UK patent court cases

All the court decisions listed in this section are available on the free-to-use website www.bailii.org.

Infringement Arrow declaration Declaration for use outside UK only

(1) Teva UKLimited (2) Teva Pharmaceutical Industries Limited v Novartis AG and

(1) Novartis AG (Switzerland)

(2) Novartis Pharmaceuticals UKLimited v(1)TevaUKLimited(2)DrReddy’sLaboratoriesLimited

(3)GlenmarkPharmaceuticalsEuropeLimited

(4) Tillomed Laboratories Limited

(5) Zentiva Pharma Uk Limited

(6)AristoPharmaGmbh(Germany)

(7) Viatris UKHealthcare Limited

[2022] EWHC 2779 (Ch)

19 October 2022

Bacon HHJ

This decision relates to Teva’s application for what is referred to as an Arrow declaration, that its proposed acts of importing and selling generic fingolimod to treat relapsing-remitting multiple sclerosis at a daily dose of 0.5 mg p.o. was obvious at the priority date of European Patent EP2959894 (‘EP 894’), for which Novartis AG is the registered proprietor.

Teva’s application is what is left of two separate sets of proceedings between Teva and Novartis. Before trial, Novartis informed Teva that it was de-designating the UK from EP 894 and dropped its infringement action against all of the defendants. The result of this is that once EP 894 granted it had no effect in the UK, which is now a generic market.

The sole issue was whether the court should exercise its discretion and grant the Arrow declaration sought by Teva, despite no patent rights existing in the UK. Obviousness was not considered.

The judge referred, in particular, to Fujifilm v AbbVie [2017] EWCA Civ 1. In this decision the court granted the declarations even though these were sought in relation to patents where AbbVie had abandoned the UK designations. However, the facts of this case were considered unusual as a result of AbbVie’s conduct.

An argument advanced by Teva (amongst others) was that a UK judgment would have potential utility to a decision in Germany on whether to grant a preliminary injunction against Teva. On this point Teva and Novartis both submitted evidence from witnesses as to whether, and to what extent, a decision of the court granting the declaration would be taken into account by a German court in deciding whether to grant preliminary injunctive relief against Teva on the basis of EP 894.

The judge did not consider the evidence before them to establish how much weight a German court would give to a granted declaration, beyond the fact it would be taken into account and be ‘of interest’.

Further, the judge held the fundamental problem with Teva’s line of argument was that the case law consistently establishes that if the only or predominant purpose of the declaration sought is to use the judgment for a foreign court, a declaration is only likely to be granted in unusual cases where a very compelling justification for doing so (referring to Fujifilm v AbbVie).

Teva’s answer to this was that the effect of the declaration would be felt in the UK because Teva’s supply chain to the UK involves transit through Country A (redacted), and if injuncted in Country A it would be time-consuming and expensive to alter its supply chain, thus threatening its ability to supply to the UK. On the evidence before her, the judge accepted that a declaration would have an impact on Teva’s supply chain in so far as it is taken into account in Country A.

An argument by Novartis that Teva should already have taken steps to identify and plan for an alternative supply route was considered ‘hollow’ by the judge, since Novartis were unable to identify any country through which Teva would have been able to plan an alternative supply route.

Nonetheless, it was held by the judge that Teva succeeding on this point was not enough to grant the declaration. The fact that a decision in Country A would affect the UK market indirectly did not change the fact that the purpose of an Arrow declaration in the UK would be to use it in the courts of Country A and other countries, rather than to obtain or enforce any right in the UK.

The judge differentiated the present case from the Fujifilm case, where a central plank of that decision was the impact of the declaration in dispelling uncertainty on the UK market, given the conduct of AbbVie. In the present case, there was no such uncertainty. This was in line with the decision taken in Pfizer v Hoffman-La Roche [2019] EWHC 1520 (Pat).

Other factors considered by the judge included whether UK legal rights were required for a declaration to be granted, Novartis’ conduct in abandoning its UK designation before trial, the need for certainty for Teva’s customer (the NHS), and alleged inadequacy of Novartis’ undertakings.

In summary, Teva’s application for an Arrow declaration was refused.

[2022] EWCA Civ 1617

8 December 2022

Arnold LJ, Nugee LJ, Sir Christopher Floyd

Teva unsuccessfully appealed the decision reported above. The Court of Appeal considered that the judge had correctly refused to grant the Arrow declaration.

Declaration of non-infringement Abuse of process Costs

Lisa Dräxlmaier GmbH v BOS GmbH & Co KG

[2022] EWHC 2823 (Ch)

8 November 2022

Sir Anthony Mann

This judgment relates to an application for a declaration of non-infringement filed by Dräxlmaier against BOS in relation to European Patent (UK) No. 3266631.

BOS had sued Dräxlmaier in Germany under the corresponding German designation of the same European patent. It had been accepted that the English proceedings no longer served a useful process and could be brought to an end. However, there was disagreement as to how they should be correctly brought to an end.

Dräxlmaier gave notice under section 71 Patents Act 1977 requesting confirmation that its product did not infringe BOS’s English patent. BOS did not respond. The case was unusual as it related to a patent which had been allowed to lapse by BOS due to failure to pay the renewal fee, albeit shortly after the communication from Dräxlmaier. However, during the six-month grace period, Dräxlmaier paid the renewal fee, reviving the patent, and then subsequently filed the declaration of non-infringement. BOS attempted to surrender the patent but Dräxlmaier resisted this application.

BOS filed a strike-out/summary judgment application which was the reason for this judgment. The BOS position was that the proceedings were or had become an abuse of process as they were pointless.

The judge identified that the overwhelming purpose of the proceedings was to obtain an English decision that could be presented to the German court. He then went on to consider in detail whether there could be an abuse of process in a case which only considers infringement and is for the purpose of providing a decision for foreign proceedings.

He reached the conclusion that at least at the point where BOS sought to surrender the patent, the proceedings did not justify the use of court resources and should have been brought to an end. However, whilst noting that it was just about possible to characterize Dräxlmaier’s actions as an abuse, what was relevant was that the proceedings were unjustifiably maintained by the claimant.

The judge went further to conclude that the action should never actually have been brought. However, with an eye to costs, he noted that BOS’s failure to engage with the declaration of noninfringement notice was also problematic.

The judge issued an order to stay the proceedings rather than make a striking out order. He then requested both parties to agree costs based on his views in this judgment.