Legal Case Summary

The next and final case for argument is the pharmaceutical versus Watson lab now to the most patient group of all and that here for the entire procedure this morning whenever you're ready Mr. Green. Thank you for your riders and good morning. This old chain with the topic of what we're dealing with a combination oral campus office. By way of background and I think it's quite familiar with the background based on the sense of breathing with this to put the argument into perspective. There's a product called orthotrycycling that product was covered by a series of packages issued to Orville when that application filed in 1983. The patent ensued the 815 patent is a patent which is issued to cover the follow along product or the tricycling law

. The only difference between orthotrycycling and orthotrycycling law is the amount of estrogen cubes. In orthotrycycling, 35 micrograms of estrogen in orthotrycycling law. Can I search for a romantic patient argument? Absolutely. Because I understand you know we have some cases that clear value in others that suggest that a range of sufficient for anticipation but I'm having a lot a little problem here. We've got other cases like adephyno that's seen to suggest otherwise. In this case we're not if we were just talking about one range, this one range and that was it then I think I might agree that there were a finite number of ways you can go within that range

. But it seems to me the patent disclosure has numerous ranges. It has numerous variables. So we are talking into the thousands or millions of potential variations. So it seems to me not to be a good fit with the cases that have been willing to accommodate that. So I'd like to hear your response. And that's a very good question, Granger

. It goes right to the heart for the error occurred. And that is the view of that particular range. The case law from this court is absolutely clear. If you go back to the engraved case which sites really slippery and that case law says you don't stand back and look at it. Prior art disclosure, we're asking the question of anticipation from the standpoint of an individual walking down the sidewalk. It's supposed to be viewed from the position of a person of ordinary skill in art

. And that's the fact what's done in this case and that view was expressed by Dr. Barnhart. And not reviewed by others that the range in this case is a 20 to 50 microgram range of EE. And the district court went astray. It's finding of no anticipation because it simply ignored the testimony by Dr. Barnhart

. But it's not going to work. It was on that place. It said that range is a finite range. So you don't use that. There are numerous other variables within the claims, right? There are numerous variables within the claim which also means to be viewed from the standpoint of a person of ordinary skill in the art. And again, it's a combination error here

. The first one is what does that range mean? And the under-budded top of the money means 20 to 25, 30, 35, 40, 45, 50. Dr. Barnhart top of the fine is that that range meant that there is nothing in the record that contradicts that. Now the question is and I'd say we've got a lot of cases that are thrown around here but I would also direct the court back to the in-rate graves case. And it's citation to in-rate the grays because what does that say? This is a CPPA case, as far as I know it's not been overturned by this court. And it says a reference anticipate the claim

. If it discloses the claim to invention quote such that a skilled artisan could take its teaching and combination with his own knowledge of the particular art and be in possession of the invention. That's a clear instruction below that the entire reference is being viewed by the standpoint of a person or a person of ordinary skill in art and what do we have here? We have example four example four right to the five five four or six and the same examples. We have example four and not rebutted example four specifically covers or low tricycle. Claim nine in the O6 patent specifically covers or the tricycle. Or the tricycle was at the time one of it not the most successful combination or converse up as ever. A person of ordinary skill in the art is aware of that

. A person of ordinary skill in the art is going to read the O06 patent and recognize what example four and it claim nine. It's how a person a skill in the art know that it's 25 microleaders that's a desirable dosage in the in the O06 patent. The O06 patent is a range you're either and if that's a really big range it I would submit that based on the top one in this case it's really not that large. Yeah but the district core it is the drain up myself. It seems to be concerned that there was no express teaching in 25 there was no express teaching over reduction by ten or five hours. The reference itself did not say move in five microgram increments but the test that we was not rebutted that trial that the only approved oral contraceptives as of that time in the United States always move for varies by five microgram increments

. That was not rebutted. And the unrebutted testimony Dr. Barnhart was the same effect. It's not a wide range it's really 20 25 35 40. Before your time. I was just can do move to the obviousness it seems like the a lot of the concerns that the district court had revolved around the cycle control

. Yes and with regard to a reasonable expectation of success or you know others can you respond to why in your view that's not relevant or not dispositive or you said to the obvious there are certainly several answers that first reasonable expectation of success is the director George McLean. McLean says not being about cycle control. What the claim says is an oral contraceptive. It doesn't say anything about the cycle control benefits of that but let's look at the record as to whether there really was such a concern. What is your some level of concern that there might be a change if there's a reduction in the amount of oxygen. One can say that there's a possibility that there might be a reduction but there's also a possibility that there's not going to be a reduction because and this actually goes back to the heart of one of the key issues in this case dealing with obviously an expectation. The record had it only information about a low dose of 20 micrograms. There was never in the history of oral contraceptives as far as I know and certainly in the US a product would contain 25 micrograms. The testimony from again this was not rebutted including back or down one of the Oracle experts was that he didn't know what to expect and the inside testimony from ortho which is under retactic order we do pause it in the brief. Specifically addresses the question of the expectations of what would come from that the amount of cycle control that would occur and the expectation was they would have a successful oral contraceptive and that's really the only question that's involved. And what was the motivation here? The motivation because of the bad side of that. The the I'd say it was multifacted and a month of testimony came in through again Dr

. The record had it only information about a low dose of 20 micrograms. There was never in the history of oral contraceptives as far as I know and certainly in the US a product would contain 25 micrograms. The testimony from again this was not rebutted including back or down one of the Oracle experts was that he didn't know what to expect and the inside testimony from ortho which is under retactic order we do pause it in the brief. Specifically addresses the question of the expectations of what would come from that the amount of cycle control that would occur and the expectation was they would have a successful oral contraceptive and that's really the only question that's involved. And what was the motivation here? The motivation because of the bad side of that. The the I'd say it was multifacted and a month of testimony came in through again Dr. Barnard the FDA said you should prescribe look to the clinch it you should prescribe the lowest dose possible to the patients. The motivation to reduce was also a market motivation and we have this in our free to come to the perfect for as I can't for it directly where the market was clearly moving down the respect to the amount of estrogen and it isn't that motivation to decrease extra extra to at least coupled with some sort of motivation or concern with regard to cycle control. The motivation to move down is to a civil way with the the problem associated with the concern was that there was a problem with breakthrough bleeding that when you decrease the estrogen level that creates the other concerns right? There was a concern expressed based on the data that the table for in the past this 20 micrograms of there's no data. I'm here in Dr. Busquall says in his in his book that there if you go to the estrogen that your patient a tradeoff isn't that isn't that and what you've been arguing a teaching away? There is indeed the possibility that by moving to 25 there might have been a reduction in estrogen but there again was no evidence that such would actually occur and even if falling up in your question right even if it's a tradeoff it doesn't then motivate one not to make the product the motivation in fact was clearly there to make it even if there were some amount of reduction of cycle control as you lower the amount of estrogen. The fact is a few additional women might potentially have a reduced amount of cycle control doesn't mean you've been decide not to make a product where a vast majority of women are going to benefit by that lower amount and again the motivation is clear in the record the FDA said move down

. Barnard the FDA said you should prescribe look to the clinch it you should prescribe the lowest dose possible to the patients. The motivation to reduce was also a market motivation and we have this in our free to come to the perfect for as I can't for it directly where the market was clearly moving down the respect to the amount of estrogen and it isn't that motivation to decrease extra extra to at least coupled with some sort of motivation or concern with regard to cycle control. The motivation to move down is to a civil way with the the problem associated with the concern was that there was a problem with breakthrough bleeding that when you decrease the estrogen level that creates the other concerns right? There was a concern expressed based on the data that the table for in the past this 20 micrograms of there's no data. I'm here in Dr. Busquall says in his in his book that there if you go to the estrogen that your patient a tradeoff isn't that isn't that and what you've been arguing a teaching away? There is indeed the possibility that by moving to 25 there might have been a reduction in estrogen but there again was no evidence that such would actually occur and even if falling up in your question right even if it's a tradeoff it doesn't then motivate one not to make the product the motivation in fact was clearly there to make it even if there were some amount of reduction of cycle control as you lower the amount of estrogen. The fact is a few additional women might potentially have a reduced amount of cycle control doesn't mean you've been decide not to make a product where a vast majority of women are going to benefit by that lower amount and again the motivation is clear in the record the FDA said move down. The prior to talk that if you if you if you lowered this or you were going to cost further bleeding I mean how does that make commercial sense? The problem I think your honor is it's not a unitary concept it doesn't mean that if you reduce the oxygen and in fact it does cause additional bleeding it's going to affect all women. Well is it also the case that the OSTC pattern says the purpose which contains the wide range says the purpose is to lower total monthly steroid dose while still obtaining equivalent bleeding patterns and protection against prevent Satan so that suggests that you could lower the dose without increasing bleeding pattern. Well indeed your honor is I said there is no evidence at all if I go into 25 you're going to have an adverse effect on the bleeding pattern. The evidence is if you go down to 20 that clearly took place and there is there is no record testimony if a what would happen at 25 because there was no product that at 25 that also couples with the issue of where where is the unexpected results from the standpoint of how do you judge unexpected results and this court has found that unexpected results can only be viewed in terms of a difference from what was expected and there is nothing in the record that tells you what to expect if you were going to move to a 25 microgram belt is from 35 nothing was out that or that if you did that that there would be cycle control problems. There is no evidence at all if I'm moving to 25 there in fact will be there's a concept of a threshold effect you know that even today where that one is is to how much of reduction you can encounter and have an actual reduction and doctor barn ready to testify to that there's the discussion that's the threshold effect where is there any proof is a where that threshold actually is is was there some level of potential concern some concern what was the expectation that you were going to have once you reduce from 35 to 25 you can't find that in the record it doesn't exist it doesn't exist because there was no data and doctor Darni said specifically in his testimony when I asked it so what happens when you move from 20 to 25 he said well you know I don't know because there's no data on that and without proof of the expectation that's to be shown to be unexpected then when you move from 35 to 25 there cannot be a showing that unexpected results on the topic of unexpected results there are probably 10 different issues that we have with the unexpected results and let me just start with the fact that there was no original expectation the cross-study comparison data that is a study comparison between data was 10 years old in the more current data it was not ahead to comparison the FDA itself will not approve a product market approach from the standpoint of no difference with respect to breakthrough bleeding I'm us or the head to head showing there's a decision it was recently issued through a man that at the district court level that actually says well then how can there be a showing unexpected results in this case there's no showing that would allow the marketing of the product with that argument that there was no change in the in the cycle control the fact is you're into your rebuttal time there's a place I do want to at least conclude the point you're making you are certainly correct or under let me just conclude on that point from the standpoint of the actual data that is shown in table five even through the analysis done by or though there was a difference it wasn't the same three out of the first six cycles were shown to have worse cycle control thank you thank you then we have just some questions will restore two months of rebuttal time is keeping even if this happens that will add to it in time let me start by maybe about or any myself with it in that judge Chester sat for the sixth day very lengthy trial for a substantial amount of the judge has been actually reduced by chance and even though he had the burden approved by clear and his evidence but he had as it may he made factual findings that support his judgment of no anticipation and no obviously and as the score tells that is a view of only upon an overturnable owned by demonstration of clear error and I I spark here because I think this informs the rest of my comments because this court has said clear error means that what the district judge decided to quote K over his universe is implausible in life of the entire record or where it chooses one of two permissible views of the evidence that is acceptable so I will now deal with the evidence but I think what's important to do to set the stage is that there was ample evidence on every question your owners asked and every point we asserted the trial judge Chester made factual findings and the score although obviously this is ultimately questionable has said repeatedly that everything from what the prior art discloses to motivation to make the invention to reasonable expectation of success and unexpected results are factual fine well let's commit that let's turn and if you think that's okay the district court made the one finding that movement failed to demonstrate why a person skilled in the art would have looked to the O6 patent to create a lower dose of a way in my view that question is irreversible to the obvious this inquiry our case law doesn't require that a patent challenge or identify a particular reason to choose a particular piece of art this isn't completely entirely different field and in fact I think there is a clear reason what would have looked to the O6 patent so you want to you know I know there are numerous findings upon which you can rest but this is at least one where I had a bit of a problem and the question on the test is whether or not one would have started with the O6 patent yeah well they say put the burden that seems the district court put the burden that seems on movement to demonstrate why a person skilled in the art would have looked to the O6 patent at all I don't know that that's a fear you know I think I can address that that that I think what Judge Hussler was referring to is that's the that's what that's how looped chose to try the case looped looping chose to attack the obviousness of the patent by citing the O06 patent and indeed that was pretty much the central point of their case so they he looped and chose to focus the trial judge on the O06 patent and and pitch their entire argument to the proposition that the O06 rendered the 850 and patent that covers orthochysicum low either anticipated or obvices so I think they're on in fairness I think that's what Judge Hussler was indicating and indeed it might be interesting to note that from the starting point that this was a basically a do-over or I think was interesting that happened at the patent office is that the O06 was the patent focused on by the examiner indeed Janssen's patent lawyer when first receiving a rejection over the 554 the swallow patent that no Mr. Jander please we think Janssen thinks the O06 patent is the closest prior art went on to distinguish over it by showing unexpected results and obtain patent ability the essence of review of the entire record of looped case is that is that the patent office are strong and the O06 patent renders it anticipated or obvious and you're on and therefore I think it would be helpful if I just review what we think is a critical evidence that supports and judges findings on why there was no anticipation and also why there's no why this is not as long as you can make sure in that analysis that they include the question of unexpected results simply because you raised it here yes the reading of the patent is this is for a method and a contraceptive method and product and the unexpected result analysis seems to be focused primarily if not entirely on this breakthrough bleeding problem which is not something covered by the patent I mean there's contraception there's a you know it break through brief bleeding issue but it's not something that's claimed in your patent so why is that relevant or certainly why is that dispositive anything well ground on the answer that the multiple ways first of all the score to sell before that the inherent properties of a composition or even a method of using a particular product our part our part the parcel of the product even though every invention even though each and every element is claimed in the young in each case they considered toxicity and other aspects of the composition even though they weren't all made with the claim but in addition this is the one-five patent is an oral contraceptive patent and the claim construction etc

. The prior to talk that if you if you if you lowered this or you were going to cost further bleeding I mean how does that make commercial sense? The problem I think your honor is it's not a unitary concept it doesn't mean that if you reduce the oxygen and in fact it does cause additional bleeding it's going to affect all women. Well is it also the case that the OSTC pattern says the purpose which contains the wide range says the purpose is to lower total monthly steroid dose while still obtaining equivalent bleeding patterns and protection against prevent Satan so that suggests that you could lower the dose without increasing bleeding pattern. Well indeed your honor is I said there is no evidence at all if I go into 25 you're going to have an adverse effect on the bleeding pattern. The evidence is if you go down to 20 that clearly took place and there is there is no record testimony if a what would happen at 25 because there was no product that at 25 that also couples with the issue of where where is the unexpected results from the standpoint of how do you judge unexpected results and this court has found that unexpected results can only be viewed in terms of a difference from what was expected and there is nothing in the record that tells you what to expect if you were going to move to a 25 microgram belt is from 35 nothing was out that or that if you did that that there would be cycle control problems. There is no evidence at all if I'm moving to 25 there in fact will be there's a concept of a threshold effect you know that even today where that one is is to how much of reduction you can encounter and have an actual reduction and doctor barn ready to testify to that there's the discussion that's the threshold effect where is there any proof is a where that threshold actually is is was there some level of potential concern some concern what was the expectation that you were going to have once you reduce from 35 to 25 you can't find that in the record it doesn't exist it doesn't exist because there was no data and doctor Darni said specifically in his testimony when I asked it so what happens when you move from 20 to 25 he said well you know I don't know because there's no data on that and without proof of the expectation that's to be shown to be unexpected then when you move from 35 to 25 there cannot be a showing that unexpected results on the topic of unexpected results there are probably 10 different issues that we have with the unexpected results and let me just start with the fact that there was no original expectation the cross-study comparison data that is a study comparison between data was 10 years old in the more current data it was not ahead to comparison the FDA itself will not approve a product market approach from the standpoint of no difference with respect to breakthrough bleeding I'm us or the head to head showing there's a decision it was recently issued through a man that at the district court level that actually says well then how can there be a showing unexpected results in this case there's no showing that would allow the marketing of the product with that argument that there was no change in the in the cycle control the fact is you're into your rebuttal time there's a place I do want to at least conclude the point you're making you are certainly correct or under let me just conclude on that point from the standpoint of the actual data that is shown in table five even through the analysis done by or though there was a difference it wasn't the same three out of the first six cycles were shown to have worse cycle control thank you thank you then we have just some questions will restore two months of rebuttal time is keeping even if this happens that will add to it in time let me start by maybe about or any myself with it in that judge Chester sat for the sixth day very lengthy trial for a substantial amount of the judge has been actually reduced by chance and even though he had the burden approved by clear and his evidence but he had as it may he made factual findings that support his judgment of no anticipation and no obviously and as the score tells that is a view of only upon an overturnable owned by demonstration of clear error and I I spark here because I think this informs the rest of my comments because this court has said clear error means that what the district judge decided to quote K over his universe is implausible in life of the entire record or where it chooses one of two permissible views of the evidence that is acceptable so I will now deal with the evidence but I think what's important to do to set the stage is that there was ample evidence on every question your owners asked and every point we asserted the trial judge Chester made factual findings and the score although obviously this is ultimately questionable has said repeatedly that everything from what the prior art discloses to motivation to make the invention to reasonable expectation of success and unexpected results are factual fine well let's commit that let's turn and if you think that's okay the district court made the one finding that movement failed to demonstrate why a person skilled in the art would have looked to the O6 patent to create a lower dose of a way in my view that question is irreversible to the obvious this inquiry our case law doesn't require that a patent challenge or identify a particular reason to choose a particular piece of art this isn't completely entirely different field and in fact I think there is a clear reason what would have looked to the O6 patent so you want to you know I know there are numerous findings upon which you can rest but this is at least one where I had a bit of a problem and the question on the test is whether or not one would have started with the O6 patent yeah well they say put the burden that seems the district court put the burden that seems on movement to demonstrate why a person skilled in the art would have looked to the O6 patent at all I don't know that that's a fear you know I think I can address that that that I think what Judge Hussler was referring to is that's the that's what that's how looped chose to try the case looped looping chose to attack the obviousness of the patent by citing the O06 patent and indeed that was pretty much the central point of their case so they he looped and chose to focus the trial judge on the O06 patent and and pitch their entire argument to the proposition that the O06 rendered the 850 and patent that covers orthochysicum low either anticipated or obvices so I think they're on in fairness I think that's what Judge Hussler was indicating and indeed it might be interesting to note that from the starting point that this was a basically a do-over or I think was interesting that happened at the patent office is that the O06 was the patent focused on by the examiner indeed Janssen's patent lawyer when first receiving a rejection over the 554 the swallow patent that no Mr. Jander please we think Janssen thinks the O06 patent is the closest prior art went on to distinguish over it by showing unexpected results and obtain patent ability the essence of review of the entire record of looped case is that is that the patent office are strong and the O06 patent renders it anticipated or obvious and you're on and therefore I think it would be helpful if I just review what we think is a critical evidence that supports and judges findings on why there was no anticipation and also why there's no why this is not as long as you can make sure in that analysis that they include the question of unexpected results simply because you raised it here yes the reading of the patent is this is for a method and a contraceptive method and product and the unexpected result analysis seems to be focused primarily if not entirely on this breakthrough bleeding problem which is not something covered by the patent I mean there's contraception there's a you know it break through brief bleeding issue but it's not something that's claimed in your patent so why is that relevant or certainly why is that dispositive anything well ground on the answer that the multiple ways first of all the score to sell before that the inherent properties of a composition or even a method of using a particular product our part our part the parcel of the product even though every invention even though each and every element is claimed in the young in each case they considered toxicity and other aspects of the composition even though they weren't all made with the claim but in addition this is the one-five patent is an oral contraceptive patent and the claim construction etc. address the fact it has to be contraceptively effective and what the evidence at the trial show is the cycle control is sufficiently serious problematic for the woman what will happen is she will cease taking the oral contraceptive and thereby become pregnant leading to a whole host of legal and ethical issues that she would then have to face so whether or not a contraceptive is effective which is what's claimed in the patent this part parcel invention is the side effect of cycle control and that was recognized by the patent this because indeed the patent was allowed by showing them unexpected results in terms of the cycle control and in terms of whether or not these results were unexpected or I'm going to address that in two parts and to respond to Mr. Green as well the evidence is clear on the first problem of that that ortho-pricyclo low demonstrated substantially the same quality cycle control as ortho-pricyclo the 35 micrograms failed indeed Dr. Sarah Berger their expert admitted that and as a result the judge found that it was ample statistical evidence to support that based on Dr. Commute and Dr. Darnin in addition let's talk about why the results were unexpected well we know from all the evidence was this by that there were teachings in the prior art if you Lord estrogen by 10 micrograms afterlund and undergrad taught by 10 micrograms you would get poor cycle control and we cite five prior art publications in our brief that all parking to that teaching of acro-winded endocrine so that's what the skilled artisan thought in 1998 if I take estrogen down 10 micrograms I'm going to get poor cycle control which will then defeat the entire purpose of the contraceptive now mr. Green suggested your honors that there was no evidence that you would be concerned about that with 25 wrong Dr

. address the fact it has to be contraceptively effective and what the evidence at the trial show is the cycle control is sufficiently serious problematic for the woman what will happen is she will cease taking the oral contraceptive and thereby become pregnant leading to a whole host of legal and ethical issues that she would then have to face so whether or not a contraceptive is effective which is what's claimed in the patent this part parcel invention is the side effect of cycle control and that was recognized by the patent this because indeed the patent was allowed by showing them unexpected results in terms of the cycle control and in terms of whether or not these results were unexpected or I'm going to address that in two parts and to respond to Mr. Green as well the evidence is clear on the first problem of that that ortho-pricyclo low demonstrated substantially the same quality cycle control as ortho-pricyclo the 35 micrograms failed indeed Dr. Sarah Berger their expert admitted that and as a result the judge found that it was ample statistical evidence to support that based on Dr. Commute and Dr. Darnin in addition let's talk about why the results were unexpected well we know from all the evidence was this by that there were teachings in the prior art if you Lord estrogen by 10 micrograms afterlund and undergrad taught by 10 micrograms you would get poor cycle control and we cite five prior art publications in our brief that all parking to that teaching of acro-winded endocrine so that's what the skilled artisan thought in 1998 if I take estrogen down 10 micrograms I'm going to get poor cycle control which will then defeat the entire purpose of the contraceptive now mr. Green suggested your honors that there was no evidence that you would be concerned about that with 25 wrong Dr. Darnin explained that a facita of personal ordinary school of art would have looked to the experience with the 30 micrograms of 20 micrograms in comparisons in acro-winded endocrine when forming an expectation about what would happen when reducing the Edo's age from 35 to 25 micrograms he further explained that a personal ordinary skill in the art would have expected the same relative decrease in cycle control with such reduction appendix 13994 line 10 through 14004 point eight so as a result there was ample evidence and in fact that's what the prior art taught and many authors subsequent and faculty in an endocrine agreed with that proposition moreover there was a general teaching in the art at that time by many references seven references that you cited it was understood by all skilled artists that if you lowered estrogen you would get increases problems or poor cycle control as an additional reason what the prior also taught which their experts never addressed in the trial these are tri-phase aggressiveness and to your point earlier you're on about the question of anticipation this is not an estrogen pattern the a-five one the a-one five is a combination prized asic measurement patterns with six variables protestant protestant dosage estrogen estrogen dosage pill-free period and number of days in the phases and the looping argument ignores all of those elements of the pattern because they don't help them and they have no answer and they want you to focus on estrogen only what's the prior teach if you wanted to try to reduce estrogen the primary teaches unique to make compensatory changes which means if you want to lower the estimate you need to increase the protestant their expert never addressed that we have ample evidence that that's exactly what would happen and indeed proof of the marketplace Dr. Sarah Berger first testified as their expert that oh there would have been no expectation there was nothing out there then across the combination I asked her about her service to park Davis as a consultant before she was a higher expert in this case on Mercett and Esther step 20 microgram pills poor cycle control and I compel her with the evidence to admit that in fact as a result of the poor cycle control of the 20 microgram pills first that it was it acknowledged in the market that the cycle control was bad and it was leading to this situation by when so what do they do well in one till they raised the amount of estrogen in subsequent phases in another in the other they actually had the woman take the contraceptive for five of the seven days of the total three period was that teach us was that teach all skill artists if you want to touch one element of the regimen you make compensatory changes somewhere else that was totally ignored Dr. Barnhart didn't admit it Dr. Barn even addressed precisely and in addition what Dr. Barnhart did and this is really a perniciousness in my view of what loop and his impact can do to you we're not Barnhart tied to limit the class here's the game he played he told Judge Shestler well I'm going to limit to one of seven dosages on estrogen and I'm just asking well what about 35 micrograms is the preferred dose he says well I'm going to know I'm just going to pick 25 even though the patent is just the 35 is the preferred dosage but when you want to the limit the class the range of possibilities even though the patent says five to seven days till free period he said I'm just choosing seven so we cross it's aminem why why do you pick the preferred dosage and ignore the ranch didn't really have a good answer to that but in fact what he was doing which obviously caused the judge to seriously question his credibility is sting playing you had to accept the entire ranges or you set the preferred ranges but you can't have it both ways now back to the end so you're on for all of those reasons there was no no motivation but no expectation success I want to put something else is I'm not sure very many patterns and you also say that these various ranges that are possible to include the anticipation if they do they do and they do your honor because even though under our range cases the 25 milligrams is shown at the 25 milligrams a hundred is within the range of 20 50 however the 815 patent is a ration patent with six variables which the undisputed testimony said each variable is interchangeable it is synergistically related to the others Dr. Schoen testified that even making certain assumptions about the number of progesterogen bell stitches as well as the progestins and the estrogens he had eight hundred and forty one million possibilities if you calculated the class just using the preferences so Dr

. Darnin explained that a facita of personal ordinary school of art would have looked to the experience with the 30 micrograms of 20 micrograms in comparisons in acro-winded endocrine when forming an expectation about what would happen when reducing the Edo's age from 35 to 25 micrograms he further explained that a personal ordinary skill in the art would have expected the same relative decrease in cycle control with such reduction appendix 13994 line 10 through 14004 point eight so as a result there was ample evidence and in fact that's what the prior art taught and many authors subsequent and faculty in an endocrine agreed with that proposition moreover there was a general teaching in the art at that time by many references seven references that you cited it was understood by all skilled artists that if you lowered estrogen you would get increases problems or poor cycle control as an additional reason what the prior also taught which their experts never addressed in the trial these are tri-phase aggressiveness and to your point earlier you're on about the question of anticipation this is not an estrogen pattern the a-five one the a-one five is a combination prized asic measurement patterns with six variables protestant protestant dosage estrogen estrogen dosage pill-free period and number of days in the phases and the looping argument ignores all of those elements of the pattern because they don't help them and they have no answer and they want you to focus on estrogen only what's the prior teach if you wanted to try to reduce estrogen the primary teaches unique to make compensatory changes which means if you want to lower the estimate you need to increase the protestant their expert never addressed that we have ample evidence that that's exactly what would happen and indeed proof of the marketplace Dr. Sarah Berger first testified as their expert that oh there would have been no expectation there was nothing out there then across the combination I asked her about her service to park Davis as a consultant before she was a higher expert in this case on Mercett and Esther step 20 microgram pills poor cycle control and I compel her with the evidence to admit that in fact as a result of the poor cycle control of the 20 microgram pills first that it was it acknowledged in the market that the cycle control was bad and it was leading to this situation by when so what do they do well in one till they raised the amount of estrogen in subsequent phases in another in the other they actually had the woman take the contraceptive for five of the seven days of the total three period was that teach us was that teach all skill artists if you want to touch one element of the regimen you make compensatory changes somewhere else that was totally ignored Dr. Barnhart didn't admit it Dr. Barn even addressed precisely and in addition what Dr. Barnhart did and this is really a perniciousness in my view of what loop and his impact can do to you we're not Barnhart tied to limit the class here's the game he played he told Judge Shestler well I'm going to limit to one of seven dosages on estrogen and I'm just asking well what about 35 micrograms is the preferred dose he says well I'm going to know I'm just going to pick 25 even though the patent is just the 35 is the preferred dosage but when you want to the limit the class the range of possibilities even though the patent says five to seven days till free period he said I'm just choosing seven so we cross it's aminem why why do you pick the preferred dosage and ignore the ranch didn't really have a good answer to that but in fact what he was doing which obviously caused the judge to seriously question his credibility is sting playing you had to accept the entire ranges or you set the preferred ranges but you can't have it both ways now back to the end so you're on for all of those reasons there was no no motivation but no expectation success I want to put something else is I'm not sure very many patterns and you also say that these various ranges that are possible to include the anticipation if they do they do and they do your honor because even though under our range cases the 25 milligrams is shown at the 25 milligrams a hundred is within the range of 20 50 however the 815 patent is a ration patent with six variables which the undisputed testimony said each variable is interchangeable it is synergistically related to the others Dr. Schoen testified that even making certain assumptions about the number of progesterogen bell stitches as well as the progestins and the estrogens he had eight hundred and forty one million possibilities if you calculated the class just using the preferences so Dr. Schoen gave an alternate opinion so Dr. Schoen was talking about the 815 is some of the oh six half correct yes your honors the one that they claim anticipates right oh six so Dr. Schoen passed it another way he said let's assume we just took the preference in each of the six one million one hundred and twenty six thousand six hundred and thirty eight possible measurements even if you were to just have the preference for the seven day bill free period you still get three hundred and seventy five thousand five hundred and forty six right now Dr. Schoen your question what the case is is in order to have anticipation by our reference of subsequent reference where a species is claimed where the gene is as disclosed the skilled artisan and this is pretty much well settled at least last time I checked in this court must immediately envisage a limited class and each member of that class our testimony was there was no limited class and the skilled artisan would not immediately envisage each member Dr. Berger didn't even address it and Dr. Barnhart never ever identified the class all his testimony to some of the substance was he just focused on the estrogen dose and and a bit of a nod to the pill free period but he never for instance answered and was never asked on direct examination Dr

. Schoen gave an alternate opinion so Dr. Schoen was talking about the 815 is some of the oh six half correct yes your honors the one that they claim anticipates right oh six so Dr. Schoen passed it another way he said let's assume we just took the preference in each of the six one million one hundred and twenty six thousand six hundred and thirty eight possible measurements even if you were to just have the preference for the seven day bill free period you still get three hundred and seventy five thousand five hundred and forty six right now Dr. Schoen your question what the case is is in order to have anticipation by our reference of subsequent reference where a species is claimed where the gene is as disclosed the skilled artisan and this is pretty much well settled at least last time I checked in this court must immediately envisage a limited class and each member of that class our testimony was there was no limited class and the skilled artisan would not immediately envisage each member Dr. Berger didn't even address it and Dr. Barnhart never ever identified the class all his testimony to some of the substance was he just focused on the estrogen dose and and a bit of a nod to the pill free period but he never for instance answered and was never asked on direct examination Dr. Barnhart what is the size of the limited class taking into account the the possible protestions the possible protest in those just the possible estrogen estrogen dosages in the bill free period in other words a proper question when the prior reference was a six part contraceptive regimen look at the titles of the 006 it's not the estrogen pattern each prophecy oral contraceptive that's what it is that's the invention so just for us back to you I think your first question to Mr. Green is the failure on anticipation is simply the inability to prove and was there burdened during convincing evidence that there was a limited class and that the skilled artisan would immediately envisage to the limited class simply put we treated the pattern properly with all the ranges that the better disclose the 006 loop and cherry picks and they actually expect you expect to accept the proposition that you would just look at one element of the range and one element of the right manufacturing in five the limited class of five micrograms yes what your under your first question was the question is didn't loop and did they manufacture didn't they quite a manufacturer with limited class of five micrograms I'm not aware whether they did or not. I'm not assuming I see my time is running out let me say to the point is in this case you have a rare occurrence Dr. Samuel Peslaw the inventor of the 006 the five micropads had subsequent patterns these are skilled at using extraordinary arts but what's important these patterns were issued after the 5.5 or in the 006 what did he teach the skilled arts but before the 8.5 teaching away about his cycle about his 777 rating is closed in the 5

. Barnhart what is the size of the limited class taking into account the the possible protestions the possible protest in those just the possible estrogen estrogen dosages in the bill free period in other words a proper question when the prior reference was a six part contraceptive regimen look at the titles of the 006 it's not the estrogen pattern each prophecy oral contraceptive that's what it is that's the invention so just for us back to you I think your first question to Mr. Green is the failure on anticipation is simply the inability to prove and was there burdened during convincing evidence that there was a limited class and that the skilled artisan would immediately envisage to the limited class simply put we treated the pattern properly with all the ranges that the better disclose the 006 loop and cherry picks and they actually expect you expect to accept the proposition that you would just look at one element of the range and one element of the right manufacturing in five the limited class of five micrograms yes what your under your first question was the question is didn't loop and did they manufacture didn't they quite a manufacturer with limited class of five micrograms I'm not aware whether they did or not. I'm not assuming I see my time is running out let me say to the point is in this case you have a rare occurrence Dr. Samuel Peslaw the inventor of the 006 the five micropads had subsequent patterns these are skilled at using extraordinary arts but what's important these patterns were issued after the 5.5 or in the 006 what did he teach the skilled arts but before the 8.5 teaching away about his cycle about his 777 rating is closed in the 5.5 or and 061 he said quote effective low dose contraceptive regimen with ideal cycle control may be achieved by the party from the 777 regimen of the spali times and administering a low dose of steroids over at least 2048 I will start a veteran is appendix 13883 line 16 through appendix 13887 line 24 is starting testimony regarding the spali pattern and judgment response one of your questions is also this close at the 724 patent a 1472 another presqually patent and it was subsequently reported in the birth control book now let there be any questions about how serious this would be the loss of article which was passed by to by Dr. Schoen at 8832 8837 very important was a study of no yesterday with a point one through five doses and 35 micrograms and then same amount of progesterate in 25 micrograms you know what happens eight times more pregnancy with the 25 micrograms than the 35 from point six nine to 35 to 5.71 and there be any doubt that a skilled artist at that time would not have been motivated just to lower the estrogen from 35 to 25 when he had a prior art reference says you will get eight times as many pregnancy as I have been through by saying this and I think it's very important looping board the burden by cleansing and here demonstrate clear error you compare these briefs and what you see is there is a positive of record sites in the looping briefs the Jansen brief is loaded with them though he didn't bear the burden at all the substantial weight of the evidence and the substantial amount of the evidence not just from our experts but from what prior art references from what all three leaders in the field were we was this was a remarkable invention and I'll close with a quote from Dr. Michelle Dan Michelle I'm a California who Dr. Berger recognized as cold and actually the king he's probably deleting living authority on contraception and he wrote about price cycle low OTC low wasn't the exception to the general relationship between ethanol estradiol and cyclical control given that it had excellent cycle control at the lower dose of estrogen that is the quintessential statement of non-hobbleness though we are in the field said OTC low is the exception to the rule because the rule was if you take estrogen down you're going to get the housey cycle control women will put taking a pill and it doesn't work as contraceptive he says it's the exception they cited no evidence no prior art that said that the cycle control wasn't as good as OTC or the price cycle and no prior art reference can loop and point to that suggested that 25 micrograms that a drop of 10 micrograms in that ratio would achieve the unexpected good cycle control here Bruton if there was such motivation out there where was the prior art we have all the prior art which says don't you dare take it down 10 micrograms for those reasons you're on it we respectfully request that this court affirm good stuff very good thank you thank you um and mr. Green we started with two and since mr

.5 or and 061 he said quote effective low dose contraceptive regimen with ideal cycle control may be achieved by the party from the 777 regimen of the spali times and administering a low dose of steroids over at least 2048 I will start a veteran is appendix 13883 line 16 through appendix 13887 line 24 is starting testimony regarding the spali pattern and judgment response one of your questions is also this close at the 724 patent a 1472 another presqually patent and it was subsequently reported in the birth control book now let there be any questions about how serious this would be the loss of article which was passed by to by Dr. Schoen at 8832 8837 very important was a study of no yesterday with a point one through five doses and 35 micrograms and then same amount of progesterate in 25 micrograms you know what happens eight times more pregnancy with the 25 micrograms than the 35 from point six nine to 35 to 5.71 and there be any doubt that a skilled artist at that time would not have been motivated just to lower the estrogen from 35 to 25 when he had a prior art reference says you will get eight times as many pregnancy as I have been through by saying this and I think it's very important looping board the burden by cleansing and here demonstrate clear error you compare these briefs and what you see is there is a positive of record sites in the looping briefs the Jansen brief is loaded with them though he didn't bear the burden at all the substantial weight of the evidence and the substantial amount of the evidence not just from our experts but from what prior art references from what all three leaders in the field were we was this was a remarkable invention and I'll close with a quote from Dr. Michelle Dan Michelle I'm a California who Dr. Berger recognized as cold and actually the king he's probably deleting living authority on contraception and he wrote about price cycle low OTC low wasn't the exception to the general relationship between ethanol estradiol and cyclical control given that it had excellent cycle control at the lower dose of estrogen that is the quintessential statement of non-hobbleness though we are in the field said OTC low is the exception to the rule because the rule was if you take estrogen down you're going to get the housey cycle control women will put taking a pill and it doesn't work as contraceptive he says it's the exception they cited no evidence no prior art that said that the cycle control wasn't as good as OTC or the price cycle and no prior art reference can loop and point to that suggested that 25 micrograms that a drop of 10 micrograms in that ratio would achieve the unexpected good cycle control here Bruton if there was such motivation out there where was the prior art we have all the prior art which says don't you dare take it down 10 micrograms for those reasons you're on it we respectfully request that this court affirm good stuff very good thank you thank you um and mr. Green we started with two and since mr. Papis went over some we'll give you another three minutes so you've got a total of 500 I appreciate that otherwise I was going to be talking stream we could ask so let me just micrograms of nergestimate not a hundred maybe or two 15 or 250 which is a tissue here for the or the price cycle and through or the price cycle low product not even probably so for respect to that through factor for the judge clearly got that wrong if you read our brief as pages 42 to 43 and reply page 23 what she's her testimony was this in her view she's a practice inclination she's seen an innumerable number of patients she doesn't think there's any difference among any of the oral contraceptives she uses the orthotrike cycle she uses the low S in 120 even as 20 micrograms she uses it for a decade or so she's on cycle control she sees no clinical difference between 20 all the way up to the 35 whatever's in the marketplace today so when she said she didn't see a difference clinically between where the tricycle and orthotrike cycle and low it's because she hasn't see a difference between any of them so there's no unexpected result here and that's where the the lower court really sorry that this record went astray because in interpreting that to be that was an unexpected result was plain wrong her testimony what is there all the same there is no difference in that case mr. Pappas started with the issue of what happened to pto what happened pto was worth a went directly for the showing of unexpected results there was no argument that there was lack of motivation or some teaching away or any of the other argument that have been made today not before the patent exam so it's not as though Lupin's position was altered dealt with by the patent exam and those issues were never raised the only issue raised was I expect result Lupin's position on the unexplored results today brings into the picture an enormous amount of information that patent exam is not yet mr. Pappas said that well where's the data that shows that there was a difference again it's an art brief the commuted data he did a regression analysis he found that actually there was a statistically significant difference between ortho-pricycline and ortho-pricycline law it three out of the first six cycles dr. Darni's testimony is those of the most critical cycles looking at the early cycles from this endpoint of this continuation due to early bleeding the comment with respect the aminucci and that you need to look at the nexus that this court is recognized between a product and its properties again and nothing to do with this case that's a molecule and I agree wholeheartedly the position of this court when it comes to molecule pens is that the compound and its properties are inexorably intertwined this is not a compound path this is about a regiment a regiment that's explained in column one that we think about line 51 that's a difference from the prior art or in the amount of effigin is maintained over three phases whereas you have an increasing amount of projected that is the teaching across the entire spectrum of that patent and that's why when you look at and I do believe that the law actually looks at cases such as this with a position through the eyes of a person or in their skill in the art and there is some amount of rational thought that goes behind that and the reason why this court says look at it through the eyes of the first court in their skill in the art is so that you don't find a million possibilities what you find is one clear teaching an example for and in claim nine that there's a really good product out there it's called worth a try cycling you want to find a species within a genus there it is it right there and what is one of our very skill in the art do looking at the state of the art wanting to look at lower in estrogen which by the way the district court found at page eight twenty the person of her in their skill in the art wanted to create ortho oc regimens with lower ebilsages that was a fine-line district court and I would also point you to the grind testimony from ortho at the age six to four five and six to six seven with respect to lowering the estrogen delts where he said even there's a problem potentially that there may be some lower cycle control yeah we're moving forward that way but as that's the way the market was headed I see but that by that time is out you appreciate you taking the time I'm putting it back into my time thank you we thank both council

The next and final case for argument is the pharmaceutical versus Watson lab now to the most patient group of all and that here for the entire procedure this morning whenever you're ready Mr. Green. Thank you for your riders and good morning. This old chain with the topic of what we're dealing with a combination oral campus office. By way of background and I think it's quite familiar with the background based on the sense of breathing with this to put the argument into perspective. There's a product called orthotrycycling that product was covered by a series of packages issued to Orville when that application filed in 1983. The patent ensued the 815 patent is a patent which is issued to cover the follow along product or the tricycling law. The only difference between orthotrycycling and orthotrycycling law is the amount of estrogen cubes. In orthotrycycling, 35 micrograms of estrogen in orthotrycycling law. Can I search for a romantic patient argument? Absolutely. Because I understand you know we have some cases that clear value in others that suggest that a range of sufficient for anticipation but I'm having a lot a little problem here. We've got other cases like adephyno that's seen to suggest otherwise. In this case we're not if we were just talking about one range, this one range and that was it then I think I might agree that there were a finite number of ways you can go within that range. But it seems to me the patent disclosure has numerous ranges. It has numerous variables. So we are talking into the thousands or millions of potential variations. So it seems to me not to be a good fit with the cases that have been willing to accommodate that. So I'd like to hear your response. And that's a very good question, Granger. It goes right to the heart for the error occurred. And that is the view of that particular range. The case law from this court is absolutely clear. If you go back to the engraved case which sites really slippery and that case law says you don't stand back and look at it. Prior art disclosure, we're asking the question of anticipation from the standpoint of an individual walking down the sidewalk. It's supposed to be viewed from the position of a person of ordinary skill in art. And that's the fact what's done in this case and that view was expressed by Dr. Barnhart. And not reviewed by others that the range in this case is a 20 to 50 microgram range of EE. And the district court went astray. It's finding of no anticipation because it simply ignored the testimony by Dr. Barnhart. But it's not going to work. It was on that place. It said that range is a finite range. So you don't use that. There are numerous other variables within the claims, right? There are numerous variables within the claim which also means to be viewed from the standpoint of a person of ordinary skill in the art. And again, it's a combination error here. The first one is what does that range mean? And the under-budded top of the money means 20 to 25, 30, 35, 40, 45, 50. Dr. Barnhart top of the fine is that that range meant that there is nothing in the record that contradicts that. Now the question is and I'd say we've got a lot of cases that are thrown around here but I would also direct the court back to the in-rate graves case. And it's citation to in-rate the grays because what does that say? This is a CPPA case, as far as I know it's not been overturned by this court. And it says a reference anticipate the claim. If it discloses the claim to invention quote such that a skilled artisan could take its teaching and combination with his own knowledge of the particular art and be in possession of the invention. That's a clear instruction below that the entire reference is being viewed by the standpoint of a person or a person of ordinary skill in art and what do we have here? We have example four example four right to the five five four or six and the same examples. We have example four and not rebutted example four specifically covers or low tricycle. Claim nine in the O6 patent specifically covers or the tricycle. Or the tricycle was at the time one of it not the most successful combination or converse up as ever. A person of ordinary skill in the art is aware of that. A person of ordinary skill in the art is going to read the O06 patent and recognize what example four and it claim nine. It's how a person a skill in the art know that it's 25 microleaders that's a desirable dosage in the in the O06 patent. The O06 patent is a range you're either and if that's a really big range it I would submit that based on the top one in this case it's really not that large. Yeah but the district core it is the drain up myself. It seems to be concerned that there was no express teaching in 25 there was no express teaching over reduction by ten or five hours. The reference itself did not say move in five microgram increments but the test that we was not rebutted that trial that the only approved oral contraceptives as of that time in the United States always move for varies by five microgram increments. That was not rebutted. And the unrebutted testimony Dr. Barnhart was the same effect. It's not a wide range it's really 20 25 35 40. Before your time. I was just can do move to the obviousness it seems like the a lot of the concerns that the district court had revolved around the cycle control. Yes and with regard to a reasonable expectation of success or you know others can you respond to why in your view that's not relevant or not dispositive or you said to the obvious there are certainly several answers that first reasonable expectation of success is the director George McLean. McLean says not being about cycle control. What the claim says is an oral contraceptive. It doesn't say anything about the cycle control benefits of that but let's look at the record as to whether there really was such a concern. What is your some level of concern that there might be a change if there's a reduction in the amount of oxygen. One can say that there's a possibility that there might be a reduction but there's also a possibility that there's not going to be a reduction because and this actually goes back to the heart of one of the key issues in this case dealing with obviously an expectation. The record had it only information about a low dose of 20 micrograms. There was never in the history of oral contraceptives as far as I know and certainly in the US a product would contain 25 micrograms. The testimony from again this was not rebutted including back or down one of the Oracle experts was that he didn't know what to expect and the inside testimony from ortho which is under retactic order we do pause it in the brief. Specifically addresses the question of the expectations of what would come from that the amount of cycle control that would occur and the expectation was they would have a successful oral contraceptive and that's really the only question that's involved. And what was the motivation here? The motivation because of the bad side of that. The the I'd say it was multifacted and a month of testimony came in through again Dr. Barnard the FDA said you should prescribe look to the clinch it you should prescribe the lowest dose possible to the patients. The motivation to reduce was also a market motivation and we have this in our free to come to the perfect for as I can't for it directly where the market was clearly moving down the respect to the amount of estrogen and it isn't that motivation to decrease extra extra to at least coupled with some sort of motivation or concern with regard to cycle control. The motivation to move down is to a civil way with the the problem associated with the concern was that there was a problem with breakthrough bleeding that when you decrease the estrogen level that creates the other concerns right? There was a concern expressed based on the data that the table for in the past this 20 micrograms of there's no data. I'm here in Dr. Busquall says in his in his book that there if you go to the estrogen that your patient a tradeoff isn't that isn't that and what you've been arguing a teaching away? There is indeed the possibility that by moving to 25 there might have been a reduction in estrogen but there again was no evidence that such would actually occur and even if falling up in your question right even if it's a tradeoff it doesn't then motivate one not to make the product the motivation in fact was clearly there to make it even if there were some amount of reduction of cycle control as you lower the amount of estrogen. The fact is a few additional women might potentially have a reduced amount of cycle control doesn't mean you've been decide not to make a product where a vast majority of women are going to benefit by that lower amount and again the motivation is clear in the record the FDA said move down. The prior to talk that if you if you if you lowered this or you were going to cost further bleeding I mean how does that make commercial sense? The problem I think your honor is it's not a unitary concept it doesn't mean that if you reduce the oxygen and in fact it does cause additional bleeding it's going to affect all women. Well is it also the case that the OSTC pattern says the purpose which contains the wide range says the purpose is to lower total monthly steroid dose while still obtaining equivalent bleeding patterns and protection against prevent Satan so that suggests that you could lower the dose without increasing bleeding pattern. Well indeed your honor is I said there is no evidence at all if I go into 25 you're going to have an adverse effect on the bleeding pattern. The evidence is if you go down to 20 that clearly took place and there is there is no record testimony if a what would happen at 25 because there was no product that at 25 that also couples with the issue of where where is the unexpected results from the standpoint of how do you judge unexpected results and this court has found that unexpected results can only be viewed in terms of a difference from what was expected and there is nothing in the record that tells you what to expect if you were going to move to a 25 microgram belt is from 35 nothing was out that or that if you did that that there would be cycle control problems. There is no evidence at all if I'm moving to 25 there in fact will be there's a concept of a threshold effect you know that even today where that one is is to how much of reduction you can encounter and have an actual reduction and doctor barn ready to testify to that there's the discussion that's the threshold effect where is there any proof is a where that threshold actually is is was there some level of potential concern some concern what was the expectation that you were going to have once you reduce from 35 to 25 you can't find that in the record it doesn't exist it doesn't exist because there was no data and doctor Darni said specifically in his testimony when I asked it so what happens when you move from 20 to 25 he said well you know I don't know because there's no data on that and without proof of the expectation that's to be shown to be unexpected then when you move from 35 to 25 there cannot be a showing that unexpected results on the topic of unexpected results there are probably 10 different issues that we have with the unexpected results and let me just start with the fact that there was no original expectation the cross-study comparison data that is a study comparison between data was 10 years old in the more current data it was not ahead to comparison the FDA itself will not approve a product market approach from the standpoint of no difference with respect to breakthrough bleeding I'm us or the head to head showing there's a decision it was recently issued through a man that at the district court level that actually says well then how can there be a showing unexpected results in this case there's no showing that would allow the marketing of the product with that argument that there was no change in the in the cycle control the fact is you're into your rebuttal time there's a place I do want to at least conclude the point you're making you are certainly correct or under let me just conclude on that point from the standpoint of the actual data that is shown in table five even through the analysis done by or though there was a difference it wasn't the same three out of the first six cycles were shown to have worse cycle control thank you thank you then we have just some questions will restore two months of rebuttal time is keeping even if this happens that will add to it in time let me start by maybe about or any myself with it in that judge Chester sat for the sixth day very lengthy trial for a substantial amount of the judge has been actually reduced by chance and even though he had the burden approved by clear and his evidence but he had as it may he made factual findings that support his judgment of no anticipation and no obviously and as the score tells that is a view of only upon an overturnable owned by demonstration of clear error and I I spark here because I think this informs the rest of my comments because this court has said clear error means that what the district judge decided to quote K over his universe is implausible in life of the entire record or where it chooses one of two permissible views of the evidence that is acceptable so I will now deal with the evidence but I think what's important to do to set the stage is that there was ample evidence on every question your owners asked and every point we asserted the trial judge Chester made factual findings and the score although obviously this is ultimately questionable has said repeatedly that everything from what the prior art discloses to motivation to make the invention to reasonable expectation of success and unexpected results are factual fine well let's commit that let's turn and if you think that's okay the district court made the one finding that movement failed to demonstrate why a person skilled in the art would have looked to the O6 patent to create a lower dose of a way in my view that question is irreversible to the obvious this inquiry our case law doesn't require that a patent challenge or identify a particular reason to choose a particular piece of art this isn't completely entirely different field and in fact I think there is a clear reason what would have looked to the O6 patent so you want to you know I know there are numerous findings upon which you can rest but this is at least one where I had a bit of a problem and the question on the test is whether or not one would have started with the O6 patent yeah well they say put the burden that seems the district court put the burden that seems on movement to demonstrate why a person skilled in the art would have looked to the O6 patent at all I don't know that that's a fear you know I think I can address that that that I think what Judge Hussler was referring to is that's the that's what that's how looped chose to try the case looped looping chose to attack the obviousness of the patent by citing the O06 patent and indeed that was pretty much the central point of their case so they he looped and chose to focus the trial judge on the O06 patent and and pitch their entire argument to the proposition that the O06 rendered the 850 and patent that covers orthochysicum low either anticipated or obvices so I think they're on in fairness I think that's what Judge Hussler was indicating and indeed it might be interesting to note that from the starting point that this was a basically a do-over or I think was interesting that happened at the patent office is that the O06 was the patent focused on by the examiner indeed Janssen's patent lawyer when first receiving a rejection over the 554 the swallow patent that no Mr. Jander please we think Janssen thinks the O06 patent is the closest prior art went on to distinguish over it by showing unexpected results and obtain patent ability the essence of review of the entire record of looped case is that is that the patent office are strong and the O06 patent renders it anticipated or obvious and you're on and therefore I think it would be helpful if I just review what we think is a critical evidence that supports and judges findings on why there was no anticipation and also why there's no why this is not as long as you can make sure in that analysis that they include the question of unexpected results simply because you raised it here yes the reading of the patent is this is for a method and a contraceptive method and product and the unexpected result analysis seems to be focused primarily if not entirely on this breakthrough bleeding problem which is not something covered by the patent I mean there's contraception there's a you know it break through brief bleeding issue but it's not something that's claimed in your patent so why is that relevant or certainly why is that dispositive anything well ground on the answer that the multiple ways first of all the score to sell before that the inherent properties of a composition or even a method of using a particular product our part our part the parcel of the product even though every invention even though each and every element is claimed in the young in each case they considered toxicity and other aspects of the composition even though they weren't all made with the claim but in addition this is the one-five patent is an oral contraceptive patent and the claim construction etc. address the fact it has to be contraceptively effective and what the evidence at the trial show is the cycle control is sufficiently serious problematic for the woman what will happen is she will cease taking the oral contraceptive and thereby become pregnant leading to a whole host of legal and ethical issues that she would then have to face so whether or not a contraceptive is effective which is what's claimed in the patent this part parcel invention is the side effect of cycle control and that was recognized by the patent this because indeed the patent was allowed by showing them unexpected results in terms of the cycle control and in terms of whether or not these results were unexpected or I'm going to address that in two parts and to respond to Mr. Green as well the evidence is clear on the first problem of that that ortho-pricyclo low demonstrated substantially the same quality cycle control as ortho-pricyclo the 35 micrograms failed indeed Dr. Sarah Berger their expert admitted that and as a result the judge found that it was ample statistical evidence to support that based on Dr. Commute and Dr. Darnin in addition let's talk about why the results were unexpected well we know from all the evidence was this by that there were teachings in the prior art if you Lord estrogen by 10 micrograms afterlund and undergrad taught by 10 micrograms you would get poor cycle control and we cite five prior art publications in our brief that all parking to that teaching of acro-winded endocrine so that's what the skilled artisan thought in 1998 if I take estrogen down 10 micrograms I'm going to get poor cycle control which will then defeat the entire purpose of the contraceptive now mr. Green suggested your honors that there was no evidence that you would be concerned about that with 25 wrong Dr. Darnin explained that a facita of personal ordinary school of art would have looked to the experience with the 30 micrograms of 20 micrograms in comparisons in acro-winded endocrine when forming an expectation about what would happen when reducing the Edo's age from 35 to 25 micrograms he further explained that a personal ordinary skill in the art would have expected the same relative decrease in cycle control with such reduction appendix 13994 line 10 through 14004 point eight so as a result there was ample evidence and in fact that's what the prior art taught and many authors subsequent and faculty in an endocrine agreed with that proposition moreover there was a general teaching in the art at that time by many references seven references that you cited it was understood by all skilled artists that if you lowered estrogen you would get increases problems or poor cycle control as an additional reason what the prior also taught which their experts never addressed in the trial these are tri-phase aggressiveness and to your point earlier you're on about the question of anticipation this is not an estrogen pattern the a-five one the a-one five is a combination prized asic measurement patterns with six variables protestant protestant dosage estrogen estrogen dosage pill-free period and number of days in the phases and the looping argument ignores all of those elements of the pattern because they don't help them and they have no answer and they want you to focus on estrogen only what's the prior teach if you wanted to try to reduce estrogen the primary teaches unique to make compensatory changes which means if you want to lower the estimate you need to increase the protestant their expert never addressed that we have ample evidence that that's exactly what would happen and indeed proof of the marketplace Dr. Sarah Berger first testified as their expert that oh there would have been no expectation there was nothing out there then across the combination I asked her about her service to park Davis as a consultant before she was a higher expert in this case on Mercett and Esther step 20 microgram pills poor cycle control and I compel her with the evidence to admit that in fact as a result of the poor cycle control of the 20 microgram pills first that it was it acknowledged in the market that the cycle control was bad and it was leading to this situation by when so what do they do well in one till they raised the amount of estrogen in subsequent phases in another in the other they actually had the woman take the contraceptive for five of the seven days of the total three period was that teach us was that teach all skill artists if you want to touch one element of the regimen you make compensatory changes somewhere else that was totally ignored Dr. Barnhart didn't admit it Dr. Barn even addressed precisely and in addition what Dr. Barnhart did and this is really a perniciousness in my view of what loop and his impact can do to you we're not Barnhart tied to limit the class here's the game he played he told Judge Shestler well I'm going to limit to one of seven dosages on estrogen and I'm just asking well what about 35 micrograms is the preferred dose he says well I'm going to know I'm just going to pick 25 even though the patent is just the 35 is the preferred dosage but when you want to the limit the class the range of possibilities even though the patent says five to seven days till free period he said I'm just choosing seven so we cross it's aminem why why do you pick the preferred dosage and ignore the ranch didn't really have a good answer to that but in fact what he was doing which obviously caused the judge to seriously question his credibility is sting playing you had to accept the entire ranges or you set the preferred ranges but you can't have it both ways now back to the end so you're on for all of those reasons there was no no motivation but no expectation success I want to put something else is I'm not sure very many patterns and you also say that these various ranges that are possible to include the anticipation if they do they do and they do your honor because even though under our range cases the 25 milligrams is shown at the 25 milligrams a hundred is within the range of 20 50 however the 815 patent is a ration patent with six variables which the undisputed testimony said each variable is interchangeable it is synergistically related to the others Dr. Schoen testified that even making certain assumptions about the number of progesterogen bell stitches as well as the progestins and the estrogens he had eight hundred and forty one million possibilities if you calculated the class just using the preferences so Dr. Schoen gave an alternate opinion so Dr. Schoen was talking about the 815 is some of the oh six half correct yes your honors the one that they claim anticipates right oh six so Dr. Schoen passed it another way he said let's assume we just took the preference in each of the six one million one hundred and twenty six thousand six hundred and thirty eight possible measurements even if you were to just have the preference for the seven day bill free period you still get three hundred and seventy five thousand five hundred and forty six right now Dr. Schoen your question what the case is is in order to have anticipation by our reference of subsequent reference where a species is claimed where the gene is as disclosed the skilled artisan and this is pretty much well settled at least last time I checked in this court must immediately envisage a limited class and each member of that class our testimony was there was no limited class and the skilled artisan would not immediately envisage each member Dr. Berger didn't even address it and Dr. Barnhart never ever identified the class all his testimony to some of the substance was he just focused on the estrogen dose and and a bit of a nod to the pill free period but he never for instance answered and was never asked on direct examination Dr. Barnhart what is the size of the limited class taking into account the the possible protestions the possible protest in those just the possible estrogen estrogen dosages in the bill free period in other words a proper question when the prior reference was a six part contraceptive regimen look at the titles of the 006 it's not the estrogen pattern each prophecy oral contraceptive that's what it is that's the invention so just for us back to you I think your first question to Mr. Green is the failure on anticipation is simply the inability to prove and was there burdened during convincing evidence that there was a limited class and that the skilled artisan would immediately envisage to the limited class simply put we treated the pattern properly with all the ranges that the better disclose the 006 loop and cherry picks and they actually expect you expect to accept the proposition that you would just look at one element of the range and one element of the right manufacturing in five the limited class of five micrograms yes what your under your first question was the question is didn't loop and did they manufacture didn't they quite a manufacturer with limited class of five micrograms I'm not aware whether they did or not. I'm not assuming I see my time is running out let me say to the point is in this case you have a rare occurrence Dr. Samuel Peslaw the inventor of the 006 the five micropads had subsequent patterns these are skilled at using extraordinary arts but what's important these patterns were issued after the 5.5 or in the 006 what did he teach the skilled arts but before the 8.5 teaching away about his cycle about his 777 rating is closed in the 5.5 or and 061 he said quote effective low dose contraceptive regimen with ideal cycle control may be achieved by the party from the 777 regimen of the spali times and administering a low dose of steroids over at least 2048 I will start a veteran is appendix 13883 line 16 through appendix 13887 line 24 is starting testimony regarding the spali pattern and judgment response one of your questions is also this close at the 724 patent a 1472 another presqually patent and it was subsequently reported in the birth control book now let there be any questions about how serious this would be the loss of article which was passed by to by Dr. Schoen at 8832 8837 very important was a study of no yesterday with a point one through five doses and 35 micrograms and then same amount of progesterate in 25 micrograms you know what happens eight times more pregnancy with the 25 micrograms than the 35 from point six nine to 35 to 5.71 and there be any doubt that a skilled artist at that time would not have been motivated just to lower the estrogen from 35 to 25 when he had a prior art reference says you will get eight times as many pregnancy as I have been through by saying this and I think it's very important looping board the burden by cleansing and here demonstrate clear error you compare these briefs and what you see is there is a positive of record sites in the looping briefs the Jansen brief is loaded with them though he didn't bear the burden at all the substantial weight of the evidence and the substantial amount of the evidence not just from our experts but from what prior art references from what all three leaders in the field were we was this was a remarkable invention and I'll close with a quote from Dr. Michelle Dan Michelle I'm a California who Dr. Berger recognized as cold and actually the king he's probably deleting living authority on contraception and he wrote about price cycle low OTC low wasn't the exception to the general relationship between ethanol estradiol and cyclical control given that it had excellent cycle control at the lower dose of estrogen that is the quintessential statement of non-hobbleness though we are in the field said OTC low is the exception to the rule because the rule was if you take estrogen down you're going to get the housey cycle control women will put taking a pill and it doesn't work as contraceptive he says it's the exception they cited no evidence no prior art that said that the cycle control wasn't as good as OTC or the price cycle and no prior art reference can loop and point to that suggested that 25 micrograms that a drop of 10 micrograms in that ratio would achieve the unexpected good cycle control here Bruton if there was such motivation out there where was the prior art we have all the prior art which says don't you dare take it down 10 micrograms for those reasons you're on it we respectfully request that this court affirm good stuff very good thank you thank you um and mr. Green we started with two and since mr. Papis went over some we'll give you another three minutes so you've got a total of 500 I appreciate that otherwise I was going to be talking stream we could ask so let me just micrograms of nergestimate not a hundred maybe or two 15 or 250 which is a tissue here for the or the price cycle and through or the price cycle low product not even probably so for respect to that through factor for the judge clearly got that wrong if you read our brief as pages 42 to 43 and reply page 23 what she's her testimony was this in her view she's a practice inclination she's seen an innumerable number of patients she doesn't think there's any difference among any of the oral contraceptives she uses the orthotrike cycle she uses the low S in 120 even as 20 micrograms she uses it for a decade or so she's on cycle control she sees no clinical difference between 20 all the way up to the 35 whatever's in the marketplace today so when she said she didn't see a difference clinically between where the tricycle and orthotrike cycle and low it's because she hasn't see a difference between any of them so there's no unexpected result here and that's where the the lower court really sorry that this record went astray because in interpreting that to be that was an unexpected result was plain wrong her testimony what is there all the same there is no difference in that case mr. Pappas started with the issue of what happened to pto what happened pto was worth a went directly for the showing of unexpected results there was no argument that there was lack of motivation or some teaching away or any of the other argument that have been made today not before the patent exam so it's not as though Lupin's position was altered dealt with by the patent exam and those issues were never raised the only issue raised was I expect result Lupin's position on the unexplored results today brings into the picture an enormous amount of information that patent exam is not yet mr. Pappas said that well where's the data that shows that there was a difference again it's an art brief the commuted data he did a regression analysis he found that actually there was a statistically significant difference between ortho-pricycline and ortho-pricycline law it three out of the first six cycles dr. Darni's testimony is those of the most critical cycles looking at the early cycles from this endpoint of this continuation due to early bleeding the comment with respect the aminucci and that you need to look at the nexus that this court is recognized between a product and its properties again and nothing to do with this case that's a molecule and I agree wholeheartedly the position of this court when it comes to molecule pens is that the compound and its properties are inexorably intertwined this is not a compound path this is about a regiment a regiment that's explained in column one that we think about line 51 that's a difference from the prior art or in the amount of effigin is maintained over three phases whereas you have an increasing amount of projected that is the teaching across the entire spectrum of that patent and that's why when you look at and I do believe that the law actually looks at cases such as this with a position through the eyes of a person or in their skill in the art and there is some amount of rational thought that goes behind that and the reason why this court says look at it through the eyes of the first court in their skill in the art is so that you don't find a million possibilities what you find is one clear teaching an example for and in claim nine that there's a really good product out there it's called worth a try cycling you want to find a species within a genus there it is it right there and what is one of our very skill in the art do looking at the state of the art wanting to look at lower in estrogen which by the way the district court found at page eight twenty the person of her in their skill in the art wanted to create ortho oc regimens with lower ebilsages that was a fine-line district court and I would also point you to the grind testimony from ortho at the age six to four five and six to six seven with respect to lowering the estrogen delts where he said even there's a problem potentially that there may be some lower cycle control yeah we're moving forward that way but as that's the way the market was headed I see but that by that time is out you appreciate you taking the time I'm putting it back into my time thank you we thank both counci