Following a reference from the Austrian Supreme Court, the ECJ ruled on two questions relating to the conditions applicable to repackaging of pharmaceutical products in a parallel imports case. The decision broadly followed the earlier opinion of the Advocate General from October 2008.
The Wellcome Foundation Ltd (“Wellcome”) owned the ZOVIRAX trade mark, registered in Austria for pharmaceutical products and marketed within the EEA by Wellcome or with its consent. Paranova Pharmazeutika Handels GmbH (“Paranova”) imported branded ZOVIRAX products from Greece, where they were sold in packs of 70 tablets. To comply with Austrian regulations, Paranova repackaged the products in packs of 60. Paranova’s packaging differed from the original in that it included the words “Repackaged and imported by Paranova” in bold type and block capitals on the front, the manufacturer was referred to on the sides and back in normal type and there was a blue band at the edges, as regularly used by Paranova.
Paranova informed Wellcome of its intention to market ZOVIRAX in Austria, and enclosed colour prints of the outer packages, the blister packs and the instructions for use. Wellcome requested a complete sample of the packaging and that Paranova disclose the state of export and the exact reasons for the repackaging. While Paranova disclosed the reasons for the repackaging (different sizes of packaging), it refused to disclose the state of export or to provide a sample unless Wellcome paid.
Wellcome sought an injunction preventing Paranova from marketing ZOVIRAX in packaging with the features referred to above and without informing it of the state of export and precise reasons for the repackaging.
The dispute reached the Oberster Gerichtshof, which made a referral to the ECJ. The Austrian Court required clarification as to what is decisive in evaluating the conformity of the new packaging. Does proof that repackaging is necessary – in order not to hinder effective access to the market - need to be shown in relation to just packaging itself, or also the presentation of the packaging?
As such, the Austrian Court asked firstly whether Article 7 of the Trade Marks Directive (and the case law of the ECJ) should be interpreted as meaning that proof that reliance on the trade mark would contribute to an artificial partitioning of the market must be furnished not only with regards to the repackaging in itself, but also as regards to the presentation of the new packaging (Question 1(a)). To the extent that this question is answered in the negative, the referring court further asked whether the presentation of the new packaging is to be measured against the principle of minimum intervention or (only) against whether it is such as to damage the reputation of the trade mark and its proprietor (Question 1(b)).
The referring court finally asked whether Article 7 (and the case law of the ECJ) should be interpreted as meaning that the parallel importer fulfils his duty of notification only if he informs the proprietor of the trade mark and also of the state of export and the precise reasons for the repackaging (Question 2).
Question 1(a) had already been answered in the negative in Boehringer II (C-348/04), where it was held that the condition was directed at the fact of repackaging - and the choice between a new carton and oversticking - and not at the manner or style in which it had been repackaged.
In considering the remaining questions the ECJ referred to Bristol-Myers Squibb and Others (joined cases C-427/93, C-429/93, and C 436/93) in which the Court ruled that Article 7(2) must be interpreted as meaning that the trade mark owner may legitimately oppose the further marketing of a pharmaceutical product where the importer had repackaged the product and reaffixed the trade mark unless, amongst other things, the importer gave notice to the trade mark owner before the repackaged product was put on sale, and, on demand, supplied him with a specimen of the repackaged product.
This condition enabled the proprietor to check that the repackaging was not carried out in such a way as to directly or indirectly affect the original condition of the product. It further allowed the proprietor to check that the presentation after repackaging was not likely to damage the reputation of the trade mark. The condition that repackaging was necessary to market the product in the importing member state was directed only at the fact of repackaging the product and not at the manner or style in which it had been repackaged (Boehringer II). Similarly, the presentation of the new packaging of the product must also not be assessed against the criterion that there should be the minimum possible adverse effect on the trade mark rights.
In conclusion, the answer to Question 1(b) must be that Article 7(2) is to be interpreted as meaning that, where it is established that repackaging of the pharmaceutical product is necessary for further marketing in the Member State of importation, the presentation of the packaging should be assessed only against the condition that it should not be such as to be liable to damage the reputation of the trade mark or that of its proprietor.
As regards to Question 2, the ECJ confirmed that it was for the parallel importer to furnish the trade mark owner with the necessary and sufficient information to enable it to determine whether the repackaging of the product under the trade mark was necessary in order to market it in the Member State of importation. The kind of information to be furnished will depend on the facts in each case. The ECJ could foresee that in exceptional cases the state of export could be required to be disclosed where the absence of that information would prevent the trade mark owner from evaluating the need to repackage.