therapeutics and issue in this case is nearly two years of patent term or lifesaving pharmaceutical product that the patent office charged as applicant elect despite admitting  district court that for at least five hundred forty six days of that just turn just clarify where we are it as i understand it you're not disputing that you could have probably be charged with the thirty days which otherwise would be saved by the safe harbor is you miss the safe harbor where your contention is that you can only be charged for the time after the fond of the opposition in the european patent office yes your honor so essentially yes i mean there are a number of different ways in which you might carve this up and frankly i apologize for some of the math in the brief certainly i think for five hundred forty six submit that there was nothing further that we could have done to advance prosecution and that that's got to be off the table under statute one fifty four b two c one of the statute requires in terms of the period of time that the deduction equal to  is for you to agree with us that we're entitled to this quantum of additional patent term and then remained and you don't care how we got well in all candor yeah that's correct your honor however  i think that the patent office recognizes there's an issue with ca they do that in their brief i think it's a page thirty nine where they say look there are times when an applicant is going to get charged but you know what this is not a regulation it's reasonable so hard she  think you have sorry that that's not right you have to be consistent with the statute and then they come back and say well the one makes it sort of consistent with the one really doesn't isn't maybe i'm wrong but the one i don't see is that really as a as a fact here because you're saying ok we didn't meet the safe harbor provisions of the one still you can't dock us for a period of time february twenty to twenty let them through eight twenty one twelve when as the parties agree and you cite that paragraph nine we couldn't do anything and then we're waiting for a ruling on the r c is precisely right you're right in fact i actually think the one highlights the problem we see it as opposed to being a broad and they are caught in the situation just i mean this is classic being raised by your own pig heart here i hear your honor i mean there are lots of ways in which we might not have the privilege of standing before you here today one the patent office  acted within four months right right there to we might have filed within the this thirty day they call a safe harbor and call it a life preserver i guess because it certainly doesn't seem like it's any boats in my view we also could have said our hands and here's why i think it's really crazy we could have intentionally delayed we could have sat or has and just waited and waited and see what happens with the  congress said it's important for us not to charge applicants unless they're actually doing something the fairies and trying to create submarine pats on the rohrabacher statements in legislative history w suggesting and i think what the patent office admits and their paper is this provision of the patent office which it deems to be a safe harbor would actually reward folks for sitting on their hands and doing the opposite of the the patent office has done here in terms of its regulatory scheme the one demonstrates that it's not doing what it's supposed to do it hasn't saved the application of c eight because see it has two parts in the first part there's an assumption baked in and the assumption is that the applicant can have done something from day one here we don't have that and the second part is the is it the penalties goes further and identifies the period of time in which the applicants going to be docked and that's nowhere present in one fifty four beats you see three in fact congress was very specific in b to c one they say here is the period of that you can be docked in this circumstance and then in c three it says mr patent office go ahead and identify those circumstances it says nothing about qualifying that period of time and when we do look at the period of time spent in which there are you basically is that we're trying to have a bright line rule here we don't want him the each time period calculation result in a complicated litigation and so this is reasonable that's basically what they're saying and and i mean are they right would would these complications potentially become complex if you have to do it on a case by case basis and determine whether the pat knapp in that act reasonable i have three three points to make on the air on one first of all just because setting a general rule if that gives saying that general goes against the statute you're out little but so with respect to to the general setting you know that doesn't save you if there are situations where applicants get swept up in terms of the case by case here i understand the panels doesn't want to be charged or have litigation every time they do a patent term adjustment calculation but if you look the way that the regulations are set up there's a delay and b delay and see delay and you have to subtract out the overlaps and then you look to see what applicant delays there an offset it by that much i'm not so sympathetic to an argument that we can't do a particular ised assessment when in every case there is p t a there is already done a particular  assessment well but i guess there are even with this you're having another complexity on top of what is already a complex fashion but if you want to take advantage of it is it true i mean is it true that it would make it more complicated if we were approached at the way you'd like but i don't believe it does at all if you look at those pages of the appendix which i've set forth for your honor you'll see that what the patent office does now sure so it's mechanical but if the patent applicant wants to take advantage of the want the lifesaver right then they need to come forward with facts to support the application of the one which the patent office is ready to look at an every time it was confronted with an investment situation at determining whether the applicants efforts were only reasonable and that could get pretty complicated well we're not looking at reasonability here though in this in that sense honor i mean frankly when you see a number like five hundred forty six days pop out of calculation that the charger six hundred forty six the charges apple can delay that ought to raise a red flag i don't think we're talking about hundreds or even dozens of cases where that's the case here the for whatever reason the patent office upturn on the amount of law and it's they have an interest in having a workable system and what they're saying is  every the terminations required us to look at what the applicant it or didn't do make an assessment as to whether that was reasonable that would be unworkable it seems to me that it would be difficult easy fix to see it's not my place to tell the patent office what to do of course but where there is it where there's a situation where the applicant did not have access to that information the patent office seems very willing to have the applicant provide that information and considerate already on a case by case basis with respect to do you want that's the fix just ask just have it have it in c eight a sit in a situation where you flush out let's make the applicant flush out the the the the ability to have access to that information moreover your honor the statute is the statute and congress said equal to or equal to the amount of time in which you failed to engage in concluding prosecution reasonably by regulation and just by ease of administration you can't violate what the congress told you to do because only ask you one question i assume that you would have no problem with three regulations ca if it said submission of a supplemental reply or other paper other than a supplemental reply or other paper express expressly requested by the examiner after applying has been filed in which case it is the key part this period of adjustment adjustment set forth in section one point seven zero three shall be reduced in accordance with the provisions of and then that seems right to me or i mean that's that seems exactly right as what you would say is the way that regulation shouldn't work and in that case those five hundred forty six days at least maybe even the thirty days in which you could roof there could be some line drawing you might say for example well look we give you the you took notice on day five forty six you have thirty days they convention safe harbor it was day thirty one that you did five forty six is what me what that particular circumstance at what point what's the circumstance at which your applicants fail to engage it's not a five forty six part is it after is a day thirty one after you receive noticed etc that's what congress asked them to time for each one of those fifty seven days the member i talked about c eight how it has two parts and the first part baked into it in the sumption the assumption being that the applicant could not have done anything from day one  provision that gilead could point to and say aha you are at odds with the mandate of congress with stat with with particular statutory language here we've got that it's it is one fifty four b c one is it and c three taken together even or separately for that matter that's the that's where they ran afoul by virtue of the c eight regulation so i think one we have action we're not challenging whether it's actually the delay or or or potential for delay here we had a bunch of delay on the on the part of the patent office and it's not fair for them to use this regulation which is against the statute t that eighteen months off of our patent to her actual delay otherwise i don't know that you could show actual delay here certainly the patent was delayed quite a bit but i don't  acted reasonably using the statutory language this is to me that just potentially opens up all sorts of problems where someone in your position could say well yeah they sanest the opposition from the european patent office but you know that x then deliver our copy and it was it was reasonable for us to be delayed because we didn't get it and straighten out with that x until two months later so on and so forth you can imagine all sorts of or stories where applicants might say well we behave reasonably even though we were late and it seems to me that if the panel is trying to avoid getting into that kind of situation which is a reasonable checked there are what's really is a reasonable objective but you can't go against the mandate of the statute congress an equal to the period in which the applicant has failed to engage in concluding the application of the process of the application reasonably if that's the concern then there are mechanisms within the patent office where they can say look they do it in d one they say let us know what the facts are and we'll assess them and we'll see if you're entitled to this safe harbor or not and then we can challenge that so that's already there in in in the regulation with respect to that the thirty days but you can't just say it doesn't say for the patent office has informed the bar has affirmed the happened here was it as a result of your making you can actually cause the delay and therefore you shouldn't be docked for well what i'm saying is it's a good it does answer that question well here the statute says we're  docked for that period equal to the amount of time in which we fail to engage reasonably in concluding prosecution the patent office admittedly looks that for five hundred forty six days of that six forty six in which we were docked there was nothing further we could have done but to advance prosecution i don't really believe it adds is that question at all again gillion presented the question of actual versus potential for delay which had no statutory hook whatsoever here we have the the very language of the authorizing statute one fifty four b to see want that's is equal to and everyone on this side of the bench agree that there was nothing more that the applicants here could have done for a year and a half for five hundred forty six days of that period therefore by docking us that amount they are adverse to the statute there against what congress told them they must do and thank you thank you very much i will give you two minutes for a status request i mean aside from a safe or well or aside from the safe harbor of course if they'd done that we would not be here at all but they also could have submitted a status request that could have called the examiner the notion that there simply locked out and this is a black box is incorrect but even setting that aside i think i'm explaining that they could have done what they could have asked for a status report from the european patent office no star they could have filed a status requests with a patent examiner your honor essentially sorry when was when with this there's no specific timeline essentially if the applicants are trying to push their application along they can contact the doesn't understand what you're saying i'm sorry why does that how does that bear on whether they could done something  when they made the argument that during the entire five hundred forty six days there was absolutely nothing they could have done to try to reduce this amount of delay or to try to move the application along and that's incorrect because they could have filed a request for status they could have reached out  potential p t o delay which i don't think there's any doubt occurred here early specially occurred here in the p t o reasonably rationally and subtract the time that has actually been wasted or potentially based and that was the back to the request had something that was stripped or than that and said you can't be charged with the way if there was no possibility of doing anything to avoid the lie it's a statute so that if there if the regulation triplet to have that standard that if there were no possibility that the applicant could have done something sooner i still think under john are that the future rationally could subtract the amount of time back to c three they're entitled to the strongest administrative deference and again this case is under arbitrary and capricious the future only needs a rational reason for subtracting that time and whenever applicant interferes with the peaches ability to timely process applications not just appellants applications but as it's not the only question that question is whether the applicant behave reasonably or right and congressman civically said that the p t o gets to define that term except for one narrow example that was defined and one fifty four itself once the p t o defines the failure to engage reasonable as filing an s during the time period after an r c a it's almost a natural byproduct or least a rational byproduct that the next step would be as attraction of p t a time would go back to the r c of self that's the potential mount of time that's been undone that's been wasted statute says show be reduced by period equal to the period during which the applicant failed to engage in reasonable efforts to conclude prosecution and for the five hundred forty six days the parties agree he couldn't do anything that hasn't been in the briefs that isn't in dispute it so isn't a situation where here the say during that period ending on a guess or this twenty first twenty twelve during that period in there how did the i d s of do when he that he's saying i'm on the hook for the period you know when i didn't file during the safe harbor a life saver provision whatever you want to call it but the period that he's being dark for the five hundred forty six days the parties agree couldn't do he didn't nobody everyone agrees in print if i'm wrong that he couldn't do anything during the five hundred forty six day period so how can you doc someone for that period when the statute could have tried to move the application on the issue of that argument before the briefs are designed in the briefs is not your honor i mean i don't think anyone's argued that i don't recall anybody i mean i could be wrong i could have in the priest but it didn't seem to be anywhere in the briefs that the office was saying there was something he should have done during that five hundred forty six day period as far as i can tell that's the case am i wrong i think during that time period correct there was nothing that you could have done about the european patent office letter because but there were some office didn't say she could have done anything more i think ultimately your honor setting aside we think that's  an argument why is it a rather than if the statute says you're on the hook for a period during which she failed to engage in an rezin in reasonable efforts right act and everyone agrees here that during the five hundred forty six day correct correct your honor but what it what did he not do that well looking back retrospectively is often how we can determine whether a party was failing to reasonably engage in the p t o can say that that time period that's been undone come up i'm sorry how often does this particular problem come up under d one specifically you know the sort of situation that we have here is this a is this a one off case or the other cases like this it's actually relatively common your honor for parties to learn about as a matter of course as far as i'm aware no other parties ever challenged and this case we think is even easier because of the d one provision that allowed them to possibly buy something or are other there are other situations which people miss the safe harbor and the same well so i think if i understand your question correctly you're on or you're getting at the the case by case inquiry that appellant said it is not required but we think clearly would be within its illustrated by the fact that appellant's themselves don't seem to be able to agree on how much time they information through other litigation and also met and i d s and they can raise the exact same kind of arguments that appellant's have here obviously and that but apart from that about apart from situations where there's and we didn't get the information so you couldn't have done any are there are there other situations where the question of what constitutes reasonable efforts come about i think and even in a fact pattern as the court saw and delia at parties could raise a kind of argument if i understand really at during appellant was arguing that well what if we have a situation where there's information sitting in the mail room and we don't know about it and i think your honor even mention that kind of example well that's an argument where they're going to say we couldn't reasonably have submitted that and therefore we entirely entitled to issue bright line rules like c h and then especially in a case like this where they make an exception or do you want because that badly want this kind of information to be submitted timely form patent office information and w deadlines to that the statute impose us with respect to these proceedings of those deadlines interact with the interpretation of the word reasonable under and that we're looking at well i think it's a good way to frame the case you of delay or potential delay by applicants behavior and filing this i do yes and so they do kind of work together on arts the peaches in a way trying to prevent what you might call double dipping in terms of time here they're saying we're not going to give you a delay type  it would depend on how late they follow a rule one point nine seven which was cited in the but no your honor sets wider timelines for when it hard can submit information that doesn't mean they're going to get p t a time for and that kind of dichotomy is in the statute itself section one fifty four have violated deewana i think under their duty of candor on a one point five six i would say be a violation your honor i think it would be would be very risky because if the next office action was a notice of allowance and they could be subject to a huge delay under a huge reduction that case what was saying is i guess leaving aside for the moment when they did file the i d s i guess the p t o on september thirteenth of twenty thirteen issued the first office action after the filing of the september of the february two thousand and two two thousand and eleven r c e and who they have would they have been untimely if they had filed the idea in other words would we be in this situation so the one was implemented in two thousand they came back and fixed in two thousand and eleven as her counsel argue that well there are situations where folks learn about stuff in litigation well that's not the one at all i mean if you actually look at the brief  by the agency by the patent office that it was to encourage people to file i d s as in those limited circumstances serially or otherwise i guess or hurt a question or a suggestion that maybe we could  to the examiner with a status report or pick up the phone and call the examiner well had we done that the day before we learned of the european material that would be an other paper advance the prosecution it turns the world on its head by filing an other paper that is a status report request we have them fall within the realm of c eight because the patent office didn't ask