Morning ladies and gentlemen. We have five cases on the count of this morning. Three pattern cases and two veterans, P.S., a ladder, being submitted on the breach, and will not be argued. The first case is Duramid. I don't know this table. This is Paddock, 2010, 14, 19, Mr. Brammer. Good morning, Your Honours, and may I please the court
. Today, this court reviews the summary judgment of the district court that found that a particular equivalent was foreseeable and therefore outside the scope of the doctrine of equivalents. That judgment was an error for two reasons. First, the district court misapplied the standard for foreseeability because it took a particular sentence from this court's FESTO-10 decision out of context, and therefore applied a per se rule that if an equivalent was identified in the prior art or mentioned in the prior art, it was, as a matter of law, foreseeable. There is a mention to a lot of times, but are I here to talk about polyvinyl alcohol? Your Honour, we're talking about a specific polyvinyl alcohol coating, Opadry AMB, that Paddock used. And in terms of those mentions, I think the main reference that was at issue below was a PCT application applied for by ColourCon. That PCT application noted that all of the previous attempts to make a PVA coating for pharmaceutical applications had been unsuccessful. Back up moment, don't we have to assume that someone's still in the art with known that the PCT application? Certainly, if we were dealing with the anticipation or obviousness, it's clear that we would assume that a person's still in the art with no all the prior art. Certainly, this Court's case law goes to that side. If it's in the prior art than a person's ordinary skill would have known of it
. Now, whether that was the original intention of the Supreme Court in creating a foreseeability exception or way of rebutting the presumption, I think is less clear. But isn't our in bank in FESTO? So it seems to me in discussing foreseeability, we knew pretty clear that you would assume that a person's skill in art with no all the prior art was that there was one sentence in particular on 1377 that would have said indeed the alleged equivalent would known in the prior art and the invention of certain engineering foreseeability. Does that suggest that the person's skill would know of PCT application? I think you're correct, Your Honor, that the assumption would be that a person's ordinary skill or a reasonable applicant, however you want to phrase it, would know of that PCT application. But there is still a disputed question of fact as to what that PCT application actually taught particularly in conjunction with the other information available on the record. Listen to each exactly the same coding that we're feeling with you. It did teach the Opadrya and B coding, but the important fact was that it also taught that all previous PVA, PVA based coding had been unacceptable. They were too tacky, their plasticizers compromised their moisture barrier properties and made them unsuitable for pharmaceutical applications. And we have expert testimony on the record that because the PCT application didn't include any data to show that the Opadrya and B coding actually work to overcome these disadvantages of prior PVA based coatings, a person of ordinary skill in the art wouldn't have accepted or believed that Opadrya and B would have been usable in the pharmaceutical context. And that's the context that this court has to look at the equivalent through the lens of
. Whether this Opadrya and B coding would have been understood at the time, December 1998 when the amenable was made, to be usable with a pharmaceutical composition that involved a moisture sensitive active pharmaceutical ingredient like conjugated destrogens. And as I mentioned, the inventor testimony we have available in the record shows that a person of ordinary skill would have required stability data. Data showing whether the moisture sensitive active pharmaceutical ingredient actually degraded in a tablet that was coded with Opadrya. The irony is that they made it work in the assuming. Excuse me, Aaron? The irony is that they made it work. They're using D.D.G. right? Well, they certainly made it work and this goes
. So, the assuming the remainder of the claim that says the moisture barrier comprises ethyl sedulums by this procedure. Correct, Your Honor. And this goes really to the issue that several of the discourse previous decisions have gone to, which is the issue of before and after developed technology. And this happens to be a technology that was right on the cusp of development at the time of the amendment. So the PCT application we're talking about was published in 1996. What's left is the factual dispute about whether a person of ordinary skill in the art would have read that PCT application. And from that actually taken away from it that Opadrya and B could have been used as the coding in an actual pharmaceutical composition. Based on the language in the PCT application itself disparaging previous PVA based coding and the fact that the.
.. What about the coding that was playing in the PCT application? It is, but it was never tested. There's no test data provided in the PCT application. That test data to show whether it actually worked would only have come later. And even the later data, and there is some dispute about whether that data is in the prior art, shows mixed results. Confusing data that, you know, on one side of the scale it may have suggested, you know, there were certainly conclusions in some abstracts that suggest that Opadrya and B could have been used as a moisture barrier coding. But in those same abstracts it provides statements that suggest that various characteristics of this coding such as sorption, desorption, hysteresis and other things would have potentially made it unsuitable for pharmaceutical applications. So there are a lot of references to this. There's a German patent, a very man-hine, mentioning PVA for this purpose
. There's manufacturing, chemist, a document, paper-fired, Whiteman, Jordan, and all the other stuff. Well, you're on our, and I think that goes to two different things. The Gropenbacher patent from 1976, that doesn't actually discuss the use of PVA as a moisture barrier coding. That actually talks about the use of PVA either as a sustained release agent, and this court is previously dealt with the use of PVA as a sustained release agent in the Smith Klein case, which I'll discuss in a moment, or as a subcode to help apply the actual moisture barrier coding. So that's not actually the use of the Jordan reference, and this is the May 1995, I believe, abstract. No, you may not be 90-95. Correct. So that doesn't actually describe open-dry AMB. It describes color cons attempts to make a PVA based moisture barrier coding and the problems it ran into using other plasticizers like polyethylene glycol, 400 or 4000
. And from that development effort, they later found that soy elacetin might overcome these disadvantages. Now, those later efforts were also discussed in abstracts, but the main point is there was no evidence on the record to show that these abstracts were part of the prior art. That's kind of the fundamental factual question that needed to be resolved at summary judgment. Now, the district court ignored those abstracts, and I think while that reaches the correct end, it did so for the wrong reasons. The district court applied a per se rule that evidence that a particular equivalent was unsuitable for the claimed invention was irrelevant. It didn't matter, as long as the equivalent was mentioned in the prior art according to the district court, it was foreseeable. What case suggest that there had to be proof of suitability? Well, I think this court did it in the companion cases of Blackso versus Apatex and Smith Klein versus Excel. In Blackso, this court said it scoured the record for any evidence of a verifiable scientific reason that the equivalent in question there was not suitable for use with the claimed invention. The only evidence that was found in question was that the court did not find enough evidence to sustain summary judgment
. Only after it found no such evidence did it allow summary judgment to be affirmed. On the flip side, in the Smith Klein case, where the same patent was at issue, the same limitation was at issue, but a different equivalent was being considered, the court didn't find enough evidence to sustain summary judgment. What case suggest that in order to have a be foreseeable doubt, the court did not find enough evidence? Well, I think that the Blackso case does, because the only way that summary judgment was affirmed there is after finding that there was no verifiable scientific reason to show unsuitability of the equivalent for the claimed invention. I think that the court's Festo decision itself has language to the same end. In the Festo 2003 decision, this court noted that the original purpose of the sleeve that was at issue there was to hold certain magnets in place. In the case of the equivalent in question, the aluminum sleeve was probably not going to be unforeseeable because aluminum was well known material. But it remained in the case anyway for further trial on that issue by the district court, particularly because it wanted to give the patent to determine or to provide evidence to show whether it would have been foreseeable that unforeseeable that aluminum could be used in that particular invention. With those particular rare earth magnets. Now, of course, when the case came back up to this court in 2007, Festo had changed somewhat its argument
. It was looking at a different purpose. So instead of looking at the original purpose of the sleeve, which was to hold the magnets in place, it was now arguing that because the sleeves were magnetizable post amendment, their actual purpose was to provide some shielding. And this court, I think, correctly found that that purpose, the post amendment purpose, wasn't properly the focus of the foreseeability inquiry. Here, the claims original purpose and the claims post amendment purpose was the same. It was to provide a moisture barrier coating or the limitations purpose at issue was the same. And that was to provide a moisture barrier coating for a pharmaceutical product that had a moisture sensitive active pharmaceutical ingredients, specifically conjugated estrogens. So here. But because you've got really the opposite to your argument that if the PDA was foreseeable, it was a moisture barrier. Is that sufficient? No, it isn't, Your Honor
. Because moisture barrier coatings are used in a number of applications, only some of which, and only some coatings would be suitable for a pharmaceutical application. We have to be a specificity with the NO, the NO side of us. Does it have to be that specific? No, under the A property of moisture barrier foreseeable with a moisture barrier? Well, I don't think that the prior art would have to show that a PDA moisture barrier coating was equivalent in terms of the function way result test to an ethyl cellulose moisture barrier coating. And I think this court's Festo 10 decision pretty clearly resolved that. But the factual issue, the factual dispute here, and what is set up by the expert testimony on the record, is that in order for a person of ordinary skill in this art, to believe that a PVA based coating could be used with a pharmaceutical composition, they would have to see stability data. Data that showed that when you put the coating on an actual tablet with a moisture sensitive API in it, the API wouldn't degrade under certain stability testing conditions. So that's really the question that the district court should have been trying to resolve, but it did not get to that point because it simply applied its personal. I see that I'm in my rebuttal time. I'll say before you. Thank you, Your Honor. If you please, the court, good morning, Your Honors. Ed Hough for the appellate. This is a very straightforward case of prosecution history of stoppil and why in this instance it clearly precludes reliance on the doctrine of equivalence. There's nothing unusual about this case in our view for sure. The patentee here, Duramed, made a deal with the patent office. They filed their original claim one. I think the problem is it wasn't known to be suitable for this kind of application. So is there such a requirement? No, there's no requirement under Festo that it be known to be suitable for the use as a moisture barrier coating comprising Ethylcellulose, the post-element claim
. Thank you, Your Honor. If you please, the court, good morning, Your Honors. Ed Hough for the appellate. This is a very straightforward case of prosecution history of stoppil and why in this instance it clearly precludes reliance on the doctrine of equivalence. There's nothing unusual about this case in our view for sure. The patentee here, Duramed, made a deal with the patent office. They filed their original claim one. I think the problem is it wasn't known to be suitable for this kind of application. So is there such a requirement? No, there's no requirement under Festo that it be known to be suitable for the use as a moisture barrier coating comprising Ethylcellulose, the post-element claim. I think what we have to look at is it suitable, not suitable, is it foreseeable for use as a moisture barrier coating. Which it clearly is. All those references that Your Honors have already asked about do talk about just that. PVA being used as a moisture barrier coating, a film coating, Opadry AMB is aqueous moisture barrier. It's right in the trade name that they used for this product that was commercially sold by ColourCon prior to the date we're talking about the date of the amendment here. It was also published in technical articles. In fact, two of those articles that we cite were authored by Expert Buckton, who was Duramed's expert in this case. What about the PCP outpriced and self-sufficient? Yes, I think it is. And Judge San found that patent, he also relied on a few other references, prior references, to find the support clearly for why it was foreseeable
. I think what we have to look at is it suitable, not suitable, is it foreseeable for use as a moisture barrier coating. Which it clearly is. All those references that Your Honors have already asked about do talk about just that. PVA being used as a moisture barrier coating, a film coating, Opadry AMB is aqueous moisture barrier. It's right in the trade name that they used for this product that was commercially sold by ColourCon prior to the date we're talking about the date of the amendment here. It was also published in technical articles. In fact, two of those articles that we cite were authored by Expert Buckton, who was Duramed's expert in this case. What about the PCP outpriced and self-sufficient? Yes, I think it is. And Judge San found that patent, he also relied on a few other references, prior references, to find the support clearly for why it was foreseeable. He didn't rely on four of them. He didn't say they were not in evidence. He just didn't rely on them because there was an objection at the hearing. I think if you look at column 10, check the patent, there is this, a lot of alternatives to weapon cellulose. I was thinking that the manufacturer, the cellulose, they eliminated all those. But PVA isn't there, very simply. How does that relate to the foreseeability? They didn't foresee it, but they listed six, seven lines of other alternatives. I think the standard, the test is not whether or not the inventors here sought to be foreseeable, particularly not when they wrote their patent application. The test, the legal test, is whether a person of ordinary skill in the art would find the only alleged equivalent, but PVA in this instance would be foreseeable
. He didn't rely on four of them. He didn't say they were not in evidence. He just didn't rely on them because there was an objection at the hearing. I think if you look at column 10, check the patent, there is this, a lot of alternatives to weapon cellulose. I was thinking that the manufacturer, the cellulose, they eliminated all those. But PVA isn't there, very simply. How does that relate to the foreseeability? They didn't foresee it, but they listed six, seven lines of other alternatives. I think the standard, the test is not whether or not the inventors here sought to be foreseeable, particularly not when they wrote their patent application. The test, the legal test, is whether a person of ordinary skill in the art would find the only alleged equivalent, but PVA in this instance would be foreseeable. That is why we go to these prior references, all of which were before the amendment was made a few years after the filing of the application. I think that may very well be correct, yes. But I don't believe it wasn't the application, it's correctly noted by your honors. In the briefing, to the extent we follow the briefing, I believe it's being urged that the standard should be suitability. I don't believe there's any legal support whatsoever. We haven't found the case that supports a doctrine of suitability in order to find foreseeability. Suitability equals foreseeability. We don't know really what it is suitable for. We just have a finite legal authority to support their position, whereas I think Festa and all the other cases sit in our briefs do support our position that doctrine of equivalence is not applying this case because of the prosecution history of stop what that occurred
. That is why we go to these prior references, all of which were before the amendment was made a few years after the filing of the application. I think that may very well be correct, yes. But I don't believe it wasn't the application, it's correctly noted by your honors. In the briefing, to the extent we follow the briefing, I believe it's being urged that the standard should be suitability. I don't believe there's any legal support whatsoever. We haven't found the case that supports a doctrine of suitability in order to find foreseeability. Suitability equals foreseeability. We don't know really what it is suitable for. We just have a finite legal authority to support their position, whereas I think Festa and all the other cases sit in our briefs do support our position that doctrine of equivalence is not applying this case because of the prosecution history of stop what that occurred. I really have nothing more to add to the briefing unless you're on as have any questions. I really have to penalize place to where I'm doing. Thank you. Mr. Bromand, do you have any other questions? I do, your honors. Two points. The first is whether there's any case law to support this suitability requirement. I think Smith Klein is clear. In Smith Klein and Glaxo, the two cases, the court considered prior art that disclosed the equivalent in question and that prior art was before the patent office in the prosecution history
. I really have nothing more to add to the briefing unless you're on as have any questions. I really have to penalize place to where I'm doing. Thank you. Mr. Bromand, do you have any other questions? I do, your honors. Two points. The first is whether there's any case law to support this suitability requirement. I think Smith Klein is clear. In Smith Klein and Glaxo, the two cases, the court considered prior art that disclosed the equivalent in question and that prior art was before the patent office in the prosecution history. But in Smith Klein, the court remanded the case for further proceedings because it wanted the patent to have an opportunity to show whether that particular sustained release agent, which coincidentally was PVA, would have been known to be a suitable equivalent for use in that particular case. The case is talking about known in the field of the invention they don't talk about known for use. Well, your honor, it talks about it certainly being known in the field of the invention, but what it has to be known to do is to be usable with that invention. At least as the invention existed, at least as it existed pre- amendment, correct? That would have been valid if that happened. I don't believe so, your honor. You're talking about an anticipation. Well, no, I don't believe that it has to be specifically with conjugated estrogens, but for example, if there's no evidence in the record that conjugated estrogens are special compared to other moisture sensitive active pharmaceutical ingredients, I don't think there has to be a specific reference that says use PVA with conjugated estrogens. But there does have to be.
. But in Smith Klein, the court remanded the case for further proceedings because it wanted the patent to have an opportunity to show whether that particular sustained release agent, which coincidentally was PVA, would have been known to be a suitable equivalent for use in that particular case. The case is talking about known in the field of the invention they don't talk about known for use. Well, your honor, it talks about it certainly being known in the field of the invention, but what it has to be known to do is to be usable with that invention. At least as the invention existed, at least as it existed pre- amendment, correct? That would have been valid if that happened. I don't believe so, your honor. You're talking about an anticipation. Well, no, I don't believe that it has to be specifically with conjugated estrogens, but for example, if there's no evidence in the record that conjugated estrogens are special compared to other moisture sensitive active pharmaceutical ingredients, I don't think there has to be a specific reference that says use PVA with conjugated estrogens. But there does have to be... I mean, as Dr. Tori points out, it was known to use it with the chemical or invention, with this particular estrogens compound. That would be anticipatory. So what do you mean by suitable? I mean that it would have to have been known to have been usable with pharmaceutical compounds that were moisture sensitive. This particular coding would have to be known to be usable with moisture sensitive pharmaceutical compounds, because that's what this invention was. A pharmaceutical composition with a moisture sensitive active pharmaceutical ingredient. And in Smith's client, this court specifically asked the patentee.
.. I mean, as Dr. Tori points out, it was known to use it with the chemical or invention, with this particular estrogens compound. That would be anticipatory. So what do you mean by suitable? I mean that it would have to have been known to have been usable with pharmaceutical compounds that were moisture sensitive. This particular coding would have to be known to be usable with moisture sensitive pharmaceutical compounds, because that's what this invention was. A pharmaceutical composition with a moisture sensitive active pharmaceutical ingredient. And in Smith's client, this court specifically asked the patentee... asked the op... ...remended so that the patentee could get an opportunity to show.
.. asked the op... ...remended so that the patentee could get an opportunity to show... We have to face it doesn't show that it would be suitable for this moisture variant. It doesn't show it to the satisfaction of a person of ordinary skill in the art. But that, at least from a factual standpoint, and this is a summary judgment case, there was expert testimony to show that a person of ordinary skill would not have accepted that the lack of data in the PCT application would have overcome the statements about previous PVA-based coatings being unacceptable and pharmaceutical compositions. There was no stability testing, stability data in the PCT application that would have shown that opadry A and B was suitable for that purpose. The other question that Judge Lurie mentioned was, does the subjective knowledge of the inventor's matter, I think that's kind of where Judge Lurie's question was going. And while it may not be dispositive, it certainly is one fact that would suggest what the outcome should be on an objective for seeability analysis. Thank you. Thank you