Swiss Claims, Skinny Labels and Subjective Intention

February 2015

The UK Courts have issued some important guidelines on the interpretation of "Swiss" second medical use claims.

Summary

In two recent judgements1,2, Arnold J gave a detailed analysis of the issues that should be taken into account when determining the scope of second medical use claims in the UK.  In the first of these, Arnold J refused to grant the patentee, Warner-Lambert (WL), the interim relief they sought to force the defendant, Actavis, to take certain steps to prevent their generic product (Lecaent®) from being prescribed for pain, an indication for which WL still had a patent.  In Arnold J’s view, there was no serious issue to be tried because WL had failed to demonstrate any subjective intention on the part of Actavis to sell their product for the patented indication.  Nevertheless, he refused to strike out WL’s claim for infringement in favour of deciding the case at full trial.  While it may be a few months before we have more clarity on the interpretation of second medical use claims, these judgements give us an insight into the determinative points behind this thorny issue.

Background

WL’s product, Lyrica® (pregabalin) was approved for three different indications: epilepsy, generalised anxiety disorder (GAD) and neuropathic pain.  Patent protection for the drug itself had expired but WL still had a second medical use patent for  pain.  Actavis wanted to enter the market for pregabalin with a label limited to the non-patented epilepsy and GAD indications (a so-called “skinny label”).  In exchanges before the trial, WL asked Actavis to explain what measures it would take to ensure that its product would not be used for the treatment of pain.  Actavis stated that their summary of product characteristics (SmPC) and patient information leaflet (PIL) would only mention the non-patented indications.  They also agreed to notify pharmacists specifically that their product was not indicated for the treatment of neuropathic pain. 

WL, however, wanted Actavis to do more.  In the UK, the majority of doctor’s prescriptions referred only to the drug’s non-proprietary name (INN) and without any mention of the indication.   As a result, pharmacists were generally unaware of the indication behind the prescription.  Moreover, because generic drugs were cheaper, pharmacists had a strong commercial incentive to dispense generic drugs.  Accordingly, it was foreseeable that pharmacists would dispense the generic version for the patented pain indication.  WL wanted Actavis to minimise the risk of this happening by, among other things, placing an appropriate notice on the outside of the Actavis’s product.  When no agreement was reached, WL sought an interim injunction against Actavis.

Infringement of Second Medical Use Claims

In deciding on whether or not to grant the interim injunction, Arnold J had to decide whether WL’s claim for infringement raised a serious issue to be tried.  This required an assessment of how second medical use claims should be interpreted.

Swiss or second medical use claims (i.e. claims to the “use of X for the preparation of a medicament for treating Y”) originated at the EPO to allow new uses of existing medicines to be patented.   The EPO has interpreted3 such claims as purpose-limited process claims in contrast to the purpose-limited product claims (i.e. claims to “product X for treating Y”) now required under Article 54(5) of EPC 2000 (“EPC 2000 claims”).

The present case centred on the interpretation of “for treating (neuropathic) pain” in the claim.  It was accepted that “for” was to be interpreted as “suitable and intended for”.  The issue that divided the parties, however, was whether  the use of pregabalin for the preparation of a pharmaceutical composition  was intended for treating (neuropathic) pain. This depended on, firstly, whose intention was relevant, and, secondly, what was meant by “intended”?

On the first question, Arnold J held that it was the intention of the manufacturer that was relevant.  Referring to Actavis v Merck4, Arnold J held that a second medical use claim was “directed at the manufacturer”.  It followed therefore that it was the intention of the manufacturer rather than the person who disposes of the pregabalin that was relevant.

On the second question, WL drew an analogy between the meaning of “intended” in second medical use claims and the knowledge and intention requirements of contributory infringement.  With the latter, a person would infringe if he supplied means relating to an essential element of the invention in the knowledge that those means were suitable for putting, and were intended to put, the invention into effect.  WL noted that the knowledge and intention requirements of contributory were satisfied if the supplier knew that ultimate users intended to put the invention into effect.  WL argued that, because it was foreseeable that pharmacists were likely to dispense the generic product for neuropathic pain, Actavis intended to sell pregabalin to treat neuropathic pain.

Arnold J disagreed.  Firstly, contributory infringement was a specific provision distinct from the case of (primary) infringement that WL was now pursuing.  Secondly, contributory infringement distinguished between the knowledge of the supplier and the intention of the user.  It therefore did not follow that supplier’s knowledge equated to the supplier’s intent.  Arnold J went on to say that a claim for contributory infringement would inevitably fail because wholesalers and pharmacists would not use Actavis’s product to manufacture a medicament downstream.  Accordingly, there could be no intention on the part of the person supplied to put the invention (a process of manufacture) into effect.

In Arnold J’s view, “for” in second medical use claims imported a “subjective intention” on the part of the manufacturer that the medicament would be used for treating the specified indication.   Arnold J was persuaded by Actavis, who drew attention to the position of an inventor who patented a first medical use for a compound and marketed the compound for that use.  If a second inventor later patented a second use for the same compound, it would be foreseeable that the first inventor’s product would be used for the second indication.  If foreseeability was enough, the first inventor would infringe the second patent simply by continuing to do what he had done previously.  Accordingly, Arnold J held that nothing less than a requirement of subjective intention would protect the first inventor from infringement.  Because WL had not initially relied on any allegation of subjective intention on the part of Actavis, the judge concluded that there was not a serious question to be tried.  Even when WL later pleaded subjective intent, WL’s new pleadings merely reinforced that it was foreseeable that Actavis’s product would have been used for pain. This did not amount to subjective intent.

The Dutch judgement5

In arriving at his decision, Arnold J acknowledged that, at least on the face of it, the Hague Court of Appeal had reached the opposite conclusion in finding that, Sun, had infringed Novartis’s patent for the use of zoledronic acid for the preparation of a medicament for treating osteoporosis.  However, Arnold J was quick to point out the factual differences in the Dutch case.  For example, Sun had won a tender to be the exclusive supplier of zoledronic acid for the insurer, VGZ.  As pharmacists were obliged to dispense the Sun’s product, it was inevitable that Sun’s product would be dispensed for the patented indication.  The facts of the case might well have justified an inference that Sun intended to supply zoledronic acid for treating osteoporosis.  The Dutch Court, however, did not find for infringement on the grounds of subjective intent but, instead, found Sun guilty of contributory infringement.  Unlike the UK Court, the Dutch Court regarded the second medical use claim as a product claim.  This was in sharp contrast to the approach taken by Arnold J, who held that Swiss use claims were purpose-limited process claims for which there could be no contributory infringement given the lack of a manufacturing step downstream by users of the product. 

A developing area of law

The differences in reasoning between Arnold J’s decisions and the Dutch case highlight that this is a developing area of law.  Thus, despite concluding that there was no serious issue to be tried, Arnold J ordered the case to go to trial so that he could fully consider the facts before definitively deciding on the law.  The full trial is scheduled to take place in June 2015 and, while the decision is keenly awaited, the problems thrown up by generic pharmaceuticals marketed with skinny labels may not be fully resolved, because the judge acknowledges that the issue is one which may require consideration by the Supreme Court..  While we should get more clarity on second medical use claims, these will eventually be superseded by the new purpose-limited product claims under EPC 2000.  It remains uncertain as to how EPC2000 claims will be interpreted in the UK given our court’s conclusion that they differ in scope from second medical use claims.  However, as EPC2000 claims are purpose-limited product claims there may be more scope for patent holders to successfully establish contributory infringement based on the intent of the end user.   

1 Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat)

2Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 223 (Pat)

3 G05/83 [1985] OJ EPO 64 and T1780/12 [2014]EPOR 28

4Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444, [2009] 1 WLR 1186

5 Novartis AG v. Sun Pharmaceutical Industries (Europe) B.V., Court of Appeal The Hague, The Netherlands, 27 January 2015, Case file number: 200.1 50.713/01

This update was prepared by Hsu Min Chung, Partner in our London office and Mike Nelson, Partner in our Leeds office.

If you would like further advice on this or any other matter please contact Hsu Min (Tel: +44(0) 207 776 5100) or Mike  (Tel: +44(0) 113 233 0169) or your usual HGF representative or visit our Contact page to get in touch with your nearest HGF office.