on this case presents it's under rule two seventy one as to whether on the safe harbor applies to the activities that are accused of infringement and that's and sixteen fifty one for example so this is the clinical study who are correct and the clinical study was done by what what what is a maybe i don't know that question clearly you know what is your infringement by a dozen doctors is not being accused of infringement the clinical study itself would fall into the safe harbor the clinical study is the activity that creates the database if you was involved in the and the a and it was filed with the f d a we don't disagree with that but the clinical study in conducting the clinical study is not accused of infringement this was done again by a dozen doctors  there was a pharmaceutical product life style strategy meeting held for dr class and presented a paper which included a reference to the patent dispute in the back and he says if a fifteen zero five where he talked what is the patented process which has nothing to do with a clinical study which you have already been completed prior to in october completed prior to the november meeting that was attended by the venture actually filing the patent application is one of the steps of the claimed invention so actually filing the patent application and getting the patent is an active infringement of mr dr classes investing is a commercial transaction ok you're taking your money and you're investing it in something you're commercializing that money when you buy inventory that's a commercial transaction when you sell inventory you make profit but profit and loss are both parts of commercialization no company exists without expenditures and then returns that's all part of the commercialisation process and i would disagree paying your patent attorney is a step of commercializing whatever your invention is it's not a profitable step to cost you money in this case was a very then you have that is still it's still part of the commercialization it was just a bad idea just to buy inventory but you later have to sell off the low cost it's still part of your process is still part of your commercial enterprise commercialization doesn't mean successful commercialization now that with the first step is accessing the data source not creating the data source once again the data source is created and already reported to the f d a before the a fringy activity began so you're telling this is what we call a second look right you're saying the f d a stuff is already done but then when you access it afterwards it's very another purpose and so all of that is infring adverse event so if you've already done it before and we're now on the second round how can you have a new adverse event is that different than the other adverse event you encountered when you get ready for the f d a submission correct this is new as  infringement does your infringement theory also include sales and things that happen subsequent to the patent is just if you're talking about the damage theory yes yes because we have a product by process for kids claim which says every time you sell this newly patented whatever it is what it where whatever term you still is moving patented or intellectual property protected commercial product you are now that's an act of infringement of in that is being sold which is commercializing it absolutely not it's absolute not always exempt once exempt and that is not something we're arguing it's fundamental to the law it's the second look at issue if i do my clinical studies and i get my drug approval and i have my f d a approved drug my pharmaceutical our manufacturing facility has to look back at that information to make sure they make the drug that is now subject to infringement on the and the like they have to make it the same way it was made for the clinical study so one doesn't forget everything in the clinical study one manufactures a pharmaceutical so it's fundamental in pharmaceutical law that that activity is exempt while it's being used and done the activity is exempt and the activity never becomes an exempt that clinical study always remains exempt but if you then manufacture a pharmaceutical it infringes somebody else's patent you  be using some of the information from your clinical study otherwise you're not complying with the f d a me ask you this kind of test if if we were to agree that the district court extended the safe harbor protections from that should've gone applies to that existing pharmaceutical because of the discovery of something new about that for the sibyl so i'm not saying clinical studies existed before based upon a clinical study that there are you just it's already been reported by the f d a and we're not we're not going back out saying that study itself at anything to do with friends that's still protected but as a farmer not removing that protection that protection last but again the information from pharmaceutical protected pharma school studies are used every day in the manufacture of non protected drugs they're being used here in the manufacture of intellectual property so it's the information that's taking a second look at and reusing in the manufacture of intellectual property the and so that's great and then people individuals who are not participants in the study filed the intellectual property because they identified protection that was available based upon taking it's not alice if you look at our score as a different way of looking at novelty versus looking at our score as a different way of looking at section want to one patentability the i'm not trying to ignore that those are two very different questions on that certainly survives one hundred one this is kind of the subject matter doesn't survive alice corpse from reinterpretation of whether novelty exists or not yes it doesn't alice didn't say nothing's nothing is an obligation on her of a and m this well the pattern here is essentially running a clinical trial looking at the data from the clinical trial and then discovering new information that could give the commercial value to looking at the data and doing something to commercialize that doesn't sound to you like the kind of steps of a patent that sounds good but might have a problem with i mean first grader the the first step you said is not actually a step running a the method of creating and using data so sure you mean the creative part yes but it i assume you're not reading data that you're not creating the data that's in the clinical trial you're there was nothing after a thorough reads emanation there was nothing in the prior art that included the last of the potential commercial value does it bring the potential commercial value of second life stuff and the commercializing the newly identif product information based upon the analyzed data maybe just wasn't in the prior knowledge requires that not that it sounds familiar to you but that it actually be found in the prior art we have to remember the patents were filed i believe in two your original patent on your blockbuster drug expired and you would on the next blockbuster drug ever greening was of the concept when these patents were filed so if you take alice go back to when these compounds are filed it sounded completely unknown to everyone the pharmaceutical industry again members by two thousand one doctor classroom who was never been employed by a large pharmaceutical company was the invited the final speaker at this conference attended by every pharmacy will probably include the line it was a eighty one did exist it was cancelled that claim thirty three had the last step commercializing the newly identified product information based upon the analyzed data that was cancelled the p t o required classes to limit the commercialising step to what was being claimed thirty six at that time claim thirty six reads commercializing comprises formatting the data relating to at least one associated with exposure to or use of the product or documenting the same such of the manufacturer distributor of the product must inform consumers users or individuals responsible for the use or physicians or prescribers about at least one new adverse event associated with exposure to the use of the product so the commercialising was limited to that particular type of the commercialising which reads on a product label that r commercializing step comprises protecting the intellectual property interest in the newly identified product information the p t o cancelled that claim in fact the p t o cancelled all claims that dealt with protecting intellectual property right examiner did not find in the prior art informing the users of at least one new adverse event and that's some reasons for allowing one story a one four hundred four to the question about  choir's one to include with one's product in order to maintain approval for your product so that is ok so if we agree with you in the district court that i guess some of his argument about the second set he wants to say you did all of this for the f d a approval that's in the but then in the drawer and then you're going through all of this again for purposes of commercial sale once you've gone through the process before the f d a of identifying the purported adverse event and knew how you should use the product differently than you used in view of that adverse event it's no longer noons if you come back later and look at that exact same data and come to the exact income pollution you're not identifying a new adverse event that identification of the new adverse event occurred during the original clinical trial study and on that point i think it's important to also look at the study report that class and identified at a one five four zero which was provided to the f d a on that page of the report said of a one five four zero it lists i documents the people who analyzed the clinical study that also i don't write the date they did that two of those people jamen shawn michaels case that are on that page were the identified inventors on the leader so i wanted to clear up it was the same people who did that and there are some to the panic claims because i don't want to mislead the court there are too deep in the claims that survived the reexamination one cla personalization step which i noted was limited to informing the public of your adverse event it said further comprises documenting inventor show and then there's another claim from that one that covers the documenting who analyzed the study and when they did it so therefore falls under the safe harbor one other factual issue i would like to point out class in identifies the november to manufacture that you actually manufacture the process used to make the product need to be a manufacturing process not of us as a country that too but adding a label wouldn't  but that was as i was sure you understand his argument claim thirty six first of the labeling issue including one thirty one which depends frequently thirty six incorporates to documenting inventor show so that that's believe that the one's talking about documenting a better ship or the one is a better intellectual property related they don't say that obtaining intellectual property rights a man talking about and that  only to the extent that the commercialising stuck if you will give a patent includes getting intellectual property as a commercializing step so the to the stick except that it's in the definition in the past so the only other point i want to make in her bottom was the issue of once exempt always except once exempt always them to cannot be the rules and it simply is not the whole once again the chemicals and their constituent percentages is information that was submitted the f d a if you use that information is no longer protected you can now go make a pharmaceutical using the exact thing formula from your study doing your study you're protected using that formula that formula loses protection when you go commercial otherwise the real no such thing as a pharmaceutical patent that's the basic pharmaceutical patents are what's the formulation that formulation is protected when you're doing the study and generating the information once you figure out what that formulation is if you then go and sell it you're infringing the brand names capital so it's not once protected always protected the activity once protected is always protected me is done the information from activity is once protected and then never again protected you can argue that that's the same thing with the labels yes the activity that generated that label is protected because we well except that the labeling is the element of claim thirty six and so it is part of the care the final product that's out there just as each of the ingredients is part of that product and if we had a formulation patent no one would argue that using the same ingredients is a clinical study is still protected it's not using the same label generated very clear to say is now no longer protected the argument that calling the f d a requires us to put a label on there so therefore it's still protected the f d a requires you to put certain chemicals in that pharmaceutical and that's not protected just because the f d a requires you to do it will you sell it doesn't  if the f d a in requires you in the limited case for the f d a requires you to continue to practice a method to continue to certify and verify that your pharmaceutical  simply another piece of our formula back which is the if the pharmaceutical in the jar in the label on the outside the jar the two parts of the product the kid and those two parts are required by the f d a but that doesn't make their mean they're protected by