Merck Sharp & Dohme BV and Others v Abacus Medicine A/S and Others.

JurisdictionEuropean Union
ECLIECLI:EU:C:2022:893
Date17 November 2022
Docket NumberC-224/20
Celex Number62020CJ0224
Procedure TypeReference for a preliminary ruling
CourtCourt of Justice (European Union)

Provisional text

JUDGMENT OF THE COURT (Fifth Chamber)

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 15Directive (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/ECArticle 47a – Safety features – Replacement – Equivalent features – Delegated Regulation (EU) 2016/161 – Article 3(2) – Anti-tampering device)

In Case C‑224/20,

REQUEST for a preliminary ruling under Article 267 TFEU from the Sø- og Handelsretten (Maritime and Commercial Court, Denmark), made by decision of 3 April 2020, received at the Court on 29 May 2020, in the proceedings

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,

THE COURT (Fifth Chamber),

composed of E. Regan, President of the Chamber, D. Gratsias, M. Ilešič (Rapporteur), I. Jarukaitis and Z. Csehi, Judges,

Advocate General: M. Szpunar,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

– Merck Sharp & Dohme BV, Merck Sharp & Dohme Corp., MSD Danmark ApS, MSD Sharp & Dohme GmbH, by M. Bruus, advokat,

– Novartis AG and Ferring Lægemidler A/S, by C. Friis Bach Ryhl and T. Ryhl, advokater,

– H. Lundbeck A/S, by J. Brinck-Jensen and M. Vittrup, advokater,

– Abacus Medicine A/S, by J.J. Bugge, advokat,

– Paranova Danmark A/S, by E. Pfeiffer,

– 2CARE4 ApS, by K.E. Madsen, advokat,

– the Danish Government, by M. Jespersen, J. Nymann-Lindegren and M. Søndahl Wolff, acting as Agents,

– the Polish Government, by B. Majczyna, acting as Agent,

– the European Commission, by É. Gippini Fournier, L. Haasbeek, K. Rasmussen and H. Støvlbæk, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 13 January 2022,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of Articles 34 and 36 TFEU, 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 (OJ 2017 L 154, p. 1), 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 (OJ 2015 L 336, p. 1), and Article 47a and Article 54(o) 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 (OJ 2001 L 311, p. 67), as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 299, p. 1) (‘Directive 2001/83’), and Article 16 of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83 (OJ 2016 L 32, p. 1).

2 The request has been made in the context of seven sets of proceedings between |(i) manufacturers of medicinal products, namely Merck Sharp & Dohme BV, Merck Sharp & Dohme Corp., MSD Danmark ApS, Novartis AG, H. Lundbeck A/S, MSD Sharp & Dohme GmbH and Ferring Lægemidler A/S, proprietors of trade marks under which the medicinal products they produce are sold, and (ii) parallel importers of pharmaceutical products, namely Abacus Medicine A/S, Paranova Danmark A/S and 2CARE4 ApS, concerning the importation into Denmark of medicinal products placed on the market in other Member States by those manufacturers.

Legal context

European Union law

Directive 2015/2436

3 Recital 28 of Directive 2015/2436 states:

‘It follows from the principle of free movement of goods that the proprietor of a trade mark should not be entitled to prohibit its use by a third party in relation to goods which have been put into circulation in the [European] Union, under the trade mark, by him or with his consent, unless the proprietor has legitimate reasons to oppose further commercialisation of the goods.’

4 Article 10 of that directive, entitled ‘Rights conferred by a trade mark’, provides:

‘1. The registration of a trade mark shall confer on the proprietor exclusive rights therein.

2. Without prejudice to the rights of proprietors acquired before the filing date or the priority date of the registered trade mark, the proprietor of that registered trade mark shall be entitled to prevent all third parties not having his consent from using in the course of trade, in relation to goods or services, any sign where:

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

(b) the sign is identical with, or similar to, the trade mark and is used in relation to goods or services which are identical with, or similar to, the goods or services for which the trade mark is registered, if 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;

(c) the sign is identical with, or similar to, the trade mark irrespective of whether it is used in relation to goods or services which are identical with, similar to, or 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, in particular, may be prohibited under paragraph 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 those purposes, under the sign, or offering or supplying services thereunder;

(c) importing or exporting the goods under that sign;

…’

5 Article 15 of that directive, headed ‘Exhaustion of the rights conferred by a trade mark’, provides:

‘1. A trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Union under that trade mark by the proprietor or with the proprietor’s 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.’

Regulation 2017/1001

6 Recital 22 of Regulation 2017/1001 states:

‘It follows from the principle of free movement of goods that it is essential that the proprietor of an EU trade mark not be entitled to prohibit its use by a third party in relation to goods which have been put into circulation in the European Economic Area, under the trade mark, by him or with his consent, save where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods.’

7 Under Article 9 of that regulation, entitled ‘Rights conferred by an EU trade mark’:

‘1. The registration of an EU trade mark shall confer on the proprietor exclusive rights therein.

2. Without prejudice to the rights of proprietors acquired before the filing date or the priority date of the EU trade mark, the proprietor of that EU trade mark shall be entitled to prevent all third parties not having his consent from using in the course of trade, in relation to goods or services, any sign where:

(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;

(b) the sign is identical with, or similar to, the EU trade mark and is used in relation to goods or services which are identical with, or similar to, the goods or services for which the EU trade mark is registered, if 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;

(c) the sign is identical with, or similar to, the EU trade mark irrespective of whether it is used in relation to goods or services which are identical with, similar to or not similar to those for which the EU trade mark is registered, where the latter has a reputation in the [European] Union 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 EU trade mark.

3. The following, in particular, may be prohibited under paragraph 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 those purposes, under the sign, or offering or supplying services thereunder;

(c) importing or exporting the goods under that sign;

…’

8 Article 15 of that regulation, entitled ‘Exhaustion of the rights conferred by an EU trade mark’, provides:

‘1. An EU trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on...

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2 practice notes
  • EU Anti-Counterfeit Regulation Does Not Per Se Allow Repackaging Of Parallel Imported Or Parallel Traded Pharmaceuticals
    • European Union
    • Mondaq European Union
    • 13 January 2023
    ...handed down three decisions and answered the questions in the negative (Merck Sharp & Dohme BV and others v. Abacus Medicine A/S and others, C-224/20) ("MSD Case"); Bayer Intellectual Property GmbH v. Kohlpharma GmbH, C-204/20 ("Bayer Case") and Novartis Pharma GmbH v. Abacus Medicine A/S, ......
  • EU – Parallel trade in the life sciences sector – Q&A
    • European Union
    • JD Supra European Union
    • 24 February 2021
    ...with an equivalent. Finally, INTA too has confirmed this view in the Joint cases C-147/20, Novartis Pharma GmbH v. Abacus Medicine A/S and C-224/20, Merck Sharp & Dohme B.V. et al. v. Abacus Medicine A/S et al.: “INTA submits that repackaging is not the only possibility under the new requir......
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