Actavis UK Ltd & Ors v Eli Lilly & Co (Rev 1)

Indirect infringement requires proof that, at the time of supply, the supplier knows or it is obvious that at least some ultimate users will intend to use the supplied means to put the invention into effect. Speculative, maverick or unlikely use is disregarded. A negative declaration may be granted where the issue is sufficiently defined, the claimant has a real commercial interest, and the declaration serves a useful purpose. Future uncertainty does not necessarily prevent relief; the court may grant the declaration with liberty to apply if circumstances materially change. Statements of future intention do not create a contract or promissory estoppel without the necessary offer, acceptance, consideration, promise or reliance.

Actavis sought declarations that supplying a generic pemetrexed product in the United Kingdom, France, Italy and Spain would not indirectly infringe Eli Lilly’s patent. The product was a liquid concentrate which its product information required to be diluted only with 5% dextrose solution. Lilly argued that pharmacists might later use saline, particularly if stability data became available or because of concerns about diabetic patients.

The Court of Appeal had remitted the dextrose issue after holding that dilution in sufficient saline could fall within the patent claims. Actavis also sought declarations concerning two letters said by Lilly to constitute binding undertakings or to support promissory estoppel.

1. Declarations granted. The supply of the Actavis product would not, for the foreseeable future, amount to indirect infringement. Both sides were given liberty to apply if circumstances materially changed.
2. Under section 60(2) of the Patents Act 1977, the relevant question was whether Actavis knew, or it was obvious to a reasonable person, that the product would be used by at least some customers to put the invention into effect. Speculative, maverick or unlikely use was disregarded.
3. Pharmacists would initially follow the product information. The available stability period in dextrose was sufficient, there was little prospect of reliable saline stability data being published, and there was no persuasive clinical or pharmaceutical reason to change diluent. The small quantity of dextrose was not a material concern for diabetic patients, particularly in comparison with chemotherapy drugs routinely administered in substantially larger quantities of dextrose.
4. Even if saline data and a motive to change emerged, Actavis’s product information, communications, contractual measures, supply controls and monitoring of pharmacy worksheets made it probable that saline would not be used. The stock-piling and tender arguments were speculative and did not establish foreseeability.
5. A negative declaration was appropriate under the court’s broad discretionary jurisdiction. The issue was sufficiently defined, Actavis had a real commercial interest, and the declaration served a useful purpose. The court could grant relief despite contingent future facts, while protecting both parties through liberty to apply.
6. The letters did not create contracts. They contained no offer accepted by Lilly and no consideration moving from Lilly. They also did not create promissory estoppel because they contained no promise that Actavis would refrain from enforcing a strict legal right, and Lilly had not established reliance.

The judgment concerned issues remitted following the Court of Appeal’s decision in the same litigation. The Court of Appeal had upheld the finding of no direct infringement but reversed the finding on indirect infringement and remitted the dextrose issue. The present court granted declarations for the UK, French, Italian and Spanish designations and liberty to apply.