i think that to proceed independent of the outcome of the one i think fair reading of that statement is from momentous point of view it doesn't matter whether this patent changing its plans and lose some costs that it's already spent and which has already spent millions of dollars developing the current formulation and now it's faced with the the november one press releases indicating that something went wrong with the phase one trial method and maybe it's the problematic phase one trial that if anything is might cause momentum to somehow pivot with  development of a formulation and think so could you describe what that what how are we supposed to understand the content of that press release that was a little technical about ten points and  really understand what that means but can you nevertheless try to explain to me where is my mentor now if all i could tell was it was bad news labels so where are they in the face of that bad news as nothing to do with the patent it has and it was very costly to get all the way up to fifty three which whatever that is it sounds like it's for further along than phase one but the focus of the opinion was there just wasn't there enough of an immedia time sandoz has not done that it will suffer any media and substantial adverse impact from not being able to seek or secure a patent adjudication before filing an application for f d a approval and in contrast we have shown that here we momentous years further behind in the development process than sandoz it has a more significant harm that it is currently suffering than what sandoz was suffering even though sandoz was at fave three not phase one my where i'm from the point i'm making is what the court decisions that is that sanderson not for the record but in that it was going to make a business decision as we are here based on whether or not the patent stands after the agency yes the congress created these new administrative proceedings but didn't in in hand also turn over the keys to the federal court system and so therefore that's why consumer watchdog wasn't able to come here neither was  not saying that comment is like those two obviously momenta here is an aspiring competitor it's not a competitor and it's years away from being a true competitor and as we observed in the sandoz opinion there's a lot of speculation that to have to be made through a chain of contingencies to know whether or not you and your product that you say you've selected and think would infringe actually is going to make it all the way through to even filing an f d a application let alone having it approved for you to enter the market so i think that's the concern that we have if it is true that you have to have a concrete home you know despite the fact that immediacy and redressed ability concerns are somewhat relaxed you still have to have a concrete harm that's the thirty five twenty four paragraph thirty two momenta is at a fork in the road in the development program as a result of the patent offices wrongful action and that's the action that cause this movement to harm we spent millions of dollars developing a expenditure of money even a large amounts of money for the possible but you know to to deal with a possible harm down the road i mean that's what the supreme court held in clapper's not necessarily alone good enough final infringement this this willing applies to us in two ways we want to practice this subject matter we're currently practicing subject matter we have current concrete development plans this is what distinguishes them from clapper much like the farmers in judge chin who the alfalfa growers who wanted to plant and wanted to keep their seed untainted and had to spend money because of the fear of taint and we've proven the facts that are harming us here the board has acted and and because of its  challenge to a d c statute to pharma industry that they think that by could challenge that the companies there were spending money to avoid potentially being having this law enforced against them under a reasonable fear unlike in clacker what if hypothetically there was some scientific study that conclusively and definitively found in everybody agreed that any would be by a similar applicant you know after they spend twenty million dollars trying to develop something that's a bio similar but there's only a one percent chance that that formulation will actually ever enter the market because of all the vagaries of difficulties and uncertainty of the science and then also getting through the f d a approval process there's a study that says you only have a one percent chance of making it would that be enough if you ha this money developing this by similar and because of the board's action which is what harms us now we are forced to change paths that is harm even if there is a one percent chance we might ever get because the harm i could who was who's complaining about president clinton's line item veto of a tax credit that would benefit the kind of sales they were making and then in the tax when it didn't go to them a tax credit which would be purchasers but the supreme court held and they rejected the government's argument that they couldn't show that as as well so it did the harm to movement it is from the agency action this is not a d j actions not an action really between us and bristol myers squibb this action but not appeal it despite its current conflict harm to us placing us in this work in the room where we'll have to make a decision one way or the other and add to that we're going to be a stock in the future by this where that water triggers us another way this is another way are if there's no injury in fact and there's no standing to appeal then we then what the a stop over really for certain apply in such a certain situation because you never had a right to where it was the prevailing party which rendered the case moot the court there was willing to vacate that or grow but that's and it follows that following the bank or approach in the  the party that received the adverse board decision wanted to undo that board decision on appeal they had the right to appeal that rep and then that was haven't done anything to deprive the the right to appeal is the question is whether they have standing in the first place it has done it so they've taken some voluntary act which is mooted the case of what i would say they've done here is they have taken the deliberate strategic actually of coming just inconsistent with like decades of the supreme court law about what injuries sufficient to allow somebody to challenge agency action and that this is very unlike  own they would suffer injury if down the road they get approval and we sue them for infringement they'll suffer harm from the people not only about iran i'm saying there's a legal restriction on them imposed by the see action under these circumstances allusion to believe is also relevant your honor and we think both of those cases make it clear i mean clapper is absolutely clear that it says you know what you're complaining about costs that that what they have to show is that they incur certain costs as a reasonable reaction to a risk of harm because unless the harm to it seeks to avoid is not certainly impending the harm that they seek to avoid is being found too afraid  were actually subject i don't know that or the government action that they complained about was not directed to them it was directed against people that they communicated with right correct talking about all of their own ledge harm ties to a fear of infringement and they cannot infringe now they are protected now there is no infringement now unless and until they contain approval for probably  today in court that infringes but more importantly where it phase one we are exactly the situation that this court that knowledge and centers and sentence this court stated a base twelve seventy nine of seventy three  and every case is going to have to report going to have to resolve it in this particular petition or over the line or under the line where is the line this court recognized in sandoz there's a bright line here as there should be for there is a hard floor for all cases which is this concrete injury which clabber described as well as that that's what your problem is because the supreme court cases seem to say that this kind of injury is sufficient to challenge agency  you're suggesting the supreme court standing case and say that you can't have standing based on future injuries that they can so long as the risk is certainly impending in fact they see this clearance and certainly impending in paragraph twenty three of their affidavit that they say is on thirty five twenty one of the record they say my method considered multiple options for developing by a similar one was to make a biased similar version similar to branded the harm is if they get so in the future as that paragraph goes on to say their worry is down the road if they get approval they make it suit but think about you know you mean they have to show that they are going to be sued for infringement right now i mean spring court has has has even that heart her judgment context said that that's not the test for departure you have to show to the doesn't have to be at risk of imminent suit they specifically certainly impending has been stretched beyond the breaking point when as here the plaintiff alleges only an injury at some indefinite future time and the acts necessary to make the injury happen or at least partly within the plate his own control this is about monsanto there was no control by the play developed of the growers they're choosing whether or not their fields would be contaminated be coming from the other field that was happening then they're saying here is that the risk of harm is real and immediate because they are spending millions of dollars to develop a product which may be off the market because it's infringing there's it's not as though they're saying we're going to spend some money in the future develop these highly complex biologic products i mean this isn't like it's momentous in the business of manufacturing and selling bikes and it needs to know whether it can make a ten speed bike for a cruiser bike you know the biologics or seem to be very complicated and very hard to to make for whatever reason and it's uncertain whether they'll actually be able to successfully navigate the very difficult uncertain path advantages for your client that these people have no way in your view to challenge the validity of a patent and without running the risk of spending millions of dollars that they could lose they have no way of getting in the terminations to a product that infringe which is the law for example with the vice part of a contract a point there is no way that somebody who wants to compete with your client and thinks that the patent this invalid can enter the market with out fishel acts after the end is filed but it can't be more than a year before marketing is planned for this and that so that correct so what would your in fact on the same facts well they were has had to succeeded on the face three trials i suppose before the end could have been filed but this still would not have been commercial marketing they would have been in the  they could have waited file during the face of the trial before they're facing trial knowing the timeline knowing that at that point that article three of course nothing prevents that would be three be enough in your view for them to permit them to review an there there a gap is there a delta between what the buy a similar act provides which is you know once someone files and f d a application they're now considered to be infringing right and at some point before that can someone have the right to appeal an adverse patent board decision here given that the  controversy or at least somewhat relaxed i don't listen because i think it's the artificial act of infringement that creates the the potential risk of harm that's the necessary injury in fact and that's a even get to the point of challenge without filing an application and that requires millions and millions of dollars that they have to put it risk even before they can get a determination of whether they're barred by the pat before investing enormous amounts of money secure some sort of the terminations as to whether it's all for now are not because the patent covers them well iran of course think they can get information from the board which they got off what you're asking is they have no right to sue to get through to show review of an adverse board decision it's pretty good situation for your client well your honor it's only a good situation here because as it happened we prevailed at the board because we have a strong path but but the fact is the r remains there it serves its function what they are asking is one of two things either give them standing so they can get to an article three court well before but it would ordinarily be available which we think is forbidden by article three or  an avenue for appeal but it requires article three standing and there's all sorts of cases in which people can have the or before an agency but not have article three standing by genesis one consumer watchdog is another and we believe this is the third or because they we want the court to reach the absence question so if you know the court wants to hear about those issues that's of course our preference would be to get those issues because this is an exceptionally weak and that and standing we are i agree with all but the harm your honor is exactly the harm congress in vision which is having to be placed in the choice of spending millions of dollars a new copying you know people practicing and invalid you can and we will create an artificial actor infringement that we're going to surround article three and you can challenge the patent under hatch waxman even though you are not infringing that is one avenue  that case where that party was not practicing the subject matter as we are with that party didn't have concrete plans as we do to practice subject matter and where that party would never face an infringement suit and therefore never face these topple the stock the provision didn't matter but the government appeal then we would request that you vacate and you have the authority to do that in your adult discretion as this court has recognized and so does the supreme court but more importantly even if and judge change even if you think that we need to to establish that we are as threat we have a certainly impending being sued in the collateral way right and i don't and clapper is a very different case and clatter is about imagined government action that might hurt them and that's not what we have we have a government that we fused to cancel a pattern that right now and that's enough but even if you thought what if it's it's really the failure of the phase one that's really blocking your choices to operate that the failure in phase one has nothing to do with the with whether patent is about a stable liquid formulation that goes into a syringe doesn't have anything to do with with the p k and the movement is is proceeding with the program it is at the in some ways we need to know the answer now more than before because we're if we do make if we do the just the kernel we have to know whether we can practice this well that or not the failure of phase one makes you more of a concrete harm than the success of the phase one that would so i'm just trying to understand the logical extension of your position if moment five years ago they hadn't spent any money yet but they were very interested in the potential of pursuing a bio similar for the currency and it filed an i p r and lost the i p r would you say that you would still have standing because you're on the cusp of spending a lot of money and then ultimately pursuing a phase one and then a phase three and then an f d a application would that be enough in your view for standing because in the end what's happening here is choices that need to be made for a business to organize its affairs to spend a lot of money either this way or that way and so without having spent any money yet that's still the enough of a concrete our that would be  because what we have here is monies that are very concrete plans that are not only concrete but they're in place money has been spent the desperation is that some cost will be lost as a result of this action if we can't challenge it and plans will have to be changed and millions more will have to be spent there wouldn't have to be spent we are so we have easily cleared the hurdle of injury in fact under all precedent of which i'm aware your case it would be a harder  millions of dollars of plane tickets proceeding along this path and it's not our choice that the patent office granted this invalid patent twenty thirteen after we had already invested lots of money in this program and then we took  e remedy that congress gave us which was to go to the patent office say you've made a mistake and the patent office has now made another mistake by saying no this patent actually is some kind of invention even though it's a combination of nothing but