Second medical use claims and skinny labels

The latest instalment in this saga came in the form of a monster judgment of Mr Justice Arnold, handed down on 10 September 2015.

The judgment, which runs to over 170 pages, relates to the full trial on the merits of the action, the previous decisions relating to Warner-Lambert's request for interim injunctions and Actavis's applications to strike the claims out completely. As readers may recall, Arnold J in the Patents Court, and Floyd LJ in the Court of Appeal, expressed different views on how second medical use claims in Swiss-form should be interpreted, and on indirect infringement of such claims.

In this latest judgment, Arnold J found the relevant claims invalid on the ground of insufficiency, meaning (unless overturned on appeal) the infringement discussion is somewhat academic. However, the judge considered the various potential constructions of Swiss-form claims in some detail. The judgment is very long and detailed so what follows is necessarily a summary.

Previous interim decisions in the action

By way of recap, the claims in issue were in Swiss-form, namely "The use of drug X in the manufacture of a medicament for the treatment of Y".

Arnold J had originally struck out Warner-Lambert's claim of indirect infringement by Actavis, on the basis that as the Swiss-form claims were to a method of manufacture, and the claimed method was not being put into effect in the UK, there could be no indirect infringement through the supply in the UK of "means relating to an essential element" of that invention.

As regards the claim of direct infringement, he allowed it to continue but had indicated it would be likely to fail on the basis that, as he interpreted such claims, "for the treatment of Y" requires a subjective intention on the part of the generic manufacturer that its product will be used for that treatment.

On appeal from that interim decision, the Court of Appeal indicated that in its view, "for" meant either subjective intent or, if that subjective intent was not present, that the ultimate intentional use of the drug for the patented indication was reasonably foreseeable by the manufacturer. The Court of Appeal also reinstated the indirect infringement claim, although it did express some doubts as to its merits.

Judgment of 10 September 2015 – direct and indirect infringement of Swiss-form claims

In his judgment Arnold J considers all of these points again in great detail. Interestingly, he determined that the Court of Appeal's view as regards interpretation of Swiss-form claims was not part of the formal reasons for its decision and therefore was not strictly binding on him. Nevertheless, while he expressed considerable doubts about the correctness of the Court of Appeal's interpretation, he decided it was not "plainly wrong" and therefore decided to apply both that interpretation and his own.

As regards his own interpretation that there must be a subjective intention, Arnold J found that it was clear that Actavis never had that intention, given all the steps they had taken to try to prevent or at least mitigate unauthorized use.

As regards the Court of Appeal's interpretation and approach, he had to consider the position concerning reasonable foreseeability (by Actavis) of an ultimate intentional use (by doctors or pharmacists) at various times in the history of Actavis's development and launch of its product.

Also relevant was the history of the dispute between the parties, bearing in mind how Actavis's state of knowledge and actions altered over that time. Having done so, aside from a negligibly small number of circumstances where such use was foreseeable very early on, he concluded, on the facts, that at no stage was such intentional use foreseeable.

Accordingly, Arnold J held that Actavis was not liable for indirect infringement on either interpretation. Relevant to these conclusions were that Actavis had both used a skinny label for its product and taken steps to notify superintendent pharmacists that its drug was not licensed for the patented indication.

As regards indirect infringement, an issue which he had originally struck out but had been revived by the Court of Appeal, Arnold J said that he was puzzled and baffled by the reasoning of the Court of Appeal for reviving it. He noted again that the contrary decisions in the Netherlands and Germany did not address the language of the claims in the context of indirect infringement. Having addressed all of the Court of Appeal's reasoning, he confirmed his original decision that there was no indirect infringement by Actavis because the 'invention' was a process of manufacture, and that process was not being put into effect in the UK by anyone, nor was there any prospect that it would be.

Threats

Actavis had raised a counterclaim against Warner-Lambert, alleging unjustified threats of patent infringement. This cause of action is available in the UK to 'persons aggrieved' by such threats.

Actavis's case was that Warner-Lambert's approaches to various entities, including government bodies and pharmacists, warning that the prescription and/or dispensing of generic pregabalin to patients for the treatment of pain would infringe its patent, amounted to such threats, and Actavis was 'aggrieved' by them.

As Warner-Lambert lost its claim for infringment (and the patent was found invalid), Arnold J found Warner-Lambert liable for unjustified threats in relation to some of these approaches.

It is worth noting perhaps that these UK threats provisions will apply to both unitary patents and European patents subject to the jurisdiction of the Unified Patent Court, providing a remedy (in the UK courts) to any person aggrieved by any unjustified threat relating to activities in the UK, regardless of whether proceedings for infringement would be brought in the UPC. Accordingly, patentees will need to be careful when raising the threat of proceedings in the Unified Patent Court that these threats do not give rise to a potential action, and associated remedy, before the UK courts.

Postscript

At the end of Arnold J's judgment, he expressed a note of what appears to be exasperation at the need for a system to address the conflicting policy issues surrounding second medical use inventions, balancing the patentee's right to enforce second medical use patents with the generic manufacturer's lawful right to market the drug for off-patent uses.

He sees the solution less in extended patent litigation (he notes that "I have now lived with this case for nine months") than in altering the prescribing practice for second medical use indications.

Arnold J's suggestion was that the drug be prescribed by its generic name for off-patent uses, but by brand name for patented (second) medical uses.

However, at least in the UK, this requires centralized guidance from health authorities and it is worth mentioning that the Secretary of State for Health intervened in these proceedings and noted the desirability of this approach as a sensible solution. We shall see whether it is adopted in the UK in some way. We will be considering this case in more detail ourselves and further commentary and opinion will be published in our next patent newsletter.

Useful link

Full decision: Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Company LLC [2015] EWHC 2548 (Pat) (10 September 2015): http://dycip.com/ewhc2548