Case C-418/01

IMS Health GmbH & Co. OHG

v

NDC Health GmbH & Co. KG

(Reference for a preliminary ruling from the Landgericht Frankfurt am Main)

(Competition – Article 82 EC – Abuse of a dominant position – Brick structure used to supply regional sales data for pharmaceutical products in a Member State – Copyright – Refusal to grant a licence)

Summary of the Judgment

1. Competition – Community rules – Application by national courts – Assessment of an agreement or practice which has been examined by the Commission or has already been the subject of a Commission decision – Conditions

(Arts 81 EC and 82 EC)

2. Competition – Dominant position – Abuse – Refusal of an undertaking in a dominant position to allow another undertaking access to a product or service that is necessary for its business – Assessment of whether the product or service at issue is indispensable – Criteria – Licence to use a brick structure for supplying regional sales data for pharmaceutical products

(Art. 82 EC)

3. Competition – Dominant position – Copyright – Rights over a brick structure used to supply regional sales data for pharmaceutical products – Refusal to grant a licence to another undertaking – Abuse – Conditions

(Art. 82 EC)

1. Where the national courts give a ruling on agreements or practices which may subsequently be the subject of a decision by the Commission, they must avoid taking decisions which conflict with those taken or envisaged by the Commission in the implementation of Articles 81 and 82 EC.

(see para. 19)

2. In the assessment of the abusive character of a dominant position, in order to determine whether a product or service is indispensable for enabling an undertaking to carry on business in a particular market, it must be determined whether there are products or services which constitute alternative solutions, even if they are less advantageous, and whether there are technical, legal or economic obstacles capable of making it impossible or at least unreasonably difficult for any undertaking seeking to operate in the market to create, possibly in cooperation with other operators, alternative products or services. In order to accept the existence of economic obstacles, it must be established, at the very least, that the creation of those products or services is not economically viable for production on a scale comparable to that of the undertaking which controls the existing product or service.

It follows that, for the purposes of examining whether the refusal by an undertaking in a dominant position to grant a licence for a brick structure protected by an intellectual property right which it owns is abusive, the degree of participation by users in the development of that structure and the outlay, particularly in terms of cost, on the part of potential users in order to purchase studies on regional sales of pharmaceutical products presented on the basis of an alternative structure are factors which must be taken into consideration in order to determine whether the protected structure is indispensable to the marketing of studies of that kind.

(see paras 28, 30, operative part 1)

3. The refusal by an undertaking which holds a dominant position and owns an intellectual property right in a brick structure indispensable to the presentation of regional sales data on pharmaceutical products in a Member State to grant a licence to use that structure to another undertaking, which also wishes to provide such data in the same Member State, constitutes an abuse of a dominant position within the meaning of Article 82 EC where the following conditions are fulfilled:

- the undertaking which requested the licence intends to offer, on the market for the supply of the data in question, new products or services not offered by the owner of the intellectual property right and for which there is a potential consumer demand;

- the refusal is not justified by objective considerations;

- the refusal is such as to reserve to the owner of the intellectual property right the market for the supply of data on sales of pharmaceutical products in the Member State concerned by eliminating all competition on that market.

(see para. 52, operative part 2)

JUDGMENT OF THE COURT (Fifth Chamber) 29 April 2004 (1)

(Competition – Article 82 EC – Abuse of a dominant position – Brick structure used to supply regional sales data for pharmaceutical products in a Member State – Copyright – Refusal to grant a licence)

In Case C-418/01,

REFERENCE to the Court under Article 234 EC by the Landgericht Frankfurt am Main (Germany) for a preliminary ruling in the proceedings pending before that court between

and

on the interpretation of Article 82 EC,

THE COURT (Fifth Chamber),,

composed of: P. Jann (Rapporteur), acting for the President of the Fifth Chamber, C.W.A. Timmermans and S. von Bahr, Judges,

Advocate General: A. Tizzano,

after considering the written observations submitted on behalf of:

after hearing the oral observations of IMS Health GmbH & Co. OHG, represented by S. Barthelmess, H.-C. Salger, C. Feddersen and G. Jung-Weiser, Rechtsanwälte, and by J. Temple-Lang, of NDC Health GmbH & Co. KG, represented by G. Janke and T. Lübbig, and the Commission, represented by A. Whelan and S. Rating, at the hearing on 6 March 2003,

after hearing the Opinion of the Advocate General at the sitting on 2 October 2003,

gives the following

Observations of the parties

Reply of the Court

Observations submitted to the Court

Reply of the Court

The third condition, relating to the likelihood of excluding all competition on a secondary market

The first condition, relating to the emergence of a new product

The second condition, relating to whether the refusal was unjustified

On those grounds,

THE COURT (Fifth Chamber),

in answer to the questions referred to it by the Landgericht Frankfurt am Main by order of 12 July 2001, hereby rules:

Jann

Timmermans

von Bahr

Delivered in open court in Luxembourg on 29 April 2004.

R. Grass

V. Skouris

Registrar

President