one of my ma clerks the past year and it's just been an absolute pleasure to work with them i'm convinced by his ability to think through problems and help me think more deeply about chimeras congress specifically take away that right that didn't happen here the law is clear and last it produces an absurd result that congress couldn't possibly have an intended plain limitations of the day actions in this act none of which apply here first each of the limitations on its face applies only to subsection k applicants sentence is not a subsection chaotic and second after notice of commercial marketing so subsection a applies to a limited subset of patents which currently does not include the two patents we're talking about and will never include those two patents but moreover himself how how how do we know that it will that get let let let out of the the litigation so it's included on the product sponsors list but it doesn't end up in the litigation so those are left over patent essentially and you requires one and two  it is not a claim meaning argument anymore no this is i think the plain meaning is clear a day as well i'm just the question why you can't provide notice until you're you've let your license that's what the district court held think about that a day that this is what she's says it says you provide notice quote no later than unquote hundred eighty days before and this is the key phrase the first commercial marketing of the biologic product licensed under subsection  licensed qualified biological product meaning the product mix has to be licensed for commercial marketing it does not say you have to wait for licensing to get the notice you need licensing the commercial market you don't need twelve year period and the various restrictions on litigation to be independent of which of each other there's no cross reference so the fact that in some cases there may be an extra six months you know someone but i mean remedy regime that says we don't want litigation too early on that you would be able to conduct the litigation the day before filing your application it's a good question think about the context they were talking with her because they were contemplating that there's would be plenty of time during this twelve year period of exclusivity to deal with all the outstanding patent litigation so you can leisurely go along and and and resolve the past misconstrue this topic strange information but the idea the key point was resolve the patent disputes before the twelve year period expires so the price competition can start the next were filed four years after the beginning of the exclusivity period it would seem unlikely that at that point the two would be able to bring in ordinary detail actions in light of the immediacy test of medicine  lawsuits that were otherwise right why would they do that they're looking why not me but i thought why is this one of the wise right when we don't even have an application that precisely defines the product against which we're going to measure infringement because the only issue is whether we have the look we're nine years into this process just think about the situation do you have a precisely defined absolute right that that that cannot change absolutely how do we know that  scheme just under the usual standards then isn't there a possibility that the product could shootings during this process so that you would have litigation that was corrected to some product which ultimately isn't going to be approved or not a and roll after nine years tens of millions of dollars even while quittance clinical trials with one hundred patients we've passed with flying colors we are in the last lap with a very long race there is no realistic possibility that we're going to change th understand it was just last summer the for very first application under the biosimilars provision was even even so i thought we were going to conclude that there is basically no substantial uncertainty about  eighteen months to three and a half years out we're in that same timeframe you could have done the same things in those cases who knows when would be first of all you haven't filed cation nobody is different in biosimilars right because in boston there's more work  didn't need to have an active infringement they could just say that we're on our way of getting example and into pro chance either and i think it's damaging to your position to suggest that because the argument  s i understand it is the did this elaborate structure in the statute is dealing with two seventy one e a printer and to the extent that the staff is talking about infringement suit bought brought by the patent he must be talking about infringement suits other two seventy one he it is and i'm just it's not the it's not the exclusive remedy my example is going to be this and she's big one of the biggest products is called e p o roche was coming out with an alternative to e p o something similar can't be infringement there's an artificial act of infringement that they're allowed to bring suit on that you know but you can't sell the product until at least it's been approved so i don't understand how that can be an infringement suit by the other two seventy facing lawsuits in a four to twelve year period and at that point in time you're not likely to have a case or controversy so they created a case or controversy for instance say we would not have that in year ten or eleven as you white proclamation there would be no case or controversy so this caught next change process which during the exclusivity period can and can proceed at a leisurely pace and the artificial active unfriended creates an artificial act of infringement so you can actually have an early lawsuit that's why they created so you could have early lawsuits long before the twelve years expires long before approval and you can resolve all patent issues we are in a completely different circumstance the twelve years it period has expired we have a case or address and so what that the act itself doesn't bar the doors i go back to my original point that if you read the plain tax and the plain text does not stop this lawsuit you just move on and certainly i don't think it or  argue it creates absurd results i don't think because this we are carrying on the purpose of the act by trying to expedite price competition then you just move your standard d j analysis that's what that's what you should do in some cases it might not the the x e action reports on the statute there's actually little of any floor debate about it do you agree that the purpose of these provisions in the creation of the artificial act of infringement as was said during the legislative history that the purpose of that was to enable the resolution of the patent dispute before the time of commercial marketing while i agree to judge died there's very little legislative history on it you're absolutely correct on that i think there are idea of goals that were being achieved in the statute for the one that i mentioned one of the role not necessarily no i don't think that that's clear from the legislative history i think the goal here was to create an orderly process for the resolution patent dispute involving biologics that was the goal in with the congress was doing was balancing a lot of interests here in part there was a desire to speed the approval of biologics the similar similar just no question about that but all you have to do is look at the name of the statute which also talks about innovation in clearly understand both what the question is was one of the purposes of the statute and the structure that we're dealing with here designed to permit the resolution of patent disputes before commercial marketing the goal was to try to do it quickly whether it would coincide exactly with the date when the buy a similar applicant is otherwise ready to go to market or not those things are very difficult to time precisely you don't do that with had cracksman and they didn't do it here what they tried to do was to create an efficient and orderly process and it can move very quickly  one of the goals was to get an early resolution of patterns sure ok sure so why wouldn't we want to construe this these provisions here as directed to two seventy one he infringement the act of infringement this talked about when the patent he is required to or the first biologic is required to sue has to refer to seventy one infringement  when we're when we're talking about a day in the actions for infringement that has to be to seventy one the infringement right of the statute is not limited to two seventy one on the bridge when i know you're giving a general answer to a specific question  a gives the reference of product sponsor the right to select the venue and this was part of the congressional policy is clear and unequivocal so important right that is given to the reference products sponsor if we accept the notion that they can jump the gun and file a d j action one day one day before filing their application in order to game the system it totally undercuts in defeat that provision of the b b c i a now that's one example and it's an important example both contingencies if you file if you comply if you don't comply covers everything in prescribed when they may proceed and right i may not i get some version of my question and explain that in a concrete way sure what would be the harm done to what congress had in mind in creating this regime by allowing this suit to go forward assuming that it otherwise that the you know  they seem to concede that once they actually make their filing of their b l a with the f d a that the statutory restrictions are going to kick in and limit what d j actions can be brought if you read those provisions think that are some broader statements from some of the briefs on that but be that as it may i mean that's an exception that was one of the rules if one could simply skirt all of this by saying what i gather to seventy one a action and not a two seventy one he actually again you could accelerate the ability to look at the past of you would defeat the provisions for example and all of the exchange of information with the statute requires users of there's a process there where they have to provide information on the product they have to provide information on the process they're going to use to make the product all of this information comes out it can be taken into account in the negotiations back and forth over which patents are going to be asserted and to prioritize the insertion of those patents to process the congress created with they would have as a free for all they call it to seventy one a case they file a one day before they filed their application with the f d a and now they say we can proceed with this lawsuit and we don't it would be in tension with the provisions that are in the statute they now have picked picked the venue for the action the statute would seem to say that the action needs to be dismissed or we're going to have t are we going to have two seventy one a j filed one day before the application was filed and then we're going to have another lawsuit that follows the procedures and the i think the concept is that the statute generally was designed to allow  works very well the problem is when you get to a situation like this where there was a victory expires before the statue is even an act and how to deal with it that's what we're struggling with it's not clear that congress really thought about that situation or intended to deal with it and that gets back to the question of you know why would allow ing a to seventy one and eighty two if it qualifies under that name in standard to proceed under these kinds of circumstances it's not other than the choice of venue i'm not sure that you've identified any adverse effect from that well i think if you read the sections the declaratory judgment sections of the statute i think they various exceptions listed in there there are the exceptions putting aside the biologic statute and ex wife had to act which were written into the twenty two and one is exceptions but if you look at the exceptions t twenty two and one there are always stated in terms of the nature of the controversy rather than the party bringing and congress didn't do that in the biologic statute they didn't say a controversy with respect to whether this biologic  infringes the patent or can't be the subject of a darker judgment action instead of following that course they chose instead to identify the person who can bring it has the case apple can which when one reads the context of the statutes it makes sense that someone who is in their position would be treated as a subsection applicant they are not a k have become now right that they are seeking a declaration of right now they are they are not an infringer but they're seeking a declaration of their rights under the patten as if they were an infringer when i bring a d j action in say that i don't owe you money on the contract i don't have to pay it forward looking that's inhe declaratory judgment action and what they brought here is a declaratory judgment action that seeks a declaration of their rights as a subsection k applicant i think what you're pointing out is that there are a lot simpler ways of draft of this factory to accomplish what you say it should accomplish which would be to say a controversy between someone who is or are made peter b a k applicant has barred  of easy ways to write this which they didn't choose to do in construing the statute you have to look at the context in the the purpose of the statute congress almost never unfortunately writes the statutes with the clarity that we as lawyers looking back a few years later might have been able to employ when we were doing it but there is a weird in the region that all agree our map there is clear evidence here  what congress intended to do was to occupy this field and to regulate the way that patent dispute involving biosimilars are going to be handled by the court one seldom sees a scheme is detail ridiculous it is the scheme that one would regard as optional or voluntary or they could be sidestepped by the expedient of filing your lawsuit the day before you submit the application it just doesn't make sense when there would not be too seventy one infringement either way but allowing the issue to be litigated to create the artificial act of infringement i think that's what congress was doing here in order to allow these cases to proceed but coming back to my point your honor on the question of whether they are a subsection k applicant they really want to have it both ways and fundamentally that's their position for purposes of immediacy and reality they're coming in and they're telling the court look here they try to satisfy the issue the problem of immediacy reality and so when you're talking about immediacy of reality sure we're subsection k applicant but then when we get over to talking about the b p cia suddenly they say they're not the truth of the matter permissible but put that aside i'm still not resting in a concrete way let's assume they really were an applicant and then again what is the harm to what congress concrete harm of the statute which governs interchangeable and as a very special of bio some are it's one that is qualifies as a higher status in what you'll see when you read through that is that there are various exclusivities that the first interchangeable get and the periods during which that exclusivity continues are triggered in keyed off the l six litigation that's prescribed in the statute so those are pretty important in those affect the interest of the public in the rights of other potential makers of biosimilars down the road can you just clarify do i mean do we know one way or the other either because it's  generally the case under the statute or something about this particular plan on sentences part whether interchange ability will be an issue with respect to the product and they want to get approval for we don't know at this point what they're trying to do but it's a reason why congress has tied all of this to the litigation to unfold according to the plan in the scheme that's laid out in the statute and that is the way the sachin has is written if they have to apply to right but there's a benefit to be regarded as an interchangeable enormous benefits of flow from that in the exclusivity in congress has tied that to the l six litigation and we don't know whether they're going to seek those benefits we don't we don't but it's another indication that what congress has done is to provide a scheme here which is highly interdependent you can't just take little pieces of it apart and to allow the litigation to proceed independent of the idea in this parallel first we know they haven't submitted to be l a so the product really isn't defined and and there's nary a case out there where a court has allowed and found a d j action to be right to be a case of controversy biologics this is true of devices it's true of pharmaceuticals no one of the chances that they would change the product i think it depends on what happens in the space three clinical trials and that's a very important point one doesn't know what's going to happen in those phase three clinical trials what we do know is that the f d a could have dispensed with those clinical trials in didn't also one of the statements i was struck by that was made by counsel in the argument this morning  structurally what they have is identical to you can or sap but you know if you actually look at the language that they put in the declaration that they submitted it's in the appendix of twenty fifty three what you'll find is as they go through all these analytical tests that they did there were some things they say are identical and some things they say are highly similar which is a red flag and maybe the reason that the food and drug administration required that these phase three clinical test  they said they were sort of not infringement defenses and we have limited visibility into what they have and what they do under the b p cia one of the things you get in this exchange is for example process information we haven't asserting infringement claims under our patents in they get approval sure we're going to see them on those but at this juncture we have a limited visibility we don't know anything about the process one of these two panels not all the there are other limitations in those claims so you know is it likely sure we have an important product here and we have patents but that's the reason this process exists in the in the statute for the exchange of information once i'm not trying to the answer to that your honor i mean certainly if you go through you file the application with the f d a could they amended i don't think that they could amend it to change the structure or the composition that is the limitations that are in effect here but keep in mind they were to argue the stance it was a bar of the section no they were a little cute in the you did not we did not know and they were a little cute in the opening papers they said they were going to market what they called a bio similar we didn't to do based on the complaints and that's all we had at that at that at that stage we file our papers we certainly flagstaff's you in the event they're going to pursue the cape affidavit it was entirely clear th now position they fell declarations we took some depositions by the time this was greek and decided by the district court there was no doubt that they're following the cape half way they made that clear in the papers that they filed it's clear in the declarations and the testimony  they embraced it because they thought they that helped them on their immediacy and reality argument that they were going down the gay pathway in so that i come back to where i was a few minutes ago that puts them in the position of wanting to have it both what is your understanding of what the approval review process is one application will first this is the first the very first time that someone is going to be seeking approval as guidance documents that have been put out by f d a and i think the things that stand out from this are first the f d a could have dispensed with the face three clinical test in the getting in one doesn't know what's predicted based on analytical data and on the phase one results so what we know what the objective evidence shows what the district court found and this is within the province of the district court to make these findings was that we don't know that it's speculative at this point and that's why we're not at a stage where a declaratory judgment actually present to the immediacy and reality and it's required or to present the point of reference it still seems to me that the filing of the application with the f d a is a very very important milestone is the case is decided by this court of recognized to milestone for a number of reasons first it trials are successful this is not going to be a huge gap in time and there's good reason to require that in general one would wait but it would depend on the facts and circumstances i can't give you a yes or no answer to different exclusivity period for certain approvals based not either a loan or at all by a similarity but on interchange delivery and i think his suggestion was that a we don't even know if you're going to seek a stablish interchange ability to get those extra benefits and in any event this is a statutory connection between the sequencing as to patent litigation and us and waiting until you know exactly what the application is and what the standard is it's going to be i actually don't know the question about which exclusivities will be applied and whether we're actually going to be seeking interchangeability finding i just don't know at this point maybe the company does but i don't have that information i apologize i think the question is not so much what your plans are but he he's saying that this i fully understand the point yeah i think the look this whole case provision is about actions under two seventy one and therefore the declaratory judgment limitations under a b and c are limiting the congressionally contemplated procedure for the b fall yeah i would respect approvals and i was hoping that you would be able to shed some light on it you see i don't i don't see that at all so the question the question that was put to council so what damage will result from having declaratory judgment action sitting side by side with an action under two seventy one c and interest there is no damage so the one thing that he identified was well don't you defeat the patent information exchange through the declaratory judgment action we might disclose that information early but when we get to the per process into some they want to eat we will go through the patent exchange process so you can sit perfectly comfortably side by side that's number one no damage along second the forum shopping issue just for discretionary reasons but that doesn't argue in favor of the tax barring the lawsuit in fact the plain text when you read it each of those provisions even if we were a catholic and even if we were catholic and neither a b or c would bar this declaratory judgment action one way we know that is that the engine below never you ask the question judge and just below never argued that the text of this fact bart our  lawsuit count his response was well we didn't know that there were proceeding under k we identified that we were proceeding with a bio similar that is case number one and number two we had depositions they were fully judgment action it doesn't have to be absolute certainty if it was the glaxo case would have come out differently and the type of case would have come up differently in those cases and those were filed approval with a anywhere from eighteen years of three and a half years out of course things could go wrong brett in the end the cases we can get the court has traditionally used the application as sufficiently fixing things you don't have i don't know and we don't know how why is what you have be changed but we don't have a fixed issue i thought your issue was more along the lines of who knows how phase three will come out what here's what you have to look at this is why the case is focused on meaningful preparation it's enough we have enough confidence that we're going to succeed that we've devoted nine years and tens of millions of dollars to this project that to launch and tell you that there's sufficient certainty to clear the way what we get to do we can get so that we can get to market when the da approves and i  characterization and we need to record cites a one five seven two and a one five nine two but there is no rigid rule that you have to file application to create declaratory judgment or jurisdiction as amgen proved when they sued roche six months before roche filed a new drug brand new molecule application but if you look at those two sites they explain the bio similar process and how you get approved what they're explaining is one of the sites says the foundation for bio similar approval is the preclinical characterization we pass that with flying colors and the the f d a has said that the phase three trials for biosimilars for going to be purely confirmatory we've already proven our molecule is there molecule we've proven that in and the cases you don't even have to run to these three trials the only cover here i would say this way your are i can't tell you today exactly what are not infringement positions may be and it will be dependent claim to structure i can tell you that yes if amgen is right what they said to the public in their