Aristo Pharma GmbH v Takeda Pharmaceuticals USA Inc & Anor

Facts

Takeda Pharmaceuticals USA Inc owned supplementary protection certificate SPC/GB13/052, which protected Elvanse, a treatment for attention deficit hyperactivity disorder. The SPC identified the product as lisdexamfetamine (LDX). LDX is a pro-drug in which lysine is covalently bound to dexamfetamine (DEX). After ingestion the bond is hydrolysed and DEX is released. DEX is the pharmacologically active component, and lysine has no relevant activity of its own. It was not in dispute that LDX improved on DEX: its slower, more prolonged release allowed once-daily dosing, which is a particular advantage for schoolchildren. Aristo Pharma GmbH and Stada Arzneimittal AG each brought an action against the Takeda parties, advancing the same case. They argued that the active ingredient was really DEX, not LDX. Because DEX already had an earlier marketing authorisation, the SPC was invalid under Article 3(d) of Regulation (EC) 469/2009 and Article 15 of Regulation (EC) 469/2009. Takeda accepted that the SPC would be invalid if the product was DEX. The two actions were tried together in the Patents Court under the Shorter Trials Scheme. Each side called one expert, and neither expert was cross-examined. The claimants relied on a judgment of the German Federal Patent Court holding Takeda's German equivalent SPC invalid. Takeda has appealed that judgment.