compounds that issue was not done within the united states and a number of other of the i'll call them preliminary stages without putting any weight on what preliminary or is not really at issue in this case is it that is why all  ok ok now i have a patent on something called the onco mouse that i i developed at harvard as a researcher there at the cost of many millions maybe even billions of dollars of my university funders how does that onco mouse get protection under the way you read the supreme court's decision well the supreme court decision doesn't really reach i think specifically what you're bringing up because it reaches it specifically tell me how you're going to deal with the ancona you what mark you're mark and you now are developing a drug for breast cancer and you of course are going to test it on situation so that in that instance you would say the the onco mouse has full protection of the patent act and you would be paying the royalties is that right well and we would negotiate the royalty amount well i believe that well from the perspective of briefly and i'm asking you what merck thinks you are not taking the position heart i gotta have a position on that that's the central issue we're going to be dealing with here well you're on respectfully dissent because the supreme court the solicitor general and even in canberra offset that the compounds being used here were not used as research the compounds may not there were a few methods there for patents ones they there were two experiment at issue here that is all there receptive and the let's not go into this case just stick with my own come out well well you aren't i've only got ten more minutes to know you're going to suspend him on this issue so you might as well get used to rid you and i know that there never has been there was nothing for them to raise an issue about so you had until the footnote eighteen the supreme court's opinion you did not have a research tool exemption now apparently under the footno are these research tools or not if there is no record on which the judge could make that decision because i have to make a record that's why you remand record as to give them a chance to do whatever they need to do to build the record to make the decision the supreme court has given us a new question which we never had to ask before is it a research tool now we have to ask that question it's only appropriate to build the record on which make the decision you  research tool use that may be exactly right in fact that's pretty close to what the federal circuit said the first time around but that's for the district court to decide right  why because merck didn't know enough about the mimetic to know what it was testing that it was just a search for some sort of a new pro but in fact the record makes very clear through the testimony of dr goodman and through the the the contract between the parties that all of the medics that were being tested head to head with th high level acids where animals were caused to get a disease because they're more traditional i think you don't have to pursue those who are really there because my food and and rabbits are more traditionally pre clinical embassy and the safety and here i don't believe there's anything to a man to the district court we're talking about there the mice and the rat acids the record is clear there is no testimony that those assets did not contribute drawn between the kinds of results the kinds of data the kind of research that would be plainly pre clinical within the scope of the sachin and that which would not and that  call had once the opposite tried it came in to say the the i have does not care anything about ethics the mechanism of action or pharmacology cares about safety and only safety and so did not bring in a single witness to say by the way that she has a really doesn't tell you anything about advocacy and it called no witness whatsoever so it cannot be a jury issue where the pla you're breaking it down as to which experiments might have generated the information that we go to the f d a can we look at it in terms of which patents are incapable of research tools aren't something within the exemption why can't we deal with that well known that the supreme court said that it has to reach that issue it has not gone yet because there was of course no issue to reach before they said well they understood so then you'd have to break things out according to which experiments were performed with the research tools that and using that tool as a tool not to improve the tool according to the clinical trial studies of the european court an excellent distinction perhaps to be adopted by u s law as well are you familiar with these  at trial that will would support any other division this experimental program other than by the type of assaye that's how the case was litigated and that's how  own on the premise that the supreme court did indorse the jury instruction and that's exactly right here precisely right and i also would point out that in the last paragraph three fourteen is the express the quote the form of that it was indeed in fact real law the infringement at the i called the preclinical stage the experiments that we're now talking about that is before those that were necessarily are required to be provided to the f d a the jury i'm not sure i understand your honour's question the jury did found that these experiments and for his claims yes on the basis that it was forward with evidence and the burden of persuasion so the operative question in this court is was the jury required to believe any of the testimony with four or five of the witnesses relied on time and if so does that by moving back the boundary of the data which would be relevant to f d a approval with respect your honor i do not believe the supreme court was all that question because of the issue about whether or not this court that whether or not the we are here we are the answer i suggest to your honor that the answer is not that difficult if you look at the evidence that we put forth was in the briefing go down the witnesses they were not required to believe these witnesses dr cherrish was impeached not one but two federal district judges judge keep in in denying merge motion for summary judgment and judge fitzgerald in denying murs motion for judgment of the matter while the end of the trial both of those judges found there were significant credibility issues with dr jerusha testimony and the jury was not required to believe and what does that have to do with whether they check data sufficiently close or exemption because they would or would not be of interest to the f d a no your honor i don't say that matter of law i'd say that is a matter disputed fact which was decided by the jury based on its assessment of the credibility of  really saying that the supreme court decided you know an issue but i have the perception that this particular issue was quite precisely joined before the court in fact before us we've got understand the intricacies of the supreme court's new standard and testified precisely with that in mind i don't think they need to testify precisely that in mind these are facts and with their understanding with the law and the test of the supreme court supreme court is that the new reasonable related test is broad enough coming leave adequate space for experimentation and failure on the road to regulatory approval that's correct to run a supreme court also and that and that's what they were all testifying to right is that we were doing this experiment regardless of success or failure and we knew that it was within the exemption or without honor as to what inferences can legitimately be drawn from these experience what was reasonable for them to believe and there was disputed testimony about that because mr meyer and mr young flick both said that of action for each of the sixteen can now here there's not ten witnesses listed there's only five and as you can see here dr cherish carries the brunt the first axis the only support listed here by murder is dr cherish testament do you think if the jury had understood africans see mechanism of action pharmacology and pharmaco kinetics to be part of the reasonably related standard they would have made the same finding your i believe the jury did so interesting because the jury instruction that they were given is consistent with the test adopted by this united if we conclude that you don't have much left except in all type of patent what is the effect of that on your the only argument to be made is that the patents are research tools i think the jury the verdict still must be sustained because clearly for the reasons we put forth in our peptide that to have a cell attachment property that that's a research tool it can be used anything can be used as a research tool urine underneath you and that's exactly what happened here the drug experiments or or would you put it more in the ten percent category that you've mentioned is eleven percent the partners agree but if in fact that were something that that seemed to make sense with this argued to the supreme court that there was a certain small amount of activity which was in fact sufficiently removed from anything that might have been viewed as a submissive bill to the f that it's in some other category whether you call it basic research or research tool whether there's a distinction between the i don't know but in any case officially removed even from the broadest view that the the government was taking as to what was exempt i believe we stated in our research that these ties were used to control our for for ten percent of the experiments the supreme court did category termination and there were two problems with that first as a district court said look basically the evidence was the same for office categories and there was no real basis for deciding differently as to them but more importantly there are important distinctions that we are that could lead to different decisions in trucking the point i was making about the chick cam lances about a lot of them were used as controls in which the peptides themselves were not being tested but the did what they did do is take the statutory exemption and define it broadly more broadly than her absolute way in and the courts had in the past so from that viewpoint th would be a different overriding premise of law before the jury than that which they had even though the trial judge's instructions were in fact are repeated unsupported by the supreme court of the court remarked that they were somewhat broad and the narrowing would come from the full at the statutory interpretation and application which i think you must agree pushes back in time and therefore in scope in sweep the experiments and the kinds of experiments that might be considered relevant to ultimate f d a registration do you see it that question here because merck had the burden of proof merck had the bird come in for credible witnesses the operative question is was the jury required to believe these witnesses and clearly was not a witnesses in fact the court should do that the courtship confine itself to the procedural issue at hand the procedural issue that the supreme court didn't touch and sent back for this court to deal with which is strictly the application of rule fifty review was the jury required by law to believe dr church to believe mr bines and the answer that is clearly not to district court versus hyundai three or three after sixty two that's out of the first circa two thousand and two in those decisions the courts have held that we are a party employee or even an expert witness t d for the party bearing the burden of proof and are not cross examined with respect to their testimony the jury may not disbelieve their testimony simply because they are employ purported cross examination and dr cherished i would urge the score to actually read what it is i'm sorry with respect to dr houston mr florence got up here and said there was testimony about efficacies and the chick