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UK – Actavis v Eli Lilly / Supreme Court

12 Jul 2017

Actavis UK Limited and others v Eli Lilly and Company, UK Supreme Court, 12 July 2017, [2017] UKSC 48

The UK Supreme Court today gave its judgment in the long-running Actavis v Eli Lilly case concerning Lilly’s Alimta vitamin regimen patents in the UK, France, Italy and Spain. The Supreme Court allowed Lilly’s appeal and held that Actavis’ products directly infringe Lilly’s patent in the UK, France, Italy and Spain.

In doing so, the Supreme Court has reformulated the UK Improver questions on equivalence. The second question has been reformulated by the UKSC to make it clear that the skilled person knows that the variant works (to the extent that it actually does work) when they are considering whether it would be obvious that the variant achieves the same result in the same way. The decision also makes it clear that assessing the scope of protection of a patent is a two stage process: first work out what the patent claim means; and then consider whether any variant infringes by equivalence.

Lilly’s patent concerns the safe and effective use of a cancer drug, pemetrexed, in co-therapy with vitamin B12. Actavis’ proposed products differed only in relation to the salt form of the pemetrexed. Actavis sought declarations of non-infringement in relation to the UK, French, German, Italian and Spanish patents in the UK courts. Actavis removed the German patent from the UK litigation in 2014 after the Düsseldorf Court found that it would be infringed by Actavis.

On appeal in 2015, the Court of Appeal refused to grant the declarations sought by Actavis on the grounds that Actavis’ proposed products would indirectly infringe Lilly’s patent. However, the Court of Appeal found that the patent would not be directly infringed.

As well as overturning the Court of Appeal’s decision on direct infringement, the Supreme Court has upheld the Court of Appeal’s decision on indirect infringement – that is Actavis’ appeal was unsuccessful.

The judgment can be read here.

Summary: Emma Fulton, Daniel Brook & Stephen Bennett, Hogan Lovells