Second medical use and skinny label claims in the UK

This decision, in which the judge decided there was "no serious issue to be tried on infringement", was based primarily on the judge's finding that a subjective intention was required on the part of Actavis in relation to direct infringement of the Swiss form claim in issue. For this part of their case, Warner-Lambert had only been relying on the fact that Actavis ought to have known that their product would be prescribed for the patented use, which is based on the intention of the end user.

We further reported that this decision, at least in so far as indirect infringement of a Swiss Form claim is concerned, seemed to be inconsistent with subsequent decision of the Dutch Court of Appeal in the Hague, in a case between Novartis and Sun Pharmaceuticals. In that case, Sun was found liable for indirect infringement of a Swiss form claim, despite use of a skinny label that did not mention the patented use. The English court had dismissed the equivalent indirect infringement claim in the Warner-Lambert case based on established law relating to indirect infringement of process claims, which include Swiss form claims. There have been two interesting recent developments in the English Warner-Lambert litigation.

Warner-Lambert's claim survives – in part

First, based on the decision to refuse an interim injunction, Actavis applied to strike out Warner-Lambert's claim for infringment of the patent in its entirety. At the same time Warner-Lambert applied to amend its case on direct infringement to plead subjective intention on the part of Actavis. Interestingly, having been relatively uninterested in this part of their case originally, Warner-Lambert also sought to maintain its claim for indirect infringement, following the decision of the Court of Appeal in the Hague.

On 06 February, Mr Justice Arnold dealt with these two applications. He refused to strike out Warner-Lambert's case entirely. While he remained of the view that subjective intention was required for direct infringement, and Warner-Lambert's amended pleading did not disclose reasonable grounds for alleging such intention, he allowed this part of the case to go forward. He accepted that he might be wrong as regards the requirement for subjective intention for direct infringement, and this was a very important, developing area of the law that needed looking at by a higher court.

He did however strike out the claim of indirect infringement, which he maintained was hopeless. His explanation for the apparent difference between his position and that in the Netherlands was that it seems the Dutch court was not addressed on the further claim construction issues raised by a claim of indirect infringement. As to these, he was of the view that the law was developed and clear, such that this aspect of the claim should not continue. This may be subject to appeal.

Injunction granted against the NHS

The second, perhaps more immediately interesting development, was a decision apparently made on 26 February. It appears that Mr Justice Arnold has granted an order against the UK National Health Service (NHS) requiring it to issue guidance to the effect that physicians must prescribe pregabalin by brand name for the patented second medical use (pain). This guidance would be contrary to the general prescription guidance in the UK, which is always to prescribe generically absent very good reasons to do otherwise. There had been indications in the evidence submitted in this case that local health authorities were refusing to accede to the patentee's request to prescribe pregabalin by brand name for the patented use, based on there being "no clinical reason to do so". Prescribing by brand name means the pharmacist fulfilling the prescription must dispense the branded product.

This mandatory injunction is a major step forward in the enforcement of second medical use patents in the UK. This seems to us to be a sensible and practical solution to the problem, certainly while there remains doubt as to the scope of second medical use claims.

Useful link

To read the full decision (issued 2 March, subsequent to initial publication of this article) please see: http://dycip.com/ewhc485