Bayer Intellectual Property GmbH v kohlpharma GmbH.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2022:892
• Date: 17 November 2022
• Docket Number: C-204/20
• Celex Number: 62020CJ0204
• Procedure Type: Reference for a preliminary ruling
• Court: Court of Justice (European Union)

Provisional text

JUDGMENT OF THE COURT (Fifth Chamber)

17 November 2022(*)

(Reference for a preliminary ruling – Intellectual property – Trade marks – Directive (EU) 2015/2436 – Approximation of the laws of the Member States relating to trade marks – Article 10(2) – Rights conferred by a trade 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)

In Case C‑204/20,

REQUEST for a preliminary ruling under Article 267 TFEU from the Landgericht Hamburg (Regional Court, Hamburg, Germany), made by decision of 2 April 2020, received at the Court on 13 May 2020, in the proceedings

Bayer Intellectual Property GmbH

v

kohlpharma GmbH,

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:

– Bayer Intellectual Property GmbH, by C. Giesen and U. Reese, Rechtsanwälte,

– kohlpharma GmbH, by W. Rehmann and D. Tietjen, Rechtsanwälte,

– 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 G. Braun, É. Gippini Fournier and L. Haasbeek, 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 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 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’).

2 The request has been made in proceedings between Bayer Intellectual Property GmbH (‘Bayer’), the proprietor of the German trade mark Androcur, and kohlpharma GmbH concerning the marketing in Germany by the latter of medicinal products bearing the trade mark Androcur imported in parallel from the Netherlands.

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.’

Directive 2001/83

6 Recitals 2 to 5 and 40 of Directive 2001/83 state:

‘(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.

(3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.

(4) Trade in medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations), and such disparities directly affect the functioning of the internal market.

(5) Such hindrances must accordingly be removed; whereas this entails approximation of the relevant provisions.

…

(40) The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.’

7 Under Article 40 of that directive:

‘1. Member States shall take all appropriate measures to ensure that the manufacture of the medicinal products within their territory is subject to the holding of an authorisation. This manufacturing authorisation shall be required nothwithstanding that the medicinal products manufactured are intended for export.

2. The authorisation referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.

…’

8 Article 47a(1) of that directive provides:

‘The safety features referred to in point (o) of Article 54 shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled:

(a) the manufacturing authorisation holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with;

(b) the manufacturing authorisation holder complies with point (o) of Article 54 by replacing those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product. Such replacement shall be conducted without opening the immediate packaging as defined in point 23 of Article 1.

Safety features shall be considered equivalent if they:

(i) comply with the requirements set out in the delegated acts adopted pursuant to Article 54a(2); and

(ii) are equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products;

(c) the replacement of the safety features is conducted in accordance with applicable good manufacturing practice for medicinal products; and

(d) the replacement of the safety features is subject to supervision by the competent authority.’

9 Under Article 54 of that directive:

‘The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:

…

(o) for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:

– verify the authenticity of the medicinal product, and

– identify individual packs,

as well as a device allowing verification of whether the outer packaging has been tampered with.’

10 Article 54a of Directive 2001/83 provides:

‘1. Medicinal products subject to prescription shall bear the safety features referred to in point (o) of Article 54, unless they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article.

…

2. The [European] Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures supplementing point (o) of Article 54 with the objective of establishing the detailed rules for the safety features referred to in point (o) of Article...