to the application seeking f d a licensure and in particular counsel this is why just out of curiosity why do you think it ties to the last application which was the supplemental application or supplemental applications that seek to change the scope of the license that the biosimilars has received from f d a and when you think counsel you think any change of scope at all restart the need for the one hundred and eighty days suppose it was a very minor minor minor supplement an ever so slight change to the wording on the label that was really of no significance or consequence but they filed it you think that starts the one hundred and eighty day clock over again even if there were no change to the manufacturing facility no change to the underlying product itself now your honor let me clarify it is only changes that would seek to change the scope of the license that the bio similar receives from f d a for example changes like the changes that i am just made here that require approval by f d a before they can be implemented are the sort of changes that we're contemplating something that is ministerial for example changing the identity of the supplier of some components that the bio similar uses in its process use that's the sort of change that might be reported to f d a perhaps in an annual report but changes being affected regulations that f d a has some of this change may alter d the scope of the license and some may not but in this case it's clear we're making changes to the manufacturing facility and the labeling that goes to the product those are significant changes that f d a in its expert opinion has decided require f d a pre approval so i think that's a very sensible line for the court to draw that when there is a requirement of f d a pre approval as there was here that i sort of change that triggers the notice of the sec the language of the statute which is where you wanted to start and for me that really carries the water in this case the language of the statute says they have to provide you notice of the biological product if there were zero changes and i understand this is not your argument but if there were zero changes to the biological product but just a change for example to the location of the manufacturing facility that would require f approval but that change would make no change to the underlying biological product so since the statute only requires them to give you notice of the biological product why would the one hundred and eighty dollars day time period that it may not change just because there's a supplemental application based on for example the location of the manufacturing facility that may have no impact on the biological product to be licensed it just has an impact on the location of the manufacturing facility and your honor in our view that change to the manufacturing facility works of the label goes to the product that has actually been licensed by f d a and  necessarily requires a look at what the biosimilars license permits it to do in this case so to be clear in your view is an extraordinarily broad one your view of how the statute should be interpreted is that any change at all to the application necessarily changes the biological product that has been licensed any supplemental application requires approval by the f d a they all do everyone and so no matter how ministerial the change even if it has no impact on the underlying product your view is any change at all that is filed in the form of a supplemental application is going to restart the one hundred and eighty dollars day clock no your honor that is not our view and let me explain it only changes significant that they change the scope of the license that the buy a similar has received from f d a so the ministerial changes that you're referring to would not alter the scope of the license but here we're talking about changes that require sure you'll correct me what the supreme court said in the sandoz case was that the biological products can be the subject of an element notice prior to receiving a license from f d a and in answering that question the supreme court did not go away end on the issue that's presented in this case which is what happens when the bio similar has a license and seeks to change the scope of that license that issue just wasn't presented in that case because  not received a license from and nd of all there was no allegation my engine in that case the chandos product had changed in any meaningful way after the filing of the initial application now it is true  supreme court recognized that the product that is the subject of the application can change over the course of the application cycle and there's the language that amgen quotes in its brief about how nothing in the notice obligation turns on the precise status or characteristics of the by a similar application but it's important to understand the context in which that statement rose and jim was making an argument per se argument that there could be no notice provided prior to licensure and it was pointing out that changes might occur in support of that argument so the status and characteristics of the application to the supreme court was referring to there are the status or characteristic of whether the on that question that that's not to say that the supreme court didn't say things that are relevant to the disposition of this appeal the supreme court reiterated that the purpose of the ele notice provision is to allow for the resolution of disputes over patents prior to because and it's a little bit off this topic but why is it that you didn't if if your primary concern right now is the infringement of the process pat why didn't you seek an injunction based on and you know an infringement of a valid and infringed patent and not just hang your hat on this noticed into both the patent merits and the injunctive relief factors that the statute contemplates and for that answer i want to explain a little bit about the procedural history because it is a little complicated there are litigations below between  indicated the change in the manufacturing facility did you not we did your honor and as a result of that discovery we filed nd case six o two action which is the action that actually underlies this appeal and in that case we have not even had a little sixteen conference yet engine filed a motion to dismiss that has not been ruled on doesn't mean and i say that have an injunction in that case even without the row sixteen conference well your honor as lamson let me let me ask you this is judgment i am sorry let me ask you your friend on the other side mr specifically said that he was not saying that every supplement would trigger a new notice and is it your position that there is no form of supplement that would ever trigger a no notice in other words on the opposite side of that scale so i think the answer is that as long as your supplement i try and change it and try and you know put it through his problem it will require a new application and that application is the statutory trigger for a whole bunch of disclosures under now to for example but isn't there a possible mischief here i mean with all of these often a process patent is one of the things that if that is where infringement is alleged because a lot of times it's hard to do th generic to create the generic without using a patent to process and so couldn't doesn't this imply that there could be a bait and switch that you could say as you did here that we're going to use x process and then turn around and use  someone else but it didn't do that and now it because l it's about timing it's a heads up notice about watch it's not an opportunity for further information or disclosures about the means of production congress also addressed access to information  changes could be pretty significant for example it cited this court's opinion this court's opinion saying that changes to manufacturing processes or changes to therapeutic uses might occur but the supreme court said those don't matter and that makes sense this is a special provision given to drug manufacturers alone no one else in town law does anybody get this has got and congress recently determine that you get that has up once when the product is going to come to market practice which is that in its initial notice as initial application it used the place where its clinical product was produced later in the process when you get closer to commercial marketing and you have a better idea of how much product you're going to need when it's going you and let me pick up on the last point that mr lincoln mentioned which is the public interest backers in our view the district court didn't make any finding after the public interest there is it's true six of the opinion a statement about the public interest but we don't view that as a finding i think if you read the opinion as a whole it's clear that the district court was resting its decision to deny our motion on its legal analysis in our view that legal analysis is flawed let me return after giving notice file supplemental applications that were you'll be real process and the real label that they intend to use congress could not have intended to create a statutory scheme that could be so easily games we know that congress didn't create that scheme from the tax section l eight and also from the related provisions including section eline which focuses the attention of the parties and the courts on the status of the application as this court has held under section l nine no infringement suit can be brought because no case of controversy exists until the application has been filed it would be nonsensical i would submit for congress to have intended parties like a biosimilars like amgen will make the sort of changes that we're talking about a number of times unless there are further questions we ask that the district court be reversed and that we receive an order in joining hands in for marketing the current version of its embassy product