Brussels Commercial Court: Parallel Imported Pharmaceuticals Must Comply with Latest Packaging
22/06/2017

On 27 April 2017, the President of the Dutch-language Commercial Court of Brussels (Nederlandstalige Rechtbank van Koophandel/Tribunal de commerce néerlandophone) decided a case concerning the repackaging of parallel imported pharmaceuticals, in which it applied the so-called “BMS”-criteria which the Court of Justice of the European Union (“ECJ”) developed in Bristol-Myers-Squibb (Case C-427/93).

The ECJ held in Bristol-Myers-Squibb that parallel imported products can be repackaged: (i) if repackaging is objectively necessary to market the product in the country of importation; (ii) if the repackaging does not affect the original condition of the product inside the packaging; (iii) if the new packaging clearly states who repackaged the product and indicates the name of the manufacturer; (iv) if the presentation of the repackaged product is not liable to damage the reputation of the trade mark or of its owner; and (v) if the importer gives notice to the trade mark owner before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product. If these five conditions are satisfied, the trade mark owner cannot legitimately object to the further marketing of a repackaged pharmaceutical.

The dispute before the Commercial Court of Brussels related to the parallel import and repackaging by Pi Pharma NV (“Pi Pharma”) of pharmaceuticals of Merck Sharp & Dohme Corp. and MSD Belgium BVBA (together, “MSD”). MSD is the marketing authorisation holder of a pharmaceutical with the active ingredient montelukast which it markets under the trade mark “Singulair” in various presentations, including formats of 28 and 98 tablets. After the Federal Agency for Medicines and Health Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/Agence Fédérale des Médicaments et des Produits de Santé, the “FAMHP”) had objected to the use by MSD of two shades of the colour blue for its logo as this could hamper the legibility of the labelling, MSD changed the logo to a single dark blue colour. On 16 January 2015, Pi Pharma notified MSD that it had received a licence from the FAMHP to distribute parallel imported “Singulair” products on the Belgian market. Pi Pharma imported the products from Poland where MSD also markets Singulair in packaging formats of 28 tablets. Subsequently, Pi Pharma repackaged the product into a new packaging of 98 tablets.

MSD claimed that Pi Pharma infringed its trade marks and copyright since Pi Pharma: (i) had failed to indicate on the packaging the identity of the company responsible for the repackaging of the product; (ii) had damaged MSD’s reputation by using two shades of blue for the logo; and (iii) had failed to demonstrate that repackaging of the product was objectively necessary in order to gain effective access to the Belgian market. 

First, with regard to the third BMS-requirement, i.e., that the new packaging must clearly state who repackaged the product, the Commercial Court held that consumers or end users would be likely to believe that the trade mark owner was responsible for the repackaging or re-labelling of Singulair. Because the products sold by Pi Pharma did not fulfil the third BMS-requirement, the Court decided that Pi Pharma thus infringed MSD’s trade marks.

Second, on the fourth BMS-requirement, i.e., that the presentation of the repackaged product must not be liable to damage the reputation of the trade mark or its owner, the Commercial Court held that the use by Pi Pharma of two shades of blue is in contradiction with FAMHP’s viewpoint regarding the use by MSD of two colours for the “Singulair” logo. Furthermore, the Court referred to the obligation contained in Article 7, para. 2 of the Royal Decree of 19 April 2001 (the “Parallel Importation Decree”) which requires parallel importers to take all necessary steps to remain informed of the latest changes with regard to the license for parallel imports. Accordingly, the Commercial Court concluded that the presentation of the repackaged product was “inadequate” and that there was a risk that the reputation of the trade mark and/or its owner would be damaged.

Third, regarding the first BMS-requirement, i.e., that repackaging must be objectively necessary to market the product in the country of importation, the Commercial Court again referred to the ECJ’s reasoning in Bristol-Myers-Squibb. The ECJ had held that repackaging must be allowed where it is necessary to market effectively the parallel imported pharmaceutical in the country of import. Indeed, allowing trade mark owners to object to such practices would lead to an artificial partitioning of the markets. Conversely, the ECJ had added that repackaging was not objectively necessary if less drastic means of repackaging were available. This was confirmed by the ECJ in the Orifarm case (C-297/15) and by the Belgian Supreme Court in the Cozaar-cases (See, VBB on Belgian Business Law, Volume 2016, No. 12, p. 12-13, available at www.vbb.com ). According to the Commercial Court, Pi Pharma failed to show that repackaging was objectively necessary to market Singulair in Belgium since Pi Pharma could have over stickered the product. Therefore, the Court reached the conclusion that the first BMS-requirement was not fulfilled either. 

Based on the above reasons, the Court held that Pi Pharma infringed MSD’s trade marks and copyright and issued an injunction against Pi Pharma to stop selling infringing Singulair products on the Belgian market.

Voir aussi : Van Bael & Bellis ( Mr. Thibaut D'hulst ,  Ms. Eleonore Waterkeyn )

Mr. Thibaut D'hulst Mr. Thibaut D'hulst
Associate
tdhulst@vbb.com
Ms. Eleonore Waterkeyn Ms. Eleonore Waterkeyn
Associate
eleonore.waterkeyn@vbb.com

Click here to see the ad(s)
Tous les articles Droit de la propriété intellectuelle

Derniers articles Droit de la propriété intellectuelle

Brexit : ‘farewell’ aux droits européens de propriété intellectuelle!
20/02/2018

Le Royaume-Uni cessera de faire partie de l’Union européenne le 30 mars 2019. À cette date, les droits...

Read more

Court of Justice clarifies exhaustion of trademark principles and broadens test for economic link...
06/02/2018

On 20 December 2017, the Court of Justice of the European Union (“ECJ”) handed down its judgment in Case C-291...

Court of Justice clarifies exhaustion of trademark principles and broadens test for economic links between trademark owners Read more

Brussels Court of Appeal decides that Aldi’s Buval Pilsner does not infringe InBev’s Jupiler Pilsner
25/01/2018

In a decision of 12 December 2017 the Brussels Court of Appeal overturned the first instance decision and decided that Ald...

Brussels Court of Appeal decides that Aldi’s Buval Pilsner does not infringe InBev’s Jupiler Pilsner Read more

Portrait photograph deserves Trade Mark Protection
22/01/2018

On 16 November 2017, the Board of Appeal of the European Union Intellectual Property Office (the “EUIPO Board of App...

Read more

Derniers articles de Mr. Thibaut D'hulst

Portrait photograph deserves Trade Mark Protection
22/01/2018

On 16 November 2017, the Board of Appeal of the European Union Intellectual Property Office (the “EUIPO Board of App...

Read more

Bill Implementing Unitary Patent and European Unified Patent Court
15/01/2018

On 6 November 2017, the Belgian government submitted a bill to the Federal Chamber of Representatives amending various pro...

Read more

Parallel Importation of Pharmaceuticals: Supreme Court Acknowledges Objective Justification
15/02/2017

The Supreme Court (Hof van Cassatie/Cour de Cassation) recently handed down two judgments on the repackaging of parallel i...

Read more

Belgian Court Fines Skype EUR 30,000 for Refusal to Cooperate with Data Protection Law Enforcemen...
26/01/2017

On 27 October 2016, the Court of First Instance of Mechelen (the “Court”) ordered Skype Communications SARL (&...

Read more

Derniers articles de Ms. Eleonore Waterkeyn

EU General Court Finds Body-builder Silhouette is Descriptive and Cannot Be Registered as Trade Mark
22/11/2016

On 29 September 2016, the EU General Court (“GC”) ruled on the validity of a trade mark registration sought by...

Read more

ECJ on Reimbursement of Legal Fees in IP Litigation
23/09/2016

On 28 July 2016, the Court of Justice of the European Union (the “ECJ”) issued an important judgment on the re...

Read more

EU Council Adopts Directive on Protection of Trade Secrets
22/06/2016

On 27 May 2016, the Council of the European Union adopted the Directive on the protection of undisclosed know-how and busi...

Read more

Duty to Disclose when Making Ex Parte Request for Anti-counterfeiting Seizure
20/08/2014

On 30 April 2014, the Court of Appeal of Antwerp (the “Court of Appeal”) confirmed the invalidation of th...

Read more

LexGO Network