In the latest judgment, issued on 28 May 2015, in the on-going Warner-Lambert v Actavis dispute relating to Warner-Lambert's patent EP 0 934 061 and Actavis' LECAENT product, the UK Court of Appeal has made some important findings regarding indirect infringement and "Swiss form" claims.
The litigation concerns Warner-Lambert's prescription-only drug pregabalin, which it markets under the trade name LYRICA and which is prescribed to treat epilepsy, generalised anxiety disorder and neuropathic pain. Warner-Lambert's patent covering pregabalin itself has expired, but it has a second medical use patent for the use of pregabalin for the preparation of a pharmaceutical composition for treating pain. Actavis had applied for authorisation to market its pregabalin LECAENT under a skinny label, which would restrict its use to treating epilepsy and general anxiety disorders. Warner-Lambert brought an action against Actavis for direct and indirect infringement of its patent arguing that the skinny label would not prevent the cheaper Actavis product being dispensed for the treatment of pain.
To briefly recap on the various stages of the dispute so far: Warner-Lambert had applied for an interim injunction that would force Actavis to take certain steps to prevent its generic drug being prescribed for pain. This application was refused at first instance by Arnold J. He found that there was no serious issue to be tried because Actavis, as the product's manufacturer, did not have a subjective intent that the product be used for the patented use. Buoyed by Arnold J's finding of 'no serious issue to be tried', Actavis then applied to strike out the infringement claims. Arnold J thought that Warner-Lambert had failed to plead a case on direct infringement but, regardless, he ruled that the claim should go to trial in June because the construction of s60(1)(c) of the UK Patents Act 1977 (which concerns infringing acts in relation to products and patented processes) was a developing area of law and so a judgment should be made at a full trial with knowledge of all the facts. Arnold J then held that the case on indirect infringement should be struck out. Warner-Lambert appealed against the High Court's judgment on the interim injunction application and on indirect infringement.
The Court of Appeal upheld Arnold J's decision to refuse the interim injunction application but took a different approach on the construction of 'for' in Swiss form claims. Floyd LJ held that the skilled person "would understand that the manufacturer who knows (and for this purpose constructive knowledge is enough) or could reasonably foresee that some of his drug will be intentionally used for pain is making use of the patentee's inventive contribution, in the same way as a manufacturer who actively desires that result... therefore, the skilled person would understand that the patentee was using the word "for" in the claim to require that the manufacturer knows (in the above sense) or can reasonably foresee the ultimate intentional use for pain, not that he have that specific intention or desire himself."
Floyd LJ therefore considered that Warner-Lambert had an arguable case of infringement, although he caveated this by saying that unqualified relief would not necessarily follow a finding of infringement.
Warner-Lambert's second appeal against the striking out of their indirect infringement claim was successful. Whilst the Court of Appeal recognised that Arnold J had been right to identify difficulties in the indirect infringement claim ("namely the absence of a downstream event which, as a whole, can be regarded as putting the invention into effect"'), it decided that it should go to trial.
Floyd LJ gave three reasons for this decision. First, the German and Dutch courts had decided that, at face value, indirect infringement can arise in these circumstances. Second, if threatened or actual infringement of the process claim under section 60(1)(b) could be shown then it would follow that downstream dealings in the direct product of the process could also be infringements under section 60(1)(c). Therefore 'downstream' infringement could be established leading to the possibility of indirect infringement. Third, 'putting the invention into effect' in section 60(2) could arguably refer to more than one person i.e. the manufacturer and the supplier who intentionally uses it to treat pain.
It will be interesting to see how the High Court applies this new interpretation of Swiss form claims and Floyd LJ's three findings in respect of indirect infringement at the trial in late June.
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