Roche Products Ltd & Anor v Kent Pharmaceuticals Ltd

For the purpose of Article 7 of the EU Directive 89/104/EEC, consent to the exhaustion of a trade mark proprietor’s rights must ordinarily be express or otherwise unequivocally demonstrated. A CE mark ordinarily communicates compliance with EU regulatory requirements and regulatory permission to market, not the proprietor’s consent. A different objective meaning may in principle be proved by a general trade custom, but subjective evidence from a few traders is insufficient. At a Civil Procedure Rules 1998 Part 24 hearing, a defendant generally must produce evidence which, if believed, would defeat the claim. The possibility of obtaining better evidence later is insufficient where it could reasonably have been obtained for the hearing.

Roche brought trade mark infringement proceedings after Kent bought in France and imported into the United Kingdom test strips made and packaged in the United States. The products had been supplied for a restricted clinical trial in the Dominican Republic and bore Roche marks and a CE mark. The packaging stated that they were made in the United States for export only.

Kent accepted that infringement was established under Article 5 unless it could rely on Article 7. It argued that the CE mark amounted to Roche’s consent to marketing in the EU. On 23 February 2006 Lewison J granted Roche summary judgment under Part 24. The appeal concerned whether Kent had shown an adequately arguable evidential basis for the Article 7 defence.

1. Disposition. The Court of Appeal, in a unanimous judgment delivered by Neuberger LJ with Ward LJ and Moore-Bick LJ agreeing, dismissed the appeal and upheld summary judgment for Roche.
2. Article 7 consent. Applying the authoritative guidance in Zino Davidoff, consent must be expressed so that the proprietor’s intention to renounce its exclusive trade mark rights is unequivocally demonstrated. Consent will normally be express, although it may be inferred from surrounding circumstances before, at or after the goods are placed on the market outside the EEA, where those circumstances provide unequivocal evidence. Silence, absence of objection and failure to reserve rights are insufficient.
3. Meaning of the CE mark. The objective function of a CE mark is to record compliance with EU regulatory requirements and the regulatory authorities’ acceptance that the goods may be marketed in the EU. It does not ordinarily communicate consent by the trade mark proprietor. Absent clear or cogent evidence to the contrary, the mark therefore did not make Kent’s Article 7 defence sufficiently arguable.
4. Market understanding. Neuberger LJ accepted, for present purposes, that a mark might acquire a special or wider objective meaning through a general understanding in the relevant trade, by analogy with the custom-of-trade authorities Smith Hogg and Yangtze. The point was not finally decided because Article 7 consent is an autonomous concept and the evidence was inadequate. Statements by a few traders about their subjective understanding were unhelpful and arguably inadmissible. The evidence also concerned parallel importers only. Consent is a two-way process, so Kent would have needed evidence of a general understanding among relevant trade mark proprietors as well.
5. Summary judgment. Under Civil Procedure Rules 1998 Part 24, where claimants have made out their case, the defendant will normally need to produce evidence which, if believed, would defeat the claim. Flexibility may be appropriate where necessary evidence cannot reasonably be obtained at the interlocutory stage, particularly if it is solely in the claimants’ possession. That exception did not apply. Any convincing expert evidence could reasonably have been obtained for the application, so the prospect of obtaining it later did not justify a trial.
6. Earlier authority and reference. Glaxo was distinguished on both facts and law. There the packaging was identical to the French home-market packaging, and the EMEA licence number, together with that identical packaging, made the consent argument fit for trial. The arguments advanced in the present case were also materially different. A reference to the ECJ was neither necessary nor appropriate, since the approach adopted was the approach advanced by Kent and was not challenged by Roche.

1. Court of Appeal (Civil Division) — On 20 December 2006, dismissed Kent’s appeal and upheld the summary judgment, [2006] EWCA Civ 1775.
2. High Court of Justice, Chancery Division — On 23 February 2006, Lewison J granted Roche summary judgment in the trade mark infringement proceedings under Part 24.