if you can find a place to put it where we can see what you're showing us or you may have to move that back at last if you're going to point to anything below halfway i think it's  i think your friends really need some coffee passion suit don't teach how to do a clinical study they don't talk about clinical studies they don't relate to doing a clinical study so there really is nothing in these patents to be excluded back to seventy one  it says accessing at least one adverse event data source that stores adverse event that it doesn't say generate adverse event data generate an adverse event data base that's what's done and submitted to the f d a so this is not a patent about doing something to submit something to some organization this is a patent about after that activities occur try to see if i understand your argument is it that to the extent that's a lower court or they may have argued to the lower court may have been under the belief that the analyzing step was performed before the patent issued you're saying that's not true it's performed the minute you look at the database and that could be done even today is that your argument you're going to the one fifty four to seventy one are i was going to claim one of the six three nine patents in the ad allies in step and in particular i thought maybe where you were going with this and that might be jumping ahead and i might do will face the thought where you're going with this was to say to the extent that anybody saying that all these steps were before or some of them perform before the patent issue is a com certainly can decide this case based on those other issues which were before the district were not designed i think you should not assume that you can ignore them that's whether addressed in the brief i do not assume that but my understanding is that that would require the other side to cross appeal those issues you know ok them then they are they are addressed this dish you are making does not go to the other two issues it's only two seventy one issues we can all understand what these claims are actually about and that's the basic confusion and any sort of pharmaceutical you have clinical activity and that's protecting that's on the left hand side of the shark that's where you do the clinical studies after that activity is no longer protective if it's the same activity that led to that it was engaged in the clinical studies and that was submitted to the f d a it's the same information we're talking about same information which is not protected is not the same activity so you're saying that this embers event information you can submit to the f d a and it's protected but then when the f d a requires that you put that information on the label it's not protected groups because it's also not the step of labeling ok as we confuse to be seeking labeling it's not it's simply identification of information as required to be labeled does not speak english again it's not under two seventy one we the act of submitting a label to the f d a for approval might call under the safe harbor but the completely separate and unrelated act of slapping a label on a product and selling it is not anything done related to submission before the federal correct or to correct what happens if you don't put the information on the label is that the f d a then you have the authority to revoke the approval of the and certainly that's the same thing you have must look at a different patent we all agree has not to do two seventy one on a patent on the compound itself or a patent on the method of treatment the compound is derived from clinical but that was necessary to maintain the approval was information and the use of which generation of which was protected by two seventy one so why isn't this the same thing here that the information that you originally submitted to the f d a about adverse events has to be put on the label to continue here or if the approval and so it to momenta they had to do the test again it wasn't the information from the test of had it it was the act of the test physically mixing the chemicals and doing the test in a mentor they did it once for approval they did it again and they did that test again no one's redoing the test every time you stick a label they're just sticking a label sticking a label it's not it's not the the activity ok it's not it's not an activity that generates any information the f a a says you think it's required to maintain your approval but it's not information is correct but it's not active x brah sticking a label on a package is information is required because it's an activity required to maintain proof but it doesn't generate any information that you would send to the f d a does it it's just the information it's not generating any information in momenta they were read generating information with every match so on your  which is in french when the labels on the on the package the class and patents are infringed when you go through the steps right so which step so tell me again i know you've got this long claim trial it's not just covered right if it's just c he says i didn't know this before well the actually the observer in the clinical trial is the named inventor the company would look and say there's a new one they would take the clinical observer and make them the inventor because they're the ones that found this and that's just that's what happened with the solomon that they found this new adverse event and they named two people i believe at defendant as the inventors guy and they people putting things on the label which the f d a requires you know it's a patent on identifying which of those things are novel and entitle to patentability it's not just anything that goes on this is the argument in there in the three really covers things that are put on the label as required by the f d a correct if you identify an adverse event that's not required to be on the label let's assume the adverse event is how could that be pa on and again that's not what we're here for that there was three previous patents and there's there's six or seven patents in this family the first three patents went through a secure reexamination two of them survived and one of them did not these are two subsequent patents in that people don't take this within three hours of food that is akin to a method of treatment ok just as i said take it three times a day instead of twice a day that's a different method of treatment you're entitled to a pap by say take want to be outside of the area and i think with mentors in the area if you stand outside that area then what in the what in the pharmacy what is it that a pharmaceutical company can do that is not likely to result in information they have to tell the f d a about i were running out of time i just want to ask you one of the question do you agree that with respect to the alleged infringement here some of the steps took place before the issuance of the patent and that you're using one fifty four to say that there's nonetheless infringement as a result of that yes the step of applying for the patent obviously in some of the claims a step for applying for the patent obviously occurred prior to the issu if you see a publication you go ahead and crank up your factory do the first five steps wait to look at issues and now you can do anything you want to with the other stuff and french the patent will wouldn't make sense and that's the statute doesn't say you can and does not so you can't  claims are the same or different as found in a four ninety three which is the declaration of our expert and i in the context of a summary judgment you have to assume there are facts are correct there isn't even any refuting declaration from anybody that says the claims are different so that if you really can't be presume the allegations in the right to be true and reviewed the alleged infringing conduct against the safe harbor to see whether it fell within the scope of the safe harbor on that basis the district court properly he the complaint failed to state a claim the district court's decision was correct because the infringement allegations in this case go to conduct that lies at the very heart of the safe harbor in particular the complaint accuses maxon of engaging in infringing conduct including conducting a drug interaction study on silent or discovering that efficacy of silane or could be affected by the timing of consumption of food identifying the food effect as an adverse event that had to be reported in a package insert for silent or indeed there appears to be no dispute that just sort of activity the conduct of clinical trials and the identification of adverse events for the f d a clearly falls within the safe harbor it is what pharmaceutical companies must do in order to obtain now i think if you have the type of claim where you know you could be performing the claim for purposes within two seventy one one or you could be performing for commercial reasons there's there's go be some instances where you're outside the safe of the scope of the safe harbor in some instances where you're in so in your hypothetical you would be outside the scope if you're producing the product even though in order to later sell the product the a would require you to use that same formula those separate sales the separate creation and sale of those other drugs the individual pills the separate ones are not under two seventy one right even though ultimately pursuant to federal law you have to sit still with that formula yes that would be the more traditional case and i think the reason this case is different is the accused conduct here and the patent claims that issue are not to a method of making a pharmaceutical product or method of using pharmaceutical products there to a method of collapsing in from analyzing information submitting it to the f d a identifying adverse events but when you commit separate acts of slapping the label on a drug and selling it totally unrelated f d a approval but required by the f d a just like the formula is required to be used with those separate acts that have nothing to do with seeking f d a approval getting f d a approval maintaining you know meeting submission and development with those separate x m l two hundred seventy one a safe harbor protected activity i'm understanding the question correctly and i don't think it's this case because i don't think that's what the claims cover yeah i don't know what that that what i described i wouldn't fall into the same or not contending at least for this case we are goes to the creation of the label so what but the one of the poems i'm having is how can it be that two seventy one however has the application for this i think it's covered because of the inventions at issue here and what the use of the patented invention is so the claims are not just you did things you you identified adverse information and then you re used it to file a patent application that is not what these claims say the claims say access an adverse event is their own method claims both patents three independent claims act as an adverse event data source analyze the adverse event data to identify an essential adverse event regulated by a regulatory agency create an adverse event database and then the last step is commercialization so that the pret that the method includes as part of it regulatory activity and that means that the use well i think is that the safe the same partner statute refers to use of the patented invention and even plaintiff can appear to concede when you're looking at the patented invention you need to take into account all the steps of the patented invention the patented invention here isn't just applying for a patent the patented invention includes a number of steps and all of that with the accused as the identified as being infringing word patented invention doesn't necessarily require all the steps of a process to be performed in order for that to qualify as the patented invention yes and that's exactly our point actually that it's really good i thought that went against you know it really doesn't because if you look at the claims and you accuse kind act the to perform all the steps here the steps include regulatory activity so it necessarily relates to regulatory activity so if you have exact language but really this is reasonably related to the development and submission of information under federal law yet and here the claims actually refer to the collection of adverse event information to be is required to be submitted to f d a that is rate within the claim it's a post i wrote a claim that says collection of adverse information data which no doubt everybody would agree that element is related to submissions yet and then the rest of my come claim is about using that adverse information data to do something completely different right using the adverse information data to create a book whereby all information on all adverse events will be centralized for all products or some make the claim i guess the point is supposed to claim it makes a huge departure one element of it one step is something that could arguably say be said to fall within the safe harbor but nobody could argue that not even the heart of the invention is related to safe harbor protected activity and certainly almost none of the elements are is somebody then nonetheless protected into the safe harbor when they perform all of those steps and otherwise infringe a claim that's written like that i realize mcclave and i don't think we'd go so far i think our argument is related to these particular claims that are not kind of primarily focused on other activity and not primarily focused on collection and analysis of that word vented it to be submitted to f d a here if you look at the six three nine tatt it includes four st having trouble with the majority or percentage of steps the mcclane would amount to performing a patented invention which falls in the safe harbor well we think it's all related because the focus of the claim is collection and analysis of adverse event data required it's all related but to be if he were correct that filing a patent application was what set aside one of the elements that act is not to protect under the safe harbor so you would have one step no but the performance of the entire method yes i mean she could have drafted claims that didn't cover regulatory activity but here to your point the accusation goes against all the steps of the claim said and so all of the acts that we did including conducting food clinical studies collecting that data submitting it to the f d a difficulties i feel like basing your argument we're back to where i started which is your argument seems to be if any staff of domestic standing alone if it stood alone would have been protected under two seventy one e then a claim no matter how many other steps it has automatically justified just really not  because that's not this case we're not taking it that far but since case the essential element of the claim that got added in and that goes to our initial element that's like heart of the invention just for the invention i mean that's all been rejected every here we don't think the commercialization is just to filing a patent or the commercialization activity includes labeling and activity that's essential to regulated activity so in front of you before we run out of entered case precludes infringement under section two seventy one because it is if you look at the allegations and in the complaint the the studies that were conducted and the performance of the method steps did incur before the class and class and patents issued including the filing of attack applications and so all the steps were not performed before the patent issued  monsanto says infringement of a multi step method clean cannot live by the performance of the single step after the issuance of the patent when the issuance initial steps were performed prior to issu brief that were with regards to zero six nine patents all of the claims that were in the published application were cancelled in november two thousand and six so the predecessor to claim one of the zero six nine pat an even added until four years after the public the patent application published and that even that clean was substantially amended during prosecution examiner rejected those claims over the prior art and the language regulated by a regulatory agency requiring disclosure of the event in a package insert was added in february two thousand and eleven that's almost nine years after the patent application published and with regard to the six three nine patent when it published in august two thousand and six did not have any method claims at all and those are the sole claims in that now issued patent in december two thousand  class in scandal all those claims and and and then added to the claims that are more related to the ones that issued and even those new claims didn't have the limitation regulated by regulatory no factual basis we know what the prosecution history right but the question is the original claims had essential adverse event the final claims had regulated by regulatory authority added to a guy in the  it says essential adverse event is one regulated by regulatory authorities they have a declaration from a doctor who is an expert who set those are equivalent terms it was simply to explain to the patent office what essential adverse event met by saying that's one regulated by regulatory agency was not a change yes there's a change but in order to get outside the scope you have to have an essential or important change it can't be a minor change the only evidence of that change is a minor change so one address that we've already context the other issue is even here today in some of these examples we talked about collection of adverse event information submission of adverse event information some of the questions that the judge moore s analyzing adverse event data it doesn't say creating generating submitting it doesn't say collecting adverse event those are clinical activities this patent talks about patenting activities and there is no submission in this patent to the a as was stated by opposing counsel the submission is to the p t o which is not an agency that regulates drugs or anything else so the activity of this patent although it is connected to clinical activity it isn't the clinical activity it's a post looking at the clinical activity clinical activity is done with the submission the collection this mission the f d a that happens then someone else in the p department analyzes the data looks for patentability amongst that data identifies and some of these claims identify the inventors and then take it and file a patent on it knowing that the f d a is already required this label we are now