judgment stemming from its decision to strike x s experts infringement report how i did it says expert's opinion it was not a new theory at most it was a subset or targeting a subset of the to try that again traced to the mab and taxane and the experts in frederick theory accused that the same treatment treated with cat cilla following pretreatment with these two other chemotherapy agents why is it so my firm was not involved that specific time in this case we came along after the infringement contentions so after the motions for summary judgment were ordered it was fudging his position that there was no narrowing the fear with the whole time was also did not say at least traces of mabyn attack saying what what is the percentage of patient population they would receive the drug with just those two other drugs so i think i read somewhere in that express myself but i think i read somewhere that the narrowed if you don't mind me using that phrase the narrower infringement contentions would only cover four percent of the people who take this medication is that an accurate statement i believe that was the prognostication that jack's expert made based on the data before him yes it would be a small percentage however we're willing to adopt the the the district court found that disclosing the broader contention of administering catskill to all patients mean the criteria required by the cats a label meaning at least trace through the map in a taxing before cat cilla does not adequately disclose and there  what it is right correct me if i'm if i'm in gentex shoes and i know that there's this broader class of patients who are accusing infringement i have to develop infringement series for all of the various subclasses this is not the same as a new infringement theory where you're embellishing someone l litigation with new infringement theories that they were not aware of and the one made this error worst is when the court applies case law directed only to new friends with theories not nearer theories and there's no dispute that the court relied only on case law concerning new theories the district court not the district court and not gentex has anyone identified a case where a district court properly struck in french with theory for being nearer than what was in the didn't do that that was didn't text mistake about the abuse of discretion standard that we have to apply how obviously very deferential yes it is your honor first reaching the factual factual mistake that the broader contentions don't disclose the narrow contention that was it was an error that led t combination with gentex admission that it's encouraging capsules administration in accordance with that label those two things alone should have provided sufficient circumstantial evidence on the intent element of inducement to get past s now where things went awry here is a court look past the instructions on the castle label and proceeded to apply case law concerning off label administration or off label prescription of drugs and although the court said that that's a distinction without a difference that's not actually true and these on label cases such as the santa fe case you can infer the drugmakers intent purely by the instructions on the label and that's where we are here to the castle label and we can look at it it's at appendix two thousand two hundred and fifty two specifically says here's cat's cilla you should give it to patients that have been previously treated with traces and have an attack saying that's the infringement theory that's what the label says you should do infringement you start to look other places to try and infer the drugmakers intent because you don't have you don't have a label to point to and in that situation like judge freeman did at the district court she looked at the prevalence of the drugs used in a specific infringing scenario and other factors that were not appropriate to look at when you're in a situation in an on label case and sanity actually actually says that as well you know if there are substantial non infringing uses or there's a low prevalence of the specific infringing subclass that's immaterial when the intent can be inferred from the drug label itself circumstantial evidence to find intent to get beyond summary judgment in this case reserve the rest of my time for a vote on it thank  summary judgment of non friend meant and on top of that this patent does nothing but express a plan and hope to look for something that might work with breast conditions and it's therefore invalid for three different reasons but you cross appeal that's our cross appeal expert because obviously it's a very deferential standard of review from this work which which defers to a district courts both application and understanding of their local rules and their understanding what was going on in their courtroom this district court had presided over this case for several years at the time she struck the sec hurt she heard a tutorial kind of talking hearing she heard argument on ruhleben she heard argument on two summary judgment sions and she recognized that this was a market change in the infringement theory and correctly so and that it would prejudice us and i can explain how where do we have where is the prejudice the prejudice it's both in the in validity and infringement that still so this was before the infringement contentions basically were based on the cuts i would label if you're taking in accordance with a kind silently will then somehow that triggers this inference upon inference an inference that infringes these patent claims and throughout the litigation priest suit to that is your infringement theory then gentex own clinical trials anticipate your patent claim inherent as a patient what infringes infringes now anticipates before and that was and so and the district court found that only after the court rejected their priority they claim to two thousand and five did they change their theory and that debunks a notion they didn't change their theory they did  district court found that that was the cause and effect that they changed they didn't tell anybody either so they didn't comply with the local rules in trying to change it and they knew how to comply with the rebel rules because previously in the case they had moved to him in their infringement contingents after they didn't test or do you you think there's a distinction between narrowing your theory of infringement and having a negative limitation or is that the same just a semantic distinction no i think it's critical and it's what matters here and so to the infringement theory what they did here was add a negative limitation and the upshot of that was before it had been the entire cat silent population infringes when you give cats  according to the label and now it's affirmatively at least ninety five percent of the patient population does not infringe and this suppose in some population which at best is less than five percent if it exists at all  the infringing population now gentex does need to do different studies and different tests because we need to do discovery from them why now do you think what's different what's different about a patient who only receives trustees imagine a taxane and nothing else that makes them infringing when you don't think it's a patient who has received other chemotherapy agents infringes we need to know from them why that's different and now the ninety five percent is effectively a control over right they say it doesn't infringe we would need to test that and we had no reason so as we should have tested the whole there's no reason to test any subpopulation they had never and why but if even if we thought they were breaking it up into some populations which ones would we have chosen gender age you know prayer or other conditions health factors supposed that i'm trying to try to distinguish between the narrowing that one would regard as being assertive in the ordinary course of things if you drop a few claims are you drop out several patents those are narrowing that no one would even blink an eye at that's happened all the times perfectly fine versus the kind of prejudicial negative limitation or other changes that you're saying really do  change the whole ballgame in a prejudice potentially prejudicial way i mean if if i added that our claims only extend to people with grey eyes let's say that's not technically a negative a limitation but it is a strong restriction of the class of potential infringing conduct in a way that supposed would would you say that something like that had the potential for that it couldn't reason that you're saying it couldn't let me try another way to explain why this is prejudicial here all along there we were taking their infringement theory their broad infringement theory that whole cats aila patient population infringes as a concession that any art that covered that population would therefore anticipate if it predated the patent they took away that concession that would change the how we would frame our invalidity defenses they also then added the defenses and they're adding a concession that we didn't know about that now we need to figure out why is it you think those people don't infringe and what is it about your claims and the cat silent drug that makes it act differently in these two sets of populations and so whatever it may be in the case in other cases and you know you can think of other kinds of hypotheticals this case it was prejudicial the district court who was very familiar with this case and the theories the parties had advance in it recognized it was a change recognized prejudiced an antec recognized that it and laying prejudice aside that you know separate and apart the does report concluded they violated the local rules by not moving to amend at which would have required them to show diligence in doing so like they done that they moved timely and she concluded they had to move timely she concluded that if they wanted to change their opinion after february order they need to do so right away and said as your honor mentioned the late waited until may and they didn't exactly directly tell us we had to confirm with them that their expert had to change their theory and she said that prejudiced into it was too far along the case trial was set for november of that year trial is set for months away in the judge that in order that their the is different than the sanity case because insanity case this court recognized that the label there expressly called out the sub class that was infringing it's this is different this case is different in two ways from stand yet this case is in some ways not like anything you've ever had because they're claiming is that this the label which says give to somebody who's had trust to some in test trustees who have an attack saying it's totally silent as to two things in a way that is different from sanity is completely silent absolutely nothing about encouraging actively promoting inhibiting pacts to or expressing death be one which is what their claims cover so most of your cases there's no there's no space or leap of faith between well are you are you not encouraging giving this drug to somebody who has the hospitalization risk factors that are covered in the claims the question sanjay was you know did does the label do that in this court said yes it does because it says give the drug and then the only example of people who would give the judge for that purpose were in the athena trial which was there and it had it laid out the factors that's not this case there's nothing in this case that directly you know where the the label here is silent both as to the claims  says nothing disclaims and it's also silent as to this supposed it's up last there's no active inducement with respect to those who have received and nothing else and then unlike santa fe as well the district or conclude that this is a hidden additional limitation were people give this drug only to people with gray eyes that that's the french my contention and the labels says nothing about great she just says give the drug to people who satisf indication that it would be limited to people with particular covered under the supreme court's case law and this court case law i don't think you can infer from the label that was silent about very eyes the level of promotion and encouragement that would be required to allow a case based on on the label as this one is and in here there's the added fact that they don't dispute that and best you know the this supposed subclass is less than five a very small that the vast majority of the patients and that's backed up they would be receiving and contrary to the standard of care they ask a standard of care is that you should receive a rd agent per jetta when would your answer be different if it was the class that was identified w not five percent but was ninety five percent it would be perhaps a harder case your honor but no i think the label would still be silent that late the label is silent again the gulf here between what the label says it all and what the claims cover the there's that you get into the willful blindness here there's no evidence that jinn in tech knew that encouraging anybody to take cat sila was causing the expression of packs the inhibition packs one expression of death you want to think willful blindness has any application at all to intent in the supreme court talks about it in terms of knowledge and global tax but not intent and in from the criminal law from which it drives it's really talking about knowledge on intent so do you think will one uses a place for analyzing intent well i think one can like break it down into sort of too many buckets that to not matter the question is do we meet the statute which requires active inducement and you act and you have to have the specific intent to promote or encourage someone to infringe the claims not just take an act and when you when you look at here there's there's no we had no knowledge that giving cat sila to anyone much less this sub population that they come up with very late late late into the case was it was infringing their patent claims but i ask you about the cross yes please  i'm wondering why we have jurisdiction over the cross appeal now you've correctly i think identified this as a cross appeal case perhaps in an excess of caution but in any event but the problem i see defending a judgment on an alternative ground because it seems to me and i'm the we have a couple of cases that that talk about this it seems to me that there is no jurisdiction in that setting unless i'm missing something well so we did not raise a counterclaim this is just a defense in this case and so it is an affirmative to go ahead so that i think your appellate jurisdiction judge price and stems from the one thousand two hundred and ninety one judgment on an infringement that's the judgment is properly to satisfy all the requirements for jurisdiction for an appeal which would mean that you couldn't appeal from the denial of summary judgment if it's not across appeal i have for some reason such as that you didn't file a counterclaim but rather you felt the defense and therefore you couldn't your judgment isn't going to be broader than a simply a not infringement judge but then it seems to me have to deal with the problem that the judgment if it's predicated on your defense of invalid it actually is broader in its effect on the plaintiffs right because in a later proceeding for example the collateral estoppel effect of a judgment on that it's predicated on invalidity would bar them in a way that a judgment predicated on an infringement but not so it seems to me that suggests that they don't have to be across appeal and if so where do we have jurisdiction was so i think you have jurisdiction over the case the only claim in the case is their claim the only claim in the case is their claim for infringement the judgment on that claim was entered in our favor on grounds that we don't infringe and that they have no evidence and principle and that's the top line when judgment that judgments on appeal we know to that i think the two i but i think because i think the questions are separate do you have appellate jurisdiction over the judgment yes i think you do under one thousand two hundred and ninety one the only claim is their claim judgments entered there's a final judgment this case that cases properly in this court if we want to defend the judgment  on the alternative grounds that the claims are invalid because that would i think it could be a clue to things because that it can't be that you can't reach it because it's an alternative ground to the judgment that's probably before you so i think you probably want to do things we did appeal in your view  no because i think a conditional cross appeal is it has a different meaning i think it's well in other words if we rule in your favor on the issue on which you're absolutely are you saying we nonetheless should deal with the cross appeal i think you don't have to w think that's i think we would like you to hold these pans invalid because just as a public service like these patents are they they are just merely a plan to hunt for something they lack utility they they aren't enabled they are hugely broad they don't specify any compounds appropriate did you run across advanced software design corporation that standing here and it i don't recall are and some con against my con those are two cases that deal with this problem now advanced software's like this case with one exception which is an exception you pointed out that had a counterclaim in it so i'm other than that it's a cookie cutter of this case so i'm wondering is that enough to convert this from a case in which as in the event software case we dismissed the cross appeal into a case in which we don't i think that your suggestion earlier was yes that's and i think yes i think it is an important factor because i think the only claim in genesis infringement theory stemmed from the court's decision on a priority date issue as miss maynard recognized that decision came down in february of two thousand and seventeen the month before that in open and thirty specifically there was discussion of some potential potentially invalidating prior art and if i didn't his counsel said that will this this previously clinical trial they're being given a much different cocktail here that's not just true su the way it's worded i don't think it needs to say herceptin attacks and nothing else when it says her stepped in in a taxi and that's what the contention is and just to be clear perception is is a brand of map on the on the prejudice issue didn't check recognize it did the district court did find there could be some prejudice over the actual prejudice is never really explained again if the infringe contention is say i'm targeting people with gray eyes blue eyes and green eyes and then later the expert says well sorry i can't support those theories on the ladder to the defense still has to prepare it's not infringe a position w about that what we heard from meaner and about how there with the broader infringement contentions it was some ability to rely on those for proving validity or applied to the broader theory doesn't apply however i haven't seen from genentech any specific prior art that falls into that looking at their position as if they were practicing a part and so they were practicing the part it was dang not included in  more narrowed infringement contentions again i don't i did see that argument being made in the briefing or any specific instance of a piece of prior art but if that were the case would that be a prejudice thing it could be law but the real dispute here pertained to whether there was under experimentation which is also a factual inquiry on enablement the real question came down to was the was any experimentation required undue and there was no real quantifying evidence hard evidence quantifying the amount of this experimentation it would be required hygenic says expert analyzed the wants factors and said no one do experimentation expert says well looks like the number of compounds you have to identify would be enormous i don't know what enormous means the district court in either this case is not like the law of case where there was evidence showing that the experimentation with it had been performed on tens of thousands of compounds each of which would have taken weeks to assaye that's a life time of on to experimentation we don't have any such quantifying evidence here on written description presented expert testimony on the issue extensive expert analysis saying the person of ordinary school in the r would have understood that the inventor was in possession of the invention gentex countered that with attorney argument only and fo utility this court has told us that that's usually not a high bar there is no debate that the patent is closed utility with respect to prostate cancer hygenic says expert provided testimony indicating that you could correlate those findings  understanding with respect to prostate cancer over to breast cancer showing the utility there and i believe i'm out of time thank you thank you at i really appreciate that and i'll limit my comments to the cross appeal the that this pattern as i indicated in my opening remarks really just set forth a plan to hunt for something that may or may not work with breast cancer every working example is about prostate cancer and there's nothing in so that so basically for all for the same reasons it lacks utility testimony that a person is feeling are not just in for from the fact the prostate working examples that that that they would work with with breast cancer and the patent only says what could be done what might be done the examples beginning with example twelve will be determined might be considered the district court held that there was nevertheless a disputed fact because there was she felt like there was an analytical reasoning the patent to go from the one to the it's a method of treating that compositions that are defined only by their function so and under the claim construction order it doesn't encompass just things that directly affect facts to your death the wind but also anything that indirectly effects the pathways upstream from them in such a way that it affects them and that as is it's undisputed is an enormous subset and but in the end they say well it would be routine all they say is w be routine to test but one all they say is it would be be retuned rich routine to test for pax two but they there's not a single example of a class of compounds or any compound of them then that you could use to treat breast conditions so the column eight through column twelve there's just a laundry list of large molecules and small molecules and but they point to nothing in the patent and nothing in the patent teaches anything about treating which was even an example of something that treats breast conditions or breast cancer and then there's no examples of how to effect death be one in which the claims covers well instead they focus on will be routine to test for what affects packs too but even under wyeth the enormous number of compounds that we need to be treated especially given their infringement theory now that it matters what you had before so not only do you have to figure out which compounds are in you know in this that you have to figure out like and under what conditions would it matter and nothing in the patent teaches someone a skill in the art how to do that