here since you started cooking for me and now it's over and i bet that time has flown past pretty fast for you that's for me because the older i get the faster time seems to fly but for sure will be an extraordinary member of the bar and someone that we can look back and continue to thank for her contributions both to the corps but especially to my chambers so with bar thank you very much the number of issues involved and the number of parties involved in the we see today the breakdown of the arguments i want to make sure that i i have this correct mr garson you're going to do  or questions being invalidity of the one three zero that are the three six four pad lacks an adequate disclosure of utility and this report committed legal error i concluded otherwise based on the known energies or fact of  example sixteen futility of the of the prior art being improved is not the touchstone of utility inquiry improvement itself is that touchstone and that finds its basis in the statu alloy steel the utility that it had had to be new material different than the existing steel and that statement came and it found its support in the dow chemical versus halliburton case of the supreme court in one thousand nine hundred five and in that case the supreme court clearly stated that if you have a known chemical and you simply dilute it you have to show that the critical improvement there the advance that you claimed over the prior art had to be linked to that and proven composition of matter so you'd have to link it worse off principles not hypothetically and how can something that's worse than a prior art you know for me that's a very good question in that context you have to prove that being worse than it actually has some function for example the second vendor then comes up with a different way of trapping mice as to prove that that second mouse trap is functionally somehow better than the first mouse trap it can't just merely be a different way of doing it  obviously over the first nostra there could be very complex question and here though the big question is whether or not you have an existing mousetrap for example and you change one element and claim that's an improvement of the mousetrap for example if you had a simple snap component are the quid pro quo change for the patent system itself and one of those important aspects of it is showing that you have usefulness and indeed the statute itself goes back and says the improvement has to be useful of the the second is that this particular crystal structure has greater stability under certain kinds of conditions does your argument require a saying the first is legally irrelevant then the second is unsupported by the record no the second is also illegal or are because the basis for it was the same and i think it's important at this point to step back to talking about example sixteen to understand what the resistance a degradation higher food effect something like that but here the stability that you're talking about that word isn't talking about the classic sense of stability it's talking about conversion from one form to the other form form a to form be informed be to seven to one forty eight that as a matter of law you don't have to prove that this stability makes a better pharmaceutical composition because it doesn't have to be better than the prior but stepping back if it's not better than the prior art what is what is example sixteen show to make the final that stability in that context conversion stability was actually useful she didn't make that finding she refused to make the finding based on her interpretation a law which was saying you don't have to show it's better as the identical chemical compound regardless of its form a or form be just a crystal in structure that matters determine what the crystal criteria structure would be following that burn implementation of the guide burn explicitly identifies nine solvents that one should use to do the crystallization experience and then also the evaporati cooling conditions that oppose it with an implement the whole point of the burn article your honour's was to determine the answer to the question are polymorphous possible yes or no so the amount of information that's burned intended to provide was so to get a pose implement the polymorph screen and at trial as to that burnt reference dr steve which was outcomes expert proposed that in fact that is all that anyone needed to do in fact when that was done by s s c i a third party with it did it and then he added yes it added it had eight of the nine solvents your honor didn't have one of the nine solvents but it did have the conditions that are spelled out in the burn article then there are a lot of other also tests not published  burned in addition to the reference that as a c i did but in this case that distinction really doesn't matter i guess what i'm wondering is to what extent can anybody say if there was a very defined set of procedures that one would do to do more screen like it was there an answer book already out there this is what you do this is the universe of procedures you undertake whenever you do appalling more screen no it wasn't an encyclopedia the universe however burn had enough information to say the first step the low hanging fruit the easiest path to take risk but a nice office is the concern i have is the other side put on evidence and testimony that there is some huge number of possibilities that you would do and it would take a lot of time and then don't we have case law group and let's say when there are a large number of possibilities and there's nothing in the yard to really suggest going down a particular subset of those large number of choices then we can't say it's really obvious to do just start shooting in the dark for a start walking into a dark forest looking for treasure when we don't really have any information as to where in the course we should start walking down and that would be correct if that there's just a huge number of choices yes maybe there's a starting point but in the end it's a huge number of choices that you would want to do that you would need to do to satisfy yourself as opposed to some very limited set of things which is what i guess you're trying to ask your honor there are directions that a person or is going there could take and dr bernstein and the adversary here is taking the position that in general not looking at burnt in general there are a lot of choices that one could make and the district court made the same finding in general there are many choices that would could take but the other side did not dispute at trial and the district court didn't much make a finding specifically as to burn that said that that was different or that was not narrow enough and in fact burnt within the world of possibilities that a person or his skill in the art would have which includes different solvents and as you see in the briefing includes anti solvents or slurring those are not discussed in the burning reference the burn reference is one technique published in the prior art in giving that targeted approach versus other polymorphs that may not be when there isn't enough guidance and that would open the door then to what the other side has explained as a lot of variables that one could look into unusual characteristics that could treat no susceptible pain that's the invention that set forth in the seven three seven patent the next occurred when groot all separ to make room for all synthesize a brand new crystal one thirty patent and that's what led f d a to approve to pence it all as the first and only opioid to treat pollinger a patent pain now in analyzing the validity of the three six four patent the district court undertook a highly factual analysis of the seven hundred seventy nine address the obviousness point and it seemed to me that the district court had a couple of different components to  there would be a lot of choices here for rejecting obviousness the one that the other side focuses on the idea that there clearly procedures to follow if not to get a complete answer at least to start and whatever would fall out of that process which the f d a more or less tells you to follow through gives you an  follow or to be on this well your honor i think the analysis in that capacity starts really back at the question of is depends at all even polymorphic if we assume that you would go down that path then the question because what tests would you apply and how would you apply them burn being one of them but there were other articles and other prior art articles out there about all kinds of different tests that need to be done we don't know whether or not there's hydrates salt it's polymorphs we don't know how many forms of polymorphous we have we don't know if we're going to get a polymorph that is more stable or if we get one that's more stable we have no idea if it has the same bioavailability as the crystal that was previously made remember what happens here which is sort of overlooked by council here is we not only discover a new crystalline form that happens to be stable at room temperature but it also happens to have the same analgesic property as the original crystal form there's nothing in the prior art that suggests that's going to happen in fact there's lots of science out there to suggest that the more stable form may not be as bioavailable as the original form that's crystal so we have a lot of variables the way i look at it is we've got a lot of leavers that are out there to to move into different combinations to try to even look for a polymorph to begin with byrne is helpful but it's not the it's not the answer book i like that it's not the answer book on what to following out pops polymorphisms that's not what that was that's not what the record shows and that's certainly not what the evidence was in this case there are so many variables here crystals falling out of the process you don't know the properties of them that is whether they'll be good stuff or not so it's good stuff yes and what the what the district  d in that capacity was the dissolution test after the after form a was identified they had to analyze for made compared to formby in the dissolution test is what told us that it most likely had the same analgesic property as the original form and that itself wouldn't be routine it would be well but the results that the more importantly the results would not be no in fact it's sort of rebirth run the task you either find nothing or you find something why isn't went in for you from these well i think it goes back to the reasonable expectation of success it's what we're doing in that capacity is taking the results of the test and saying we would have had a reasonable expectation looking backwards when we start the test let's look i'm assuming your hypothetical least let me assume the extreme of your hypothetical that everybody knew exactly what the test is in coming up with the invention at the time of the invention and time of the work we have no idea of before we before we send this thing through the polymorph machine if that if that's what the court is be getting the information of whether polymorphs exist and that if you had a reasonable expectation that you would get that information you could not so let me let me try both crystallize or they don't exist and they do exist you'll be able to define are you saying that those resulting polymorphs would in fact be a non obvious invention that merits a patent under those circumstances under in the hypothetical that you gave which doesn't have any of the variability that that i think exists in this case i think it would be a very difficult case to make of non obvious because i understand a lot of your argument to be based on the theory that well even under my hypothetical we would have no idea what structures there would be if any would exist and what they would look like more kind of properties they would have and so therefore invent iran get credit for that but under my hypothetical it seems like it's just extremely routine atomic like activities that you would undertake that you would necessarily undertake yeah well and i think as i understood your hypothetical it really reduced it to a binary analysis right use you send it in and get information the one the one issue i think i would might take with your hypothetical it as a we apply that this is don't forget the case law here we've got to have a reasonable expectation of success of the invention not the information the process not the machine not the levers not anything else but we have to have a reasonable the inventor has to have a reasonable expectation success of getting the invention of the invention here is a brand new cryst utility and i do take issue with the council's comment by the way and in his opening this is not an improvement patent there's not an improvement here this is a brand new crystalline form that didn't exist before the inventors of the three six four pa so it's not surprising that if you put if you put form a n you get form a out what they didn't put on any evidence of is if you put in form be like from example twenty five that you would get for me and that makes entire process and describes processes that that i think that you are saying that's where the variability resides but it it lifts up the entire process made now through the polymorphic testing right it was made in iraq it was made known and identified but don't forget what we did we made it we had to make that new crystal and discover it before we could claim it and again i can't emphasize enough the district court had all of this evidence including the byrd article including the flow chart your honour's looking that would be for it and kurt testimony from some of the top polymorph experts in the world on this issue and made a very detailed factual analysis and concluded that in this case to pensacola hydrochloride produced or quick not have been predicted it was not an obvious in this case by the other side that what would come out of the test was not predictable and so the theory is he's long as the test was utterly routine what ever comes out is obvious unless there's unexpected results which there aren't here what is wrong with that theory as a matter of obviousness about it feels she feels potentially dangerous but i'm not getting much of how to think about whether that is a significant doctrinal step and whether it's a bad step or a good step i would urge the court that i think it's a bad step that assumes that number one there is a molecular structure something that suggests that this may be polymorphic and there may be more than one form don't forget when we put this ring through probably more screens we don't know if there's three forms four forms five we don't know how many forms there would even be even if it was polymorphic this is it this is a completely unexpected situation when we when we're talking about even if there is support to do a get this and you go here and if you get that you want to the next person but whether or not the test is easy or laid out to get to the invention as section one of three says doesn't doesn't create an obviousness issue doesn't matter how the invention was arrived at what's math what matters is whether the invention itself is non obvious in light of the prior art really goes to reasonable expectations it does but if the success is defined by the invention which is case in which case law this court set is the invention here is form a it's not doing a polymorph screen it is it is is having crystalline form a which is a specialized crystal and in this instance it does have success for those particular claimed ranges we can just recognize the fact that the obvious and alternately can land on both point regions and so i think there's a potential parallel to this situation if a significant differences in those cases that as i generally refer to them in the result variable we're talking about a new characteristic of something that already exist right there's a new benefit there's a new characteristic we put it through a test we found out that there is some new aspect of this it's heat resistant it's whatever the result is of the test itself dealing with a characteristic of something that's already not we're not dealing with the same thing here a three second i'm not sure that really captures the universe of what judge then was talking about and you can have a result of effect variables that will affect the creation of different things with different  you know percentages of x or percentages y so it can actually be a new thing not just but maybe i'm just misunderstanding that but the invention the creation of some brand new crystal in form not it's not it improvement it's not a change it's not something that is in the prior art it is a new creation of a new crystal that is going through th variability and there may be some predictable results it's that if i understand the hypothetical but the crystal in structure is a brand new crystal in structure i don't think the court has case law that says when you create a brand know the other side is and form a form of the there is no difference in terms of utility and it's not a big deal and because they behave precisely the same so even if we get to the question of whether one is more stable than the other it doesn't matter if one turns into the other at any point in time because they both have the exact same properties it doesn't matter they're interchangeable so what could you give us a little more on your  final answer on utility sure i guess i'd start with the first part of yours which is actually itself important the fact that form a turns out to be form a cop form the logically equivalent to for b is not just happenstance it's important significance because the idea that we've discovered a new polymorph that has that same pharmacological activity and is stable is itself unexpected and it is itself useful in the sense that we now can shift to form a keep it stable at room temperature and know that we're not giving up any of the pharmacological activity that we originally discovered the fact that it has form of a logical activity the fact that it is stable at room temperature and as the court looked at example twenty five we demonstrated that usefulness in utility after all this is a drug that the defendants anxiously want to copy and put on the market it is useful in treating both no susceptible pain and probably neuropathy will let the infringement analysis itself what i had to support is going to say is that it's pure legal there but it's not it's factual findings straight up and there's nothing that's anything different indeed it's a making of the row case because the car instruction to engage in infringing act and to the extent that doctors prescribe it they would be maad motivated and you're making the argument this point both for you and for who was the loser on the inducement when it one of the generics if it's no longer there so that the carve out those factual findings are not clear they're plausible they're based on the classic battle of the experts which is going back to chile real quick judgment going back to your point about whether or not the district court found more stable was useful she did not she found that there there was a legal bar to even addressing that factual finding but you heard my friend from crossbones to they state that you actually do need dissolution testing to determine whether or not what's the most quote stable the form that exists at room temperature whether or not it's useful and that agrees with dr bernstein's their experts testimony attend nine eleven of the record where he said nor determine what is most suitable you can't just know what's the most stable form you  invention of the product is what matters the improvement is what matters in the improvement here is that you have form a instead of form d and the fact the form a has the same properties as a sphere of course a runner is not enough in terms of the quid pro matter they have the same as their expert even stated it doesn't matter whether you have form a or form be so while they're saying they're trying to save their patent on obviousness by saying that it's unexpected you need the dissolution testing it wasn't there and that's what makes this case that here to show that it's useful and under brunner there is no utility to that because it's still just an object of research they left it for someone else to discover what about it's used to treat a different form opinion a different form  i'm i'm not sure i understand ok it's emitted by growth on their argument is that it's the identical chemical structure it's the same thing it's just arranged differently and it treats as the same identical pharmacological fact that's what the then the question still comes back to why does having form a matter what did they give to the public to assure them that they had a useful invention and the answer is what makes this case even more unusual is that they had the dissolution testing they had that testing they disclose something useful that is good for the public that is part of the quid pro quo but it's still an object of research and it doesn't matter if you have four major for me ok thank stating or holding if any do that you can have a reasonable expectation of successes to something you can or even identify in advance cuban would be the closest case around it where there's a sequence for that and nobody knows the sequence ahead of time but the key quote is the enabling methodology is this close and therefore combining and it's an obvious to try case combining the prior art which had the direction to find out sequences and had prior compound but didn't know the result had a what we have one in which among the things you cannot even predict is whether the thing existed that's not true and if you can because just somehow or other there are a bunch of codeine sequences that are going to be the gene right at that point while one does not know how many forms there are that's the routine this of doing the problem or screening it to find out the result to say what is the polymorph landscape and that's exactly that byrne article was intended to address so in conclusion the distinction was between using the routine steps following the prior art versus what the court addressed which was predictability and that's also the experts response specifically when asked about as a c i is an appendix one zero nine zero seven was asked specifically about as a cia as a reference and if one followed that does that still make it not obviousness and the experts answer was it's not predictable so the only distinction here that the judge and their experts why don't is not knowing the answer head of time and it's not addressed in w what happened was there was a specific carve out of anything dealing with your neuropathic pain so there was nothing in the indication and there was no testing within the label showing anything about  and a doctor would not see this label and so oh this must be for tripodi of pain and so there's therefore no possibility of encouraging the infringing use and in fact jensen knew that jansen did not think when it internal janson documents describe that the indication was not covering europe of that pain so janssen then went out and spent fifteen million dollars on testing in order to get a second medication that specifically went to a type of pain that indication that is now on their label is not an activist as label so even janssen knew that this was not that pi not perfect pain could not exist within the scope of the act and this is little and because of that there can't be any indication to underneath indication when there's a discussion of the d p and study to support indication one yeah i have these and people's labels and i see how they've removed indication too and they've removed any discussion of the d p and study to support their indication one would have doctors somehow see and read and understand the overall context of what's going on doctors would understand the context but they would also see  about something else and do some sort of literature hunt where you combine something that some some other label with what activists does and then say oh from that we can infer that activists is doing infringing conduct in fact what you have to did we specifically carved out and then we filed a section eight in our and a notice letter saying we don't infringe this and so therefore that all together that would lead to that something sumption that not only were we not acting to encourage our friendship we were doing everything we could the world research changes so that for example here assuming that you know nothing happens to twenty twenty five we're talking here now about the difference you can twenty five and twenty eight right twenty five and twenty  respond on that assumption so by seven years from now there's new research and everybody now understands that chronic form of pain covered by the only explicitly stated indication is understood fa issue though is what is the act that is actually being performs or has to be kept marketing with this at some point when it marketing comes along perhaps there would be some issue of intent that could clearly be inferred for example if if contrary to  label that was that was produced a little while ago and you're also having mission i guess it might have i mean legally is just as a legal matter but also it is also the problem is that we there's no evidence in the record obviously of what we're going to do in ten years so by sort of mistrust you have to be fixed the climate and look at the only action word jump right into infringement i wanted to respond to judge trying to us for a case i wanted to give you one finds or verse on the three six four pfizer versus tev a five five five fed appendix nine sixty one nine seventy activists in west words labels to be introduced infringement of the one three zero patents all the experts agreed in this case all three medical experts in this case agreed that the indicated use on defendants proposed labels includes poly neuropathic pain counsel i did not tell you that the medical expert that they hired agreed with all of the other medical experts was undisputed in the record the instruction here appears in the indication section which is where f d a requires parties to put down their intended use this is induced infringement the district court committed legal error when it used non infringing uses to negate the finding of intent and induced infringement and that's contrary to this court's precedent on at least three occasions would it not in the real world be relevant to assessing intent as manifested in some sort of encouragement whether there actually is anything else that anybody could use the thing for of course it's not well i think it may be relevant but well that's the question right we see that the decision it's made a factual finding about intent as manifested in  of encouragement but the court but the district court cannot use that finding to negate the induced infringement as per astra zeneca this court said that as long as some users will be instructed to use th an infringing manner that non infringing uses could not work or would not negate the finding of induced infringement it was in fact irrelevant in that case whether or not there were non infringing and in fact got approval for what extended release and twenty eleven was it and then later extended release and twenty twelve i may have the dates wrong first with indication one second with indication to doesn't that tell you that the world of providers would not automatically assume that indication one is an encouragement of indication too otherwise what was the need well as the record reflects the need was a marketing one by f d a f d a required that second the p n study in order to say that this is been approved for d p n but the record is unequivocal on what doctors will do we had three medical experts including the experts from the defendants who testified very clearly that indication one includes polly neuropathic pain there was no equivocation on that and the district court made a factual finding that some users will in french the problem is she committed a legal error when she when the district court used non infringing alternatives not infringing uses to take that away and that is what was improper that's the