second even if plaintiffs could get past claim preclusion they still are not likely to succeed on the merits due to either a specification disclaimer or a violation of section one twelve's written description of harman and third the injunction should be vacated as quickly as possible the benefit of both dr reddy's and the public who is looking for this generic version of suboxone film i would like to start with the claim preclusion issue plaintiffs have identified what they say is only one distinction between the is not a random admission by the plaintiffs they had to make this admission because the prior art shows that there were there was there were examples such as the schmidt reference in which you had uniformity up until the drawing stat to get past particular way and so if you read judge mcnulty's decision when you get a flavor of is that because the word dr was gone he thought he had to read the claims of three or five patent differently but judge andrews in delaware did not find that there had been lexicography he found that there had been a specification disclaimer and his repeated statements that you could not you cannot read this is this the shared specification of these two patents without finding it disavowal could not be clearer so applicants that if you use what they refer to as conventional drying it results in on uniform films they explain why it results in uniform films there are a couple of different factors at play the formation of the skin on top as well some lifting up from the the the conveyor belt that occurs which results in on uniformity so they explain all that they have an example it's example c g in the specification where they say that when they when they used to quote conventional drying of the claim just read by itself was not specific to the use of efficient mixing here both the five hundred four and three or five patents require a drug content uniformity measurement that's that shows a lack of uniformity of no greater than ten percent when you look at the specification it says that two to have that degree of drug content uniformity after going through the drying process you cannot use solely conventional convection air drying from the top what we know is that earlier th there is a generic tablet that's available on the market and so judge mcnulty said in essence the lack of a generic film isn't a big deal because the active ingredient is still available on a tablet form the undisputed evidence below however w that for many people they are unable to use the tablet you have to keep it under your tongue for about six minutes for exists all and many people can't do that that they don't like the taste of the evidence was and so they swallow it too quickly and if you swallow too quickly you don't get the right the right dosage whereas the film only has to be on your tongue for a matter of seconds in order for those of to be delivered and again the undisputed evidence below was that allowing access to a generic film would not just reduce the cost but would meaningfully increase access even to the underlying active ingredient for the many people who can't afford the brand which isn't covered by many insurance companies because it's so expensive including the evidence was the insurance  support oh no certainly not your honor the the evidence in the record about the authorized generic and other potential market insurance appears in the comp in the confidential version of the had as of june a significant first mover advantage right now we believe we still have a significant first mover advantage if we can get on to the market if however this injunction drags on every day it drags on the head start we got by getting by defeating them  tablets you can actually look at the plaintiff's brief and the coke handing appeal from the delaware litigation what they say in their brief in the delaware litigation in this is out excuse me if this is page tablets which as i explained earlier need to be kept under the tongue for six minutes and that patients who swallow a tablet before it is dissolved do not receive proper dose in the delaware case plaintiffs themselves are touting the advantages of the film over the existing generic tablet where please the court i have a few quick points i'd like to make the claims of the three zero five patent are different from those that were litigated in delaware in the five one fork and they don't contain the words dr the film has to be dried otherwise there's nothing to put under the top that doesn't mean that drying is cleaned and it doesn't mean that help drying is performed this is in any way limiting the specification when five as an entirely different approach to control trying to achieve uniformity described as an alternative once driving drawing are not part of the claim then the issue of even though the language of the claims read without reference to the specification might be considered broad enough to encompass the future in question so even though the word frying is not in the claim the argument being that based on will go the other way and require a textual hook that's pacing in m b o the other thing here these are composition claims and what what we understand your all to me doing is trying to import  or product in a i don't know whether there was this was addressed in the opinion but there's a bar to simply reading and process claims from baldwin and vanguard into the composition claim because the batches limitation of which it formed a part had been defined in terms of a particular process we don't have that here and the medicine's case suggests in that footnote the was an emphasis below that there need be no textual hook that there is a free standing disclaimer there was no finding of a freestanding disclaimer the decision below is rooted in the words dried and dry but on continuously cast film i think or something very important but the court needs to understand the r l it made it this was in the delaware proceeding that it's film was a cast film and that's part of the record in this case it's exhibit thirty two to the lingere declaration that docket entry seventy one it's also clear from appendix four thousand and forty from the the trial opinion that there was a the admission that the arrows film was a cast film and in this case when trying to argue that the claims were essentially the same the are all said that a cast film means material materially the same thing as a continuously cast film that said three fifty six in the oral argument set fifty nine sixty two minutes and dr mi g s declaration at fifty nine twenty two twenty three so i pointed already to the important distinction between a composition and method claim there are various steps that would need to occur to make a cast film for example mixing on a tape spilling device and there was no make no mention in the claim of a method for measuring tension in the court said that can't be read in even though it's necessary to take whatever the judge construe dryden drying to mean and put it in here even though those words are not part of the claim and then i have mentioned baldwin and vanguard baldwin the courts that the court said in that case and this was a key again in the medicine's distinguish that a decision distinguishing baldwin courts must generally take care to avoid reading process limitations into an apparatus that in vanguard case you wondered that the appeal which will be heard in the first quarter of this this this year well we're arguing that there shouldn't be any disclaimer attaching to the words driving dr process limitation should not be read into the composition claims but just because the way the judge in delaware we believe erred in reading across reading driving driving is process limitations that's a different any way they're gone from the claims that are there are asserted here so we're in a different situation as far as likelihood of success on the merits is concerned we've established a likely to success and merits based on these claims without trying trying with the judge fully aware of what it taking place that formed the majority of the argument well we believe as well that we're going to succeed in removing the disclaimer from driving drunk in the delaware case and now the cork on an abuse of discretion standard is isn't weighing whether it should upset the apple cart or irreparably change the market irreparably harming preclusion and written description arguments go away we've heard about other factors therefore factors here there isn't any any serious argument about  any legal error work clear error or that the court looked at the evidence on a regular bill harm and in this case ninety nine percent i mean if your is us revenue derives that will help people treating who need help with other dependants addictions treatments for cocaine addiction alcohol addiction all of that will be put on hold we don't know whether it will resume or not that's the stuff of a record will harm now the aroma my friend at your almost certainly disagree with what happened below but that's not the stuff of an abuse of discretion on the court look below also at the computing public interest you don't know what price the r l will with price its product at exactly that's not in the record but it is sure is that it will be cheaper but in this case the court found that in give your would not be able to launch develop other products they'd be delayed for on average two years so w may disagree with with the the district court below that's not the stuff of of of clear error and it's not the stuff an abuse of an abuse of discretion  i'm reminded of i don't remember the case but judge friendly is often quoted in the standard for abuse of discretion it's as if the the reviewing court must have a sense that the district court had come close to losing its senses here we have a preliminary record the judge pointed to the preliminary nature of the record witnesses were not provided that the court looked at the the patent look saw that continuously cast film can be made in many many ways that the claim presumably saw that the claim also was a composition claim not a process claim and refused to quest of irreparably harmed and all of this would be for not not only if we we win at the end of the case as we expect to do but if this this court respect to plaintiff's counsel argued that the word dried was deleted the word dried was not the leader this is not a case like m b o where some claims said that there had to be an immediate retraction of a needle and other claims left out the word immediate here the word dried was replaced with different phrases the final element the final imitation of the claim in the five one four which referred to even measuring uniformity in the matrix subsequent to cast him in drying was replaced with a phrase measuring uniformity in the continuously cast film plaintiffs repeatedly argue below in response to our intice a patient argument that when that uniformity is measured in the continuously cast film it's after drying that the continuously cast film is exactly the same thing as a matrix subsequent to casting and drawing in the language here could not be clearer page three seventy nine in the appendix for example the fact of the matter is the claim is to the final film and that film has been dried page three twenty seven the final film of the three zero five patent claims is dried they repeatedly argue below that this is just that the films and the three or five just like the films in the five point four despite starting out as a flow of the matrix wind up as a dried film drying is an element of these claims there's a suggestion that a person of skill in the art would not need these claims requiring drying here's what their expert actually said this is page ten thousand and ninety nine in the appendix a person of ordinary skill in the art reading the claims of the three zero five how can we understand the drying occurs so you go from a what matrix you wind up with a final dried film that's when you measure uniformity it is exactly the same thing in the five and four in the three zero five this is a this composition claim that is not the case these claims are limited to films which are cast films the specification explains that there are various methods of making a film you can have cast films you can have extruded films you can have cast films that are cast into sheets you can have  into individual wells these films must be films which are created through a continuous casting method a particular process in fact plaintiffs distinguish the prior art during prosecution on the basis of the process  used to make these claims films if you look at out for example page forty three fifty seven in the appendix the patent prosecutor this is the very last office action for the three o five patent distinguished prior art which cast into wells rather than into a particular sheet they were distinguishing the prior art based on the process if you look at dr langer there experts declaration below he again distinguished the prior are on the basis of the process this is at page thirteen sixteen in the appendix so you can the requirement that a particular process be used as right in the claim and they relied upon that to get these patents issued they relied upon it to address potential which is a patient in obviousness arguments below this case in that way is just like medicines co here yet there's a requirement of a cast film and medicines co there was a requirement that the film be created through a compound in process and what this court said in rejecting an argument that there was a improper effort to read or process the limitation into the injection a compound in process is a limitation here we don't have to go to the specification to see that a certain process is required to make this composition it's in the claim itself it has to be made with a casting process  on the question of why the court should address these issues now and not just wait which i think was suggested plaintiff actually opposed our motion to expedite this appeal and argued to the motions panel that there was no reason to hear this case quickly just wait for the five  obviously the motions panel rejected that suggestion because this was set down for an expedited appeal we have no idea when the five one four case will be argued and we have no idea when that case will be decided what we do know is that in the meantime there are many people who are not getting treatment they need from a generic version of the where they could have done is go to judge andrews and sought a injunction pending the appeal then could have come to this court on the five one four case and sought an injunction pending appeal they didn't do that and so they took this three o five patent which is not  the junction on an emergency basis and now we're fighting that injunction that never should have happened after some player they should have done this through the five hundred four if they thought they had a good case and the fact they didn't i believe is telling on the plenary injunction standard where they're required to show