Richard Meade QC and Isabel Jamal represented the Respondents/Claimants, Actavis, in this declaration of non-infringement (‘DNI’) appeal relating to a patent held by the Appellant/Defendant, Eli Lilly. The Patent concerned the use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy. Actavis sought to use other pemetrexed salts (‘the active ingredients’) in their product. DNIs were sought over the UK, French, Spanish and Italian designations of the Patent.
Floyd LJ dismissed the appeal insofar as it related to direct infringement and allowed the appeal insofar as it related to indirect infringement. On a proper construction the claim only covered pemetrexed disodium (and did not cover the alleged “equivalents” of pemetrexed diacid, ditromethamine or dipotassium) but the claim would cover solutions containing sodium ions and pemetrexed ions with at least a 2:1 ratio. Therefore, although the active ingredients would not directly infringe, where a pharmacist reconstituted or diluted the products in saline there would be a stage when “pemetrexed disodium” was present and used and this would amount to indirect infringement. However, as the active ingredients could also be reconstituted in dextrose, Floyd LJ ordered that the issue of whether there would be indirect infringement if Actavis launched a product for reconstitution or dilution with dextrose should be remitted to the Patents Court.
Issues relating to private international law and the Rome II regulation were dealt with obiter, but the Court of Appeal indicated that Eli Lilly’s appeal was not well founded.
Richard Meade QC and Isabel Jamal were instructed by Bird & Bird LLP.