on three of the issues that are in the briefs the copyright issue the two seventy one g statutory interpretation issue and the verdict issue with respect to the copyright issue the d dismissing syngenta scobee right claims in there and really thereby preventing syngenta from proving copyright infringement with respect to the non required elements of the past aside label as expeditiously as possible after an application including one that contains language that differ in composition in labeling from the original registrants labeling i have two questions for you on the point you just made one is you've distinguishment quine on this very basis that you've stated here but do you think seth claim this correctly decided under the statute that smith kline was decided yes it was correctly decided because in the smith kline case and in the smith kline statute perhaps waxman ach place the burden on the applicant to show that the labeling for its new drug was the same as the labeling approved for the l sensually same label no not an identical and substantially same label they come up with a product that utilizes an active ingredient and in that sense it's a generic up the past a side or herbicide convey to the users of those pesticides a free for contemplates just literally been done before we've already gone through the process that speed up the process which facilitate the process so you show up with a meat to your meat to show up with the century th resources the e p a is certainly capable of looking at the labels as the label review manual says make a case by case combination on the acceptability of the language to ensure that it's conveying to the users what we speaking nobody has suggested that identity is required rather the argument is that in the context of this expedited review procedure the policy is for is for expedition and as a practical matter expedition is at least enabled in a practical way by allowing either identity or something conveying misinformation or bad information but the statute says they can do that into context when there's substantial identity either because there's permission there's a license because these entities have a lot of interactions with each other potentially and there are opportunities sometimes it's a customer supplier situation where the original right distraught is providing the active ingredient to the generic they could negotiate for here i'm going to summarize what we kept as a practical matter do that if we have to get labels that are as a result of copyright considerations very likely to be quite different in wording from the pioneer label that that's a policy argument your honor that ought to be directed to congress and the f m c decision decided in two thousand and five you know fourteen the layout and that's why i suggested was asserting her with respect to the revised splay bills there are many different ways to convey the geek the directions of use the other information that is contained within the know what you want to have your cake and eat it too i mean on the one hand you're saying that different language is ok under under fee for a and yet when that happens when your competitor comes up with a different  changed the name and in some instances they didn't even change the name from syngenta well but there could be all sorts of differences with respect to how you convey the required pieces of information i question though is more specific which is just  you know that that's the primary issue here is that they tried to change some of the words from being the identical verbatim copying to paraphrasing but they've stayed too close and need to to go f you know easily administered anough paraphrase standard that you contemplate is going to interact well with the fare for expedition regime well what the statute are requiring is that what the e p a has  reviewing the labels is to make sure that the terms used and this comes out of forty c f r one fifty six point ten can be easily read and understood by the average person likely to use or supervise the use of the pesticide so there is an element of judgment here and the e p a is more than do you contemplate that the e p a will consider the copyright question or that's entirely up to the applicant it the copyright issue is up to the to the applicant and the i'm so so and the e p a actually has a congressional mandate shall we say to expeditiously process these things and ken rudin and applicants are going to have to figure out how much paraphrase is going to satisfy the pioneer karate or come through the original registrant an opinion a license and the second problem here with the district court's holding is that she didn't list the entire when you make that point in your blue brief that even if the judge was right about fifty ousts the copyright act as to let's call them required elements and here required means not just required of the pioneer but required of the generic once there's a pioneer which is a much larger class because there has to be at least substantial similarity where you make the argument that even if the judge was right about that it was the judge in correctly dismissed the copyright claims as a whole row right and we are where did you say that in your blooper if it be in the page numbers yes i'm looking for it in the heading i don't see it so i want help  in dismissing your copyright claims even as two non required elements i immediately thought boy i don't remember hearing from reading in your blooper if the second argument so i don't care about the joint appendix i want a citation  even if required claims are required aspects of the label are ousted the district court was still wrong and we want a vacate or on that ok i'll get you that cite rebuttal when the two seventy one g issue the plain language does not require the product made by the pap to process to be made by a single entity liability arises from the importation use sale in the taken as s s s i let me stipulate for current purposes that the language of the statute favors you including to seventy one g and including one fifty four eighty two nevertheless there is a concern we selected i think in an from context most recently in the supreme court's house and decision clarity maybe even expression of intent to change something clear like that do we have that here or is that not the right question to ask well we certainly don't have here a clear expression meant maybe i can focus it this way assume with me that the statutory language here treats foreign and domestic manufacture identically as indeed the language appears to do then to seventy one g in your view would quite dramatically change the scope of protection for a domestic offers to sell imports or sells that's identical between two seventy one am to seventy one peter may be a case of divided importation the single entity requirement would apply there but to seventy one g the concern is that if i under to seventy one and you have to have a single entity it concern would be that if two seventy one she could apply to a domestic process that actually results in a product you might have a different rule applying it to seventy one eighty where you have to have a single entity requirement into seventy one g b or you wouldn't have to have a single entity requirement for the performance of the process steps and so how the question is does that cr doesn't matter if you might have two different situations you know that that's certainly true that's true statutes can be interpreted differently just like to somebody one app has got the language and it didn't limit it to in a  manner that would be in french if it was performed in the us which you know such language into some one so congress into seventy one g was closing the loophole but to the extent there is a single entity requirement into seventy one g where there was a need to resolve any type of ambiguity under the jury verdict what the district court had reasoned was that neither party had asked the court to submit a separate issue with respect to the question of instructions did not utilize the instruction proposed by willow boy and in the final instructions will would only objected to the jury instructions with respect to the seven six one pat related to the burden shifting aspect we're putting on will award the burden under section two ninety five to prove non infringement the verdict form then and question seven asked the jury the question  did defendants prove non infringement and the jury responded no they did not and significantly willow wood did not object to the verdict form with respect to question some well i would only objected to the verdict form with respect to question one with respect to whether that really entity should be broken out with respect to the well from this question and in discussing that objection the district court expressively stated that to a seven zero six six so the jury then returned a verdict of finding that the defendants in french the seven six one patent and defendants included willow would limited and the court erred by then want them under the permanent injunction will would limited is the source of the technical they sell the technical to willow would usa willow wood ltd might also sell the technical too to that engages in infringing conduct here this may clear in our brief and as i think was raised in the court's questioning seventy one g did feel a whole it allowed united states process patten owners to sue when the when the a limited then does that gets it to the port in hong kong or shanghai and will usa pays for it picks it up at the port typically in california and then  b hong kong can is that a term that can be used if the goods never appear in hong kong but go through shanghai and was it i think typically most of the goods went through hong kong but some would go through shanghai and they would be f o b shanghai ok those  actions like importing so so how how do you respond to that i respond in a couple ways your honor first of all if you look at the legislative history of two seventy one g was very very clear what two seventy one g and one fifty four a one we were trying to get it was trying to take care of the problem of process is taking place outside of the united states and then the resulting product coming but it doesn't say using a process that if it were you are right he doesn't say he doesn't use that to seventy one f language but i don't think you need it because the implication here is that the importation orse the subsequent sale or offer to say under two seventy and discussion of the single entity rule and starting with i think it was v m c might have been the first case or merely option or was it the passage of two seventy one she i think it was two seventy one g b if i understand it correctly  i think again well what was contemplated under two seventy is the idea that we're going to give process patent holders the same scope of protection whether the process is engaged in the united states or with a process in gauged an outside of the united states with a product coming in and i think that is made clear by the legislative history when to do something when she legislative history says the process patent bill which resulted in  and their view would in fact give those two situations the same scope of protection on the assumption which i guess i'd like you to indulge that  made by a process under two seventy one g includes made in the united states it let's call it fractured manufacturing which is to say manufacturing that wouldn't satisfy akamai in the u s under the made by the process language it doesn't say whether whether that manufacturing yorkers abroad or here you know there's a section in chisholm says just there is no difference according to where the manufacturing is so that now the only question is who's doing the selling is the selling or the importation of the resulting product going on in the united states if i may ask your honor to make sure are are you suggesting that if the single entity rule is not required for domestic process patent infringement that then given syngenta understanding of two seventy one i think the scope would be the same yes that's right i think if if this court was inclined to say there is no more single entity that the poor to seventy one g for true seventy seventy one g for the process if if the single entity rule is is not found to apply to seventy one but remains a pleasurable to seventy one a and b then there would be a different scope of protection for the same process under that circumstance the right did not a foreign domestic difference it would just be a difference according to what a product which resulted from the process or a process that didn't produce a product so th going out if the process is being conducted outside of the ice i would say that's not up it's i would say that's not obvious ok there is no one from the statute to that effect is there whoever without authority imports in the united states offers to sell uses within the united states a product which is made by a process patten in the united states shall be liable you are correct right you are correct so even more so that we then would have two different guidelines of law one applying  the case and all process that right that is probably true yes that is true but i still think we would be a sensually setting out to different areas of case law where two seventy one day where there's no process where there's again as you say no product ultimately involving would require a single entity whereas where a product does result that there would be no requirement of a because your honor i think that would be it would be inconsistent with the idea that to seventy one gee when you read the legislative history was trying to essentially fill in this where he was trying to say if a product is made outside of the united states and you imported into the united states such is the case here that you can still get infringer you can still find liability and having with you earn to your honor is the the m a crisp brief talks about yes to seventy one would require certain to say when g e required certain things to happen but it doesn't require the underlying info range ment of the process patent it doesn't require single entity and if you think about it that way to impose a liability because one company let's assume for a minute there is no single entity directing or controlling the overall activities to impose liability on one company it seems gauging in only part of the invention and another performing parts of the steps of the process and i don't understand how that comes in but the point your honor is the invention as as the supreme court said in akamai the reason for the single entity rule is because the invention is what the patent will do or has a right to exclude others from is the right to engage in all of those steps and that isn't occurring under that interpretation of two seventy one g you even even even in one entity that did it you get two entities a process performer and a domestic seller domestic seller doesn't go anywhere near the process just buys about it and then sells it so what's odd about seventy when she plainly gets the domestic seller i agree with that and i don't dispute that at all but what i'm saying is the invention what is claimed by the patent holder what the patent holder came up this revelation that he or she had protects a certain number of steps put together and by not imposing a single entity you would be giving broader scope of protection to that invention merely because the the product resulting from those steps occurred but didn't occur through a single entity by making myself clear that i did want entire trial was tried to figure out whether will be will a limited engaged in any activities who is subjected to jurisdiction in the united states the jury we talked about what he did with regard to the one thirty eight pattern that's the subject of the two seventy one g issue the subject of the seven and one patent and we discussed all of that issue when the jury came back and said you didn't do you will or limited didn't do anything and i just yes question related to this which he testified that that was true for everything including the five kilograms so i understand i want to know but so you're saying there's more than just a full behind absolute and they were absolutely and that is the identical or substantially similar selecting a fact of leave the test for copyright infringement describe the labels that the generic should use to get the expedited review from e p a to encourage competition and nerika entry to the market now congress didn't write those words in a vacuum and i ask you something do you think it's these provisions you're talking about we've had the copyright act and the first need to provision operating together for the past thirty years what what sort of problems have arisen i mean there's this case but but it seems kind of i to me that thirty years of coexistence and now all of the sudden there's problems so how do you speak to that why doesn't that show that these two statutes can coexist you're under two responses i do want to get to the actual problems but also a decision from this court finding force and gentle that brand upholding copyright infringement claims on a generic label against a generic label that said what when i ask you something i'm so ill of course so there's the eastern district of pennsylvania case you're saying that hasn't created any c has created problems for the agency their problems akin to the problems you see in the record in this case which is you have generics who are trying to satisfy the many requirements of the front in the label and also as well  it here are trying to avoid copyright infringement claims that requires e p a to go back to the generic label and say you can't make those changes you're suggesting because they don't meet the first standards there's a lot more back and forth  between the agency and the generics there have been in addition we've seen other district court litigation the united states has filed statements of interest and participated in those cases we don't have a court of appeals decision but in addition we know what congress won it was expedited review of these the me tubes because in section and seven you asked the one thirty six w dash eight which i understand has reacted by congress every five or ten years there are tables there they talk about the specific time frames now if you have a new active ingredient the agency has up to twenty four months to review and approve with the me to use the statutory framework allows only four months and that makes sense because what congress understood is that there would be a purpose to having the same label when you had the same underlying ingredient communicate important health and safety information and e p a allows the generics to market their generic pesticides as having the same active ingredient as brand name x three for containing language words identical or substantially similar it's understood that if generics submitted such labels substantially similar labels that that those labels would infringe the copyrights and the original thirty or fifty page label  had no doubt that congress there are two to satisfy the purposes of the hatch waxman amendments which are very similar in terms of facilitating generic entry to the market to fair for that congress would not have wanted the generic to be held up in copyright track generics on to the market and of course e p a can't do that unless the label view when congress wrote those words identical or substantially similar or differing in small ways when we're talking about communicating important health and safety information but that was setting up a copyright trap for the unwary and  uncomfortable about saying we're going to find a kind of implied repeal ouster of one statute by another when the to be ousted statute has a safety valve built into it at least one because then you wouldn't have a conflict or the conflict would be defined and shrunk it would simply have when there is a certain kind of activity encouraged this much by another statutory regime where the underlying economics doesn't seem to have anything to do with the speech itself that they would be actually quite hard harmonious well your honor we have for fair use as is you know language at least in cases that suggest some kind of case specific and maybe a court of appeals deciding it for the first time on its own in a categorical way when there hasn't  for the last say fourteen years since f m c and thirty years since nine hundred eighty eight has this been really a practical problem and somewhere near the core i think of your argument about fifty or is that cases i believe the kids as settled i know there weren't any there weren't appeals from those decisions they may have been appealed and then settled that was for an app and you decision and now but this is the narrow circumstances given the language in the front but if the court were not to do that for their their reasons if if for a fifth right encourages the generics to use identical or substantially similar labels and they're doing so to comply with a statute take even last year on that let me first just respond to judge toronto with respect to your question for the specific up page number is as judge still pointed out page twenty five is the answer the heading one page twenty five is the district court of pesticide labels the district court granted will of which motion for summary judgment once and justice copyright claims dropping the footnote the footnote explains the difference between the required elements non required elements and then the very next sentence on page fifty five make specific reference to the district court creating a judicial exception to copyright protection for pesticide labels in their entirety what's respect to be the issue that the government argued about this litigation but one thing that's very interesting i just ask do you have any reason to think that that's because at least since the government pretty fast after f m c said we think this is wrong that the pioneer companies have said these copyright claims they're really not worth much and so we're not going to press it much no i think that there are so many different ways that one can express the various components of the label that these companies who often times almost use a regular course work with regulatory consultants they come up with their own language to distinguish themselves it's a rare case like we have here with well of wood where they cop you got a copyright liability for it what are the remedies that you have some would be seeking well there could be statutory damages under the copyright act so here then that would be what minimum of seven fifty per dipped depending upon how that interpreted in terms of whether it's per label or one label as applied to the entirety of a particular product there could be other damages or could just be equitable relief to prevent the copying in the use of an infringing label and do you think an injunction would be warranted if it was as i think it's the premise of your view that with enough effort they could fiddle with the words of their label and get a non infringing one and injunction in those circumstances against the marketing of the product really i think the injunction would prevent the copying to the extent that they can design around just like you can in patent context th design around in the end with what about what about lost profits or actual damages or disgorgement of their profits on the assumption that they could have done the label perfectly well those are available remedies but we never got to that point at the dis level because the case was dismissed that summary judgment going back to the injunction question i presume that you have to balance all of the factors that are required for an injunction public interest all those different things as well and the is correct yet that the the output of all factors are set forth in the bay and you know the government's arguments are really policy arguments at bottom you know if they believe that there are problems with them being