In February 2012, the European Commission (the “Commission”) issued guidelines concerning the enforcement by EU customs authorities of intellectual property rights with regard to goods, in particular medicines, in transit through the EU (the “Guidelines”).
The Guidelines aim to offer clarification with regard to the EU legislation governing intellectual property enforcement by customs authorities and its application to goods in transit (i.e., Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights and the implementing Commission Regulation (EC) No 1891/2004 of 21 October 2004 laying down provisions for the implementation of Council Regulation (EC) No 1383/2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights – the “Customs Regulations”).
The need for such a clarification had been demonstrated by India’s and Brazil’s requests for consultations with the EU at the World Trade Organisation ("WTO") in May 2010 regarding certain customs detentions of pharmaceuticals in transit in the EU. The pharmaceuticals concerned were covered by patents in the EU, while they were considered to be generics in the countries of provenance and destination. The WTO procedure is now understood to be over after the parties reached an understanding.
In the Guidelines, the Commission indicates that it is crucial for the EU to find a balance in preventing pharmaceuticals which infringe intellectual property from entering the EU market without hampering the legitimate international trade in products during their transit through the EU.
To this end, the Guidelines try and offer guidance to the principles established by the Court of Justice of the European Union (the “ECJ”) in the joined cases C-446/09 (Philips) and C-495/09 (Nokia) which concerned goods in transit in the EU that had been stopped by customs authorities under suspicion of infringing design rights and trade marks respectively (See, This Newsletter, Volume 2011, No. 12, p. 5). The Guidelines make it clear that these principles do not only apply to trade marks and design rights but also to other intellectual property rights such as patents, including supplementary protection certificates.
The Guidelines point out that if goods are protected by an intellectual property right in the EU and are placed under a suspensive customs procedure or in other customs situations (e.g., temporary storage, entry into free zone or free warehouses), this does not constitute sufficient ground for the customs authorities to act against them.
On the other hand, the Guidelines add that this situation also does not necessarily preclude the application of border measures to protect intellectual property rights. According to the Guidelines, the customs authorities can act against goods in transit which are covered by an intellectual property right in the EU on the basis of the Customs Regulations when these goods are the subject of a commercial act (e.g., advertising, sale, offer for sale) which targets the EU market. The same is true when it is clear from correspondence or other documentation that there are plans to divert the goods to EU consumers.
Moreover, the Guidelines underline that customs authorities can act against goods in transit in accordance with the Customs Regulations when certain elements give rise to suspicion that intellectual property rights are infringed. The Guidelines provide some examples of such elements and indicate that the lack of reliable information regarding the consignor or manufacturer of the goods, the fact that the destination of the goods is not declared or a lack of cooperation with the customs authorities are factors that may justify a temporarily detention or suspension of the release of goods in transit.
The Guidelines can be consulted here.
