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.