Regeneron Pharmaceuticals Inc. v Alvotech Hf. & Anor

I am not going to give any detailed reasons, partly because in the unusual circumstances of this case, delay, which I would normally deal with now, is going to be a substantive issue down the track and I do not think it would be right for me to make a preliminary decision about that. I do not think it is appropriate to go into that now.

Whether or not I would have granted expedition if this had been opposed across the board is a question I do not have to decide because the defendants, represented by Mr. Lykiardopoulos, King’s Counsel, are not opposed to, and in fact seem to welcome, a degree of commercial certainty that comes with some expedition.

I would not normally simply take the parties’ word for the fact they both want expedition as a reason for doing it, but in the present case there is some significant substance to what they are saying and the court can accommodate an expedited trial of the short length and narrow scope that is sought. However, in the course of the very helpful discussion today, quite a number of individually quite minor points, and one large one, have come out which give me very significant concern about whether this could be ready as early as, say, 20th October. In fact, I am pretty confident it could not. There are the points about the date, points about whether the IPO received the notification (although that may be fairly formal) and the point about Alvotech’s activities in the UK, where it appears likely that any factual dispute will fall away, but one cannot be fully confident of it yet.

The really substantive point is that Alvotech and Fisher intend to plead a case that an injunction would be disproportionate, even if they are otherwise unsuccessful, and/or should be refused because of what they say is significant delay. The proportionality question seems to me certain to involve an assessment of whether damages would be: (a) modest and (b) capable of ready assessment. I am not stating a conclusion that those are absolute requirements in the case law for refusal of an injunction, but they are clearly matters that could arise in argument and will require non-trivial pleading and preparation of some evidence and arguments, I expect, albeit though it seems unlikely that they will require oral evidence.

Taking those matters in the round, I think it would be risky to expedite this to any earlier date than 3rd November and that is what I am going to do. I will direct that this will be heard on an expedited basis, starting on 3rd November. I think it is far too ambitious to try and complete the hearing within a day and I will allow two days and that also provides an opportunity for pre-reading in the week before if I should turn out to be the judge, which is quite likely.

So that is my conclusion. For fear of giving away anything confidential, I will simply say that I have an adequate degree of confidence that it will be possible to do justice by hearing the trial then and giving judgment in short order thereafter. I cannot offer any certainty about the relative dates of the judgment and what has been called “the milestone”, but I am mindful of it and also of the date of SPC expiry.

That is my decision in outline and we should just make a decision about what directions to give.