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Insight

When can you re-brand an imported drug using an alternative trade mark for that drug?

12/12/2013
SummarySpeciality European Pharma Ltd v Doncaster Pharmaceuticals Group Ltd and another [2013] EWHC 3624 (Ch) case concerned parallel imports and re-branding in relation to a pharmaceutical product Summary
Speciality European Pharma Ltd v Doncaster Pharmaceuticals Group Ltd and another [2013] EWHC 3624 (Ch) case concerned parallel imports and re-branding in relation to a pharmaceutical product containing the active ingredient trospium chloride.  The court held in this case that replacing the trade mark on the imported product, with that which was used in the Member State of importation was not objectively necessary to gain effective access to the relevant market.

The Facts
Madeus GmbH (Madeus), who held the patent to trospium chloride until 2009 when it expired, markets and distributes trospium chloride products in various European countries.  It is marketed in France as Ceris, in Germany as uriVesc, and in the UK as Regurin.  On 7 May 2009, Madeus appointed Speciality European Pharma Limited (SEP) as exclusive licensee of the Regurin trade mark in the UK taking over distribution of the 20mg Regurin product.  In September 2009, they launched a 60mg Regurin product.

Doncaster Pharmaceuticals Group Limited (Doncaster) is a parallel importer of pharmaceuticals.  In late 2009, Doncaster started to import Ceris from France into the UK by affixing the trademark Regurin instead.  In 2011 it started to import uriVesc from Germany into the UK and to re-brand as Regurin

The question with which the Court was concerned was whether Doncaster is entitled under Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU) to affix the Regurin mark to the pharmaceuticals which they import from other Member States in the EU.

The Law
Article 34 TFEU prohibits quantitative restrictions on imports between Member States and all measures having equivalent effect.  However Article 36 TFEU does allow for some exceptions including where it can be justified on the grounds of protection of industrial and commercial property.

The Judge did touch upon the relevance of Article 7 of Trade Marks Directive (dealing with exhaustion of trade mark rights) since it had been the subject of numerous ECJ cases in the context of re-boxing of pharmaceutical products.  However she concluded it did not apply in the current situation (i.e. where the parallel importer replaces the original trade mark with another mark) emphasising Article 34-36 TFEU are the correct provisions to consider.

In considering Article 34-36, the Judge concluded that the main question to answer was that which was formulated by the ECJ in Upjohn:

"in all the circumstances prevailing at the time of marketing was it objectively necessary to replace the original trade mark, in this case Ceris and/or uriVesc, with that used in the importing Member State, namely Regurin, in order to gain effective access to the trospium chloride market in the UK?"

The key parts to that question were the ideas of "necessity" (judged objectively) and "effective access" (i.e. what proportion of the market was open to it?).

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