the united states court of appeals for the federal circuit is now open and in fashion god save the united states and this honorable court first case for argument this morning is twenty dash one thousand and seventy four amgen versus a credit st the patents were about produces the antibodies within the clams the two anchor antibodies to brand new antibodies created by the inventors together because this last is this is drugs laurie a testing knew any buck in the bodies determining whether they had the functions of walking and binding and the court also found that it would take a substantial amount of time and effort test for these broad claims now that sounds like an do experimentation and that's the key factor in the name and so you've got a pretty uphill battle function which is blocking the fact that they buy into a particular region as dr pepsico explained that binding means that they have to have the three dimensional structure and the electro chemical complementarity the binding to the sweet spot is in having the electrochemical complementarity and the three dimensional structure is the strike to be able to bind to the sweet spot is the structure the kids do that function of blocking but i don't think that really should matter because ultimately what the question is can you make the each of the four oxley's four hundred distinct antibodies without undue experimentation and there's two things that i would want to talk about with respect about the st is the road map and the road map is using in twenty one b twelve on the right and as a result because those two cover the entire sweet spot skilled artist ones can use them to identify all of the at most four hundred distinct antibodies that bind any one that sweet spot and the record shows science superman eyes mice this to anchor antibodies this is actually the opposite of cases like a direct where the artisans are asked to find a few small molecules that treat h p v likely millions or at least tens of thousands of list possibilities with no guidance except individually synthesised each test each for activity that sort of specifications more like a trial and error research plan to hunt for you needles that work in a haystack ones that don't not do not but here you have the standard tools of advice science like immunize mice the reliably generate the full spectrum of plant down to bodies and dr reef six planes that look if you do superman is a sion you will be certain to make all the claims antibodies including the defendant's examples and with out and do experimentation to come up with the four hundred or so that bind to the sweet spot so i don't think in terms of this the roadmap there's any real question on this record that filtering antibodies down to those with the desired characteristics was not under experimentation forty years ago the jury was allowed to reach the same conclusion now and certainly wasn't required to accept the contrary as proven by clear and convincing evidence i think that w when the district court was talking about millions or difficulty of coming up with them all there are two things going on there st the court credited snow if you're a general on speculation that quote you could be immunizing maestra one hundred years but there might be some kind of dance body the body will bind but i think the answer that is you can predict and the evidence showed that if it's going to bind to the sweet spot it will block and the way antibody scientists when you look at predictability you don't it will block and but the specification here tells you exactly how to make those four hundred dollars immunizing the mice and using the of the two anchor and the bodies which cover the full sweet spot to find each of the approximately four hundred dollars distinct an would you not agree that there are two functions that have to be met to enable these claims so to deal with in the claims i think the answer is it would have to buy i to the sweet spot we do that is structural because you have to have the three dimensional structure that you can sort of visualize in order to match the size the unusual shape of sweet spot and the electro chemical compound charity but if you want to call the functional truly shouldn't matter because the standard tools produce the approximately four hundred dollars distinct antibodies that will bind to the sweet spot and will thereby block the interaction i mean whether or not you actually produce th using the mice or the other mechanisms to stop wished through the roadmap is a factual question and there was evidence there from which the cherry could find that yes you will produce each and every one dr e specifically so testify that you will cut those every one of those distinct ones in the full set of fifteen or sixteen depending on the claim so i guess i'm having trouble seeing where your road map in your examples get you to enablement of the full scope of the claim which would also include the competitor antibodies which seem to me substantially different quite well that there was no evidence that the competitor antibodies warrant and the three hundred and eighty four that were produced was in the three thousand these are simply the want these are ten of the twenty six representative and their bodies that were fully characterized for which we gave sequence and other information in the patent there's no evidence whatsoever that the three hundred and eighty four dollars didn't include things like these competitor antibodies but even something to that aside testimony was that it would produce each and every one of them and the jury was unable to credit that and look they didn't even ask him if he originally didn't even ask for the three hundred and eighty four examples that were produced by our roadmap in order to show gee there might be something missing here it's very hard for the jury to say look you're missing something from a three hundred and four you're about doesn't produce it when the other side didn't even characterize him and say look there's something missing here is there any truth to the notion that gee these are going to come oratory you may have noticed that that number did not appear in the district court's opinion and that's because that number was never presented to the jury or the court to the contrary we asked and this is a three thousand eight hundred and sixty nine we a inventor how many species if you do the roadmap how many would successfully accomplish the claim function his answer quote i don't know a specific number we then asked our expert dr reef same question this is a and two i can't give you a number on what the total is we have no idea how many candidates other companies universities other countries came up with and didn't publish or didn't follow or how many others would come up with if they had an incentive to keep trying this number four hundred is not in the record it's not supported by the patent moving on to the issue of predictability which is really i think as judge laurie noted the heart of presented on unmaking twenty six examples so why hasn't been able to we as you know we believe that the written description opinion was erroneous and we can talk about that in a moment if you'd like but under wyeth and identical and so it is plain that if you have a functional limitation and in this case we don't merely have a functional limitation we have a purely functional claim that if you have a functional limitation you have an enormous number of candidates and here the candidates are in many millions in fact astronomical if you follow the rules of the patent and you have to test each and every one well that is a classic example of unto experimentation so the fact that i believe the district court of the knowledge of golden california hills during the gold rush the fact that you knew that there were gold in the hills and that you knew how to use a pan to find it doesn't mean you were entitled to every ounce of gold on every square mile of the california countryside that's really  and so and why it's in those cases can you help me absolutely your honor in it to use the analogy that counsel used about the needle in a haystack if if this is a needle in a haystack juan's was looking for hay in a haystack  onto experimentation to screen of course that was the entire substance of this trial was the number of candidates how hard it would be to screen with the predictability was so the central issue in this case was not an issue it was at all and that's not surprising because the issue and frankly the the full scope analysis done in this case simply wasn't in play it wants well can i just ask you a little bit about that because i'm still a little confused about why the number of experiments matters if the experiment themselves and the methods to be used are predictable and maybe i'm just not understanding the fact here clearly i am not a expert in this area and the science is hard but it seems to me that  we have a pretty detailed road map of what you have to do to either through the route way of doing it or through the conservative substitution way of doing it to come up with different antibodies and then you just run kind of conventional tests to determine whether they are internal and how well they work why it is the fact that you might have to do that a one million times versus you know a one hundred times as long as qualitatively it's not difficult  experimentation a couple observations on that your honor if i may st it was important that the district court noted this is a twenty three that the roadmap that we heard so much about in the papers and in counsel's presentation would required does require essentially same amount of work as as the original work i mean step two of the roadmap is just go out and generate antibodies and screen to see if they perform the function well that's that's what they were doing originally  reece their expert as to the quantity of experimentation which is of course the fundamental question here said that doing analyzing those millions and millions of antibodies to see whether they work testing them would be quote an experimentation then more work than any scientist would even contemplate doing so that's really the focus and i guess that argument can i just follow up with one last question then yes sure thinking about this in larger terms of you know claiming a genus in terms of a functional claim like we have here it seems to me that the logic that you're proposing and that we would have to find then is that essentially there is no way to  claim a large genus of a functional claim if the only way to figure it out is through running every single instance through very routine experimenting and very predictable results is that correct i mean how would you how would you claim that the genus of antibodies any other way well you run to the primary way you claim a genus in any field is by structure not by function and of course we can get to the the how of arkansas but that's but that's what i'm asking about and i just i don't know the answer to the i think our president is not altogether clear on that is that basically i mean is it so difficult to claim a function only because it's always going to result in an und experimentation it's just not permissible to claim a genus functional is that it should be claimed by structure i am not sure as a factual matter i would go that far your honor particularly as the science evolves we all read in the paper in the last two weeks that the protein folding problem at least by one account had been solved so there may be a fact pattern and there may come a time where function dictates structure sufficiently that it is predictable and therefore the finding of  i mean when you have their own experts and dr malan the inventor saying the only way you know even with a single amino acid change is to test it and that's it a three hundred and seventy six a and that was specifically about conservative substitution when those are the facts of this case it is difficult to envision how of a functional claim could possibly be valid under again the circumstances of this particular think it is for the reason why they are not unable but either one of them you have to test for bookbinding you have to test for blocking so yes it is it is doubly problematic for the plaintiff in this case for amgen but either one of them would be more than sufficient to justify upholding the district court's opinion if if i'm mates are there any other questions the court has on and the enablement issue well that's the that's the main issue right kinds of fits quote bind to different parts of the sweet spot quote come in a different orientations so there was no commonality among the among those twenty three dollars d structures to the rest it was admitted that there was not sound like you could say i can i can visualize i can see that structure and i know if it's repeated it will bind or it will not bind what is in or out your point is right and it goes beyond that you're on a if i may then very briefly on written description i'm sure i'm on time i did not i should have started my timer the one thing i wanted to note on written description is that the court the district court found that it failed or rather it satisfy the representative species test for one reason and one reason only and that was it found that one of the disclosed antibodies was eighty percent similar to one of the competitor antibodies the problem with that finding is there wasn't a single expert on either side of the v that said eighty percent similarity tells us anything because the difference between similarity and identity is is light i mean i've been told i i resemble one of the denver nuggets centers facially but no one would say were identical in any material way i stink at basketball and i'm not seven foot to the test that everyone agreed to was eighty percent identity as the minimum threshold for finding representative species and it was undisputed that there was not eighty percent of between any of the disclosed antibodies in the patent and any of the competitor antibodies similarly and perhaps even more importantly it is undisputed that no antibodies to school ost in the patent are e g f a mimic or as your honor mentioned previously bind to more than nine residents and gent did not have the g s a mimics yet they claimed them and they claimed that they possessed them through the written description analysis and they simply didn't if you want to look at and ninety seven quote we don't have any g s a binders maybe those are the key to pfizer success so the basis of the district court finding this really goes to judge laurie's question about the relative threshold respectfully of the district court the basis of  conclusion that written description test was satisfied this is simply incorrect under the undisputed factual record and of course that was just that was it sex question for the jury which the district court affirm its finding that the written description test was satisfied by engine that is why i pointed out it was it was a simple misunderstanding of what all of the experts agreed was the appropriate test that test was not even attempted to be satisfied by hams and so with that thank your honor i would like to start with two items the st is the road map and then turn very quickly to conservative constitution because that's where this goes and billions comes from for the road map if you look to the testimony cited on page th and two from dr race he actually walks through empirical experience on how many antibodies were found and explained that it's a small number he comes up with closer to one hundred we were generous and said four hundred but the undisputed science is the kids on the show the shape and the small size of that sweet spot you just wouldn't expect a large number of distinct antibodies to buy in there it's going to be a small number which brings me to conservative substitution interrupt this is just since we're talking about conservative something to show and i'm not sure i quite have my facts right but the number kind of and about at least in my head was that that could result in you know a one million combinations i understand your  about how it's not really all that different and solution considering that way village it's assumed that that number is right and you know you have to do the test on every single one of them to determine whether it binds and blocks or not why is needle in a haystack even if you were and we don't actually believe that the requirement for enablement is you have to be able to make some very odd him every single conceivable body not within a period of time but if you can make them  particularly produce them according to the method that isn't even an experiment it is production and if you were liable to make them it's not an do experimentation it's a success and that's why this is the precise opposite  question of fact for the jury the jury decides what's relevant in terms of the features and the jury decides it as a matter of fact and dr pascoe put up the models and a light box to show where you have hydrophobic greasy patches which tend to lie and which need to line up and it's really not relevant for oral argument for these purposes if the court has now questions i really want to thank the court for its indulgence thank you if there's other questions we ask for the court to reverse and i think we heard in the entirety of the argument i want to thank