The English Patents Court handed down its judgment in Warner-Lambert v Actavis  EWHC 2548 on 10 September 2015. The dispute relates to Lyrica® (pregabalin), and follows four interim decisions of the Patents Court and a decision of the Court of Appeal on an interim appeal. The decision considers in detail the issue of infringement of a second medical use claim in Swiss-type format, and is likely to become a leading authority in the UK and influential in other EU jurisdictions too. The Court had to grapple with the difficulty of finding a balance between protecting the patent monopoly, whilst at the same time allowing market entry and competition for the non-patented indications.
We discussed the facts of this case and some of the interim decisions in our July quarterly briefing. [Accessible online here]
By way of a brief summary, pregabalin is marketed by Warner-Lambert under the brand name Lyrica® for the treatment of neuropathic pain, general anxiety disorder and epilepsy. Patent protection for pregabalin itself (under European Patent No. 0 641 330) expired on 17 May 2013. Warner-Lambert obtained an SPC in the UK which extended protection for pregabalin to 18 May 2018, but allowed the SPC to lapse for non-payment of fees. Warner-Lambert’s data exclusivity in respect of the data used to obtain the marketing authorisation for Lyrica expired on 8 July 2014. Warner-Lambert also owns European Patent (UK) No 0 932 061 entitled “Isobutylgaba and its derivatives for the treatment of pain”. The Patent is a second medical use patent in Swiss-type form. Claim 1 reads:
“Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain”.
Actavis, wishing to launch a generic version of pregabalin, obtained a UK marketing authorisation for general anxiety disorder and epilepsy (the ‘Non-patented Indications’) but carved out the patented indication (neuropathic pain) (“a skinny label”). Its generic product was manufactured by Balkanpharma in Bulgaria.
Warner-Lambert commenced an action for patent infringement, seeking an injunction and damages.
Actavis and Mylan challenged the validity of the Patent on the grounds of obviousness and insufficiency. However, in this note we focus on the issue of infringement, which was argued fully and subject to very full consideration by the Court.
In this regard, the Court started by observing that a claim in Swiss-type form is a purpose-limited process claim, directed to the process of “preparation” i.e. manufacture (which can extend to packaging with appropriate instructions). It is not a product claim.
Since the manufacturing process was carried out in Bulgaria, the only basis available to Warner-Lambert for an allegation of direct infringement was s60(1)(c) of the UK Patents Act 1977, which provides that,
“a person infringes a patent if … where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process, or keeps any such product whether for disposal or otherwise”.
It was common ground between the parties that the use of the word ‘for’ in Swiss-type claims does not mean ‘suitable for’ as it usually does in other types of patent claim. Instead, it means “suitable and intended for”. Unusually, this introduces an mental element into the assessment of liability under s60(1)(c) (intention generally being irrelevant for liability for infringement under this provision).
However, this gives rise to three important questions: (i) what is the nature of the requisite mental element; (ii) who must possess that mental element; and (iii) at what time?
Warner-Lambert argued that the mental element required is simply that the manufacture foresees that its product will be dispensed for the patented indication.
Actavis argued that this was not sufficient. Its position was that liability would be incurred only if the manufacturer “intended” that its product would be dispensed for the patent indication. It was common ground between the parties that intention is a subjective state of mind, but must be objectively assessed and may be inferred from appropriate facts.
The Court of Appeal had decided in an interim appeal earlier in the case ( EWCA Civ 556) that neither party was correct in its contentions. The correct test was whether the manufacture “knows or foresees that users will intentionally administer its product for pain.”
The judge at first instance (Arnold J) preferred the “intent” test of Actavis, but held that he should follow the decision of the Court of Appeal (even though it was strictly not binding on him). In applying the Court of Appeal’s test, the Patents Court decided that the reference to “users” primarily referred to the prescribing doctor, but the intent of the dispensing pharmacist may also be relevant. The intent of the patient was held not be relevant. Also, the Patents Court decided that the time at which the mental state of the manufacture had to be assessed was at the date of manufacture.
Arnold J concluded that it was not foreseeable to Actavis that its generic product, Lecaent®, would be intentionally administered for the treatment of pain save in a small number of exceptional cases, by medical professionals, that were proper to regard as de minimis.
Warner-Lambert also relied on indirect infringement under s60(2) of the UK Patents Act 1977. This provides that:
“a person infringes a patent if … he supplies or offers to supply in the UK a person … with any of the means, relating to any essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the UK”.
The Court re-iterated that Swiss-type claims are claims to processes of manufacture, not methods of treatment (which are in any event not a patentable invention under Article 53(c) of the European Patent Convention, as a matter of public policy). Since no acts of manufacture were carried out by any party downstream from Actavis, and there was no prospect of such an act, the Court concluded that Lecaent® was not suitable for putting, or intended to put, the invention into effect: either the invention has already been put into effect by the time that Lecaent® leaves Actavis’ hands, or it is not put into effect at all. The Court therefore concluded that Actavis was not liable for infringement under s60(2).
It is curious that the law on infringement of Swiss-type claims continues to give such difficulty, over thirty years since the Enlarged Board of Appeal of the European Patent Office approved claims in this form in its landmark decision in G 05/02 Eisai/Second medical indication  OJ EPO 64, of 5 December 1984.
The difficulty stems from the lack of nexus between the novelty-conferring feature (the new indication) and the act claimed (manufacture of the product). This is particularly acute in circumstances where the dosage form and posology is the same for the various authorised indications.
Ironically, the Court decided that the specification did not make it plausible that pregabalin would be effective to treat central neuropathic pain (as opposed to peripheral neuropathic pain). On this basis, it concluded that the claims in Swiss form relating to neuropathic pain were invalid on the grounds of insufficiency. So its conclusion in relation to infringement was, strictly, unnecessary.
Warner-Lambert has appealed against the findings of insufficiency and non-infringement under s60(1)(c ). Permission to appeal was refused in relation to the finding of non-infringement under s60(2). Mylan and Actavis have in turn appealed against the decision upholding the validity of the claims directed towards the treatment of peripheral neuropathic pain. The date of the appeal is not yet known. The Eversheds Life Science team will continue to track and report on the dispute in future briefings.
Three remarks about the broader ramifications of the case can be made.
- First, prior to the decision in this case, disputes in relation to second medical use patents in Swiss-type form in courts in the EU generally proceeded on the basis that there must be at least indirect infringement (under s60(2) or its equivalents). For example, the Dutch Court of Appeal in Novartis v Sun (in relation to zoledronic acid) and the Landgericht Hamburg in Warner-Lambert v Aliud (in relation to pregabalin) ruled to this effect. However, the judge commented that the reasoning in those decisions simply does not address the difficulties which he had identified with Warner-Lambert’s case on indirect infringement. We understand that the Dutch Court of Appeal has recently reversed its decision in Novartis v Sun, in light of this decision of the English Courts.
- Secondly, the judge (Arnold J) suggested that the best solution in the UK to the problem of protecting the monopoly conferred by a second medical use patent, while allowing for competition for non-patented indications, is to separate the market of both products ensuring that doctors and pharmacists write prescriptions for the patented indication by reference to the patentee's brand name and write prescriptions for non-patented indications by reference to the substance's generic name. He identified the need for a system to be put in place which would issue “centralised and authoritative” guidance as to when this practice should be adopted. He called upon the Secretary of State for Health to take steps to put such a system in place, and to liaise with his counterpart in the Welsh, Scottish and Northern Irish administrations to ensure that such a system operates across the whole of the UK. At the time of these remarks (10 September 2015), the judge believed that:
“it is reasonable to expect that, if it has not already by now, in the fairly near future most prescriptions for pregabalin for pain will be written by reference to the brand name Lyrica®”.
However, six weeks after making these remarks, in a subsequent application by Warner-Lambert for an interim injunction against Sandoz, the judge accepted that the evidence showed that the NHS Guidance is not yet fully effective, and may not be so for some time to come. He commented that, if the NHS Guidance is proving less effective than anticipated, this would be “very disappointing” and called upon doctors and pharmacists to continue to follow the guidance pending any decision of the Court of Appeal. It remains to be seen whether his suggestion of a centralised system will be taken up by the Secretary of State for Health or NHS England.
• Thirdly, the Court made it clear that this case is exclusively concerned with claims in Swiss form. Article 54(4) of the European Patent Convention 2000 (“EPC 2000”) introduced the possibility of the grant of claims in the form “product X for treating indication Y” (a purpose-limited product claim). Following the decision of the Enlarged Board of Appeal of the EPO in G2/08 Dosage Regime/Abbott Respiratory,  OJ EPO 456, such claims in EPC 2000 form have superseded claims in Swiss form for applications filed on or after 29 January 2011. EPC 2000 claims have a different scope of protection to claims in Swiss form and the judge pointed out that his reasoning in relation to Swiss-type claims does not necessarily apply to claims in EPC 2000 form.