mileage products were surrounded by erroneous legal standard under the guise of credibility terminations and let's look at what phase of the erroneous legal standard here well in this case there were simply the court was incorrect in finding that  know it's a factual your honor the question in this case we believe is whether or not to judge make clear error is factual determination and our point is any had two experts one expert of how our we possibly can test that the answer is wrong or by reviewing the evidence which is uniformly consistent with the conclusion that the court was surrounded by  right love he didn't say that's not right he he he really that you if you're going to have a controlled release product you have to have ethel cellulose and be definitely that's not as medicine that treats the cross disease and that the socialist is the substance that make sure that it's gradually and sustained release in the small intestine and the entire coating protects it from dissolving in the stomach where we don't want it to get to so there's really no disagreement among the experts about the purpose of the chemicals the debate is really very straightforward and this is the only issue on which the parties disagree was the core each of their core surrounded by b desson i'd have to said it was or was it what dr elder called a binder evidence to determine if judge sleeps of judgment that relied on doctor all this testimony is supported by the evidence is there sufficient evidence to support that put another way it's never enough in a did you handle the product no did you explore or conduct any scientific tests microscopic or otherwise to determine if these things paul vi under bridges existed the answer is known on in the contrast actually manufacture and our bottom line is this i don't believe that you can then come before the appellate court and hide behind a total lack of evidence by the defendant in this case and say judge got it clearly wrong or right clearly wrong as are different fair enough but i would say clearly wrong is demonstrated by the fact that there was no test and no analysis done by dr elders he applies his general knowledge roll the dice on this one and they said rather than have are all these experts plowing around through what we do we're going to wait and see if you can prove your case in the trial  you can search judge fleet's opinion he doesn't even address this he ignores the i'm not saying about the judge the trial judge has to to cite every piece of evidence that but when he has probing competent evidence what they told the f d a you can search the entire end of the word binder for each never appear remember this was a trial where both experts are paying dr david's testimony is granulation as opposed to the dr fluid bed that was used to coat the particles and so what it what happened at the trial dr davies said ok this machine can be used to do bot i will do scientific tests to pasta he to he cited no scientific literature for the proposition that binder bridges agglomerate into pasta and he has no support for it whatsoever and next year honors i would ask you to there's also evidence if you look at the eleven thirty eight this is the crossroads and what you'll see in the first box is granulation suspension number one which is happens according to their own documents the little squared and says add part to lactose munna hedrick lactose that's the sugar core and then it says spray with the grand  saying that's how it's prepared and he explains the process and then he does what any self respecting scientist who deserves credibility in this board would do the tests to see i'm going to dissolve the product and see if the results i get are consistent with binder bridges or is it consistent with a code is so simple he finds that it's consistent with the lactose score and the final point your honor because i see him into my moreover he analyzed dr davies expert report as well as the experimental test protocol and the exact same results he reached different conclusions what those results showed the trial for believe with believes d held that such credibility determinations are difficult if not virtually unreviewable now the appropriate standard view in this case is clear therefore this court must have a clear and definite conviction that an error was made  going to get that into my reviewing the facts so we have to review the facts don't we i believe that it's perfect for this court to look at the facts and see if there are there is some evidence to support judge sleep determination on  that if they were the trial judge they were to come out with a different conclusion that's not reversible that's not clear clear is a firm and definite conviction that the fake was made and it's more than just the appellate court saying you know i will decide this differently that was what the supreme court said worst or cholera worst or insert and there are several different factors and parameters that are very important to determine whether you're going to get a coating or whether you're going to get a bind a bridge or something in between where does the milling operation description that occurred after and that's a very good point because we believe that not only did the and us support that we have a two part component that even if hypothetically one were to assume if we asked our experts to do a trial that a coating was formed in the this spring in the almost bouncing around how does that spray not covering the bulk of the granules completely well because what you have is you have the particles are being blown up from the bottom they're fluid eyes they're then that ball will hit another ball and it was back form a bridge and form and it warmer that will build up in a multiple and very large numbers of lactose particles all together it's actually easier for me to envision that what you have is like little bits of glue coming in and you've got one ball hitting the drop of glue and then hitting another ball as opposed to that's much more difficult if you want to use these types of systems to actually fully cohesive and completely surround any of those balls or  that mixture is in compressed under great pressure support a tablet that tablet is homogeneous is uniform it is not a competition of a bunch of little coated cores astra zeneca would have and then that tablet is coated with an saying yes we would we would probably describe it differently in that what we would say is that we have a tablet that achieves controlled release by using a mixture or diminish or if you want to call it a matrix of little binder bridges that have been compressed together with lactose but back to your question earlier that i don't believe i answered is that after you have this granulation where you basically form in the water it's a very different sizes of lactose which held together a bridge that is not subject to an interior code that goes through two additional process steps are at least two but two that are relevant to this case and the first one is that it's milled and so it's actually ground up at a speed of about seven hundred and other components and compresses it together into a tablet we do understand from the records of your people who live or went about trying to figure out how to manufacture this product designing around corner i get that from somewhere in the record is that a mistake and sessions i'm not sure of the record went into the intentions of violin and designing their product mylan that believe that they have a unique formulation actually  control the release of our product is we using a binder bridges and so that once you go through this done that the entire code does all the way and then the tablet the center great and it basically spray all these little binder bridges into the intestines and then it's wasn't supported by the evidence which we think should not happen we still have documentary evidence that sufficient support judge least the termination at the end itself now although counsel for astra zeneca points to certain portions of the  challenge you to go look at those portions and find any description of an intermediate layer surrounding a leftist corp it isn't there because that's not my product the district court correctly found that my island and on its face even may be the best evidence of infringement because the f d a has certain requirements and because under two seventy one and two that you're looking at you want to determine whether the product that is likely to be marketed or would be marketed should be and to get approval is what would would infringe  that in this case the end it describes our product and it describes the manufacturing process to reach that product and clearly following the description in the end we do not have a labor surroundings that for now one final point that i would like to disagree with which is a well you mr pappas said at the outset of his argument that the only element that is an issue is the layer surrounding that core that's the only element in issue with this appeal because the when i'm looking at the page of page a eleven twenty seven which is the page that was pointed to by appellate counsel during their argument i don't see any description there of a coding or coding system i was referring to a page which i don't system and i believe that is maybe somewhere around pages it's a ten and one  you see the coding system and that's the bottom of page eleven twenty nine yes i believe that was just referring to the actual trade name of the product we don't believe that there's a district court found there was never description of the adult sale of your voting system doesn't cook we don't think it does we think it was minor bridges yes  moreover i guess there's another important question which should be raised is that the agreed upon construction is not just that you have a coding but is that you have a coding that completely encloses on all sides a court so even if you were to buy that some of the awful clothes doesn't cut it there is clearly no evidence that any lactose particle much less a core of light those particles are completely enclosed on all sides by the coatings and in fact we believe that the actual results from dr davies testing which i believe to be my progress optical microscope are presently attendance shows not what you would what you would expect if you had completely cut a course your coding system doesn't cope we don't believe that we have a layer surroundings that core and just the fact that we use something called aqua close that is described in its literature as a coding system we don't believe that that  that although we think it's much smaller than that with dr davies a head admitted that if we had a conventional granulation that it would form binder bridges dr davies pointed to nothing that was unconventional about code or our granulation process that would lead one to believe that you actually form the coding and therefore we believe that mind which is a form just in the last point that i think i haven't addressed which is the descent of it the fact that our products need to the center it is not evidence that any lactose particles are completely coated dr elder testified that when you get that all the lactose particles themselves are quite readily soluble in water when you compress and compact them because they're very far i have which not only purple i want to make really one sentence from the anderson case a supreme court case because i think it puts this out we in perspective court said that when reviewing the evidence and not standing what the they may think of the expert quote documents or objective evidence may contradict the witnesses story or the story itself may be so internally inconsistent or implausible on its face that a reasonable fact finder would not credit questions it is the job of this court to weigh the evidence to see if there is any actual basis for the evidence that was marshaled against as if like gentlemen you are firm to all of you i thought a minute plural i thought a segment judge larry let me take on one issue which i think is important about coding so that based on some of the questions the you'll know from eleven examine the evidence you have affirmative evidence from dr davies it's consistent with the end and was based on actual scientific testing that there was a coating completely surrounding the ct on the other hand on the