Pfizer Ltd v F. Hoffmann-La Roche AG & Anor

Arrow declarations are discretionary. The court must consider justice to both parties, whether the declaration would serve a useful purpose, and any special reasons. There is no absolute jurisdictional bar merely because the defendant has no UK right. A foreign-court benefit may be a legitimate purpose, but the court must guard against forum shopping. Where UK patent rights and related uncertainty have disappeared, and the dispute concerns a foreign patent and foreign law, the possible persuasive value of an English judgment abroad is insufficient by itself. Commercial value and shielding conduct may support relief but do not overcome that deficiency. If relief would not be granted irrespective of the technical merits, the court may decline to decide a proposed Gillette defence in detail.

Pfizer sought Arrow declarations concerning its proposed UK and European launch of biosimilar bevacizumab. Roche’s European patent families covered combinations for breast and ovarian cancer, but Roche had withdrawn the UK designations and no UK rights could arise. Pfizer argued that its proposed uses were anticipated or obvious and that an English judgment would reduce uncertainty, including in Belgium, from which the UK market would be supplied. Roche argued that declarations should not be made without UK rights and that any benefit in foreign proceedings was insufficient. The central issues were whether the court should exercise its declaratory discretion and whether it should determine the technical merits if relief would in any event be refused.

1. Arrow declarations refused. The court declined to grant the declarations and therefore did not determine Pfizer’s alleged Gillette defence in detail.
2. Under Civil Procedure Rules 1998 Part 40 r40.20, declaratory relief is discretionary. The court should consider justice to the claimant, justice to the defendant, whether the declaration would serve a useful purpose, and any special reasons. The approach is pragmatic rather than jurisdictional, as explained in FSA v Rourke [2002] CP Rep 14 and MessierDowty v Sabena [2000] 1 WLR 2040.
3. The Arrow jurisdiction permits declarations addressing whether a product, process or use was old or obvious at a particular date. Pending applications may be relevant, but their existence is not sufficient. There is no general jurisdictional bar merely because the defendant has no UK legal right. The court must identify the real purpose of the declaration and examine carefully any predominant purpose of use in foreign proceedings.
4. Reasoned English judgments may have persuasive value in other EPC states. However, the present case differed materially from FujiFilm v AbbVie [2017] EWHC 395 (Pat), where threats and unclear undertakings created continuing commercial uncertainty in the UK. Here Roche’s complete withdrawal of UK designations meant that no UK patent uncertainty remained. The possible use of the judgment in Belgium was insufficient, particularly because the Belgian dispute would concern a Belgian patent and Belgian law. The court was no better placed than the Belgian court to decide those issues. The fact that the EPC provides a common legal basis did not alter that conclusion.
5. Under Belgian law, the reasoning in Syral v Roquette and the approach in Orion/Novartis v Eurogenerics supported the conclusion that a reasoned foreign judgment could be relevant to apparent validity, but the Belgian court would assess relevance in context and could give the judgment little or no weight. It would not be bound to follow it automatically.
6. The technical evidence disclosed an apparently strong case of obviousness and a compelling case for a Gillette defence. Roche’s de-designation was inferred to be shielding, and the declaration would have real commercial value. Those matters did not outweigh the absence of a useful UK legal purpose. It would have been inappropriate to conduct a detailed merits determination after deciding that the declaration should not be granted.