 2001/83, Art. 47a(1), and 2015/2436, Arts 10(2) and 15)

   (see paragraph 102-107, operative part 3)
6. EU trade mark – Effects of the EU trade mark – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products after repackaging and reaffixing of the trade mark – Opposition of the proprietor – Whether permissible – Bristol-Myers Squibb condition

   (Arts 34 and 36 TFEU; European Parliament and Council Regulation 2017/1001, Arts 9(2) and 15; European Parliament and Council Directives 2001/83, Art. 47a(1), and 2015/2436, Arts 10(2) and 15)

   (see paragraphs 116-118, operative part 4)
7. EU trade mark – Effects of the EU trade mark – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products after repackaging and reaffixing of the trade mark – Opposition of the proprietor – Not permissible – Condition relating to the presentation of the repackaged product – Presentation not liable to damage the trade mark’s reputation and that of its proprietor – Concept – Forms of repackaging liable to damage that reputation – Question of fact – Assessment by the national court

   (Arts 34 and 36 TFEU; European Parliament and Council Regulation 2017/1001, Arts 9(2) and 15(2); European Parliament and Council Directives 2015/2436, Arts 10 (2) and 15(2))

   (see paragraphs 121-125)
8. EU trade mark – Effects of the EU trade mark – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products after repackaging and reaffixing of the trade mark – Repackaging in new outer packaging – Reaffixing, on that new outer packaging, only of the proprietor’s trade mark – Presentation liable to damage the trade mark’s reputation or to make it difficult for a consumer to understand the origin of the medicinal product – Adverse effect on the function of indicating the origin of the mark – Opposition of the proprietor – Whether permissible

   (European Parliament and Council Regulation 2017/1001, Arts 9(2) and 15(2); European Parliament and Council Directives 2015/2436, Arts 10(2) and 15(2))

   (see paragraphs 127-130, operative part 5)

[See the text of the decision.](https://curia.europa.eu/juris/documents.jsf?num=C-224/20)

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