court there are as you indicate two related cases today and there are also two important issues presented by this case one of general jurisdiction and one of the specific person jurisdiction the court's indulgence i'll start with the first of those two issues big can you can you start with the specific jurisdiction just that to reflect at least the way i'm thinking this case should so the reason there's a case of controversy in this artificial act of infringement  to tell me why what i'm thinking is is incorrect is that congress has reasonably determined that the filing of an end application has a close enough causal connection to the only thing that will actually harm the pioneer drug company which is the because plans future intents are not enough to support a specific personal jurisdiction right now when i point out i mean it seems to me either there are not enough work for there to be an article three case of controversy or there are enough to support specific person i don't think that follows your honor and i think that if your logic actually work correctly there wouldn't be any need for congress to create the artificial act of infringement that is  and say no this is close enough why isn't that what congress has done here so that mylan my finding an end application has sufficiently announced its intent to compete in  india well i don't think that's what it's done it certainly hasn't announced any greater intent to compete in delaware than in any other jurisdiction in the country so so why isn't there a specific jurisdiction anywhere well i think that would i mean that's a sufficiently conclusion right there to make me at least have some pause to think that there's actually a specific personal jurisdiction in all fifty states and i also think with up with isn't it true though even if you could argue that the act infringement because you sought approval to act in every single state that that's there wouldn't necessarily translate to specific jurisdiction in every state because you still have the overlay of them the reasonableness analysis that has to be done well i suppose that's true but i guess what i'd like to say is i think the logic of this argument first of all if there's if there's you go get over the minimum contact specific of ailment sort of prong before you even get to substantial justice and fair play and so i think the problem is if there is jurisdiction in any jurisdiction because of the act of filing the end it would logically be in maryland now this court zeneca decision is an obstacle to that to be sure and i'm happy to talk about that but we haven't purposefully availed ourselves of delaware at all and with all due respect to your honor i think there is a problem with the analysis that you're parsing it true because i mean i obviously have thought about this and you put it in terms of intent to compete but that's certainly not the way my friends on the other side talk about it i think they talk about it the way you would more logically talk about it with all due respect which is they talk about this future act of infringement that will take place in directed to the place that is you can have injunctive actions to prevent harm that is going to be directed into the stay right with you this is a person jurisdiction isn't limited to retrospective relief or already occur if i don't i would certainly can see that your honor but i don't think there's any support for the proposition that purely future acts that may or may not take place and it's also worth taking into account here that once you file the paragraph or certification in the end there are a lot of different off ramps if you will that may prevent you may prevent a generic company from ever marketing the drug in any state let alone a specific stake can you explain why there is a case or controversy in the absence of a sufficient likely connection to the future of competition and you get an f d a approval you know if it makes nothing happen doesn't affect them one bit unless there's an actual likelihood that you're going to it well i think i'm not sure that's right which is to say i think that once we call into question the validity of the patent that there may be enough there to get you over the article three minimum without regard to contemplating how that is going to be implemented in a marketed product because if we get the invalidation of their patent and i think they've suffered an injury and survive but you don't get an invalidation  get court so what is it that gets you into court there must be a case or controversy there must be you must be threatening and injury in fact and i guess i'm having a hard time understanding what that is other it's a bit metaphysical i guess i mean which is to say it's a highly artificial act of infringement it is i think necessitated by congress reality that just by filing it we haven't actually threatened a future sale in all fifty states i think if that were the case you would even need to treat the paragraph for filing it's artificial act of infringement you just contemplate the thousands of of infringement actions that could eventually become to put i don't think that's the way actual commercial sale it exactly your honor exactly and but the problem is they had to do that because they protected all the pirate activity that would have been subject to an infringement action absolutely and they don't want to put they want to encourage generics not discourage them so they don't want to put them in the position that by doing that the contemplation that would end the actions would be necessary in advance of the paragraph work certification that they then are in a position where they've already infringed where you're  min provides this is an act of infringement you have an obligation to file suit within a relatively short period of time rules school's out and so it seems to me that what i hear you saying is that newman that is that is that is our humble point i mean i'm trying to be responsive to judge trotters line of questioning but i do think we you know when we filed the paragraph or certification i do not think the right way to think about that is that that is in any way directed at there's a there's clearly jurisdiction in west virginia which is where my good wine is incorporated and that is the only and that one should disregard acts or at least the consideration that oth erwise could very well be really even to specific jurisdiction but we're not asking you this we're not asking for a special rule we just don't think there are any other specific acts directed at your relevant act so i think if for example you know milan has you know its headquarters is in west virginia but it has offices in pennsylvania if it contrary to the facts of this case had prepared the end in pennsylvania i think there might be a good argument that there would be specific personal jurisdiction over my client in pennsylvania here i don't take issue that there is in of all the pre filing activity would be relevant jurisdictionally even if not relevant even if not enough to create a cause of action yes i think that's right even immunized activity i think can be relevant for a specific personal jurisdiction so even if you want to think about it in the strongest form that those pre filing acts are immunized from liability accident they're still relevant for the specific personal jurisdiction analysis and so that remain your view that that was right and zeneca to argue that there is no active infringement on the state of marriage i do think that's right i think that's right first for  reasons that are kind of unique to the fact that there's a federal facility there and it's you know it's sort of happenstance that the f d a is located in maryland of course if the other side's right and if judge trados theory is right then that is at the seneca decisions actually wrong or at least just missed the obvious reason why there actually is a specific personal jurisdiction or at least minimum contacts with maryland which is under their theory their specific personal jurisdiction in all fifty states  tend to use the approval being sought to enter a market i'm not one hundred percent sure so i'll try i mean i try to get you an answer to that but i'm not a percent sure it's not obvious to me why that's a statu requirement but i don't want to give you an answer that i'm not prepared to get i understand that these circumstances are unique because of the structure of the tracks but do you have any i didn't see any cases cited for the proposition that exempt x can be jurisdictional irrelevant that you know i don't know that the question had specifically come up with and i didn't really view it as part of my friends on the other side's argument so i don't know that we've really specifically looked into the question in that way i really don't see any reason why that wouldn't be true but i mean that's you know i've been i've looked at a lot of personal jurisdiction cases and there's just nothing in those cases that suggest that whether your act is itself immune or exempt that somehow that makes it jurisdictionally irrelevant i mean i think what the court's cases and particularly if we're talking about specific personal jurisdiction after walden make clear is that it's the defendant's contacts with the forum that matter and that's why in answer to judge newman's question i don't view us as asking for any special rule here whatsoever it's just that the logic of the district court opinions here is that because we provided the statutorily required will tell us that there are many contacts with you know where to put in specific jurisdiction what judge newman i'll listen for those as well because what matters is not just contacts with delaware but they're the defendants litigation related contacts with delaware and that's what's missing in this case because they're located in delaware i mean we've filed the steps in this case we filed the statutorily required notification letter in new york but to a delaware corporation so they're located in delaware they have some ongoing suits against other generics in delaware but again that's their contact not our contacts and then with respect to delaware more generally i'm not here to tell you that at least through distributors that we do no absolutely your honor but in beverly hills fan you actually had the company was selling the product in virginia at the time the alleged to be that the relevant product in virginia that's not happening here at the other thing at least as i read the court's opinion that was really driving the analysis in the beverly hills case is that there was no other obvious forum for that litigation and that is not a problem we had here there is a mending suit in west virginia we admit it to personal jurisdiction in west well two things your honor one is that i think this would become a ground among all the parties i mean you know that congress and hatch waxman can't have can't trump the defendant's personal jurisdictions right so even if it would be convenient in hatch waxman litigation to continue the status quo ante which was general jurisdiction cases being filed in delaware even if that's convenient that can't trump my client's rights but second i think most important congress thought about this at least if you look to legislative history and in the house report that said page ten of the generic pharma brief congress haven't had a solution in mind to this which is use the normal means of consolidating litigation and multi discipline litigation to much more directly on point than anything on the other side of this case and it does seem to me quite telling the congress when it thought about this didn't say well of course we're going to have a super court somewhere if and you know by the way they're going to have super court somewhere i think more logically it the exception and calder is the general rule and as i read the courts called it's everett rather read the courts while the decision what is so relevant there about the defamation tort at issue in calder is that it is actually an element of t were directing your paragraph for certification to ok with all due respect your honor i think that is exactly the analysis that the supreme court rejected in the wall the case because remember the wilding case  there were multiple claims but the claim that the ninth circuit let go forward was not the claim for the unlawful seizure of the money in the airport in georgia where the connection to nevada was quite fortuitous the claim that the ninth circuit allowed to go forward with the claim about the false affidavit that they allege that the officer put in once the individuals were already back in nevada and the arguments if you look at me look at the footnotes in justice thomas decision the arguments that the pla made in weldon are exactly the same arguments that my friends on the other side are making here they said well you had somebody who was in nevada the tortfeasor alleged toward fuser knew they were in the vatican and by putting in the false affidavit they were knowingly targeting somebody who was resident there and the court i think cannot be more emphatic that it is not the plaintiff's connection with the forum that matters what matters are the defendants my clients litigate related contacts with the four and those are what are just simply absent in this case and which to be sure i mean that's you know they're absolute in part because of the nature of the hatch waxman act i'll grant you that and that might be a source of concern if there were no forum for this litigation but there's a thank you your honors may please the court i will turn to the specific jurisdiction point although i don't plan to join to the general jurisdiction point zero time permitting congress decided in this statute that there was a clear present immediate infringement congress passed a law that says that the and itself of the paragraph or sort of occasion constitutes infringement i know the court in the supreme court used the action and other words creating the artificial case of controversy but not creating jurisdictionally relevant conduct well it i don't think there is such a thing as artificial case of controversy there is a case or controversy because congress decided that filing the and and the paragraph for certification in and of itself constitutes infringement infringement occurred i don't understand that companies that there's a case of that question unless mylan plans to take sales away from you and that's exactly what michael and plans to do that is why the end is filed that's why the paragraph for certification is that's why the supreme court called this a of my windows filing for every and applicants filing that says we intend to use the approval once you give it to us to market well that is the announced intention that's the only reason why you would finally and that's the purpose rory i'm trying to ask a very specific question do they did clear that in the in the end of filing or someplace else really not in so many words it doesn't say we intend to do this i didn't do it no matter what it seems awfully intuitive that that's why you would go to it i'm just asking a very snowy and i'm answering that question by saying that the whole purpose of the statutory scheme to put this in play to cause an immediate present threat now in addition of course what mylan has done is not a not only done threatened to to market the products in jello and delaware other states it is also registered to do business in delaware is registered just sell manufacture and distribute products in delaware it is licensed to do business whereby the pharmacy board in delaware it is engaged in litigation in the cause of action that occurred in the state so you have to say that either the act of infringement occurs but in the state of delaware or the that we are allowed to look at at as well but the plaintiff is in delaware if you're going to infringe a patch someone's patent you're infringing york you're threatening their rights you're undermining their rights and you're doing that work that player i only thing that in a normal circumstance say i'm a regional seller and i only sell and two or three states that if i sell and infringing products in those states that you then can sue me in your home if it's in a in two thousand and ten mining chose to register to manufacture distribute and sell pharmaceuticals in delaware knowing full well that twenty two years earlier the delaware supreme court clearly and unambiguously spelled that doing so doing would line when did in two thousand and jan would constitute consent to the jurisdiction in general jurisdiction in delaware maybe bears or at least get you argue about this you know address and i guess it's the chamber's argument about unconstitutional conditions and i think both you and him and  zeneca have what seem to me all of one sentence that gets at the point which says well of course delaware has a strong interest in saying if you want to do business in our state you must consent to be sued in our state on causes of action having nothing to do with our state it's a sentence that the nice insertion tell me why that's well in the first place this is an argument that was not raised by my understand and under this court's jurisdiction jurisdiction the amoco case if it's not briefed in the opening brief it is well tell me why delaware and it actually has an interest in saying if you want to do business here you will on causes of action that don't concern us well i might say first of all answer that question but first of all the supreme court of the united states has already answered this in the near book case it says this is in the nature of a contractual relationship in order to do business here and to and to have access to our courts you must consent to jurisdiction in our courts so that you not only have the right to participate and bring cases in our courts but the ever responsibility and burden to be responsive in those courts to citizens bringing cases here in the near both cases the supreme court said that's a contractual type relationship it is a voluntary decision by the party doing business and it is is not it why my colleague here would have raised that point had the thought that this was an unconstitutional condition why he didn't raise it he didn't brief it it's in one sentence in a footnote in the reply different though than the fact that that the state of ohio is not allowed to say that as a condition of doing business in ohio you either have to consent to jurisdiction or you have to waive the running of the statute of limitations and the supreme times yes but but but this is a different situation this is phil regularly related and tied to the fact that you're being given the opportunity to participate in the courts of the state of delaware you do not have to register to do business or you do not have to do business in delaware once you do you do not have to do register to do business in delaware there are consequences and my colleague of put points out in his brief he says that you're going to provide an incentive for corporations not to do business in particular states or not to register to do business in particular states it's right in the brief so there's a voluntary choice here you're entering commerce in the state of you're going to have to be responsive to people bring suits against you in our courts that's a reasonable transaction that doesn't have anything to do with the statute of limitations or the removal case that is also mentioned in the briefs is this is a reasonable  relationship it's a reasonable exchange the supreme or as i already found that the supreme court has are also said in a number of cases that this is of the personal jurisdiction the right to personal jurisdiction is a right of personal begin with the question of whether or not mercedes benz was registered to do business in california the dima case specifically refers to the perkins case and the goodyear case as cases and as those cases said where there was in the goodyear case that those were cases where there had not been consent to jurisdiction and the fact is that the goodyear case is the very first case cited in the dimer case and the anderson justice ginsburg knew what she was talking about she reverted to give your case something like fifteen times i went through this yesterday fifteen times in the course of your opinion she knew that goodyear was a case where there had not been consent and then that case and a dime personal right that no question it may be waived and there's no question what delaware law was cool was very clear the robert mitchell case makes clear that if that if the state makes it clear in the statute or by construction then it is something that's clear unambiguous and and available so violent to to consider twenty two years after that decision knowing that that decision had been made knowing that this was a waiver of all right it went ahead and waived those rights and petition signed up to do business in delaware knowing all of those things so there isn't there is really no question about it the cases by the united states supreme court that says that this is constitutional of the united states supreme court they can't because he calls them discredited or archaic it doesn't mean that they're not the law of the united states supreme court that constitutes general jurisdiction in addition to participated in and delaware court all of those support specific jurisdiction in this case so there are two points it is clear that there is general jurisdiction but it's also clear that there are specific jurisdiction in the context of this case with this cla is other than the fact that in that case there wasn't jurisdiction over mylan in maryland well i think that it's presidential only with respect to the fact that the peculiar facts of the case the government office in maryland and the issue that was also involved about petitioning the government so for those that case are certainly not precedent here because of the factual completely different we're talking about different circumstances so that case is not president biden would you agree that if compensation for that also you can join in the issue of literacy before the patent before you are ready to market so that you aren't stuck with it for years in the courts before or certification as generating the opportunity to state an artificial aspect of and cringe now to proceed and then we're sort of involved with how how complex how completely other relationships it seems to me that we're generating a house of cards which really has nothing to do with the issues all of the aspects of practice and distribution where it was manufactured i think was overseas and all the all the rest of it so where does that leave us  sense by taking these acts of infringement the preparation of testing the trials and that sort of thing that would have been actual infringement saying no we're going to allow those to take place the bargain is that then when you're ready to do this when you intend to move forward those acts of infringement become light and material when you file the and then the paragraph for certification you're bundling all that together and that then is the act of infringement that those inference to be drawn from the statute itself and that and the then the and the picture that it presents is the act of infringement is doing damage to the patent holder on the if the act infringement by announcing this intention and there is shouldn't be any doubt that that's why you don't have to say that judge toronto that i'm going to intend to do these things because you wouldn't be fine with me on that if you did not intend to do it and everything in the history of mylan and the facts of the script this case support the proposition that that intent was real the threat was real and the damage was done by the filing of the end of which is an active in french mint which church the patent holder where the patent hold seems to me that it's a it's put into effect so that there's a statutory scheme that can take place and as the supreme court put it it's the it's it's as the statute says it's the act of infringement itself but it's also the provocation of litigation i think that's the word united states words of the united states supreme court it in if it it or noun says that you'd better do something you better file a lawsuit you are being provoked because this is about to take place and you better defend yourself because if you don't find yourself these bad things are going to become come to fruition and those are going to be damaging those are going to be damaging where you wish were eventually your patented products and is not an infringement infringement is not something that happens in a vacuum it is actual harm itself and it's harm to whom it's harm to the patent holder it's immediate harm and and judge the congress has already decided that for us this is damage occurring right when those statutory events take place and how do they play themselves out they play themselves out in an invitation to come into court just get to intrude upon and that that last bit on that is everywhere on the assumption that mylan will in fact direct if there's nothing there's nothing wrong with that because as you point out if when they actually do start signing the product those talking isn't i'm cognizant that i have some additional time i would like to make three points in rebuttal if i could the first is to just try to elaborate on an answer to a question to judge of malley which is you know has i had a moment to reflect their i mean i really am quite confident though i haven't been able to do any legal research while i sat there that immunize conduct can give rise to personal jurisdiction and to give you just a for instance i mean imagine that the plaintiff in walton had sued not the sort of law enforcement agent but the prosecutor who was involved in the preparation of the allegedly false affidavit and assume that the will that walden as to that suit actually brought it in the right form and filed the suit against the prosecutor in georgia now i don't have any doubt that the prosecutor would enjoy absolute immunity and that suit would get dismissed on the merits based on an absolute immunity defense in a heartbeat but i also have no doubt that there would be personal jurisdiction over the prosecutor for purposes of that suit even though the relevant conduct was immunized and that may be the way to think about this which is to say that the reason there is not an article three problem is because but for hatch waxman the very acts of preparing the ndaa would be an act of infringement that would give rise article three injuries and the way that hatch mutlaq so you can imagine and still not i don't think i've heard an answer to the question what injury in fact is there to them manufacturing activity which might be taken to a place entirely in one state is more than enough i think to give rise to an article three injury and i don't think then the right way to think about this is that that you're doing this because you want to use the end and you never have widespread distribution network but in particular it has been down to where you will direct your product into dell well only if we prevail in the litigation and at that point the sales that we make won't even be infringing sales and we haven't even sort of talked about this but part of the conundrum i'm having is they seem to think the problem here is the end anticipates infringing sales in all fifty states but the one thing this whole process does is make it almost entirely unlikely there will be any infringing sales if the allegations of their complaint are correct injury in fact here comes from the sales with all due respect i don't think since it would come from the moment we manufacture they have an infringement case and of course you don't mean your factual just stockpile how are they hurt they are harmed because you are infringing their pact i mean competitor start manufacturing and that manufacturer swears on a stack of bibles that they're just manufacturing it's something they do out of it's like a hobby if there are not going to sell to anybody i would think to an absolute certainty that i have article three standing as the patent holder to enjoin them because the very act of manufacturing in violation of my patent is an article three entry you may disagree with me but i think i'm right about that  it would arguably impact the value of those property rights i mean i think that's right i mean i don't want to pass myself off as an expert on you know ten k filings but but i thought that that seems right to me it seems even more right that regardless of the security disclosures there is an injury in fact for article three purposes that takes place at the point of the declaration of invalidity or the point of manufacture and it just i don't think it's right that absent  contemplated future sale that there is no article three injury and therefore you have to trace down where the sale may take place so that was really the first point the second point i wanted to make was just simply you know as i predicted i think you know mr olson i think moved on to general jurisdiction quite quickly because i do think he has a problem i listened to what he said in terms of the litigation related contacts that the defendant has with delaware and what i purged was the registration to do business and the litigation in the for those of the two other things i heard the sides the fact that we sent the statutorily required letter to new york to a company that was based in delaware now neither of those two things is live a geisha related content we registered to do business but that ever got to the point of distributing this product there it would really be through the activities that we've registered for but that's a question that if you really wanted to get into but do you do you see anything like between the due process consent analysis and then unconstitutional conditions and no i don't which is why i don't think we've waived anything i just think there are two sides of the same coin the two ways of looking at the same issue so if i just mention i want to get to general  a table of the other thing that they point to is litigation that we've initiated in delaware again i can't think of anything that's less related to this litigation which is the test under specific personal jurisdiction and i would add that what you really have in terms of our initiated litigation is for suits each one of which at least one of the defendants was a delaware corporation so all it shows is that we know what personal jurisdiction is and we know where to sue people which is in where they're at home you sue corporations where their own at least if you're relying on general jurisdiction to bring me to that i'm going to get a chance to say more about this but the one thing i really do think it's important to recognize is that this whole issue doesn't get away just by sort of a kind of misuse of the word consent because of course we concede and of course justice ginsburg in her decision in diameter concedes and of course good you're concedes the come somebody can still consent to jurisdiction so the case is talked about the situation where the only situation that's relevant for specific or general jurisdiction question is when you have in a decide to fend it who has not consented but consent and at various points both other parties make this clear consent is a voluntary concept and the only thing voluntary that my client has done is engaged in the modicum of business that is necessary for you to then be required by delaware to register and then be required to appoint in egypt for service and prospects given that given that the penalties are so minimal and delaware as opposed to what was what the supreme court was looking at him bendix why you know you certainly had the option to not consent i don't think we did if we wanted to be in compliance with delaware law delaware law at this not say register or not if you decide not to register that's totally fine you just have to pay five hundred dollars if you go that's not the way the statutes written the statute as written is if you do business in delaware you must register and then of course it deals with the consequences of registering the consequences of not registering and with all due respect i don't think the analysis here turns on whether the penalty for not registering is five hundred dollars or five hundred million dollars i mean i think i don't think either way it is an obligatory statutory requirement that we register and so i think because in that case they had a dormant commerce clause challenge teed up for them and not a due process clause challenge i mean you know i'll sort of grant you that sort of the premise of that cases well you know there's there's a problem that there are real consequences if you register but they didn't have an attack on that so i think you know i really think that's your answer there and i think there is you know there's a reason there which is i think it was easier to conceptualize you read those opinions and i think the court thought it was doing quite balancing but i think it's easier to conceptualize what was going on there is being facially discriminatory compared to the situation that you have here i think you could try to make a commerce clause violation here but we've really focused the court's attention on the due process clause the other aspect of