Warner-Lambert Company, LLC v Actavis Group PTC EHF and Others (Defendants/Proposed Defendant)
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 06 February 2015 |
| Neutral Citation | [2015] EWHC 223 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 06 February 2015 |
| Docket Number | Case No: HC-2014001795 |
[2015] EWHC 223 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case No: HC-2014001795
Andrew Waugh QC and Miles Copeland (instructed by Allen & Overy LLP) for the Claimant
Adrian Speck QC (instructed by Powell Gilbert LLP) for the First to Third Defendants
Hearing date: 3 February 2015
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
On 21 January 2015 I dismissed an application by Warner-Lambert for an interim injunction in this matter, holding that, on the basis of the evidence and arguments then before the court, Warner-Lambert's infringement claim did not raise a serious issue to be tried and that, even if it did, the balance of the risk of the injustice favoured refusal of the relief sought. The background to the matter and the reasons for those conclusions are set out in full in my judgment of that date ( [2015] EWHC 72 (Pat)), which I shall take as read.
I now have two applications before me. First, by application notice dated 23 January 2015 Actavis applied to strike out Warner-Lambert's claim for infringement of the Patent pursuant to CPR rule 3.4(2)(a) alternatively for summary judgment dismissing that claim. Secondly, by application notice dated 27 January 2015 Warner-Lambert applied for permission to amend its Particulars of Infringement to plead a case of subjective intention, as foreshadowed at the previous hearing (see the judgment at [112], although the form of the proposed amendment differs from that proposed at the previous hearing). It was sensibly agreed between counsel that in these circumstances I should consider Actavis' application on the basis of Warner-Lambert's claim as proposed to be amended.
It is convenient before proceeding further to note two points about Warner-Lambert's proposed Amended Particulars of Infringement. First, they delete the allegation of infringement pursuant to section 60(1)(a) of the Patents Act 1977. Secondly, the draft which accompanied the application notice also deleted the allegation of infringement pursuant to section 60(2). At the hearing, however, counsel for Warner-Lambert informed me that Warner-Lambert had changed its mind and wished to maintain this plea. Nevertheless, as at the previous hearing, Warner-Lambert's arguments were almost entirely devoted to its case under section 60(1)(c).
It is also convenient to note two further pieces of evidence which I was shown about what is happening on the ground. The first, which was relied on by Warner-Lambert, consists of a paragraph in the Minutes of Meeting of the North of Tyne Area Prescribing Committee ("APC") on 13 January 2015 which reads as follows:
" Generic Pregabalin
The patent for Lyrica® (pregabalin) with respect to generalized anxiety disorder (GAD) and epilepsy expired in July 2014 but there is a second medical use patent protecting pregabalin's use in neuropathic pain which extends to July 2017.
Pfizer have contacted CCGs and community pharmacies to highlight that they believe the supply of generic pregabalin for use in the treatment of pain, whilst the pain patent remains in force in the UK, would infringe Pfizer's patent rights. They are therefore requesting that clinicians prescribe pregabalin by brand (Lyrica®) for neuropathic pain.
The APC supports generic prescribing where clinically appropriate and have issued a document – APC Guideline on Medicines that are Not Suitable for Generic Prescribing … which outlines clinical circumstances were they believe prescribing by brand may be appropriate.
Whilst recognising pharmaceutical company rights with regards to patent protection, the APC does not believe there is any significant clinical difference between the branded and generic pregabalin products. Providing patients have sufficient information provided to them to take their medication safely and, providing prescribers prescribe in line with their GMC responsibilities around 'off-label' prescribing, the APC do not believe it is clinically necessary to prescribe pregabalin by brand name."
I would make two comments about this. First, in my view it emphasises the desirability of NHS England (and NHS Wales) issuing guidance on this subject. Secondly, and more importantly for present purposes, it is not suggested by Warner-Lambert, nor could it be, that the stance adopted by the APC is a result of anything Actavis have done. Moreover, it can be seen that the APC has adopted this stance despite Pfizer's letters to CCGs and community pharmacies.
The second, which was relied on by Actavis, consists of a paragraph from the Newsletter of the Pharmaceutical Services Negotiating Committee ("PSNC"), which represents NHS pharmacy contractors, dated 2 February 2015
" Important: dispensing of Lyrica/Pregabalin
At present the generic pregabalin is listed in Part VIIIA of the tariff as a Category C line with reimbursement currently based on Lyrica. Where a generic prescription for pregabalin is presented to the pharmacy, if the pharmacy is minded to dispense the generic, they should first satisfy themselves it is not being provided for the patented indications (peripheral and central neuropathic pain). If it is being provided for those indications, the pharmacy should dispense Lyrica and may wish to advise the prescriber."
Like the APC minutes, this emphasises that the situation which confronts the parties in this case depends on the past, current and future actions of third parties who are not under either party's control or direction.
Do the Amended Particulars of Infringement disclose reasonable grounds for alleging subjective intention?
The first question to be considered is whether, assuming that I was correct to hold in my previous judgment that the word "for" in the "for treating" part of a Swiss form claim imports a requirement of subjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition, Warner-Lambert's draft Amended Particulars of Infringement disclose reasonable grounds for alleging subjective intention on the part of Actavis. As counsel for Actavis accepted, it is both necessary and sufficient for this purpose that the manufacturer's acts are targeted or aimed at that consequence. As counsel for Actavis also accepted, in a proper case such an intention may be inferred from objective facts even if (as will usually be the case) there is no direct evidence of it.
It is not disputed, at least for present purposes, that Lecaent has been and will be manufactured by Balkanpharma-Dupnitsa AD ("Balkanpharma") in Bulgaria, that Balkanpharma changed its trading name to Actavis on 12 May 2014 and Balkanpharma is owned by Actavis' parent company. Furthermore, counsel for Actavis made it clear that Actavis was not taking any point on the fact that Lecaent is manufactured by Balkanpharma rather than Actavis. Accordingly, I shall mostly refer for convenience to Actavis rather than Balkanpharma.
The Amended Particulars of Infringement allege at sub-paragraph 4(a2) that the manufacture of Lecaent has been and will be undertaken in circumstances where Actavis both know and intend that a major proportion of Lecaent will be used for treating pain. Numerous particulars are pleaded in support of this allegation. Counsel for Actavis submitted that neither individually nor cumulatively did the particulars plead a sustainable case for drawing an inference that Actavis intended that Lecaent would be used for treating pain.
Before turning to consider the particulars, two points should be noted. First, it is common ground that for this purpose the facts pleaded in the particulars must be assumed to be true. Secondly, counsel submitted that the particulars must be read against the uncontentious background, and in particular (i) the steps which Pfizer have taken (see my previous judgment at [51]–[61]), (ii) the steps which Actavis have taken or promised that they will take (see my previous judgment at [62]–[66] and [79]–[82]) and (iii) the steps which third parties such as NICE, PAG and now the PSNC have taken (see my previous judgment at [53] and [57] and paragraph 7 above). I did not understand counsel for Warner-Lambert to dispute this point, but in any event I accept it.
Sub-paragraphs 4(b) to (e1) of the draft Amended Particulars of Infringement plead that over 54% of pregabalin is prescribed for pain; that the majority of prescriptions are written generically; that about 95% of prescriptions do not state the indication; that it is therefore inevitable that generic pregabalin will be dispensed by pharmacists for treatment of pain; and that use of a "skinny label" will not prevent pregabalin being dispensed for pain and that Actavis know this.
Actavis contends that these allegations simply ignore all the measures that have been taken and will be taken. More importantly, however, Actavis contends that they do not amount to an allegation that Actavis intends pregabalin to be dispensed for the treatment of pain, but only an allegation that this is a foreseeable consequence of Actavis marketing its product under a skinny label. I agree with this.
Sub-paragraphs 4(e2) and (e3) allege that these facts "would have" formed the basis for Actavis' decision to launch a skinny label generic pregabalin product; that they "would have" formed the basis for Actavis' forecasts of sales and revenues...
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