efficacy disclosure from the prior patent so so what was new if there was some sort of practice that was needed by the clinician that was already disclosed in the prior art immediate release to a patent so i think that's kind of a red herring argument here they disclosed in the prior art anywhere from fifty to two thousand milligrams per day was an appropriate dosage and in the extended release patent they said that also was the dosage for a fifty kilogram person so i think that that issue needing a clinician to prescribe a drug everyone needs a clinician to prescribe a drug but you have to look at it in the context of the problem to be solved in the pa what really is different from the prior art in this patent and that really is two words a jelling agent that's it the problem was trying to solve dose dumping there's no dispute and aster briefing that we could find were they disagreed that the solution to dose dumping the prior failed to teach that because they can't it didn't teach the solution the tao reference taught it the seiko reference taught it to their own dr davies who testified in their infringement case but of course did not testify in the woody case for good reason he said that the nor was he asked about it he was not asked about it that's correct he he was not asked about that in the infringement portion of the trial that's correct his declaration was introduced into evidence and he said as of the date of the extended release patents that providing extended release was incredibly well you've wasted all of your time one on the other parts but why are you focusing on motivation to combine because that's what the district court said you lost you lost because the prior art was overwhelming in terms of providing reasons why you wouldn't a skilled artist and would not make this combination and he totally rejected dr park your expert as cursory unqualified lacking credibility and he but this your seaman mr montgomery mr c who were speaking very technically i have read all of these transcripts i mean dr park tried to tell of the jelling age it was effectively like jello i mean you know he wasn't talking to my children he was talking to a judge and trying to explain you know how to decide this case said and after november the caliber a c and semen came across infinitely more credible with regard to whether one of skill in the art would have done this in light of the state of the prior art which is what they were supposed to do about jello please ignore my hamburger french fry thing for nearly a year or so you know i think that the district court rejected the credibility of your expert and found there's eminently credible then there's all the body of prior art that taught a way which is what they were test experts say that sure they said it but if you look at the underlying art in the articles there is no teaching away there's no clear discouragement to make an extended release for example they say that you would have wanted to increase the dose of of some one hundred fifty milligrams  correct well fine increase it to two thousand milligrams per day that was in the two eighty lb there's nothing new there formulator would have looked at that and said ok fine i'll increase it to two thousand milligrams a day maybe i have to make to extend release tablets but that's a problem that could be solved by formulator so that's really not supported by the by the actual articles the dea to receptor theory dr seaman a few months before the critical day published a paper saying that it wasn't two there were other theories there was before theory there's a five beach t theory you've got to look underneath that the literature there were many theories that were out there the judge grabbed onto this key to theory but dr c minutes of contradicted  but we have to move on maybe we can continue and yes your honor that the fundamental problem with the clinician post is is this whole teaching away idea that came into the case only when the conditions were introduced in the problem is one of both wa and fact because this court's president makes clear to have a clear or a teaching away the prior art has to be grounded in the prior art has to discourage or discredit the solution in the claims the solution in the claims here is solving the problem of those dumping for a water soluble drug with single piece of contemporaneous evidence in one thousand nine hundred seven or before not from a skilled person not from an inventor not from asterix no one expressing this problem or any kind of skepticism or even a slight concern the typing would not benefit from extended release all except for the three experts who test and who are found to be incredible credible and have amazing resumes but despite their credibility determination drawn or the fact is for teaching we have to be grounded in the prior art not of that support to survive even clearly erroneous review the credibility terminate should still have to fall off actually possible story that's not contradicted by the evidence and we can go through the evidence that these experts were trying to testify about your honor on the effective dose that it should be so high you would want to extended release we can look in this record at the k c paper person goldstein or see all say that two hundred fifty seven hundred mics per day is effective now dr mcgovern wanted to say he didn't believe that but what he reaching say roughly a thirty seven percent effectiveness that sledgehammer against these due to receptors and it's only thirty seven percent effectiveness and you really need in order to help these these ill patients with  schizophrenia you need to be able to slam at those the two receptors at sixty to eighty percent in the first thirty minutes if you can't you're not going to be able to stop them from having you know a mental break of some sort and so quick typing seemed like from the literature not an ideal candidate for suspended release because everyone is killed they are new when you went the direction suspended release you had a slower ramp up period so you don't you know i'm going to start with thirty seven percent in the first thirty minutes you're going to have some lesser percent it's going to take you longer to build up and with these kind of patients who are right on the edge that the psychic break you need to be able to hit those receptors really quick stats how interesting points on that your honor first the literature from dr seaman himself in ninety seven and even ninety nine said that for other four percent of the d two receptors but you want it to be at sixty eighty percent which is why everybody said it wasn't an ideal drug for treating these kinds of illness dr seaman's paper says that at their reputed doses it was twenty to forty four percent occupancy now he said something the doses that you're giving patients this is all you're able to have work thirty to forty percent or whatever that means that it's therapeutic in working apple in twenty to forty four percent meaning of this whole theory that you need to sledgehammer go higher is not true you're eating in that's at a seventeen for seventy five it's at bottom is a simple case i said i submit the judge in a very detailed very comprehensive opinion made a number of findings of fact none of which i submit has been shown to be clear for the with respect to motivation in the words of of k s r there is no need or problem known in the art at the time with respect to the immediate release of a typing product that provided a reason to make a sustained release product not defendants alleged to reasons improve compliance and reduce side effects but the immediate release product was not even on the market at the time therefore no known compliance problem in fact the literature suggested there would not have been a compliance problem the literature suggested and taught that twice a day which was the recommended dose of the immediate release product from the clinical trials was just as good as once a day in terms of compliance and in fact again dr rice conceded that because his immediate release quick typing was substantially free from the most troublesome side effect of e p a s that it was less likely to have implants problems therefore there was no reason for a person of ordinary skill to think that a sustained release would work any better than immediate release with respect to compliance and with respect to side effects in which their argument was sustained release would have reduced possible side effects we asked dr park to defendant formulator one of the side effects of typing his answer quote i don't know i don't care no wonder the district court found reason testimony not to be credible no wonder the district court found they had proved by clear and convincing evidence that there was a motivation or reason to go to sustained from can always obvious every time and all the time i thought to myself we're talking about sleeping pills i believe prefer not to sleep for twenty four hours straight it would seem to lack you know credibility to say that every single drug making it into a suspended release would would in this particular case with the record we have in the district court it's not in fact if defendants were correct with respect to their general motivation arguments you couldn't get a patent on a sustained release product if they were all motivated to make  clearly not the case based on the evidence that's in this record with respect to teaching the way one might look at the u s versus adam's case a leading case on the issue that in that case the court referred to what we called long accepted factors as deterring investigation into what the claim combination was in that case here we have the long accepted factors of be clinical trial literature pointing toward the higher doses we have taken the consensus that dr seaman talked about the of you needed sixty to eighty percent d two receptor occupancy to achieve anti psychotic efficacy and reese talking about the treatment of acute is a friend ix we are going to sledgehammer high doses get control of the dangerous symptoms all three reasons are consistent they all point toward higher doses expression such as in the wetzel paper that you needed to go to a higher dose to to improve and get better efficacy similarly with respect to the dea to occupancy the se paper that defendants put so much weight on that as the one hundred ninety seven paper in fact is consistent with dr seaman's testimony at trial the paper at a three o seven nine refers to a quote general rule at therapeutic levels of neuroleptics which is these kinds of drugs occupy the d to receptor and at a three zero seven eight the clinical requirement that of seventy five percent due to receptor occupancy receptors so all of this tends to support his testimony pointing toward the higher doses meaning that because of the sustained releases the characteristics of a lower peak and a slower release you can't yet country indicated or would have been thought to be counterproductive even if it even if the person of ordinary skill were found to be just a formulator i submit that it's harmless or a formulator alone would not know whether there was a need for a sustained release product if you separate the should it be made from the could it be made the formulator doesn't know whether it should be made whether there was a medical need for putting aside the question of whether it could be made a reasonable likelihood of success and even there the district court found based largely on credibility determinations found that there was no reasonable likelihood of success why well the formulators of that who testified on behalf of the of the defendants ignored the many possible routes to sustain release they focus just on the one the a b and c root which happened to be the preferred root of that issue even dr park their expert said these other routes were quote commonly used at the time to make sustained release the literature talked about normally being a very difficult it's complex time consuming that's at eight ten seventy eight and a twelve sixty one doctor part of find that making a sustained release would have been easy but he used hindsight he started with the claims and work backwards to see where in the  no wonder the court found no reasonable likelihood of success thanks a few comments about secondary considerations which the court found to exist in this case and as supporting a conclusion of non obviousness with respect to commercial success there's no doubt about the success commercially of cervical x r which is the patented product itself over a billion dollars a year recently those kinds of drugs are called blockbusters the only issue is nex us that is that it really is additional here now the evidence indicated that the sales of the product were due to the patented invention that is the fact that it was sustained release sales increased after new indications of treating bipolar depression and major depressive disorder after those indications were obtained in two thousand and nine and ten there was testimony about a hockey stick the sales went up like a hockey stick because why physicians preferred the x our product over the immediate release product because for these depressed patients they were better able to tolerate the drug one percent one given propre only the next day so these high functioning people who happened to suffer from you know bipolar disorder or major depressive disorder could function better the next day physicians like the patients liked and that's why the sales went up as to the difference as to the effect of the earlier two eighty eight prior patent patent and to cover the compound defendants are you that it was blocking you shouldn't consider commercial success or at best it was weak well if that were true the market for the x or product would have collapsed in march of two thousand and twelve when the exclusivity given by the first patent disappeared in fact what happened next our sales have gone up by a couple hundred million dollars clearly there's no relationship between the two as to unexpected results there's no doubt that quick type that circle x or has a unique combination of approval from the f b i it's the only drug in the world in the world to be approved for both treat proceeding with bipolar depression and major depressive disorder let me just say in conclusion and that the brief arguments about there's no invention here there's no difference over the prior compound patent it's pharmaceutical evergreen it's better it's a real invention here why do i say that i say that because this product has helped seriously ill patients they prefer it they take it they like it the physicians like it that's why they prescribe it that's why physicians prefer there is an invention here and it wasn't pre stage by or suggested by the prior art in fact  basically what's an unknown mechanism of action or a black box into a teaching way over to this whole sledgehammer idea dr kelly breezy admitted at trial that applies only to a cure or treatment resistant patients it doesn't apply to the majority of patients who need a put it into a saner we formulation the reason what fixation of success number four on these other routes of sustained release dr park didn't use hindsight it can't be hindsight when the priorities close the exact same problem in the past and in the exact same solution the experts looked at each p m c based those it forms because as the art pot the da manual say go one three eight application it's the cheapest and easiest sustained release method to use it's been around for decades  over the i r that's that's the simplicity in the objective reach of this claim your honor it has no release profile dr pruett home admitted at trial there is no release limitations at all in this claim other than more than immediate release there's no blood levels there's no in vitro release dissolution probably want to go would tell you as i understand it is you can bill you can use this jelly needed to build a shell around it and prevent it from eating out at all until it gets to a certain point in the body or until a certain amount of time weeks with the exact same type of h p and release but the question is who wanted to kill me or have been motivated to go to saco given what it teaches and use that principle to apply it to quick type even if we would submit yes but even if not say go the one that can't be hindsight when the art identifies the exact same problem in the exact same solution that's what dr park was saying was so simple and easy because we have here again it's not like cycle bends appreciate this is no release limitations