does not have to follow the notice of commercial marketing but that choice has a repercussion the l nine provision specifically l nine a prevents either party from filing a d j action until that appetite's has to make a choice with this second phase or second wave of litigation does it want the certainty of filing the notice of commercial marketing and giving itself the right to sue before launching in the face of potential intellectual property right that weren't part of the first where the litigation again is that it's a choice but what the district court has done is said in all cases we are going to make the notice of commercial marking mandatory even when appa text has provided the l to a exchange meaning that in that case the r p s has had the application has had the opportunity to sue litigate and bring an injunctive relief should appetites give the notice of commercial marketing but it also could bring injunctive relief on all of the patents listed in that initial phase the l two l three four five face now were not before this court on any patent based injunction were here on a notice provision and so on that notice provision that we're talking about what we look at is the statute itself the plain meaning of the statute congress obviously created a statute which was one of those choices is for an applicant and this court came down insanity emden with the decision that because there's a specific remedy in l nine c we shall provision an l two was not mandatory because there was that specific  participate in an information exchange if the hundred a day provision is imposed no matter what well that's a great question your honor because actually with appa texas interpretation if you choose to participate in the l two exchange you are not then balance that the l eight a notice of commercial marketing provision is mandatory in all cases you could see the example where there are no statutes left to li subsection l is about litigation litigating the patents so if you choose to go through the l to a process which this court acknowledges is optional but if you choose to do that what you get is the benefit of potentially not using the notice of commercial marketing but then again about similar applicant could use that in fact all the time in the hatch waxman context we see generic companies not launch at risk because they want the certainty those patents biosimilars and you've seen it in the media briefs are are very complex often times they they deal with billions of dollars it's very possible that they as app attacks did here choose to follow the l two exchange and it's very possible that for that sing reason for that same certainty they choose to follow a notice of commercial marketing why it was not mandatory in the sand of the engine case by the majority was because of those maxims of statutory construction if you were to say that the help to exchange was mandatory in all circumstances then it would render l nine c superfluous in that same regard and the the court ordered from and what they could do is bring up the patent basin junction on anything at that point but we're not here on a path base injunction similarly your honor the second maximum statutory construction is that when congress creates a new right and clearly the notice of commercial marketing is a new right in most cases the companies that are accused of infringement don't have to give a notice of commercial marking one hundred eighty days in advance herein to be p c i e congress put that in there but when congress creates a new right in a statu six group of patents do you think that the analysis of l a day would be different with respect to cases in which there are l seven patents no your honor because the l seven patents there's a procedure in there for the r p s to bring those atoms if they so choose into the litigation but what l eight refers to is a notice of commercial marketing that you must give that notice of commercial marking but circumstances l a eight must be read the shall must be read as must but that provision as the court noted there cannot be read in isolation just like the court did not read in isolation importantly apa text shows here to go through the l to a process it provided the abbreviated and what does that do from a policy perspective the court there was concern that without providing the able to provision and without  notice of commercial marketing how would amgen know what patents to actually bring a d j action on in fact the court said the subsequent failure to provide notice of commercial marketing doesn't apply the subsequent failure and that's what actually the title talks about subsequent failures and in fact the court makes mention of the fact there was a complete failure to provide any of the patten exchanged hands and it said so in this case as in here we find that it's mandatory but for the same reasons the court said under l two ebay because there's a specific remedy created by congress for a specific statutory right we must honor that right it's not just the concluding sentence of the that the majority wrote that that is apa texas basis for this in fact throughout the opinion the court notes and goes on to state with respect to paragraph l eight we do not find any provision in the that contemplates or specifies the consequence for noncompliance with the notice provision here here but what the what do they say they distinguishes us they say because sanders did not provide the all today information engine was unable to compile the patents the judge acknowledges however while it is true that paragraph l ninety specifies the consequence for a subsequent failure to comply with paragraph l a day after the applicant has complied with l two  it does not apply in this case your honour's that's not this case it does apply in this case where sanders did not comply with the way they found it was mandatory but they carved out a distinction and that distinction is the same rationale that they used when they when they were looking at the l two a so based on the statutes a max maximum statutory construction language that we've just talked about and based on  one hundred eighty days the briefs and appa text lay out something that i think's important to know and the district court got this wrong the district court cited to the fact that this would be a unique situation where you would have to give this notice of commercial marketing and somehow it would end in a twelve and a half year exclusivity period your honor that's just not the case because sanders elected not to make the l to any information held the paragraph on line he did not apply however the hundred eighty day notice of commercial marketing provision if that was mandatory in all cases it wouldn't be it would require that only after the effective date of f approval of any applicants a b l that i would someone be able to give that notice of commercial marketing now if i understand it correctly the the f d a is not authorized to  its approval effective until after the exclusive period but is it also prohibited from actually making the decision with respect to approval well before the expiration licensure until that twelve year exclusivity ends so the triggering act whether you call it licenses or approval or effectiveness the triggering act as far as the f d a is concerned whether it's by statute or by practice in the f d a is not going to happen until after the twelve year exclusivity period is that what you're saying correct ok and if we read it to mean that this provision applies in all cases there wouldn't be a single abiotic and this one is a perfect example there's only one patent issue the fact discovery is over closed on friday the court of schedule the trial for july is very possible that there's no patent left issue in this case and yet if we read it mandatory even though we followed the disclosure provisions of l two and they've had our application for more than a year and nothing has prevented them from bringing an injunction on the current patent one pattern remaining  we're not here on that injunction court is being asked to rewrite l h to protein language that actually appears elsewhere in the statute what i mean is are in are there are places court should rewrite section eight at bellator so that it has that same language that's that's the position that is being provide that define the failure to give to comply with two way as an act of infringement and then in two seventy one and four specify the exclusive consequence for that you cannot reach the majority of decision in the sandoz case without that statutory underpinning so again the drafters knew how to specify an exclusive remedy when they wanted so and what the what the majority in th of this court's decision in sandoz lays out it provides a defined statutory period in which to resolve patent disputes before launch of the biosimilars and that the seems to be an argument that is made by the then be in a position to move forward it would never have been necessary to seek a preliminary injunction without a notice period we would say we have no idea when this product is coming on the market we need to move for a preliminary injunction right now and whichever party was unhappy with the it was going to be almost inevitable absent always inevitable that there would be patent disputes in everybody's similar case and they simply said we're going to establish a bright line  value in having a bright line one hundred eighty day period and that's how the statute is constructed and therefore i think that that's absolutely right and i think that what what we see here is there's a misperception that that they wish to not launch at risk and incur potentially ruinous damages and they wish to flush out whatever patents there are this statutory regime has been deliberately architected to allow the players and particularly to now buy a similar if it wishes to move forward and say well i would like to have resolved the panacea before i go on the market and potentially billions of dollars  don't make the all to a disclosure becomes effectively impossible to then clear out or to obtain certainty regarding patents and that they're taking a chance of saying maybe i'll be will be subject to that rule as liability and so the incentive i think is similar wants to not to take that risk then it will make the disclosure if it's willing to incur at least in some level that risk it will it will not but but why do i say that we need one hundred eighty days for the benefit of the judicial system first of all we don't want a situation where in every single bio similar case it begins with a probably needless preliminary injunction motion we don't want to situation where these products come on the market and then i yanked off the market as the amicus engines and because the biotechnology innovation organization size in its brief you even if it is not it is potentially harmful for people to have a situation where they switch back and forth between these products they're not like generics they're similar but not identical and if there is a public harm having a situation where a bio similar is launched on the market the patent holder moves for a problem in our injunction the thing is yanked off the market after a month or two and then it comes back on the hundred eighty days as intended exactly as this court held unanimously in that part and i'm talking about section to be of the sender's opinion its  provide the all two way information that's the act of infringement and then section two seventy one e four says the remedies that are listed here in the only remedies that can be given for an act of infringement under section two seventy one the two se were to consider it if one were to consider it a remedy it is in no way shape or form an exclusive remedy and it doesn't thereby in a stand in the way of enforcement of the notice provision for the manifest benefit of the judicial obviously these are huge products with lots of resources but equally that is true on the other side and as we have seen in the natural axemen context there are certainly situations in which those who wish to will flood the market i would refer to the court it was too late that was gone i didn't and so yes that by all means but this is true on both sides of the equation and the whole purpose of one hundred eighty days is to prevent a situation where we have fired over and over again in every single similar might not necessarily remember they're not free to bring that that declaratory judgment action until and unless and until they give the eight a notice that's what all nine a success neither side can can bring an action declaratory judgment action rather you know i'm it may cause catastrophic come to the market but i think there's a good deal of money to be made here and i'll do that and that is why we have one hundred eighty day protected period to say you can't do that you've got to have that has to be an opportunity what it is asking is this court to give context to the remedial provision that is there in l nine b for a violation of the l eight eight commercial marking provision councils pointed out  in response to one of the court's questions that the l nine provisions l nine eight prevents either party from actually file out filing a d j on those subsequent subsequently listed pat but by not giving the notice of commercial marking the b l a is making a choice that congress intended that choice is you don't get the right under l nine b to bring a d j action in fact in l nine see the r p s can bring a d j action that way as well so under any scenario councils write the r p s can bring a d j action but only one scenario where the a b away chooses not statutory based relief injunctive relief that's extra statutory not part of the scheme should apply in all cases in so doing what counsel is saying is even though l is based the title of the extra statutory remedy of a preliminary injunction should be available to it in all cases so it can have patent certainty this court has said the supreme court has said in whitman versus american trucking association where congress has health fundamental details of a regular regulatory scheme in vague terms or ancillary provisions it does not one might say hide elephants in mouse holes the elephant in the room here your honor is whether or not they can have twelve and a half years exclusivity and they're trying to get that elephant through mouse hole by saying even though it's not listed as a specific remedy we think it's ok for a court to take that extraordinary remedy for the potential to stop a similar from launching into what isn't just for anshan it's a carefully balanced statute that allows the io similar applicant and patients around the country to actually benefit from the affordable care act in competition are choices to be made and there are consequences from those choices apa text shows unlike sandoz to provide its information to provide it to be elaine its manufacturing information engine is not prevented as we sit here today from brain that injunction today they played in their complaint both for eliminating permanent injunctive relief we are not here under l the patent part for the merits of their one remaining patent and nothing prevents them from bringing new pat and in fact if they did apa tax like any other b l i would have to make a decision whether or not to launch in the face of additional patents it's the same thing that happens in the  there might be other patents out there what the statute doesn't require is complete certainty and all the engine would like to say the congress intended there to be complete certainty and that's why the extra one hundred eighty days is there there's actually an incentive of course eight as mandatory so there's an incentive written into the statute for you to go down the path in exchange information face at the outset and that actually helps with patent certainty because you can go through that discovery process which we've completed you can put forth the patents that congress intended to be litigated early you can have the assessment of all for the i'm finishing up your you can have that assessment for not only the engines of the world but the biosimilars who are trying to bring biosimilars competition under the