# C_2023015EN.01000201.xml

| 16.1.2023 | EN | Official Journal of the European Union | C 15/2 |
| --- | --- | --- | --- |

16.1.2023

EN

Official Journal of the European Union

C 15/2

---

Judgment of the Court (Fifth Chamber) of 17 November 2022 (request for a preliminary ruling from the Landgericht Hamburg — Germany) — Novartis Pharma GmbH v Abacus Medicine A/S

(Case C-147/20) (1)

(Reference for a preliminary ruling - Intellectual property - EU trade mark - Regulation (EU) 2017/1001 - Article 9(2) - Rights conferred by a mark - Article 15 - Exhaustion of the rights conferred by a trade mark - Parallel import of medicinal products - Repackaging of the product bearing the mark - New 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 - Unique identifier)

(2023/C 15/02)

Language of the case: German

Referring court

Landgericht Hamburg

Parties to the main proceedings

Applicant: Novartis Pharma GmbH

Defendant: Abacus Medicine A/S

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
  must be interpreted as meaning that the proprietor of an EU trade mark is not entitled to oppose the marketing by a parallel importer of a repackaged medicinal product in a new outer packaging bearing that mark, where the replacement of the anti-tampering device of the original outer packaging of that medicinal product 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 traces of opening on that packaging and where those traces would cause such strong resistance on the part of a significant proportion of consumers on the market of the Member State of importation or on a substantial part of that market to medicinal products repackaged in that way that it would constitute an obstacle to effective access to that market, which must be established on a case-by-case basis. |
| --- | --- |

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

must be interpreted as meaning that the proprietor of an EU trade mark is not entitled to oppose the marketing by a parallel importer of a repackaged medicinal product in a new outer packaging bearing that mark, where the replacement of the anti-tampering device of the original outer packaging of that medicinal product 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 traces of opening on that packaging and where those traces would cause such strong resistance on the part of a significant proportion of consumers on the market of the Member State of importation or on a substantial part of that market to medicinal products repackaged in that way that it would constitute an obstacle to effective access to that market, which must be established on a case-by-case basis.

| 2. | Article 5(3) of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83
  must be interpreted as not precluding the barcode containing the unique identifier referred to in Article 3(2)(a) of that delegated regulation from being affixed to the outer packaging of the medicinal product by means of an adhesive label, provided that that label cannot be removed without being damaged and that, in particular, the barcode remains perfectly readable throughout the supply chain and throughout the entire period referred to in Article 6 of that delegated regulation. |
| --- | --- |

2.

Article 5(3) of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83

must be interpreted as not precluding the barcode containing the unique identifier referred to in Article 3(2)(a) of that delegated regulation from being affixed to the outer packaging of the medicinal product by means of an adhesive label, provided that that label cannot be removed without being damaged and that, in particular, the barcode remains perfectly readable throughout the supply chain and throughout the entire period referred to in Article 6 of that delegated regulation.

---

(1)  OJ C 215, 29.6.2020.

---