Amgen, Inc. & Ors v Janssen Biotech, Inc.

This matter was last before the court in September, when I made a directions order (my order of 12th September 2023), but left open the trial date to be argued today. By paragraph 8 of my order I said that: “The trial date will be decided at the CMC”, which is today.

Pertinently, I identified as two possibilities for the trial: June 2024, with a time duration of five days in court and two days split between pre-reading and the preparation of closings, or September 2024. One reason for not making a decision then about the trial date was to give the various claimants the opportunity to discuss and coordinate their positions with the objective of streamlining the issues.

Today I heard from Mr. Hinchliffe KC, for Janssen, the patentee, and (I list them in no particular order), from: Ms. Jamal for Amgen; from Mr. Campbell KC, for Samsung; from Ms. Moggridge for Accord; from Mr. Ivison for Celltrion; and from Mr. Delaney, representing Fresenius, who were not before me on the last occasion, but who, to put it rather crudely, are falling in behind the other claimants and about whose position I think I probably will not need to say any more of substance.

The two major bones of contention today, which are related, are: whether there has been enough streamlining of the issues to be confident, or at least sufficiently confident, that the trial will fit into the five-plus-two slot in June; and, secondly, how to case-manage the allegation which Janssen has made of “skinny label” infringement under section 60(2) of the Patents Act 1977, it being common ground, at least to this extent, that if the skinny label issue is included in the trial along with all of the validity issues and full-label infringement issues, it will not fit into the June slot, but might fit into the September slot, depending how long the skinny label issue would take to try, which is a matter to which I will return.

The streamlining that has taken place is as follows: the claimants previously before me in September (and, although its pleadings say something else, Fresenius, since it has indicated that it will fall in line), have, on the whole, reduced their prior art attacks to three in nature, which I can refer to as: UNIFI, Ochsenkühn and Sands, although they rely on slightly different documents to found these attacks. Amgen alone relies on an article called Allocca.

The claimants have agreed to share experts and whilst they do not fully commit to using the same counsel, they only want to reserve the right to have different counsel address the court only on a narrow corner of the case, which is to do with whether two of the citations amount to anticipations, as well as rendering the patent obvious.

I have said that the attacks are reduced to three, but involve different documents. That is particularly pertinent to Ochsenkühn. Mr. Hinchliffe, for Janssen, submitted that some of the claimants had increased the number of citations on which they rely since September. That is true, but not, I think, the helpful way to look at the picture as a whole. As a whole, there has been a reduction in the prior art cited by the claimants as a group.

After the short adjournment today, Ms. Jamal, for Amgen, said that if it was the tipping point, Amgen would be prepared to drop the Allocca prior art in order to keep the July date. I will return to that, but note at this stage that I was not particularly impressed with the fullest degree of thought having been given to Allocca and there does not appear to be clarity at the moment about whether it is a separate citation in its own right, in substance, or whether it is the vehicle for an attack which is really obviousness over common general knowledge alone with all that would entail.

I should also mention that two of the claimants intend to argue that there is no infringement of the claims by the full-label launch intended by them on the basis of a potential interpretation of what is referred to as the “44-week integer”. But the claimants do not intend or seek permission to use different counsel for that at trial and my clear impression is that it is not a particularly heavy point.

I am grateful for what I am sure has been a significant effort on the part of the claimants to get to this stage. Even the agreement to share experts and, in general, counsel, must have required careful thought and discussion. On the other hand, I am a little disappointed that minor matters, such as which precise citation to rely on, obviousness versus anticipation and perhaps Allocca and the infringement point, mean that the defendants are not running a truly single and entirely streamlined case. In other similar situations that I have case-managed, the multiple generic companies opposing a patent have been able to go away and, no doubt with a serious degree of effort, come up with a truly unified front. That is much to be preferred and, for future reference, that is what I, at least, and perhaps other judges, would be looking for when we encourage this sort of exercise, and when listing decisions depend on it.

Be that as it may, I conclude that the matters – and I make it clear I leave aside skinny label for the moment – that remain for trial would fit into the June slot, provided that, as has been indicated by Amgen, Allocca is removed. The reason I require the removal of Allocca is that I do accept Mr. Hinchliffe's submission that the slot in June – and, again, I emphasise leaving aside skinny label – is tight and it is unclear at the moment what Allocca would contribute. But it does look to me like a different kind of citation and that is how it was argued to me at the hearing in September. Certainly if it were to become the vehicle for a CGK-alone attack, then it could make a really significant difference.

So my interim factual conclusion is that the streamlining that has taken place, whilst one could have wished for more and whilst it is slightly imperfect, is good enough that the issues other than skinny label could be tried in the June slot. That does not necessarily mean I am going to direct the June slot, because I still have to deal with the very significant matter of the skinny label allegations.

The position on the skinny label allegations is a complicated and difficult one. Janssen has pleaded its case out against Amgen, Samsung, Accord and Celltrion, but not yet against Fresenius, and the allegations are in relatively consistent form. The broad allegation is that the claimants intend – albeit only contingently and in the event of a particular scenario that I will come to shortly – to launch their products with a skinny label, but that that would infringe, none the less, under section 60(2), because even with the removal of ulcerative colitis, which is the condition to which the claims of the patent-in-suit are directed, it is obvious or known to the claimants that clinicians will prescribe the claimants' drugs for ulcerative colitis and that such use would not be, as is sometimes expressed in the cases, “maverick”. The assertion is that the invention would then be being put into effect within the meaning of section 60(2).

I identify, at this stage, that the currently pleaded allegation is in relation to a skinny label which would not include ulcerative colitis, but would include Crohn's disease. That is at least potentially important because it is said by Janssen, that the posology for the two conditions is identical and, therefore, that if the label includes Crohn's disease, it is all the more likely that clinicians would be willing to prescribe it also for ulcerative colitis, which is a related condition.

It is an obvious possibility that if this issue, by which I mean the skinny label generally, were to go forward that the claimants might, at least as an alternative, put forward a still skinnier label, removing Crohn's disease. But, in agreement with Mr. Campbell, I take the view that that is not the current scope of the pleading.

The claimants have expressed their intentions, or lack of intentions, in relation to a skinny label in a number of different ways. The strongest position, by which I mean the position by which intention to have a skinny label is most strongly controverted, is on the part of Samsung, who elevate the contention to the level that it applies to strike out Janssen's section 60(2) claim altogether, and there is a formal application to do so, which there will not have been time to deal with today.

It is right to say that even Samsung does not wholly rule out doing a skinny label, but it says that it has no current intention to do that; that that is a contingency that would only arise if Janssen wins on full-label infringement and validity at trial and that the circumstances in which it might conceivably do a skinny label are too far off in the future and too uncertain and that Janssen's case accordingly does not even reach strike-out level because it is so speculative.

Other claimants take a different line. I have received confidential information regarding the position of two of them. To avoid issues with confidentiality (which I will say I think have been significantly overdone by all the parties) I will simply refer to the place where they appear in Mr. Hinchliffe's skeleton, which is paragraphs 15(a) and 15(b). If it had been necessary to get into the details, I would have grappled with whether the confidentiality asserted is overdone or not, but it is not necessary to get into the details; it is enough for me to say that the specific regulatory strategy of two of the claimants engages with the possibility, however remote it might be said to be, of using a skinny label.

Other claimants have taken a different line in their evidence. For example, Celltrion, in the evidence of Mr. Hilton, of Bird & Bird, are much more upfront in saying that because they have invested a lot of money in their product, and they would naturally want to monetise it by selling it with a skinny label, even if they lose at the trial of full-label infringement and validity.

I digress to mention that, as one would expect, all the claimants express overwhelming confidence in the strength of their case in relation to validity and/or full-label infringement, but it will be quite apparent that that is not something I can deal with today and I take no account of the strengths or weaknesses of any party's position on those issues in reaching my conclusions today.

There are two main aspects I have to address in deciding what to do as between June for the existing issues, with some kind of deferral of the skinny label arguments, on the one hand, and September, or possibly later, for the existing issues plus the skinny label arguments all in one trial. The first is the loss, or perhaps I should more accurately say non-occurrence of the June trial, which is said by the claimants to pose the risk of commercial prejudice, and the second is the impact of the time that it would take to try the skinny label issues if they were to be included at some stage.

In relation to both of these points, I need to look forward in time to see what the practical position would be in terms of the burden on the court, depending on what I do.

Turning first to the significance in commercial terms of the June trial, the critical point here is that the relevant SPC expires in July 2024 and the claimants are anxious to be able to begin supply as soon as possible after that if it is lawful in the light of Janssen's patent to do so. Whether they are able to do so depends on some matters which are relatively unknown and, in particular, it depends on whether the NHS carries out a tender and, if so, when, for the supply of generic Stelara (the drug in question).

I touched on this when I looked at the matter in September and my overall conclusion is that, whilst it is uncertain when such a tender might take place and when it might conclude, there is a real possibility, which I ought to take materially into account, that it will conclude in time, such that if the June trial were to take place and judgment be given relatively quickly, those claimants who were commercially in a position to do so could begin supply a couple of months or so before September. That is if all goes well.

As well as facilitating supplies at a lower price to the NHS and allowing the possibility of profits to the claimants, this is an area where the claimants, as between themselves, being in competition, is significant because there is, in my view, a non-trivial possibility that one of them may obtain a first-mover advantage, which they would not if the decision did not come down until after a September trial.

I do not consider it necessary to go into the particular expression of views in the evidence that has led me to this conclusion, but in a nutshell, I am persuaded by the evidence of Mr. Parker, in particular, from Samsung's solicitors, and other evidence relating to situations in the past, that the NHS is incentivised to move quickly when there are multiple generics in this sort of situation and that whilst things might intervene to stop them, they are likely to want to do that if they can. Therefore, I do conclude that there is commercial advantage to the claimants in having the June trial.

What then of the question of how to deal with the skinny label issue, which cannot be fitted into a June trial? Mr. Hinchliffe, for Janssen, relies on the general proposition that the court tries to determine all the issues in a case at once and, apart from the fact that in intellectual property matters, damages are bifurcated by default, I think he is right about that and the court needs to be satisfied that there are real reasons to case-manage matters differently.

Therefore, I do take that as a starting point, but it cannot be applied blindly or unthinkingly and situations arise where it is appropriate to split off other issues. Every case must be considered on its own merits and, on any view, this is an unusual situation, given the number of parties, the commercial picture, which I have already discussed, the timing and the nature of the skinny label issues.

I first identify that it is reasonably clear, and Mr. Hinchliffe did not really argue otherwise, that the skinny label issues are really quite severable from the other issues, in terms of technical overlap, the time point to be considered, the facts in issue and the questions of claim construction. At one stage, Mr. Hinchliffe floated in his skeleton the idea that claim construction might be relevant to both the main issues and the skinny label issues and that it was necessary to avoid inconsistent constructions, but this rightly faded away and Mr. Hinchliffe, pragmatically and sensibly, I think, argued this part of his case only in terms of the inevitable need to re-educate the court on the truly basic technology in this matter if two trials take place instead of one.

That makes it possible to try the skinny label issues separately, but it does not necessarily make it desirable and, again, I have to, I think, burrow into the facts, and there are two particular facts that I think I take into account. They perhaps pull in different directions.

First of all, it may be that the skinny label issues may never need to be tried at all if the patent is revoked at the first trial or, less likely, I think, and more hypothetically, found not to be infringed on the basis of the 44-week issue. I cannot allocate any particular likelihood to this, as I have indicated already, but it is a real issue.

Secondly, a difficulty with the skinny label issues is that, at the moment, none of the claimants has formulated with any precision what it is that it would want to do, in terms of either the indications covered in its label or the instructions or notifications to prescribers and healthcare providers about what they should do if the situation should come about, which on this hypothesis it would, that the ulcerative colitis indication is covered by the patent-in-suit but excluded from the label.

It is possible that the claimants have given more thought to this than they have really reflected in their evidence, but although I think they vary in this respect, I reach the overall assessment that they have not given much thought to this and that means that the issues for trial next September are currently very difficult to define. That is not to say that Janssen's pleading is deficient, subject, of course, to Mr. Campbell's application to strike it out in due course, it just means the issues are not well-crystallised. At the same time, it does mean that the claimants could not put forward a suite of documents and measures, even if they have not actually done them, for consideration at a September trial.

I have also heard submissions about how long it would take to try the skinny label issues and, on this front, estimates vary extremely widely. Mr. James (Amgen’s solicitor), who has given the most concrete evidence for the claimants, thinks that it could be up to 15 days; Janssen's evidence is that it would only be three or so.

I struggle to reach a clear view on this. I am sure that Mr. James's estimate, with the best will in the world, is wide of the mark and much too long, because I think many of the issues would be common to the claimants and, to the extent that his estimate is based on the need for the claimants' respective teams to shuffle in and out of court because of confidentiality reasons, my preliminary view is that the confidentiality of the materials involved has been significantly overstated.

However, at the same time, I strongly suspect that Janssen's estimate is too short and I say that because, even if there are common issues and even if confidentiality problems are overcome, which I would very much hope they can be, the skinny label issues are almost bound to require the claimants, for reasons which I think are justifiable, to instruct truly separate counsel, who are likely to have to make separate submissions, possibly even slightly inconsistent submissions, at the trial.

I also note that there would need to be a considerable degree of legal argument because although there is a tenable position that the law applicable to these situations was decided in the Court of Appeal's decision in Grimme, that cannot unquestioningly be applied to situations where what is in issue is an EPC 2000 claim in the context of a second medical use patent.

For these pragmatic reasons, I think that undertaking a joint trial of all the issues in September is a dicey one, in the sense that it could well take longer than is available. It would be, relatively speaking, something of a disaster to drop the June trial in favour of September only to find that September was not possible either.

Balancing those practical difficulties with the commercial desirability of a prompt result arising from the trial taking place in June and, hopefully, a judgment fairly soon after that, I have reached the conclusion that the June trial should be kept, with the removal of Allocca, and that the skinny label issues should be stayed. The should be liberty to apply to lift the stay if the situation changes or more information becomes available, but in the absence of such an application the stay will last until the result of the June trial is known.

I should say two other things, however. I do not think that the claimants, and certainly not all of them, have been as co-operative as they might have been. They offered an undertaking that they would not launch without giving six weeks' notice – that is in the skinny label scenario, I should say – and I will require that undertaking to be given, but they were slow to engage with the possibility of giving any other undertaking. I also think that, at least for any individual claimant, if not for all of them, if they had positively wanted to, they could have turned their minds to, and put forward, a concise statement of their intentions, more readily to enable the skinny label issues to be tried in September.

The conclusion that I have reached is an unfortunate one, to some extent, because it means that in the scenario where Janssen prevails at trial and the claimants give the six-weeks notice to which I have referred, there is almost certainly, or at least very likely, to be an application for an interlocutory injunction by Janssen. It may not happen, but it seems to me to be extremely likely. Also, there may be multiple interlocutory injunctions. One cannot know.

I have said that it would have been better for the claimants to engage more fully with the skinny label scenario. There is nothing formal that I think it is appropriate for me to do in that regard, but I do reach the conclusion, which I think it is right to express, that by taking the course they have the claimants have created a situation where the way will not have been cleared for any skinny label which they do seek to launch, following their failure at the main trial, if that is the way that things turn out. Such a factor is not, of course, conclusive on an application for an interlocutory injunction, but I record it in this judgment because sometimes it does turn out to be a key factor that the alleged infringer has not cleared the way and I think it is right to make clear that I think that if any of them had wanted to, or even if they had all wanted to, the claimants could have arranged matters to enable a decision on the skinny label more quickly.

My overall conclusion is that the trial will take place in June, with the five plus two estimate, on the basis of the claimants' indications about the cutting down of the prior art and the limited use of separate counsel, on the basis that Allocca is removed, and on the basis of the undertaking to give 6 weeks’ notice of launch to which I have referred above.