possesses the necessary qualifications and you know i've said this before that we have one of the weird things about being a judge is that we pick the best candidates out of a large group and then they join us and in cases like aaron they nonetheless far exceed whatever high expectations we had in the st instance and then in the real world you law firms or your companies work hard to keep those people for as long as you can and in our judges world they leave after a year year and a half we have to say goodbye temporarily but you know i say to women's groups that i speak to i tell them i know you want to be and you will be therapy with lawyers and i know you want to be and you will be fabulous mothers but you can have it all but maybe not all that watts well sometimes there's an exception and we found her in here  even charity is amazed at the way erin is able to juggle her life and that's a pretty high feat so it's understandably very sad that erin and her crew including my st set of twins grand clerks be moving across the country but have no doubt for her future success personally and professionally she's  joy and comfort to my chambers and i thank her for all of hard her hard work her great judgment richard judgment her warmth and just the pleasure of having her around so thank you generous in the time maybe the st time but not so much in the nd subsidies prosy thank you your honor and may please the court in fact that's where i was going to start and explain that this case in the one that follows involve methods for delivering e some sort of fact to finding that some point i don't think so because we have a complete and total taking of our patent claims in both of these cases so there shouldn't have to be in a sort of individual evaluation of the taking here and ultimately what we're saying to this court your honor is give us or our patents back that's what we're that's the remedy we see from this court is just the right court to tell them i mean what about the court of federal claims will in this case be there the court of federal claims could give us compensation if this court were to say one affirm the judgment of the peta and then to not rule substantively on the takings claims in this case but i think both sides have urged the court argue that we have waived this by not presenting it to the agency but in fact in article one agency would not be in the position to declare its own statute that created it unconstitutional and so it is that the the most well st of all i think i'm tempted to say without being too cute about it that marbury versus madison is the answer to that do you have anything that's more specifically directed to  think the more specific direction is both to say that separation of powers answers that question yes they do have both marbury and separation of powers are pretty general you have a case in which the supreme court or other courts have but same time i would point out that in the case that is cited by the government for the proposition that we could have raised this that was a case where the remedy that was great that could have been granted at the agency level was the replacement of t are constitutionally appointed but it does if it is it seems to me at the very least passing strange to ask the agents in article one agency to declare that it is itself remember that that vast body was judged article three judges were selected and put on that court suppose that the judges of that court that concluded that the court itself was unconstitutional create created the temporary emergency court of appeals problem article one judges would start see one article one judge in to article three judges and they couldn't do that i think would be a harder question than with if you had article one judges about their authority to do that and in fact you know i remember the oil states argument sitting there waiting to argue the sas argument where the chief justice took issue with the petitioners counsel in oil states for even referring to the administrative patent judges before the p t have as judges it is if i if i may i will be certainly happy to continue with the constitutional argument i had intended to start with happy claims and then get to the constitutional this before for other panels not me and for other panels and i think what they've said in terms of their authority is that well how do you implement that if you find it's unconstitutional what do you do with that and i understand they're only answer is well then we don't institute because we have the authority to not institute do you have a better answer than the government's because i you know will ask them but if that's their sole  place to use it but do you know any other anything else they could do within their authority if they viewed the statute as being unconstitutional i think that they could either decline to institute as they've suggested on any patent that was issued or it perhaps applied for before the effective date of or they could i suppose institute and then make a decision that as a final written decision on that very issue and then say we've instituted but we regret that we instituted because we don't have the authority to do that the i p r statute of course is unusual in that regard in terms of the institution decision and the final written decision to make with regard to the comparison to dinner parties reexamination which this scheme took place of when congress passed in a party's reexamination act it made it prospect of only and that's an important distinction both with regard to what congress did later as well as what cell genes expectations were at the time of the patent issuances with regard to beneath future in at once by congress that surely any sort of you in that in that light let me let me ask you that looking for an analogy here in another area suppose under the homestead act of eight hundred and sixty two where people were given the right too get property in unsettled areas on the condition that they settle and form their supposed that the act that had a provision in that said that said anyone with a previous felony conviction was not eligible for the homestead act allocation and congress discovered after five years that a lot of people who had previous felonies had actually applied for and gotten grants of homestead  and decided this is causing all sorts of trouble on the frontier a lot of violence and decided that they would let them in at the statute that said the interior department may inquire investigate how it to whatever extent this case to adverse possession and even if the even if the the nefarious land obtain or in your hypothetical had obtained the obtained  though he or she had a felony conviction i guess an eight hundred and sixty s would say he the practical reality would be that at some point even if he didn't have a claim of right at the initial at the initial time or he was not proper he should not have probably been given it maybe by in terms of investment and in terms of reliance in terms of all of the the requirements of the everest possession law he has a claim that he has regardless of what  conditions were at the beginning a claim of right after that happened and i think that's analogous to what we have here but i'd also add your honor that in that case you're talking about a one choir meant that was in place at the very beginning of the reexamination statute i should be clear about that was passed when celgene received its property right it had every reason to believe that the only adversarial litigation it would face to take away its patent would be conducted in district court under a strong presumption of validity which would have to be proved by clear and convincing evidence in this case it is as though to use an a land analogy that i've been thinking of i own a house in northern virginia and i believe that i have the entire bundle of steps to both my property and to my house but let's say that the leverage in your legislature decides to authorize or imposed the ability of  special panels of boards absolving appeals to revisit the question of what access the public should have to my property and after the fact they declare of that my house and my property should be open to the public thomas opinion for the court says explicitly but a public franchise is a form of property rights entitle to the same protection as any other property and for that proposition it cites to the supreme court's old decision in james v campbell which was the that was quoted in horn the rayson case that says that patents are property like anybody else's so contrary to the contrary to the government's submission in this case there is a valid property interest we had a very very much of reliance interest for the many years and we built a business on it quite frankly without any expectation into two thousand and eleven but there was going to be a new board ready with new procedures that results in a seventy five percent  as having already decided this issue and i point out that the takings issue in pat let's was not treated with any great degree but to the extent that it was it relied on a standard that the supreme court has now made clear was only dictum from a case in an chevron versus lingle the supreme court has said that's exactly the wrong standard so pet let's does not stand in the way of this court revisiting the issue and quite frankly when this case is compared to the other cases that are either pending or have presented this issue to the court i've looked at the briefs in those cases and this is the case that presents this case most completely and square really and with that regard we agree with the government's suggestion that this case might be an appropriate vehicle for innovative truly beneficial and again would actually against the grain of the state of the art in two thousand it required not just a doctor's prescription in the in the world of medicine where doctors prescribing authority is viewed as not only prime primal but something really important and at the end of doesn't that also suggest that people would have been out there hunting for that people to the board in this case decided that there was a generic motivation to improve and they say well that wasn't generic it was very specific to this particular drug because at that stage that's true but what what the law requires is that the motivation be a motivation to create this invention not just any improvement and if there's always a motivation to improve and we've known that since the expression build a better mousetrap in the world will be the path to your door what this case is about is taking random pieces from different pieces of prior art and saying well what you would do  assemble all of these in such a way that you would interfere and put it check on the doctors prescribing primacy and require approvals before a a pharmacy can issue this prescription you see it when you send a moment ago that there's always a motivation improve and that seems to me to be right but i thought that was contrary to the at least part of your submission here which was this is to work so well that there really wasn't a motivation to improve i don't think that's perfection well inclined but close well if the talk at the time of the application gets true arc and and yet don't you think that in an area in which the consequences of failure are so catastrophic  that working towards any improvement at all there would be a motivation that anything that could possibly make this more efficient even if so far there had been a catastrophic event w with the proposition that generically and in the abstract everybody wants to make something better write a new and improved with it's been on the shelves all of my life and that's great but that doesn't answer the obvious  question the obvious question is sensitive to context it's sensitive to the particular set of prior art in that and the context of the prior art finds itself it and so yes in fact i'll even concede to you and concede that the government is question because whether or not there's a generic motivation to combine where's the motivation to make this particular intention and their and their context is critical part of the context is prescribe dr primacy in making the decisions about who gets what drug in fact that's recognized in the powell reference that was cited where powell says the doctor prescribing the little bad is entirely responsible for the patient's welfare well that's not true under our invention our method is partially responsible as well is the pharmacy responsible for the prescribers welfare if i could just make one comment about it to conclude about and you've been very generous on this one and i'll try to make it up to you on the nd case try dishman may be the closest reference that the government has but it's really not all that close that was the close appealing program administered by the v a but that was a program about getting the drug in monitoring the effects of getting the particular drug for several weeks before determining whether the prescription could be continued or had to be stopped that's not an unusual thing doctors monitor the way that prescriptions are given and whether it has side effects all the time the invention here with far beyond that and it wasn't just adding a prescription code which is the way the government briefs this case it is about adding the prescription code after a physician take a risk assessment to interfere potentially with the physician's discretion in prescribing and bar a prescription from even being issued and with that again thank you for your generosity of time and all were turned if you'll have me for  say st that there is a lot in the reply brief and and that's what he's making here about this notion of overriding the doctor's decision this was something that was raised only at their own hearing it wasn't in the briefing before the board and at that page twenty five a drunk physician could potentially i'm getting late prescribed what am i to a patient who was intending to become pregnant and so in the board's decision at page twenty five of the record of the board says no that's a new argument we're not go consider it and they also said there's no substantial or credible evidence sufficient credible evidence to to support it although in their brief they say they have a long string site that they cited to say that yes we did make this a low on the long string all about this affirmative risks assessment the nothing about this overriding that doctor and in fact that's not required by the claims they never were able to cite anything the claim that required it nor is it supported by the specification in fact when they talked about this whole notion of perspective which they talked about at the hearing along with the overriding the doctor the house the board asked them where is that in the claim and at seven two hundred and twenty three dollars seventy two cents up the record they basically said no that is required by the combination of step c d and e the board addressed those limitations in that decision so this whole notion of overriding the doctor it's simply not supported it's not that they referenced they actually said the difference of the distinction the primary distinction between this captain and the earlier steps system is that duties were shifted from the pharmacist to the doctor so it became the it's the prescribe or who is paramount in the prescription pill that occurs after the prescription is written by the doctor and therefore is a check in effect that doctors prescribe the conduct yes the prescription approval code promised after the to tells me that this is a no go isn't that the implication of one the implication of the s that there has been a risk assessment but when you look to the seventy two before they actually dispense prescribe prescribe or fills out a new prescription for the drug so it's ultimately the prescriber after the risk assessment the prescriber is doing the risk assessment then they prescribe they sent an approval code and then the approval code is what allows the teach teaches an approval code in the context of these trial products they're also pharmaceutical products and what the board found at page twenty is that it would be obvious to  skill in the art to limit dispensation of a drug that was associated with avarice rest to those at high risk to certain risk groups and further they also found at this twenty four of the records the board found that a person of ordinary skill would recognize that this approval code that cunningham use for trial products could similarly be used for controlling the administration or disposition of partner pharmaceutical prescription products and furthermore it basically said that this is combination of prior art elements the steps they're all targeted to a known purpose of controlling drug distribution and to achieve the predictable result of avoiding distribution to high risk patients would you say of your colleagues  and said that when you're working in this world of high risk drugs that there would always be some motivation to improve upon their system methods to always try to closing loopholes to make sure that that the record neither of those would have been of available to a person of ordinary skill at the time of the invention other than celgene employees so with respect to your ordinary person of skill in the art there would not been nothing to dissuade them from improving upon considering constitutional issues and so we think here the general rule that parties are required to raise arguments before agencies in order to preserve them should apply they so that does the board have the authority to decide  some constitutional yes or no with the board could do here if they had raised this argument before the board and the board agreed that this predicted that applying i p r to this patent would violate the constitution then the board could whether or not this court finds forfeiture in this case that interview ability problem would still exist because in another case when it was raised before the agency you know if the agency declined to institute on the ground that it was unconstitutional it still wouldn't be reviewable there so i don't think that interview ability of that question really bear it sorry of i don't think the under review ability of the agency's decision to decline to institute really should change the court's forfeiture analysis here it would seem i'm just looking at all of the cases we have tomorrow with this collection keeps coming yes or no and we've a lot i did it in only one presidential opinion because the briefing was not sufficient but never really decide this question that we have attorney working on that case but i do know that it is one example where the issue is preserved but you know there are as you recognize there are a lot of cases raising this issue and if the court wishes to go ahead and resolve it we fully recognize that the court might want to exercise  pen is a public franchise and that cases in the future should we should we wait until their cases are you familiar with that case i think i've heard not not very familiar hon the st chance to opine on the issue which can as a supreme court recognized in elgin can be beneficial to courts when later reviewing it but we were in a circumstance where as i said and top off it was a non presidential two paragraph opinion by the board i assume that doesn't bind other key tabloids so we could end up with a situation where you've got six people have decisions three going one way three going the other all of which are not unprecedented right i mean that's the regime  are and you know for those reasons we as we stated in our brief we recognize why you might want to go ahead and decide the issue and we think that that on the merits it's very clear what there is no about the merits is that the government's you are you arguing that a patent can't be a property right for purposes of the unless and until it's invalidated is that your view i think so your honor our position are is just that what happens when you know in this case when when the board conducts i p r in deter what the board is doing is determining that the patent holder never had a valid property interest because the patent never satisfied the substantive conditions of patent ability and then the patent isn't actually canceled until this court would affirm that determination  client taints patent that client knows what the standards are in the district court proceeding and they can anticipate that whereas in the i p r proceeding whether we had reexamined so whatever the standards were different so the expectation when the issued at the patent holder was on notice of that you know when when he applied for the patent and this patent was subject to both ex parte reexamination and interparty as reexamination and the supreme court made clear in what was a standards matter because that's how you a the risk of your subsequent that you might subsequently lose the patent in the proceedings and as your friend pointed out the risks were different under the old regime because of a different standard different standards and so forth that just to be clear under interparty is reexamination expertise reexamination the same standards apply as you in this proceeding the only difference is the the standard for initiation which now they actually have to prove a reasonable likelihood of it is true that there isn't there are more participation r reexamination could be prompted by a rd party filing something with the agency and as the supreme court explained in cuozzo the purpose of inner parties review is the same basic purpose as inner parties reexamination and x parties resume anation and then also just on the question you know he's also compared so i think it's really important to to keep in mind that these patents were subject to agency administrative reconsideration when they were issued and then nd to the extent that they're complaining about the differences between district court litigation and agency you know so that portion of the opinion has not been undermined and then this other portion of the opinion that i'm talking about where the court held that there was and that there was no copyright in the presumption of liberty that you know doesn't involve that in house at the rationality  all so we think that patrick's is clearly still good law as is joy technologies and that that there has been no taking here really for the fundamental reason that you know once this court agrees with the the the board that the substantive conditions of patentability aren't met here there is no property that is being taken away how far i mean how far you would go with the proposition that there's no property right in the presumption of liberty suppose that the owner party statute it was an acted by a congress that was vehemently opposed to patent protections and said that the burden  be to show by clear and convincing evidence that the patent was valid you still think no problem no no taking your honor i'm i'm i'm not saying that there is that there would be no procedures that that was adopted in the i p r statute congresses had decided we're really going to turn the screws on the pad and we're going to expect them require them to show by clear  cheer there has been a change because the clear and convincing evidence standard is the same standard sorry be that the fact that you have to sorry sort of the preponderance of the evidence standard that applies in your party's review is the same standard that applies in  been no change in the standard if even though that's true if you want to compare it to district court litigation i agree that the standard of proof has changed but this court held in pat lax so in patmos but you don't think the change  way that it could be brought back before the agency for reconsideration it could only be invalidated in district court and by contrast here for forty years there has been agency reconsideration of patents and so it's if anything this is a much easier case than padlocks side about the ordering of the overwriting in the in the case was made that overwriting was a new argument made by celgene it wasn't what was a new argument was that it would interfere with a so called drunk doctor making an  prescription that was said to be a new argument but there's actually not an implication that express word of the claim that is important with regard to the timing of the approval and that's the word a pawn in the claim and it's only a part of the approval code that the prescription can be issued that's been our argument all along my friend also referred you to a number of places in the specifications for instance at the bottom of column twelve that is discussing the physician's initial prescribing that has nothing to do with the generation of the approval code if the court looks at column thirteen lines forty five to about line fifty four you will see that the approval code is preferably not provided and i'm reading from the patent here unless the prescribe or the pharmacy the patient the patient's risk and the patient's informed consent have been properly registered in the storage media so there's a failsafe that goes above and beyond just the physician saying ok go ahead and prescribe the drug with regard to the question of constitutionality and waiver i completely forgot to mention in my opening argument the square case which was followed by the case of the court where the board said we won't entertain constitutional arguments my friend side of thunder basin and left out the part where the court recognized that the adjudication of the constitutionality of congressional enactment has generally been thought beyond the jurisdiction of administrative agencies but squints out that pointing out that we arguments that are being made about this being simply a procedural change are belied by the real world facts that seventy five percent of claims versus twelve percent in x party reexamination are being st patent i guess i should say not practicing and it is to not be provocative but the term that's actually used in the literature is reverse patent trolls like see fed who petition and upon the mere petition let alone the institution the market change and of these were vers entities that are bringing these challenges who are not practicing at all in the space that are able to then short the stock and make money for their hedge funds and that's exactly and the fact that they're making money off of the drop of our four decisions that refused to take up the question of constitutionality square's the one case that existed at the time of the board decision in this case who post dated it and top golf was about a month before who  my memory is correct you know those were both in june and july of two thousand and eighteen