reports of opioid and opiate abuse this is been characterized as a scourge it's been characterized as an epidemic now extended release oxy oxycontin which is the product at issue here extended release oxycontin contains a large amount of pretty powerful pain reliever which is enough for twelve or more hours of continuous pain relief when the extended release version was put on the market for the first time users quickly realized that they could crush or dissolve this extended release formulation and get an immediate and powerful high the results of this were addictions overdoses and deaths it's not insignificant is it that that was on the market for  their bit of time before the question with the right language is before the problem of that abuse became very very well known at and remembering i guess and correct me if i'm wrong because it's not not an insignificant consideration in your so called objective in disha feature that not really before two thousand was there significant  with regard to long felt need i would say that the need the need has been felt for a while to have some sort of abuse deterrent formulation but the need became most urgent in two thousand and one but but it when we get to secondary considerations which i hope to by starting with obviousness of that concluding with indefiniteness i hope that you'll see that there are other more powerful secondary considerations in this case but with  issue it was well known to in jails to compounds to prevent abuse right and you know what you're suggesting use well that was for well the case that's made that was made by the trial court and buyer friends on the other side of the trial court was that well just that was just it was just an obvious invention waiting to happen but if this was so well known for so long other than  medication in the different yeah that right it was a different medication in a different additive but let's take a look at what what the district court found in the basket was that it actually took the combination it actually implies was the language that judge stein used and i think that's a page a seventy seven and what he relied upon and this is in the third volume of the appendix the short the small one that page a seven nine four nine zero we get the context which page this is page five of the reference it's a seven nine four nine zero action is likely to retard the release of the drug and then here is the language of the district court found compelling in a manner similar to some known sustained release products which include waters well will hide molecular weight polymers to retard drug release so that's the end of the quote which relied upon and that's what the district court thought suggested that for an extended release so be perfectly good but he didn't look at the next sentence were duction of the jelling agent concentration to a level which would be not g of the drug substance severely limits the abuse resistance potential or potential that what does that mean severely limit now let's turn to another part of bastin which we argued but that the district court did not re severely limited release with the gelug agent in the tablet fifty percent of the drug came out after two hours and no further release up to twelve hours no further really that's not controlled release that's no and he made a finding that the was not on discouragement to doing so and we don't really wait wait sure i'm sorry so we we have to review those findings based on a n well first of all the answer is that we're not shrinking away from the clear standard here i think the courts should be left with a definite and firm conviction but he made a mistake by not reading the entirety of the past and if with regard to what we don't know he didn't read he just didn't mention well he didn't want that but i think this would have been very important language especially in light of the fact that we pointed it out to him and in light of the value then pointed out to all and we did because he was aware he was so the fact that he didn't conclude that it was as important as you say it is because of a matter of judgment call on his part which factors into the flesh you know whether there was clear or well i think judge player with with respect i think that the failure to to consider all of the aspects of the reference that we mentioned instead you only consider the parts of what if page of that not my points insures he didn't call that if it thank you it we did absolutely do so he page sixty one ninety nine of the record you'll see that judge stein a trial was particularly concerned about best and he says this and are friends of any on the other side point out when he says that he's concerned that of the reference in fact not just part but only one sentence when there is a when there isn't david i don't recall maybe i'm mistaken i don't recall his saying that he wasn't reliant on this testimony that was in front of him a problem with someone against this eroni of spying and the bastard reference considered as a whole what you see is you see jelling for controlled release and jelling for abuse deterrence and he says past and says they've lived together we say best and says stop don't do that go a different direction that's that is exactly what the clear are standard whether considered or not judge art on both sides of the equation here on the abused her inside on the one hand and on the controlled release side best and says don't mix them together they don't work together well trafficked it'll keep the drug from ever getting  what vast and tells you is that the amount of gelatin that it takes to control release is not compatible with the amount of gel that it takes to deter abuse that's exactly what that sentence at the end of the portion that was not quoted by the district  rebuttal time i haven't even mentioned secondary considerations other than my colloquy with judge toronto or the definition in depth on this issue which i'm happy to leave to the briefs but on secondary considerations perhaps i should say the following  but it was a huge success in that regard these are these are the abusers who now cannot get this up their nose or into their arms the f d a i think is even more important here because the f d a is recognition of this invention  game changer as one that all that changed the the risk benefit calculus and they recognized that the old version of oxycontin was removed from the market for safety considerations they would not approve disconnected from the underlying inquiry but more importantly how do you connect that as a logical and then entry matter to the question whether this would have been obvious or not absolutely so first of all  would have had to discover it in the fact that they didn't tells you maybe it wasn't all that obvious to connect the f d a sure so so first of all the regard to the invention here the invention here is not a personal good it's not something that a either a legitimate user or an abuser wants necessarily is it this is a public good so it's the f d a that's looking out for the public good here they're making this determination and they're making a determination that now takes old ox tin and it's potential generics out of the picture it's no longer on the market it recognizes that old oxycontin was removed from the market because of the safety considerations and it becomes such an invention that the a gives for the first time in its history labeling that recognizes the abuse deterrent effect of this drug the purpose of the secondary consideration analysis is as the supreme court in graham and so many other cases from this court have made clear it is to check judges and i was there say lawyers also who may not be the experts in the area but this is the way that objective people have let for a claim of not obviousness that whether this was a long felt need or it was a short felt need it was a desperate need and it was the it was filled and it was filled against the advice of the arc with which was what  and told and ultimately not just the approval in the withdrawal but the abuse deterrent label this is something that other drug manufacturers tried to get and didn't get we got it for the first time ever it is the first time that people use gels to control abuse in a controlled release drug and that was so important here because the controlled release was not just one hour of pain relief but twelve continuous hours of pain relief that's the invention here it's reason they are except that you also have case law trans ocean this one case that comes immediately to mind but says they always have to be considered you have a number of opinions pointing out that sometimes and i would say here it is at least as powerful evidence of innovation remember that obviousness is ultimately you're just looking for the presence of something we know it's not because it overcame one of two so is this under one of the three something that should be problem of stopping release after two hours there's there's no specific structuring it and bastien system there was a table which council referred to in his argument in which the gel was part of an immediate release tablet and in that case the drug stopped again without trying to to the extent that you can explain this to me and i will see you in a medium that the what is it about the so the problem so to speak with respect to the table was that you had an immediate release tablet it was in a controlled release tablet and so the object was to have immediate release of the drug what judge stein found is that if you wanted to have a sustained release version of the drug you would have the gel to modulating the properties the release of the drug in the prior art exactly talk that there were other references the royce reference for example which judge signed discussed specifically taught using the exact jelling agent here as something that could modulating the release of the drug rep and i'm trying to get one later down to some level of technical paragraph that council referred to after age seventy nine for nine to zero and it was specifically the effects of the  that they could retard the release of the drug which would happen in a sustained really say that to a trial they saw that they looked at table for it retarded been released so much that after two hours there was no more release they're thinking that's a bad thing for the media certifying for immediate release itself and thing if you want to control the release if your experts say oh no no no that's not the only way you can use jail people would not have been deterred from from trying to create a twelve hour drive by reading baskin and if so what did your expert say about why they wouldn't be deterred the because of the teachings of the prior art dissertation that the court referenced in its opinion and the jank article which teach that p e o was a widely used agent to control the release and you can actually look at the curves that one skilled in the art can adjust the amount used to control relief that's exactly right around the royces it does a good example of that the jang article is a good example of that judge kind carefully analyzed all those prior art references and and found that one skilled in the ar would have known would have been motivated to use p e o would have been motivated to use it in a sustained release those which warm and would have been motivated to use it to solve the abuse problem there joshi reference for example which judge s referred to in his opinion that joshi referenced talks specifically the use of p e o as a gel to prevent abuse of pharmaceutical formulations so here what we had was a known problem motivation to solve that problem known predictable techniques for solving the problem and no unexpected results not even really an allegation of unexpected results here and secondary considerations that the court found didn't support a finding of non obvious just just to take one example you referred to were several times can you point to me where in something say if the end product you're trying to get is one that provides as firmament provides controlled release and not just control in the sense of stopping it after a short period but having release of the drug for an extended period i think about using  around line thirty nine do you see that sustained release those which forms may be prepared from the higher molecular weight polymers you molecular weight greater than about three hundred thousand and there's reference to poly ox in the parents article there and if you continue down you talk it goes on to talk about contemplating and the mixtures to make the price respective amounts of various polymers shall be within the skill of the worker if we go to a four five seven three one modify the p e o to get the release they want this is well within the level of skill in the art this is exactly the evidence that judge stein considered carefully commented on it was a ruling a judgement that the rulings  both ways in the case there were some defense defenses that were rejected by the court other defenses that the court credited there was some evidence from defense experts that was not credited by the court it was other evidence  was there was obviously evidence on both sides so many of these contentious issues but there is no question in their god i've seen the mockable commercial success in fact their former product went off the market altogether and they were able to market this new formulation widely and those of us who have broken a leg in the last year or two  have had the benefit of it that's pretty impressive as it is that they came up with something that nobody else yet perhaps not thought of that perhaps been able to figure out how to do well with respect to the our sales of the product there were high sales judge stein recognized that on the issue of commercial success there was no connection the evidence didn't support a connection between the actual one hundred three issue that it's about not be attributable to that it's so much better and this is what's different about it because the the sales of the product wear the same with and without the safety features so for talking commercial success the there was no demand for those patented features as a matter of fact for do recognizes that had the generics been allowed to come on the market with the original oxycontin with them they would have taken tremendous i guess i keep thinking that we are getting caught up in thinking about secondary considerations as if it's a set of individual silos unrelated to the evidentiary inquiry now the fact is that this product had so much better a safety efficacy profile from what came before that the government regulator said you can't even sell the old stuff anymore and nobody else can either it's that much better major contribution to the public to the public good what do we do that there was some a claim associated with the invention that flows from the f d a as actions this was not something where he couldn't fit it into a bucket any ignored it he recognized the evidence but the evidence was counter w the strong technical evidence of obviousness here the predictable results that were cheaper with a known technique and the fact that the other secondary considerations when you looked at the commercial aspect of sales aspect here it was no nexus to the claimed invention there was no skepticism the inventor testified he couldn't identify any skepticism here the f d a his actions were not deemed to be industry evidence of skepticism it was just the f d a doing its job waiting for data and then approving the labeling for the abuse avoidance and taking the old product off the market this is the way the the or case in the secondary considerations once the the strength of the technical case the findings of fact on the lack of secondary considerations as a whole that's all highly fact found at the end of the day there clearly is a legal question on obviousnes no i believe that that's more factual than legal it's because the the the particular considerations i don't think this is a sort of a checkbox exercise where you determine is there  a secondary consideration or not and then once you get done you just weigh in a legal fashion the check boxes this is one where the evidence supporting all of those aspects of the obvious analysis obviousness analysis is highly factual and so the ultimate legal conclusion even with respect to the balancing has to take into account the fact findings and the determinations that are made as to the not just the existence of that evidence but the relative strength of it thank you your honor i think it's possible that either i've spoken with communicated in my opening argument because one of my colleagues pointed out to me that bastion does concern analgesics i think the question to me might have been whether bastien concerned other drugs that's clear at  why would it be startling that one would use the gel in a controlled formulation which is what you're suggesting that's not what started w it was used to control the release on the other hand it was used to deter abuse so why is the combining the two of them inconsistent for exactly the reason that we pointed out with regard to best bastions bastien suggest other words which would avoid that holding it up for the rest of the twelve hour period the judge toronto was talking to my friend about it severely limits the abuse resistance potential of the temple that's part of the hot don't combine these two the document to creatures it controls release and it deters abuse and then the second piece of the analysis was and that would have given skilled artist sense a reason to see if they can get both to work at the same time and that was just a matter of i mean it's called routine experimentation and if you didn't get to the right balance if you've read best in the simply suggesting that that's what you do then that's how he was able to do it because he thought bastion was a teaching in favor of that old we say and i think that the document actually bears this out best and says not won't work because if you were do sit to a level that will allow the rip the drug to release it won't have me that he said there was enough in the prior art including kasten that made it obvious to try to see if you could get both of these benefits at the same time and then the rest was really routine experimentation right but  evidence to support because because best and says that it's that it's not going to work but you have other testimony from skilled harness and that it would be routine to achieve that proper balance not about best not friend about whether what his expert said about bass and the answer is they didn't say anything about best on the last two points i have very quickly are that the c p d paper which was written two years after the invention here still didn't come up with this it simply said on a very technical paper break it's not a very technical paper but it is written by technical five very expert people including people for my recollection that i mean i don't mean this for me it was more sociological that it was  the technical choices one might make to solve the problem it was about documenting the problem is that whether or not that's a fair fair conception of the c p d paper it also did have two specific suggestions for deterring abuse one of which was