good morning everybody will begin this morning with case number sixteen dash three thousand four hundred and forty four and from pharmaceuticals l l c versus bio farm it will start with mr w morning your honour's for the record gordon go beat this appeal involves a critical legal issue reviewable de novo and it's whether the trial court erred in failing to instruct the jury on the wall surrounding the ownership pharmaceuticals which is a generic pharmaceutical company organized by one of the top pharmaceutical seculars here in chicago is a virtual company and so mr canby organized the company would pick products work to obtain f approval he was responsible for marketing and distributing the the the product and then he would contract out with rd parties to do manufacturing in this case while farmers that was the manufacturer in the trial all sides agreed that that was the terms of the arrangement there's some very specific things that we cited in the brief that were greeted by both sides but after the f d a approved an terms product while farm essentially held the product hostage refused to ship it and and we brought a claim for breach of contract because their refusal to do so the issue here our position is it's controlled by federal law federal law controls the question of who has the right to market and distribute a pharmaceutical product and that right only arises after you file an application you prove the safety and efficacy of your product there is some information on your background is the owner you have to deal with potential pat challenges liability issues there's a whole back and forth process between the the owner and the and the f d a to obtain approval mr dubey i know that judge did not give the jury instruction that you that propose and there were some issues with expert which i know we're going to get to but were you limited in any way from arguing factually what you're trying to propose now so we just leave we we were we were not argue the lawyers were allowed to argue their points and that's obviously one of one of our complaints so you were able to argue to the jury that as the and the owner you also owned the underlying pratt to all sides argued made these these points and they actually put in an expert on the stand to testify as to what the law was from their perspective so rather than the than the judge instructed the jury on these points and the significance of this whether you can have a secret interest in them and of the wasn't disclosed to the f d a whether could be held in trust which was their what you could argue as to that point where i know on the expert there were some restrictions and on the jury instruction but the court from what i could tell looking at the transcript did not limit you factually in any way from arguing that is that fair that's that's fair yes so factually we're able to make the point they were able to make their point factually they're also want to have an expert testify on this but this is i mean the bizarre thing about this this this trial just seanie of is that that was the critical issue dispute was the ownership of this and we had a we had a jury instruction that the ownership of it but the consequences of the ownership of the consequences of it they they said that that they own within trost and a point in their fifty three page brief that they never address ok and so let me just tell you like for example the jury instruction this is the best example that an unbiased farms counterclaim  by a preponderance of the evidence one antrim promised pile farm that would provide bio farm with an ownership interest in s a telegram and exchange for manufacturing the product now what does that mean by the ownership interest in this a teleg issue and that is issue was never was never presented by the court that legal issue whether or not you could hold an interest in trust whether it could be just transferred contractually in secret without anyone knowing about it and this comes back to the federal that that i'm talking about so which you have argued in your proposed jury instruction number eight yes you wanted the court to instruct that if you own today and you all of the underlying product essentially it's a paraphrase and but that's what you wanted the court to instruct the jury on as a matter of law you have cited a number of federal regulations in your brief can you identify is the owner it talks about a change in ownership of an application a if it doesn't talk about who's the owner of the product it's focused on the application and requirements and what you have to do with the f d a if you want to change the ownership of the application for that and it sells right you're jumping to the product from that explain to us how you get to the product from product you're the one that's responsible for the products liability filing reports every year there's there's no where is it that says your premise there that that and that is the product it's i astri that we talk about in the brief there's no underlying product other than the and there's there's there's nothing there there's there's less alternately there is that there's not there's a there's a is they so when one party is in the fore and this is one of the things we want to have our expert testified to when he was blocked from talking about and that's a separate issue right and so that the issue is a relates to this is there is no there is nothing other than the ndaa and so when they talk about it product as being something separate there's simply isn't under the under these regulations there's there's there's no our client interim didn't have a physical product that it owned they weren't asking for an ownership interest in our company the only asset that arc that our company even own was the anvil so when they said we're not give a ship in less you give us ownership interest and in some instances they said of the anda in other instances they would say of the product there's there is nothing to own other than the end up but the issue before the trial was the contract for the ownership of the product the issue is not that and that no i don't think i know there were issues surrounding anna and i wasn't in a trust but the main issue in the breach of contract was who owned the underlying s position your honor is is that the that there ready was no the issue in the trial was not who owns s a telegram out in space i mean ownership comes with it you have to you have to own something the only thing the only only thing that our client ha drug scene scene the of because because it's the issue was was rephrased by by a form it was i in our judgement it was attempt to misstate what the federal waters here on this i mean that that's the whole that's the whole reason why we did this and we didn't just file the jury instruction we when we did three things we filed a motion in limine to prevent them from making this argument that there was that there was anything there we moved specifically to prevent their expert from being able to make this argument develop on that how does that differ from the expert schwartz so expert schwartz was a was a lawyer a former f d a lawyer and his sole job was to get up on the witness stand and testify without looking at the single document of the case without on is is specifically not something for expert testimony and and bio pharm doesn't even respond to any of those cases in the briefs not to work and they don't respond when we talk about what the regulations provide now one cit their expert report or in their brief about the long these issues the only thing they say to put it back to it back to the question i just asked and you're right he testified about what the f d a would infer yes but i did that read his expert testimony as saying this is what the law says well i mean i think i didn't read i'm staying at as this is what this regulation stands for it seemed more that he was testifying about based on his experience with the f d a and then attorney at the f d a who had handled these that when they received him and the application this is what it meant to them yes so he was in the legal department he wasn't he wasn't a review wasn't his testimony about an owner of the product that was at issue in the end you know used to use he said that you can contract and sell amanda without having  wasn't talking about the law at all he's actually talking about his experience with with and those contract manufacturers and and and in the like i mean to me the idea that you'd exclude somebody who's who's done hundreds and hundreds of these type of contract arrangements and exclude his testimony on this but allow a lawyer to get up on the scan the judges and give any instruction on the legal issue and give his give his issue correct so the issues that he had to do with they're talking about the and and the most significant thing i think from from the briefs is is and in fairness to the to the district court what i mean what happened is that my question was for the next question that was asked that distinguishing between the product itself and the end that not just the and that he was testifying about the pr own anything other than this one and that that they're one and the same his his you wasn't even opinion about whether they're one of the same he was good his purpose was to testify that there was no significance essentially no legal significance to the f d a by the virtue of the fact that that the application was approved in the name of antrim our point was that the fact that the parties agreed that an interim would be the owner had had all the significance in the world and and that the only issue in dispute for the please the court counsel on this appeal in terms of trying to reframe this case as a dispute about who owned it was not it was a breach of contract case in which the primary dispute was whether there was a contract at all st additionally to prevail on its claim you had the burden of proving its own performance causation and damages by preponderance of the other and as we said out in our brief we believe that this appeal starts from the premise that all of those factual disputes were resolved in  meant multiple instances in which they are but the most salient of which is this focus on the alleged for material terms no there were more terms at issue and under negotiation and indeed for example if you look at numerous terms under to get under to go shushan and with the example he gave the primary simply gave was a lack of a quality agreement and he is the head of quality at bio farmers known for saying somewhat of a disciplinary no quality agreement parties didn't reach to an agreement and my client's position is that they were not obligated to sell the product that they made to antrim without an agreement and it was indeed it was the refusal to sell that product to antrim without an agreement that kicked off this case if by a farmer's relationship with anshul was not exclusive why wouldn't buy a farm then attempt to sell the product to others prior to expiration because well while far manufactured the assets help was obviously hoped that the case would settle it did not and ultimately the product expired and they did not ultimately go but the other reason to your honor is that this is a market that continued to great over time and it's one of the reasons we believe that there are also no damages in the case but those are the to me but do you have any case that would support that failure to file a rule fifty motion would waive your right to challenge a jury instruction or the admission of expert testimony or exclusion of expert testimony no your honor but here the practical effect of it is that if we start from the premise that there is no contract then it means that every all of the legal issues that were raised by angela her most are because there was no offer an collapse into one another in terms of the four elements they require to prove it only law to prove a claim for breach of contract as a practical matter doesn't make any difference if the instruction was erroneous or if an expert was allowed to testify but shouldn't have wouldn't that fifty i think it depends on the case judge i have an i q of admit i have not gone through the other possibilities where it might or might not in this case if there is no contract if there is no causation there is no damages there are no damages  schwarz to testify and mr schwarz testified about what the f d a would infer from it and the application and ownership issues that the court would not allow and granted the motion in limine a on relevance grounds to keep out the testimony of an trump's expert mister i'll mess up his name but mr print jealous and how do you distinguish th schwartz left it for the jury to decide whether an agreement was and the reason for that the reason that was important evidence was that the primary way that andrew tried to use this argument about the end in the product was the logical syllogism that we put on twenty five to twenty that my client and how tempted not have any contractual rights to some kind of equity arrangement in the venture of selling its product once it went out and that was that was really what mr schwartz was there to rebut that that it was not any kind of evidentiary admission from which testified in mitigation why wasn't mr print jell sense opinion based on his years of practicing in the industry not with the f d a but it dealing in in the industry and submitting and and working in this it's typical that party structure the relationship in that way that's not relevant here in this case as to whether anshuman biopharma should remain even if it's true i say i scran for the sake of argument that in literally every other instance every other contractual ation ship  to manufacturing and a holder it was set up the way that they said that doesn't preclude my client from doing something different indeed all that i that was his opinion was or was his opinion that based on his experience the person who filed the so i want to start with were we i think we're replying to the last time some questions just seemed that you raised again about the product we've now heard still another theory about what's the product that's even different from what their position was in the brief and so i want to take a minute on this because this is been a moving a moving position in their brief this is a piece twenty nine running over a page thirty one fact witness in this case and the question was asked of him this is mr shaw what is the product in not own it who doesn't own it nobody owns it that was the position in their brief that was the position it was in the trial but remember this what they told us is that they refused to ship that they were refused to ship because they were getting ownership while they were not getting ownership of something that nobody owns this goes back to mike and so now he's telling you and this is this isn't even in the brief there's the physical product that was in the position of the trial court that was in the position even in their brief that that's asking for ownership of the n b a that has nothing to do with it there will sit st and so that is absolutely not the case and then when the trial started they took the position that antrim was actually holding the end of court in trust now they filed a fifty three page brief nowhere in their brief you can look through it again and again are you going to find one state with them explaining their position that there was being held for them in trust so they in closing argument they said the and it was being held for  interchangeably and that's how it's used in the regulation you know a company will say i own over many products and think you're talking about the ownership of the anda ok it was a physical product that's not in the position that's in there brief of the denial of their counter claim but they sued us too and the jury ruled in our favor in connection with their counter claim and so if you apply the law and try to decipher what will what happened here it's our view that this case began and then with this issue about the ownership of the of the enda and for that reason the failure to instruct these issues that we raised about the experts exclusion of ours that they had their experts century to testify of the agency's intent and motive we would respect we asked the case be reversed and remanded still be one more quick question we have on jury instruction eight when the court rejected at it invited you if you wanted to submit an alternative at the final pretrial conference that you could i couldn't tell if you submitted an alternative to jury instruction eight at any point did you do so we did not submit an alternative instruction there was no dialogue with the court rejected out again i did