the honorable the united states court of appeals for the st circuit is now in session all persons having any physicist before this honorable court may give their attendance and they shall be heard god save the united states of america and this honorable court court is in session today's cases will be called as previously announced the times will be as a lot of the council the next case to be heard today is a key via therapeutics incorporated versus alex michel the nd at all appeal number tw proceed with a couple minute opening statement and then we'll have questions for you thank you thank you am i on muted you were good go ahead  minutes reserved for report all counsel instead of giving a rebuttal time if you if something comes up during the appellee argument that you have not already adequately covered in your briefs or had a chance to cover in your principal presentation you may bio a whitten reply brief without further weave of court by midnight tonight eastern time and that will be in lieu of rebuttal time this morning i understand your honor and thank you a key via the only oral drug ever approved by the f d a to treat iron deficiency anemia in individuals with chronic kidney disease was improperly excluded by c m s from medicare part d and as a result a key b a is losing millions of dollars that can never be recovered and critically ill patients have lost coverage for this unique drug correctly the government doesn't invoke deference for its shifting interpretation of the mineral products exclusion in the district court said it looked to whether a drug is active ingredient is a mineral a sensible interpretation that does not include exclude or ixia who is active ingredient is a novel organic compound on appeal the government doesn't even acknowledge what it told the district court now contending implausibly that a mineral product is any product that contains any mineral in any amount the government tried to cabaniss over bro interpretation by imposing a use limitation that is not merely a textual but anti textual in any event that interpretation also would not exclude orexia because ideate in patients with c k d is not the same thing as iron deficiency as the record in this case shows c m s independently violated the a p a through its arbitrary decision making even now the government is unable to reconcile its erratic treatment of different drug products as just one example c m s covers electrolytes even though it concedes they are minerals and that they are used to treat a mineral deficiency the government's procedural arguments on indorsed by the district court are wrong the decision is plainly final agency action and its jurisdiction objection fails both because  suing on behalf of anyone who could seek it and it's your review and also because a key be a claim if not the same as any claim that any such person could bring and accordingly denial of the preliminary injunction should be refer thank you mr waxman so this is judge howard and i have a two part question involving the likelihood of success on the merits so i am looking at the princip fed pages twenty eight and twenty nine and there and i'm taking them slightly out of context just for the sake of saving time but there are assertions made on twenty eight dollars twenty nine cents and so i quote on twenty eight  complex so my my st question is are these assertions accurate and nd if they are accurate can you still win without powered could could but so if so if it be if the government is correct in its assertion that the product here contains a mineral without getting into other properties of the product if the government is correct in that assertion can you still win oh yeah ok yes but there's no doubt it was one of be any f d a prescribe drug that includes a mineral in any quantities and for any indication i mean that would exclude i don't know who would be most but it would exclude thousands of pharmaceutical drugs that nobody would sensibly contend are minerals and that are included under part d but the definition of what a mineral product is which by the way c m s outside of this litigation has never ever articulated to our knowledge is added told the district court a substance that quote any manufactured substance that contains a mineral as an active ingredient we think that they have appropriate definition if not the definition they urge in this court which is also an indication of arbitrary  but excepting that as a definition of what a mineral product is the record is utterly clear that it does not cover this because the active ingredient in  naturally occurring in organic substance it is a chemically synthesized organic compound and therefore yes we would have to win i hope that answers your question thank you so  much just before i turn you over to judge sell you if i didn't say this already if you do find that you need to file a rebuttal please limit it to three pages thank you not mineral and i struggle with the notion but we somehow have to read the language mineral product necessarily to mean not the mineral must be very active ingredient or an active ingredient in the  process being what it is we could probably well poorest because if i could see you i might not like the color of your necktie all right but i'd really prefer it if you if you answered the question i asked you all right yes what is what is the what is the lashon then now for reading that the language middle product which does not seem to me to be of any direct relationship to the mineral being the active ingre in the enemy rather narrow one specific way that you would like us to read it well the all number one we think it is a this court is in a position since no deference is sought for or not covered under part d that can cane a mineral as one of the substances lippa tor is an example we gave in our and our brief but you know which contains a mineral salt but the congress can't possibly have thought to exclude every prescription pharmaceutical that includes a mineral as one of its components and so the question is what did congress have in mind what is the best understanding of what it has in mind there are twenty six dollars the government offered below two different suggestions one was that it was a quote manufactured substance that contains a mineral as an active ingredient that is a much more limited subset and it makes sense because when the mineral is an active ingredient it is by definition acting to supply to treat a mineral deficiency of some sort that's true with respect to iron supplements it's true with respect to with respect to non prescription iron supplements like ferr sulphate it is not true with respect to a rick cea which treats not an absolute deficiency of honor but that the the the the chronic kidney disease patients inability to use on iron to create hemoglobin that is to absorb the iron and utilize it so my short answer to your question i apologize for the stem winder is that that the presence of a mineral in a compound that is prescribed by law that is authorized by f d a to be a prescription medication cannot possibly be the task but it is because it would exclude a vast number of drugs that no one contends are covered but what i don't i get i don't understand issue that it may not be within the statutory proof you i question was was really on the other end of the spectrum why should they even grenier be vitesse i'm struggling with the notion of weaving  intervene into the language because it doesn't seem on reasonable on its face for the secretary to apply mineral product as it's used in this in this statute to i no one has suggested and of course this may be a case this may be an instance that would have cried out for the expert agency to have given some explanation for what it understands minute product is which it never ever did including in the communication that denied our request that the or rexy of for i d s a be included and in the quinn the federal courts in this case it is offered two different definition now in both court both cases and i hope this is responsive to your question the government tries to cabin its definition by saying well you know it not of what they have to have a mineral as it's either it's active ingredient or some ingredient better also have to be used to supply to a two to correct a mineral deficiency in the body now i have three quick points i want to make about that number one that is for the reasons i just stated that is a post hoc litigation rationale unsupported by any document ever ever submitted by t agency or probably gated by the agency number two it is arbitrary and capricious because it doesn't account for either of the two feet i did or of the following two things number one as i said the treatment of iron deficiency and niemi in c k d patients is not the supply is not to remedy the fact that a patient is not ingesting or not able to store anough iron as the declarations of dr church oh the articles that we've submitted the record and the brief for the center for medicare advocacy on pages eleven through fifteen explain see iron deficiency anemia is the inability not to ingest enough iron it's the inability to absorb or utilize it here here's that here's an exe a good analogy my car stops running i have a full tank of gas or a half a tank of gas or three quarters of a tank of gas but there is a blockage in the fuel line a compound that is introduced into the car to remove the blockage from the fuel line is not properly categorized as supplying a gasoline deficiency and that's exactly what occurs here and rd the government has no explanation even under this used definition for how it is covering a whole category of drugs electrolytes that consist of inorganic mineral salts that are used to defeat treat a mineral deficiency or its coverage a vitamin d analog which the government says and i quote are chemically synthesised compounds that are often prescribed to see k d patients to treat conditions arising from vitamin if the answer is no and there is no avenue for manufacturers like the key bia to participate at all d in the agency's administrative hearing process i'm just curious because my function is that p b s did its due diligence why you nonetheless received it and bought care so what the record reflects is a couple of things stretch and agreed upon and obligated each party before the c m s rendered this decision and the government for the fact that there was one change in the agreement decision to exclude a rick cea but that was just a formulaic change of than in the number of directors that would serve on the board of directors and in any event with respect there is no case law ought to support the fact that even if the distraction had post dated the determination if it was an acquisition of the patents and the assets rather than a merger of two companies that that injury there's just no case law whatsoever to support the notion that a company could not buy an asset that was already impaired and claimed on the last that it was being a reparable ie injured as we are here with the government agrees does or doesn't dispute certainly that we're losing millions of dollars and we have no basis whatsoever on which we can recover because the government is and even fighting it by those fundamental problems the district court correctly how that when used as an iron replacement product for the treatment of iron deficiency learning at a rate the at in the now product excluded from coverage under medicare part  on your your last point about the merits of the case can you just give me what you consider to be a citation or a name to what you consider to be the closest analogue to this case either either a federal court case or an administrative case on the merits question on on vitamins and minerals products yes i'm not aware of any court that has interpreted that fighter meaning and mineral products exclude them all right and in administrative decision i wanted to look to the case to sort of figure out how to decide this case what replacement product and the explanation for why it can treat a functional iron deficiency is that the iron that is being the body of a more abnormal ball form of iron that this particular really uncomfortable and i think i can understand why the district court chosen instead to go to the merits rather than then deal with facts of the government's procedural argument in illinois counsel the supreme court recognized that this process could result in that way but that it was still at the process that congress could enact it and it would be sort of unusual to think that congress had created that you know this beneficiary who was you know of very limited interest in a particular prescription for particular illness as being a sour get for him in your factual that has millions of dollars on the line out i understand the jurisdiction channeling issue and the question the judge so you with that thing and i have to say i share his discomfort but i know with the sort of stocking worse approach has been going on for a while how long have you been in france been the process how long have i am afraid i don't understand the question how long ha channeled through your the agency but if you take a minute to wrap up i would just thank thank the judges for their time we at do you believe that the claim could be channeled but because this is automobile united states court of appeals is now recess until the next session of the court god save the united states of america and this honorable court counsel you may disconnect from the meeting