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.

Friday, 6 February 2015

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.


Anonymous said...

Can it really be right the "process" of the Swiss form claim ends once the product is prepared and that the intention to use it for the patented indication has to be present during that time in order to infringe.

Would Arnold really hold that there was no infringement if a company produced and stockpiled large quantities of drug for one (unpatented) use, then subsequently found out that it could also be used for a second (patented) use and began openly selling it for that second use? I find it hard to believe that he'd say "well, they didn't have the requisite intention when they were working the process, so no infringement".

Anonymous said...

Well at least Arnold J has acknowledged this will all need to be sorted out by the Court Of Appeal or Supreme Court.

Looking forward to Actavis' disclosure on its knowledge and objective intent on the pain market for pregabalin. Sounds like that will be very painful for them.

Anyone know when the Court of Appeal is going to review the preliminary injunction decision. From the dodgy guidance that's kicking around ( as set out in today's judgment) it sounds like the PI is very much needed!

Darren Smyth said...

To the first Anon - no, Arnold does not say "the "process" of the Swiss form claim ends once the product is prepared" - "manufacture" can be interpreted broadly. He said this at [37]:

" was common ground between counsel that it was at least arguable that, in this context, manufacture (or, more strictly, “preparation”) should be broadly interpreted as extending to, for example, a person who packaged and labelled the product (if different to the manufacturer of the pharmaceutical composition). It is also worth pointing out that the fact that a generic supplier subcontracts manufacture will not necessarily cause any difficulty. Nevertheless, I remain unpersuaded that the relevant intention can be that of a person who disposes of the product subsequently in the chain of supply, such as a pharmacist."

Note in any case that "manufacture" certainly includes the packaging and labelling. I think that was always inherent in a Swiss claim.

Anonymous said...

Roll on the appeal so that all this can be sorted out. It is creating huge amounts of legal and commercial uncertainty in the industry right now.

So today's judgment says that Arnold J still holds to his decision that Actavis do not infringe but the Court of Appeal may disagree with him.

This is where we need the appellate Court to jump in quick to give some certainty.

Anonymous said...

If he thinks the Appeal Court will disagree, why not make the right decision in the first place?

I think he woke up during the night after his first judgment in a cold sweat. "Oh No!!! What have I Done????"

Anonymous said...

I think the problem I have with this is intention not being considered part of the process, but "putting the invention into effect" being considered to end at the end of the manufacturing and labelling steps.

If a third party will add the requisite intention at a later date and the manufacturer well knows that, why should they escape liability?

The invention isn’t using the drug to make a medicament – it’s using the drug to make a medicament for the particular therapeutic purpose. The medicament is inarguably an essential element of the invention. If the manufacturer supplies that essential element and knows that their customer will add the requisite intention and therefore “put the invention into effect” why should they escape liability simply because the customer has not themselves carried out the manufacturing steps?

Anonymous said...

I can't believe Judge Arnold has been so dismissive of the Netherlands Court of Appeal ( with some very eminent lawyers sitting for this case).

The Dutch Court of Appeal has indeed given a Swiss claim the same effect as an EPC2000 claim and that may well provide good guidance on the policy considerations needed when construing "for" in the Pfizer Swiss claim for pregabalin.

The Dutch Court has come to a very sensible and clear outcome whilst making it clear what generics will have to do to achieve a launch of their product for the non patented indications. Lets hope the English Court of Appeal will get there too.

Anonymous said...

If the Judge is a fan of Frozen then he should know to " Let it Go" . The Court of Appeal never bothered him anyway"!

Anonymous said...

It is now time to stop pussyfooting around with the doctors, pharmacists and health services. Up until now drug companies ave kept them out of the legal battles for whatever reason. Maybe pooping on your customer isn't the done thing.

They are however a problem and they are planning to infringe the Lyrica pain patent. Pfizer should sue the health service that encourages generic prescribing in this case, as well as the pharmacists and the prescribing-software providers.

Go on Pfizer. Our health service is one big money making scheme now for zero-risk service providers. Let them pay. Make them pay.

Anonymous said...

The SmPC for the Activis product will not mention pain, so isn't there a problem with supplying this to a patient? Presumably, the patient needs to be able to understand the benefits and risks of the drug they are taking, hence the inclusion in the box (albeit illegably small, although you have appreciate the neat folding).

Anonymous said...

Pfizer, you are back on top! Now, get your preliminary injunction from the Court of Appeal. The pharmacist bodies (albeit they cant control the situation) seems to be right behind you. The High Court judge just didn't get it in terms of what would work for pharmacists in this second medical use scenario.

Anonymous said...

UK judges just don't cut it anymore. Pharma in the UK is finished.

Anonymous said...

Don't feed the troll. The foregoing deserves no comment.

Anonymous said...

Please do not instruct us what we should and should not think and comment on. I have seen such a troll statement before and I believe it is used when a view other than your own is proposed. There is enough censorship on this blog without you (a kat in disguise? D?) attempting to control things further.

To all sense and purpose the comment is correct. Pharmaceutical research in the UK is a shadow of its former self. Most pharmaceutical R&D is conducted everywhere but here. What little there is is conducted on the cheap, not simply low cost, as it provides poor value for money. Get-rich-quick is the motto of UK investors who attempt to cash in early before the large investments need to be made.

As fr the UK judges, well I think the lack of quality now spreads though the profession. Private practice agency work appears to be the order of the day. A lack of understanding of pharmaceuticals, the research or the business, results in poor quality IP portfolios and minimal valuable exclusivity. The real big investors (big pharma who in-licence the compounds and invest in the large-scale clinical trials) see this in their diligence activities.

The judges? What with so few cases in the UK, it is hardly surprising there is a lack of experience and poor quality decisions are inevitable.

If such comments offend the anti-troller, so be it.

Anonymous said...

I still don't get it as to why an actual or potential
Defendant to a patent action, in this second medical use scenario, doesn't have to do anything. Why isn't the generic in touch with DoH or NHS to get the right policy set so their generic product does not get used in an infringing way?

Anonymous said...

17:10 - Because, these govt department (although ostensibly businesses) see themselves as above the law. If a supermarket controlled the price of its supplies in the way the NHS does there would be many complaints and possibly even a competition law inquiry. Although, the supermarkets would still get away with it because anti-competitive behaviour is endemic in business and will never be controlled.

Anonymous said...

I gather it's going to the Court of Appeal on an expedited basis. Quite right too. The High Court judge pivoted everything on the NHS guidance on prescribing by brand and it seems he had no reason to work on that basis.

Anonymous said...

Anyone know how to follow the case? When is the hearing and where?

Anonymous said...

You could try keeping an eye on this:

Although it often doesn't give much advanced warning.

Anonymous said...

Simply can't understand why the NHS hasn't done what the judge told them to do ie issue guidance for prescribe by brand, Lyrica, when the medicine is for pain. They are just cheap skates- they simply don't want to pay the usual price for pregabalin for pain ( what the patent covers). Instead they just want their prescribing system to be continued to be used by generics and pharmacists to infringe the patent. So much for the Government' s policy of incentivising lifesciences R&D. It's like something out if "Yes Minister" .

Anonymous said...

Doctors earn several times the salary of scientists who invent and develop these drugs, without which they are nothing. It's a topsy turvy world.

Anonymous said...

I echo the sentiments of Anonymous @ 11:21.

Yes, it is a topsy turvey world.

But this is not a new condition. At it certainly is not a condition limited to the world of innovation. Take a gander at the pay disparities between teachers and athletes and entertainment people.

But to quote the venerable "Pogo," we have met the enemy and he is us. The royal "us" no doubt, since I would not want to offend any particular person. But truth be told, the disparities exist because as imperfect the world may be, the royal us still "vote" with our feet and our pocketbooks.

So while the truth remains that within the problem lies the solution, the equal truth remains that insanity can be defined as repeating the same actions and expecting a different result.

Anonymous said...

Let's also compare patent and trademark attorneys and scientists. The most able people I know are scientists and too many patent attorneys I know are second rate - you'd never guessed they had a science background and their legal knowledge is focused on procedural aspects. Substantive application of the law to the science is sadly lacking. TM attorneys do not even have science backgrounds and they are very well rewarded for filling out simple forms. General lawyers believe they are a 'cut above' patent attorneys, yet just chose well in their career.

Topsy Turvy.

Scientists and teachers are the solution, yet they are considered unworthy of just reward.

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