Roche AB v Orifarm AB (Ö 566-06)

25 April 2007

Sara Sparring

Roche markets its drug for treatment of Parkinson’s disease under the trade mark MADOPARK in combination with the words QUICK MITE in Sweden. In the UK and Ireland the same drug is marketed by Roche under trade mark MADOPAR in combination with the suffix 62.5 DISPERSIBLE. In 2004 the Swedish Medical Products Agency (the “MPA”) decided that Roche is not allowed to use the suffix 62.5 DISPERSIBLE in Sweden as the use of short abbreviations and suffixes, which do not carry an established and relevant meaning, is not acceptable as part of a name for a pharmaceutical product.

Orifarm parallel imported the drug into Sweden from the UK and Ireland and changed the labelling on the drug’s packaging to MADOPARK QUICK MITE, the trade mark used by Roche in Sweden. Roche brought an action against Orifarm requesting an interim injunction under a prohibition of a penalty of a fine on the ground that Orifarm’s use of Roche’s registered trade mark constituted a trade mark infringement. With reference to MPA’s decision from 2004, Orifarm claimed that the relabelling of the packaging of the drug constituted an objectively necessary measure to gain effective access to the Swedish market. Further, Orifarm stressed that the issue of patient safety and resistance from the customers to a product marketed under a different name than the one marketed by the proprietor in support of its actions. Roche argued for its part that the fact that Orifarm could not use the suffix 62.5 DISPERSIBLE did not justify unauthorised use of the trade mark MADOPARK.

The District Court and the Court of Appeal dismissed Roche’s action. The Swedish Supreme Court referred to the principle of EEA-wide exhaustion of trade mark rights and established, in accordance with case law from the ECJ, that a parallel importer has the right to keep a trade mark on a certain product, but not to relabel the product before marketing the product in the country of import. However, according to the principle of free movement of goods there are exceptions to the principle under certain conditions that gives the importer a right to change the label or change the packaging before a product is marketed in the country of import. One of these conditions is when it is objectively necessary in order for a parallel trader to gain effective access to the market in the country of importation. According to the Supreme Court, Orifarm does not have the right to take broader measures than necessary to gain access to the Swedish market. Despite the fact that it has been necessary for Orifarm to relabel the product it is uncertain that Orifarm automatically had the right to relabel the product with Roche’s protected trade mark MADOPARK. However, the issue of patient safety and resistance from consumers to a product marketed under a different name than the one marketed by the trade mark proprietor has to be considered. Taking that into consideration and for the purpose of settling the issue of injunction under penalty of fine the Supreme Court found it likely that Orifarm’s relabelling was necessary to gain effective access to the Swedish market. The District Court will assess the factual circumstances of the case and the main hearing shall take place on 15 May 2007, if Orifarm’s request for a preliminary ruling from the ECJ is not granted by the District Court.