it was not withdrawn for any safety or efficacy reasons it was just a business decision that was made by the covidien at the time and so with respect to long felt that unmet need in terms of shortages we have to look at the whole history of that thirty year period and in which lives or in the soul and not just focus on that two thousand and five time period where there was a business reason for a supply shortage there is no evidence in the record that that shortage was a result of human the priority process didn't result in a pure enough sufficiently pure product that it was approved by the f d a and critically mylan and as a generic version as a generic substitute is not cl develop then the market went for that the market it was not for the ninety nine percent market didn't have the knowledge of the ninety nine percent meaning hospitals customers if you look all the way down the chain smilin none that was that was satisfied by mylan ties a product that wasn't already satisfied by the lives of sword in the district court abused its discretion and made at least three clear errors that we would like to talk about today we believe there are a number of other errors the first year has been reading up the cost of nexus requirement finding it largely irrelevant for f d a approved products and so called civil products the second error is that it clearly here for one of the arguments for a different way and that's similar to the nets or versus shell case where we're effects are very similar and shell was using the conventional purification process to get to the clean purity level  the other different way is that many of these dioxide is a strong accident and the proof is in the putting the judge was meant the claims don't don't claim any type of limitation dealing with the stands for the exact opposite of position in that you can in the when you're looking at the different way you have to look at the different chemical properties of the compound and to see how a person of working skill in the ar would understand whether or not it's operating in a different way so even though it's not part of that claim one would have to look at how strong is it how is it reacting and does it provide a different result and the judge was right on stage twenty four when he said that one if it was a strong accident one would expect a different result and he made a mistake if you looked at the yield in the four bindo indian patent application assuming that that was representative our product but that is not you have to look at our and the submission which shows that we're only have yielded eighty eight percent and when you look at the correct after which is purity which is what the patents are trying to achieve we get ninety four it's warrant for it's not to get caught up in the semantics of the two function wait result is really just a tool for determining whether or not they're in substantial differences and in this case we focused on function would result because is sometimes difficult to why you have to have an hour in a in a chemical clinton yes in that case you're right if they do have the same function way result but structurally they're very different one may find it better there are still oxide magnesia dioxide come from different elements on the on table of elements yes absolutely your honor the there are rogoff there don't you start with the notion that we're dealing with something that's  substantially different we would agree with that that is substantially different than that with there's no dispute here that we don't we don't literally in scripture we design around this process using a differen oxidation agent that had that functions in a different environment as well nexus has to be the path to the novel features as opposed to the patented features it's like you want i don't know i feel like this is the week where people want to return to the just to the heart of the invention idea that you want every doctor him irritated even after it finding that there is no difference in degree he has found that the claim could still not be obvious because the process to go from ninety five to ninety nine forecast was the buffer that's actually used where you inject live as ern into the body so the idea that you couldn't use even a mild acid is doesn't make any sense particularly in the context where the claims require a polar salt and water and acid is definitely a polar s have tools to to to purify get rid of the remaining five percent impurities so why was it not obvious because you couldn't do it so the first reference that stated in one thousand nine hundred two it talks about how it reached apparently a ninety four point five percent purity level by h p l c that it said the remaining five point five percent were pretty closely related i suppose we know from all the documents that were produced that they were never able to get a higher purity product because they would be separate out the doesn't mean that you can separate the the ingredients and gets it one that's pure from the other so for example there are mathematical models that would allow you to have two peaks that closely overlap you can do an integration under the current and you can determine yes that's ninety four percent this peak in five percent this peak but you will never get enough separation to be able to actually use preparative h p l c to separate those out now with respect to their purity levels in this argument  textbooks he undisputed evidence is that the strength of oxidation and the way that something is going to function in a particular process is going to vary based on ph reactance jeopardy sure and other conditions and hundred ninety where they said our purity is much lower we need special permission to release a batch of this material so that so that there is not a shortage and we need f d a to help to determine what the impurities are and a term and how to get rid of them and yet despite purposes but we're not to the same specifications i think their specifications were like eighty percent purity mylan institutional and before specifications required greater than ninety nine percent purity so do more bandits if really there was no concern about the their product is far results in a far less pure form of i s p and they argue it doesn't work without acid and that's what they argue below the to in response to the r and r by the magi argument there blueberries argument great grief and today you came in and you start making some argument about the lack of a reference to ph in something i didn't see that argument in your read brief and i don't even understand it and you started by saying well any chemist would know and maybe judge morey understood whenever the heck you were talking about but i sure didn't and i didn't see that argument in your red brief so maybe you should take a minute neither tell me where it is or explain it to me better because i'm a little concerned maybe you didn't raise any of those arguments because i only spongers to your read brief i  understand your rep reefed to say it doesn't need to have an absence of acid or it needs to have acid i understood you to be making a very different argument so i don't know how to get around this based on the arguments you made in the red brief and i kind think the ones you made today are are different from whatever your read brief but i'll be the first one to admit this technology is complex maybe i'm missing something so take a few minutes and try and surely let some of the arguments were responding to do arguments  there was no new argument in their reply with regard to whether or not the oxidation process would not work without an ass and that's something they raised all the way through out the reef fish twenty six with a response to the r r below so that's not a new argument so  they're making in their reply briefs brand new and it is comparing apples and oranges they're comparing the first purity of ninety four point five percent which is after all the possible purification that hearst to do to their cru to the greater than ninety nine percent purity and that the invention is the understanding that it's the oxidation stuff and it's the nature of the mixture that the isis self and blue is present and that allows you l c and identified and was clearly able to identify that ninety four point five percent of the mixture that he got was ice b and the other five point five percent was closely related impurities are safe that we presented at the