same disease and condition f d a cannot approve another application for the same drug for the same disease and condition for seven years after to prove dars but six months into our seven year exclusiv that's exactly what f d a did and it did it for intervener jacobus near the meaning of the key term same drug same disease and condition those playing terms are admitted there admitted both in the record and there admitted the briefing below both parties f d a and intervenor jacobus have said that they agree that those terms mean what catalyst says they mean and frankly that ought to be the end of this case this is a  clear throughout the act and throughout other provisions of the food drug and cosmetic that act that it intended here to create broad exclusivities d to spur drug makers to bring orphan drugs to the market quickly so if i might your honor i'd like to begin not only with the plain language of same disease or condition but also the specific exceptions in three hundred and sixty c c and the reason i'm addressing those are honors because this court's precedents make quite clear what to do in a situation where congress lays out specific specific exemptions like these we cited for example john lee lynn a case in the circuit and us vs for they stand for the proposition that when congress provides exceptions in a statute it does not follow that courts have authority to create a there's here the exceptions are listed principly and three hundred and sixty dollars ccs subsection b if we can't  supply sufficient quantities of the drug you can reach our exclusivity or if we consent perhaps we have a contract with another manufacturer or some other type of arrangement and we consent to them serving  part of the patient population that's another exception to our exclusivity there is also a clinical superiority related provision that follows in the in section subsections see through eve we can talk about that at length but the point is that these are the exclusive list none of these applies in this case and under this court's precedent f d a cannot create another unwritten exception so if i might your honor let me show you what a is actually attempting to do and it's brief and the easiest way to do that it's not just referring to the text of their brief but is referring to the regulation where they describe what they do in applying exclusiv  now as i mentioned the statute actually says same drug same disease and condition but if you look at the regulation at twenty one c f r three hundred and sixteen point three one what f d a is actually done is insert different words congress did not choose to do that your honor what they insert here is is it sufficient to change the sentence in the following way no longer does the sentence say may not approve another application for the same drugs for the same disease or condition that's the statutory language the regulatory language is that f d a may not approve another application for the same drug for the same use or indication within the same disease or condition now let me suggest this use or indication in a number of circumstances as the government admits and its briefing can mean the same thing a same disease and condition you can have a drug that's a crude the entirety of the disease or condition but here in this case use or indication is more narrow than same disease or condition and what effectively f d a is doing is deciding it will narrow the scope of our exclusiv to something that congress did not intend and then give up the specific indications within that same disease and condition among different companies it cannot do that under the plain language of the text so are also of course other provisions in f d a is regulations that ignore the plain text of this provision elsewhere in the regulations they simply replace the term same disease and condition with same indication or use and of course in certain cases including this one those two terms mean something different so what they're actually doing here is saying that a pediatric use for indication for the same disease and condition which is uncontested both of her lambs  a could determine that a different drug is clinically superior under its regulations and under the statute and thus a different drug but that did not happen here in fact we know that jacoby says drug is not clinically superior to ours the way following they say for example if a drug could be designated to tree ovarian cancer but it only approved the drug stage four ovar where two or three very carrots are and they say that the reading you would put out it is a war with the obvious purpose of congress in an acting the this that your response to that as best i can tell from the reefing that this hypothetical was that the most likely scenario is that th know your honor both for legal and factual reasons related to ovarian cancer so let me start with the legal reasons if i might f d a has authority does look go ask me a question that brought up the support of just a moment ago has a determine in a situation where some and created population like for example stage three or stage two or stage one of ovarian cancer to determine that a drug that comes along later is clinically sapir and therefore  if there is a different drug out there then the restriction which is applicable to same drug same disease or condition would not apply in their exclusivity would not bar those now as to the population of drugs for ovarian cancer are currently something like two thousand one hundred and twenty two drugs approved for a variant cancer as far as we can tell from going through the records that are available not a single one of those drugs would be barred by a ruling if a ruling in our favor came out in this case and it were applied in that context not a single one of those drugs would be barred as far as we can tell from the record but even if there were an issue that issue could be addressed this clinical superiority tool that f d a has and let me explain just a bit more if i might your honor about how the statute deals with this issue so back to section three hundred and sixty c c this is the overall policy that congress adopted and importantly congress did not choose to do it f d a is seeking to do here so in three sixty's d c we talked about the basic restriction on same drugs same disease subsequent approvals that does not apply to the holder of course so we could get a drug on the market quickly and then supplement the scope of our approvals as quickly as we can that isn't what happened with ovarian cancer there were multiple drug makers they came in with  exclusivity and then pursuant to the statutory provision updated those to be broader and in fact they also the statute as i indicated earlier in the exception section allows a somebody  exclusivity to contract with another company and then give consent to them doing it as well but if none of that is is still covering the core patients that i think your your question raises concern about the f d a has the ability to deal with it now that question came up f d a is response was not we can't do that deal with that through clinical superiority if they did not say that what they said was we would have to take a look at it why couldn't the exception d take care of stage three and earliest stages again factual question and i can provide you with a back channel answer we can supply the entire population all patients and here's apply we can supply the ninety nine percent who are adults right now and then we could supply the pediatric patients through different mechanisms in the statute and those mechanisms sometimes are called compassionate use or expanded access we c also of course of teen approval we have the data to obtain approval for pediatrics just as much data as jacobus had available so there is not factually a insufficient quantity of drug we can cover everybody and we would your honor so you're saying that the exception fall in sufficient quantity cannot apply simply to situation where there is not an approval for those other uses i do not think so your honor because that is a factual question governed by the regs that have to ask us if we have sufficient quantities and we would demonstrate to them that we do they'd make a record and we would satisfy that in court i see your honor that my time is up drug act is designed to increase access to approved drugs to patients with rare diseases or conditions yet under catalyst interpretation approval of a drug to treat just one percent and affected populations and would deprive the remaining ninety nine percent of all noble individuals of an approved drug to treat their condition and for a period of seven years my understanding mr stringer maybe i read that record incorrectly  honor to to address the facts of this case i think it's important to note that catalyst does not have approval here to treat pediatric lambs has not gotten that approval and it has not shown that its drug is safe or effective for that use catalysts itself what the language says is that f d a may not approve another application under section three hundred and fifty five for the same drug for the same disease or condition and so that that beginning language the approve another application language and they express direction to look to section three hundred and fifty four of the same drug for the same disease or condition until the expiration of the seven years from the date of the approval of the accrued application or the issu the license and my understanding is is that same drug means if it has a same active ingredient or and the facts in this case are that  drug does have the same active ingredient i mean isn't that conceded you're on others there's no dispute here that it's the same drug but i think the important language to focus on here is the approve another application and it isn't a disease is it i mean i guess if it was the same drug for treating a different deceived that it would have an application correct that would be true if it were a difference disease your honor but i what is important to do here and i don't think that the court would be plowing new ground to say this and then it says and then it's modified by the phrase until the expiration of the seven years from that date so there is a modification for the approval for another application for the same drug for the same people who are suffering from a rare disease or condition you know our that's exactly what f d a has done here is that they have to tie the scope of the exclusivity to the investment that the drug manufacturers actually made in order to show that their drug is safe or effective for use and again that leads back into this approve another application language which the d c circuit and the spectrum case and the th circuit and the segments alcaeus explained  important and at the use of the word application directs the f d a to actually look at the application that is before the f d a and examine the proposed uses or indications within that application and to make a determination about whether that drug manufacturer has shown that its drug is safe or effective for those particular usis let me ask you this question it seemed clear to me the your regulatory resolution if preferable to the statutory resolution but that's not something that we can do if the plain language of the statute says same drug and same  sparse like here they are just a few dozen cases of b t r b d s disease when the company isn't live refuses to proceed to obtain the use then we do have the problem that you talk about that these needs not being met so why couldn't the assurance to satisfy those needs exception and that situation uses or indications and so hasn't had to consider the question the way that your honor is talking about i think one important thing to know about the exceptions is that when an exception applies breaks the earlier exclusivity holders exclusivity entirely and allows the nd drug to enter the market for all indications and uses so here in this case if an exception applied including the if if f d a were to determine before to ensure that they can that they they don't have sufficient availability of the drug for example in that particular exception that there has to be notice an opportunity to to i guess in essence to say look we can provide the drugs for pediatric if that's required and we have it i mean has that been done here so that has not been done here your honor because again because of the f d a is interpretation of the exclusivity provision and as you say this this allows the manufacturer to come in and explain the extent to which it can provide this drug but i would just underscore the point that i think judge anderson was getting at there is sort of a mismatch year and a bit of confusion about why we would be asking whether or not catalyst can provide its drug to a portion of the population which again it does not have approval to treat it does not have approval for treatment of the pediatric population lent but i understand that but that's a decision policy decision that the f d a did or or didn't do but at the end of the day the statute from my perspective is not unambiguous so you'd be asking us to write a statute and that's not what a court does we don't rewrite contracts that are right statute so at the end of the day the question becomes not maybe what the f c c it wants to do but it seems to me that is that the language of the statute is such that x the city someone has exclusive before a stamp drug for the same disease for a period of time then  the f d a has to follow the procedure that has been put in place in the statute by congress well your honor i would resist the conclusion that that there is that exclusivity provision unambiguously answers the question in this case because again i think looking at the language it points to section three hundred and fifty five the new drug approval process and in that process f d a doesn't approve a drug for a disease or condition in the abstract it actually looks to the application indication to the statutory language that does not exist right now your honor i think it does exist or at least it's a reasonable interpretation for it and the police can i can see your honor i think it comes in through the express reference to the new drug approval process to the explicit reference to section three hundred and fifty five dollars and to f d a is actual examination of applications looking at what the drug manufacturer language something like for the same drug with respect to the same use full of the same disease you have to your interpretation just necessarily inserts that word use before disease does it not you're i don't think it does again i think that f d a is interpret ing this provision in context and understanding the fact that when you look when f d a approves an application it's not approving an application in the abstract for a particular disease or condition it's approving it again looking at section three hundred and fifty five dollars in the new drug approval process it's doing that approval with respect to the particular indications for uses that is true that is true but the designation provision you can see is brought on the designation proceedings preceding gumba full the approval and they approve it for a disease so then the approval of the use comes later and that's exactly right your honor and i think that's an important point is that the designation is much broader because at that time there is very little now on about what the drug what which uses the drug will be safe and effective for however once once you get to choice to make these kind of policy decisions and to calibrate this provision and create coherence which we in the orphan drug act and the new drug approval process through which f d a actually approved these drugs in the chairman's whether or not they're indications to a nd approval for a potentially has a use or indication now callus offers a reading that three section three hundred and fifty five out of the statute reads the references to use or conditions out of the broken to allow another manufacturer into the market but here are consider the facts of this case catalyst has a crew of all to serve adults with ones it does not have approval to serve pediatric patients but once and the reason is it has never attempted to make a showing that its drug is safe and effective for pediatric patients is drug can not serve pediatric patients and the problem here is not a problem of in sufficient quantities of catalysts drop to the contrary catalyst could flood the nation with as many doses and strongest possible and that drug still could not serve pediatric patients because it does not have approval for that  manufacturer not even having approval in the st place to serve the population so the fact that congress crafted that exception in three hundred and sixty c c b the way it did shows that congress necessarily understood they have the for your honor let me start with sufficient quantities of by my it is not true that the only way to serve patients is through a drug approval under section three hundred and fifty five before either  catalyst or jacobus were approved as drugs approved under that section they both supplied pediatric patients with the active ingredient as a drug that court can review but there are ways to supply drugs to patients outside the context of an approval under three hundred and fifty five and your honor to make that point incredibly clear i would like if i could to refer you all this is an internal f d a document it's a decision document on the exclusivity issue but they discussed the possibility that jacobus could continue to apply our sorry supply its drug to pediatric patients other patients despite our exclusivity and they explained that jacobus could do so under an expanded access program which of course is not a formal drug approval so when mr suggested we could not serve pediatric patients there are many ways for us to that we have had an expanded access program for this exact drug before we and we have had compassionate use programs and we would instantly make the drug available with i s approval under those programs for patients that were pediatrics so it is not the case and in fact there's five ways that we could supply pediatrics or that it or that another company could supply p b x the way i just described what we would do jacobus could continue to supply under its expanded use or expanded access program we have course to get drug approval for those pediatrics what we were which we would pursue on an expedited basis if there  a settlement of these this and other cases we could consent to jacobus doing that and of course our drug companies prescribe off label to pediatric patients all of those questions get roped into the factual issue and judge that was a separate set of issues that is at issue here there were two sets of exclusivity for two different diseases one had expired a generic drug this is common passed out in both cases a generic drug had plummet long and was being sold with a label for the st expired exclusivity and so that presents a very different issue than present here the question was whether or not the generic was selling for the same word different disease or condition and and not sub set of the same disease and condition and you can tell that your honor because it page one hundred and forty four of sigma talc and one hundred and forty five they explained that the question presented is whether or not you have meet a generic selling for different disease and condition and they go further and they say the statutory language in this case same drug same disease and condition is unambiguous so when they say in both cases that the question is whether or not it's disease  question of whether or not the generics were being labeled to treat the disease that was still subject to exclusivity they weren't they were being what they were label to treat a disease for which exclusivity expires this language the core language that what the case law that answers your question no you should not make any of it anything of that because ratification or acquiescence those two doctrines only apply when you have a very clear indication not present here that congress was addressing the very specific issue in play and if i might your honor when he i'm sorry in two thousand and seventeen when this was last amended congress chose to read retain the term disease and condition it didn't change it to use or indication it retained it it wrote same disease or condition so that's additional evidence that they mean what they say congress did not choose to put user indication to the statute it any point in time even given the opportunity