representations still obtained it's going to be a little difficult to talk about that issue so i would ask the parties is that something which the passage of time has rendered no longer necessary to respect confidentiality or not honor i think with respect to the licenses in particular the answer to the question is yes the passage of time has changed things so we can talk about we can talk about i but yes and in particular we can talk about what the terms of the licenses are your hon even more difficult because at this point now we're trying to conjure a plot for the world where other folks have been or licensed centuries occurred and now we're trying to figure out at that point remember because they skipped they jumped to the head of the line and decided to launch at risk now the fact that they were trying to or unwind all of that at this stage becomes even harder but the unwinding sense you mean i think it's involved going back to july and figuring out what would have happened in that four month period before the others enter the market but that's not where we are right now where we are right now as there are already two other players in the market so it if you judge if for example this case were to go back to judge calmly yes you were asked as of now what's the irreparable harm wouldn't that be a tougher call from you and tougher to lift your honor i don't think so and the reason i say that is that even though there are certainly an important period here which is between july and know very much that that's and that's happened and that's happened and i recognize that but your honor the impact of that launch that began in july and continues to this day your position with respect to the injunction that you would see is that you would not seek to enjoin patients who are currently on i am tense product but only patients who  began to use that after the injunction that's gross is entered that's correct and we're talking about there's at the trial in this case is is unable even twenty six so we're talking about five or six weeks and only  patients who would become starting patients taking amgen strug between now and then that seems to me be a pretty small window of i wonder if that's significant enough projected is that they're going to they're going to get the largest worker chair with respect to that to this product the market share we're talking about is just the share of new patients between now and april th right well i think it's actually i think in terms of looking at a reputable form at this moment your honor i think that that's right but that is huge remember this is a huge drug and with respect to the biosimilars it's a huge market with respect to them as well so even though we've made a concession that we're not going to ask people who are  stored on the drug to come off one of the perverse aspects of that your honor is that the more remember they did that they decided to take self help to infringe the patent and at the patent and go forward and as they do that they are they're actually increasing the amount of patients that have been stored with this drug and then to turn around and say that in that context that we're somehow we should we should somehow be put in a box and with respect to ripple harm seems perverse and i would say  mission a while back you appealed it to the school and it was rejected so nothing about that is perverse you may disagree with that but that was the judgment at the time and your honor i'm not suggesting that the judgment on the rule eight motion was perverse or anything like that despite the fact that we get we tried to get before you which quickly as we can what i'm saying though your honor is that and i apologize if i'm not being clear about this is that what as they continue to store patients that becomes an additional argument for them that you know in terms of bound to poor trips for example that you want to look at this in a different light and what we're saying is that again if you think about this in terms of what they did launch it deciding to launch at risk with  infringement argument in the face of i p r decisions that it up help the validity of these patents that put us in a box where we then can basically say that even though the trial is in april that there is an important time left on this very very significant important drug every day counts you know in our in our estimation of god yes or refreshment isn't a preliminary injunction to launch its product let me deal with each one of those three areas are the st one is the notice of commercial marketing that was in may of two thousand and eighteen they were approved until thirteen months later in june of two thousand they would not be able to get approval for that drug until they responded to the complete responsibility or it took them seven months to do that they didn't do that until december th two thousand and eighteen when they did it when they responded your honor they did they went from a full label and said we don't want that anymore or do what they want to that you're aware of that and so and so in and they didn't change back to the full label until march after they made  determination commercially that they that they didn't think they would be able to successfully sell the product that way so that takes us to more much ok now now the nd part the runner is it is the point in april that the district court is that all of their witnesses and we tried to pose everyone we could get our hands on said in sworn testimony that while they were making sort of want to readiness plans that there was no decision to actually i can tell you what happened in one of the other cases your honor in this in this very situation and it's referred to referred to in the district court and if i think it's footnote six in the district court's opinion was another biased on the i'm going to be careful here in terms of what i say in terms confidentiality and the other five similar told of they said if the typical or other thing happens we will launch on x date and what we did once we were told that if we went to the district court judge and we said they told us this we'd like to set up a procedure for a plunderer injunction motion and we did that and and that may be nice but my question went to morrow whether they required to do that or they typically do that and that was very nice that you know that one particular candidate i think i think your honor it's mixed i think it's mixed sometimes people do tell and this is an example that i'm giving you right here sometimes they don't but what what i what whether they have a requirement  number saying that there is a sort of a flat out requirement that they tell us what i am saying is that in in the sesson the issue of delay and looking at whether a form is imminent that it's extraordinarily important to focus on what they are telling us and what they are telling the court and what they told us and what they told the court even weeks after they had been f d a approval was that they had made no determination to launch and that that and in fact one of the statements of counsel was date katie specifically i think your honor i think they would have been the reason i say that is that they were making those statements to the district court in order to maintain privilege over opinions and what they were saying is hey we don't  say i'm sorry to maybe they were making those arguments in order to say that they had not come up to a point at in time at that point where they would have to produce the opinions of counsel on the issue of willful infringement and so they were arguing  argument to the district court as late as june after f d a had approved their product they were they were affirmatively saying it is not right for you to determine whether or not we have to produce the opinions of counsel because we haven't made a decision to launch and so in that context our position is that and again as it's whether it's when we're required to actually go and what the what the district court said is your require in this context even though they're telling you they haven't made a decision you're required to do it even before even if you get to court as we did before they launched the product and this court is never found to lay in that circumstance and if you think about it it  doesn't make a lot of sense and the reason i say that is that the the whole point of looking at the lay is that if you suffer the irreparable harm if you allow the sales to start and you allow them to continue and the status quo changes at that point if you just sort of wait around well yeah maybe maybe that's a good indication that you don't think that the hormuz reparable but we've got in there before they launch maybe as you can squish moving from the irreparable harm licensees launch that it's even going to get harder and we put in an x we put in testimony from an expert that's in the record on that and even though the other thing that we did your honor and again this is in the record is that we pointed out and this is from testimony the time is that the district court the other side seems to be saying you seem to be saying it could have launched you were prepared to launch and therefore that they were it was incumbent upon thanks to the p r early right well the district court found that based on discovery and  if you really are threatened a threat will harm if the threat of credible and grep what harm is credible then you're going to get to come into court early before someone actually makes the final decision and pushes the button to launch in the fact that there was a decision maker out there that had to make that final able to mid june five amgen witnesses testified giving a fairly specific launch date in july and i could walk through them our plan is to launch sometime in july that's robert jackson shane hart we're targeting being called a lodge in july to the f d a in december but that actually supported the district court's decision because it's a well known fact in the discourse as it in its opinion that six months after got a response letter f d a is likely going to be granting that approval and that meant that we're going to get approval in june so this h all the spontaneity of a rocket launch it knew we knew that this was going to happen the skinny labor we went back to the full label in march no request for an injunction we got approved with a full label in june no request for an injunction  vote the way you articulate it sounded like you were saying that the approval was a done deal there was no question i was suppose there are some questions to start to get you're supposed to get a decision within six months on this issue and it is and it's  not having done so prior to the f d a has approved it seems to me that your your case in question becomes stronger as you closer to the july date but i don't know that you have a terribly compelling case for delay prior to the f d a approval well than that i think it does go further back because it's your entirely cable one way or the b b c ideas structure you can go in and you're given discovery to find out things like the launch that you're given an artificial act of infringements you can get into court early you're those things are geared are available to you from the moment somebody files there or there or biosimilars application that's an artificial article project when you're confronted with all of those opportunities all of those vehicles all of those ways of finding out the launch and preventing it before someone pushes that final button if you have all those things it's simply not reasonable to let an opportunity go by after opportunity go back and even if it otherwise it's all in the discretion of the district court whether i or someone else might think that this was an ok time ok timing the district court was with the parties it here and after hearing after hearing and saw all this unfold that just over exercised his discretion to say based on these repeated delays and the eleven start lar in the th hour attempt to prevent it which kind of person a little what do you think the right rule is that a judge should use in assessing the presence of licenses these of the irreparable i think it's highly contentious judge bryce and i think the district court here was very sensitive that court looked at the financial terms and that's sealed maybe i should mention that the fine in the specific financial terms are mentioned in his opinion and also looked at when the entry would occur and it was a short time away and the district was able to infer from know roughly how much harm it was going to suffer and the harm was in a record because it was letting a competitor after competitor after competitor into the market that's a fair and reasonable inference of the district you're draw and it isn't hard clear air of a district court with braun that imprints on the of facts where you have licenses but the district court would be in error by finding that those licenses effectively  answers and there was another party it was using it but it's pacifically carved out certain things that would prevent it from being a competitor or it's used in a very different product and sort of those kind of menace aren't or if they were to minimize right or if they're denied us but you know pfizer you know my line these are no slouches your honor these are serious competitors in the market so under certain facts you could license people you could license even potentially competitors the market and the district court on a careful analysis could under particular facts find no you can still have a reputable harm from time at this point i think the notion of sending this back to the district court for reparable harm analysis on the facts as they exist today there's no way this case comes out differently and so it seems to me that you know effectively the passage of time has and sometimes mooted all this because now we have the competitors on the market it's not a future entry it's current entry now we are in the market and we're actually you know patients are being treated with our drugs so it seems to me that under the circumstances it's really just not a good basis for reversing even apart from the fact that the district court committed no clear error and then there was no abuse of discretion and that's even without going to the public interest factor which i'd like to turn to last and that is that the district court really understood that the injunction sought here would address would there was a period of exclusivity for it and they obtained that period of exclusivity and they've come to the composition of matter patent by disclosing her stepdad and making it of people of being used by others following the expiration of the patent could've been solved if you'd gone back to the skinny label but mechanically i was left wondering if you had decided to do that if you decided in july you know what we're too worried about the possible infringement let's go back to the skinny label what would you have had to do to implement the skinny label so had to be at the a so i think i should draw draw distinction here if we were worried about infringing we wouldn't necessarily have to change the label we might never change the way we market but if we're subject to an injunction that said he and there mind you the problem here is they never asked for a skinny injunction that only prohibited the infringing uses but if they asked for that injunction and they were granted such an injunction we would have to make a choice do we change the way we market should we go back to the f d a and ask them to adjust the labels of the label only has one on it for the you know the truly clearly nobody claims that there infringing uses those are the types of this is would have to make but ultimately it was the burden of genotype to go to the district court and ask for an injunction that only prohibits infringing activities and doesn't reach non infringing activities that are in the public domain that was their burden and they simply never before the district court said i want to err on junction they never said in their opening brief i don't even understand the  we wanted to change the label and we thought it was necessary to change the label we would have to go back to the f d a and if you didn't change the label presumed lead still the exposed to an argument that yeah you may be saying in your marketing that this is only for the limited purposes but you label it allows it to be used and i suspect that there will be arguments along all of those lines there are you know raised and addressed by the jury at an upcoming trial in april whether or not there isn't too swift and things like that and i suspect that they will point to the label as an inducement but that's all a matter of things for a while later saying that simply goes too far you can't take things that have been done to the public domain away from your competitors when they're not accused infringing of any other patent if there are no other questions i would be happy to visit it myself thank you for those reasons we asked for the judgment being out there with an eight hundred and sixty three label but saying well we're really not marketing that that wouldn't that would not do the job in our point of the public interest seventy five percent of the uses everyone agrees are based are infringing uses with respect to the  approved their product and they said to the district court if we were to launch in two months versus six months versus a year and jim would still make need to make preparations to launch to be an prepared  enough and i think the point that was that we never said in a course you know they were thinking about from the period of december through march going with the skinny label we we never said they couldn't do that and in fact our position is that if they here i'm not i'm not selling you with that you're not selling you with that ok so where in the courts coming from in that question and and i don't look on that as a representation may think other than what we're yeah that's where i started ok good good because you want to look here's what here's what the can only get help you well let me it lends itself well that certainly is about opinion letters but think about it in this context your honor if they were saying it was a light so that they could protect continue to protect their opinion letters how can they turn around and say well you know that but it but it was right in terms of us being able to make a determination that harm was imminent in terms of the pulmonary injunction and the point that i wanted to get to directly to iran because i you know i want to try my best to see if i can sell you on this is that if you look at what the council says is making a distinction at that point in the record between getting want ready and whether they will ever launch before the expiration of these pacts they're getting it already talking about engine they're getting it all ready for an ultimate decision maker to decide and what's the decision whether or not we take that product and we launch it before the expiration of the pads now in that context your honor for us to be sitting there and told that even though f d a approval has occurred and even though we were in front of the district court within three weeks with three and a half weeks after f d a approval occurred your honor that we that and we delayed the district court felt that it was jammed i get that it was very frustrating for straighted by the fact that he felt that he was jammed in the situation but i would ask your runners to consider whose fault is that is that our fault or is that the fault of the people who were telling him thirty six witnesses that we're talking i say i don't buy or b i think that this records closer to that circumstances and knows squarely on where the district court is i hear your honor and the one thing i would say to you is it's one thing if the district court said you know what i'm looking at all this including what you've going to me to and i don't buy that he didn't say that he never even dealt with these these statements that i'm reading to you and so what i'm saying that we well your honor he certainly certainly should have been aware of them but the fact that he didn't say anything about them i think that this is done as a fire drill and he wrote what i thought was given the time constraints and given the fact that he has to deal with the heaviest docket in the country right now two hundred and fifty dollars cases per judge per year in delaware the fact respond to that because i think george carlin is a terrific judge we've been in front of him for a couple of years now on this case and so i am not suggesting that judge connelly is somehow you know sort of lacking in terms of you know sort of ability  you i can convince the court that in that context we if there was any if there was any sort of blame is not even the right word if you're going to put the risk on one of the one on one of the porters in view of those