Our first case this morning is Lily versus Zena Goldleine. Mr. Medlek. Initially, I would like to simply note that with respect to our appeal from the inequitable conduct defense, I have to ask any questions from the panel or comments made by Lily. It is our intention to handle that during our reputal and to focus the opening 10 minutes on the other issues. The issue before the court, first issue that we want to address, of course, is the anticipation issue. The issue is certainly not what is explicitly shown or stated or expressed in the Chakrabardi 1988 reference. Well then why are we talking about anticipation if there is no express showing of each and every feature of the claimed invention in a single reference? Your honor, if an express showing were required, we wouldn't have cases such as pedering, shaman, the principles of which have been reaffirmed. Reaffirmed by this court is recently as two weeks ago in the out of the universe, is great lakes case and earlier than that in the Bristol-Mirror Squib versus Ben Benude decision. We are entitled to look to what one of skill in the art would envision when he or she reads the reference. And here it is important to note that one of skill in the art is not a lawyer or judge even a patent examiner. How many compounds are envisioned within the Chakrabardi article? How many in total? Your honor, that's a question that I don't think I read. I read 45, 58, 75 or thousands and you're telling me there's anticipation here? What I'm telling you, your honor is if we follow the pedering analysis and apply it to the Chakrabardi reference and even more compelling case for envisioning by those skills in the art is presented. We have in the Chakrabardi reference a broad statement of a genus contrary to what the district court found, contradicting itself by acknowledging that there is indeed a family of compounds. If we look in the reference itself there is a figure with ours and our ones and our twos and a table that tabulates different substitutions. We also have, as in the pedering case in the Chakrabardi pattern specifically, which was the prior art there, we have something that focuses the attention of the reader of one skill in the art. To something more manageable, yes, if we look at the broad genus it could literally be an infinite number of compounds
. It could be thousands. But we do have something that focuses the attention precisely as in pedering. In pedering it was six examples which expressly disclosed eight compounds. No particular statement that the compounds were good, bad or indifferent, those were the eight that were chosen. It could focus the attention of the reader and again it's important to note the reader here is a PhD medicinal chemist. We'll focus your attention to the pedaling of the lens of the pen. In this case your honor we submit that what focuses your attention is if you go from the broad genus disclosed in the Chakrabardi reference then there are 45 particular compounds that are tested and then there are five that are singled out as preferred. In pedering the CCPA took the eight compounds and tabulated the substitution pattern that you arrive at. There was nothing in the Kaur patent to identify a particular substitution pattern, the court did it, and used that as a vehicle to determine what does one skilled in the art see. Here if you take the five compounds and realize that that provides a focused, smaller, more manageable group to look at and engage in the same exercise, you get the tables that we have produced on pages 19 and 20 of our opening brief. Once you have that you come up with 18 compounds. Now interestingly of the 18 compounds 11 of them, 11 are expressly identified in the reference. The five preferred and then there are another six that are there. It requires only one to excuse me, I have that back, or a seven that are expressly there. It requires you to envision only another 11. Again we submit when you're talking about a PhD chemist, he's going to see those compounds just as surely as if they're expressed in name
. That's of course the words of the CCPA in the Schaumur case. He'll envision them, the entire subgenus just as surely as if they're identified by name. I would have thought that you would really focus on the obviousness argument. I mean the five, am I correct that the five Chacobardi compounds are, if you look at 22702 and 703 of the, excuse me the joint appendix are 9, 12, 7, 29 and 34. Those are the preferred ones. They are what are referred to as the preferred compounds. Yes sir. Now the one that's, I mean it seems that 9, 12, 17 and 29 all are marked by a presence of flooring. I'm probably maybe not saying this in the chemical way properly. So bear with me on that. Now 34 is different. Compound 34, the last of the five preferred seems to be different. How does compound 34 match up with a landspede or ethical landspede? How does it match up with it in terms of going from one to the other? Well, Your Honor, to go from one to the other in that particular instance you'd have to make two substitutions. Our argument is not that compound 34 is the closest prior art from which the obvious analysis should be judged. Oh no, I understand that. No, I appreciate that
. The reason I was asking is that it, I mean it seemed that in the Chacobardi article it's indicated that halogens with flooring show some enhanced acts. And I noted that of the four of the five preferred compounds in Chacobardi for them, the first four all have flooring in them. And I was wondering what if anything was meaningful about 34 because the thrust, I mean I think what Judge Young was saying is that Chacobardi would teach away from starting with ethical landspede on an obvious analysis and then going to a landspede. Because he's saying you know these have all got flooring in them, but then you have this 34 that didn't. So I apologize for being sort of round about. No, that's perfectly right. It's taking out loud with you. I think if I may, focusing attention on compound 34 really suggests the obvious analysis that we've done with respect to flumezoping, it's the more appropriate analysis if you're going to look at the floor and even compound. Okay. Flumezoping. How do you get around the unexpected results? How do you get around the extensive analysis of secondary considerations, even if you do engage in a bit of a stretch to get to a primaface case of obviousness? Well, you're on with respect to flumezoping which I'll dispose of quickly. There is no unexpected result. And even the court, the district court acknowledged that flumezoping would be a place to start. The only unexpected result of this argued was elevated liver enzymes and the court basically found that the assertion made in Lily's IBS, the information disclosure statement to the patent office to the extent that there to the effect that there wasn't unexpected superiority of a landspede over flumezoping turned out to be untrue. As to the more focused inquiry of the secondary indicia, your honor as it relates to obviousness of a compound 222, if we weigh what's there, and again we submit that what needs to be done here is you have to weigh the factors favoring obviousness and the factors favoring non-obviousness here. I would respectfully disagree with your honor that we have to stretch to get to structural obviousness here
. Lily conceded it at the patent office. Lily itself, when it submitted its application acknowledged that compound 222 is the closest prior art in that it was the next adjacent homologue. In the last month, we have the on bank decision of this court in Dillon, which tells us that when you've got such close compounds, you would expect the next adjacent homologue relying on the CCPA decision in Papish to result in similar properties. We don't need absolute predictability, but we need a reasonable expectation that the properties would be similar, not better than. So if we begin with a compound which is so closely related to a landspede, namely compound 222, with knowledge to be sold by Lily itself, that's on one side of the ledger. All Lily has, when you toll up everything, is the so-called cholesterol evidence. That's really what the case turned on as far as unexpected result. And what exactly is that evidence? That evidence, which also turns out to be something less than the patent office considered it to be, is simply that test showed that in female beagle dogs, given some 20 times the projected human therapeutic dose, it was noticed that cholesterol was elevated with Ethyl Lanzapine compound 222, as contrasted with Lanzapine. The district court expressly found that to the extent Dr. Scruby's declaration suggested that that result was extrapolatable to humans, it was misleading. Now the court doesn't need to decide whether that is intentional or not to realize pursuant, for example, to the court's decision in the Sintex versus Apatex case, that the premise for which this patent was allowed has been, had its legs cut out from under it. That evidence should be given such minimal way, it cannot be said to apply to a significant aspect of the invention, particularly when we realized that cholesterol was one of close to 50, close to 50 toxicity tests that were done and several tests going to pharmacological properties. That tells us that, and as to everyone but cholesterol, Ethyl Lanzapine, at least is good, if not better. If, by happenstance, your honor, Ethyl Lanzapine was not the one that was formulated and that could have happened, if it was a Lanzapine that came first, we'd be arguing here about a patent on Ethyl Lanzapine. We'd be hearing about the better results and the unexpected results of Billy Rubin, an albumin, an erythricite count, all suggesting the unexpected superiority of Ethyl Lanzapine over a Lanzapine. That's all the unexpected results that get you here, is one little factor on Lily's side of the scale to be contrasted with the overwhelming similarity of the molecules
. Then we have, again, then you go to flumezapine how close they are, one substitution away, Lily's own acknowledgement that these are so close, that these are the closest prior art that needed to be overcome. I see that I'd probably into my rebuttal time already, Your Honor. Thank you for your question. Ethyl Lanzapine, that's off patent right now. I'm sorry? Ethyl Lanzapine is off patent. The patent covering it is no longer effective, isn't it? The underlying patent, I believe, has expired yet. So why not use that as a molecule for anti-psychotic drugs? Well, to do that, Your Honor, that would somewhat defeat the entire purpose of the Hatchwaxman Act. We'd have to go file an NDA to all the studies that are necessary. Hatchwaxman allows us to work with what's on the market for which an NDA is orbiting file. Presumably nothing would stop anybody from doing that. But interestingly, your Honor, for the 20 or so years that the underlying patent was available, Lily now tries to denigrate their own patent as the literature of failure, it was out there protecting this entire class of molecules and preventing people from doing an immunable work with them. Well, Lanzapine was essentially disclosed in that as one of the species, isn't it? We certainly agree with that. It was admittedly covered by the claim. Okay. Thank you, Mr. Mendelich
. Mr. Lipsey. May I please the Court the problem with the anticipation analysis which Sina has advocated? Is it asked this Court to make a factual finding regarding what would be envisioned in the mind of a person of ordinary skill in the reading Jackrabardi in 1988 without also considering all the other information that's also in the head of that person when that person reads the article. That article by its terms is addressed to the search for a safe atypical antipsychotic drug. The trial court here made extensive findings about what people engaged in that search knew and more importantly didn't know. The evidence showed that the cause of schizophrenia was unknown. There was no animal model of the disease. While you could test for the myriad properties known to in here and close the beam, nobody knew which combination of those was responsible for atypical efficacy. No one knew which combination was responsible for toxicity. The crude animal tests, which is all that's disclosed there, were not predictive of atypical efficacy in man. They were only indicative of potential antipsychotic activity. Many compounds that had been identified with those tests in fact it failed in the clinic. People knew that safe atypical antipsychotic efficacy could really only be established by testing and actual schizophrenia patients. What about the five preferred compounds that were disclosed by Chuck Boy? Of those five, four had a halogen atom, an electron withdrawing with the priori called luraleptic substituent. The fifth had a hydroxyethyl group. And while little was known about structure activity relationships in this area, two things were known
. Those two groups had acquired a special status in the art. The luraleptic substituent was believed to be important to antipsychotic activity and you saw it on all of the compounds that were put forward as potential replacements for close the beam. The hydroxyethyl in the trial court made a finding right on this, was known to enhance antipsychotic potency by improving penetration into the brain. So when a person of ordinary skill in the art with everything that that person knows in his head reads Jackerbardi and sees a description of five compounds. Four with the art recognized luraleptic substituent. One with the art recognized hydroxyethyl substituent. The trial court found is a fact that that person would not immediately envision a compound like a lanzapine that has neither one. And that finding of fact is not clearly erroneous and it disposes of the anticipation contention on appeal. What about the chuckle party number six, which was also high activity type of a compound? That's exactly the point, Your Honor. It wasn't a high activity compound. Compound six did not have the car score of three, which was the minimal activity that was proven at trial. I mean, necessary for identification. It had a two on it though. It had a two. It was found to be inadequate compounds with a two were not identified as preferred in any of the Jackerbardi writings. Closer peen had an activity of three and it was only compounds with an activity of three or four that were considered for further development
. So that analysis actually disposes and if I may, compound six was specifically not one of the ones called out as preferred. So when you look at the five. Not one of the five. But it was listed. It was listed along with 45 other individual compounds. And it had marginal activity. It had marginal activity. But it was not low activity. It was marginal. It was one point removed from activity. Well, Mrs. Is Good as a Myel is my old grandmother used to say, Your Honor, it was not sufficiently active to be a potential candidate for development as a safe, atypical anti-sacotic drug. Now, one thing that was said in the opening, there is no generic disclosure in Jackerbardi 1988 that encompasses all kinds of pain, the way there was in the formula in Petering and in Chalman. We've dealt with that in our brief. It simply isn't there. Now, that same analysis, that same extensive factual finding that the trial court made about what's actually in the head of people of ordinary skill in the art also disposes of the obviousness argument
. The trial court found as a fact that there was no legitimate motivation to start with compound 222 that had an inadequate car score of only two and lacked the neuroleptic substituent as a development candidate in the first place. Is that, in part, is that because of the first four of the five preferred compounds are all have the fluorine orientation. Correct. And the Ethelolanzapine does not. Does not. More does it have the hydroxyethyl group that was on the fifth that also was recognized in the art as improving potency? That's exactly the point. They tried to say that compound 36 or 34, whatever the number was, showed that hydrogen was preferred. It showed no such thing. It showed that hydroxyethyl was preferred. Why would compound 34 not point you to Ethelolanzapine? Because Ethelolanzapine didn't have the hydroxyethyl group on it either. Those compounds, Ethelolanzapine compound 6 compound 222, whatever you want to call it, was an uninteresting backwater in Jack Robardi 1980A and became of interest only after Lily later discovered that it's adjacent home blog happened to be the solution to the search for a safe at the Galatasagodic drug. Now, again, the trial court found no major motivation to start with 222, no legitimate motivation to modify it other than by putting a neural optics substituent or a hydroxyethyl group on it, no legitimate motivation to take the neural optics substituent office when may be and that would have been going in exactly the opposite direction of the weight of authority in the art. Is that what the unobviousness type of a situation you're claiming is that the removal of the halogen was contraindicated by the law. Well, Flomazine was to a Lanzapine because the rest of the structure is the same isn't it? That's correct, but that was a hugely important. But the rest of the structure is the same. The rest of the structure is the same, but that's like saying that the car without the engine and the car with the engine, the rest of the structure is the same
. Well, except the people skilled in the art and the evidence here is overwhelming perceived that neural optics substituent like a halogen atom to be hugely important in obtaining it as a kind of activity. And while it might have been obvious arguably to change it to some other electron withdrawing component, it certainly would not have been obvious that the trial court so found to take it off and not replace it with any other neural optics substituent. And more importantly, what is the replacement in all unzapine then? They're both methyl, right? No, but the fluorine is over on the other side of the... But it's over on the other side of the... And that to get to a Lanzapine, first of all, you can't just take it off, you have to start with a whole new chemistry. But the molecule of a Lanzapine doesn't have it there and it doesn't have any other neural optics substituent in its place. And in that respect, that is in part why it was so unobvious. But they're both methyl bases. They both have a methyl substituent, but a Lanzapine does not have the neural optics substituent that everybody working in this field, regarding it so important. And secondly, the court found there was no reasonable expectation of success in making either of these modifications. You ended up with a molecule that lacked the neural optics substituent or the hydroxyethyl, both of which were known to be important to making these molecules go. The art was highly, highly unpredictable. There were rafts of failures. And I think if you do nothing more than read the first paragraph of the Davis article, which is at page 1809 of the record, that will give you a feel for the degree of difficulty that people in this art were encountering in attempting to find a safe, a typical, anisecotic drug failure after failure after failure. And what was the source of the failure? It was posited not to be the fluorine atom, as Zenath contends. It was suggested that it was the hetero atom, the sulfur or the nitrogen that was in the ring system, that perhaps was the problem. And if you change that, you would never end up with a Lanzapine. Now, if you want to talk about properties, the evidence in the record shows, with respect to these compounds, exactly what people in this art already knew. Small structural changes in closepine replacement type molecules led to unpredictable and grade changes in properties. For example, the record showed, if you took ethyl to lumeza peen, it created all kinds of blood problems in dogs. But the adjacent homolog, the methyl compounds, lumeza peen, didn't create those problems in dogs. The ethyl substituted compound, 222, and a garden variety toxicology test, done at the doses that everybody at Lillie used for this class of compounds, showed a very large, statistically significant increase in cholesterol in the female dogs at the 8 milligram dose, yet the methyl compound, one removed from it, did not. Small changes in structure lead to unpredictable changes in properties. And more significantly. Ethyl Lanzapine, though, was disclosed in the 574. It was not in the species. It was encompassed generically by the claim. It was encompassed broadly
. There were rafts of failures. And I think if you do nothing more than read the first paragraph of the Davis article, which is at page 1809 of the record, that will give you a feel for the degree of difficulty that people in this art were encountering in attempting to find a safe, a typical, anisecotic drug failure after failure after failure. And what was the source of the failure? It was posited not to be the fluorine atom, as Zenath contends. It was suggested that it was the hetero atom, the sulfur or the nitrogen that was in the ring system, that perhaps was the problem. And if you change that, you would never end up with a Lanzapine. Now, if you want to talk about properties, the evidence in the record shows, with respect to these compounds, exactly what people in this art already knew. Small structural changes in closepine replacement type molecules led to unpredictable and grade changes in properties. For example, the record showed, if you took ethyl to lumeza peen, it created all kinds of blood problems in dogs. But the adjacent homolog, the methyl compounds, lumeza peen, didn't create those problems in dogs. The ethyl substituted compound, 222, and a garden variety toxicology test, done at the doses that everybody at Lillie used for this class of compounds, showed a very large, statistically significant increase in cholesterol in the female dogs at the 8 milligram dose, yet the methyl compound, one removed from it, did not. Small changes in structure lead to unpredictable changes in properties. And more significantly. Ethyl Lanzapine, though, was disclosed in the 574. It was not in the species. It was encompassed generically by the claim. It was encompassed broadly. It was not described, in fact it hadn't even been made for years after that. And in fact, there's a lot of talk about the 574 patent. The 574 patent is a statutory bar printed publication in this case. Nothing more, nothing less. There is no double patenting issue in this case. No, we're not talking about double patenting. We're talking about obviously. Correct. But the way it's not that- Respect to whether or not the ethyl Lanzapine was already disclosed in the 574 patent. It was encompassed, but not disclosed, not described. It could not have been claimed specifically in that fact, because there was no description of that compound. But the genus covered it. The genus encompassed it, but that has long been the case. The genus claimed covered the ethyl Lanzapine. Correct. And as this court held in Enray Bayard, the fact that a compound may be encompassed by one of these very broad multi-million compound genuses in the prior art does not at all mean that it's obvious
. It was not described, in fact it hadn't even been made for years after that. And in fact, there's a lot of talk about the 574 patent. The 574 patent is a statutory bar printed publication in this case. Nothing more, nothing less. There is no double patenting issue in this case. No, we're not talking about double patenting. We're talking about obviously. Correct. But the way it's not that- Respect to whether or not the ethyl Lanzapine was already disclosed in the 574 patent. It was encompassed, but not disclosed, not described. It could not have been claimed specifically in that fact, because there was no description of that compound. But the genus covered it. The genus encompassed it, but that has long been the case. The genus claimed covered the ethyl Lanzapine. Correct. And as this court held in Enray Bayard, the fact that a compound may be encompassed by one of these very broad multi-million compound genuses in the prior art does not at all mean that it's obvious. Now, again, going back to properties. The properties that make a Lanzapine a safe, a typical Lannis-eggonic drug are hugely medically significant. They are highly unpredictable as the pattern of failure reflected, amply in the record shows, and they were long sought by many scientists working in this field. And that fact pattern has been found in cases such as Enray Bayard and later in cases like Yamannucci to be an unobvious patentable in advance. Indeed, this compound is patentable here for the very same reasons that the discovery of non-addictive analgesia in May was patentable. That property was highly significant, and it was a highly unpredictable art area. And if you read May closely, you'll see that the adjacent homologue in the prior art there actually turned out to be an unaddictive analgesic, albeit unknown to the art. Still unobvious because it wasn't disclosed in the prior art as a non-addictive analgesic. And here, notwithstanding everything you've heard and read in the brief, compound 222 is not disclosed in the prior art as a safe, atypical, antipsychotic drug. The 574 patent doesn't say anything about atypical properties at all for any of those compounds. So, see, where is the closest in the prior art that you come to an actual disclosure of compound 222, the Ethelolens? Well, compound 222 is explicitly disclosed in the prior art in Jacobarty, 1988. But other than that. Our point on that is the only thing that would cause you to start with that as a point of departure is hindsight, is knowing later on that the methyl compound, in fact, was the solution. And while they, their reply brief is rife with hindsight. It's rife with reference to our invention and the thought processes of our inventors. That's all totally improper
. Now, again, going back to properties. The properties that make a Lanzapine a safe, a typical Lannis-eggonic drug are hugely medically significant. They are highly unpredictable as the pattern of failure reflected, amply in the record shows, and they were long sought by many scientists working in this field. And that fact pattern has been found in cases such as Enray Bayard and later in cases like Yamannucci to be an unobvious patentable in advance. Indeed, this compound is patentable here for the very same reasons that the discovery of non-addictive analgesia in May was patentable. That property was highly significant, and it was a highly unpredictable art area. And if you read May closely, you'll see that the adjacent homologue in the prior art there actually turned out to be an unaddictive analgesic, albeit unknown to the art. Still unobvious because it wasn't disclosed in the prior art as a non-addictive analgesic. And here, notwithstanding everything you've heard and read in the brief, compound 222 is not disclosed in the prior art as a safe, atypical, antipsychotic drug. The 574 patent doesn't say anything about atypical properties at all for any of those compounds. So, see, where is the closest in the prior art that you come to an actual disclosure of compound 222, the Ethelolens? Well, compound 222 is explicitly disclosed in the prior art in Jacobarty, 1988. But other than that. Our point on that is the only thing that would cause you to start with that as a point of departure is hindsight, is knowing later on that the methyl compound, in fact, was the solution. And while they, their reply brief is rife with hindsight. It's rife with reference to our invention and the thought processes of our inventors. That's all totally improper. There is no shortcut. The analysis is dictated by the statute. The test is in the statute. The analysis is dictated by Graham versus John Deere. The stuff on which the analysis is done is the complete trial record. And when you do the Graham analysis on the complete trial record and use the test in 103, nobody, people of ordinary skill in the art, as a matter of fact, would not have gone this direction. They would have gone some other direction. And those fact findings are not clearly. Even if you start with the compound 222, it would not be obvious to go to the Ethelol. The compound 222 had the Ethelolubon. Right. It would not be obvious to go to the methyl. It would not be obvious to go to the methyl. The first of all, what somebody of ordinary skill in the art actually would have done would have been to take that compound and put some kind of electron with drawing some constituent on it to try to improve the properties. Maybe not fluorine, maybe chlorine, maybe something else. And even if you went so far as to say you'd start with 222, there wasn't any suggestion in there that methyl would be better than Ethelol for any purpose at all
. There is no shortcut. The analysis is dictated by the statute. The test is in the statute. The analysis is dictated by Graham versus John Deere. The stuff on which the analysis is done is the complete trial record. And when you do the Graham analysis on the complete trial record and use the test in 103, nobody, people of ordinary skill in the art, as a matter of fact, would not have gone this direction. They would have gone some other direction. And those fact findings are not clearly. Even if you start with the compound 222, it would not be obvious to go to the Ethelol. The compound 222 had the Ethelolubon. Right. It would not be obvious to go to the methyl. It would not be obvious to go to the methyl. The first of all, what somebody of ordinary skill in the art actually would have done would have been to take that compound and put some kind of electron with drawing some constituent on it to try to improve the properties. Maybe not fluorine, maybe chlorine, maybe something else. And even if you went so far as to say you'd start with 222, there wasn't any suggestion in there that methyl would be better than Ethelol for any purpose at all. And in fact, the only discussion in the article about short alkyl substitution is in two sentences that are dealing with the fluorine-substituted series. There are seven compounds in those two sentences. Eight, if you count the unsubstituted compound that Ethelol compared to, and the only series that has all eight of those compounds is the fluorinated series. The trial court found is a fact that the person of ordinary skill in the art knowing what they know would read those two sentences as relating to fluorinated compounds and not compounds like compound 222 that were not. Now, again, to make the point, 222 is not disclosed in the prior art as a safety typical antipsychotic drug. 574 says nothing about atypical properties. Jackerbardi 1980 says that the compound lacks the sufficient minimal activity to be of interest. And the fact of the matter is, the fact that there may be a handful of true pharmacological tests that you can do on the compound where you get roughly equal potent results does not equate with atypical antipsychotic efficacy in humans. We saw from the myriad failures of compounds that people thought had antipsychotic efficacy based on animal tests that turned out not to. And again, Dr. Paul testified about this. His testimonies in the appendix, Dr. Polar testified about it. Dr. Nichols testified about it. It's all right there
. And in fact, the only discussion in the article about short alkyl substitution is in two sentences that are dealing with the fluorine-substituted series. There are seven compounds in those two sentences. Eight, if you count the unsubstituted compound that Ethelol compared to, and the only series that has all eight of those compounds is the fluorinated series. The trial court found is a fact that the person of ordinary skill in the art knowing what they know would read those two sentences as relating to fluorinated compounds and not compounds like compound 222 that were not. Now, again, to make the point, 222 is not disclosed in the prior art as a safety typical antipsychotic drug. 574 says nothing about atypical properties. Jackerbardi 1980 says that the compound lacks the sufficient minimal activity to be of interest. And the fact of the matter is, the fact that there may be a handful of true pharmacological tests that you can do on the compound where you get roughly equal potent results does not equate with atypical antipsychotic efficacy in humans. We saw from the myriad failures of compounds that people thought had antipsychotic efficacy based on animal tests that turned out not to. And again, Dr. Paul testified about this. His testimonies in the appendix, Dr. Polar testified about it. Dr. Nichols testified about it. It's all right there. Those people would not perceive that compound as being in atypical antipsychotic drug. There is no evidence it's a safety typical antipsychotic drug at any dose. We dealt with all the other issues in our brief. Ford has the trial, Ford's opinion. The judge did a very careful and thorough job and to offend JC Penny, your honor. It's all inside. Is that by weight or number of pages? Either. I'm not by any measure. Either. Thank you. Thank you. Mr. Mentley, you have a little more than three minutes remaining. First, the suggestion that there is no evidence disclosed in the Chakrabardi 1988 reference is just wrong. There is a genus disclosed. The figure is there
. Those people would not perceive that compound as being in atypical antipsychotic drug. There is no evidence it's a safety typical antipsychotic drug at any dose. We dealt with all the other issues in our brief. Ford has the trial, Ford's opinion. The judge did a very careful and thorough job and to offend JC Penny, your honor. It's all inside. Is that by weight or number of pages? Either. I'm not by any measure. Either. Thank you. Thank you. Mr. Mentley, you have a little more than three minutes remaining. First, the suggestion that there is no evidence disclosed in the Chakrabardi 1988 reference is just wrong. There is a genus disclosed. The figure is there. It may not use the same patent parlance, but there's a figure. There are our groups. There's a genus as surely as they was in the Chakrabardi. It isn't Mr. Lipsey right. There was nothing in the art that would have led you if you want to start with flumezzapine to make the hydrogen substitution. Or if you want to start with two to two to make the methyl substitution. In the first place you wouldn't have started with either one of those. In the second place there would have been nothing to cause you to make the substitution. Where is the suggestion first for the starting and second for the substitutions? When all everything seemed to be teaching exactly to the opposite as 221 pages of district court opinion pointed out. First of all, you're on our we maintain that as we argue in our briefs there is no requirement to find a particular place to start. The only support for that is one statement in the M and Uchi case which was really a motivation to combine case when all told. There were pits and pieces from prior irreversible. The only support for that is a federal circuit opinion. Those are kind of binding on us. Your honor, the statement must be read in context of the facts of that case
. It may not use the same patent parlance, but there's a figure. There are our groups. There's a genus as surely as they was in the Chakrabardi. It isn't Mr. Lipsey right. There was nothing in the art that would have led you if you want to start with flumezzapine to make the hydrogen substitution. Or if you want to start with two to two to make the methyl substitution. In the first place you wouldn't have started with either one of those. In the second place there would have been nothing to cause you to make the substitution. Where is the suggestion first for the starting and second for the substitutions? When all everything seemed to be teaching exactly to the opposite as 221 pages of district court opinion pointed out. First of all, you're on our we maintain that as we argue in our briefs there is no requirement to find a particular place to start. The only support for that is one statement in the M and Uchi case which was really a motivation to combine case when all told. There were pits and pieces from prior irreversible. The only support for that is a federal circuit opinion. Those are kind of binding on us. Your honor, the statement must be read in context of the facts of that case. This seems to me to be as close to Yamanochia as anything I've read in the five or six years since that case. Your honor, the Yamanochia decision certainly didn't report to overrule such cases as Merc versus Biocraft, Mills, Bow, All, Sighted on Page 27 of our brief. The fact that a priori reference is not only available for a particular best disclosure as a starting point, even for example, Merc versus Biocraft. But one of skill in the art has to be able to perceive that this drug is useful for this purpose so that as that be motivated to make changes in it to reach the result in obviousness. And I don't see how one of skill in the art would perceive that any of these drugs are going the right direction or perceive that there's a suggestion to make an alteration to get there. Your honor in Dillon which came after May, Dillon made it very clear that you don't need both a structural similarity and an expectation of similar properties. Here we really do have both. Much as Mr. Lipsy wants to run away from Lili's 574 patent by trying to read into the claimed limitations such as safe and effective atypical antipsychotic, they're not there. We have a compound claim. Accordingly, the disclosure in 574 itself, in Chakrabardi 1988 itself, that these compounds, this class of compounds was chakrabardi. Chakrabardi tells us, after saying that this is an example of Fy preferred, this class deserves further study. That's enough motivation to take compounds that Lili itself said, well worthy of study would be reasonably expected, not absolutely expected. They don't have to be the best. We don't have to establish for obviousness that there's an expectation that what we will get when we go down a particular path will be better than something else. Fulton tells us, we can have more than one obvious substitution
. This seems to me to be as close to Yamanochia as anything I've read in the five or six years since that case. Your honor, the Yamanochia decision certainly didn't report to overrule such cases as Merc versus Biocraft, Mills, Bow, All, Sighted on Page 27 of our brief. The fact that a priori reference is not only available for a particular best disclosure as a starting point, even for example, Merc versus Biocraft. But one of skill in the art has to be able to perceive that this drug is useful for this purpose so that as that be motivated to make changes in it to reach the result in obviousness. And I don't see how one of skill in the art would perceive that any of these drugs are going the right direction or perceive that there's a suggestion to make an alteration to get there. Your honor in Dillon which came after May, Dillon made it very clear that you don't need both a structural similarity and an expectation of similar properties. Here we really do have both. Much as Mr. Lipsy wants to run away from Lili's 574 patent by trying to read into the claimed limitations such as safe and effective atypical antipsychotic, they're not there. We have a compound claim. Accordingly, the disclosure in 574 itself, in Chakrabardi 1988 itself, that these compounds, this class of compounds was chakrabardi. Chakrabardi tells us, after saying that this is an example of Fy preferred, this class deserves further study. That's enough motivation to take compounds that Lili itself said, well worthy of study would be reasonably expected, not absolutely expected. They don't have to be the best. We don't have to establish for obviousness that there's an expectation that what we will get when we go down a particular path will be better than something else. Fulton tells us, we can have more than one obvious substitution. Taking flumezapead, there's a clear motivation to judge himself found in the Sullivan and Franklin article to suggest that the fluorine itself might be causing toxicity problems. What better motivation than to just take it off? And if you take it off, your honor, you wind up with hydrogen. You don't have to substitute anything. And if you also consider obvious to substitute chlorine because of the disclosure, sure. But that doesn't make hydrogen less obvious. Particularly when you have a compound such as compound 34, which is one of the preferred Sullivan and Franklin. Sullivan and Franklin aren't recommending any substitutions or changes. They're just reporting the use of flumezapean in dogs. And they're suggesting that the fluorine might be a problem, which would say to one skilled in the art, there's my motivation to get rid of it. And if I have a motivation to get rid of it, where am I going to wind up? Any final comments here? Uh, definitely. Given the time, of course, you're out. I have plenty of money. I'm going to do the circumstances. Well, rest. Thank you very much. Our next case is
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