and so the horror and this is your honor to the best of our knowledge after the research this is the first time that a generic drug company after obtaining new validity ruling and making a unquestionably legitimate launch of commercial product thereby triggering one hundred eighty day exclusivity period to running this is the first two million dollar bond was based on a declaration from a businessman from plaintiffs who made assumptions based on his experience with the similar product as to cost his into spades only price and dissipated sales and it's a substantially larger figure the district court did not even acknowledge that that the region had been filed she gave no weight to one versus the other she just bought the plaintiff's decorations and that's the number of without any further consideration so as i say as far as we can tell this is the first time a generic company has ever been enjoined after succeeding question you want us to decide whether the district judge saying that it was i think she said as likely as not that she would be reversed whether that's fishy too in that case declined the injunction odd situation about this case under the district judges unprecedented standard for doing this post decision injunction it is meted easier for to get injunctive relief after they've lost the case no i don't think so i think it was a matter how much weight was given to the relative arms and in the balance a invalidity which the judge in her further decisions when they were the planes were attacking it is that i'm standing by it i'm sticking by my decision she went through i think she got it wrong she didn't appreciate that under the statutory scheme there are three junctures with which is generic company can go on the market legitimately and she clearly would have preferred that the struggle of course is which waxman she heard compelling evidence about the high probability high likelihood of success in formulating this product the immediate release product of that on the market commercially for i think it was thirty or forty years there was prior art showing that this chemical into tea had been put into extended release vehicles and it was reported as successful certainly don't need to suggest that in this case let me tell you the evidence of the good drugs in her in getting it right she heard that the skill the call in to tea was what they call formulators cola type one drug or a category one drug that was highly sought the will it's absorption as it goes through the gastrointestinal tract was relatively uniform and various other characteristics about this drug which indicated that release drug of the three times a greater dave flexeril to come up with the different those that profile that would solve the insomnia problems of and his judge robinson correctly found admissions from urine in subtle ways that they could not prove that their once a day product eliminates those side effects there was no statistical evidence there is no  district judge got it right she said they had the best mode she said the best mode improve the quality of the product in the production process with then she said because she concluded the study of the dew point  evidence of obviousness and original painting could then when presented with arguments a post trial made a series of statements about the strength of those fines and ultimately said that  soldier in in in enjoyed it there was not error because of the balancing test that exists under rules of sixty two c essentially what the argument is is if the party lose and has to show well two things on that one she said it was financially the financial harm that that could be compensated through her money but the other thing she said in that regard was that it was self inflicted harm but this was a circumstance where the law doesn't require  in the event of a very close case and destroy essentially the market for the branded drug and that's a believe what injunction is proper she balanced those harms and essentially said if i let this go on the market will be gone there's a reputable the backup was a calculation by self one representative of what that price in the market was what the expected expected sales would be of a generic product in the in the period of the injunction  what the competing sales might be and a price sort of a price numbers calculation and remember this near drugs sold for a much lower price and so the issue is you know whether or not a higher granted price which if you're going to reverse on the rest of this that's exactly where i was i was going on thank you very much ken do you really think it strengthens your argument to refer to the district court as being slipshod and her approach and your are we i apologize for using that kind of language in that and i take full responsibility for that and i don't my politics for using any might feel good at the time to write something like that but in retrospect if you're on your absolutely correct there were there were some of the reforms sort of better for them or a lot of the same thing a profile originally in her original opinion was quote unquote disclosed and winchell and that that simply incorrect neither party had argued that when she will actually disclose the pharmacokinetic profile either of the extended one sixteen and again that is incorrect as well that was what she thought back on that the c max was disclosed and then one could then calculate according to her findings the other parameters the c max if you actually look at it that she cited is not court then relied on to say well look at those clinical trials from two thousand and seven of flexeril the two numbers you measured there they fall from the claims so therefore that's sort of an inherent property of flexeril but one of the hard to know or it isn't possible to know what particular plasma concentration is in fact a factor in that was something that both sides agreed on its lack of p k p d relationship like what would me what would be needed in the prior ar related to methylphenidate and we're not here arguing that we have a new extended release technology that's not what this case was ever about or new dissolution profiles it was about the ability to do batch which those other companies failed to achieve a therapeutically effective extended release cycle bend supreme product in the absence of information in the prior hour about what concentrations would be effective to achieve dissolution profile that had been chosen by the inventors and from the kinetic profile that had been chosen through their analysis of their own through their modeling exercise and remember one and that goes to the aspect of that's not what the invention of this invention is what happened before they made to be that met the dissolution profile that's what the invention was it's your argument instruct people to do that they tell you to do the studies and whatever results results but the number two again in the absence of a relationship between the properties that are measured for single those ba wildly different result and that's what the patent it's about when talks about why fluctuations in plasma levels and you only need look at if we're going to consider the later study flexible which we suggest shouldn't thank eighteen for for c max if you go back and talk about what it other people actually disclose and what did the evidence show at trial what other people might end up with it was totally different the plasma levels were not identified in the prior art no one of skill including dr amidon himself who put that put in everything he said there was no information in the prior whatsoever or low that's what a lack of a t j t v relationship means and to then go from that to say well there's no information about that concentration from going at the fact to say well then you just aim for wants because you then assume that it would have the same effect those two things they don't stand together they're complete opposites to better if there's no p k p d relationship than how can any particular d in essence what happened there is with respect to again the invention here is not a novel a novel dissolution profile invention is the plasma concentrations in claim three and in the dissolution profound claim j one hundred you'll see that and she focused on a few similarities solubility and other things but did not focus on the fact that if you read the two one five pattern itself a common it's called for it talks knew something different than what the conventional wisdom is to cut through the peaks and valleys i'm going to go real high or up early and then come down to real low so i think that will work creating of need to do that was what they did in days what they did but but the point is obviously he said it in a different context but that's the very point that they've been arguing is that there are few profiles critical and indeed in the absence of that output or an obvious well if they had actually found in disclosed  void for indefinite is the rejected or clean prescription or challenge of the indefiniteness on that but that was the context in which that was made that was not their invention they didn't disclose that we don't know what it is to the state of just following up on your earlier question judge millie i should have cited the residing in the references to articles from sure in ploughs latest j a twenty five forty five to twenty five sixty three we are they actually wrote articles showing extended release cycle when supreme with extended release dissolution profiles this drug in extended release profiles actually disclosed in those talk about what happened that i was a many many years before without any documentation whatsoever with judge robinson's that is if this were a jury trial i wouldn't even allow him to testify but it's a bit strong she heard  think that this is just to summarize i think there are limits are largely already doing about factual findings of the judge the judge heard conflicting evidence in many cases and