Swiss claims: a Kat reflects on the Warner-Lambert v Actavis appeal

This Kat posted a short report of the Court of Appeal, England and Wales, judgment delivered by Lord Justice Floyd in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWCA Civ 556, and has in the meantime been cogitating and ruminating (hard as that is for a non-ruminant carnivore) on what it all means.

To remind readers on where we were before this appeal decision, Warner-Lambert marketed the drug pregabalin for three authorised indications -- epilepsy, generalised anxiety disorder ("GAD") and neuropathic pain -- under the trade mark Lyrica.  The product patent had expired, but Warner-Lambert still had a patent EP 0 934 061 which has claims in the Swiss form relating to the use for treatment of pain as follows:

1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.
3. Use according to Claim 1 wherein the pain is neuropathic pain

Actavis had applied for a marketing authorisation, now granted, under the abridged procedure with a skinny label limited to the treatment of epilepsy and general anxiety disorders.  Warner-Lambert sued, because they considered that the Actavis product was still likely to be prescribed for the patented indication and that Actavis was liable for such sales.

In a first judgment, Arnold J denied interim relief to Warner-Lambert, holding that a Swiss form claim required subjective intent on the part of Actavis that the drug would be used for the treatment of pain, that Warner-Lambert had no pleaded case on subjective intent, and that therefore there was no serious issue to be tried.  He also held that the balance of convenience in any case favoured refusing the interim relief.  He refused permission to appeal on the basis that although an appeal on claim construction may succeed, on the balance of convenience point there was no prospect of success.

"What do you mean --
not a serious issue?"

In a second judgment, Actavis applied to strike out the infringement claims, "no doubt encouraged by the judge's finding that Warner-Lambert had not established a serious issue to be tried".  Warner-Lambert had in the meantime applied to amend its pleadings to include a case based on subjective intent.  Although Arnold J considered that Warner-Lambert had still failed to plead a case of direct infringement, he nevertheless allowed that case, in respect of direct infringement of the claims, to proceed to trial in view of the fact that an appellate court might in due course take a different view in an area of the law which was still developing, and that it was sensible in such circumstances to decide the facts first. The trial is scheduled for the end of June. In a third judgment, delivered later on the same day, the judge decided to strike out the claim of indirect infringement, and thus refused to allow it to proceed to trial.

In a fourth judgment (see here and here), Arnold J granted Warner-Lambert's request for an order against the National Health Service requiring it to issue central guidance that, when pregabalin is prescribed for pain, the prescription must say Lyrica (if a prescription names a branded product, generic switching by the pharmacist is not permitted).

Warner-Lambert appealed against the first and third judgments, resulting in the present appeal decision.  The appeal against the first judgment failed, but that against the third judgment succeeded.

The first point that strikes this Kat as relevant, and rather glossed over in some of the commentary he has read, is that the first decision on interim relief was affirmed and that the appeal in this respect was dismissed.  Warner-Lambert sought an interim injunction to require various undertakings from Actavis, including the imposition of contractual terms on the supply of Leceant to pharmacies that it would not be dispensed for the treatment of pain, and the marking of the individual packages  that they were not be to dispensed for the treatment of pain.  Even though, by the time of the appeal, the controversial measures had been rather softened (the contractual terms sought were less onerous, and the marking was sought in respect of the bulk packaging, not the individual packages), Floyd LJ still refused the relief, remarking:

In my judgment, the judge properly evaluated the material before him on this aspect of the case and came to a conclusion with which this court could not interfere.

Where Floyd LJ and Arnold J did part company, however, was on what a Swiss form claim means.  This point is rather complex, and a significant issue is that the parties' cases changed between the first instance and appeal.  Before Arnold J, it was common ground that the word "for" in claims such as those in the patent were to be understood as "suitable and intended for".  The question was whose intention was relevant.  Arnold J concluded that it must be the manufacturer's, not that of someone else downstream such as the doctor or the pharmacist, and that it had to be subjective intent - simple knowledge that such use might occur was not sufficient.  But Floyd LJ then records:

The next point to note is that both parties have retreated to a degree from the common ground before the judge that "for" means "suitable and intended for". Thus Mr Turner [Counsel for Warner-Lambert], in his written submissions, whilst continuing to accept that the claim requires an element of "intention-like mens rea", submits that it is wrong to start with the word "intention" and embark on an exercise of deciding what that means, and to go on to hold that that form of intention must be attributed to the manufacturer. The word in the claim is "for", which denotes purpose. Mr Speck [Counsel for Actavis], for his part submits that it is not appropriate to fix on the word intention and then embark "on a wide ranging review of how the word 'intention' or 'intended' is used in different areas of the law" when the real issue is what the mental element in the claim is. I agree that a search for the appropriate meaning of "intention" which does not appear in the claim, is likely to throw one off the scent.

What strikes this Kat about this passage -- his second thought -- is that the thing that "is likely to throw one off the scent" was recorded as being common ground at first instance.

So, rejecting the idea that subjective intent is what is needed to infringe a Swiss form claim, what Floyd LJ then decided to be the correct test was based on knowledge or foreseeability:

I can therefore see no reason why the skilled person would conclude that the word "for" implied subjective intent. He 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 intentionally be used for pain is making use of the patentee's inventive contribution, in the same way as a manufacturer who actively desires that result. In my judgment, 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, in respect of direct infringement:

Applying the law as I believe it to be, it is plain that Warner-Lambert have an arguable case of infringement. 

But then immediately sounded a note of caution.

On the assumption that infringement is shown at trial, it does not follow that unqualified relief will follow as of right. Those are issues for the trial or any enquiry which follows.

Now, based on the positions as argued by the parties, this Kat considers that the view of the Court of Appeal is as tenable as that of the first instance judge.  But he will now venture into the lion's den and suggest that perhaps they are all incorrect.  Bear with me dear reader, as I recognise the gravity of disgreeing with all of Floyd LJ, Ryder LJ, Arden LJ and Arnold J.

But not everyone
does ...

The problem this Kat has is that they all rely on the subjective state of the infringer, whether it is subjective intent, or knowledge, even if the knowledge is constructive knowledge.  But there is no reason to construe a Swiss claim as requiring a subjective element -- it can instead be considered to have the objective criterion of instruction.  In other words, this Kat suggests that the "for" in a Swiss form claim means "with instructions for".  This could be satisfied by the package label and/or insert, in which case a skinny label would escape infringement (and why else have a skinny label?), or it could be by other more general means such as advertising or instructions given to doctors, in which case infringement might be found even with a skinny label.  So this Kat's third thought is this: perhaps the English courts are still not quite on the right track on Swiss form claims.

In the present case, this objective assessment of Swiss form claims would lead to the same result as the first instance decision - no realistic chance of infringement being found and therefore no prospect for success of the action.

This Kat's fourth thought is that Arnold J allowed the case on direct infringement to proceed to trial because this was a developing area of the law and "therefore the proper course is to establish the facts at a trial before attempting definitively to determine the law."  This is not actually what has happened.  While still at the pre-trial stage, Floyd LJ has defined an interpretation of Swiss form claims that will now be binding on lower Courts and the Court of Appeal.  We still await the facts, which should emerge at the trial later this month.

All of this claim construction was with regard to direct infringement, but this part of the appeal was on the granting of interim relief, and the appeal was in any case dismissed because the assessment of the balance of injustice favoured Actavis, as Arnold J had held.

So now we come to the successful part of the appeal, namely the striking out of the case on indirect infringement.

Here, Floyd LJ stated:

I agree that there are difficulties with the indirect infringement claim for the reason which the judge gave, namely the absence of a downstream event which, as a whole, can be regarded as putting the invention into effect. However, for three reasons, each of which is in my judgment sufficient, I would allow the indirect infringement case to go to trial.

The first reason is that which I have already given, namely that the courts of two EPC member states [Germany and the Netherlands] considering this same question have held that, at face value, indirect infringement can arise in these circumstances.

The second reason is that, if, as I have held, there is a case of threatened or actual infringement of the process claim under section 60(1)(b) [infringement of process claim], then it follows that dealings downstream in the direct product of the process are also infringements under section 60(1)(c) [infringement by direct product of a process]. Although this may not add anything to the direct infringement case, it is wrong to strike it out as a viable additional cause of action.

The third reason is that I consider it is arguable to say that when section 60(2) [indirect infringement] speaks of "putting the invention into effect", it may be legitimate to look not just at whether any one person is carrying out the invention in a sense which would give rise to liability of that person for an act of infringement. It may be that the invention is put into effect if pregabalin is manufactured by one person and supplied to another who intentionally uses it for the treatment of pain. In those circumstances, a person who supplies pregabalin with the requisite knowledge (i.e. that prescribed in section 60(2) itself) does provide means suitable and intended to put the invention into effect, albeit by the combination of manufacturer and user, rather than by any one person alone. It may be that this is the reasoning which underlies the decisions in the Dutch and German cases which I have referred to.

So now this part of the case will also proceed to trial.

There is more, much more, that could be said about these decisions.  But there is also much more left to come in the action.  The full trial will grapple with applying the new interpretation of Swiss form claims to the facts as they will emerge in the trial in relation to direct infringement.  Moreover, the three reasons given above for allowing the case on indirect infringement to proceed to trial themselves raise many further questions to be determined - how is infringement by the direct product of the process to be assessed in relation to Swiss claims?  Could that include the doctor or pharmacist, in respect of whom the ratio legis of the exclusion from patentability of methods of medical treatment is to remove from patent infringement?  For indirect infringement under Section 60(2), can the invention be put into effect by a series of people?  Does it matter that one or more of these may be the doctor or pharmacist?  In which case, do Swiss claims really circumvent the prohibition on patenting of methods of medical treatment at all?

It is extraordinary that such fundamental questions about Swiss claims are unanswered when they have been with us for three decades.  They have another couple of decades of life left in Europe: will we know what they really mean before they are finally retired?