Merck Sharp & Dohme and Others (Intellectual property - Trade marks - Parallel import of medicinal products - Repackaging - Judgment) [2022] EUECJ C-224/20 (17 November 2022)

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(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)

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

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

– 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,

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

– 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,

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.

‘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.

(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;

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.’

‘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.

(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;

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 the market in the European Economic Area under that trade mark by the proprietor or with his consent.

‘(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.

(14) This directive represents an important step towards achievement of the objective of the free movement of medicinal products. Further measures [to] abolish any remaining barriers to the free movement of proprietary medicinal products [may] be necessary in the light of experience gained, particularly in the [Committee for Proprietary Medicinal Products attached to the European Agency for the Evaluation of Medicinal Products established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1)].

(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.

(41) The marketing of medicinal products whose labelling and package leaflets comply with this Directive should not be prohibited or impeded on grounds connected with the labelling or package leaflet.’

‘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 notwithstanding 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.

‘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.

(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.’

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

(a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name;

(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:

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

‘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 54.

5. Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in point (o) of Article 54 to any medicinal product subject to prescription or subject to reimbursement.

Member States may, for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the repositories system referred to in point (e) of paragraph 2 of this Article.

Member States may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in point (o) of Article 54 to any medicinal product.’

‘Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:

For medicinal products authorised under Regulation (EC) No 726/2004 [of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1)], Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive.’

15 Article 59 of that directive lists the information which must be included in the package leaflet accompanying the medicinal product.

‘Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of this Title.’

17 The first subparagraph of Article 63(1) of Directive 2001/83 is worded as follows:

‘The particulars for labelling listed in Articles 54, 59 and 62 shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.’

‘Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show:

19 Recitals 2, 3, 11, 12, 29 and 33 of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83 (OJ 2011 L 174, p. 74) state:

‘(2) There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source. Those products usually contain sub-standard or falsified ingredients, or no ingredients or ingredients, including active substances, in the wrong dosage thus posing an important threat to public health.

(3) Past experience shows that such falsified medicinal products do not reach patients only through illegal means, but via the legal supply chain as well. This poses a particular threat to human health and may lead to a lack of trust of the patient also in the legal supply chain. Directive [2001/83] should be amended in order to respond to this increasing threat.

(11) Safety features for medicinal products should be harmonised within the Union in order to take account of new risk profiles, while ensuring the functioning of the internal market for medicinal products. Those safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering. …

(12) Any actor in the supply chain who packages medicinal products has to be a holder of a manufacturing authorisation. In order for the safety features to be effective, a manufacturing authorisation holder who is not himself the original manufacturer of the medicinal product should only be permitted to remove, replace or cover those safety features under strict conditions. In particular, the safety features should be replaced in the case of repackaging by equivalent safety features. To this end, the meaning of the term “equivalent” should be clearly specified. Those strict conditions should provide adequate safeguards against falsified medicinal products entering the supply chain, in order to protect patients as well as the interests of marketing authorisation holders and manufacturers.

(29) This Directive is without prejudice to provisions concerning intellectual property rights. It aims specifically to prevent falsified medicinal products from entering the legal supply chain.

(33) Since the objective of this Directive, namely to safeguard the functioning of the internal market for medicinal products, whilst ensuring a high level of protection of public health against falsified medicinal products, cannot be sufficiently achieved by the Member States, and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 [TEU]. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective.’

‘(1) Directive [2001/83] provides for measures to prevent the entry into the legal supply chain of falsified medicinal products by requiring the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging of certain medicinal products for human use for the purposes of allowing their identification and authentication.

(11) To facilitate the verification of the authenticity and decommissioning of a unique identifier by wholesalers and persons authorised or entitled to supply medicinal products to the public, it is necessary to ensure that the structure and printing quality of the two-dimensional barcode encoding the unique identifier allow for high-speed reading and minimisation of reading errors.

(12) The data elements of the unique identifier should be printed on the packaging in human-readable format so [as] to allow the verification of the authenticity of the unique identifier and its decommissioning in case the two-dimensional barcode is unreadable.

(15) The verification of both safety features is necessary to ensure the authenticity of a medicinal product in an end-to-end verification system. The verification of the authenticity of the unique identifier aims at ensuring that the medicinal product originates from the legitimate manufacturer. The verification of the integrity of the anti-tampering device shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.’

(a) “unique identifier” means the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product;

(b) “anti-tampering device” means the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with;

22 Article 10 of that delegated regulation, entitled ‘Verification of the safety features’, is worded as follows:

‘When verifying the safety features, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall verify the following:

Before removing or covering, either fully or partially, the safety features in accordance with Article 47a of Directive [2001/83], the manufacturer shall verify the following:

(b) the authenticity of the unique identifier and decommission it if replaced.’

24 Article 24 of that delegated regulation, entitled ‘Actions to be taken by wholesalers in case of tampering or suspected falsification’, is worded as follows:

‘A wholesaler shall not supply or export a medicinal product where he has reason to believe that its packaging has been tampered with, or where the verification of the safety features of the medicinal product indicates that the product may not be authentic. He shall immediately inform the relevant competent authorities.’

25 Article 25 of Delegated Regulation 2016/161, entitled ‘Obligations of persons authorised or entitled to supply medicinal products to the public’, provides, in paragraphs 1 and 3:

‘1. Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public.

3. In order to verify the authenticity of the unique identifier of a medicinal product and decommission that unique identifier, persons authorised or entitled to supply medicinal products to the public shall connect to the repositories system referred to in Article 31 through the national or supranational repository serving the territory of the Member State in which they are authorised or entitled.’

26 Under Article 30 of that delegated regulation, entitled ‘Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification’:

‘Where persons authorised or entitled to supply medicinal products to the public have reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features of the medicinal product indicates that the product may not be authentic, those persons authorised or entitled to supply medicinal products to the public shall not supply the product and shall immediately inform the relevant competent authorities.’

‘When it receives the information referred to in Article 35(4), the hub shall ensure the electronic linking of the batch numbers before and after the repackaging or relabelling operations with the set of unique identifiers decommissioned and with the set of equivalent unique identifiers placed.’

‘For each batch of repackaged or relabelled packs of a medicinal product on which equivalent unique identifiers were placed for the purposes of complying with Article 47a of Directive [2001/83], the person responsible for placing the medicinal product on the market shall inform the hub of the batch number or numbers of the packs which are to be repackaged or relabelled and of the unique identifiers on those packs. He shall additionally inform the hub of the batch number of the batch resulting from the repackaging or relabelling operations and the equivalent unique identifiers in that batch.’

29 Pursuant to the second paragraph of Article 50 thereof, Delegated Regulation 2016/161 became applicable from 9 February 2019.

30 Directive 2015/2436 was transposed into Danish law by the varemærkeloven (Law on trade marks), Paragraph 10a of which corresponds, in essence, to Article 15 of that directive.

31 In accordance with the provisions of Chapter 3 of the lov om lægemidler (Law on medicinal products), in the version applicable to the dispute in the main proceedings (‘the Law on medicinal products’), parallel importers of medicinal products who, in order to meet the conditions for marketing in Denmark, relabel or repackage them in new outer packaging must, in addition to a marketing authorisation, hold a manufacturing authorisation.

‘2. Manufacturers of prescription medicinal products for human use shall provide medicinal products with safety features. …

5. The Sundheds- og Ældreministeriet [Ministry of Health and Senior Citizens. Denmark] shall take the necessary measures to guarantee the objectives pursued with safety features and their purposes.’

33 Under Paragraph 62(1) of the bekendtgørelse No 1297 om recepter og dosisdispensering af lægemidler (Order No 1297 on prescriptions and unit dispensing of medicinal products) of 28 November 2019, pharmacies are in principle required to supply the cheapest medicinal product within the category of authorised medicinal products capable of replacing the medicinal product prescribed by the doctor (generic substitution principle).

The disputes in the main proceedings and the questions referred for a preliminary ruling

34 The applicants in the main proceedings are manufacturers of medicinal products and proprietors of the trade marks under which the medicinal products they produce are sold.

35 The defendants in the main proceedings import into Denmark medicinal products placed on the market in other Member States by those manufacturers.

36 Before they are placed on the market in Denmark, those medicinal products are repackaged in new outer packaging. In some of the disputes in the main proceedings, the trade mark of those manufacturers is affixed to that new outer packaging, whereas, in other of those disputes, that mark is replaced by a new product name. In the latter case, the new outer packaging nevertheless indicates that the medicinal product which it contains corresponds to the medicinal product marketed by the proprietor under his or her trade mark and that the blister packs inside that new outer packaging bear that mark. The new package leaflet accompanying the medicinal product in question also indicates that that product corresponds to that sold by the proprietor under his or her trade mark.

37 The applicants in the main proceedings claim that, in circumstances such as those of the disputes in the main proceedings, trade mark law confers on them the right to oppose the repackaging of the medicinal products in question in new outer packaging.

38 The defendants in the main proceedings contend that that repackaging is necessary and therefore lawful.

39 According to the referring court, the question which arises in the main proceedings is whether the applicants in the main proceedings may oppose that repackaging, thus compelling the defendants in the main proceedings to market in Denmark the medicinal products concerned in their relabelled original outer packaging, after having replaced the package leaflet accompanying those medicinal products and affixed a new unique identifier and a replacement anti-tampering device to that packaging.

40 In that regard, that court states that, on 18 December 2018, the Lægemiddelstyrelsen (Medicines Agency, Denmark) published a document containing questions and answers about safety features on the packaging of medicinal products. In its updated version of 20 January 2020, that document includes, in the section entitled ‘Parallel imports’, the following question: ‘Would it be against the regulation for a parallel importer to replace the anti-tampering device with another device?’.

Yes. The Medicines Agency considers that it is a general rule that parallel importers must repackage the products in new packaging according to the new rules of the regulation. That also follows from the purpose of the new rules of the regulation, including the requirement for an anti-tampering device to be designed in such a way that any opening of, or tampering with, the package can be identified. Parallel importers which open the packaging of medicinal products and break the anti-tampering device for the purpose of placing a Danish package leaflet etc. in the packaging must therefore, in accordance with the new rules of the regulation, repackage the products in new packaging and attach a new unique identifier and anti-tampering device on the packaging, as well as upload information etc.

The document entitled ‘Safety features for medicinal products for human use – Questions and answers – version 18’ – drawn up by the Commission, states that, under certain specific conditions, it is possible for parallel importers ‘lawfully’ to open the packaging of medicinal products with a view, inter alia, to placing a new package leaflet in the packaging and then replacing the original anti-tampering device with a new anti-tampering device, provided it is carried out under the supervision of the competent authorities and provided the new anti-tampering device seals the packaging completely and covers all visible signs of the lawful opening. In addition, the replacement of the anti-tampering device must be carried out in accordance with [good manufacturing practice] for medicinal products and a parallel importer who lawfully opens the packaging of medicinal products and attaches a new anti-tampering device must verify beforehand the authenticity of the unique identifier and the integrity of the anti-tampering device on the original packaging in accordance with Article 47a(1)(a) of Directive 2001/83.

As mentioned above, since parallel importers must, under the new rules of the regulation, repackage the products in new packaging, the Medicines Agency considers that the exemption described by the Commission can be applied only in exceptional situations, including, for example, where there is a risk to the supply of medicinal products.

In Denmark, that exemption cannot in principle be used in connection with a new application for marketing authorisation for parallel imports. Those applications will have to satisfy the general requirements, including the general rule that medicinal products must be repackaged in new packaging.

The exemption, as described by the Commission, means that, where a marketing authorisation for parallel import for the specific product has been issued, where the medicinal product is marketed and where a parallel importer, in a specific and limited situation, wishes to make use of the exemption from the general rule on repackaging, parallel importers may apply for an exemption by submitting an application for an exemption from the regulation on labelling. … In addition to following that guidance, parallel importers must adequately describe how they intend to replace the anti-tampering device, submitting pictures of both the original anti-tampering device and the new anti-tampering device. In addition, it must be demonstrated that the replacement of the anti-tampering device will be carried out in accordance with [good manufacturing practice] in such a way that the new anti-tampering device completely seals the packaging and covers all visible signs of the lawful opening. Furthermore, an exemption should cover all the products concerned, including the form and strength and the related countries of export.’

42 Taking the view, in those circumstances, that the disputes in the main proceedings raise questions of interpretation of EU law, the Sø- og Handelsretten (Maritime and Commercial Court, Denmark) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Must Article 15(2) of [Directive 2015/2436] and Article 15(2) of [Regulation 2017/1001] be interpreted as meaning that a trade mark proprietor may oppose further commercialisation of a medicinal product which a parallel importer has repackaged in new external packaging to which the trade mark has been reaffixed, where:

(a) the importer is able to achieve packaging which may be marketed [in,] and gain effective access to[,] the market of the Member State of importation by breaking the original external packaging in order to affix new labels to the inner packaging and/or replace the package leaflet and then reseal the original external packaging with a new device to verify whether the packaging has been tampered with, in accordance with Article 47a of [Directive 2001/83] and Article 16 of [Delegated Regulation 2016/161]?

(b) the importer is not able to achieve packaging which may be marketed [in,] and gain effective access to[,] the market of the Member State of importation by breaking the original external packaging in order to affix new labels to the inner packaging and/or replace the package leaflet and then reseal the original external packaging with a new device to verify whether the packaging has been tampered with, in accordance with Article 47a of [Directive 2001/83] and Article 16 of [Delegated Regulation 2016/161]?

(2) Must [Directive 2001/83], including, in particular, Article 47a and point (o) of Article 54, be interpreted as meaning that a new device to verify whether the packaging has been tampered with (“anti-tampering device”), affixed to the original packaging of the medicinal products (in connection with additional labelling after the packaging has been opened in such a way that the original anti-tampering device has been fully or partially covered and/or removed), within the meaning of Article 47a(1)(b), is “equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering [with] the medicinal product” and, within the meaning of Article 47a(1)(b)(ii), “is equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products”, where the packaging of the medicinal products … displays visible signs that the original anti-tampering device has been tampered with, or … that can be established by touching the product, including:

(a) through mandatory verification of the integrity of the anti-tampering device carried out by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public (see Article 54a(2)(d) of [Directive 2001/83] and Article 10(b) and Articles 25 and 30 of [Delegated Regulation 2016/161]), or

(b) after the packaging of the medicinal products has been opened, for example by a patient?

Must Article 15 of [Directive 2015/2436], Article 15 of [Regulation 2017/1001] and Articles 36 and 34 TFEU, then be interpreted as meaning that repackaging in new external packaging is objectively necessary for effective access to the market of the State of importation, where it is not possible for the parallel importer to affix additional labelling and reseal the original packaging in accordance with Article 47a of [Directive 2001/83], that is to say without the packaging of the medicinal products … displaying visible signs that the original anti-tampering device has been tampered with, or … that can be established by touching the product, as described in Question 2, in a manner which is not in accordance with Article 47a?

(4) Must [Directive 2001/83] and [Delegated Regulation 2016/161] in conjunction with Articles 34 and 36 TFEU and Article 15(2) of [Directive 2015/2436 and Article 15(2) of Regulation 2017/1001], be interpreted as meaning that a Member State (in Denmark [the Medicines Agency]) is entitled to lay down guidelines, in accordance with which, in general, repackaging in new external packaging is to be carried out and it is only on application, in exceptional cases (for example where there is a risk to the supply of the medicinal product), that additional labelling and resealing may be permitted to be carried out by attaching new security features to the original external packaging, or is the Member State’s issuing and observance of such guidelines incompatible with Articles 34 and 36 TFEU and/or Article 47a of [Directive 2001/83] and Article 16 of [Delegated Regulation 2016/161]?

(5) Must Article 15(2) of [Directive 2015/2436] and Article 15(2) of [Regulation 2017/1001], in conjunction with Articles 34 and 36 TFEU, be interpreted as meaning that repackaging in new external packaging carried out by a parallel importer in accordance with the guidelines laid down by a Member State, as referred to in Question 4, must be regarded as necessary for the purposes of the case-law of the Court of Justice of the European Union,

(a) where such guidelines are compatible with Articles 34 and 36 TFEU and the case-law of the [Court of Justice] on parallel imports of medicinal products?

(b) where such guidelines are incompatible with Articles 34 and 36 TFEU and the case-law of the [Court of Justice] on parallel imports of medicinal products?

(6) Must Articles 34 and 36 TFEU be interpreted as meaning that the repackaging of a medicinal product in new external packaging must be objectively necessary for effective access to the market of the importing State, even if the parallel importer has not reaffixed the original trade mark (product name), but instead given the new external packaging a product name which does not contain the trade mark proprietor’s product trade mark (de-branding)?

(7) Must Article 15(2) of [Directive 2015/2436] and Article 15(2) of [Regulation 2017/1001] be interpreted as meaning that a trade mark proprietor may oppose further commercialisation of a medicinal product which a parallel importer has repackaged in a new external packaging, in so far as the parallel importer has reaffixed only the trade mark proprietor’s product-specific trade mark, but has not reaffixed the other trade marks and/or commercial indications which the trade mark proprietor had affixed to the original external packaging?’

43 By its first to third questions, which it is appropriate to examine together, the referring court asks, in essence, whether 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 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 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 leaves visible or tangible traces of that original outer packaging having been opened.

44 In that regard, it must be borne in mind that, under Article 9(1) of Regulation 2017/1001 and Article 10(1) of Directive 2015/2436, the registration of a trade mark confers on the proprietor exclusive rights which, according to Article 9(2)(a) of that regulation and Article 10(2)(a) of that directive, entitle that proprietor to prevent all third parties not having his or her consent from using in the course of trade any sign which is identical with that trade mark in relation to goods or services which are identical with those for which the mark was registered.

45 That exclusive right of the proprietor of the mark was conferred in order to enable him or her to protect his or her specific interests as proprietor, namely to ensure that the trade mark can fulfil its function. The exercise of that right must therefore be reserved to cases in which a third party’s use of the sign affects, or is liable to affect, the functions of the trade mark. Amongst those functions is not only the essential function of the mark which is to guarantee to consumers the origin of the product or service, but also the other functions of the mark, such as, in particular, that of guaranteeing the quality of the product or service, or those of communication, investment or advertising (see, to that effect, judgment of 25 July 2018, Mitsubishi Shoji Kaisha and Mitsubishi Caterpillar Forklift Europe, C‑129/17, EU:C:2018:594, paragraph 34 and the case-law cited).

46 It is apparent from settled case-law that repackaging of the product bearing the trade mark by a third party without the authorisation of the trade mark proprietor is likely to create real risks for the guarantee of origin of that product (judgment of 17 May 2018, Junek Europ-Vertrieb, C‑642/16, EU:C:2018:322, paragraph 23 and the case-law cited), it being noted that the concept of ‘repackaging’, within the meaning of that case-law, includes relabelling (see, to that effect, judgment of 17 May 2018, Junek Europ-Vertrieb, C‑642/16, EU:C:2018:322, paragraph 30 and the case-law cited).

47 However, according to Article 15(1) of Regulation 2017/1001 and Article 15(1) of Directive 2015/2436, the rights conferred by a trade mark are not to entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the European Union under that trade mark by the proprietor or with his or her consent. Those provisions seek to reconcile the fundamental interests of trade mark protection, on the one hand, with those of free movement of goods in the internal market, on the other hand (see by analogy, as regards Article 7(1) of Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks (OJ 2008 L 299, p. 25), judgment of 20 December 2017, Schweppes, C‑291/16, EU:C:2017:990, paragraph 35).

48 In that regard, it must be borne in mind that, although Article 15 of Regulation 2017/1001 and Article 15 of Directive 2015/2436, which are worded in general terms, comprehensively regulate the question of the exhaustion of the rights conferred by a trade mark and although, where provision is made for harmonisation of measures necessary to ensure the protection of the interests referred to in Article 36 TFEU, any national measure relating thereto must be assessed in relation to the provisions of that regulation or that directive and not Articles 34 to 36 TFEU, that regulation and that directive must, like any secondary EU legislation, be interpreted in the light of the TFEU rules on the free movement of goods and of Article 36 TFEU in particular (see by analogy, as regards Article 7(1) of Directive 2008/95, judgment of 20 December 2017, Schweppes, C‑291/16, EU:C:2017:990, paragraph 30 and the case-law cited).

49 More specifically, it follows from Article 15(2) of Regulation 2017/1001 and Article 15(2) of Directive 2015/2436 that the trade mark proprietor’s opposition to repackaging, in that it constitutes a derogation from free movement of goods, cannot be accepted if the proprietor’s exercise of the rights conferred by a trade mark constitutes a disguised restriction on trade between Member States within the meaning of the second sentence of Article 36 TFEU (see, by analogy, judgment of 17 May 2018, Junek Europ-Vertrieb (C‑642/16, EU:C:2018:322, paragraph 25 and the case-law cited). Trade mark rights are not intended to allow their owners to partition national markets and thus promote the retention of price differences which may exist between Member States (judgment of 11 July 1996, Bristol-Myers Squibb and Others, C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282, paragraph 46).

50 A disguised restriction within the meaning of the second sentence of Article 36 TFEU will exist where the exercise by a trade mark proprietor of his or her right to oppose repackaging contributes to artificial partitioning of the markets between Member States and where, in addition, the repackaging is done in such a way that the legitimate interests of the proprietor are respected. This means, in particular, that the repackaging must not adversely affect the original condition of the medicinal product and must not be such as to harm the reputation of the mark (see, to that effect, judgments of 10 November 2016, Ferring Lægemidler, C‑297/15, EU:C:2016:857, paragraph 16 and the case-law cited, and of 17 May 2018, Junek Europ-Vertrieb, C‑642/16, EU:C:2018:322, paragraph 26 and the case-law cited).

51 However, the conclusion that the proprietor may not rely on the rights conferred by the trade mark in order to oppose the marketing under his or her trade mark of products repackaged by an importer amounts to conferring on the importer certain rights which in normal circumstances are reserved for the trade mark proprietor himself or herself. Consequently, in the interests of the proprietor as owner of the trade mark, and to protect him or her against any misuse, those rights must be recognised only in so far as the importer concerned complies with a number of other requirements (see, to that effect, judgment of 28 July 2011, Orifarm and Others, C‑400/09 and C‑207/10, EU:C:2011:519, paragraph 26 and the case-law cited).

52 Thus, according to settled case-law, the proprietor of a mark may legitimately oppose the further marketing in a Member State of a pharmaceutical product bearing his or her mark and imported from another Member State, where the importer of that product has repackaged it and reaffixed that trade mark to it, unless:

– it is established that the use of the trade mark rights by the proprietor thereof to oppose the marketing of the repackaged products under that trade mark would contribute to the artificial partitioning of the markets between Member States;

– it is shown that the repackaging cannot affect the original condition of the product inside the packaging;

– the new packaging states clearly who repackaged the product and the name of the manufacturer;

– the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner, and

– the importer gives notice to the trade mark proprietor before the repackaged product is put on sale, and, on demand, supplies him or her with a specimen of the repackaged product (see, to that effect, judgments of 11 July 1996, Bristol-Myers Squibb and Others, C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282, paragraph 79, and of 17 May 2018, Junek Europ-Vertrieb, C‑642/16, EU:C:2018:322, paragraph 28 and the case-law cited).

53 As regards, in particular, the first of the conditions set out in the preceding paragraph of the present judgment, the Court has held that a trade mark proprietor’s opposition to repackaging of medicinal products contributes to artificial partitioning of the markets between Member States where the repackaging is necessary in order to enable the product imported in parallel to be marketed in the importing Member State (judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 18).

54 That condition of necessity is satisfied, in particular, where the circumstances prevailing at the time of marketing in the importing Member State impede the placing on the market of the medicinal product in the same packaging as that in which it is marketed in the exporting Member State, thereby rendering repackaging objectively necessary for the medicinal product concerned to be marketed in the importing Member State by the parallel importer (see, to that effect, judgment of 10 November 2016, Ferring Lægemidler, C‑297/15, EU:C:2016:857, paragraph 20 and the case-law cited).

55 Conversely, that condition is not fulfilled if repackaging of the product is explicable solely by the parallel importer’s attempt to secure a commercial advantage (judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 37).

56 According to the case-law of the Court, the condition in question that packaging be necessary concerns both the actual fact of repackaging the product and the choice between new packaging and relabelling (see, to that effect, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 38). As the Advocate General observed in point 118 of his Opinion, in so far as the recognition of the right of a parallel trader to market in new packaging a product bearing a trade mark without the authorisation of the proprietor of that trade mark amounts to giving the parallel trader a licence normally reserved to the proprietor, namely a licence to affix that trade mark to that new packaging, such repackaging in new packaging constitutes a greater interference with the prerogatives of that proprietor than the marketing of the product in its relabelled original packaging.

57 The Court has thus held that the trade mark proprietor may oppose replacement packaging where the parallel importer is able to reuse the original packaging for the purpose of marketing in the Member State of importation by affixing labels to that packaging (judgment of 23 April 2002, Boehringer Ingelheim and Others, C‑143/00, EU:C:2002:246, paragraph 49 and the case-law cited). However, the trade mark proprietor is entitled to oppose the parallel importer’s use of that replacement packaging only on condition that the relabelled medicinal product is able to have effective access to the market concerned (see, to that effect, judgment of 23 April 2002, Boehringer Ingelheim and Others, C‑143/00, EU:C:2002:246, paragraph 50).

58 In that regard, it should be borne in mind that, as is apparent from recitals 2 and 3 of Directive 2011/62, read in conjunction with recital 1 of Delegated Regulation 2016/161, the EU legislature adopted that directive in order to address the increasing threat to human health constituted by falsified medicinal products by introducing, in Directive 2001/83, measures to prevent the entry of falsified medicinal products in the legal supply chain.

59 Directive 2011/62 thus inserted into Article 54 of Directive 2001/83 a point (o) pursuant to which the outer packaging or, where there is no outer packaging, the immediate packaging of medicinal products other than radiopharmaceuticals referred to in Article 54a(1) of that directive must be equipped with 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 concerned, to identify individual packs and to verify whether the outer packaging of that medicinal product has been tampered with.

60 Pursuant to Article 54a(2) of Directive 2001/83, Delegated Regulation 2016/161 establishes the detailed rules for those safety features. Recital 1 of that delegated regulation identifies two types of safety features, namely (i) a unique identifier and (ii) an anti-tampering device. An anti-tampering device is defined in Article 3(2) of that delegated regulation as the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with.

61 More specifically, Article 25(1) of Delegated Regulation 2016/161 requires persons authorised or entitled to supply medicinal products to the public to verify those safety features. In addition, Articles 24 and 30 of that delegated regulation prohibit wholesalers and persons authorised or entitled to supply medicinal products to the public from supplying medicinal products to the public where they have reason to believe that its packaging has been tampered with.

62 Furthermore, Article 47a(1) of Directive 2001/83 provides that those safety features may be removed or covered only under strict conditions, intended to guarantee the authenticity of the medicinal product and the absence of any tampering.

63 In particular, it is apparent from Article 47a(1)(b) that those conditions include the condition that the safety features in question must be replaced by ‘equivalent’ safety features. Under that provision, in order to be regarded as such, a safety feature must, inter alia, be equally effective in enabling the verification of the authenticity of the medicinal products concerned and their identification, as well as in providing evidence of tampering with them.

64 It thus follows from that provision, read in the light of recital 12 of Directive 2011/62, that the EU legislature, which expressly provided for the possibility of ‘replacing’ the safety features referred to in paragraph 60 of the present judgment, did not intend to prevent the reuse of the original outer packaging, even where that packaging had such features. That interpretation is borne out by Article 34(4) and Article 35(4) of Delegated Regulation 2016/161, pursuant to which an equivalent unique identifier may be affixed both to a repackaged pack, in new packaging, and to a relabelled pack.

65 That being so, it follows from Article 47a(1)(b) of Directive 2001/83 that such reuse is possible only on condition that the original safety features can be replaced by features which are equally effective in enabling the verification of the authenticity of the medicinal products concerned, their identification, and in providing evidence of tampering with them, in accordance with the aim of Directive 2011/62, which, as is apparent from recital 29 thereof, is to prevent falsified medicinal products from entering the legal supply chain.

66 In that regard, it should be noted that, under Article 47a(1)(a) of Directive 2001/83, the holder of a manufacturing authorisation – authorisation that, as is apparent from Article 40(2) of that directive, any actor in the supply chain which packages medicinal products must possess – must verify, before removing or covering either fully or partially the safety features referred to in paragraph 60 of this judgment, that the medicinal product concerned is authentic and that it has not been tampered with.

67 Thus, in accordance with Article 47a(1)(b) of Directive 2001/83, a replacement anti-tampering device must make it possible to verify, with the same effectiveness as an original anti-tampering device, that the outer packaging of a medicinal product has not been unlawfully opened between the time at which that medicinal product is repackaged and that at which it is supplied to the public.

68 Consequently, the presence on the outer packaging of a medicinal product of possible traces of having been opened is not, in itself, sufficient for the view to be taken that the replacement anti-tampering device is not equivalent, within the meaning of the second paragraph of Article 47a(1)(b) of Directive 2001/83, where there is no doubt, on the part of wholesalers and persons authorised or entitled to supply medicinal products to the public, that those traces of opening are attributable to the repackaging of that medicinal product by a parallel importer. In that regard, the reference on that outer packaging to the repackager provides information to downstream actors in the supply chain as to the possible origin of those traces of opening. That reference, combined with the anti-tampering device and the replacement unique identifier, enables those persons to ensure that the presence of such traces is due to lawful tampering.

69 Moreover, since the function of the anti-tampering device is precisely to reveal any opening of the packaging to which it is affixed, the presence of such traces is inevitable. Accordingly, an interpretation different from that in the preceding paragraph would make it impossible, in practice, to relabel a medicinal product, thus rendering redundant Article 47a(1)(b) of Directive 2001/83, read in the light of recital 12 of Directive 2011/62, and Article 34(4) and Article 35(4) of Delegated Regulation 2016/161, which, as was found in paragraph 64 above, expressly so permit.

70 It follows from the foregoing considerations that the fact that the replacement of the anti-tampering device of the original packaging of a medicinal product leaves visible traces of opening on that packaging does not preclude the finding that the new device is equivalent, within the meaning of Article 47a(1)(b) of Directive 2001/83, or, therefore, that that replacement has been carried out in accordance with that Article 47a(1).

71 Thus, first, in the light of the considerations set out in paragraphs 58 to 70 of this judgment, repackaging in new packaging must be regarded as objectively necessary where the anti-tampering device with which the outer packaging of the medicinal product concerned is equipped cannot objectively be replaced by an equivalent device, within the meaning of Article 47a(1)(b) of Directive 2001/83, it being recalled that, as was found in paragraph 68 of this judgment, the presence of traces of opening is, in itself, insufficient to support the inference that the condition of equivalence has not been satisfied.

72 In such circumstances, the exercise by the trade mark proprietor of the right conferred by the trade mark to oppose such repackaging would constitute a disguised restriction on trade between Member States, within the meaning of the second sentence of Article 36 TFEU, in that it would contribute, contrary to the purpose of trade mark law, to artificially partitioning national markets within the European Union and thus to promoting the retention of price differences which may exist between Member States.

73 That interpretation is supported by the essential function of the trade mark, which is to ensure that the consumer or end user can identify the origin of the product bearing a mark by enabling him or her, without any possibility of confusion, to distinguish it from others which have another origin. That guarantee of origin means that the consumer or end user can be certain that a product bearing a mark offered to him or her has not been subject at a previous stage of marketing to interference by a third party, without the authorisation of the trade mark proprietor, in such a way as to affect the original condition of the product (see, to that effect, judgment of 11 July 1996, Bristol-Myers Squibb and Others, C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282, paragraph 47).

74 Where there is no doubt, in the minds of consumers, that traces of the outer packaging of a medicinal product having been opened are attributable to the repackaging of that product by a parallel importer, the guarantee of origin of that medicinal product is ensured.

75 Secondly, the Court has held that the existence on the market of the Member State of importation or on a substantial part of it of such strong resistance from a significant proportion of consumers to relabelled medicinal products that there must be held to be a hindrance to effective market access also constitutes an obstacle to the effective access of a relabelled medicinal product to that market, such as to necessitate repackaging by replacing the packaging. In those circumstances, repackaging of the medicinal products in new packaging would not be explicable solely by the attempt to secure a commercial advantage, but would be aimed at securing effective access to the market in question (see, to that effect, judgment of 23 April 2002, Boehringer Ingelheim and Others, C‑143/00, EU:C:2002:246, paragraph 52).

76 Similarly, if a significant proportion of consumers in the importing Member State are opposed to the idea of acquiring a medicinal product whose outer packaging bears visible traces of being opened which are caused by the replacement of the existing anti-tampering device by an equivalent device carried out in accordance with Article 47a(1) of Directive 2001/83, the effective access of that medicinal product to the market of that Member State must be considered to be hindered and, therefore, its repackaging in new outer packaging must be regarded as necessary for the purposes of its being marketed in that Member State.

77 In the circumstances described in the preceding paragraph, the trade mark proprietor’s opposition to such repackaging cannot be accepted in so far as it would contribute to artificial partitioning of the markets between Member States.

78 However, as the Advocate General observed, in essence, in point 139 of his Opinion, a parallel importer cannot rely on a general presumption of consumer resistance to relabelled medicinal products whose anti-tampering devices have been replaced. In the light of the considerations set out in paragraphs 51 and 54 of this judgment, the possible existence of such resistance and its extent must be assessed in concreto, taking into account, in particular, the circumstances prevailing in the Member State of importation at the time at which the medicinal product concerned was marketed, and of the fact that traces of opening are visible or, on the contrary, can be detected only after a thorough verification by wholesalers or persons authorised or entitled to supply medicinal products to the public pursuant to their verification obligations under Articles 10, 24 and 30 of Delegated Regulation 2016/161.

79 In the light of all the foregoing considerations, the answer to the first to third questions is that 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 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 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.

80 By its fourth question, the referring court asks, in essence, whether Directive 2001/83 and Delegated Regulation 2016/161, read in conjunction with Articles 34 and 36 TFEU and Article 15(2) of Regulation 2017/1001 and Article 15(2) of Directive 2015/2436, must be interpreted as meaning that a Member State may require 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.

81 As a preliminary point, it should be noted that, as is apparent from paragraphs 64 and 65 of the present judgment, Directive 2001/83 allows, for the purposes of repackaging, the reuse of the original outer packaging, provided that the original safety features can be replaced by features which are equally effective in enabling the verification of the authenticity of the medicinal products concerned and their identification, as well as in providing evidence of tampering with them.

82 In the absence, in Directive 2001/83 and Delegated Regulation 2016/161, of any provision indicating that one form of repackaging should be preferred over the other, it must be held that, provided that all the requirements referred to in Article 47a of that directive are satisfied, repackaging in new packaging and relabelling of parallel-imported medicinal products are equivalent forms of repackaging as regards the effectiveness of the safety features.

83 In those circumstances, it is necessary to examine whether the Member States have a discretion allowing them to require parallel importers to repackage in new packaging rather than to relabel the medicinal products which they import.

84 In that regard, it should be recalled that, as is apparent from recital 12 of Directive 2011/62, that directive introduced into Directive 2001/83 provisions providing for adequate safeguards against falsified medicinal products entering the supply chain in order to protect patients as well as the interests of marketing authorisation holders and manufacturers.

85 In particular, in order to ensure the effectiveness of safety features, Article 47a of Directive 2001/83 lays down the strict conditions under which the safety features referred to in paragraph 60 of this judgment may be removed, covered and replaced when medicinal products are repackaged.

86 As was observed in paragraph 66 of the present judgment, under Article 47a(1)(a) of that directive, the holder of a manufacturing authorisation – authorisation that, as is apparent from Article 40(2) of that directive, any actor in the supply chain which packages medicinal products must possess – must verify, before removing or covering either fully or partially those safety features, that the medicinal product concerned is authentic and that it has not been tampered with. In addition, Article 47a(1)(b) of that directive requires the manufacturing authorisation holder to replace those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering with a medicinal product without opening the immediate packaging of that product. Pursuant to Article 47a(1)(b)(i) of that directive, Delegated Regulation 2016/161 lays down the requirements which replacement safety features must satisfy and, in accordance with Article 47a(1)(c) and (d), the replacement of the safety features must be carried out in accordance with applicable good manufacturing practice for medicinal products and be subject to supervision by the competent authority.

87 In the light of the considerations set out in paragraphs 84 to 86 above, it must be held that Directive 2001/83 and Delegated Regulation 2016/161 lay down exhaustive rules as regards the conditions under which the safety features referred to in paragraph 60 of the present judgment may be replaced.

88 In addition, an analysis of the provisions of Title V of Directive 2001/83, entitled ‘Labelling and package leaflet’, permits the inference that the EU legislature carried out full harmonisation with regard to those safety features, which are referred to in Article 54(o) of that directive, which appears under that Title V.

89 First, Article 60 of Directive 2001/83 provides that Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of Title V of that directive.

90 Secondly, the cases in which the Member States may adopt provisions departing from the rules laid down in Title V of that directive are expressly listed in Article 54a(5), Article 57 and Article 69(2) of that directive.

91 In those circumstances, where the power to lay down different rules is not expressly granted to them, the only requirements to which the Member States may subject the labelling of medicinal products, which includes, as is apparent from paragraph 88 of this judgment, safety features, are those laid down by Directive 2001/83.

92 Consequently, as regards the replacement of the safety features referred to in paragraph 60 of this judgment, the Member States have no power to lay down requirements that differ from those laid down by Directive 2001/83 and Delegated Regulation 2016/161.

93 That interpretation is borne out by the objectives pursued by Directives 2001/83 and 2011/62.

94 Although, as is apparent from recital 2 of Directive 2001/83, the essential aim of that directive is to safeguard public health, recital 3 of that directive states that that objective cannot be achieved by means which hinder the development of the pharmaceutical industry or trade in medicinal products within the European Union. Thus, it follows from recitals 4, 5 and 14 of Directive 2001/83 that that directive aims to remove barriers to trade in medicinal products within the European Union in order to attain the objective of the free movement of medicinal products (see, to that effect, judgment of 11 June 2020, ratiopharm, C‑786/18, EU:C:2020:459, paragraphs 31 and 32).

95 As regards, more specifically, safety features, it is apparent from recitals 11 and 33 of Directive 2011/62 that the EU legislature considered that, in order to ensure a high level of protection of public health against falsified medicinal products while ensuring the functioning of the internal market for medicinal products, the rules applicable to those features should be harmonised at EU level.

96 The attainment of the objective of Directive 2001/83 of ensuring the free movement of medicinal products within the European Union would be compromised if Member States were able to impose requirements additional to those laid down by EU law, by further restricting the possibility of relabelling the original outer packaging of a medicinal product where repackaging is necessary, even though, as was pointed out in paragraph 81 of this judgment, that power has been expressly provided for by the EU legislature.

97 As the Advocate General observed in point 156 of his Opinion, although, in the disputes in the main proceedings, the parallel traders claim the right to repackage medicinal products in new packaging, that might not be the case in other situations, in which such repackaging would be perceived as an additional burden having the effect of impeding the free movement of goods.

98 It thus follows from a systemic interpretation of Article 47a of Directive 2001/83, read in the light of the objectives of that directive and of Directive 2011/62, that that article brings about exhaustive harmonisation as regards the conditions under which safety features may be replaced. Accordingly, Member States may not impede the marketing of medicinal products, whether or not they are repackaged, equipped with those features by requiring additional requirements to be met.

99 That interpretation is not called into question by the fact that, in recital 14 of Directive 2001/83, it is stated that that directive represents ‘an important step towards achievement of the objective of the free movement of medicinal products’ and that ‘further measures [to] abolish any remaining barriers to the free movement [may] be necessary’. Complete harmonisation in a particular field is not incompatible with the fact that such harmonisation is in a state of continuing evolution. The fact that Directive 2001/83 lays down a complete system of rules for safety features of medicinal products in no way means that the European Union legislature cannot amend or adapt those rules or, if necessary, introduce new ones so as better to attain the objectives of removing barriers to trade between Member States and the protection of public health (see, by analogy, judgment of 8 November 2007, Gintec, C‑374/05, EU:C:2007:654, paragraph 29).

100 In the light of all the foregoing considerations, the answer to the fourth question is that Directive 2001/83 and Delegated Regulation 2016/161 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.

101 By its fifth question, the referring court asks, in essence, whether 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 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 impedes 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.

102 As was stated in paragraph 57 of this judgment, the trade mark proprietor may oppose the repackaging of a medicinal product by replacement of its outer packaging where the parallel importer is able to reuse the original packaging of that product for the purpose of marketing in the Member State of importation by affixing labels to that packaging, provided that the relabelled medicinal product is able to have effective access to the market concerned.

103 However, where the circumstances prevailing at the time of marketing in the importing Member State render repackaging of a medicinal product in new packaging objectively necessary because those circumstances impede the marketing of that medicinal product in its relabelled original outer packaging on the market of that Member State, the trade mark proprietor does not have that power. In such circumstances, a trade mark proprietor’s opposition to the repackaging of that medicinal product by replacement of its outer packaging would contribute to artificial partitioning of the markets between the Member States.

104 In that regard, it is true that the Court held, in paragraph 36 of the judgment of 26 April 2007, Boehringer Ingelheim and Others (C‑348/04, EU:C:2007:249), that that condition that repackaging be necessary is fulfilled, in particular, if a rule or a practice in the importing Member State prevents a medical product from being marketed in that Member State in the same packaging as that in which that product is marketed in the exporting Member State.

105 However, such a rule or practice can justify a restriction on the exercise of the trade mark proprietor’s rights only if it complies with EU law.

106 Where a rule of a Member State or a practice of its authorities infringes EU law, the obstacle to effective access of the medicinal product concerned to the market of that Member State is due not to the trade mark proprietor’s opposition, but to that rule or practice.

107 Accordingly, the answer to the fifth question is that 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.

108 By its sixth question, the referring court asks, in essence, whether 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, hereinafter, as regards that condition, ‘the Bristol-Myers Squibb condition’) – 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.

109 In the light of paragraph 79 of that judgment referred to in paragraph 52 above, the sixth question must be understood as meaning that, by that question, the referring court asks whether the Bristol-Myers Squibb condition is applicable where that importer does not reaffix the proprietor’s trade mark to the new outer packaging of the repackaged medicinal product.

110 In that regard, it must be borne in mind that, under Article 9(1) of Regulation 2017/1001 and Article 10(1) of Directive 2015/2436, the registration of a trade mark confers on the proprietor exclusive rights which, according to Article 9(2)(a) of that regulation and Article 10(2)(a) of that directive, entitle that proprietor to prevent all third parties not having his or her consent from using in the course of trade any sign which is identical with that trade mark in relation to goods or services which are identical with those for which the mark was registered.

111 Consequently, it is necessary to examine whether, in circumstances such as those described by the referring court, namely where the trade mark which appears on the original outer packaging of a medicinal product is replaced by a different product name on the new outer packaging of that medicinal product, the parallel importer uses in the course of trade a sign identical with that mark, within the meaning of Article 9(2)(a) and Article 10(2)(a), in relation to the imported medicinal products which he or she wishes to place on the market of a Member State.

112 Article 9(3) of Regulation 2017/1001 and Article 10(3) of Directive 2015/2436 list, in a non-exhaustive manner, several types of use which the proprietor of the trade mark may prohibit (see by analogy, as regards Directive 2008/95 and Council Regulation (EC) No 207/2009 of 26 February 2009 on the European Union trade mark (OJ 2009 L 78, p. 1), judgment of 25 July 2018, Mitsubishi Shoji Kaisha and Mitsubishi Caterpillar Forklift Europe, C‑129/17, EU:C:2018:594, paragraph 38 and the case-law cited).

113 In particular, Article 9(3)(a) of that regulation and Article 10(3)(a) of that directive provide that the proprietor may prohibit all third parties from affixing the sign in question to the goods or to the packaging of those goods.

114 Where, in circumstances such as those described in paragraph 36 of the present judgment, a parallel importer indicates on the new outer packaging of an imported medicinal product that that product corresponds to the medicinal product marketed by the proprietor under his or her trade mark and that the blister packs inside that new outer packaging bear that mark, that parallel importer affixes a sign identical to that mark to the packaging of the goods, within the meaning of those provisions.

115 Furthermore, where that parallel importer markets, on the market of one Member State, a medicinal product which he or she has imported from another Member State and whose immediate packaging, in the present case those blister packs, bears the trade mark of the proprietor, he or she puts that medicinal product on the market of that first Member State under that sign, within the meaning of Article 9(3)(b) of Regulation 2017/1001 and Article 10(3)(b) of Directive 2015/2436.

116 Therefore, it must be held, as was observed by the Advocate General in point 176 of his Opinion, that, in circumstances such as those described in paragraphs 114 and 115 of this judgment, that parallel importer uses in the course of trade a sign identical with the proprietor’s trade mark, within the meaning of Article 9 of Regulation 2017/1001 and Article 10 of Directive 2015/2436, in respect of the medicinal products concerned.

117 Having regard to the matters set out in paragraphs 45 to 51 of this judgment, the repackaging of those medicinal products in new outer packaging is liable to affect the functions of the trade mark and, therefore, the proprietor may have a legitimate interest in opposing it.

118 In the light of the foregoing considerations, the answer to the sixth question is that 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 Bristol-Myers Squibb condition – 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.

119 By its seventh question, the referring court asks, in essence, whether 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 it 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.

120 In the first place, it must be borne in mind that the protection of the trade mark proprietor in relation to the presentation of the new outer packaging in which a medicinal product has been repackaged by the parallel importer of that product is, in principle, ensured by compliance with the condition that the presentation of the repackaged product must not be such as to be liable to damage the reputation of the trade mark or that of its proprietor (see, to that effect, judgment of 22 December 2008, The Wellcome Foundation, C‑276/05, EU:C:2008:756, paragraph 29).

121 In that regard, it is apparent from paragraph 52 of this judgment that 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 trade mark proprietor may legitimately oppose the further marketing in a Member State of a medicinal product bearing that trade mark and imported from another Member State, where the parallel importer of that product has either repackaged it in new outer packaging to which he or she has reaffixed that mark or affixed a label to the original outer packaging, unless five conditions are fulfilled, including the condition that the presentation of the repackaged product must not be such as to be liable to damage the reputation of the trade mark and of its proprietor (see by analogy, as regards Article 7(2) of First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (OJ 1989 L 40, p. 1), judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 40).

122 Thus, that new outer packaging or label must not be defective, of poor quality, or untidy. Moreover, a repackaged pharmaceutical product could be presented inappropriately and, therefore, damage the trade mark’s reputation in particular where the packaging or label, while not being defective, of poor quality or untidy, is such as to affect the trade mark’s value by detracting from the image of reliability and quality attaching to such a product and the confidence it is capable of inspiring in the public concerned (see, to that effect, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraphs 40 and 43).

123 The Court has thus held that, in principle, the fact that a parallel importer does not affix the trade mark to the new outer packaging or applies either his or her own logo or a house-style or get-up or a get-up used for a number of different products, or positions the additional label so as wholly or partially to obscure the proprietor’s trade mark, or fails to state on the additional label that the trade mark in question belongs to the proprietor, or prints the name of the parallel importer in capital letters is liable to damage the trade mark’s reputation (see, to that effect, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 45).

124 Similarly, the fact that the parallel importer reaffixes to the new outer packaging the trade mark of the proprietor specific to that product, without reproducing the other trade marks and/or the other distinctive signs which appeared on the original outer packaging, is also liable to damage the reputation of the trade mark.

125 However, the question whether the circumstances mentioned in the previous paragraph are in fact liable to damage the reputation of the trade mark concerned is a question of fact for the referring court to decide in the light of the circumstances of each case (see, to that effect, judgment of 26 April 2007, Boehringer Ingelheim and Others, C‑348/04, EU:C:2007:249, paragraph 46).

126 In the second place, reaffixing the specific trade mark of a product in combination with the parallel importer’s trade marks and/or distinctive signs is liable to compromise the function of indicating the origin of that mark

127 In particular, it follows from the Court’s case-law that a presentation of a product which does not enable normally informed and reasonably attentive consumers, or enables them only with difficulty, to ascertain whether the 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 adversely affects the function of indicating the origin of the mark (see, to that effect, judgment of 8 July 2010, Portakabin, C‑558/08, EU:C:2010:416, paragraph 34).

128 In that regard, it should be noted, however, that the function of indicating the origin of the mark is, in principle, guaranteed by compliance with the third of the five conditions set out in paragraph 52 of the present judgment, according to which the repackager of a product and the name of the product manufacturer must be clearly indicated on the packaging of that product.

129 It is in the light of those factors and taking into account the specific circumstances of each case that it is for the referring court to assess whether the reaffixing, to the new outer packaging of a medicinal product, of the proprietor’s trade mark specific to that product, without reproducing on that packaging the other trade marks and/or the other distinctive signs which appeared on the original packaging of that medicinal product adversely affects the function of indicating the origin of the mark.

130 Having regard to all the foregoing considerations, the answer to the seventh question is that 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.

131 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

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.

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.

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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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Merck Sharp & Dohme and Others (Intellectual property - Trade marks - Parallel import of medicinal products - Repackaging - Judgment) [2022] EUECJ C-224/20 (17 November 2022) URL: http://www.bailii.org/eu/cases/EUECJ/2022/C22420.html Cite as: ECLI:EU:C:2022:893, [2023] ETMR 9, EU:C:2022:893, [2022] EUECJ C-224/20

Court of Justice of the European Communities (including Court of First Instance Decisions)