the case we just ordered was pending in virginia the district court in this case deny the plenary injunctions and we think on the basis of faulty claim constructions in particular with respect to the term  respect to the term about and i'd like to start with peak ordinarily a peak is nothing more than the numerical apacs of x ray counts for identify a particular they are different concepts that are not referenced in our claims with respect to the peace let me talk about intensity first our claims do refer to diffraction angles peaks at the fraction angles and that is a completely different concept automatically gets one hundred the a pic that's half that height gets a fifty a quarter that height gets a twenty five that concept is actually discussed in our specification we have columns listing peak locations or peak angles and separately listing peak intensities we did not include any intensity values in play want it's only about peak angles and so we think it was something i mean we deliberately omitted intensity limitations from claim one so we think it was incorrect for the district court to import intensity limitations there's another implicit requirement in the district court in this case by your argument that there are trace amounts of crystalline a in it's in the q s product the district court did not but it did not do so through the wrong frame of reference is correctly defined the wrong prism is looking for a p that is tall and dramatic or something significant we did find if in fact the court held your peaks do exist but and i quote they look nothing like the features displayed on figure one and those are the polar peaks that the court was referring to so the second thing is only intensity you limitations that were implicitly on here but it's also true and here's why that's could this is really important to our point seven it's very primal if you mix chris the lead with the different crystal that has even more intense peaks suddenly fourteen point seven can look to minimize what does crystal  there's a it's a hotly tested debate between the parties but if you we have in the record from a three six eight three seven six seven to seven to a complete recitation of all the work that was done to try to reproduce example sixteen in this litigation we have experts on it they have experts on it we say you don't get it if it will if we have that kind of a factual dispute on whether or not there products in the prior art isn't the district court entirely within its discretion to say with that kind of a disputed stake i'm not going to give you an injunction but the judge never reached that issue if the if the court were to reach that issue it could evaluate whether there was a likelihood of success on the  brand new quit nobody ever made any scepter near crystal before it was languishing on a shelf we were the first to come along and make it from non useful to useful we were the ones to do that and we did it two ways and we talk about set that is an insubstantial difference when you look at it in the context of the purpose of this invention which is to improve the crystal compared to the amorphous in our spec we talk about the fact that you improve the stability by creating a crystal form of this compound and that's what makes it a commercially useful drug the model hydra does the same thing so that's the function how do they do it well the reason crystal being compounds are often more stable than twenty to thirty months entirely irrelevant the point here is to get the kind of stability you need to get it on the market and so that's why we think that dr equivalence is something that it should be should have been addressed on the merits and it was in our view then back to peace surely requirement very quickly if you have ten percent and hydrate and ninety percent mana hydrate the pigs from a that are really large well it's only ten percent the size why because you only get ten percent of the x ray counts and according to this court in in the lock so you know there's no such thing as the minimum infringement so if we find is from crystal a in the defendant's sample then in french and it doesn't matter how tall the peaks are that's i mean that's an irrelevancy they're going to be sure they're going to be smaller if there's less of a although in the nature of the of these tests right understanding correctly the the new it's has an appearance of small pics so there becomes a problem when the peaks get small enough of distinguishing between just noise and what you're referring to as peaks and my understanding was that what the district court was concerned by was that you know when shown peaks that distinguish themselves sufficiently from just the noise i think th doesn't have rigid boundaries because the error detection depends on a bunch of things like the machine you're using how many samples you run how you prepare the samples and so there should not be a rigid boundary around the world about the point one to point two clearly there is no set standard for a rigid plus or minus point one in this r and the district never bubi evidence of correctly on that score because it is applied claim construction governing the plenary injunction motion the court evaluated and determined correctly that the defendant's products will be on a hydrate are covered by that the court also separately analyzed whether or not the defendant's products had trace amounts of crystal way and the court heard testimony from the experts watched the experts go over the data and the graphs watched they have an expert explain just how it was that just no trace amount of c i made a fact finding that fact finding is entitled to substantial that prince there's an abuse of discretion standard and on that basis alone there's no infringement there's no likelihood of success certainly not a substantial and insubstantial question the defendants have raised substantial questions for sure mr hurst referred to hotly contested bates between the parties on various issues  nine and a ten of judge anderson's decision he specifically addressed the peaks requirement and specifically said that judge payne had noted no intensity requirement the claim that's what he was percent of the mana hydrate form you'd expect a ten percent peak per judge judge pain in fact in his ruling specifically talked about the fact you might have mixtures of crystal and something else and therefore you wouldn't expect a pattern that looks just like figure one in the patent for example in that instance but personally i might still be present and the judge specifically in our case looked at the evidence of whether or not there are trace amounts for us to lie and in fact look at in what respect the intensity in requiring more and discrimination from from back when no as if that was his response to my question on that and i would assume that he would point to nine in which the trial of measured intensity above the background noise so he it at least one way of reading that is that the district was rejecting the argument that small peaks were sufficient and they didn't were nothing like the features displayed in figure one were nonsensical and small pieces were exactly what the judge looked at with respect to the evidence that abbott put in the spiking experiments for example in that context the judge had moved beyond is crystal be christlike and he was looking at or other small amounts of crystal a mixed in with crystal big and those were small peaks that were being cited by ab there was a lot of testimony with respect to a spiking experiment for example which was put in at a seven hundred ninety nine these were small peaks as a matter of fact on seven hundred ninety nine you can see that they had to highlight and blow up the evidence that was abbott's evidence that's what the judge considered so it's not of the court rejected that small peaks could sometimes be infringement it was that a small piece that abbott was relying on in this case were not evidence of c of it became apparent that the claim construction hadn't gone the way that that abbott had expected they went to their own generic and put some product into the marketplace what wasn't for profit would it be fair of us to take into consideration their temp to survive in the marketplace after a legal hadn't gone their way it is it fair to kind of hold that against them in this or reparable harm sente it's fair to hold that against them when they themselves genericized the market in other words abbott didn't pay much noise is kind of the point that the the legal rulings had cut against them and it was a survival instinct do you think it's fair to to factor that into the irreparable harm yes i do believe it is there when the when the when the brand jumps the gun and launches the generic first in other words the brand didn't wait for the generics and launch on currently with the generics and i know they have an argument that it could have polled their their authorized generic if if there was still time to pull it back but they themselves made this a generic market they withdrew their motion commercial choices and they made some commercial choices but that's inimical to proceeding with are doing irreparable harm and seeking employment or injunction at that point they faced a choice and the choice was to proceed with a legal proceeding this case is about surrender abbott purposefully removed crystal be after h j p one nine nine in awe of its applications file based on the j p one nine nine and it did define at a sixty one of the record after an intensive study the inventors of the president mention succeeded in obtaining the compound one as the special crystal in form four i crystal and completed the present invention i that is in addition the j p one ninety nine secretary described and claim crystals a and b ventor sure rye testified that crystal be reza removed in its entirety from the five or seven patent i'd like to also address some issues with regard to peac used in claim one in addition with the term he gets are the pattern and when you go back into the spec and you look at how the term peaks is used in the f described the highest angles of crystal a in different examples and i believe they recite fifteen of the highest angles in examples two and four but then when they talk about the seven angles that they claim and claim one they talk about those angles as peaks and those are the seven of the highest angles with respect to the fifteen described in examples two and four when you go back into the spec and you look at how those seven highest angles are describe they're described as distinguishing peaks was this case was the claim construction ever considered to be anything other than a product by process claimed in your litigation your honor the claim the judge did not identify whether or not it was a product or process claim the judge resolve the issue on crystal a and this entire case can be resolved on the interpretation of crystal and as crystal a because it is about is present in about as present in the claim and there are two examples as i mentioned before that talk about the highest peaks the highest angles excuse me and  the angles are less than zero point one apart and one of ordinary skill in the art in reading the specification would know that the perception of a defect ometer is about point one apart and if and that's what it says in other of its own applications and we have an example at j p sixteen zero five and that's it paragraph twenty but in this case it it says that it's plus or minus zero point two i believe however we think it's clear that one of ordinary skill in the art would construe about to be plus or minus a point one i'd also like to address i believe and what basis would we attach a numerical limit to a term that says open is about  in this case your honor because the intrinsic evidence shows the examples which are less than point one apart and because the standard setting the standard setting authority the u s pharmacopeia states that the i'd also like to address the experiments that were done on the prior art patent the three three four patent abbott mentioned that that was a hotly contested issue and we disagree the six example sixteen you're talking example sixteen on the experiments that abbott referenced first of all the contrary statements that abbott referenced are in a totally unrelated application and the apparent alleged inconsistency is currently being resolved in prosecution however i also would like to direct you to the record in lupin's case and i believe example sixteen is discussed in lupin's read brief and the fact that there were experiments that produced crystal b is discussed at lupin's read three at page ten so there is evidence that the judge considered and that evidence was also present in our case that example sixteen  three three four prior art patent produces crystals are our tests were run and we had four tests run that showed that example three three four produced a crystal but when you say the evidence that he did say and under the oh mary injunction standard he said that defendants have argued that the reason the plaintiffs left out crystal b was because crystal b was contained in example sixteen of the  three four and under the preliminary injunction standard he thought that he didn't say but we believe that he thought that there was a substantial question of the let it be raised really just real world questions it's understand that there are these products or now being sold widely on a generic basis that's correct and that's been true since the expiration of the earlier picking up on that question has in thinking about the equitable factors here should we pay attention to the fact that the institution of an injunction would change the status quo at this point i think the if you were to agree with your position on the merits i think that the correct procedure at this point in time would be to remain and for a reassessment on the merits under the new circumstances things have changed there's no doubt the same things will change we believe we are still being a reprobate harmed every day in this marketplace and that every day is causing us further repertoire but the record isn't up to date on that issue and so i think that the proper procedure is to look at the merits of the cl construction if you would agree with us on peaks and about to return it to judge andersen to review the the current circumstances but what do we do about your entry into the generic market in factoring in the irreparable harm i think your questions really hit on the head your honor i mean are we not permitted to try to mitigate our damages that's all we were doing we knew if that the market would be destroyed if generics got on but we didn't want to suffer the damage in total so we tried to mitigate or damages and we didn't a way that allowed us to pull the generic off the market if we were to reverse the situation the phrase in the pat the dead that is then irrelevant to the question think i think it probably it is not because obviously you make different levels of a different situation when you insert a generic into the market versus when you are a brat with the generic we are merely mitigating or damages we are not fully removing or damaged by any stretch so it's we're still being a rebel we aren't on the brand side of the phrase in the patent the inventors of the president mentioned succeeded in obtaining the compound one a special crystal in form i e crystal a and completed the present vention just two points we had quitted special crystal in form with crystal that this supports our point we didn't use the phrase special christian form in the claims we used the phrase the generic phrase crystal name that was a deliberate could not have been more clearly a deliberate choice because we knew how to use the phrase crystalline we had done it in our specifications and think of the redundancy that gets created by duplicative claims literally because every limitation after the phrase crystal even if you replace that with crystal a would be entirely redundant entirely unnecessary and that situation would be this claim one crystal  period claim to crystal a period always on the claimed five christly period and that's we do not think it's a sensible way to read our claims and we deliberately chose the generic term crystal lean as opposed to the term discussed in the spec crystal if play crystal diffraction peace can be reproducible two plus or minus point one or two it actually says or to recognizing that there is no concrete limit up or down point one under all someone of skill in the arts going to consult that source aren't they and if they do so isn't that going to inform it that the the out it might inform them but it would inform them that it's so flexible standard point one two point that it is the two referenced as an alternative or as the total amount produced by a plus minus one i think it's clearly an alternative your single turn because think of it this way and say