Warner-Lambert v Actavis Mark 2, still at first instance: more on Swiss claims, Skinny Labels, and no Strikeout

This Kat posted last month on the fascinating case of Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat), in which Arnold J gave the first detailed UK consideration of what a Swiss-form claim means.  He denied interim relief that Warner-Lambert requested to mandate that Actavis should take certain steps, in particular overpackaging and by contractual terms with pharmacies, to ensure that generic pregabalin was not prescribed for pain, which was still under the protection of a second medical use patent EP 0 934 061 that had Swiss form claims.  Among other things, he held that there was no serious issue to be tried, because the Swiss form claim required Actavis to "intend" that their product (sold by them under the trade name Lyceant; the Warner-Lambert pregabalin is sold under the trade name Lyrica) be used for the treatment of pain, and no such intention had been pleaded by Warner-Lambert.

So the parties were back in Court, Warner-Lambert now pleading a case of subjective intent, and Actavis, for their part, asking that the case be struck out or that summary judgment be made dismissing the case.

In the meantime, the Dutch decision, reported by the IPKat here, had issued in which Sun Pharmaceutical had been found to have committed indirect infringement of a patent with Swiss form claims relating to the use of zoledronic acid for the treatment of osteoporosis using a skinny label mentioning only Paget’s disease.  As this moggy pointed out at the time, the cases were not all square with each other, since among other things "in the Dutch case Sun had won a tender to be the exclusive supplier of zoledronic acid 5mg/100ml for the healthcare insurer VGZ".

As Arnold J explains in the decision that is out today, Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 223 (Pat) [Link to decision on BAILII added 2.30pm], this fact is highly significant:

This meant that Sun’s generic product was the only zoledronic acid 5 mg/l00 ml product that was reimbursed by VGZ, except in cases of medical necessity. VGZ required that only one product was to be designated for any patient insured with VGZ who was treated at home with zoledronic acid in a dosage of 5 mg/100 ml, without distinguishing the indication for which it was prescribed. Remarkably, pharmacists were obliged to dispense the designated product even if the prescription specified Aclasta. Thus it was inevitable that the vast majority of Sun’s generic zoledronic acid product supplied under this contract would be dispensed to patients with osteoporosis. 

Moreover, Arnold J identified a number of critical points in the Dutch reasoning, which, importantly, was based on indirect infringement (equivalent to Section 60(2) of the UK Patents Act) whereas Warner-Lambert's main case had been direct infringement under section 60(1)(c) of the 1977 Act. In the earlier judgement Arnold J had rejected the Section 60(2) allegation since

There can be only be infringement under section 60(2) if there can be infringement by the person supplied or by a user further down the chain of supply (although it is not necessary for there actually to be an infringing act). This is not the case here, since no wholesaler or pharmacist will use Lecaent to prepare a pharmaceutical composition."

The points noted in today's decision by Arnold J about the Dutch decision that explain the different outcomes are:

First, the Court (provisionally) held that Sun had committed indirect infringement of claim 7 of the patent, that is to say, infringement under the Dutch implementation of Article 26 of the Community Patent Convention, which is implemented in the United Kingdom by section 60(2) of the 1977 Act.

Secondly, it was common ground between the parties (see [4.31]) that Sun’s generic zoledronic acid product was an essential element of the invention of claim 7 of the patent.

Thirdly, the Court held (see [4.33]) that Sun had the requisite knowledge of infringing use of its generic product for the purposes of indirect infringement. Its reasoning for so holding is entirely consistent with the approach to section 60(2) laid down by the Court of Appeal in this country in Grimme v Scott and KCI v Smith & Nephew (see my previous judgment at [102]).

Fourthly, the Court took into account (at [4.34]-[4.36]) the fact that Sun had not taken steps which it could have taken, but this does not appear to have been critical to its reasoning. What was critical was Sun’s knowledge.

Fifthly, the Court did not find that Sun intended to supply zoledronic acid for treating osteoporosis, but the facts of the case might well have justified such an inference.

Sixthly, and most importantly, the Court’s analysis assumes that claim 7 is a product claim. There is no mention of the fact that it is a process claim. Still less is there any discussion of the meaning of the words “for treating” or of the mental element which those words import. I can only assume that Sun failed to draw these matters to the Court’s attention and to advance the arguments which were advanced by Actavis before me.

Seventhly, counsel for Warner-Lambert submitted that the reasoning could be justified on the basis that Swiss form claims were to be interpreted in the same way as EPC 2000 claims. I do not accept this. Leaving aside the fact that the Dutch Court said nothing of the kind, as I pointed out in my previous judgment at [13], the EPO Boards of Appeal have held that the two types of claim have different scope. I would also point out it is difficult to reconcile this submission with Warner-Lambert’s abandonment of its case under section 60(1)(a) (corresponding to Article 25(a) CPC).

Nevertheless, Arnold declined to grant Actavis's request for strike-out or summary judgment, even though he considered:

I am not persuaded that the Amended Particulars of Infringement disclose reasonable grounds for alleging subjective intention on the part of Actavis, and, if I am right that subjective intention is required, that means that the claim is bound to fail

There were a number of reasons why the judge thought that the case should proceed to full trial.

First, he accepted that it was possible that on appeal an appellate court may conclude that his construction (maintained in both judgments) of the words "for treating" in a Swiss form claim, as requiring subjective intent on the part of the manufacturer, is wrong.

Secondly, he accepted that 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."

Thirdly, he accepted that there was "another compelling reason for trial", namely that the main infringement trial had been set for June 2015.  If the if the infringement claim was struck out or summary judgment was granted, there would certainly be an appeal to the Court of Appeal and then likely the Supreme Court, so the issue would not be resolved before the trial date. (This moggy is struggling to see why this should justify a trial if the judge's main view is that there is no infringement, but perhaps it will make sense to his readers).

So the upshot, dear readers, is that the parties will have a full trial on the infringement question, with the full facts to emerge.  Arnold J speculates that these facts might include how much of Actavis's product is in fact prescribed for the patented use, which will of course be jolly interesting.

The beginning of the judgment notes two  developments that are totally opposite in their import.  The first was the Minutes of  Meeting of the North of Tyne Area Prescribing Committee (“APC”) on 13 January 2015 which extraordinarily concluded as follows:

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.”

The second was 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.”

The second is the attitude that a patentee would wish to see.  The former shows a flagrant disregard for patent rights, and, as Arnold J pointed out, "emphasises the desirability of NHS England (and NHS Wales) issuing guidance on this subject."

Clearly both this case, and the wider issue of the meaning of Swiss form claims (and in due course the meaning of EPC 2000 second medical use claims "X for use in the treatment of Y"), have a long way to run, and this Kat is excited about these developments.  In the meantime, he is sure that our readers will be interested in the differences between the Dutch decision (and surrounding facts) and the present one, and looks forward to comments.