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CJEU rules on parallel imports of medical devices

Posted on 2 July 2018

CJEU rules on parallel imports of medical devices

The law relating to the repackaging of imported pharmaceutical products is now largely settled following a series of decisions of the Court of Justice of the European Union (CJEU). Parallel importers are required to (i) ensure that the original condition of the product is not adversely affected by the repackaging; (ii) state who has repackaged the product and who the manufacturer is; (iii) ensure that the reputation of the trade mark and its owner are not liable to damage by the presentation of the repackaged product; and (iv) provide written notice (and a sample if requested) of the repackaging of the product in question to the trade mark proprietor.

Cases on these issues are now fairly rare.  However, in a recent decision, the CJEU has confirmed that these principles apply equally to repackaged or relabelled medical devices, but that the relabelling in question in this case did not amount to objectionable repackaging.  The parallel importer had simply added a small label to an unprinted part of the outside of the packaging of the device which did not conceal the trade mark and which only identified the importer of the medical device and nothing more.  Accordingly, the parallel importer was not required to give notice or a sample to the trade mark owner.


The case was referred by Germany's Federal Court of Justice, and revolved around Article 13 of the EU Trade Mark Regulation, which provides that a trade mark proprietor cannot prohibit use of the mark in relation to goods which have been put on the market in the EU by the proprietor or with his consent (its rights are said to be 'exhausted'), unless there are legitimate reasons to oppose further commercialisation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market.

Lohmann owns the EU trade mark 'Debrisoft', and manufactures and markets a dressing used for the superficial treatment of wounds (the Device).  Austrian company Junek imported the Device from Austria (where it had been put on the market by Lohmann) into Germany.  Junek had affixed a label neatly to an unprinted part of the box which featured its company contact details, a barcode, and a central pharmaceutical number which facilitates the movement of the products with pharmacies.

CJEU decision

The CJEU decided that Lohmann could not restrict Junek's parallel importation of the Device into Germany based on its EUTM as its rights in that mark were exhausted.  Given that the packaging had not been modified and the original presentation was not affected other than by the placement of the small label, the relabelling did not amount to objectionable repackaging which affected the purpose of the mark.

It is important to note the Court's finding that the facts in this case differed from previous cases concerning relabelling where brand owners could object to repackaging: in those cases there was an intervention by the parallel importer that not only concerned affixing an additional external label to the packaging or its repackaging, but also the opening of the packaging to insert an information leaflet in a different language to the country of origin of the product which bore the mark in question.

Brexit – how will the rules change?

It remains unclear how the rules on parallel imports and exhaustion of IP rights will be dealt with post-Brexit.  Pursuant to the terms of the draft EU Withdrawal Agreement, there will be a continued regime of exhaustion of IP rights within the UK and EEA in respect of goods placed on the market prior to the end of the proposed transition period (ending on 31 December 2020).  However, once the UK has left the EU, the UK may seek to retain regional exhaustion or to introduce national exhaustion (which would mean that UK trade mark owners could prevent parallel imports from the EU, and elsewhere, for resale in the UK), or international exhaustion, which would mean parallel import and resale in the UK of goods sold elsewhere in the world could not be prevented.

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