 I'm just like to say thank you to Kathy for ascribing those of us who are walking this morning as leading practitioners I hope at least as far as I'm concerned that opinion isn't revised by all of you once you've had me talk but there we go so it falls to me today to talk to you about inventive step in pattern law in particular after case of activist and ICOS full disclosure and you're probably all aware I was in activists than ICOS It's the most recent case, particularly from Supreme Court, that addresses obviousness. Throughout, much further addu? Let's have a quick chat about it. The starting point to activists and Icoces, is the history. It was to do with a patent for a compound corps to Dallafil, which is known as Cialis. Just as an aside, if someone had said to me at the outset of this that I would end up going all the way to Supreme Court. I told you I'm not very good with technology. Yes, please. Perfect. Thank you very much. Yes, if someone had said to me at the outset that I would end up going to the Supreme Court to talk about erectile dysfunction, I would have had that exact response, but there we go. So, Theolus, Tidalafil, erectile dysfunction. The starting point in all of this is that Tidalafil, which is the underlying compound, was a second in class, so that obviously brings in questions on dosage regimes, Swiss foreign claims, and so forth. The reason I flag these particular bits is important because a lot of what we talk about in IP is technical contribution. And it's fair to say that Theolus has commercially been a very successful drug, and to that extent one would say that there has been some sort of technical contribution. As I said, it was a second in class drug. Viagra was the first erectile dysfunction drug of this sort. Crucially, Theolus was more selective and is more selective than Viagra. Just to add a bit of an illustration there. A relatively common side effect of Viagra is blue vision because of its lack of specificity. Theolus doesn't have this problem. A slightly more interesting element is to do with drug accumulation and a possibility of taking a drug daily as opposed to on demand and finally as part of the specificity of Theolus, you get reduced side effects. So as I said, the reason I'm flagging these at the outset is because it's plain at some level but there is a fairly chunky technical contribution there. So what happened? First instance, the case came before Mr Justice Burse who saw that what had really gone on here was some length and extensive research. The big question really for the courts to consider was is empirical research of this thought from phase one, phase two studies and all the rest and dosage and dose response curve studies as well in particular, is that every routine and the true value of the value of judgments that might come along the way? For your reference, I'm not going to take you all through all the judgments, don't worry, but for those of you who have trouble sleeping at night, feel free to go and read those particular paragraphs of the first instance judgment. And Mr Justice Burse, as I said, found the passion to be valid and infringed. Now, this takes us on really to the crux of the matter which is how does one assess obviousness or rather to be true to the statute in the Patterns Act inventive step. And this is a statutory question. And as you can all see, this is to do with the invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art having regard to any matter which forms part of the state of the art. The first thing of course is to say, when do you ask that question? Do you ask it standing at that point at the priority date which is to a certain degree what Mr Justice Burse started doing or at what stage is it permissible to take in some events downstream from that if those events truly could be said to be routine or perhaps even inevitable. So it really is all about inventive steps as my attempt at drawing an inventive step there. And again, the thing to bear in mind at the outset is that if you go through a third examination of the case law inventive step does seem to be a truly multifactorial assessment. And the question is how do you resolve those two things? You have a single inventive step idea on the one hand and something that necessarily involves adding a bit more flavour with a multifactorial assessment. So the Leasing Parties appealed to the Court of Appeal. And interestingly, as I'm sure a lot of you are aware because obviousness first and foremost is quite often a fact finding in fact dependent assessment. The appeal was allowed and the patent was found to be invalid for lack inventive step. And this is where the first instance caught in the Court of Appeal diverged in that the Court of Appeal found that in certain circumstances and that's a key point there is in fact nothing inventive about routine steps even if the actual specific outcome itself cannot be predicted. It's enough to know that you will end up at that sort of outcome and I'll come to that point. And this is just quite a useful summary in the Court of Appeal judgment this is a bit from Lord Justice Floyd's section of the judgment and this is simply the point we were discussing which is that there are some steps which can be characterised as so routine that the skilled person would carry them out simply because they are routine irrespective of any prospect of success. And the example of course is the routine dose ranging studies and clinical testing of a known drug. Also for your note as well, C152 where Lord Justice Kitchen has a similar thing. So this takes us to a case that's now a few years old, Activism Mug. Some of you might know it as the Finasteride case. And this really is where in particular for dosing routine patterns the story really starts. And the point here is in fact the sort of presumption and I can tell you for nothing that the other side who was seeking to revoke the patent relied on this pretty heavily to say that the presumption effectively is that nearly all dosage regime patterns will be obvious. Simply because as a matter of research it is standard practice to investigate appropriate dosage regime. And of course it is for a regulatory point of view you have to find the dose of the drug that is effective, that is safe and typically you don't want to give more of a certain drug than you have to to a patient. And what Lord Justice Jacob did in this case he pointed out that it's only really an unusual case such as that particular case where simply specifying a dosing regime seeking patent protection on it is something that can confer validity on an otherwise invalid claim. And then also just taking you back now about in mind to the Court of Appeal decision. Again there's this point that although the skill team would be surprised by those results and to put it in a broad sense the lack of predictability of that exact result mainly the efficacy of a 5 meg per day drug the point being that it was a standard and routine thing to do would be to investigate the dose response which in fact is required by clinical research and phase 2b clinical trials. So it's one of those where you know the end point is there you know the steps you can take to reach the end point the fact that the number is 5 as opposed to say 10 which is the element that's going to surprise you doesn't in fact make those routine steps that you're taking along the way inventive. And that was quite an important development. Just to add a bit more context the reason why the 5 meg a day is important is because Mr Justice Burr's first instance in fact found that a 25 meg dose would be an obvious thing to do because at your starting point you take your higher doses and his point he was seeking to draw some contrast between the fact that at an earlier stage in your investigations into dose response and into suitable dosages you would very quickly in the first round of studies a light on a higher dose but you wouldn't necessarily have a lower dose in mind and that element of surprise and the judgement of stepping forward was the thing that for him distinguished an obvious and an inventive outcome which of course the Court of Appeal disagreed with. So what happened next? As the losing party we at Lili Eichos decided to appeal to the Supreme Court because as I said in the context of pattern law as a whole it's pretty unusual to have an obvious decision they've returned. In the meantime there was this issue about the generics launching on to the market and trying to preserve the position and it's quite an unusual interesting point here because what was happening in the background was that there was an SPC on the basic pattern that was due to expires so we were desperate to hold the ring so to speak until after the outcome of our permission to appeal to the Supreme Court application. So we applied for a preliminary injunction and this was heard by Mr Justice Henry Carr and again he had the benefit of both the first and the fourth appeal decisions at that point and he took the similar view to the Court of Appeal and again qualified this slightly to put in the word entirely routine which I think was an important addition there that it's that routine-ness in general does not equal a presumption of invalidity but when you have a more special circumstance where you have something that is so routine it can be said to be entirely routine that the presumption of invalidity starts to slip away and this is really what he was saying here and further is in the quote that not only was this an entirely routine step on the judge's own findings it was one that was a very likely step for the skill team to take and he references back to the bit of Lord Justice Floyd's judgement that we just saw so accordingly Mr Justice Henry Carr decided that there was no realistic prospect that the appeal would succeed and as you can see the judgement was an application simply by the Court of Appeal as to the facts as found to existing and settled principles of law now what I could say at this stage is frankly this would have saved people like me a lot of time and effort if the Supreme Court had taken a similar view but there we go surprisingly the Supreme Court decided to grant permission so what happened the Supreme Court really spent a lot of time considering that statutory question namely all about inventive step and how to assess inventive step and during the course of discussion and debate we had a lot of discussion about putting glosses on the text of that statutory question because as I said it's quite difficult to take something in the abstract namely how to assess inventive step with the facts of a particular case and both parties referred to the as I'm sure you're all very familiar with the Potsoli approach and the PO problem solution approach and the Supreme Court listened to all of this and said what they wanted to sort of guard against was adding too much gloss onto that text of that inventive step question and generally put a general warning about perhaps applying such glosses in an overly sort of mechanistic way that's paragraph 62 of the Supreme Court decision despite that Supreme Court then went on to provide a lengthy list of factors which are relevant considerations and notably the reason I have included this particular extract is in the present case and that's an important thing for you all to bear in mind particularly because of the idea about the general applicability of the Supreme Court decision in this case so just to trot through them very quickly one obvious to try that of course brings in an element of expectation of success two how routine is the relevant research and we've talked about this and that's where you have a bit of a tension between empirical research, routineness predictability and pattern protection three for the first time burden and cost of research featured on this list four value judgement this is perhaps harking back to Mr Justice Bursa's first instance about the perhaps that as part of empirical research one has to not lose sight of the fact that there will be or can be in certain circumstances value judgements along the way five alternative multiple paths of research necessarily if there's a fork in the road you'd might like to think it was a less obvious fork to take six motive obviously something that a lot of people are going to be discussing today seven unexpected and surprising results and this comes back to the slight tension between the first instance decision and the court of appeal decision on the impact and importance of surprise when you're carrying out routine studies eight, the thing that we all try and guard against is life you practitioners hindsight and nine, bonus effect however, more interestingly perhaps the today was the 10th factor that Lord Hodg who wrote the judgement for the Supreme Court and this is something he flagged at paragraph 74 and this is again back to this cautioning against perhaps a general principle being set down by the Supreme Court in this case which is where he flagged the fact that the courts have to have regard to all the relevant facts of a particular case and assessing whether an alleged invention is obvious one of those facts is the nature of the invention a 10th consideration therefore is that we are concerned with a dosage with a Swiss form claim and an EPC 2000 claim the possibility that a dosage patent with such claims that may be valid has been recognised so here you have the Supreme Court saying in case you're all worried we do endorse and indeed positively recognise that as a starting point a dosage patent can be valid although you might ask given this judgement precisely what circumstances do you need to find yourself in in order to have such a thing so this then takes us on really to the next another bit in this particular case could it be said that there was a bit of a missed opportunity to perhaps give inventive step or a bit of a shake up or in fact with the Supreme Court doing a very prudent and sensible thing here which was recognising on the facts of this case that they needn't go too far and perhaps ought not to go too far so perhaps it falls for a different case where the question of obviousness arises to go to the Supreme Court to have the idea of inventive step and again and indeed Lord Hodge really explained why this case in particular was seen as so controversial and why there was so much interest in it which is the headline point that we have been through in the Court of Appeals judgement which is that when reading the Court of Appeals judgement the routine-ness and the importance that they place on the routine-ness of everything really jumps out and I think practitioners, academics and also clients and pharmaceutical companies were quite concerned that the Court of Appeals seemed to effectively be saying at a certain level routine-ness equals inviditity because of course in today's day and age with empirical research routine is necessarily part of the picture so where does that take us? Well it takes us back to Activism Muck and the Supreme Court went back to that quote of Lord Justice Jacob and started talking about the fact that first it is generally standard practice to investigate appropriate dosage regimes. The skilled team in this case but also more broadly is generally familiar with multiple dose ranging studies so therefore the inventiveness of this is why I've included any dosage regime falls to be assessed in that context on the facts of the case the notional skilled person's task is to find the appropriate dosage regime so again it comes back to the point of really what does one have to do in order to come up with an inventive dosage regime and the Supreme Court continued to note that in fact there was no mystery to this qualification regarding dosage regimes because the skilled person's target is in large measure predetermined but again the tension there is with empirical research and with studies that one needs to go through in order to gain approval for a particular drug that process is itself in a large measure predetermined and it's something I don't think the Supreme Court grappled with as much as perhaps we would like them to have done but again it comes back to the context is key and that on the facts of this case by going through those predetermined steps the skilled team arrives at that invention so where does that take us has the threshold for inventive step moved or is it business as usual now as you can imagine there are a number of interveners that put submissions in as part of the Supreme Court proceedings and this here at 103 was really where the Supreme Court was responding to those concerns and particular as I mentioned a moment ago this concern of the idea that by carrying out routine or well established inquiries the outcome simply cannot be inventive and crucially you can see here that just the points of doubt Lord Hodge was at pains to point out that that's not the case and that secondly and the second bullet point there under the paragraph 103 reference that there is no policy reason why a novel inventive dosage regime should not be rewarded by patent now for those of you who have my slides in front of you you'll notice the typo in that one where I actually admitted to include the word not in that some might say that's quite interesting and then finally this is the point about rewarding research if it meets such retests so this comes back perhaps to the patent bog and namely the inventor attains a monopoly in return for disclosing the invention and then dedicating it to the public for use of the monopoly has expired but to do that there has to be an invention and this is where Lord Hodge really drilled down into this particular case and talked about the balance and symmetry in patent law and that where there is a pre-established or at least foreseeable target and this is the first time we have a sort of foreseeable element coming in here at the skill teams test holds the key to the resolution so what he was really saying here is that going back to Mr Justice Henry Carr when something is entirely routine and that process is so established that whilst the actual specifics of the target might not be known the fact that the target exists and that's the thing you're aiming for is enough for the purposes of defeating some kind of attempt at seeking patent protection and this is where I think it's a bit interesting because of course when we talk about a patent monopoly we talk about that patent monopoly needing to be justified by the actual technical contribution to the art and this of course has not just been considered in the Icos case but also in the Warner Lambert Supreme Court case but where does that leave us in a case like this where as I said at the outset there was a clear technical contribution this is a drug that can now be taken daily it provides far fewer side effects it's a far more specific drug from a commercial point of view which of course is not the test for obviousness it's been a very successful product so at what stage on the path does technical contribution be divorced from true innovation and this is something I think that is perhaps for another day the next thing to consider perhaps is that does activists in Icos present issues for any classes of medical innovation and I think a lot of you will get to what I'm coming from with this in particular to do with dosing regime passions now the interesting thing in this case is that Lord Hodge made a reference to the EPO's approach to all of this and that for your note if you want to do paragraph 75 of this judgment where he expressly flagged that the EPO has not sanctioned any relaxation in terms of the approach of obviousness and the consideration of obviousness for dosage patterns but where does that leave us by expressly not sanctioning any relaxation does that necessarily mean that if the threshold which is what the Supreme Court was at Payne's to say is the same for everything which of course is one would argue the right way of doing it does that mean in practice it's going to be fiendishly difficult for a dosing pattern and a dosage pattern to be valid unless going back to activist and muck there is something truly unusual about it and then unfortunately that's just going to come down to a matter of fact and degree and assessment so as I've said here in my view the Supreme Court judgment does appear to be at Payne's to avoid developing any new principle of general applicability beyond saying that dosage passions are not a special case crucially they note that the Pozzoli approach and the Lumbeck fractures remain relevant and the way that I think of it which is what I alluded to here with more or less D is to me it means more research and less development at least in the law of obviousness to me I don't feel that this has developed the law of obviousness it simply provided a little bit more research and then I think I've run slightly short so apologies or you might be relieved what is this where does this leave us so the Supreme Court decision was now was handed down in the beginning of 2019 we've now had a full year or sorry it wasn't it was having a beginning of 2019 it was hardly into 2018 we've now had a full year of cases going through the patent courts and speaking for myself having been in a few of them it really does feel like business as usual the activism I cost factors that we went through have been referenced by some judges but certainly the Pozzoli approach is still valid the Lumbeck factors are still considered and unfortunately as well there's not a suggestion that those 9 slash 10 factors identified by Lord Hodge are A something that has to be considered in every case and B crucially all of them have to be considered in every case really that takes us back to the position we were in the first place which is that inventive step is truly a multi factorial assessment and it all really depends on the fact and the circumstance of a particular case and then Mr Justice Arnold as he then was said I thought I'd leave you with this quote from him which seems I think to echo those views which is that the overall tenor of the judgement in this Supreme Court case is to confirm the approach which approves to be adopted by the courts to this question and I think that's probably a fair and succinct summary at the moment so I think what it really falls to is the future and to see whether any of the judges start to develop and apply those factors which do add a little bit of gloss in the cases going forward and perhaps if another obviousness case goes to the Supreme Court hopefully sooner rather than later so that the question truly of how does one assess inventive step and where does it sit in terms of IP innovation that really still needs to be considered thank you