interpretation of the statute which this required knowledge was a matter of st impression the issue for your understanding of you in this court is to know in order to understand the issues i think it's important to start st with the actual language and issue requires that new drug applicants list quote any patent which claims the drug for which the applicant submitted the application or which claims a method of using such a drug and with respect to which a claim of patent infringement could reasonably be asserted here and we'll talk about this a fair amount this one there's two pieces two components to that requirement one is that the patent has to be either a drug product patent or a method of use patent with respect to the drug issue and  the nd which i'll refer to as the the infringement modifier is that there has been there with respect to those claims there has to be a patent infringement claim the could reasonably be asserted supposed to come and again listing is mandatory these are c and among the requirements that manufacturers must satisfy is that they must include a description of the type of patent it is being listed i e and this is from this is from the regulation self i v drug comma drug product tama method of use and that description is also mandatory it is not optional but i think the court has recognized and certainly the supreme court has time and again that when interpreted the statute you must consider cont which means you look at the words in statute the court's also been very clear in this court has recognized that you must consider d the meeting in the context of the of the overall statutory goal and here i have think that's a really important point to focus on here because the entire purpose of the list information the reason that the orange d book exists in the st place is for for d any manufacturer is to identify patents that may become a bar to  on the context of the provision and looking at the language am i correct in understanding that the phrase claims the drug or claims a method of using such drug has a specialized meaning within the pat bar would mean a particular thing in patent law and when it looking at the context suggests the use of that those two phrases would invoke that specialized meaning both times there used are you're correct that the term claims when used in connection with a patent can have can be a term of art for certain purposes so for example in a martin hearing where you're seeking to construe what the client the scope of your claims in the past but it's also hoshi's the case that the players like because it was construe any different part of the statute where there was a reference to claims but not infringement and the court air federal circuit there's applied what they what the plaintiffs call the federal circuit said was it's meaningful that the work infringement doesn't show up in the statute in the federal circuit when i want to give an example of where the term claims would have a different me and the example they gave was where the statute actually used the used in connection with a patent there's not had a single meaning that must be ready in time i guess i guess i get that my own follow up question would be i mean there's three uses of claim the word claim in the statute and i agree when you say claim a patent infringement that would dot that doesn't seem to me to invoke the specialized meaning we're talking about but when you look at the patents which claims something right when that phrase is use it doesn't but what does the pat claim and and i don't see it unless i'm misunderstanding and i'm looking forward to hearing the rest of your argument and all the other arguments i am and i am but my starting point would be we would use that specialized meaning for those that phrase the st two places the word claims appears in the statute so so your honor to be precise the word claims appears twice as  modifier only modified the hat method of use athens and not the drug product as we know that we now know that that is wrong st of all it's wrong just as a matter basic grammar and and construction actually there was a recent decision in the facebook decision of the supreme court just earth day where the court talked about the series qualifier canada which i have nipped up phrases new is new to me but the but the supreme court described it that as this quote  also makes it clear that language now couldn't be clearer that modifier applies to both types of patents but that of course doesn't mean that we shouldn't that the district court wasn't correct in her understanding of the context and the general purpose of the of this statute and looking as judge livingston did at the phrase any patent which claims the drug for which the applicants a bit of the application so we have the addition of the new drug drug application and the patent language and the overall purpose which i understand it was to allow a limited time of exclusivity and then a period in which generics are in title to come in and to compete and that being the overall purpose it seems to me that provides another reason for adopting the patent understanding of the word claims the differentiate that from a drug product or for the combination of the active ingredient with the nd active ingredient biquad i do whatever whoever you pronounce it so if i'm looking to the text as well as the context to suggest that the narrower understanding which maybe the district court got to in a way that no party's willing to defend now and that was in the industry understanding nonetheless the narrower understanding is the correct and i am i wrong in some aspect of that understanding so your honor i agree with you to a point but i know but but there are areas where i wouldn't elaborate so st of all i there's no disagreement that the when there's a reference to the drug pants expired b it's only used in the cut the intention is the synergy between actos and another substance and the purpose for carve outs is to ensure that they don't do those those method of the uses that they're only going to replicate actos so i don't understand how misrepresenting the this is the plainest theory how current i say i'm not going to do anything that involves interaction with these other two patents i'm not going to do that that's what the carve outs for all i'm going to do is as a generic for pirate lives that's what the citizen tradition was all about asking for that and the response was now the these two patents imply the the the the patent the intellectual property but  statute part of that interpretation and i heard it i would love to give you what i think is the proper articulation standard here but what if the inclusion was there because those happens included claims which include because they could be infringed a claim for infringement put reasonably be asserted as just held they were required permitted but required to be listed in the orange book now there's two decisions that have to i understand that i don't disagree with you about that i think that's fair but the question is how you characterize how you describe them right in that that's where the regulations say if it's a drug product pat you have to identify it as a drug problem and these are these have said no the decatur had stated a claim and that's exactly those are the kinds of claims that i would submit were intended to be smoked out and addressed before generic watch that's the purpose of  know i'm well over two hundred dollars but i think it's important to articulate the standard that i think limiting principle supported understand not all patents that would be infringed under the modifier are required to be listed congress made a choice congress struck the balance by saying only certain types of drug substance drug product method of use patents have to requalify but importantly not all drug products it could be in the french are required to be listed either to get this gives meaning to the term claims only those drug patents that claim the n b a drug as here where pietist is a critical component of the combination product and specifically referenced in claim one of each of those two pens that in our view claims the drug for purposes of the statute when read in tandem with the infringement modifier now contrast your honour's if you would the pattern at issue in the lantus decision the st circuit came out differently and lance what they had mechanism that was used in a disposable injector pendant mice it was not drug specific at all it was sold for injecting multiple different drugs so i mean i think that's the bright line if you're looking for a bright line i don't know that you need to describe the other that a claim of infringement could reasonably be asserted that's that that's from the kids interpretation it's required to be listed and there's consequences if it fails to that's right i mean we're dealing with an antitrust claim seeking to impose should we give the specialized meaning to that phrase is it your position that the specialized meaning would require those two patents to be listed because they claim the they are patents which claim the drug oh i think i know you're all right if the players position is that only only patterns that literally claim on every element of the drug would qualify and as well as we arguing that's it that is an overly requirement in the st place there also your honor the players are inconsistent is a fatal inconsistency more argument is if you apply that very narrow definition of claims and method of used patterns then those methods used patterns should have been listed  d if if you look at the way they describe what the method of use claims to know this is the direct purchasers brief and seventeen they say the patents also claim methods of using the respective combinations in the treatment of descriptions to the f d a in connection with the citizen's petition in two thousand and ten and judge wesley you've essentially hit the nail on the head here what to kate it was up to with the complaint alleges tecate it was up to getting an additional round of thirty much stace d keeping generics from carving out exactly that this is exactly what congress wanted to have happened was when the composition patent the patent that really did claim the drug expired then brand manufacturers could not then use what we call secondary patency as method of use patents to nevertheless continue the drug patent monopoly beyond the expires generics will be able to carve out the methods of use and they'll they'll flood into the market because the generics will ask for a label that says use this in model therapy and carve out the methods of use this a and also use it together with an insulin secretion enhancer or a bike when i or what have you that could happen and to prevent that happening to kate it took thousand and ten when specifically called on it they reiterated it by saying no their drug their drug product patents the claim the claim actos and therefore they get all the goodies again thirty m statute does say and i gather no one is defending the district court's reading but the statute does say any patent claims the drug for which the applicants made the application as to which a claim of patent infringement could reasonably be asserted understated is that your your adversary is saying listen the combination used both as a method of use as well as a drug product is a use as to which identify for the benefit of the generics all possible bases for infringement claims so it was what's the flaw in their approach if i'm getting it right with respect your honor you did not get it right you to scription of what the statute says he lighted the the key word or one of the key words the word and opposing counsel continues to refer to the requirement that the patent support a reasonable claim  infringement as modifying the st requirement which is that the drug that the patent claim the drug it doesn't modify the statute says it has to do two separate things this whole mess in two thousand and three and their connection with it they say it's been our longstanding interpretation that this is two separate requirements if they were here they they would say the  when we say that she is tall and she's intelligent intelligent doesn't modify tall tall doesn't modify intelligent she's two different thinks and that's the point that the court made in the federal circuit they said claim and infringement are two separate things and opposing counsel said that d gave an example in which congress they said if congress wanted infringement on to claim they could have written the statute in particular way and counsel said that the example used the term infringement in the hypothetical statute that congress could have used that's not what they did they didn't just use the term they defined the other the hypothetical statute that congress could have written but did not in the hearst court case defined claim by reference to infringement they essentially gave the language that the court with with with respect to which a reasonable claim of infringement could be brought that's not what congress did they didn't smushing together they said there are two separate requirements and the harsh court says going back to claim and infringement are two separate things and here we are n'est in with a statute talked about using a term of art this is a statute we're congress is dealing with what patents need to be listed client congress uses a patent term of art so it's absolutely clear as a bell that that gets that the interpretation gets that the congress is presume modifying and even said that the playing us admit that the nd clause modifies the st with respect to method of use claims that's not so we absolutely do not admit that it modifies they are two separate requirements that's why the end is in there and the f d a says these are two separate required requirements and that that's been our longstanding and to our petition also want to respond to councils in vocation of judge coats decision and the sandoz case and and he says in a very loyal like way that she denied a motion to dismiss the claims there because there could be an in a claim a claim of induced infringement that's exactly what she held up with one modifier there she held that there could be a claim of induced infringement with respect to the method of use claims needed to give clarity to give clarity to the industry there are one hundred and forty five approved drug combinations by the f d a out there today one hundred and forty five combination drug products and we basically challenge them in our brief we said cite one other person cite give us an example of one of their manufacture that's done what your guy d where they listed a drug combination patent as claiming the individual ingredients nothing and footnote thirteen of their brief they refer to a gilliard product called gen void gen voyage is a combination product that actually has four active ingredients so of course that manufacturer listed a drug combination product in connection with that product it's a drug combination product and so i think that it's a had it if i had to hit the highlights it's the ones that the court itself has already hit number one which you would trust with your district court concluded and correct me if i'm misremembering this that that the plain meaning of claims cannot of your special specialized pat should properly be listed as method of abuse claims and that undercuts your argument right they should they were properly listed as method of use claims for  were not properly listed as drug product claims for actos and here's where the district court went wrong and followed me on this she noted what you had just noted your honor that we admit that these  patents were properly listed as method of use claims for act and she read then reason backwards well if you're saying that claims with respect to a drug product combination patent does not claim the individual ingredients what do you do about the fact that doesn't the same reasoning then imply that the should not have been listed with respect to act unfortunately this wasn't briefed or argued and from the district court no one took this position but here's the answer when you're looking at whether  a a what a product claims whether whether at a patent process properly claims something but respect to this drug if you're looking at the product then you look at the product itself with the ingredients in the product a combination product if you're looking to methods of use you don't do that by looking at the physical product you look at what we in the industry call the label that's that package insert that comes with every prescription that you get because the f d a approved not only the product it also approved the label and when you look at the label with respect to act six this is the brand manufacturer of course is going to want the broadest possible coverage for the in woods called indications uses for the following in the following way the label says you can use actos as model therapy by itself or you can use it together with an insulin secretion enhancer a bike when i all these other things the label does that ok and so and it also says you can use it alone which is where the carve out comes in the just as judge westley points out these generic manufacturers really come in and just say here's a label that says use act page thirteen of the label it's also made its way into the record on appeal in the st appeal and this court at joint appendix ninety and so you'll you'll look at it and you'll see exactly you know what i meant so that claims means exactly the same thing at the fines as the invention the label says use actos alone or you can use it together with these in i want to address the purpose of the listing statute and then how it is it gets treated so there are two overall goals to section three to five the want the st is to decide which patents need to be known by the industry about a drug that has been approved and then the nd question is which drug claims are so the question is it's a matter of congressional intent and language what the real issue here is which patents does congress want to allow a and again holder to have an automatic and in that in that area what congress also was instantly clear about is that only drug product claims only when they and they hadn't claims the drug product do we different in kind and therefore are outside of the because congress wanted unpatented to usis to be able to go forward right at the end so or even a period right and so that is the big distinction i think we need to understand so then if we turn to the statutory language the question as and the congress even sets this up they say well there are claims per patent many of the claims of drug product over it my claim my method of use and when you're making your list and you're going to have to make which of those things are clear now let's turn the page to what these patents are we reproduced in the appendix before and the four of for each have two kinds of claims each has two independent claims one independent claim with respect to come binding act with another anti diabetes agent and another independent claim regarding how you can't use actos with respect to in combination and our position as infinitely clear from congress is that when you take a look at the actos and yet for these two patents what do you allow what are you allowed to describe to the f d a about what those patents are well each of those patents do not claim the product act ups they claim a combination product and if anything is clear patent law it combination play there would have been carve outs and you would have seen products on the market a couple of years earlier now just a couple of other brief points that is to what's been said here to that mr reed ably but i think incorrectly argues that the appropriate interpretation of claims under three hundred and fifty five dollars be wined should not be the word claims but mentions if the ingredient is mentioned in the claim he says it's quite well two things about that st not only does that not pass the specialized patent meaning it doesn't has any meaning of the word claims claims meaning is that you're taking a you're late and you're late i think ownership to something you're it when the when you're using obviously in the sense of the end of the verb right well that mentioning something doesn't mean you're you're laying ownership over anything and the nd thing in the most more important thing is if you were to adopt mr reed's interpretation then if a claim in a patent simply mentions and ingredient then you have so that the judge current situation isn't exactly is a perfect example of the dynamic where this is where the case they have to go to court in order to get it and junction it could not yet an automatic stay or should not be allowed to get an alone but the its relationship to the other the other ingredients for the other alternate uses that are listed in the other patents yes your honor and you'll see that in two very specific places if you look at what you're getting at the decision judged describes agents and then later in the decision she repeatedly calls those two patents what she called the combination i think use patents so judge coat completely got what this was about this is a method  honor i think i mean address some of these points in reverse order so st of all i've encouraged the court to d review judge comes decision because i simply disagree with the way that it's been described and in fact mr so was reference to the writing by by the patent holder the patent office decides what inventions are properly claimed within the patent and the fact is that these patents in pain both types of claims and so and judge coach decision did not let me ask you a question i have or i have a drug drug x and i pad did and then the patent expires and two years after the patent expires i find a new way to use drug x with a and with compounds   which is creative but but has long after my intellectual property interest in it has expired i to renew it i can raise it like lazarus from the dad i can i give a new life what not exactly  so ok we're talking about two different patterns a pattern that you had that expired you can't use again right you know so if so it's so anyone can use it but but when i that's why i asked you specifically when i decided to use it with a and b does someone infringing on that relationship between acts and i am be bringing within it the the the intellectual property i previously patent and the question will be whether there is a reasonable claim of infringement of that the former patent that's not our position you're either the question is whether a claim of infringement of the new patent that has not expired could be a separate and that and that fits neatly within with this construct and again i go back to you know the description of my adversaries talking about i think you're conflating a couple things they conceded that these patents needed to be listed they were required to be listed but then when mr so well talks about he talks about how they were allowed to be described it's not how they're allowed to be described we're not allowed to carve out our planes from our own patterns were required under the regulation and i think purge the court to to examine this regulation is twenty one c f r three hundred and fourteen point five three see which was in force the same regular regulation was the same do they do they raise the the the legitimacy and or force ability of the expired actos at the ok think you know the point is that once you once you reach the conclusion that these patents had to be listed which now plaintiffs i can see that see that you need to look at the regulations to see how they're required to be described and the regulations i think are on him by us as well and there's really no legitimate debate you will see in those patents that there are both products product patents which include and by the way about mr so will talk about his dinner for me was just met by mentions but no where that's not the standard is an essential act of farmstead going to read it in the combination pen so that's that's not a low standard and if you've got that product that substance which is an essential ingredient in a drug product claim in the pa t and it reasonable claim of infringement could be asserted to cater absolutely reasonably concluded that it was required by law to list the other point this is in our briefs and i know we didn't get to it but there's the separate if his argument in this appeal of demonstrate anything it's that people will have different views about how to interpret this language ok to feel strongly that d interpret it correctly but it shouldn't be held  jersey decision that it addressed that issue or concluded that again looking at a different aspect of the listing provision that there were reasonable interpretive alternative interpretations the defendant there acted consistent with one of those reasonable