Arnold J has handed down a second decision in the dispute between Warner-Lambert and Actavis. He refused, on 21 January of this year, to grant Warner-Lambert an interim injunction relating to infringement of its European patent EP (UK) 09434061 on the grounds that that there was no serious issue to be tried and even if it did, the balance of the risk of injustice favoured refusal of the relief sought.
The judge's finding that there was no serious issue to be tried was based on his construction of the Swiss form claim in issue, which he held implicitly included the requirement that the manufactured medicament be "suitable and subjectively intended for" the treatment of the claimed indication. The words in bold are not included expressly in the language of the claim.
The 21 January 2015 decision is discussed here. You will recall that the patent covered use of pregabalin for treatment of neuropathic pain but not for epilepsy and generalised anxiety disorder. Actavis intends to market a generic pregabalin medicine (Lecaent) under a 'skinny label' (i.e. which does not include the neuropathic pain indication). There was no evidence of intent to market for the pain indication and therefore Arnold J held that Lecaent fell outside the scope of Warner-Lambert's indication-limited patent.
Actavis has since applied to strike out, alternatively for summary dismissal of, Warner-Lambert's entire claim, but, in the judgment the subject of this alert, Arnold refused any summary relief. Lastly, rounding off a hat-trick of refusals, Arnold J refused Warner-Lambert permission to amend its particulars of infringement. We will look at the application to amend first and the strike out application second. Arnold J's 6 February 2015 decision is available here.
Permission to amend particulars of infringement
Warner-Lambert applied to amend its particulars to include support for an inference that Actavis intended its skinny label Lecaent to be used in the treatment of pain (the indication the subject of Warner-Lambert's Swiss form patent claim). Two sets of facts were proposed to be included (and assumed to be true for the purposes of the hearing).
Firstly, facts that Warner-Lambert claimed "would have" formed the basis for Actavis' business plans: that over 54% of pregabalin is prescribed for pain; the majority of prescriptions are written generically; that about 95% of prescriptions do not state the indication; and that Actavis knew that the use of a 'skinny label' would not prevent Lecaent being dispensed for pain.
Secondly, facts directed at Actavis' intent vis-a-vis the use of its product for the treatment of pain: Actavis' Patient Information Leaflet (PIL) for its generic pregabalin includes a statement that pregabalin capsules may be prescribed to treat conditions not listed in the leaflet; and Actavis' Summary of Product Characteristics (SmPC) and PIL include safety information relating to the neuropathic pain indication the subject of Warner-Lambert's patent.
Arnold J concluded that the proposed pleaded facts did not support an inference of intention on Actavis' part (i.e. that its 'skinny label' generic pregabalin, Lecaent, be used for the treatment of pain). Instead he agreed with Actavis that the proposed pleaded facts only supported an allegation that use of Lecaent in the patented indication would be a foreseeable consequence. Even if the wording in the SmPC and PIL was not necessary from a regulatory perspective, this did not mean it was not good practice and accordingly it did not demonstrate intent on Actavis' part (notwithstanding that there was no such wording in the equivalent documentation granted to competitor Consilient).
Application to strike out or summarily dismiss
Actavis had, understandably, followed up Arnold J's decision that there was no serious issue to be tried with an application to strike out the claim, alternatively for the claim to be dismissed by way of summary judgment. Arnold J refused this application.
Arnold J's 21 January judgment was the first in the UK which squarely addressed the issue of the mental element of Swiss form claims. He acknowledged that the construction of Swiss form claims is a "developing area of law" and that it was possible that an appellate court might conclude that his construction of the words "for treating" in the Swiss form claim in issue (i.e. as meaning "suitable and subjectively intended for treating") was wrong, and that therefore this was not a suitable case for summary judgment or strike out. Rather, he thought that the construction of Swiss form claims was suitable for consideration not merely by the Court of Appeal but also by the Supreme Court.
None of the earlier cases mentioned in Arnold J's 21 January judgment, from England, Germany and the Netherlands, had been "anywhere near being definitive" on the construction of such wording in Swiss form claims.
However, the Hague Court of Appeal had, in the intervening couple of weeks, delivered its judgment in Novartis v Sun. The claim in issue in those proceedings was also in Swiss form. The facts in that case were, of course, different to those in Warner-Lambert's claim and Arnold J noted that one of those facts, i.e. Sun's knowledge, appeared critical to the Dutch court's decision. However there were important points in the Dutch court's legal analysis, including:
- The Dutch court's analysis assumed that the Swiss form claim in issue was a product claim.
- There was no discussion of the meaning of the words "for treating" or of any mental element which those words import.
- The Dutch court (provisionally) held that Sun had committed indirect infringement, that is to say, infringement under the Dutch implementation of Article 26 of the Community Patent Convention, which is implemented in the UK by section 60(2) of the Patents Act 1977.
These findings stand in contrast to Arnold J's findings in his 21 January decision that the Swiss form claim in issue was a process claim, and in consequence that there was no serious issue to be tried on infringement under section 60(1)(a) (direct infringement of a product claim) or section 60(2) (indirect infringement) of the Patents Act 1977, as well as under section 60(1)(c) (direct infringement involving the product of a claimed process).
Warner-Lambert indicated that it would seek to appeal if its infringement claim was struck out. Arnold J agreed that it would be very difficult to obtain a decision from the Supreme Court on this point before a full trial, even assuming that the Court of Appeal expedited its consideration of the matter. Consequently, even though Warner-Lambert's claim did not have a real prospect of success as matters presently stood, the proper course was to establish the facts at trial before attempting definitively to determine the law. Accordingly, Arnold J dismissed Actavis' application to strike out, alternatively to dismiss summarily, Warner-Lambert's claim.
Further points made by the judge
Arnold J made some further points, of interest to those watching developments in this field:
- He expressed the view that there remain arguments in the case before him which might be advanced but have not yet been made. For example, if it turned out at trial that, despite the fact that Actavis had not intended Lecaent to be dispensed for treating pain and despite the fact that Actavis, and others had taken reasonable steps to prevent this, in fact some Lecaent had been dispensed for pain, "[i]t might be said that…[Warner-Lambert] ought to have a financial remedy even if it was not entitled to an injunction". The problem here is that his construction makes a finding of infringement by Actavis highly unlikely, and it is difficult to see the legal basis for an award of damages without a finding of infringement, absent a foray into (an extension of) the realm of restitution.
- He cautioned that disclosure "must be limited to what is relevant and proportionate". The requirement for Warner-Lambert to establish subjective intent on the part of Actavis does not justify wide-ranging disclosure. Warner-Lambert appears to be in a tight corner here: it can only prove subjective intent using Actavis documents, but it can't go on a "fishing expedition" to obtain them.
- An NHS body (the North of Tyne Area Prescribing Committee) has indicated that it does not intend to encourage branded prescribing of Warner-Lambert's Lyrica for the patented pain indication, thereby enabling Actavis' sales in the patent protected indication. This lack of enthusiasm for patent rights on the part of the North of Tyne Area Prescribing Committee led Arnold J to comment that the situation which confronts the parties in this case "depends on the past, current and future actions of third parties who are not under either party's control or direction", and led him to note the "desirability" of the NHS issuing guidance on the subject. However, the present construction of Swiss form claims prevents their enforcement both against downstream participants in the supply chain of a skinny-label generic medicine and against the NHS. Contrast that with the alternative interpretation taken by the Dutch appeal court.
As matters stand, Swiss form claims are very difficult to enforce against 'skinny label' generic products even where the majority of such medicines would be destined for use in the treatment of the disease the subject of the claim.
In theory this does not matter because the NHS and pharmacists should comply with the patent restrictions, but we have seen that in practice it does matter. Swiss form claims are being replaced in the European Patent Office by so-called EPC 2000 claims, but that changeover will take many years to filter through.
In the meantime the legitimate interests of affected patentees are not being protected. Those interests can only be protected either by the NHS participating in the process through prescribing guidance or software, or by the Supreme Court addressing the UK interpretation of Swiss form claims and moving away from Arnold J's narrow construction.