Case C-400/09: Reference for a preliminary ruling from the Højesteret (Denmark), lodged on 19 October 2009 — Orifarm A/S, Orifarm Supply A/S, Handelsselskabet af 5 januar 2002 A/S, in liquidation, Ompackningsselskabet af 1 november 2005 A/S v Merck & Co. Inc., Merck Sharp & Dohme B.V., Merck Sharp & Dohme
Date: 2009-10-19
Institutions: Court of Justice
Subjects: case-law (EU), import (EU), interpretation of the law, market approval, pharmaceutical product, preparation for market








C_2009312EN.01002301.xml










19.12.2009   


EN


Official Journal of the European Union


C 312/23





Reference for a preliminary ruling from the Højesteret (Denmark), lodged on 19 October 2009 — Orifarm A/S, Orifarm Supply A/S, Handelsselskabet af 5 januar 2002 A/S, in liquidation, Ompackningsselskabet af 1 november 2005 A/S v Merck & Co. Inc., Merck Sharp & Dohme B.V., Merck Sharp & Dohme
(Case C-400/09)
2009/C 312/38
Language of the case: Danish

Referring court

Højesteret

Parties to the main proceedings


Appellants: Orifarm A/S, Orifarm Supply A/S, Handelsselskabet af 5 januar 2002 A/S, in liquidation, Ompackningsselskabet af 1 november 2005 A/S

Respondents: Merck & Co. Inc., Merck Sharp & Dohme B.V., Merck Sharp & Dohme

Questions referred







1.


Are Case C-232/94 MPA Pharma v Rhône-Poulenc Pharma
 (1) and Joined Cases C-427/93, C-429/93 and C-436/93 Bristol-Myers Squibb and Others v Paranova
 (2) to be interpreted as meaning that a parallel importer which is the holder of the marketing authorisation for, and possesses information on, a medicinal product imported in parallel, and which issues instructions to a separate undertaking for the purchase and repackaging of a medicinal product, for the detailed design of the product’s packaging and for arrangements in relation to the product, infringes the rights of the trade mark proprietor by indicating itself — and not the separate undertaking which holds the repackaging authorisation, has imported the product and has carried out the physical repackaging, including (re)affixing of the trade mark proprietor’s trade mark — as the repackager on the outer packaging of the medicinal product imported in parallel?










2.


Is it of significance in answering Question 1 that an assumption might be made that, where the marketing authorisation holder indicates itself as the repackager instead of the undertaking which physically carried out the repackaging to order, there is no risk that the consumer/end user might be misled into assuming that the trade mark proprietor is responsible for the repackaging?










3.


Is it of significance in answering Question 1 that an assumption might be made that the risk of misleading the consumer/end user into assuming that the trade mark proprietor is responsible for the repackaging is excluded if the undertaking which physically carried out the repackaging is indicated as being the repackager?










4.


Is it only the risk that the consumer/end user might be misled into assuming that the trade mark proprietor is responsible for the repackaging which is of significance in answering Question 1, or are other considerations regarding the trade mark proprietor also relevant, for example (a) that the entity which undertakes the importation and physical repackaging and (re)affixes the trade mark proprietor’s trade mark on the product’s outer packaging potentially on its own account infringes the trade mark proprietor’s trade mark by so doing, and (b) that it may be due to factors for which the entity that physically carried out the repackaging is responsible that the repackaging affects the original condition of the product or that the presentation of the repackaging is of such a kind that it must be assumed to harm the trade mark proprietor’s reputation (see, inter alia, Joined Cases C-427/93, C-429/93 and C-436/93 Bristol-Myers Squibb and Others v Paranova)?










5.


Is it of significance in answering Question 1 that the holder of the marketing authorisation, which has indicated itself as being the repackager, at the time of the notification of the trade mark proprietor prior to the intended sale of the parallel imported medicinal product once repackaged, belongs to the same group as the actual repackager (sister company)?






(1)  [1996] ECR I-3671.

(2)  [1996] ECR I-3457.