The European Court of Justice (ECJ) has held that a parallel importer does not repackage a medical device by adding a small label next to the original branding on an unopened box.
Article 13(2) of the 2009 EU Trade Mark Regulation (now Article 15(2) of Regulation (EU) 2017/1001) prohibits a trade mark owner from opposing the further commercialisation by parallel importers of medical devices in their original internal and external packaging as long as the content, function, size, presentation and placement of the additional label added by the importer do not give rise to a risk to the guarantee of origin of the medical device bearing the mark (Article 13(2), EU Trade Mark Regulation (207/2009/EC), now Article 15(2), EU Trade Mark Regulation 2017/1001/EU).
In Bristol-Myers Squibb v Paranova AS, the ECJ set out a list of conditions (the BMS conditions) that parallel importers must fulfil in order to avoid a trade mark infringement claim, in cases concerning parallel trade in repackaged or relabelled pharmaceutical products (C-427/93, C-429/93 and C-436/93).
In Boehringer Ingelheim, the ECJ held that a trade mark owner may legitimately oppose the further commercialisation of a pharmaceutical product imported from another EU member state in its original packaging with an additional external label applied by the importer, unless:
- Use of the trade mark rights to oppose the marketing of the re-labelled products under that trade mark would contribute to the artificial partitioning of the markets between member states.
- It is shown that the repackaging cannot affect the original condition of the product inside the packaging.
- The new packaging states clearly who repackaged the product and the name of the manufacturer.
- The presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner; so, the packaging must not be defective, of poor quality, or untidy.
- The importer gives notice to the trade mark owner before the repackaged or over-stickered product is put on sale, and, on demand, supplies him with a specimen of the repackaged product (www.practicallaw.com/8-364-5999).
L owned an EU trade mark for wound dressings. Through parallel importation J sold wound dressings in Germany which were originally manufactured and exported to Austria. L sued J in Germany successfully for trade mark infringement. J appealed.
The German Court referred to the ECJ the question of whether Article 13 meant that a trade mark owner can oppose further commercialisation of a medical device imported from another member state, in its original packaging, when an additional label is added by the importer.
The ECJ confirmed that trade mark owners cannot oppose a parallel importer's further commercialisation of a medical device in its original packaging if the additional labelling added by the importer does not threaten the medical device's guarantee of origin.
Effectively the German court was asking whether the BMS conditions applied to parallel imports of medical devices as well as to imports of pharmaceutical products. Even though medical devices are not, as is the case for pharmaceutical products, subject to authorisation procedures, the conformity assessment procedure necessary for them to be allowed on to the market made them, from the point of view of both manufacturers and consumers, particularly sensitive as health products for which the guarantee of origin provided by the mark covering the product, owing to the high degree of responsibility of the manufacturer, was particularly important.
The BMS conditions only applied when the importer had repackaged the product. Relabelling may constitute repackaging. Here, however, the additional labelling was not a repackaging, because the original presentation of the packaging of the medical device had not been altered, L's trade mark remained visible and J's small sticker merely identified the parallel importer as responsible for placing on the market, stating his contact details, a bar code and a central pharmaceutical number.
The ECJ distinguished Bristol Myers-Squibb as the facts here did not involve the opening of the original packaging to insert a translated information leaflet. Here, J had merely added a small additional label which contained necessary information about itself as importer to an unprinted part of the packaging and without obscuring L's trade mark. The attachment of this label to the unopened box meant the original packaging was preserved and the medical device inside was not modified, and so it did not affect the trade mark’s guarantee of origin. As it did not amount to repackaging within the meaning of the ECJ's case law on parallel importation of pharmaceutical products, it was not a legitimate reason justifying opposition by L to the further commercialisation of the medical device.
Most case law in this area has focussed on alterations to the condition or integrity of the goods and their original instructions, or repackaging in the form of overstickering or re-branding, particularly where the trade mark has been reaffixed to the packaging after it has been repackaged. This case law has confirmed in relation to pharmaceutical products that these practices can threaten the function of the trade mark affixed to the product as a guarantee of origin. While this decision confirms that the BMS conditions are equally applicable in relation to medical devices, if indeed there has been repackaging, it also suggests that there may be a de minimis threshold applicable to the concept of repackaging which does not include a small discretely placed additional label unlikely to jeopardise the functions of the trade mark. It will be interesting to see if this de minimis approach is similarly applied in relation to pharmaceutical products.
Case: Junek Europ-Vertrieb GmbH v Lohmann & Rauscher International GmbH & Co KG C-642/16.