Actavis UK Ltd and others v Eli Lilly & Company [2016] EWHC 234 (Pat) 12 February 2016

Case Summary  |  Judgment  |  12 February 2016

Richard Meade QC and Isabel Jamal, together with Thomas Raphael QC, successfully represented Actavis in the trial of the issues remitted by the Court of Appeal in Actavis v Lilly [2015] EWCA Civ 555. This action concerns Lilly’s European Patent No. 1 313 508 for the use of pemetrexed disodium, a chemotherapeutic treatment for lung cancer.

The “Dextrose Remission Issue” was whether the supply of Actavis’ pemetrexed diacid product with directions to dilute the product in dextrose would constitute indirect infringement of the patent. Lilly argued that it would be obvious that Actavis’ product would be intentionally diluted in saline by pharmacists and that, in line with the findings of the Court of Appeal, the resulting solution containing sodium ions and pemetrexed ions in a ratio of at least 2:1 would amount to indirect infringement of the Patent.

Arnold J held that it was not foreseeable that Actavis’ product would be diluted with saline. Pharmacists would follow the directions in the Summary of Product Characteristics that the Actavis product must only be diluted in dextrose. Arnold J also held that Actavis’ safeguards, including sending letters to medical centres and health authorities stating that its product should only be used in dextrose, would prevent the use of saline for dilution. Arnold J granted Actavis declarations of non-infringement in respect of the UK, French, Spanish and Italian designations of the Patent.

Arnold J also granted Actavis a declaration that certain letters sent by Actavis to Lilly stating that Actavis did not intend to launch its product did not give rise to a contract, nor did they found any promissory estoppel binding upon Actavis.

Richard Meade QC and Isabel Jamal were instructed by Bird & Bird LLP.