From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Tuesday, 3 March 2015

Warner-Lambert v Actavis Mark 4: harmony between parties in ‘lyrical’ patent dispute

Last Thursday, this Kat’s esteemed moggy friend and blogmeister Jeremy reported a High Court Order obtained by Warner-Lambert (part of the Pfizer group) mandating the NHS to release guidance about the prescribing of pregabalin.  The decision containing this order and the form of the guidance have both now been published – see here.  The full citation is Warner-Lambert Company, LLC v Actavis Group PTC EHF & Others [2015] EWHC 485 (Pat) (02 March 2015).

Rather than reproduce earlier posts, the IPKat would refer readers who are new to this saga to his earlier posts, here and here.

That this Order was made was intriguing to this moggy.  On the one hand, the Order can be seen as the logical consequence of a remark made in the first judgment, Pfizer’s application for an interim injunction, in which Arnold J noted:
" ... [all parties agreed that] the best solution to the problem which arises in this case is to try to ensure that prescribing doctors prescribe pregabalin for the treatment of pain by reference to the brand name Lyrica rather than by reference to the generic name pregabalin. That will ensure that pharmacists only dispense Lyrica when presented with prescriptions for pregabalin which are (at least so far as the prescriber is concerned) for pain without requiring the pharmacist to know the indication for which pregabalin has been prescribed.”
The generics companies seemed quite happy for such guidance to be issued since it reduces their liability in the infringement case.  (Merpel remarks that “They could hardly argue that the patent is not infringed because their pregabalin is not intended for use for treatment of pain, and at the same time resist issuance of NHS guidance to the same effect, now, could they?)  On this line of reasoning, why would the judge refuse the requested Order?

It was only after the pharmacist had queried
his third prescription for Lycra that Dr Mog
realised that there might be problems ...
However, on the other hand, in the same decision (to refuse interim injunctive relief), Mr Justice Arnold noted that Actavis had no intention (or, specifically, Warner-Lambert had not pleaded a case of subjective intention) to market its generic pregabalin for pain relief and that he considered that the Swiss-form claim would not be infringed by Actavis.  He considered there to be no serious issue to be tried and refused the interim injunction. How therefore, could the making of such an Order this time be justified?  One point is that since then Warner-Lambert had amended its case to plead a case of subjective intention, and, even though he did not find this case particularly compelling, in the second judgment Arnold J had refused to strike out Warner-Lambert's case or grant summary judgment, and had ordered the matter to proceed to full trial, because this was a developing area of law and a full trial should take place to establish all the facts before any appeal on the merits.

All parties accepted that section 37(1) of the Senior Courts Act 1981 gave the Court jurisdiction to mandate NHS England to issue guidance relating to the prescribing of pregabalin.  Mr Justice Arnold then had to consider whether or not to use that jurisdiction.

Citing Norwich Pharmacal, Pfizer argued that once NHS England became aware that it was mixed up in the wrongdoing of others, it came under a duty, which the Court had jurisdiction to enforce pursuant to section 37(1), to take proportionate measures to prevent or reduce that wrongdoing; in reply, Arnold J commented that the
 “obvious difficulty with this submission in the circumstances of the present case is that, if my previous judgments are correct, then it is not seriously arguable that Actavis are infringing the Patent.”
However, he then observed that:
 “it is well established that Norwich Pharmacal relief is available where there is an arguable case of wrongdoing based on the evidence available at the time of the application…[and that]… in my first judgment of 6 February 2015, I declined to strike out Warner-Lambert’s claim under section 60(1)(c), on the ground that this was a developing area of law and therefore the facts should be found before attempting definitively to decide what the law was, as being sufficient for this purpose.”
This moggy wonders whether the potential injury to the generics company was smaller in making this Order as compared to the originally sought interim injunction, tipping balance of convenience in Pfizer’s favour.

Additionally, the Court of Appeal has given permission to appeal Mr Justice Arnold’s refusal to grant an interim injunction.  Counsel for Pfizer drew analogy between this situation and “the situation where an injunction is sought pending appeal even though the patent has been held invalid at first instance, as to which see Novartis AG v Hospira UK Ltd [2013] EWCA Civ 583, [2014] 1 WLR 1264.”

These two factors, and in particular the second, were found to be persuasive and enough for Arnold J to Order NHS England to issue the requested guidance.

Following the IPKat’s previous post, one of our dear readers speculated as to whether Arnold might have relied on public law to justify this Order.  Pfizer argued in this manner, but the question was not considered in detail since there was no dispute as to the Court’s jurisdiction.

The only real point of dispute between the parties in this case was the ambit of the cross-undertaking in damages to be given by Pfizer.  Pfizer initially offered the cross-undertaking to NHS England and the Department of Health, but the defendants and some of the interested parties successfully argued that it should be extended in their favour.  The guidance issued by NHS England could impact on the business of the generics, and so this is perhaps unsurprising.  Indeed, the cross-undertaking was ultimately granted in favour of the Actavis group, the Teva group and Dr Reddy’s Laboratories, in addition to the public bodies.  Arnold J was held that the cross-undertaking should be made to the groups of companies since the injunction could result in some restructuring within those groups, and it would be inefficient to require the generics groups to have to approach the court every time some restricting occurred.

The material part of the prescribing Guidelines from the NHS to GPs and pharmacies, which are attached to the judgment, read as follows:
    Warner-Lambert Company LLC is engaged in a dispute with a number of generic pharmaceutical suppliers regarding pregabalin, which remains on patent for one indication, namely, the treatment of pain. As part of that dispute, the Court has required NHS England to issue this guidance. Our guidance is that, because of Warner-Lambert's patent rights:
    1. Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica® (unless there are clinical contra-indications or other special clinical needs e.g. patient allergic to an excipient, branded product unavailable etc which apply to Lyrica®, when you should not prescribe Lyrica® or pregabalin)
    2. When prescribing pregabalin for the treatment of neuropathic pain to patients you should (so far as reasonably possible):
    a. prescribe by reference to the brand name Lyrica®; and
    b. write the prescription with only the brand name "Lyrica", and not the generic name pregabalin or any other generic brand.
    3. When prescribing pregabalin for the treatment of anything other than pain, you should continue to prescribe by reference to the generic name pregabalin.
    4. When dispensing pregabalin, if you have been told that it is for the treatment of pain, you should ensure, so far as reasonably possible, that only Lyrica®, the branded form of pregabalin, is dispensed. However, when dispensing pregabalin for the treatment of anything other than pain, you are not restricted to dispensing Lyrica®.
    To ensure that practitioners are readily able to recall and follow the guidance above, you should consider amending the operation of any electronic prescription system that is within your power or control to include a notice or advice box which uses the following or similar wording:
    "If treating neuropathic pain, prescribe Lyrica (brand) due to patent protection. For all other indications, prescribe generically."
    We will let you know should this position change. 
As always dear readers, I welcome your thoughts…

Thanks to Tim Belcher for authorial assistance when this moggy was very jetlagged.


Anonymous said...

This case is akin to a screw. Intially Arnold started hitting it with a hammer and wondered why everyone thought he was mad. He grudgingly accepted the offer from the parties of use of their toolbox, which was full of screwdrivers. As is common these days it took several attempts with a variety of screwdrivers to find the one that didn't slip and damage the screwhead.

Now, the screw is basically in and doing its job, although it is now quite mangled and will be difficult to unscrew, leaving the Court of Appeal with the task of drilling it out.

Anonymous said...

Oh, I like what you did there Anon.

A very interesting series of events here. Seems like all concerned got a reasonable result in the end though.

Anonymous said...

Agree with Darren - Arnold basically told Pfizer what it needed to do (in his 1st decision) and none of the parties resisted the application. The ambit of the cross undertaking is interesting though - potentially huge (unprecedented?) exposure for Pfizer.

Anonymous said...

Anyone want to guess what this particular snippet means...?

"(as far as reasonably possible)"

Anonymous said...

Anon of 09:55 - Is that a sore loser condition we see there? This case had the most vitriolic comments, often in total disregard for the facts. We all remember the comments conflating this case with the very dissimilar Dutch case. This confirms the cases and respective facts cannot be fused.

Anonymous said...

(as far as reasonably possible) = except where mandated by law or professional obligation = medical emergency?

Anonymous said...

to 19:27

No, it was a plain and simple sarcastic comment ridiculing the commentator who argued with an analogy rather than the facts. Having said that, I am quite pleased with it and feel it summarised the whole case quite nicely.

Not sure why it comes across as a sore loser unless you think i am suggesting the court of appeal will overturn this particular ruling when I was referring to the earlier pronouncements from Arnold which have been appealed.

Anonymous said...

Anonymous @ 20:24,

You are "ridiculing" a commentator on another thread who got the best of your poor posts...?

And you wonder why it comes across as being a sore loser type of comment?

I will say this for you: you are surely consistent.

(that's not a good thing, by the way, not here in this aspect)

Anonymous said...

Not to worry, you can't be accused of being consistent.

Looking forward to your third fanciful reason as to why it is a sore loser comment.

Maybe you have an analogy too?

Anonymous said...

Attempts to belittle the efforts of Pfizer and to give the judge credit for the existence of these proceedings that provide "the best solution" are not justified.

touching cloth said...

If the first patent covered use for treatment of neuropathic pain, how can the patent for the second medical use also be for the treatment for neuropathic pain?

Anonymous said...


Anonymous said...

What is Pfizer's remedy if the guidance is ignored by doctors? If doctors fail to follow the guidance then it seems that there is no breach of the order (and therefore no contempt). The order merely requires the NHS guidance to be issued. What status does the guidance have? Can doctors be liable for failing to follow the guidance? Event if they are, presumably Pfizer does not have standing to enforce?

Anonymous said...

Must be a worthless patent then, what with doctors being such rebels and all.

Anonymous said...

IPKat your insight on the case has been such a great help for me.

I was wondering if anyone came up with a logical theory on why the SPCs on the original EP0641330 patent were allowed to lapse in the larger EU markets (GB, DE..)?

I know that the patent protecting pain indications is of higher value to Warner-Lambert/Pfizer, but it doesn't explain why they wouldn't wait for it to be contested opposed to not making the payments. The potential added protection for Lyrica is enormous and a company like Pfizer could easily afford it.


Anonymous said...

There are plenty of logical theories for those with a bit of imagination and the willingness to seek out the publicly available facts. I see no reason, however, for anyone 'in the know' to share the actual reason. So, wonder away!

Anonymous said...

There are plenty of logical theories for those with a bit of imagination and the willingness to seek out the publicly available facts. I see no reason, however, for anyone 'in the know' to share the actual reason. So, wonder away!

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