In a decision that is only moderately Arnoldian (139 paragraphs), Mr Justice Arnold refused today to grant an interim injunction that Warner Lambert had requested against Actavis [Warner -Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat) (21 January 2015)]. The case is a tricky one, exploring second medical use claims, skinny labels, and public policy issues around healthcare. The background is also quite complex, so this moggy will try to explain.
Background
Warner-Lambert (part of the Pfizer group) had a patent for pregabalin, which it markets for epilepsy, generalised anxiety disorder ("GAD") and neuropathic pain under the trade mark Lyrica. The original product patent has expired, and, for reasons which are intriguing but not disclosed, Warner-Lambert obtained a supplementary protection certificate which extended protection for pregabalin to 17 May 2018, but allowed it to lapse for non-payment of fees (this Kat would love to know why). Data exclusivity expired in July 2014, so in principle generic companies are now free to launch a competitive product.
The patent
Except that Warner Lambert has a second medical use patent - European Patent (UK) No. 0 934 061 - relating to the third indication, which has claims as follows:
In principle there is a well established procedure in such circumstances - the generic company can launch a product with a "skinny label" - an edited product leaflet that mentions only the permitted indications. But when one considers how things work in reality, immediately it is clear that there are problems. Prescriptions do not mention the indication for which a drug is prescribed. So in any situation, it is not clear to the pharmacist the reason for a drug prescription, let alone to the generic manufacturer for what indications a pharmacist may dispense a drug supplied to them.
The relief sought
So the interim injunction that Warner-Lambert were seeking was one of Actavis taking very special and particular steps to ensure that product that they supplied was not in the end dispensed for use in the patented indication. Thus the order that Warner-Lambert sought against the Defendant Actavis in relation to their pregabalin product Lecaent was:
The decision
In relation to the letters in 3) and 6) Actavis basically agreed anyway to write to pharmacies and Clinical Commissioning Groups to inform them that Lecaent should not be used for pain, although there was some quibbling over the precise wording.
In relation to 5), NICE had already amended its Clinical Guideline 73 "Neuropathic pain – pharmaceutical management" with a footnote:
In relation to 4), it was not clear that such a labelling would comply with the relevant regulations for packaging of pharmaceuticals, so such an order presented difficulties.
When deciding overall whether to grant the injunction, Arnold J applied the classical principles set out in American Cyanamid, and confirmed by the Privy Council in National Commercial Bank Jamaica Ltd v Olint Corp Ltd
He determined that in relation to the main infringement action there was no serious issue to be tried: in marketing pregabalin in the manner proposed, Actavis did not infringe a Swiss-form claim as Arnold construed it. In the alternative, he also decided that in any case the balance of the risk of injustice favoured Actavis:
A Swiss form claim (Use of a compound of general formula X in the preparation of a medicament for the treatment of Y) contains a medical indication with a statement of purpose - in this case "for treating pain". On the face of it, this wording brings in the intent of the doctor and possibly the pharmacist. However, if such claims were really infringed by a doctor, it would call into question the efficacy of this claim form in overcoming the prohibition (See Section 4A of the UK Patents Act 1977) on patenting of methods of medical treatment. The rationale of this prohibition is usually understood to be to exclude doctors and the practice of medicine from the realm of patent law. Thus, as Jacob LJ explained in Actavis v Merck at [75], such a claim "is not aimed at and does not touch the doctor - it is directed at the manufacturer." In this decision, Arnold went further and confirmed that intention is important in such a claim, but it is the intention of the manufacturer that matters:
Since there is surprisingly little jurisprudence on what actually is required to infringe a Swiss claim (or the corresponding form of second medical use claim under the EPC 2000 - "A compound of general formula X for use in the treatment of Y"), this part of the judgment is most welcome.
Background
 |
| Happier times ... |
The patent
Except that Warner Lambert has a second medical use patent - European Patent (UK) No. 0 934 061 - relating to the third indication, which has claims as follows:
1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.This patent would be infringed by a generic pharmaceutical company marketing pregabalin for this indication.
3. Use according to Claim 1 wherein the pain is neuropathic pain
The relief sought
So the interim injunction that Warner-Lambert were seeking was one of Actavis taking very special and particular steps to ensure that product that they supplied was not in the end dispensed for use in the patented indication. Thus the order that Warner-Lambert sought against the Defendant Actavis in relation to their pregabalin product Lecaent was:
1, The Defendants: (a) shall make it a condition of any oral or written agreement entered into with a pharmacy for the supply of Lecaent that the pharmacy shall use reasonable endeavours not to supply or dispense Lecaent to patients who have been prescribed pregabalin for the treatment of pain, by making reasonable enquiries of a person presenting a prescription for 'pregabalin' as to whether the prescription is for pain and/or making reasonable checks of pharmacy records for the same; and (b) shall make it a condition of any oral or written agreement entered into with an intermediary (such as a distributor) for the supply of Lecaent that, in any onward supply of Lecaent by the intermediary, such intermediary must in turn make it a condition of any onward supply agreement for the supply of Lecaent that the receiving pharmacy shall use reasonable endeavours as specified in (a) above.Arnold J considered that:
2. Insofar as the Defendants are to supply Lecaent to intermediaries (such as a distributor) they inform the Claimant's solicitors of the name of that intermediary prior to supply.
3. No later than the date of first supply of Lecaent to a pharmacy in the United Kingdom, the Defendants shall write a letter, in the form attached, to the superintendent pharmacist responsible for the pharmacy to which Lecaent is to be supplied.
4. Prior to launch of Lecaent in the United Kingdom the First, Second and Third Defendants and each of them shall ensure that each pack of Lecaent supplied to a pharmacist is accompanied by removable notification that is easily legible stating:
'This product is not authorised for the treatment of pain and must not be dispensed for such purposes.'
5. The Defendants shall notify in writing forthwith, and in any event before the date of first supply of Lecaent to a pharmacy in the United Kingdom, the NICE Medicines and Prescribing Centre of the Department of Health informing it that Lecaent should not be prescribed or dispensed for the treatment of pain.
6. No later than the date of first supply of Lecaent to a pharmacy in the United Kingdom, the Defendants shall write a letter, in the form attached, to all Clinical Commissioning Groups in the UK.
it is more or less common ground between all concerned 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 issue is to what lengths Actavis should be expected to go to ensure that this was what happened.
The decision
In relation to the letters in 3) and 6) Actavis basically agreed anyway to write to pharmacies and Clinical Commissioning Groups to inform them that Lecaent should not be used for pain, although there was some quibbling over the precise wording.
In relation to 5), NICE had already amended its Clinical Guideline 73 "Neuropathic pain – pharmaceutical management" with a footnote:
In addition, the Lyrica (Pfizer) brand of pregabalin has patent protection until July 2017 for its licensed indication of peripheral and central neuropathic pain; until such time as this patent expires generic pregabalin products will not be licensed for this indication and their condition would be off-label and may infringe patent.Arnold J accepted that Actavis could not force NICE to do any more than that.
In relation to 4), it was not clear that such a labelling would comply with the relevant regulations for packaging of pharmaceuticals, so such an order presented difficulties.
When deciding overall whether to grant the injunction, Arnold J applied the classical principles set out in American Cyanamid, and confirmed by the Privy Council in National Commercial Bank Jamaica Ltd v Olint Corp Ltd
He determined that in relation to the main infringement action there was no serious issue to be tried: in marketing pregabalin in the manner proposed, Actavis did not infringe a Swiss-form claim as Arnold construed it. In the alternative, he also decided that in any case the balance of the risk of injustice favoured Actavis:
In my judgment, granting the relief sought by Warner-Lambert would create a greater risk of injustice than refusing it. In my view, wrongly granting the relief is more likely to cause Actavis substantial unquantifiable harm than wrongly refusing it is likely to cause Warner-Lambert substantial unquantifiable harm.Swiss form claims
 |
| Making a Swiss claim? |
counsel for Warner-Lambert submitted that the relevant intention was not that of the manufacturer, but that of the person who disposes, or offers to dispose, of pregabalin. I do not accept this submission. As I have explained, the claim is to a process of manufacture and it is directed at the manufacturer. It is not a claim to the resulting pharmaceutical composition, nor is it directed at a person who disposes of the pharmaceutical composition. It follows that the relevant intention is that of the person who carries out the process, here Actavis (or their manufacturer).Moreover, it is a subjective intention that it be used for the claimed use that is required for infringement:
Accordingly, I hold that the word "for" in Swiss form claims 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.On this basis, there was no serious issue to be tried that Actavis's sales in the manner planned would infringe the patent.
Since there is surprisingly little jurisprudence on what actually is required to infringe a Swiss claim (or the corresponding form of second medical use claim under the EPC 2000 - "A compound of general formula X for use in the treatment of Y"), this part of the judgment is most welcome.
No pain for Actavis - Warner-Lambert fail to stop launch of generic pregabalin
Reviewed by Darren Smyth
on
Wednesday, January 21, 2015
Rating:
Reviewed by Darren Smyth
on
Wednesday, January 21, 2015
Rating:
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As I've understood it, this case is about direct infringement not occurring if Actavis take the proper steps to avoid the drug being used for the second medical use indication. It is not about the situation where doctors prescribe it for the indication and then there is test of whether Actavis are contributory infringers. It seems to me though that both of these scenarios needed consideration.
ReplyDeleteDear Anon
ReplyDeleteI agree that the case is about the former not the latter situation. However, "the situation where doctors prescribe it for the indication and then there is test of whether Actavis are contributory infringers" is I think excluded by the discussion, quoted in part in the last section of the blogpost, of who a Swiss form claim catches. If, as stated, it "does not touch the doctor" at all, then it seems to me excluded that the manufacturer can be a contributory infringer. They are either the direct infringer or not infringing.
Best wishes
Darren
The key things is the guidance from the NHS that the Judge has called for from the NHS for prescription by brand for the patented indication. Without this the patent owners price and market for the patented use will collapse. I don't understand how/ why the Judge assumed the guidance has been issued when he did his balance of convenience assessment. We haven't seen this guidance in the industry yet. Have I missed it?
ReplyDeleteBut on Arnold J's interpretation of a Swiss claim only a manufacturer who subjectively intends to make his pregabalin product for pain would infringe. So, if its an Indian manufacturer, there will only be infringement if he makes his product and brings some of it into the UK "subjectively" intending it to be used for pain. This way you blow a hole in all second medical use patents. Get a manufacturer outside the UK, don't tell him anything about what the medicine is used for in the UK and hey presto, you can ignore the patent.
ReplyDeleteSo what about a use-limited product claim à la EPC2000? Can that touch the doctor if they're prescribing the drug for the claimed indication?
ReplyDeleteIf so then the manufacturer could be a contributory infringer, though presumably it would be necessary to demonstrate inducement.
I suspect Actavis is feeling the pain of those letters to all prescribers and pharmacists. Maybe Actavis' pain relief is that they think the recipients will just put them in the bin and use the cheaper drug for pain.
ReplyDeleteSo, if Richard Arnold is right there is no infringement if a wholesaler gets the skinny label product and markets it when more than half of it will be used for the patented indication. The manufacturer did not intend this so he does not infringe and the wholesaler's knowledge or intention cannot be imputed "backwards" onto the manufacturer. The wholesaler does not infringe because he does not manufacture and the direct product which he supplies was not intended ( by the manufacturer) for use for the patented indication. This result seems bizarre. It also means that second medical use claims are of no use in stimulating research into new therapeutic uses of known drugs ( for the benefit of society). Someone needs to convince Mr Justice Arnold.
ReplyDeleteI think a Swiss style claim simply cannot be interpreted as a claim to the manufacture of a medicament. That would mean that importing the drug would only be infringing if it was a 'direct product' of the process. However Swiss-style claims do not have any manufacturing steps recited in them, so how can one tell it is a 'direct product'? The Courts must avoid being too literalist with Swiss-style claims, as they simply don't make sense when interpreted literally, and the literal interpretation certainly does not reflect the scope of the claim which is closer to a product claim, and perhaps identical to the equivalent medical use claim.
ReplyDeleteSaying that anything short of blatantly contrary to the patent does not indicate subjective intent is promoting an unduly narrow interpretation of the intent required to infringe. This leaves the known enforcement problems unsolved.
ReplyDeleteGoodness gracious look at para 99 of the judgment:
ReplyDelete'99.So far as the first question is concerned, counsel for Warner-Lambert submitted that the relevant intention was not that of the manufacturer, but that of the person who disposes, or offers to dispose, of pregabalin. I do not accept this submission. As I have explained, the claim is to a process of manufacture and it is directed at the manufacturer. It is not a claim to the resulting pharmaceutical composition, nor is it directed at a person who disposes of the pharmaceutical composition. It follows that the relevant intention is that of the person who carries out the process, here Actavis (or their manufacturer). '
Is Arnold really saying that a Swiss style claim would not catch people dealing with the product, e.g. importing? That will not survive appeal.
In a "Swiss-form" claim, what is the relationship between the "manufacture" and the novelty-providing feature (i.e. the new medical use)? To the extent that there is a relationship (and G2/08 casts doubt upon whether there is), does it derive from the label applied to the product? Producing a medicament in packaged and labelled form could perhaps be described as part of the "manufacture" of that medicament.
ReplyDeleteViewed this way, the person putting the product label together with the pharmaceutical formulation could be a direct infringer. Also, both the pharmaceutical formulation and the product label could be viewed as "essential elements of the invention" - hence bringing in the possibility of indirect infringement for those dealing with either.
Does Arnie not live in the real world? . Actavis knows very well that it's product will be used most of the time for the patented indication. Actavis knows very well it will make huge amounts of money from its supplies which are used for the patented indication. Actavis is slam dunk in the patentee's monopoly and intends to profit on the back of it.
ReplyDeleteNo doubt this is exactly why Acatvis didn't want to put in the contractual restriction with their customers. No doubt this is why they didn't want to put a cellophane wrapper saying " not for pain" on around their packages.
I don't understand why the judge didn't se what's really going on.
The judge's interpretation of Swiss claims is indeed nonsense. However, Actavis are doing little, if anything, wrong by selling the product with the appropriate skinny label. I fail to see why they should take any steps to prevent off-label use, provided they do not promote, in any way, off-label use.
ReplyDeleteThe problem for Pfizer is the combination of the weaknesses of second medical use claims combined with the NHS practice of 'encouraging' prescription by generic labeling where available.
It is the NHS that should be the subject of Pfizer's attention, not Actavis.
Darren, the reasoning behind the abandoned SPCs may be explained by an analysis of the origin and ownership of the two patents together with a little speculation. Either there was a simple rational explanation licence-related) or this was a monumental sequence of errors made. Based on the clear deliberate acts made by Pfizer across Europe, it can't be the latter. I can't think of any other possible reason, but would like to hear other speculative possibilities.
To the previous comment . I disagree with 54% of the Actavis product ( which has a weird brand name!) inevitably about to be dispensed for pain it seems to me they are stepping beyond the bounds of what
ReplyDeleteordinary decent people engaged in business would regard as honest. They will make the money out of this ( not the NHS).
What is Actavis doing to change the prescribing system?
I suspect Actavis are doing as much as they should be doing to change the prescribing system. Absolutely NOTHING.
ReplyDeleteI agree Actavis are doing absolutely NOTHING. Why? Because they don't want the prescribing system adjusted to respect second medical use patents. Why? Because they want to play the system every time there is a second medical use patent for one of their generic drugs. Why? Because for Actavis they couldn't care less about incentivising the development of medicines for new uses.
ReplyDeleteBut as a human being and potential patient I ( and no doubt every employee of Actavis) want the best new therapies I can have for a debilitating disease or symptom.
I write from Australia. Kats we would love you to write more about our cases.
ReplyDeleteHere, there remained a dispute in respect of the potential for off-label generic substitution by pharmacists when filling prescriptions for Lyrica. Pfizer argued under the contributory infringement provisions of the Patents Act that any such substitution would amount to an infringement of the pain patent. Pfizer submitted that as the seizure market for pregabalin is ‘practically non-existent’, Apotex should be taken to have reason to believe that pharmacists would supply Apotex Pregabalin to patients for pain relief, thereby infringing the pain patent.
At first instance, Justice Griffiths was not satisfied that Pfizer had demonstrated a prima facie case for the additional interlocutory relief it sought. Second, His Honour held the balance of convenience favoured the refusal of the application for additional interlocutory relief.
On appeal, the Full Court accepted Pfizer’s submissions that the primary judge had conducted ‘a preliminary trial of the proceeding’ at least in so far as His Honour rejected evidence filed by Pfizer on these key issues in favour of Apotex’s evidence.
In addition to other factual disputes, the Full Court held that whether or not Apotex had the requisite ‘reason to believe’ that pharmacists would be likely to substitute Apotex Pregabalin for Lyrica prescriptions in respect of neuropathic pain relief was not something that could be resolved before trial.
In relation to balance of convenience, the Full Court supported Pfizer’s application for additional interlocutory relief, giving considerable weight to the fact that it enjoyed a well established market for pregabalin for the treatment of pain which Apotex was threatening to disrupt.
I assume Pfizer is appealing speedily in England. A lot of the analysis on appeal in Australia would seem to be directly relevant in England.
A pommie (or English gentleman) told me recently that Judge Arnold has never decided that a life sciences patent is valid and infringed. If that is right then it shows there is a pressing need for judicial training (perhaps specifically in the life sciences sector).
Thank you all for some great comments.
ReplyDeleteTo our Australian commenter - alas we don't have time to scour the whole world for interesting decisions. If you would like to write a piece on the Australian case I would be delighted to post it. Your English gentleman is misinformed and should perhaps read IPKat more. Off the top of my head I recall the copaxone case here:
http://ipkitten.blogspot.co.uk/2012/07/breaking-news-glatiramer-acetate-patent.html
Several commenters suggest that Actavis should have the prescribing system changed. I find it difficult to credit that even the most ardent pro-patent campaigner should think that a generic company has the responsibility to change healthcare practice. That is simply not going to happen.
Anon at Friday 09.08 says "The Courts must avoid being too literalist with Swiss-style claims, as they simply don't make sense when interpreted literally, and the literal interpretation certainly does not reflect the scope of the claim which is closer to a product claim, and perhaps identical to the equivalent medical use claim." If Swiss claims are identical in scope to medical use claims, then they are invalid for the same reason.
A very much live question is whether EPC 2000 second medical use claims "X for use ..." should be construed in the same way. If I had to guess, I would guess that judges in the Patents Court and on appeal will decide that their existing jurisprudence on Swiss claims DOES apply to the new format, so that they should be construes in the same way. This, as well as the fate of any appeal in the present case, will be very interesting to see.
Darren
In their wisdom the Enlarged Board in G2/08 did not say that medical use claims and Swiss style claims have a different scope (though they hinted it).
ReplyDeleteLess wise Technical Boards of Appeal said in T250/05 and T1780/12 that Swiss style claims have a smaller scope, but they were wise enough to not explicitly say that the scope only covered manufacturing.
Now Arnold has plunged in and said it. The Swiss style claim is directed to an actual manufacture, nothing more. That is contrary to the assumption of the vast majority of practitioners and patentees. He has overnight slashed the perceived coverage that the Swiss-style claim provides. However everyone knows that the novelty of a Swiss style claim is destroyed by a disclosure of the substance being used for the condition. No disclosure of the 'manufacture' is needed to destroy novelty. So how can that be consistent with the new test for infringement of the claim?
Unfortunately the UK Courts are probably the most influential globally in interpretation of Swiss style claims, and so this decision has a lot of consequences.
Pharma's reaction to this change in claim coverage (and consequent decrease in the value of their patent portfolios) will be interesting to see.
I would like to provide this link to an article about the obstacles the NHS is facing - http://www.theguardian.com/healthcare-network/2015/jan/23/barriers-healthcare-innovation
ReplyDeletePlease note the paragraphs about purchasing, product distribution and problems with manufacturers who have 'intellectual property contamination' issues. The point I am making is that the NHS has a difficult enough time assessing drugs, knowing what to buy and the IP issues around it all. The IP system cannot ignore the fact that we are making it more difficult for the NHS to know how to purchase drugs and deal with IP issues.
Fantastic insightful posting and commentary on this enormously important case. Very adorable Kats!
ReplyDeleteNow, come on Actavis tell us ( and the nice Lord Justices in the Court of Appeal) what your real knowledge or objective intent is. Then we can have a proper diagnosis of whether there is a serious issue to be tried.
Actavis must have debilitating Generalised Anxiety Disorder ( for which pregabalin is an efficacious medicine) as they await the Court of Appeal's views.
I would be very pleased if Mr Justice Arnold ( who is , of course, a brilliant advocate and public speaker) could come along to the next board meeting of the pharmaceutical company I work for and explain to those that I report to on the Board how we can maintain our current prices and/or put our price back up again after 3/4 generics have entered the market.
ReplyDeleteHis conclusions in his judgment on this critical case for the pharmaceutical industry leave us stunned ( and with irate enquiries from the Board on how/why we have not been able to maintain our pricing pending trial or raise it again after trial on numerous products).
I propose to write to the learned judge and extend our invitation. As the Australian commentator noted, judicial training is required on these commercial issues. Open dialogue between the Judge and pharmaceutical company board members can only help.
The judge's analysis centres on "subjective intent" but even in criminal law "intention" is not limited in this way. Surely if a generic company does something knowing it is the likely consequence that should suffice for the tort of patent infringement.
ReplyDeleteIt will be very interesting to see the analysis of knowledge or intention on appeal.
In reality, the pharma "problem" here is one often faced by the software patent people, and is readily identified by asking a simple question:
ReplyDeleteWho is the infringer?
For this type of patent (purely a new and alternative use), the answer to that question is the end user (with all due deference to the good judge).
Therein the rub - end users do not have deep pockets and enforcement of the patent can easily be seen as to be a losing game for the patent holder.
What to do?
Aim for someone else along the distribution chain that does have deep pockets.
But to do this, one necessarily must then engage in a fair amount of pedantic semantics and 's t r e t c h i n g' of patent law in order to rope in those players, who, of their own individual actions, are doing nothing other than what is permitted under law for the handling of the now off-patent item.
Another problem with this tactic is that generally speaking a patent right is not a right to engage in positive actions in the market; but rather, the patent right is merely a negative right allowing the right holder (note importantly that it is the right holder and not the State) to take actions to exclude others from the domain of patent coverage.
I will also note that the option provide by the esteemed Arnold J (prescribe by name) would fail to work - at least here in the US - because it is widespread practice NOT to be limited by a prescription to a commercial name, being as it is that our insurance industry has made it a de facto practice for pharmacists filling prescriptions to routinely seek the object's (the drug of which the pharmacist is putting in the bottle) cheapest source. The business model here simply does not support the judicial means to the desired end. And here in the States, the manufacturer does not have privy and control to force others to obey such a command.
The "right" result being reached - if you want to evergreen with a weak form of claim, then you must be content with the weak reach of that claim. The Quid Pro Quo from the now off patent product must be respected - after all, had the "new use" been invented during that period of exclusivity, the rights holder would have been empowered to still block the product right (even for the new and improved use).
Clearly now is the time to import a lot of drugs, before this case goes to appeal and before the following claim starts to be used by applicants in response to literalist interpretations:
ReplyDeleteX for use in the importation of a medicament for treating Y.
The last comment is spot on! Presumably Actavis will have imported vast quantities of generic pregabalin over the weekend. Flood the market quick!
ReplyDeleteDarren - do you know when the appeal is taking place? Soon I guess. Will you post on it?
Does anybody know if the guidance the judge called for has been issued by the NHS? Do you think the MHRA might have pressed " pause" for a few days on the marketing authorisations to allow the guidance to go out?
For the commentator who believes the NHS are having a hard time dealing with IP contamination, I have to say the NHS thoroughly understand the system and the issues and play the game to their benefit (i.e. obtaining the lowest prices) as well as it could be played.
ReplyDeleteI don't know the statistics of Arnold's pharma case, but I have to say that I cringe when I read them. It always appears to me that he is attempting to teach himself the law as he is going along and is looking to re-invent the wheel. It is most unfortunate that the first Swiss-claim interpretation case landed on his desk.
ReplyDeleteDid Arnold not read the case law that resulted in this style of claim wording? Did he not ask anyone how the pharma industry operates? Did he not consider the rationale behind the amendments to the EPC?
Bring back Lord Hoffman.
I agree that Actavis should not be seeking to have changes made and I am an innovative-pharma attorney through and through. The inevitably of generic competition is part of the rules we work with and plan for.
I don't know the market size for seizures, although I assume it is relatively small in comparison to the patented use so if Actavis flood the market then then it must be the case that they are contributory infringers. More, if they actively promote sales for the patented use, which I suspect they will not do.
The pharmacist will simply be supplying product in response to a prescription having the generic name so they cannot be an infringer by conducting this act alone. They are aware what is going on, actively participating and benefiting from the situation so are also arguably contributory infringers.
The prescribing authorities (NHS and doctors) are the actual direct infringers if they prescribe by the generic name for the patented use rather than the brand name.
The ultimate end user is the patient and they do not infringe because their acts are done privately for non-commercial purposes.
Seems like the Dutch Court of Appeal has just today granted an injunction on the back of a second medical use patent in the Novartis v Sun case. They acknowledge that it is inevitable (as Sun must surely know) that the generic would be dispensed for the patented indication. Sun's e mails to insurers and wholesalers saying its product was not to be used for the patented indication were not enough. Lets hope the English Court of Appeal reads and considers this!
ReplyDeleteI am a pharmacist and I came across this blog when I tried to look up the Actavis pregabalin situation. I am at a loss to know what to do. We are being told we can have Actavis pregabalin product very soon but I have no information on what we can and can't dispense it for. You all seem very knowledgeable on the situation and what should happen. Can anyone help with my enquiry. Many thanks for reading this.
ReplyDeleteA pharmacist! You've come to a dangerous place. This is very unsettled law as this case is the first real test. So unsettled that the judge has given a very poor decision.
ReplyDeleteI assume you will be completing prescriptions directly to a doctors orders, so if they prescribe 'pregabalin', you are probably free to prescribe a generic. If they presecribe 'Lyrica' you should be prescribing only the branded drug. Am I correct in assuming this is how the rules would work for you anyway, irrespective of patents, with no mention of the indication on the prescription?
However, I doubt you will be infringing the patent by prescribing the generic in place of the brand unless you have grounds for believing it is for the treatment of pain. If you do so knowingly, I suggest you are an infringer.
Again, however, Pfizer will not be coming after solo pharmacists so you have little to be concerned about. It just isn't the done thing. The manufacturer is their target and it is their product they want to keep off your shelf.
You will probably be prescribing several generic drugs that will be used off-label for patented indications.
One more point:
ReplyDeleteWho told you Actavis product would soon be available and what indications did they say it would be prescribed for?
Thank you so much for your answer. Very helpful. I am also going to speak to Royal Pharmaceutical Society for their guidance.
ReplyDeleteYou are right on how we usually operate. For pregabalin we are all well aware that most of the medicine goes for pain.
Thanks again.
Darren,
ReplyDeleteHow can we link ( technologically on the blog) this debate to the hot debate following your posting on Novartis/Sun in the Dutch Court of Appeal?
Great that you have posted on both these cases in a timely fashion and allowed the debates to take place in the comments. Would be super if your readers/ bloggers could compare and contrast the two cases.
I was in Court yesterday to watch part 2 of this before Arnold J again. The judge said he would provide his judgment in due course.
ReplyDeleteThe judge's mood and exclamations in Court were very strange. For some reason he seems to think there is no burden on Actavis to do anything to minimise or avoid infringement. He seemed to completely ignore ( or actually stop) any argument on this. We in the industry fail to understand this. Why shouldn't Acatvis have to do what any other potential Defendant to patent infringement has to do- think of design arounds, think of ways to avoid or minimise infringement, clear a path for themselves. This judge's attitude on this is most alarming.
The judge thinks everything will be sorted with the guidance from the NHS to prescribe by brand. That may be right if it comes and comes in time with the prescribing software changes. BUT, he was told yesterday by the parties that there is no guidance yet.
Judging by his tone it seems as if whatever judgment he delivers on this application will also need to go to the Court of Appeal ( or the Supreme Court! ).
Today was the showstopper! Pfizer sought and got a High Court Order against the NHS requiring it to issue central guidance that when pregabalin is prescribed for pain the prescription must say Lyrica.
ReplyDeleteThis is a big first in the enforcement of a second medical use patent. Very innovative Court application by Pfizer based on the NHS being an intermediary or conduit and relying on jurisprudence from trade mark and ISP cases eg Cartier.
So, there will be no pain for anyone now- the position is clear and simple!
Come on Kats tell us all about the big story in Court today.
ReplyDeleteAfter today the IPKat can change its headline " Pfizer gets the best pain relief imaginable" - an Order from the High Court that NHSE must issue central guidance that prescribers must prescribe Lyrica when using pregabalin for pain and for those prescriptions pharmacists must dispense Lyrica. That's a super neat solution and is far better than any preliminary injunction against one or more generics. Pretty impressive strategy by Pfizer!
ReplyDeleteWell done Pfizer.
ReplyDeleteWe all knew this was the right outcome.
Nice website, and great discussion!
ReplyDeleteI am a pharmacist, researching the issue and also advising the local GP surgery who are more than happy to continue to prescribe pregabalin generically.
I feel that what Pfizer should have done is to introduce another product, be it a different formulation (e.g. tablets or modified-release) or a different strength, with a different brand name, and apply for the indication of the treatment of neuropathic pain. As it stands, as a pharmacy, we can and should dispense what the prescription dictates, unless we are aware that the patient is being treated for neuropathic pain, in which case we must dispense Lyrica.
Pfizer are threatening to sue GP surgeries and CCGs for infringement of the patent, but how viable is this in reality? How do they intend to verify the indication for which each patient is being treated?
Pharmacist at 18:17, I think you should probably read this later post and decision:
ReplyDeletehttp://ipkitten.blogspot.co.uk/2015/03/warner-lambert-v-actavis-mark-4-harmony.html
Doctors are not supposed now to prescribe for pain other than by trade mark Lyrica.
Thus, most of the issues now are sorted. At least until the full trial.
"Pfizer are threatening to sue GP surgeries..."
ReplyDeletePoppycock. I hope you're more accurate with your tablet counting
...it's been interesting to read all of this again, now that we have the Court of Appeal judgment.
ReplyDelete