Re-packaging of parallel imported medicinal products in Austria
April 2013
In Europe, parallel import of medicinal products is subject to various hurdles. One is when the foreign packaging of medicinal products in general does not meet the domestic requirements of the country of import. Important guidance on this issue has come from the Austrian Supreme Court.
The parallel import of medicinal products within the EU is subject to strict regulation, especially concerning the packaging.
Apart from language matters, which can be eliminated by placing a sticker on the packaging, it is the various packaging sizes that are in use in different member states, which may require repackaging. In principle however, this is precluded by the trade mark right of the manufacturer: All changes on the packaging or the product itself constitute an infringement of the trade mark. But this rule conflicts with the principle of the free movement of goods within the EU. Therefore, certain necessary and appropriate changes are permitted, if they are in order to eliminate obstacles in the distribution process.
Under what circumstances can the trademark owner not oppose re-packaging?
The European Court of Justice (“ECJ”) has declared that in general, a trade mark proprietor may legitimately oppose the further marketing of a pharmaceutical product if the importer has repackaged the product and reaffixed the trade mark, unless:
- this would contribute to the artificial partitioning of the markets between Member States.
- it is shown that the repackaging does not affect the original condition of the product inside the packaging;
- the new packaging clearly shows who repackaged the product and also shows the name of the manufacturer;
- the way a product is repackaged, will not damage the reputation of the trade mark nor its proprietor – the packaging must not be damaged, of poor quality, or untidy; and
- the importer gives notice to the trade mark proprietor before the repackaged product is put on sale, and in addition, supplies him with a specimen of the repackaged product upon demand.
Thus the manufacturer may prohibit a change of the packaging, unless re-packaging is needed to enable the marketing of a parallel imported pharmaceutical product. The ECJ does not state how these repacked products or those with a paste-on label are supposed to look. It does not respond to whether the reputation of a trade mark owner is damaged by applying a different logo or house-style to the product.
When exactly is a trade mark infringement constituted?
However, the Austrian Supreme Court (“OGH”) has set out its position on this matter, supplementing the ruling of the ECJ, as regards the Austrian market1: The mere fact that a reference of the repackager is placed on a new packaging in a more prominent way than the reference of the original manufacturer, does not necessarily affect the function of the trade mark as an indicator of origin. This means that the importer may place his name on the new packaging in a larger way than the one of the manufacturer, as long as it is clear who is the manufacturer and who is the importer – consumers must not be misled.
The parallel importer however, has to submit relevant information including a specimen to the trade mark proprietor. These are needed by the manufacturer in order to check whether the repackaging of the goods protected by his brand are necessary at all for their distribution in the importing state. The kind of information the importer is supposed to communicate depends on the individual case. The parallel importer has to inform the trade mark owner about reasons for repackaging (e.g. another packaging size requirement). It may also be necessary to indicate the exporting member state, especially should the trade mark proprietor otherwise be prevented from evaluating the need for repackaging. The importer cannot rely on the argument that there might be a risk of the supplier being exposed to pressure, which could cause problems with regard to competition. By the way: An obligation for the trade mark owner to reimburse the costs incurred by submitting the specimen is not provided!
Is a new packaging design permitted?
Is the parallel importer also entitled to issue a new product-design for the products he imports? In view of the above, one would think that this is not permitted. The courts have a different opinion: the necessity of repackaging only concerns the repackaging as such and the choice between new packaging and placing stickers on the old packaging, but not how the repackaging is performed. The importer is entitled to distribute the parallel imported products under the trade mark of the manufacturer in new packaging if, compared to the original product, its appearance is changed completely, e.g.by printing “repackaged and imported by P” on the front side and the reference to the manufacturer printed on the lateral or back side. Applying a coloured stripe design on a new packaging is also permitted, provided that the function of the trade mark as an indicator of origin and quality is not affected and that the packaging does not create an impression of being damaged, being of poor quality or being unclean.
The presentation of the new packaging is not to be measured against the principle of minimum intervention but against the standard of appropriateness. The reputation of the trade mark and its owner must not be damaged.
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