stating that in our view the central issue in this appeal is what did this court decide in the sandoz case when it said that after bringing an infringement action the civil reference product sponsor can access the required information through discovery well it seemed to say that you could do it by bringing suit for artificial act of friendship which is not what you've don of the that's what the statute says in other words what we think that what the statute says is an artificial act of in french but with respect to potentially many patents once you bring a lawsuit on any one of those you can then access the corpus of amgen argued well they cannot be the case that the similar applicant is allowed to withhold his information because the result of a situation in which infringement could effectively be concealed forever set of information that's really that's defined in the statute and is not defined by reference to any patent well but that seems to be different from walk i thought your answer was in response to my question is it do manufacturing them biological products yes you're wrong and what's preventing bringing such a suit is that we can't tell whether there's infringement and as we understand the entire st for a reasonable belief that a claim of infringement could be asserted that what what's in it in that reasonable belief language is that there has been an analysis a comparison between the accused instrumentality and a patent claim that has fact that the whole purpose of seat two is to allow you to sue for an artificial act of a ranchman if the information necessary to make terminations infringement has not been read i don't engine does not read the to see as saying that it is in some way animated by a separate desire standard to bring suit to get information but it says that means as of the applicant for the application patents so perhaps out of an abundance of caution you know without any court ruling and commenting on the scope of what levon applied to belittle to this unique context you chose not to file under  to see to or any of your cell culture medium claims but nevertheless it seems like once you've exhausted your efforts to try to reasonably acquire and investigate a possible claim for your manufacturing has and you haven't been able to succeed through the whole two three process then you you know appear to have a reasonable happen because you're out of the definition of the information is not is not based on any patent and therefore it's equally relevant to any patent that's asserted if one is looking at it in that fashion the information and i think part of the problem with saying you the way the statute deals with that is it doesn't say the information is defined by relevance to us it says in else who were the information is the application that was submitted to the food and drug administration you tie thing and such other information as was contemplated by the statute and that way we come back to this place where the end result isn't different than might be a slight temporal change but the end result isn't different than what would have happened had the procedures of the statute that followed the if that it ends up creating a situation in which you can miss patterns in which you may never learn of an infringement and it's grossly inefficient because it's essentially saying pull the trigger on lots of things and then we'll figure out which ones matter afterward would be much better and we think this is exactly what the statute was intended for to say get the information make the comparison with the accused instrumentality and then assert your claims of infringement and that that's our view that way then we get accurate regimen with respect to any patent no i think the way we read it is this is a situation where some but less than all of the required information was disclosed that information was sufficient for engine to form to focus on that a little further it's because that second round of information isn't defined by virtue of being relevant that's four and five it's defined by virtue of being a set of information about the product and that's what is required statute this court commented on that in the app a text back so on the facts of this and there's very good reasons why that would be suck but to be fair the statute also contemplates there will be times where you as the reference product sponsor will be collecting damages for sales of bio similar products out in the commercial marketplace that's to seventy one before if so it's not set up in such a way that the statue and recognizing that there are just reviews here it's set up so that the reference product sponsor can get into court and ask for a resolution before there is by a similar market entry and that's in fact for the purpose of the hundred eighty days of of the remedy part of the two seventy one and for the reference products bonsa could accidentally or deliberately fail to bring suit when it is supposed to and then it may be cabbage to a royalty remedy but again that's within the power makes a very different proposition to go to war district court and say please stop this infringing product from coming on the market as opposed to going saying there's an infringing product on the market please take it off the market  earliest we think that this court could be addressing would be giving us a decision on the the question that brings us here today if we waited until the final judgment is probably two thousand and nineteen and we think it's highly likely or at least likely they say that the right not to have to face the suit which is the immunity issue is the same as the right not to have to face competition which is your issue i don't think is a right not have to face competition it's a right to be able to go to court and say court i should not have to face competition thank your honor may have please the court the fundamental problem with merits of the appeal here is that the b p cia does not alter rule twenty six of the federal rules so procedure that's above and beyond and close to but not quite expired and the complaint just been nominated under c but it's actually a c one complaint because that patent was listed on the three eight less that amgen provided during the so called patent that it is a patent that flaw squarely under see one they just said see and there this is not a c two case even if it were a c two case there is the infringement is the infringement of product then i would be seen to be what they're saying if i think that those kind of capture what they're saying there are two problems with that one that's not what happened here they sued under c one they just didn't say that but secondly even if they sued under sea two for the product patent which i don't think c two would but even if you call that a c two suit rule twenty six still says that discovery is governed by the claims and defens infringement of the product patent and not just the cell that that's what they except maybe we're maybe we're not making myself clear as to which patents we're talking about the two nine eight is the patent they sued on undersea that's a product that  it's yes it's really the ice of forms of the product the cell patents the three point nine they did not sue under c so to ninety eight they brought a lawsuit that patent was listed on the three a list therefore that's it that's a c one suit that they brought they just put c in the complaint but it's a c one sued because that's the provision of see that that governs that act of infringement so if you were counseling and the beginning of this  process what would you suggest they do apparently you would say don't go the discovery route what route should they have well m g m had options that they they chose not to take advantage of what would be the best option for a party in engines position other than the rule twenty six option that they elected well amgen could have if they thought they had a patent that this information that they're seeking less somehow relevant to and there was one piece of information that they couldn't definitively tell yet whether it was infringed remember they got seven hundred thousand pages of information they got a complete nice zero in on let's call let's do a hypothetical let's say that  a k applicants hands over the application and the application gives lots of information about the product of bias in the product but gives no information about how to manufacture that biosimilar product and the k applicant refuses to hand over any manufacturing information along with the application under l two way so now we know that there is then if i a leash and of that mandate by congress and l to weigh so under those circumstances it seems like it would be really shooting in the dark or the r p s to list any of its manufacturing options to bring suit on patents that could be listed under three i under seek to right and so i guess you're saying then that the r p s reference products sponsor could file a lawsuit under each to see to and necessarily would have to be guessing somewhat about which patents it identified in its complaint but upon filing that very complaint the reference products sponsor in the context of the situation shouldn't be subjected to rule eleven sanctions and in fact there ought to be discovery produced by the capital and in such a litigation  actually reveal the manufacturing processes for the bio somewhere presumably their way of explaining how the mechanism should go presumably if there's if there's an absence of information that makes  reasonable then there should be a situation where rule levon ought not to be a concern i think they essentially didn't get the information under circumstances where they should of they had a patent assertion that would be reasonable filing another complaint say tomorrow under a to see to and identifying some cell culture patents and alleging that there has been a pattern infringement of those cell culture patents which would then spirit violated all today but then if the district court concluded that yes there was manufacturing information that need to be submitted under the bill to elstree process and wasn't submit that they complied one hundred percent and the were made in my theoretical world right now in your in your theoretical world violated l two way by not satisfying the manufacturing that i would agree that you should go through the patent then and and list patents under l three a in accordance with the actual information that the similar provided under l two a but for those very important pieces of information that they did not submit then it seems like the r p s is at a loss on what to do next well no i would submit that with the with the r p s has to do is list the it was the the necessary information wasn't supply the remedy as i understand it you say has to be under siege to run it through the well if you at the end of the  that's that's the theoretical construct we've created here for purposes of this argument if there's absolutely no way to have a compliance with to add a because there was  one piece of paper submitted that said i want to market a by a similar version of product x and no more detail was provided if that's not hypothetical it still would be possible for it thinks might be infringed including manufacturing atoms and engines view is well that would that would put a burden on the subsection chain applicant to have to respond to a lot of that has to list the parents there say that we get to a they now have a claim a cause of action for infringement of these manufacturing patents and under rule twenty secs discovery would presumably be appropriate for obtaining information as to those claims that are now in a lawsuit that is properly before district court so that's goes back to i guess my initial question there isn't anything stopping amgen from filing that he to seek to complain today  for its manufacturing patents that relate to sole cultures we would see there would be a debate over whether or not there was a violation on your side of the l to a requirement of handing over manufacturing information and and the district court would then have to decide whether or not there was a violation of beltway but if there was if if the district court does conclude there was a violation of two way that i don't see unless you tell  differently any reason why engine couldn't go forth on that and to see to comply i guess accepting the premise that listing patents under three is is not required and a suit under sea two is permitted once you get into a suit to suit then you can get the discovery but if you opt into the patent dance unlike the sandusky case and you provide information and at the edges there is a patent that the r p s thinks is in french but they don't have one hundred percent certainty because there's a piece of information that they don't think they can glean from the seven hundred thousand pages they got they should list epact and then go through the patent dance because the next thing that happens is that the subsequent chaotic and oh how can provide  to a is not violated we opt into the pat downs or any of the mean you think as long as you produce something unlike send us and you know say just drop it i'm not coming forward with anything then you've opted into the of you get treated as if you are completely compliant to you yes you have op you have if you make a good faith proffer of your information under to a if there's a dispute over whether or not a piece of information is required or not a package should be listed and you should go through the patent office if you if you if that doesn't happen and it is legitimate to file a c to suit and discovery would be appropriate under the was a reviewable under the collateral order dr and i think same principle applies under paul ritz also the issues are intertwined with the merits of the case the rule twenty six standard is claims and offenses and so on under those circumstances these issues on discovery are wrapped into the merits of the case in fact that's exactly what judge andrews is your decision was based on that there was no  listed is that it can never ever be asserted and so there are there is part of the reason why this dispute is going on is because by similar makers have a very powerful reason to want to expand the three a listing requirement because whenever a pact they can say a patent should have been those the other piece to judge a chance hypothetical where what if i give you some but less than all of the information required under two way i think we have a fundamental difference  significantly less than all right yes that could be disputes around the periphery but if you say i will give you the application but i refused to give you the manufacturing information it's a violation i think your spirits view is if i come and give you something