i think that one hundred fifty morning your honour's may please the court jonathan singer for a balance in assessing unexpected results in this case the district court made two errors that dramatically affect the outcome court elevated a statistical analysis of phase two data much of which was confidential in place of what the prior art reference actually said about the freeze to n perhaps more importantly what requiring a statistical analysis of that data versus looking at what the prior art actually says the overall rate the overall effect of that was to  most significant statement in the stevenson reference which stated that the most consistent results in this is the shermer testing your honor we're cheve by the point one formulation and that was not addressed by the district court in its decision and that's because the district court rejected that claim that statement in the prior art based on  two and i think it's important because the prior uses this language of comparison of the priority here is comparing one formulation to another to treat that prior art for what it says in using comparisons it proves the point if you will your honor that using a statistical analysis to assess it is inappropriate and that district court erred in doing what about using th considering it there because i think as our colleagues on the other side said you are allowed to judge whether or not the unexpected result actually occurred but in saying that baseline of what persons of skill in the art would expect  that's what we're trying to address you have to look at what the prior art actually said and i think it's important particularly with the face to face to it that the district court's opinion is at cross odds with each with itself it says that the phase two was not designed to yield statistical it's just that we significant differences between the various formulations and then found not surprisingly that there weren't any and that therefore persons of skill would treat all these things the same because they were statistically significant differences but that's not what people of skill were doing they knew that these this study wouldn't statistically significant differences but nonetheless were using it for the very purpose of the district court said that they would not which is to make comparisons between the various formulations to figure out which ones to move forward with going behind the prior if you will to use an assessment of statistics in contradiction to what the prior says is there i think the second point that i would say dramatically affected the was searching for something that would in fact treat the disease i even would in fact inhance your production and by treating each thing the same the district court elevated those things that didn't ranges in the formulation of the patents and suit fell within those ranges and so this court's range case law i think both sides have argued different aspects of that case law this court's range case law is semantics we've been arguing about an important ones nonetheless but yes we acknowledge that that is what this court's authorities say and then the question becomes in terms of the burden shifting approach or burden shifting isn't the right word the burden of production that this court places on parties like gallery and is to come forward with evidence of unexpected results teaching a way a result oriented and sure it's not the burd to production absolutely and that that's critical here in the sense that allergy and came forward that that's what the trial was about was whether allare and had satisfied that burden in showing unexpected results and therefore in making errors in assessing what measures were relevant what the prior art said in setting the expectation allegan didn't have a chance if you will if statistics are going to be required if statistically significant differences are going to be required in phase two then no once i'm going to be able to meet that standard in setting the expectation because frankly studies are soo small and if you have a prior reference structure in that sense flat out that one formulation is the most consistent in the measure that is most significant the actual objective measure the court ought to rely on that and not go behind it to make a determination at page a fifty one of his of the district court's opinion that the p values for that difference weren't significant enough the pri will judgment the ultimate efficacy of this product comes in there's a lot of dispute about it between the parties as to what the measures are appropriate what or not and the f d a is the one the agency charged by all of us to assess whether products are safe and efficacious so they can be marketed and the f d a determined again looking at statistics and using those statistics in the way that persons of skill used them that the point over five formulation was favored over the point one formulation and the district court rejected that finding again because the district court went behind that analysis to say well that's not a difference between two formulations logistically something being favored that's not enough it has to be statistically significantly different than each other again when the studies aren't designed to show that what we're trying to show we're getting drugs approved at the f d a is whether things are different than  point out of the range and nobody would have predicted that it would have had this effect it ness because everything else points to a completely different part of the right and that the differences here seem pretty minor and isn't that what the district was or it was focusing on what i said at the point one probably worked ok but the point five works a little bit better or maybe a lot better well actually i think the the the you have to take the prior for what it says in the point of five was all and in the corneal screening and other standing measures as was the worst performing and essentially didn't perform to do prove so but there is other evidence supports the other way and i know your friends on the other side going to get up and start quoting us to all that evidence may think we should just disregard it i'm not saying you should disregard the the other evidence but that other evidence doesn't point to if you will to choose the surprising result you have to remember is the increasing improvement on subjective measures which don't relate to the claims and then say ok we're going to double the amount of the vehicle which all the evidence at trial would suggest would hamper the formulation that's the surpris versus its its activity and in the in the market place it certainly that has to be relevant here are if people do not believe that that patent has sufficient strength if they believe it to be not blocking other things that they might do because they'll do it it will still be covered that has to be part of the it isn't that the patent that has the range that covers this specific formulation it does judge choose but but that people tried and attempted to use point one in point to cyclists warrant it has to affect the analysis of a blocking pattern and the district court did not assess this that people looking at this at which  described as a block did not hurt as a block and that's that's i believe what the a court case says that this is a fact specific inquiry as to whether things are in fact black and passive or not under the economic good morning they please the court this is a case about unexpected results and our gann lost that case at trial on the facts our again trying to tell a story a trial in which the percent formulation of psych was foreign performed better in the phase two trials than the point zero five percent and then the point five percent supposedly surprisingly perform better than point one percent in the face three trials and this is the basis of their own expected result the problem our dan has is that the district court found in an uncommonly thorough and detailed one hundred thirty five page long opinion that as a matter of fact the two formulations in the phase two trial performed just about the same and the two formulations in the face three trial performed just about the same and to extent i think that that all makes sense  what i hear your friends are going as we should look at any of that stuff because the actual part of our references said something different but that's not accurate your honor and again the district court was very careful to look at the references themselves on the publicly available information in determining what expectations a person of skill in the art would have formed and so for example the district court looked at the stevenson reference which was the publication that described the results of the phase t trials and one can look at the face of stevenson and see the key results it says and this can be found at page one nine two hundred of the joint appendix the results on the face of the reference are there was no clear dose response relationship between point zero one and point zero five there wasn't a superior performance in other words by the point by the higher dosage of the drug and it says that the point and contrary to what mr singer suggest of the district court of course was very careful to look at exactly what the reference described and you can find that page forty church pardon me page forty two of the court's opinion the discussion of the fact that on some measures a point one percent performed better on other measures the point of five percent for in better what stevenson says in black and white is so i can score an eight point zero one percent produce the most consistent improvement in and point one percent redeemed the most appropriate formulations for future clinical studies which is exactly what then happened in phase three those two formulations were put into the face three studies so what the district court found based on steven was that a person of skill in the art seeing no dose response seeing that all of the formulations tested had a few to no side effects had negligible blood concentrations would have thought that there wasn't a better performance  that's not at all in the just recorded your honor i think first of all the court was very careful in its analysis to distinguish between what was publicly available and what was confidential information with regard to the f d a submissions however the unexpected result is supposedly that point zero five percent performed surprisingly and unexpectedly better in the face three trials it is fair to to look at the available data  quite apart from not to figure out what a person of skill knew i would have expected but to find out whether there actually is a difference in a fact at all that would be surprising or would not be surprising and so what the court did was to having evaluated first the publicly available information and concluded that a person would have thought they did the same but one of five percent of the point one percent performed the same in phase two and in phase three the court then looked at the underlying data to see if perhaps there was a different  difference in effect that was not reflected in the publicly available information and concluded that no even if one looks at the underlying data one sees no difference in performance and i think it's not correct to suggest that the district court required statistical significance instead of considering what people of skill in the art would have thought at at page forty nine of its opinion the court specifically said it was not requiring statistical significance as the t unexpected results what the court did though was to evaluate and of course there was testimony from from our experts there at the other sites experts were not the only ones to put in evidence our experts testified that people would read the prior art and expect no difference and even to the extent that people would have been surprised in two thousand and eight in one thousand nine hundred nine when the phase three trials came out any surprise that they would have had would have been gone by two thousand and three which is the relevant time point for people still and they are looking at these at these facts so it's just not it's just not true that the court required statistical significance in order to find an unexpected result i would note in addition that you know it's one thing that the argument that that our gang makes at one point in its brief is that people of skill in the arts sometimes can can reach conclusions or make expectations without having the benefit of statistically robust studies which is of course true but it's one thing to say that people of skill in the art can form expectations in the absence of statistical evidence it's another thing to say which is what they have to say here that given statistical evidence that there is no difference in performance a person of skill in the art is nevertheless free to say well i don't care about the statistics i look at the graphs on my own and without regards to just six i make my own conclusions that's what the district court  rejected so i think again as a matter of fact it's simply not true that that there was an unexpected result z the evidence on that is is  really extremely strong on the question of the legal standard it doesn't sound to me like we have a difference in opinion on that i think everyone agrees that there is a prime aphasia case of obviousness because the resta formulation fell within the ranges disclosed in the doing one patent that it's then up to the other side to come forward with evidence of unexpected results if it wants to overcome that prim exist beat the effect of those secondary considerations was blunted by the existence of the cats won three four two patent and the dang one patent which revealed the solution to the problem no commercialization of them but that's yes because the point is that so the logic of the commercial success as a secondary consideration non obviousness is that where there is an economic incentive to solve a problem and where the solution is obvious people will bring a product to market that solves the problem and then later products the market won't be as successful but the fact here is that even though doing one told the whole world how to make these kinds of emotions and the patent that the resistance formulation is just one sort of example from the set of being one that doesn't perform any better or worse than any of the other examples in the set from being one people specifically for the purpose of preventing other people from bringing computing products to market so it's a little ironic for them to say that you know we don't know if anyone else was blocked well then why did you listed in the orange book it was clearly their intent to well i think that what a quarter was doing when it talked about the facts and circumstances it was it was responding to the comments in the merc sharpened down against a case which suggested that a categorical rule that simply saying if there's more than one patent covering the product therefore we throw out commercial success we don't look at it i think i think that a quarter was saying that's a sensible rule we can't have a categorical approach to this sort of thing but but one has to be sensitive to the what at first appears to be a blocking patent may not end up blocking it for example because people are willing to license it and in this very case the cast won three four two patent was developed at the university of georgia and on by sand blocking patent when it was owned by someone else who was willing to license it i think those are the kinds of factual nuances that a court of permits people to consider when they are in the record but record it doesn't say that there has to be some searching examination  of additional facts i think what a court of says is that based on the limited evidence that's usually available on these sorts of things that district court has to make a judgment and that's what the district court he did here i would also point out that there was evidence in the record that these were patents and that that evidence when uncontested by the other side of the court can find that at j eight hundred sixty four of sixty five which is economist testimony on the blocking effect of the patent in the market and the fact that by two thousand and fourteen when doing one expired our dance position with wrist isis had become so dominant that it was not an attractive molecule to compete with so i would just add one one other point going back to the obvious question mr singer ended with the notion that the surprise here was that the point five percent formulation did as well in the face three trials as point one even though it had a higher concentration of castor oil and of course there was plenty of evidence untrue at trial that castor oil can be a good thing that castor oil is good for treating dry and in fact the dang thuy patent the six zero seven patent specifically says that the installation of the castor oil emulsion without the cycles or an increase is the measured pure volume and that can be found  hundred seventy six so there was plenty of evidence from which people in the art would have thought that increasing the castor oil was a perfectly sensible thing to do and in fact being one had examples in which the ratio of cycles foreign to castor oil was the same as that used in the restasis product and they were found to be perfectly suitable emotions to use for the treatment of dry and so this notion that there was some kind of problem with increasing castor oil is a figment of elegance imagination it was a it was a fear that some people within our van had based on secret pharmacokinetic studies that they had conducted that lead them to think that it might be a problem but when the trials were actually run it turned out not to be a problem and in that regard thank you ray geissler is instructive which we side in our in our briefs which says that if the inventors have an  about the world that turns out to be wrong later it it doesn't mean that people still in the art of the later point in time would necessarily share that assumption and be surprised and i ask you kind of a housekeeping question in your friend can either confirm or  sort of a person that the patent because it covered restasis was a blotting pad the point i was trying to make in my opening argument was the a court case talks about this being a factual based inquiry and as part of that inquiry it ought to be a law that we can assess whether others efforts while they weren't after the same formulation as alec yet were covered by the so called locking hat that would inform the analysis of whether or not a pattern that's a quote assumed to be blocking really is regarded in the industry as a lock and the important point to remember about this is that was exceedingly narrow it related to requiring two particular experience at particular levels and so people were free to develop other cyclists warrant formulations at their will and therefore the patent wasn't really regarded as blocking the ability to use cycle of spore and to ultimately fill the need and then finally i would just read for the court two things from stevenson and compare to what the lower the district eal stanning cycles for an eight point one percent produced the greatest improvement from baseline and cornell stating and the district court rejected that finding at page a fifty based on the p values from the confidential face