CJEU on repackaging and new outer packaging of medicinal product Merck Sharp & Dohme
18-11-2022 Print this page
EU 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. Anti-tampering device.
Case C-224/20 - Questions:
(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?
(3) If the answer to Question 2 is in the negative:
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?
Ruling CJEU:
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.
