The last few years has seen a notable increase in the number of disputes concerning second medical use patents. At the same time, more and more attention has been given to these patents in IP think tanks, where there has been a focus in particular on the process whereby a generics company carves out a patented indication from the list of indications for which its medicine is authorised, and the subsequent sales for the treatment of patients with the patented indication (i.e. the cross-label use of skinny-label medicines).
Warner-Lambert v Actavis
The issue of injunctive relief relating to skinny labelled generic medicines came to a head in an application made by Warner-Lambert in December 2014 in respect of Actavis’ generic pregabalin medicine known as Lecaent. Pregabalin is the active ingredient in Warner-Lambert’s Lyrica medicine which is authorised to treat several conditions. Compound patent protection for pregabalin expired in 2013 but Warner-Lambert has a second medical use patent with Swiss form claims to the treatment of pain.
Warner-Lambert applied for a mandatory injunction forcing Actavis to take various steps to try and preserve the Lyrica market for pain pending the outcome of a trial scheduled for June 2015. Both sides had already taken (or agreed to take) a number of steps to try and prevent the dispensing of Lecaent for pain. The interim measures requested from the court included a requirement for notices to be placed on Lecaent’s packaging highlighting that it should not be dispensed for pain, and for conditions to be included in any agreement for the supply of Lecaent to the effect that reasonable endeavours should be used not to dispense it for treatment of pain.
Arnold J found in favour of Actavis on the grounds that: (i) Warner-Lambert did not have an arguable case of infringement by Actavis of its pain patent and (ii) even if there was an arguable case of infringement, the balance of the risk of injustice favoured the refusal of the relief sought.
The decision is of interest for a number of reasons, including the Judge’s comments on the construction of Swiss form claims. Arnold J held that “the word ‘for’ in Swiss form claims imports a requirement ofsubjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition” (emphasis added). Given this construction, the Judge felt that there was no serious issue to be tried as Warner-Lambert had not relied upon any allegation of subjective intention on the part of Actavis. He also noted that Warner-Lambert had originally claimed for indirect infringement but that they were right not to pursue this as “There can only be infringement under section 60(2) [of the Patents Act 1977] if there can be infringement by the person supplied or by a user further down the chain of supply… This is not the case here, since no wholesaler or pharmacist will use Lecaent to prepare a pharmaceutical composition.”
Arnold J nevertheless went on to consider the balance of convenience and felt that granting the relief “would create a greater risk of injustice than refusing it”.
Warner-Lambert appealed this decision. The appeal was heard in late April and a decision from the Court of Appeal is pending.
Warner Lambert v NHS
In his judgment referred to above, Arnold J observed that the best solution to the problem of cross-label use would be to try and ensure that doctors prescribing pregabalin for the treatment of pain did so by reference to the brand name Lyrica and to prescribe pregabalin for other indications by INN. He went as far as encouraging the NHS to issue guidance to encourage prescription by brand for pain, and encouraging software providers to amend their electronic prescription systems to prompt doctors to prescribe branded pregabalin for pain (for the lifetime of the patent).
Following some correspondence with the NHS, Warner-Lambert issued an application for an Order compelling the NHS to issue such guidance. The matter came before Arnold J on 26 February. He considered the Court had jurisdiction to make an Order and concluded that: “the issuing of guidance by NHS England is the most efficacious, dissuasive and cheapest solution to the problem which confronts Warner-Lambert”. In turn, Warner-Lambert agreed to provide a cross-undertaking in damages in favour of NHS England. The Court ordered the cross-undertaking to extend to those generic companies that had applied (and group companies).
This decision emphasises the Court’s acceptance that, under the current regulatory systems in the UK, it is difficult to prevent cross-label use and as such to enforce second medical use patents. However, it remains to be seen whether the novel approach adopted by the Court will prove to be transferable to other cases. Ultimately on this occasion both originators and generics have the same goal – namely to allow free competition in the market for non-patented indications whilst respecting the legal exclusivity for the patented indication.