the financial rewards and there are a range of miniature warrants in the act and congress was pretty clear that it was going to hand out those rewards for developing new working drugs drugs for rare diseases for which the were not yet i create treatments and the question here is whether a drug manufacturer eagle can get all of the actual warrants even though it feels to deliver on the basic quid pro quo it does not actually develop series of x periods lucky generics blocking others from entering the free market to provide patients with and with the choice of manufacturers of these reasoning of the court that is the central right here and i think if you the only way you get to eagles reading is if you zoom in and you read in isolation the st provision of three hundred and sixty c c week we think you have to look at especially as a whole an look at the one it says that there are two conditions for the f d a sort of breaking an exclusivity period and that says if the holder of the approved application cannot  assure the ability of sufficient quantities of the drug in the uk it can go ahead and approve another manufacture now the holder of the approved application is that it is the holder reference to subsection a the one who holds the application that enjoys exclusivity that's barring others from getting into the market now it does not make sense for congress to say you only look at whether or not the holder of the of the approved application to supply the market if in that's the nd condition for breaking exclusivity congress also referred only to such holder being able to waive their exclusivity now think about legal theory eagles theory is that as that st holder could destroy that expectation by simply waving its exclusivity allowing the f d a to let a whole bunch of generics rush into the market that doesn't make sense if congress actually was may be that were you know these scenarios you suggest might result from section b i mean do they somehow go undermine what is the very plain language of a which sets up a pretty clear structure that if your does of native and approved you get a seven year n that that questions presupposing and we think that comes from the references bullheaded a and b to the expiration of a seven year period now expire can just mean the end of one period but we also think that it can you know sort of just an ordinary congress passed legislation premised on the idea that only the st manufacturer to get approval for a particular drug got any sort of exclusivity award now eagle says these are floor statements this is supposed to next but legislat history that is not the case this was a bill passed by congress and presented to the president and the president vetoed it the president vetoed it he has the president like congress said no we want only the  manufacture to enjoy exclusivity now maybe that doesn't mean that this provision can only be read that way but that type of formal legislative action by both the bill from congress is part and the bill certainly shows that this language can be read in the way f d a has always read it congress read it that way the president made it so what is your best argument that is is clearly but just looking at the f d a written large as of course the supreme court has instructed us to do we don't the courts don't construe provisions they construe statutes there are a lot of exclusivity periods in the act none of them are indeterminate him and hungers has shown very clearly that when it wanted that seven year period to be extended it used very clear and very different language if you if you get the extra exclusivity because you do the require the f d a to do that so my friend suggestion that sci was somehow found to do this and that companies could collude into the situation is wrong f d a simply has a discretion to grant an exception that a waiver and that certain stance circumstances here eagle was a relatively small company that had invested millions of dollars in premiums to the market developing in trying to bring onto a market a product that it believes was clinically superior and substantially improved over tranter for patients with this rare disease particularly in so far as it reduced the administration time for this chemotherapy as well as the volume of sodium that patients endured and so we believe was a better drug at alternately conclude otherwise but what happened during the course of the development is f d a and unprecedented if not unusual move retroactively granted true and exclusivity on another indication which essentially left eagle with no option but to enter into a licensing arrangement with evil so with have so the circumstances were unusual they were driven by market considerations they were no way to far yes and none of pointed to the strange relationship and the one in that the granting of the license for her another would term this additional firm but why would you do that if there's absolutely no problem when you're looking at the substantive goal of the statute in terms of getting an adequate name way why would congress authorize an inane application i don't think it's an in your honor i think that the situation where it would be needed is where you have one drug that has excessively that drug is only able to meet patient needs and this stat from the statute but not the particular one you're advocating i think and it makes sense a congress would include it in that for that situation it could arise in other situations you could have multiple holders of exclusivity one that's expired  actual grounding in the statute if they pointed to be one here the view you're looking only one clause yes that engine manufacturers and other cases direct us to look at the entire statutory content we agree on we agree but i don't think that think you're explaining why congress would give him discretion to do it in those circumstances yes and yes maybe very sensible and not do it in those circumstances we were explaining the wording well i think the congress is choice of may approval for a person who is not the holder of the approved application so the person who is the holder of the initially approved application is a special position and it would appear that looking purposes as as my friend had this morning was to create an incentive for the developments of this these drugs and our position does just that the fact that multiple companies can be developing something and continue to have an interest a statutory incentive to continue to develop it knowing that it's possible that the other drug will get as a nation approval st but even in that situation you can continue to develop it and gone to the market later there's always going to be incentive to differentiate and make a better drug and here just to keep in mind the reason why we're in the position that we're in is that congress initially designated than dakka as a drug that met at that provided a plausible medically possible basis for clued in that it is clinically superior we forward and we proved the reasons that we said it was clinically superior to the significant reduction in ministration time for patients which is a huge factor for patients undergoing this type of can you can move there are a pretty significant reduction in sodium involved in that which is was something better about them deca it was more convenient to patients they absolutely did not believe that's on page seventy of the j a a r and they ultimately concluded that we didn't meet the clinical superior carmen at the back end but that's only because of the moving target that they've  applied to us and that's one of the things that congress addressed in the two thousand and seventeen minutes and those are significant i think usually that the court as well is familiar with agencies coming before and saying that all sorts of bad things will happen if you adopt effect to the law that congress wrote and put the impetus in congress to change it if the f d a is right that this is that you create a problem and congress did that and that is now asking this court to go back we read the statute as it existed before the two if i'm a drug manufacturer and i have something that is not clinically superior i can't i can't get it anyway because the statute has that and that's correct i mean under the under the prior  presented a medically possible hypothesis for that it was only at the end that they determine that even though there are benefits we were clinically secure so i think you're right that under b two for one of the indications that exception was  people in this situation but obviously congress has addressed the situation as it saw fit it didn't adopt a yes position across the board and it provided important protections to companies as well who are developing these drugs required f d a to provide notice of the reasons that it's making clinical superiority determinations because that was one of the real problems with the prior statute but this is a situation where the court for better or worse doesn't have to worry about these policies circumstances  united they're puting x and that's in d c right now it's steve ending the resolution of this appeal where there is a self ever greening situation happening and how this works is you are the st exclusivity holder you are the st one to create an orphan drug but before your exclusivity period expires you say wait a minute i can make a i can make a better version of this drug i can reformulated a new formulation and you can be designated again we don't want to ratchet up the de standards so then you get approved because the drug your variation is safe and effective under our reading of the statute we can say this is not actually a clinically severe version of the drug we're sorry  period for what is essentially the same drugs are the expired you don't get another seven years of exclusivity for the same drug but on eagles reading we would not have the discretion to do that because three sixty c a only bars us for approving an application for the same drug for someone who is not the holder of approved exclusivity so we would have no basis in that eagle is just you're saying you don't have to worry about any problems we think you have to look at the preacher two thousand and seventeen person of his stature has as did the two thousand and seventeen amendments had a rule of construction that said nothing invention affect what came before and we think that respecting the rule of construction means that they don't get to use it to say hey everything's fixed and we don't get to use it to say hey we like the regime that we have before neither side she gets us everything judge kelly was was right about that