they please the court i'd like to start off our presentation to talk about the issue of the stand and address that first i think it's good to point out that there seems to be this erroneous assumption that  then the f d a would be notified and would eventually have to change the listen to that patent to remove it from the orange book at that point american could change its p three patent certification to a patent is delisted from the orange book that someone like you that has a paragraph recertification could just walk in and very quickly mediately without any question from the f d a get a modification there are four patents expire in may of two thousand and eighteen to which we have peace resort of occasions those would have to expire we're not challenging those but once those expire on may eleventh if you were versus the board's decision we would be able to launch we have patent challenges to later expiring patents twenty twenty eight i don't remember the dates p four certifications that have been maintained and continue on so yes the mail level expiring molecules so if you make a diet or you're hoping that the best races die you're hoping that the x rays will cleave esther's from both the two and the five sites if you just do one it's more so then the question is you might ask why would you go to a short chain esther versus a long chain aster again you're trying to tweak the look of felicity you're not trying to trying to change it wholesale so you would want to selecting from a narrow range of short chain other words you know you know that's good and you're looking backwards you know looking backwards and saying well sure doing these things results in a good product looking forward a footnote in the petition that referenced the declaration of dr patterson who's a expert in drug discovery and development commercially making commercial molecules he explained that if there's a patent covers a molecule you'd want to change that because you're not going to get a patent on it so why invest the money in it and you don't want to infringe that patent so that was a foreign pattern there'd be a us counterpart that motivation was dismissed  maybe maybe you could license it may be really expensive and unpredictable and time consuming to do all this kind of research to do to make a series of modifications or t hard there was expert testimony i pad owners that it was explained that was not the hear thing a degree in chemistry should be able to do this but back to your question about is a patent an automatic motivation you know that's an automatic motivation in maybe in all the also in drug discovery where you're going to spend a lot of money to develop a new molecule you want to make sure you're not infringing and they can get a patent so many litigations come to this court for and a firelands having to do with the patents on the drug there's so much money involved in it case they they seem to require experimental evidence from the american whereas they didn't require that from the past the patent owner u c b they also required a marriage and to find modifications  analogous art like compounds with the same mechanism actually compounds with the same chemical class compounds with the same treatment whereas they didn't require that for u been tried on the same obviousness thirty three times that obviousness theory has led to the same result three times and that is that the claim subject matter of the six five a patent would not have been obvious to a person ordinary skill and the only the standard for reviewing the board's decision is substantial evidence and the essence of america jens dispute in their appeal brief is that the board weighed the evidence and sided with the patent seized evidence over a marriage ends evidence in a marriage and experts evidence but substantial evidence it's met multiple times in this decision by the board at least six different critical findings a factor made by the board weighing the evidence from the petitioner from the patentee from the experts from the honor we don't believe five a twenty should be a lead compound the bore did find that it was really compound but our view is that five h m t has never been used as a drug as of the prior art so looking at the prior art all the evidence relating to five h m t is as of metabolite it had never been orleans minister and there's a very big difference between how something works as a metabolite and how it works as an orally and minister drug all that was unknown whether or not five is if you look at the petition the argument is well there's a bioavailability problem of five h m t what's that bioavailability problem basically that wouldn't be absorbed into the bloodstream if it's orally administered they back and above five h m t that are perfectly well absorbed in their orally administered so it actually fits in a range of drugs that have a look foolish the higher and lower all suggested the bioavailability wouldn't be a problem is another one of the board's findings they looked at this issue of the two thousand union that's what that's what it is it's looking at but it's looking at the solution after the fact it's hindsight how would you know to only focus on the two positions and not look at the five position there's there is evidence in dispute from both parties on this point dr ross said there's plenty of evidence you would you would try both the two position and the five position in fact the prior art that is put forward by do a diaster make a change to make a change of five what dr roush found was he did a calculation he said you look at those two positions even if you do simple simple asters and you wouldn't because bungler talks about many other different possibilities if you just do simple lester's at those two positions you have eighty six at one eighty six at the other eighty six when you do a diaster and if you do a mixed diaster do one type of bester at one position and different in the others all the different well you know that's the ice a beautiful substantial in one specific substance one and that specific chemical modification is nowhere in this record in the prior art they don't even try to argue that i see beautiful is shown anywhere in this prior art and again the board found that and they've sided with the evidence submitted substantial evidence submitted by the patent expert and that was there is nowhere in this record pointing to the specific molecular modification and that specific molecular modification is the i c beautiful group they don't even have a reference that teaches that it shows that they just say well the bun guard treatise which is a general treatise on pro drugs talks about a number of different projects and one of them is out kill esther's but there's many other possibilities there's carbonates carbonates many others they could have tried all of which are mentioned and talked about and described in the by god reference their own reference in with your own if i can just talk about the unique set of facts that got us to disappear and to address your question and that is in two thousand and thirteen there were a series of first filers the challenge the patents on this drug a marriage in was one of them so they filed a paragraph for certification against five patents including this patent six five zero patent we went to trial against them in the district of delaware and on all patents all claims found valid and in french and the court there then put in an injunction against those first filers and what that injunction do it says they cannot have approval of their end until these patents expire including the six five zero patent expires in two thousand and twenty two and they had the opportunity at that point with their paragraph for certification which is a statement to the f d a we're challenging this past they have the opportunity to that point to appeal that decision they chose not to lie because they didn't want have attorneys fees against them and so in exchange for our not pursuing attorney's fees in the district court they agreed not to pursue an appeal they gave it up but when that happens they automatically convert to a paragraph three certification what is a paragraph three certification that's telling the f d a we're not seeking approval until this pat well it's actually more complicated than that you're honored if it goes beyond that as as mr hare said there's a number of issues that go to whether that would be delisted at that point this is almost insulting standing here him but standing requires an injury in fact and that injury in fact they seem to change what is that in this case they say well maybe it's the fact that the patent is valid that's one statement they if there is hypothetically if if the six five zero patent were invalidated the f d a would have to make a decision on whether or not to delist it and they would have to do that in part based on whether anyone has first file or status on the basis of that patent were a number of first filers and some of them settled so they were not in joined by the district court so so if one of those first filers met all decision further i can't think of anything that would go beyond that your honor but these are a lot of possibilities that are all self inflicted because they converted to a paragraph three they chose that if you look at the case law on standing it has to be an injury in fact traceable to the conduct of the party that the case is against in that case in our case u c b but it isn't our activity our conduct this led to this stage the conduct that led to this stage of their decision to no longer challenge the patent there is no case in which a paragraph three filer which is a statement to the f d a we will not challenge this patent we will wait until this patent expires that's what paragraph three is it's not a statement that please go ahead and still invalidate the patent it is we're going to honor this pattern and wait until it expires they cannot infringe this patent is not possible there is an injunction in place by the district of delaware which they did not contest which says you cannot approve this product until the patent expires  list there i assume the other side to go to the district of delaware and ask for the injunction they say that in their papers your honor but there's no case where this is actually occurred so i presume that's what they would try but as i said there is no case where a paragraph three filer who is honoring a patent that's what they're telling the f d a has gone into an article three court and said find the patent valid  even when they filed their appeal twenty nineteen was over a year and a half out so that's another reason why there's there's an immediacy issue and we prefer that with respect to the janssen case of course we're farther along at this point that they needed to have standing when they file their appeal and that there's a question of whether that's the case but i really want to emphasize this point because i'm not sure from the questions that i want to make sure it's clear from the briefing there's never been a case in which a paragraph or three five other has been able to come to an article three court and seek validation can't do it they can't follow declaratory judgment in any district court would it would expire i'd also like to point out that since filing the briefs there's a couple decisions from this court having to do with standing that are relevant to this that are closer to the  wouldn't you shouldn't you look something to us before today i expect you're correct on that let me ask you a question that the other side is talking about your settlement of that earlier litigation with the ok where and in their view you voluntarily willingly moved over to a paragraph through certification and so because of your voluntary act of doing that you are sensually is stopped from claiming any kind of controversy as to the patent and so therefore shouldn't be considered to have standing here could you speak to that you you're on your own volition moving over to paragraph three and how we should think about that with respect to standing here i've raised two points one sometimes companies make a business decision that it's better to you agree with that right there are yes there are differences so is your point that the standing requirements for the district or her country judgment she is different and stating requirements for an appeal here the there's a relaxation of the redress ability and the traceability or immediacy of the challenge action but you still have to prove the injury in fact so that's what i've been focused on is the entry in fact that we have