four hundred b because the act of infringement defined into seventy one he too is a nationwide act that occurs in every district in the country including new jersey that can be seen in two ways which i'll address the st is that the hatch waxman act artificially treats the post approval acts of making using and selling to end the product as having been committed pre approval with the submission of a hand and of course those acts will occur a time one that doesn't say that this time one act of infringement namely the submission is treating yet to occur but  find the patent is valid infringed the remedies provision of two hundred and seventy one the four states that the and the product can't be approved until the expiration of the patent which quote has been infri counsel even under that theory isn't isn't it possible that what they're talking about in terms of the has been infringed is the fact that normally infringing acts which would include all the activity leading up whether the commercial manufacturer used and sale of the product within friends a valid press pat the statutes treating infringement by making using and selling the end of product which is what c cases as having happened in the past and the nd point here judge is that the two hundred and seventy one to the two act of infringement is not ever been narrowly limited just to the physical and the court made that point crystal clear and glaxo vs no farm where it said the panties burden of proving ultimate infringement is not met by the filing in the end and of course that's true the act of infringement the courts have been adjudicating for thirty years in and the case is whether the proposed act making using and selling the end of product would infringe the path the court has consistently held that it is wrong to view the physical act of the act of infringement is not just the physical act of submitting it it's a michigan and for the purpose of seeking to engage in those acts so that's precisely what the supreme court described to seventy one  as an artificial act of infringement because it artificially treats those future acts making using and selling the product as having occurred new pro tune with the submission of the end of the problem to the problem i have have with that as it  straightforward way of understanding why active infringement is artificial it's really quite unlike every other act of infringement into seventy one it's a it doesn't involve making selling offering using center but that still doesn't mean even with the fact that act goes a long way toward promising a future act it doesn't mean that the future act is than it is for infringement every has waxman cases but that's point one there's a separate point can i just double check that this is and i spent some time looking for this and i guess i haven't found it so maybe maybe you have found it that is i was looking for taking as a given which which has been the law for i guess thirty five years or something that the subject matter of the hatch waxman case is whether there would be infringement  if the the and approval comes forward and the product was was marketed is there some specific language in the statute that says that judging the hypothetical x the what would happen if all this goes forward is treated as having occurred some past tense type language referring to the hypothetical i was not able to find any so as i said the true seventy one before remedy is section says if you adjudicate what is a cases this very subject matter that you describe judge then that that is then you can't you can't get approved until the patent expires that quote has been infringed that's past tense has been in fringed and of course the whole notion of the problem with that language is that it refers to the expiration of the patent that has been infringed under paragraph two c which just refers back to th has this purpose language it's amazing and for the purpose of seeking approval to engage in these acts that's the connection that's the connection the statute if you understand the statute as a whole it's  infringement which the supreme court has called highly artificial is nonetheless a defined and very real act of infringement that takes place wherever the end of file or seeks to market its product that footnote to this court has interpreted other acts of infringement sale and offered for sale as occurring where they are purposefully directed that the trans ocean the north american philip cases among others in trans ocean the court held a contract for sale is a sale and that it occurs at the location of the anticipated future performance specified in the contract a contract for sale the call for delivery of performance in the us is a sale that occurs in the us trans ocean also held that an offer for sale occurs at the location of the proposed future sale the focus the court said should not be on the location of the offer but rather on the location of the future sale that would occur in north american philips the court said a sale has both a physical and a conceptual dimension and it held therefore that a sale occurs in multiple places including a to a sale it's akin to a kin to contract or sale it's akin to an offer for sale that is purposely directed and should be understood to be occur where it's purposely directed following this court's precedent in a court at trans ocean a north american philips the filing of an and it is an act of infringement that occurs nationwide where it's purposefully directed just like a sale just like a contract for sale just like an consequences it would make it impossible and many have twice some cases to have all of the defendants consolidated in one court ours is a case of that impossible you have to use fourteen of seven right but forty seven still has trials in separate courts and that's a problem we had one thousand defendants in our case which is not untypical all in new jersey and now because of the district court's ruling we've got some cases consolidated in new jersey a separate case with the mylan defendants and west virginia we have two discovery schedules to claim construction proceedings two separate trials in two different courts all for the same patents and the same  in west virginia aren't you just so that one more time please i said actually pretty far along in west virginia before judge q we hire he would not gotten to claim construction yet ok but congress has shown it intention to have the opposite result in the america invents act congress exempted hatch waxman cases from the new rules prohibiting consolidation of patent cases congress make clear that hatch waxman cases are unique category they should be able to be consolidated in one court and that cuts against the notion that congress intended to limit venue and have some cases to just a district where the generic company decides to have somebody press a button to submit the ndaa because if the generic can pick and choose venue that way it makes it much more likely that you'll have had western cases splintered in different courts like we have in our case congress showed the opposite intention in the day and twelve should be interpreted in that light so i'll stop here unless the court has additional questions or reserve the rest of my time and i'd like to rest on our paper as i think it's sufficient for this other question on has committed acts of infringement it's undisputed that has committed looking backward in time to completed acts we heard today and it's in both their opening in reply briefs it's undisputed that the only completed act of infringement alleged here is submission of the ndaa an actual physical act with the place and it's understood that that place is not new jersey was prepared and sent from west virginia maryland so what does valiant say it says submission of an end is a nationwide act but look at the intellectual gymnastics you have to buy to get there this is actual language straight from their brief congress intended to treat the proposed acts of making using and selling the drug as having already been committed even though they have not yet actually occurred the infringement that will occur is treated as having already occurred the acts of infringement the defendant has committed include the future acts that the end  contemplated acts plans that we're told to look at the conceptual acts rather than the physical acts as judge toronto's question suggested that is a very strained reading of one thousand four hundred be valiant is asking you to treat the future as the past but that's not how congress wrote the statute and this court in the supreme court have both repeatedly affirmed that it should be interpreted according to its terms c t e called it an intentionally narrow statute  interpret both of these statutes together i mean shouldn't we assume that the congress when it set up the hat waxman scenario was was attempting to talk so it created a safe harbor for pre launch activities that might otherwise infringe like r and d or manufacturing but it also wanted to speed up the litigation so it's treated the submission of the anda as an act of infringement as a substitute for the pre launch the court issues in order that if they find that the that is valid and in french then then they talk then even though no actual sale is occurred they deem it to be may be awarded against an infringer only if there has been commercial manufacture use offer to sell or sale so the remedies provision of the act says those things are not treated as having occurred yes there's a hypothetical aspect of this of course you're asking whether the product described in the and it would infringe if marketed but if he keeps mr steiner keep saying it's akin to a sale it's really much more akin to the pre launch activities that are covered by the safe harbor that they prevail they get injunctive relief and it prevents the approval until the expiration of the patent but if you're asking congress to find the act of infringement in this context as the submission of the anda and the purpose language of the statute i would know is not as broad as their character characterizing it to be it says if the purpose of such submission is to obtain approval to engage in commercial manufacture use or sale so the purpose is actually a limiting condition but it's the the act of infringement is the submission of the anda and there's no part there's no requirement that one have the purpose of selling in any particular market let alone nationwide obviously if there were no purpose  anywhere then there probably wouldn't be enough of a dispute to support article three jurisdiction but the statute their assumption is that well you have to have nationwide sales to support article three jurisdiction and that's just not the case let me ask you sweeping in any location where any pre filing activity which would have been infringing occurs no your honor i think and if i could explain it this way i think you've got a spectrum of what the of submission could include include potentially at one end of the spectrum i would say it's clear that it cannot include anything that's described into seven thousand and eleven dollars and that refers to uses reason to be reasonably related to the development and ndaa so we know that that's part of the safe harbor at the other end of the spectrum the submission the act of tendering or presenting the and it to the f d a i think is is is consider the isn't maryland the only jurisdiction that these cases can be heard well i think we don't dispute your honor that this submission it went from west virginia to maryland and that the submission occurred in maryland but there's no dispute that nothing happened in new jersey and there is no dispute that all the preparation activities and so forth happened in west virginia which is not an arbitrarily chosen place it's been mile and headquarters since  clearly not the act of infringement and the submission is stuff related to the preparation of the submission at least one district court the goal there i'm a case in the northern district of texas has said that the submission includes that preparation i'm not sure that's the most natural reading of the statute i think the more natural reading of the statute is that the submission is is you know where it's sent whether that be via u s mail or or electronically and where it's received you could analog to mail or wire fraud i think some courts have held that that that occurs where it's sent and where it's received but it's not every conceivable place in interstate commerce and here is undisputed that nothing happened in new jersey so or thought there could potentially be more than one place where it's prepared so what goes into the preparation of the ndaa well so it's clearly it can't be interpreted to be the r in the manufacture and the bioequivalence work and things like that because that's governed by the safe harbor i think of the preparation is you know essentially the preparing of the paperwork as opposed to simply the hitting send or putting it in the mail you don't need to decide that issue in this case because it's undisputed that everything here happened in west virginia and nothing happened in new jersey but but in theory the submission could potentially extend holdings which said you could have you could have venue anyplace there was personal jurisdiction over the defendant now that that's not the law and resides under four under the st prong of one thousand four hundred dollars b means the place of  corporation then obviously now there's a reason that there's a focus more on the nd prong both on the regular and established pace place of business peace and on the act of infringement piece but to come back to my not be able to come into court and say oh well we think the defendant is going to sell in these other states so there's a venue there the active infringement would simply be the manufacture or the are indeed and so the and the submission is really quite analogous to that there's nothing at all unusual about it now mr steiner has spoken as well about the trans ocean and north american phillips cases which were not mentioned in the opening brief i'd suggest those arguments are forfeited but the regardless they don't they don't carry the day the north american phillips case is a personal jurisdiction case involving sales as the court's aware personal jurisdiction is ultimately about the fairness of being hailed into court in a given state its judge made law it's somewhat subjective to determine is it is it ultimately fair to have the defendant being sued here but it's most importantly in the court in the court is specifically acknowledged this it's not constrained by the specific statutory language of the venue statute and the supreme court and the federal circuit court have both repeatedly held the one thousand four hundred dollars b does not get a liberal construction the idea of conceptual acts of infringement is foreign to the idea of venue and it's not as though this is a case where where there is no venue anywhere and you have to terms of some sort of concept like that to find venue somewhere the trans ocean case was not a venue to the extent it talks about sale that talks about the place of performance but this is not a sales case this is a two hundred and seventy one case and all of those future activities are not before the court and and the language of two  two does not permit them notice four hundred b permit them to be before the court do you agree the sort of practical point that was made that the most efficient form of consolidation which is taking place for decades now very much limited in its availability if you were to win here because you would have  only pretrial consolidation i don't agree with that it's as stark as they have as they presented this is yes admitted li consolidations enjoin there can be a bit more challenging with this but it's undisputed in this court's decision in e m c holds that you have to have proper venue to join or consolidate those are independent requirements and i would note that mileage made every effort to coordinate deadlines and events with the defendants that are consolidated in the district of new consolidation might become a slightly higher hurdle doesn't allow rewriting the nd prong of four hundred b to look forward in time when congress used the verb tense that that look backward in time i'm happy to take any further questions the one the only thing i would say on the alternative ground is that i would direct the court to paragraph twenty nine dollars of their complaint which specifically alleges that it was my pharmaceuticals that that submitted the and in this case there's nothing that would overcome the presumption of corporate separateness to poll in m l or even m i yeah that's a good point let me ask about that  the problem is fat how can the judge i mean did the judge really decide that question i think the judge did decided that he didn't spell all the steps in his reasoning unfortunately but but the findings about the record are in the opinion if you look at pages five to six he says that there's no that that the plaintiffs here can't show that these other corporate defendants were involved in this and that is of course the basis for this argument how do you how do you make that determination on a twelve b motion that relates to venue well i would start with paragraph twenty nine dollars which is on and sixty four now there are some what i would consider and conclusory allegations that kind of lump all three defendants together but the record is undisputed that only m p i submitted and  and to the extent that you're wondering well did they get that is that i mean that's the very provision of the affidavit that matters for venue purposes so i think it's clear that they had both an opportunity and an obligation to rebut it if it weren't true post approval would infringe a valid patent and it is our submission that we should be we should be interpreted that act of infringement consistently for infringement and for venue and for personal jurisdiction as launched in the normal case there is never going to be an actual act of infringement there will never be damages and it's the principle issues are governed by the two hundred and seventy one e for a and the be dismissed for lack of venue the question is could it be dismissed because it is clear on the faces a complaint that m l l did not commit that act of infringement if i understand the complaint there are two things one paragraph twenty nine says among the three mile an end to these the one that submitted is mylan pharmaceuticals that's paragraph twenty nine and then you have eight versions of the generic allegation one for each complain that says mylan which is a term that the opening page of the complaint you read you say is going to hear after be referred to the three entities collectively submitted or cause to be submitted the and it seems to me quite literally true to say that collectively mylan submitted it if the mylan pharmaceuticals did why did why does that not mean that on the face of the complaint there is no has nothing to do with the big short answer is that the by defining mylan to be all three of those entities the complaint is alleging that all three of those entities were submitted on it's face and that's not something complaint and we're supposed to ignore one of them and just focus on the other one i don't think they're conflicting your honor i think they're supplementary to each other that is to  from day to day