Speciality European Pharma Ltd v (1) Doncaster Pharmaceuticals Group Ltd & (2) Madaus GmbH [2015] EWCA Civ 54

6 February 2015

Martin Howe QC and Iona Berkeley, instructed by Maitland Walker LLP, appeared for the Defendant and successful Appellant, Doncaster Pharmaceutical Group, in this trade mark infringement case concerning the parallel importation of pharmaceutical products in the field of urology.

The case concerned the importation by the Defendant of Madaus GmbH’s anti-diuretic drug with the active ingredient trospium chloride, originally put on the market in France and Germany by Madaus bearing the marks Ceris and Urivesc, and the sale of these repackaged goods by the Defendant under the Madaus’s UK trade mark, REGURIN. The Claimant was Speciality European Pharma Ltd, Madaus’s UK trade mark licensee and distributor.

The main issue in the case was whether the use of the REGURIN trade mark in the UK by the Defendant was necessary for the Defendant to have effective market access in the UK. The Defendant argued that the attempted enforcement by the Claimant of its trade mark rights in the REGURIN mark in the United Kingdom in order to prevent the re-branding by Doncaster of the Madaus products which Madaus had consented to be placed on the market elsewhere in Europe under other marks constituted a quantitative restriction on imports or a measure having equivalent effect within the meaning of Article 34 of the Treaty on the Functioning of the European Union which was not permitted by Article 36 TFEU because it amounted to a means of arbitrary discrimination or a disguised restriction on trade between Member States (see ECJ Case 379/97 Pharmacia & Upjohn SA v. Paranova A/S [2000] 1 CMLR 51).

The week long High Court trial was heard in October 2013 before Mrs Justice Asplin. The Judge found for the Claimant, holding that it was not objectively necessary for the Defendant to use the REGURIN trade mark in order to have effective access to the market in the UK. The case at first instance is now reported at Speciality European Pharma Ltd v Doncaster Pharmaceuticals Group Ltd [2013] EWHC 3624 (Ch) [2014] ETMR 11

The Court of Appeal (leading judgment by Lord Justice Floyd) reversed the Judge’s finding and held that there was a substantial part of the UK market, that represented by prescriptions written by doctors by reference to the brand name REGURIN, to which the parallel importer would have no effective access without rebranding. The Court of Appeal considered that the suggestion, which had appealed to the Judge, that the parallel importer could adopt is own brand name and market its parallel imports under that brand in competition with the original manufacturer’s REGURIN product, was “not a real world alternative” and that, given the supply interruptions to which parallel imports are frequently subject, it would “verging on the irresponsible to encourage a doctor to prescribe a Doncaster brand.”

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