Speciality European Pharma Ltd ('SEP') v Doncaster Pharmaceuticals Group Ltd & Anr* (Asplin J; [2013] EWHC 3624 (Ch); 20.11.13)

Asplin J found that Doncaster had infringed the REGURIN trade mark (of which SEP was exclusive licensee in the UK and Ireland) by affixing the mark to pharmaceuticals it imported from other Member States. This was because it was not necessary for Doncaster to use the REGURIN mark on its parallel imported products in order for it to gain effective access to the UK market for trospium chloride products pursuant to Articles 34 and 36 of the Treaty on the Functioning of the European Union ('TFEU').

Doncaster imported SEP's French 20mg trospium chloride product, Ceris, and SEP's German 60mg trospium chloride product, uriVesc, into the UK and re-branded them under SEP's UK trospium chloride brand name, Regurin (used in relation to both the 20mg and 60mg dosage).

Asplin J referred to Upjohn v Paranova C-379/97, where the CJ held that when a parallel importer replaced a trade mark owner's mark on a product with another of the trade mark owner's marks, Article 7 of the Trade Marks Directive did not apply and the respective rights of the proprietor and parallel importer were to be determined by Articles 34-36 of the TFEU; the question for the court being whether the replacement of the trade mark was objectively necessary to enable the importer to have 'effective access to the market of the importing Member State'. The Judge also referred to Boehringer v Swingward C-143/00 and C-443/99 where the CJ held that if there was such a strong resistance from a significant proportion of customers to relabeling of the pharmaceutical in question that it would act as a

hindrance to the market in question, repackaging of the product would be warranted for reasons other than trying to obtain a commercial advantage.

The Judge found on the evidence that there was no such resistance by customers to relabelled or generic Regurin products. Trospium chloride came off patent in 2009. Before that date, Doncaster had been relabeling parallel imports as trospium chloride, rather than as Regurin. However, with the surge of generic drugs on the market when trospium chloride came off patent, Doncaster could no longer make the same profit margins on the parallel imports unless it repackaged them as Regurin. In circumstances where 88.65% of prescriptions for 20mg trospium chloride were written generically, Doncaster would have had instant access to nearly 90% of the 20mg market if it had sold its parallel imports under the generic trospium chloride label.

In relation to the 60mg trospium chloride product, while Regurin was the only brand on the market, 68% of prescriptions were written generically. Asplin J accepted that because another product had a similar name, Doncaster was not permitted to use uriVesc in the UK and so would have had to relabel its parallel imports in the UK. However, she found that that did not mean that Doncaster had to repackage them as Regurin (i.e. it could relabel or repackage uriVesc either generically or under a new brand name).

In light of the fact that the majority of all prescriptions for both the 20mg and 60mg dosages were written generically for trospium chloride (and that the NHS policy favoured generically written prescriptions), Doncaster would not have been hindered in accessing the generic trospium chloride market if it used the generic name or a brand name other than Regurin. Asplin J rejected Doncaster's argument that the market it was excluded from was the prescription market for Regurin branded trospium chloride products. If such an interpretation of the market was accepted, Asplin J concluded that all parallel importers could find a specific market by reference to a brand from which it was excluded rather than looking at the market as a whole.

Given that there was no objective necessity for Doncaster to rebrand the parallel imports as Regurin, Asplin J found that Doncaster was merely seeking a commercial advantage by 'piggy backing' on SEP's marketing for its Regurin brand. Accordingly, Doncaster was found to infringe the REGURIN mark.