CJEU on repackaging and new outer packaging of medicinal product Novartis
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.
TRADE MARK LAW
Case C-147/20 Questions:
(1) Can it lead to an artificial partitioning of the markets within the meaning of the case-law of the Court of Justice if the safety features of original outer wrapping/original packaging which are provided for underArticle 54(o) and Article 47a of Directive [2001/83] can, in the event that the parallel trader retains that original packaging, be replaced in compliance with Article 47a(1)(b) of that directive only in such a way that visible traces of opening remain after the originally existing safety features have been partly or fully removed and/or covered?
(2) Is it of significance for answering the first question whether the traces of opening become visible only when the medicinal product has been thoroughly inspected by wholesalers and/or persons authorised or entitled to supply medicinal products to the public, such as pharmacies, in fulfilment of their obligation under Articles 10, 24 and 30 of [Delegated Regulation 2016/161], or may be overlooked in a superficial inspection?
(3) Is it of significance for answering the first question whether the signs of opening become visible only when the packaging of a medicinal product is opened, for example by the patient?
(4) Is Article 5(3) of [Delegated Regulation 2016/161] to be interpreted as meaning that the barcode containing the unique identifier within the meaning of Article 3(2)(a) of that regulation must be printed directly on the packaging, so that Article 5(3) is not complied with if a parallel trader affixes the unique identifier to the original outer packaging using an additional external sticker?
Answer 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
must be interpreted as meaning that the proprietor of an EU trade mark is not entitled to oppose the marketing by a parallel importer of a repackaged medicinal product in a new outer packaging bearing that mark, where the replacement of the anti-tampering device of the original outer packaging of that medicinal product carried out in accordance with Article 47a(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, would leave visible traces of opening on that packaging and where those traces would cause such strong resistance on the part of a significant proportion of consumers on the market of the Member State of importation or on a substantial part of that market to medicinal products repackaged in that way that it would constitute an obstacle to effective access to that market, which must be established on a case-by-case basis.
2. Article 5(3) of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83
must be interpreted as not precluding the barcode containing the unique identifier referred to in Article 3(2)(a) of that delegated regulation from being affixed to the outer packaging of the medicinal product by means of an adhesive label, provided that that label cannot be removed without being damaged and that, in particular, the barcode remains perfectly readable throughout the supply chain and throughout the entire period referred to in Article 6 of that delegated regulation.
