Case C‑297/15

Ferring Lægemidler A/S

v

Orifarm A/S

(Request for a preliminary ruling from the Sø- og Handelsretten)

(Reference for a preliminary ruling — Trade marks — Directive 2008/95/EC — Article 7(2) — Medicinal products — Parallel import — Partitioning of the markets — Need for the repackaging of the product bearing the mark — Medicinal product placed on the exporting market and importing market by the trade mark proprietor with the same kind of packaging)

Summary — Judgment of the Court (Fifth Chamber), 10 November 2016

1. Approximation of laws—Trade marks—Directive 2008/95—Parallel import of medicinal products after repackaging and reaffixing of the trade mark—Opposition of the proprietor—Unlawful—Conditions—Artificial partitioning of the markets between the Member States—Necessary repackaging of the medicinal product—Criteria for assessment

   (European Parliament and Council Directive 2008/95, Art. 7(2))

2. Approximation of laws—Trade marks—Directive 2008/95—Parallel import of medicinal products after repackaging and reaffixing of the trade mark—Opposition of the proprietor—Lawfulness—Conditions—Possibility of marketing medicinal products in the exporting market and importing market in the same packaging on the export—Marketing not limited to a part of the importing State’s market—Verification a matter for the national court

   (European Parliament and Council Directive 2008/95, Art. 7(2))

1.  Under Article 7(2) of Directive 2008/95 to approximate the laws of the Member States relating to trade marks, the trade mark proprietor’s opposition to the repackaging, in so far as it constitutes a derogation from free movement of goods, cannot be accepted if the proprietor’s exercise of that right constitutes a disguised restriction on trade between States party to the European Economic Area (EEA) Agreement, within the meaning of the second sentence of Article 13 of that agreement. A disguised restriction within the meaning of that latter provision will exist where the exercise, by the trade mark proprietor, of his right to oppose repackaging contributes to artificial partitioning of the markets between the States party to the EEA Agreement, where the repackaging is done in such a way that the legitimate interests of the proprietor are respected.

   A trade mark proprietor’s opposition to repackaging contributes to the artificial partitioning of the markets between the States party to the EEA Agreement where the repackaging is necessary to enable the product imported in parallel to be marketed in the importing State. The power of the proprietor of trade mark rights protected in a Member State to oppose the marketing of repackaged products under the trade mark should be limited only in so far as the repackaging undertaken by the importer is necessary in order to market the product in the Member State of importation. It follows from those considerations that the change brought about by any repackaging of a trade-marked medicinal product — creating by its very nature the risk of interference with the original condition of the product — may be prohibited by the trade mark proprietor unless the repackaging is necessary in order to enable the marketing of the products imported in parallel and the legitimate interests of the proprietor are also safeguarded.

   As regards in particular the criterion of the necessity of the repackaging, the circumstances prevailing at the time of marketing in the importing State, which render repackaging objectively necessary for the medicinal product to be placed on the market in that State by the parallel importer, must be taken into account in the assessment. A trade mark proprietor’s opposition to repackaging is not justified if it hinders effective access to the importing market. In particular, it should be noted, first of all, that the trade mark proprietor cannot oppose the repackaging of the product in new external packaging, when the packet size used by that proprietor in the State party to the EEA Agreement where the importer purchased the product, cannot be marketed in the importing State because of, in particular, a rule authorising packaging only of a certain size or a national practice to the same effect, sickness insurance rules making the reimbursement of medical expenses depend on the size of the packaging, or well-established medical prescription practices based, inter alia, on standard sizes recommended by professional groups and sickness insurance institutions.

   Then, where, in accordance with the rules and practices in force in the importing State, the proprietor uses several different sizes of packaging in that State, the finding that one of those sizes is also marketed in the importing State party to the EEA Agreement is not enough to justify the conclusion that repackaging is unnecessary. Partitioning of the markets would exist if the importer were able to sell the product in only part of his market.

   (see paras 15-22)

2.  Article 7(2) of Directive 2008/95 to approximate the laws of the Member States relating to trade marks must be interpreted as meaning that a trade mark proprietor may object to the continued marketing of a medicinal product by a parallel importer, where that importer has repackaged that medicinal product in a new, outer packaging and reaffixed the trade mark, where, first, the medicinal product at issue can be marketed in the importing State party to the EEA Agreement in the same packaging as that in which it is marketed in the exporting State party to the EEA Agreement and, second, the importer has not demonstrated that the imported product can be marketed only in a limited part of the importing State’s market. Those are matters to be determined by the referring court.

   (see para. 29, operative part)