Parallel Trade: Pharmaceuticals Repackaging

United Kingdom
On 7 March Advocate General Jacobs delivered his Opinion on a repackaging case referred to the European Court of Justice by the Cologne Court. The case was brought by Aventis Pharma Deutschland GmbH against Kohlpharma GmbH and MTK Pharma Vertbriebs-GmbH.

The Aventis product concerned is an injectable insulin preparation sold under the trade mark INSUMAN which is the subject to two separate central marketing authorisations, one for packs containing 10 cartridges (3ml suspension) and one for packs containing 5 cartridges (also 3ml suspension). Aventis markets INSUMAN in Germany in 10 cartridge packs and in France in 5 cartridge packs.

Kohlpharma imported 5 cartridge packs from France into Germany where they repackaged them into 10 cartridge packs presented in the same way as those which Aventis market in Germany. Pursuant to EMEA’s (European Agency for the Evaluation of Medicinal Products) 1999 guidelines entitled “Procedure for Notifications of Parallel Distribution of Centrally Authorised Medicinal Products Kohlpharma notified the EMEA of its intention to import INSUMAN from France into Germany and to bundle two 5 cartridge packs to provide a 10 cartridge pack. In response the EMEA expressed the view that bundling two 5 cartridge packs was not permitted under the terms of either of the two central marketing authorisations.

Aventis objected upon the basis that the EEC Regulation (2309/03) governing the grant of Central marketing authorisations (“the Regulation) does not preclude the right to rebundle and in addition, that repackaging two 5 cartridge packs into a new 10 cartridge pack was not “necessary pursuant to the ECJ’s current guidelines. Kohlpharma argued that under the Regulation rebundling was not permitted and was supported in this respect by the both the Commission and the Norwegian Government.

Two questions were referred to the ECJ. First, whether the Regulation precludes rebundling; and secondly, if the Regulation does not preclude rebundling, whether the repackaging was otherwise “necessary.

With regard to the first question the Advocate General’s Opinion supports the view of the Defendants, the Commission and the Norwegian Government to the effect that the Regulation does preclude rebundling. His reasoning was based upon a review of the provisions of the Regulation relating to the grant of central marketing authorisations. In particular, each central marketing authorisation is granted on the basis that the precise quantity of medicinal product in a pack is clearly indicated, both on the outer packaging and in the package leaflet and both must also show the number of the central marketing authorisation i.e. for rebundled products that for the 10 cartridge packs, not 5 cartridge packs. Accordingly, the Advocate General’s opinion was that rebundling two 5 cartridge packs into a 10 cartridge pack is not within the terms of the central marketing authorisations, either for the 5 cartridge pack or the 10 cartridge pack and cannot therefore be lawfully marketed. It is interesting to note that during the course of the hearing, Aventis indicated that their INSUMAN package leaflets for both 5 and 10 cartridge packs were identical.

The Advocate General went on to consider the second question as to whether rebundling to create a double pack constitutes a sufficient but less intrusive interference with the rights of the trade mark owner. The Advocate General repeated a key section from his Opinion in the cases involving Merck Sharp & Dohme and Boehringer Ingelheim and Others (which are still pending before the ECJ) to the effect that repackaging is “necessary if it can be demonstrated that other less intrusive methods of repackaging give rise to obstacles preventing effective access to the market for reasons such as consumer resistance to overstickered boxes may affect prescription or dispensing practice. However, there was no evidence before the Court as to whether or not the German market would have been partially or wholly closed to the Defendants if they were only able to offer 5 cartridge packs. Accordingly, the Advocate General opined that it was therefore for the national court to assess whether repackaging as 10 cartridge packs was necessary to enable the Defendants to obtain effective access to the German market or whether simply relabelling 5 cartridge packs would be sufficient.

The Judgment of the Court in Merck Sharpe Dohme & Boehringer Ingelheim & Others is expected at any time.

For further information please contact Stephen Whybrow by telephone on +44(0)20 7367 2175 or by e-mail on stephen.whybrow@cms-cmck.com.