Actavis UK Ltd & Ors v Eli Lilly & Company

Patent claims must be construed purposively in context, balancing fair protection with reasonable certainty for third parties. A specific chemical designation ordinarily retains its conventional meaning where the specification, skilled team and prosecution history show deliberate limitation. Equivalence cannot be used to recover subject matter abandoned during prosecution or to extend protection beyond the claim’s proper scope. The skilled team may include different specialists, and its knowledge must reflect the practical work required by the claim. Rules governing the availability of negative declaratory relief concern the machinery of the court and are procedural under Article 1(3) of the Rome II Regulation. They are therefore governed by the lex fori, while infringement remains governed by the lex loci protectionis.

Actavis sought declarations that proposed generic products containing pemetrexed diacid, dipotassium or ditromethamine would not infringe the UK, French, Italian or Spanish designations of Lilly’s European patent concerning pemetrexed disodium used with vitamin B12 and, optionally, folic acid. Lilly counterclaimed for threatened infringement of the UK designation and opposed the declarations on substantive and procedural grounds.

The court considered claim construction, infringement by equivalence, indirect infringement, the applicable law governing negative declaratory relief under the Rome II Regulation, and the requirements for such relief under English, French, Italian and Spanish law.

1. Construction and skilled team. The patent was addressed to a team including a medical oncologist and a chemist. The expression “pemetrexed disodium” had its conventional meaning and did not extend to pemetrexed diacid, dipotassium or ditromethamine.
2. Equivalence. Applying the Improver questions, substitution of the proposed forms was not obviously free from a material effect because the chemist could not predict their solubility, pharmaceutical acceptability or other properties without testing. Even if question 2 were answered affirmatively, question 3 required a strict reading. The chemical expression was specific, the specification and expert evidence supported that reading, and the prosecution history showed a deliberate limitation from broader claims. Extending the claims would undermine legal certainty and risk added matter or insufficiency.
3. The same conclusion followed for the French, Italian and Spanish designations. Under French law the claimed means had a known function and could not be extended by equivalence. Italian law required closer attention to the claims under Article 52 of the Code of Industrial Property. The Spanish “own acts” doctrine applied because the amendments were explicit and unequivocal.
4. Dealings in the proposed products did not constitute direct infringement. They also did not constitute indirect infringement under section 60(2) of the Patents Act 1977: the products did not provide pemetrexed disodium as required by the claim, merely producing ions in solution after dilution.
5. The rules governing whether a negative declaration should be entertained ensure that the court is invoked only for a genuine and sufficiently defined dispute. They concern procedure, not substantive patent rights, and therefore fell within Article 1(3) of the Rome II Regulation and were governed by English law.
6. Actavis had a real commercial interest and a useful purpose in obtaining declarations. The declarations were also available under the relevant French, Italian and Spanish provisions. The later proceedings were not an abuse of process.

Declarations of non-infringement were granted in respect of the UK, French, Italian and Spanish designations.

First-instance decision. The judgment records earlier jurisdictional proceedings: the jurisdictional challenge was rejected in [2012] EWHC 3316 (Pat) and that decision was affirmed on appeal in [2013] EWCA Civ 517 , [2013] RPC 37 .