Actavis UK Ltd & Ors v Eli Lilly & Company

Patent claims are construed purposively through the eyes of the skilled person, using common general knowledge. Equivalents may inform that construction, but do not create a free-standing doctrine extending protection beyond the claims.

Where a claim requires manufacture of a medicament, the skilled team may include a formulation chemist. The court cannot assume that an untested alternative salt has the necessary solubility or pharmaceutical suitability. Specific language identifying a particular salt may therefore be essential.

However, where the claim language and specification treat a salt as present in solution, the claim can cover the requisite ions in solution even if they derive from different starting materials. Supplying an alternative ingredient can then amount to contributory infringement where it is a means relating to an essential element and is knowingly intended to be used to make the claimed medicament.

Actavis sought declarations of non-infringement of Lilly’s European patent for the use of pemetrexed disodium with vitamin B12 and, optionally, folic acid. The declarations concerned the United Kingdom and the corresponding French, Italian and Spanish designations. Actavis intended to market products containing pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine after expiry of Lilly’s earlier patent.

Arnold J held that the proposed products would not directly or indirectly infringe and granted the declarations: [2014] EWHC 1511 (Pat). He also held that the conditions for obtaining declarations of non-infringement were procedural and governed by English law.

Lilly appealed. The central issues were claim construction, contributory infringement, the corresponding foreign-law position, and whether the Rome II Regulation required application of the foreign conditions for obtaining declaratory relief.

1. Appeal allowed. Floyd LJ, with whom Kitchin and Longmore LJJ agreed, set aside the declarations of non-infringement. The proposed supply for reconstitution or dilution in saline would amount to contributory infringement.

2. The skilled addressee was a team including an oncologist and a chemist. The manufacture of the medicament was an essential part of the claim. Applying purposive construction and the Improver/Protocol questions, the court held that the skilled team could not predict from the patent and common general knowledge whether the proposed alternative salts would be sufficiently soluble and pharmaceutically suitable. The claim was therefore limited to pemetrexed disodium, and there was no direct infringement by supplying the alternative active ingredients.

3. The expression pemetrexed disodium nevertheless included a solution containing pemetrexed ions and sodium ions in a ratio of at least 2:1. It was immaterial that the solution was produced otherwise than by dissolving the solid disodium salt, or that it also contained further sodium or other ions.

4. Under section 60(2) of the Patents Act 1977, an essential means need not itself be a free-standing claim element or be usable without alteration. The alternative active ingredients were means relating to an essential element. When knowingly supplied for reconstitution or dilution in saline, they enabled the pharmacist to make a medicament containing the required pemetrexed and sodium ions. The same conclusion followed under the contributory-infringement laws of France, Italy and Spain.

5. The court’s conclusions on the Rome II Regulation were unnecessary to the result. It nevertheless agreed that conditions governing the admissibility of an action for a declaration of non-infringement are procedural under article 1(3), and are governed by the lex fori rather than the lex causae.

6. The court refused modified declarations which would merely record the absence of direct infringement or risk misleadingly qualifying the finding of indirect infringement. It remitted to the Patents Court the broad issue whether supply of the products when recommended for reconstitution in dextrose would infringe, without prejudice to Lilly’s abuse-of-process objection.

• Court of Appeal (Civil Division): Lilly’s appeal was allowed. The declarations of non-infringement were set aside, and a dextrose-reconstitution issue was remitted to the Patents Court: [2015] EWCA Civ 555.

• High Court, Chancery Division, Patents Court: Arnold J granted declarations of non-infringement for the United Kingdom, France, Italy and Spain, and held that the relevant conditions for declaratory relief were governed by the lex fori: [2014] EWHC 1511 (Pat).

• Court of Appeal (Civil Division): In an earlier jurisdiction appeal in the same litigation, the court upheld the English court’s jurisdiction to determine the declarations concerning the foreign designations: [2013] EWCA Civ 517; [2013] RPC 37.