It has been a while since there has been a case involving drugs repackaging but a recent judgement has confirmed that importers who replace the original trade marked name of a drug with a mark registered in the UK may only do so if there is “objective necessity” for the re-brand in order for the importer to gain effective market access in the UK.
In Speciality European Pharma Ltd –v- Doncaster Pharmaceuticals Group Ltd, Speciality European Pharma Ltd (“SEP”) was the exclusive licensee of the trade mark “Regurin”. For many years Doncaster Pharmaceuticals Group Ltd (“DPG”) had imported trospium chloride products into the UK from France and Germany where they were marketed as Céris and uriVesc respectively. On importing the products to the UK, DPG would over-sticker the trade names on the box with the name of the generic active ingredient, trospium chloride. In late 2009 however, DPG began importing Céris by affixing the name Regurin to it and, in 2011, importing uriVesc in the same manner. But was it necessary for DPG to re-brand the products as Regurin in order to gain effective market access in the UK?
In November, the High Court held that the evidence demonstrated that it wasn’t. DPG had access to a substantial part of the product market even without the use of the Regurin trademark, not least because 68% of all prescriptions relating to the product were written by reference to the generic active ingredient, trospium chloride. DPG was merely seeking a commercial advantage by “piggy-backing” on SEP’s investment and marketing strategy in order to take commercial advantage of being able to sell its parallel imports at a higher price. The judge ruled therefore that DPG had infringed the Regurin trade mark by using it in circumstances where there was no “objective necessity” to rebrand the trospium chloride products.
Finally, one principle that emerged from the decision is that the “market” (to which access is alleged by the importer to be hindered) should be defined by reference to the product, not the brand.