03 December 2015

Patents Court grants declaration to Actavis in pemetrexed dispute

In July 2015, we reported that the Court of Appeal had upheld Eli Lilly's appeal against Arnold J's decision at trial, finding that Actavis' supply of its pemetrexed product would indirectly infringe Lilly’s second medical use patent (EP (UK) 1 313 508). Following the hearing before the Court of Appeal, Actavis sought a revised declaration relating to its new proposed pemetrexed product for reconstitution/dilution with dextrose, as opposed to saline. The Court of Appeal remitted this question to the Patents Court. 

The issue between the parties is whether there will be indirect infringement by Actavis due to reconstitution/dilution of its pemetrexed product by healthcare professionals in circumstances where Actavis’ SmPC will direct that the product be reconstituted/diluted with a dextrose solution. Lilly’s case was that it is foreseeable that, despite the instruction in the SmPC, healthcare professionals in the UK, France, Italy and Spain will reconstitute or dilute Actavis’ product with saline at least some of the time. However, in a judgment of 12 November, Arnold J agreed with Actavis that Lilly’s expert evidence and draft Amended Statement of Case amounted to an acceptance that, to begin with, healthcare professionals would follow the instructions in Actavis’ SmPC and would therefore reconstitute or dilute with dextrose solution. However, Lilly also contended that it was foreseeable that, between 6 months-2 years after the launch of Actavis’ product, stability data for the product in saline would be published by third parties and, after that, healthcare professionals would start reconstituting/diluting with saline instead of dextrose solution. 

Before Arnold J, Lilly accepted that there would be no infringement at launch; its case therefore is that there is a possibility of infringement after the stability data has been published. In these circumstances, Arnold J decided to grant Actavis a declaration upon Lilly’s admission which, in summary, is to the following effect: as matters stand, and prior to the publication of stability data (if this occurs), Actavis’ product will not infringe in the UK, France, Spain and Italy provided that the SmPC provides instructions for the product to be diluted and/or reconstituted with dextrose. The order also states that the declaration is made on the basis of the current circumstances and gives Lilly the right to argue for a varied declaration if and when circumstances have materially changed. Further, the Court clarifies that it is making no ruling as to the situation (if this occurs) where stability data re dilution/reconstitution with saline is made publicly available. In particular, Arnold J accepted that a declaration would assist Actavis in making it clear to prospective customers that, at launch, there is no question of infringement, even if Lilly is able to argue that there will be infringement at some point.

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