EN Official Journal of the European Union C 244/4

Commission notice on the customs enforcement of Intellectual Property Rights concerning goods brought into the customs territory of the Union without being released for free circulation including goods in transit

(2016/C 244/03)

Contents

1. OBJECTIVE 4

2. GOODS INFRINGING AN INTELLECTUAL PROPERTY RIGHT IN THE CONTEXT OF CUSTOMS ENFORCEMENT 5

2.1. Goods coming from third countries without being released for free circulation 5

2.2. Goods coming from third countries without being released for free circulation and bearing an identical or essentially identical trade mark 5

3. GOODS SUSPECTED OF INFRINGING AN INTELLECTUAL PROPERTY RIGHT – CUSTOMS ENFORCEMENT 6

3.1 Control and detention 6

3.2. Identical or essentially identical trade mark goods. 7

3.3. Medicines 8

3.4. Cooperation with the right holders 8

1. OBJECTIVE

The ‘Guidelines of the European Commission concerning the enforcement by EU customs authorities of intellectual property rights with regard to goods, in particular medicines, in transit through the EU’ published by the Commission services on 1 February 2012 on the Website of the Directorate-General for Taxation and Customs Union (TAXUD) need to be updated to reflect:

— Regulation (EU) No 608/2013 (1) which has replaced Council Regulation (EC) No 1383/2003 (2);

— The trade mark package (Regulation (EU) 2015/2424 (3) has amended Council Regulation (EC) No 207/2009 (4) and Directive (EU) 2015/2436 (5) has been adopted).

Regulation (EU) No 608/2013 sets out the conditions and procedures for administrative customs enforcement of Intellectual Property Rights (IPR) and it has notably extended the scope of IPR relevant to customs enforcement (trade mark, design, copyright and related right, geographical indication, patent, plant variety right, topography of semi-conductor product, utility model, trade name).

The provisions of Regulation (EU) No 608/2013 on customs enforcement of IPR must be applied taking into account the need to promote effective and adequate protection of intellectual property rights and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade, as stated in the preamble and Article 41 of the Agreement on Trade-Related Aspects of Intellectual Property Rights agreement (TRIPs agreement) of the World Trade Organisation (WTO) (6).

The trade mark package now extends the rights of the proprietor of a trade mark registered at Union level as a European Union trade mark or at Member State level as a national trade mark to prevent third parties from bringing, in the course of trade, into the Union without being released for free circulation, goods coming from third countries and bearing without authorisation a trade mark which is identical with the trade mark registered in respect of such goods or which cannot be distinguished in its essential aspects from that trade mark. This has to be taken into account in the customs enforcement of IPR.

This document therefore replaces the ‘Guidelines of the European Commission concerning the enforcement by EU customs authorities of intellectual property rights with regard to goods, in particular medicines, in transit through the EU’.

2. GOODS INFRINGING AN INTELLECTUAL PROPERTY RIGHT IN THE CONTEXT OF CUSTOMS ENFORCEMENT

Regulation (EU) No 608/2013 contains enforcement procedures to permit action by customs authorities against goods suspected of infringing intellectual property rights. Article 2 of the Regulation lists the intellectual property rights relevant to customs enforcement. Regulation (EU) No 608/2013 sets out the conditions and procedures for action by the customs authorities with regard to goods suspected of infringing an intellectual property right which are, or should have been, under their supervision or control (Article 1(1)), as the procedural powers of customs authorities are limited to ascertaining whether goods are ‘goods suspected of infringing an intellectual property right’ as defined in Article 2(7).

Regulation (EU) No 608/2013 does not set out any criteria for ascertaining the existence of an infringement of an intellectual property right (recital 10). The question of whether an intellectual property right is infringed is a matter for substantive intellectual property law, as interpreted by the competent national courts and the Court of Justice of the European Union.

2.1. Goods coming from third countries without being released for free circulation

For goods brought into the customs territory of the Union without being released for free circulation, the relevant intellectual property rights may be infringed when, during their presence within the customs territory of the Union (for instance, placed under a special procedure according to the Union Customs Code (7)), or even before their arrival in that territory, these goods are the subject of a commercial act directed at the market of the Union, such as a sale, offer for sale or advertising (see, to that effect, Philips/Nokia cases, paragraph 57 (8)), or where it is apparent from documents (e.g. instruction manuals) or correspondence concerning the goods that their diversion to the market of the Union is envisaged, without the authorisation of the right holder.

Therefore, goods coming from a third country without being released for free circulation which are suspected of violating an intellectual property right protected in the European Union by, for example, a trade mark, a copyright or a related right, a design or a patent, may be classified as ‘goods suspected of infringing an intellectual property right’ where there is evidence that they are intended to be put on sale in the European Union. Such evidence might indicate that the goods have been sold to a customer in the European Union or offered for sale or advertised to consumers in the European Union (see, to that effect, Philips/Nokia cases, paragraph 78).

2.2. Goods coming from third countries without being released for free circulation and bearing an identical or essentially identical trade mark

Regulation (EC) No 207/2009 as amended by Regulation (EU) 2015/2424 and Directive (EU) 2015/2436 extend the rights of the proprietor of a trade mark registered at Union level as a European Union trade mark or at Member State level as a national trade mark to prevent third parties from bringing, in the course of trade, into the Union without being released for free circulation, goods coming from third countries and bearing without authorisation a trade mark which is identical with the trade mark registered in respect of such goods or which cannot be distinguished in its essential aspects from that trade mark (hereinafter referred to as ‘identical or essentially identical trade mark goods’) even if the goods are not intended to be placed on the market of the Union. As explained in recital 15 of Regulation (EU) 2015/2424, the objective is ‘to strengthen trade mark protection and combat counterfeiting more effectively, and in line with international obligations of the Union under the framework of the World Trade Organisation (WTO) (…)’.

The new provisions concerning the treatment of identical or essentially identical trade mark goods brought into the Union territory, without being released for free circulation, are applicable as follows:

European Union trade marks

— In the case of the European Union trade mark, Regulation (EU) 2015/2424 entered into force on 23 March 2016 (Article 4) and became applicable on the same day. Therefore, customs authorities may, as of 23 March 2016, take action in relation to goods from third countries brought into the customs territory of the Union without being released for free circulation and bearing an identical or essentially identical trade mark to an EU trade mark.

National trade marks

— In the case of national trade marks, Directive (EU) 2015/2436 entered into force on 12 January 2016 (Article 56). Member States, in accordance with Article 54 of the Directive (EU) 2015/2436, shall adjust their national trade mark law, regulations and administrative provisions to implement the Directive by 14 January 2019. This means that, in the case of national trade marks, the new provisions concerning identical or essentially identical trade mark goods brought into the Member State where the trade mark is registered, without being released for free circulation, will be applicable in that Member State once the laws, regulations and administrative provisions necessary to comply with Article 10 of the Directive are adopted and in force, which may happen any time before 14 January 2019. Customs authorities in each Member State should therefore follow closely their national trade mark law revision in order to know from which date they should apply the provisions on transit for the national trade marks. Customs authorities may take action in relation to goods coming from third countries without being released for free circulation and bearing an identical or essentially identical trade mark to a national trade mark as of the date the national provisions are in force and apply in that Member State.

Proprietor rights in relation to identical or essentially identical trade mark goods

Article 9(4) of Council Regulation (EC) No 207/2009 as amended by Regulation (EU) 2015/2424 reads as follows:

‘Rights conferred by an EU trade mark

[…] 4. Without prejudice to the rights of proprietors acquired before the filing date or the priority date of the EU trade mark, the proprietor of that EU trade mark shall also be entitled to prevent all third parties from bringing goods, in the course of trade, into the Union without being released for free circulation there, where such goods, including packaging, come from third countries and bear without authorisation a trade mark which is identical with the EU trade mark registered in respect of such goods, or which cannot be distinguished in its essential aspects from that trade mark. […]’(emphasis added)

Rights conferred by a national trade mark

Article 10(4) of the Directive (EU) 2015/2436 reads in similar terms as those used in Article 9(4) of Council Regulation (EC) No 207/2009 as amended by Regulation (EU) 2015/2424, extending the rights of the proprietor of a registered national trade mark with regard to goods brought into the territory of the Member State which bear, without authorisation, a trade mark which is identical or essentially identical to the registered national trade mark without those goods being released for free circulation in the Member State.

It is to be noted that according to the wording and purpose of these new provisions, the rights of the trade mark proprietor shall not only extend to goods bearing a sign which is identical to the registered trade mark of its proprietor (that is a sign which either reproduces, without any modification or addition, all the elements constituting the protected trade mark or which, viewed as a whole, contains differences so insignificant that they may go unnoticed by an average consumer, as defined by the Court of Justice of the European Union in Case 291/00, LTJ Diffusion SA).

The new provisions also cover goods bearing a sign ‘which cannot be distinguished in its essential aspects’ from the registered trade mark.

3. GOODS SUSPECTED OF INFRINGING AN INTELLECTUAL PROPERTY RIGHT – CUSTOMS ENFORCEMENT

3.1. Control and detention

In accordance with the Union Customs Code (Regulation (EU) No 952/2013), customs authorities may carry out any control on non-Union goods brought into the customs territory of the Union which they find necessary (9). These controls must be proportionate and carried out in accordance with risk analysis criteria.

Apart from the general possibility of customs controls, in accordance with Article 1(1) of Regulation (EU) No 608/2013, customs authorities are also competent to detain goods suspected of infringing an intellectual property right that are, or should have been, subject to customs supervision or customs control within the customs territory of the Union, particularly goods in the following situations:

a) when declared for release for free circulation, export or re-export;

b) when entering or leaving the customs territory of the Union;

c) when placed under a special procedure.

The detention of the goods is a decision taken by the customs authorities based on the presence of reasonable indications that those goods are infringing intellectual property rights.

The detention of the goods means holding back the goods and allowing the right holder to have access to confidential information and inspect the goods in question, and may lead to the destruction of goods, without formal determination of infringement (10). This procedure goes beyond the mere activity of control carried out by the customs authorities.

3.2. Identical or essentially identical trade mark goods

As stated in recital 15 of Regulation (EU) 2015/2424 amending Council Regulation (EC) No 207/2009:

‘[…] In order to strengthen trade mark protection and combat counterfeiting more effectively, and in line with international obligations of the Union under the framework of the World Trade Organisation (WTO), in particular Article V of the General Agreement on Tariffs and Trade (GATT) on freedom of transit and, as regards generic medicines, the “Declaration on the TRIPS Agreement and public health” adopted by the Doha WTO Ministerial Conference on 14 November 2001, the proprietor of an EU trade mark should be entitled to prevent third parties from bringing goods, in the course of trade, into the Union without being released for free circulation there, where such goods come from third countries and bear without authorisation a trade mark which is identical or essentially identical with the EU trade mark registered in respect of such goods. […]’

As stated in recitals 16 of Regulation (EU) 2015/2424 amending Council Regulation (EC) No 207/2009 and (22) of Directive (EU) 2015/2436:

‘[…], it should be permissible to prevent the entry of infringing goods and their placement in all customs situations, including transit, transhipment, warehousing, free zones, temporary storage, inward processing or temporary admission, also when such goods are not intended to be placed on the market of the Union. In performing customs controls, the customs authorities should make use of the powers and procedures laid down in Regulation (EU) No 608/2013 of the European Parliament and the Council, […]’

In accordance with the trade mark legislation of the Union and the national trade mark legislation, goods suspected of being identical or essentially identical trade mark goods can be detained by the customs authorities under Regulation (EU) No 608/2013 when they are brought into the customs territory of the Union without being released for free circulation and without being intended for the market of the Union. These goods suspected of bearing an identical or essentially identical trade mark without authorisation could be found in the customs territory of the Union:

— In temporary storage,

— In transit on their way from a third country to another third country,

— Under a storage procedure in a free zone or a customs warehouse, without being intended yet for the EU market or for a third country,

— Under the procedure of temporary admission,

— Under the inward processing procedure.

Before detaining goods suspected of bearing without authorisation a trade mark identical or essentially identical to the protected trade mark, if those goods are not intended for the EU market, customs authorities may, in accordance with Article 17(2) of Regulation (EU) No 608/2013 and to avoid hampering legitimate trade, consider asking the holder of the decision granting an application to provide them with any relevant information with respect to the goods.

Once goods suspected of bearing without authorisation a trade mark identical or essentially identical to the protected trade mark, which are not intended for the EU market, have been detained, customs authorities should ensure that notification of detention is promptly addressed to the persons concerned (i.e. to the holder or declarant of the goods and to the right holder).

To reconcile the need to ensure the effective enforcement of trade mark rights with the necessity to avoid hampering the free flow of legitimate trade, the new provisions of the trade mark package establish that the entitlement of the proprietor of a registered trade mark to prevent the mere entry of goods into the EU shall lapse in certain circumstances, with respect to goods suspected of bearing without an authorisation an identical or essentially identical trade mark in transit which are allegedly intended for the market of a third country. This entitlement shall lapse if during the proceedings initiated to determine whether the registered trade mark has been infringed, evidence is provided by the declarant or the holder of the goods that the proprietor of the registered trade mark is not entitled to prohibit the placing of the goods on the market in the country of final destination because the trade mark concerned is not protected in the country of final destination.

3.3. Medicines

Although the Union legislation referred to in this notice does not contain specific rules on medicines, Regulation (EU) No 608/2013 (recital 11) and Regulation (EU) 2015/2424 (recital 19) as well as Directive (EU) 2015/2436 (recital 25) describe the need to facilitate the smooth transit of legitimate medicines across the EU.

Under the ‘Declaration on the TRIPS Agreement and Public Health’ adopted by the Doha WTO Ministerial Conference on 14 November 2001, the TRIPS Agreement should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, especially, to promote access to medicines for all. The EU and its Member States are fully committed to all the efforts made to facilitate access to medicines for countries in need in accordance with the Declaration.

Customs authorities have to take all reasonable care to ensure that legitimate legally traded medicines (11), whether or not generic, can be routed through the customs territory of the Union and will not be detained under Regulation (EU) No 608/2013.

Therefore, customs authorities should not detain medicines – in the absence of indications that they are intended for the EU market – for instance if there are similarities between the INN (12) for the active ingredient in the medicines and the trade mark registered in the EU.

Thus, customs authorities should take full precautions to avoid any detention of medicines under Regulation (EU) No 608/2013, unless they are intended for the EU market or unless those goods bear a trade mark suspected of being identical or essentially identical to the protected trade mark within the meaning of point 2.2 of the within notice.

3.4. Cooperation with the right holders

It is crucial that customs authorities have at their disposal sufficient and relevant information from the right holders to organise their risk analysis in an efficient and effective manner.

Right holders submitting an application for action should therefore always pay special attention to the obligation to provide any available information that may assist customs authorities in their assessment of the risk of infringements of the rights at stake.

Article 28 of Regulation (EU) No 608/2013 provides that a right holder is to be liable for damages towards the holder of the goods where, inter alia, the goods in question are subsequently found not to infringe an intellectual property right.

Due to the strict deadlines contained in Regulation (EU) No 608/2013, right holders should ensure that the contact persons indicated in the applications are easily reachable and in a position to swiftly react to customs communications/requests.

(1) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights (OJ L 181, 29.6.2013, p. 15).

(2) 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 (OJ L 196, 2.8.2003, p. 7).

(3) Regulation (EU) 2015/2424 of the European Parliament and of the Council of 16 December 2015 amending Council Regulation (EC) No 207/2009 on the Community trade mark and Commission Regulation (EC) No 2868/95 implementing Council Regulation (EC) No 40/94 on the Community trade mark, and repealing Commission Regulation (EC) No 2869/95 on the fees payable to the Office for Harmonization in the Internal Market (Trade Marks and Designs) (OJ L 341, 24.12.2015, p. 21).

(4) Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (OJ L 78, 24.3.2009, p. 1).

(5) Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (OJ L 336, 23.12.2015, p. 1).

(6) Annex 1C to the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.

(7) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).

(8) Joined cases C-446/09 and C-495/09.

(9) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013, in particular Article 46 thereof.

(10) See Article 17 and Article 23 of Regulation (EU) No 608/2013.

(11) For instance, medicines in mere transit through the EU territory, covered by a patent right applicable to such medicines in the EU territory, without adequate evidence of a substantial likelihood of diversion of such medicines onto the EU market.

(12) International Non-proprietary Names (INN) identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public property. A non-proprietary name is also known as a generic name. Information on INN can be found at the following site of the World Health Organization: http://www.who.int/medicines/services/inn/innguidance/en/