a very complex and sensitive process that requires as relevant here the presence of a sugar called one six a as in the breeze it's hasta be present in a certain percentile range sixty five in addition we had to mabel ramakant one of the consequences under the statute to require testing then then it is not an authorized release it would be it would be it would be an unauthorized release and in fact we had to make these to get the word in the sale of an adulterated drug well it may not be a well a printout how it happens if it's because you don't do the testing at all i suppose it might not be adulterated if it so happens that had the correct percentage so it might not be physically adulterated to be on authorized because that is a condition it's a promise we have to make and a promise we have to keep as a condition of bringing this up to the market line into the sale line so that now obviously we didn't have the content it would be became dangerous enough because ultimately result in liability to individuals and harms somebody but it is a condition of our approval and they have the authority if as a regulatory agency if we do not comply with our conditions to withdraw that provable and and in a warehouse that was due to expire both december thirty first and january first unfortunately those days of coming past so that harm is realized i know there's a bond to move to another and so that one hundred million one hundred million forgive me but yes and that's one of the pro presumably so so those are covered but i understood from your part reply brief if there continues to be a large amount of potential damages from possible loss of customer base by being unable to i'm trying to dance around what might be confidential information but lots of customer bases that is there a continuing threat is what i have absolutely and it's on page thirty of our free of our reply brief lay it out in the contracts of how this is done and we explained there in the brief the citations on page thirty there are there were four year contracts worth fifty million dollars a year that's two hundred million dollars right there and once that contract process is going to go yes is appropriate and then more details about that but i think this is long as you mention in the harm i think one thing that's very important to keep in mind here of course we deal with balancing a farm some preliminary injunction they're raising the wrong harm what they talked about mcveigh had this is that has seen message it is not an entitlement to watch the drug being made or the drug being sold it is a testing method but there harms are not addressed in terms of what the harm is from us using their testing method their harms are all about what happens if you come into the market but then they argue well you can get some other testing method to come get it to get around the safe harbor issues that we've raised so they don't match our harms are shut down by this injunction because of compliance with the f d a mandated testing that isn't there harm should have been articulated in terms of how using their test harms them and not just generally pending approval the holding in that case was dealing with something that was both approval and post sale and that sale language does actually appear in the statute issue here twenty two forty one but  talking about this information that has to be collected for regulatory approval process so it has to be read in light of that language and also said in terms we are not addressing showings of bio acquittal and that has to be read in light of that and understand the fact that case that was a completely voluntary post sale post out on the market determination to run it past that event was not mandated by the f d a now if you got bad results then you had to turn it in overlook that this whole thing is setting up the pre post lines and if we can't go into the market under two eleven one sixty five and less we've done this test first this is our starting  it talks there about approval batch five batch that you have to do and understand with these drug approval is not a red light green light in this context you have to make sure every time that what you're selling is what they've approved you to sell it's approved if verified it's what we have here this is a flashing red light all the time it's only approved of verified and this is the verified testing that we are doing here and that is why this is completely different from class and it would be very much to put on class and sometimes is assumed that you just get a red light area like in a group right b and i have been approved but the sale has not until eleven one sixty five again use the attached to our reply reap the regulations conditions for their approval and release so you have the program but you have batch approvals and you have to have that because as i said it can't be sold until we verify the existence of this percentage and you have to do that on a batch by batch faces its a nature of this type of drug that you have the flashing red where the f d a has mandated that we do it before we can get out of the starting gate is to is to draw a line that is not only outside of the text of the statute but doesn't make sense with the nature of these drugs are there any furthe move to eleven one sixty five so it's a both in the preliminary injunction filings in a footnote and then in the motion to reconsider within ten days of the decision within the appeal period there before this court there purely legal the questions they were briefed below there's no prejudice and you cannot have scientific mark a particular path right yes and no you are required to run a test to determine the presence of the one six and hydra ring structure you are not required to run this test  switch why aren't you required to run this test the f d a requires that you test for the presence and amount of that once it's an hydro structure the f d a has said publicly in documents cited in our brief and includ citizen petition that was actually end yes that yes to in their reply brief they know it's that the f d a will will allow a test which it seems to be a quibble with for better than this particular test the second time the statute says that to seventy one he one says that you that if that information that is reasonably was so so we related to two purposes smiting it information the f d a is exempt from infringement the what we're talking about here is an act which constitutes patent infringement think your answer my question is are all my question is if the st express please said for example in twenty one u s c three fifty one if instead of saying you must use the neptunes articulated in the us p instead of saying that it actually said you must use method to set to zero seven if the statute said that there still would not be a protection from infringement because this is conduct which occurred this relates to the manufacture of the product after product approval and two seventy one even one is that would be the answer to that is yes yes yes i would say that but you don't believe the statute actually does require the method of two of seven you want to fight my initial problem and yes i'd like you know t fuck up first us speech itself says that it means that any of that a test which propose which is as reliable or more reliable will be acceptable second the f d a has said that it will accept using an m r procedure where we find the record you cannot find that in the record what you cannot find in the room which you nor can you find anything in the record that indicates that an alternative procedure would not be acceptable well that's that you only method this close for determining exactly the percentage between fifteen and twenty five percent or one six terrific i believe that what the statute says is you must use what's called the test that's called out in the us pm mo for that product u s p monograph for that product does not require the use of the two zero zero seven method in the us a piece general notices and requirements say that you may use an alternate test if it is  method of manufacture that that is the takes place after f d a approval and and and still market reform it is a unique you it is a requirement that you follow a whole series of procedures every step in the manufacturing process begin where the market must be followed every step in order to market in order to market and and every step in the manufacturing process there must be a record kept up in certain circumstances but it was a requirement for marketing it was it was not a requirement for marketing in this case the f d a requires that each step in the manufacturing process the other a record be kept of that and that is that throughout the process and that starts with the ingredients and ends with the packaging every step in the production of a batch every production control method must be recorded and the records retain retain and if the f wants they can come and inspect them but there's no requirement here and there is no evidence that any record was ever submitted to the f d a with respect to these to these processes so the two seventy one the one argument here is maintain and that they are and that they are available and kept available for f d a inspection for a defined period of time and if one were to can and every one of the steps once you commit to to following those steps every one of those steps must be performed every single step and therefore if what we're talking about here is a situation in which the performance of any one of those steps constitutes a  that will affect all sorts of patents anything on their argument anything of which a record must be kept any step which must be followed and every step must be followed once you commit to following those steps every single one of those things according to the f a star argument is exempt from infringement the the up and there is simply in every one of those steps is a step takes place after product approval i was going to read language from the crossin patents expire to get the f d a approval the purpose of the statute has nothing to do with steps that you take during the manufacturing process well long after approval there's no this there's no shred of paper that has been submitted to the f d a with respect to this we turn to the harms because i want to pick up on something that said on the other side this is a situation in which the ample star urges that it be company it's not going down thirty percent in a single day these events will converted from a company that was comfortably profitable to a company that's losing money the effects on on momenta will wilt i can't tell you what it won't invent as a result of that i can't tell you what will be delayed i can't tell you what effect it will have on on its ability to employ and retain people i can tell you that on one day sixty percent of all the stock options in this company were underwater in a single day the there's an argument made that i was not made orlean this morning but that we somehow misled the court the district court specifically held that we did not the issue there had to do with the fact that we that point the in the court found that in the circumstances the injunction was effective to prevent yet another type of harm that would be irreparable which is the effect on the market of new ventures we pause and just talk about infringement for for just a couple seconds the claims here of the separation method to determine the presence of a structural signature of an ox apparently they use a process called h p l c they had met that h p l c is a separation that they argue that you should interpret the claim of the use of the separation method to you just more if you need any more questions on why this is that this past us p two hundred seven is required i'm happy to address them but identified the statutory provisions on ninety seven ninety eight ninety six of the addendum to our briefs that make it mandatory to use the u s p you have to you have to do one or the other to get to meet the regulatory requirement what difference does it make that there are two tests is that one doesn't make any difference i don't think it makes any difference the only hypothetical i would reserve it of the law you know say that one if one isn't going there be the question whether it's reasonably related to pick the patented one way or the other one but this situation there is one and it is the one that is in this if they can't shoot from the hip here and find things that are kind of good there's a you can't do their patent which tells you to look at one peak and has that is not remotely close you only need an eyeball for this to fifteen to twenty five percent of the ingredients of that you can't use their pat the quality control that is required in that pattern that is a patent for quality control that tells you not one word about how to find fifteen to twenty five percent under four peaks but again the narrowness of this is that you have this odd situation where there's arguments i can't stand here and say for the safe harbor purposes that there are other tests and then say the harm is if they run any testing it out on the markets our market share will get shut down or harm argument is about us not being able to do any for tests and staying off the market this is a testing method you don't get to keep people out of the market with a testing method that we have follow you will manufacturing control methods and speed worthless no absolutely not there will only be those that fall within the safe harbor provisions that are there although there is if there are manufacturing control methods if they are they are all going to be information that supplied in some point long after the drug has come out which was the purpose of waxman i was there i wrote that so i know what it was meant to do so long after that has been accomplished you're going to render all these  precisely to rip the point that you raise and that is this is a narrow situation where there is one mandated approach by the f d a one test and one test only if there are other ones and you make the choice one could argue that's not reasonably related under the safe harbor that that's not where it was intended to go but that's not the situation and the point here is that there's one passes and blocked off and it is in terms in terms pre batch approval pre marketing pre sales this gets us to the starting gate and if you shut it down you shut down all generic competition which most assuredly was not