The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Parvis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Monday, 8 June 2015

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?


Anonymous said...

"In which case, do Swiss claims really circumvent the prohibition on patenting of methods of medical treatment at all?"

No. Swiss claims will not be interpreted to prevent a doctor from prescribing a treatment for a patient or directly treating a patient with a medicine for an indication covered by the claims.

Darren Smyth said...

Dear Anon, thank you for your comment. In this case Warner Lambert has already obtained an injunction against the National Health Service requiring it to issue central guidance to doctors that, when pregabalin is prescribed for pain, the prescription must say Lyrica. So doctors are already prevented from "prescribing a treatment for a patient ... with a medicine for an indication covered by the claims", since they may not prescribe Lecaent for pain.
Best wishes

Anonymous said...

The comment that:

"...doctors are already prevented from "prescribing a treatment for a patient ... with a medicine for an indication covered by the claims", since they may not prescribe Lecaent for pain."

Is wide of the mark in several respects:

1. None of this is mandatory as far as the doctors are concerned - the clue's in the word "guidance". They are not therefore prevented from doing anything.

2. Lecaent is apparently not for pain anyway. Please wash your mouth out with soap and go back to the Actavis sales rep training academy to repeat your basic training.

3. The injunction related to the mode of writing of prescriptions, namely whether to write "lyrica" or "pregabalin". Either way the patient gets the same active ingredient and the method of treating the patient is entirely unencumbered.

The hysteria about patenting methods of treatment really must stop. This is no such thing.

Anonymous said...

The guidance isn't working anyway, so ultimately Doctors could be responsbile for Actavis et al paying large damages for infringement, because the price of Lyrica for pain is going to be hit hard.

Whereas Pfizer cannot sue the doctors, I recommend Actavis do. There must be some cause of action they can rely on to recover their losses.

And its time to overturn this ban on method of treatment claims. Stop giving so much deference to the actions of doctors. Everything is commercial these days and the NHS is no exception. I'm surprised no-one complains about the profits pharmacies make for selling generic product but being re-imbursed brand prices. This is NOT for the benefits of the patient/taxpayer.

Darren Smyth said...

Dear Anon from Tuesday 9 June at 22:34

Thank you for your comment. In response to your points in turn:

1. We can debate if you like how binding on doctors guidance from the NHS is. However, both parties and the Court agreed that the guidance would be effective, so that actually doctors would not prescribe generically for pain, so I would consider that doctors being “prevented”. (To the subsequent Anon - I was not aware that the “guidance is not working” - this will doubtless emerge at the trial.)

2. Leceant’s SmPC does not mention pain, indeed, but as I am sure you know doctors are not in any way limited by this in their prescribing practice - off-label prescribing is perfectly permissible. Your second sentence does no credit to your argument.

3. That is true in the present case but irrelevant to the point as to whether doctors are prevented from doing something.

You write as though you are certain about the scope of Swiss clams in the UK which is clearly absurd as the law is evidently still in flux, and the trial of this case has not even taken place yet, let alone any appeals.

I dont know what hysteria you are talking about. I have written nothing hysterical. I have written an enquiring post about what is the correct construction of Swiss claims.

Best wishes


Anonymous said...

There is nothing to debate. There is no injunction. The NHS were ordered to issue guidance, which is firstly not legally binding on doctors and secondly, explicitly provides for doctors not to follow the guidance in appropriate circumstances. Doctors are free to do what they believe is in their patients' interests. If a doctor wishes to prescribe generic pregabalin or branded non-Lyrica pregabalin, specifically for pain, they are free to do so.

Whatever the detail, the comment from Darren is wrong, but I've never known Darren to accept he was wrong in the past and do not expect him to start now.

Personally, I will accept Darren's view if he can explain how a doctor is hindered from treating their patient and the consequences for doctors in breaching this so-called court injunction.

Please bear in mind that the doctor merely writes a prescription and the drug the patient takes is the same irrespective of the name the doctor writes. It should also be noted that the prescribing software doctors use already incorporates greater restrictions on a doctor's prescribing practice by forcing the writing of the INN when the doctor chooses the branded version.

Ultimately, a doctor will wish to treat his patient with pregabalin for pain and the patient will receive pregabalin for said pain. The method of treatment being the treating of pain by administering pregabalin.

Anonymous said...

I don't see where it says the parties "agreed that the guidance would be effective". I see that they said it would be the best solution, but that doesn't necessarily mean it's a perfect solution. One might also say that "solution" is a bit ambitious in this context, in any event.

Doctors will always retain freedom to prescribe what and how they want; this case hasn't affected that one iota. Anyone who has ever met a doctor will also know that, a bit like lawyers, they can be quite headstrong. Even Richard Arnold isn't going to get all doctors to do what he orders. Guidance will influence their behaviour, but it would be naïve to think it can completely change it.

Note also that the use of "off-label" (an emotive issue for other reasons) is inapt in this context. The term better applies in the context of prescribing an active substance that IS NOT LICENSED FOR THE INDICATION AT ALL (ie there is no manufacturer with the relevant license). That is something that has clinical benefits for patients, but that is not what this case involves. Here the problem really comes from "cross-label" dispensing at the pharmacy level. The question is whether the doctor can simply write the prescription in a slightly different way (but for the same active substance) to avoid this.

The hysterical comment wasn't directed at you, Darren, but a wider observation on the commentary relating to the method of treatment issue. The second sentence of point 2 was a wee josh, so I'm sorry you didn't like it.

Anonymous said...

I agree that there is a form of hysteria surrounding these claims. Mainly that appears to be from non-chemical attorneys who are feeling a little left out. Even though options are specifically limited by statute for pharma inventions in Europe, such attorneys believe they are not getting enough attention. "Why don't the statutes and case law talk about our fields as much?", they frequently cry. The answer is simply that pharma is a more exciting beast. Not quite as exciting as the discussion over whether a four-fingered chocolate biscuit distinguishes the goods of one company from those of another, I must admit.

Non-pharma attorneys will be aghast at the issues faced outside of Europe and will have sleepless nights bemoaning all the hurdles put in the way of the pharma industry patents. I will not brag about them here.

Anonymous said...

"154.I would not admit the evidence. The main purpose of the evidence, as it seems to me, is to support a case that the guidance given by the NHS has not thus far been effective to prevent Lecaent being prescribed for pain. "

The judge must have added this sentence earlier today, I guess?

THE US anon said...

I have to chuckle at the perspective of Anonymous @9:58.

"left out" and "exciting" is a pretty nifty twist of what is actually being discussed (that the law itself is being twisted to accommodate a particular art field, and that my friend Occam would have a distinctly different solution).

Anonymous said...

The solution having the least number of assumptions is that having none. That having none is the position that accepts there is no twisting of the law to accommodate pharma. The evidence for this being in the relevant statute.

Sorry for being boring this time. The excitement can be found here:

p.s. your friend Occam is not a person but a village in little old England.

Anonymous said...

>p.s. your friend Occam is not a person but a village in little old England.

Not according to Wiki. It refers to William of Ockham, very much a person.

MaxDrei said...

Thinking about proofs of obviousness and Occam's Razor, I conclude that if William of Ockham were alive today he would definitely approve of the EPO's Problem and Solution Approach.

Anonymous said...

I was speaking to my good friend Orange, and he was saying that both he and his sister Apple dislike the problem solution approach.

THE US anon said...

"That having none is the position..." is ITSELF a twisted assumption.

Fail at the start, my anonymous friend @ 20:06.

You speak of evidence being the statute itself while we are discussing the fact that the statute itself has been twisted to accommodate pharma. It's as if you cannot even begin to recognize the concept under discussion. My first suggestion: stop talking and start listening. Open your eyes and read to understand, rather than to read and so blindly react to protect your "exciting" dominion.

Anonymous said...

Just when you thought it was safe to go back to the blog - US ANON returned.

"Statutes are twisted"

Anonymous said...

The second medical use issue is very similar to the problems which arise in the orphan drug regulation, as illustrated in this recent decision:

It seems one of the parties was worried that a report on the similarities between two drugs could lead to the exclusivity being undermined.

MaxDrei said...

Here below in quotes I repeat something I just posted on Patently-O. Why? Because I suspect that some bloggers here might also not yet have heard of the Dunning-Kruger effect and so might also enjoy the linked Wikipedia page.

"The contributer called "cat" put me on the the Dunning-Kruger Effect.

Many many thanks. When I found the relevant Wikipedia page I didn't know whether to laugh or cry, because what Dunning and Kruger pointed out is so relevant to blog threads.

And, as is often the case, William Shakespeare got there first:"

Folks, do think about supporting Wikipedia financially. What a joyous treasure chest of free information it provides.

Anonymous said...

Max, you should visit my company. Mr Topsy Turvy would feel at home.

Thanks for the Orphan Drug case. I look forward to reading that one.

Anonymous said...

The orphan drug case is certainly an interesting one (although the judgement itself is a tiresome read, which means only US Anon can comment without having to make the effort).

In conclusion, it will get the parties to a similar position from which Warner Lambert and Actavis start: the approval of the latter product (if and once re-instated) should not refer to indications approved for the former and so there can be no inducement by the content of the latter's SmPC of a doctor to prescribe off-label.

Unless the latter product does not get re-approved, the formerly-approved product is still going to be subject to off-label prescription, without any method of enforcing, such as Warner-Lambert's Swiss claim, being available.

On the other hand, the former-product will be prescribed off-label for the indications authorised for the latter. Possibly swings and roundabouts depending on the size of each market.

Anonymous said...

should say "be subject to off-label prescription of the latter,..."

Anonymous said...

The Orphan decision cites the Applicant's solicitors as M. Utges Manley and M. Vickers, but where they not represented by Bristows?

Anonymous said...

I posted a follow-up noting my error and Mrs Manley and colleagues are from Bristows, but it never passed the virus scan. I accept my error and the service provided was not up to usual expected standards and apologise for any inconvenience caused.

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