[00:00:57] Speaker 03: We will hear argument next in number 18-1397, UCB against Watson Labs. [00:01:13] Speaker 03: And because you've decided to stand up three times instead of four times, we will feel free to discuss both the 414 and the 434 in your opening argument. [00:01:24] Speaker 03: And you might feel free to do the same. [00:01:33] Speaker 04: Thank you, Judge Toronto. [00:01:34] Speaker 04: May it please the Court, John O'Quinn on behalf of activists. [00:01:37] Speaker 04: I intend to focus most of my argument on the doctrine of equivalence, but if I may, I'd like to start very briefly with anticipation of claim one of the 434 patent. [00:01:46] Speaker 04: The district court found that Cygnus disclosed, quote, retigatine freebase present in the matrix in the absence of water, end quote. [00:01:55] Speaker 04: And it found that Cygnus teaches the replacing of the water of example 15 with other solvents. [00:02:01] Speaker 04: That's at appendix 156. [00:02:02] Speaker 04: But then it somehow found that Cygnus did not disclose a patch containing ritigatine freebase. [00:02:08] Speaker 04: It reasoned that applying the conditions of example 15, the ritigatine would be primarily in its salt form. [00:02:15] Speaker 04: Now, respectfully, that doesn't make sense. [00:02:18] Speaker 04: First, even while it said that freebase was missing, it acknowledged that 1.28% of the ritigatine would be freebase. [00:02:25] Speaker 04: That's appendix 158, and it's relying on or citing appendix 4530. [00:02:31] Speaker 04: And the fact that the salt, rather than the free base, might primarily be present, a point the district court emphasized twice on 158, is legally irrelevant. [00:02:40] Speaker 04: More importantly, UCB's Dr. Lane admitted that in Cygnus, quote, the free base is the form of the drug that permeates through the skin. [00:02:47] Speaker 04: That's at 4560. [00:02:48] Speaker 04: And the person would have understood that at the time. [00:02:52] Speaker 03: Is Cygnus in the absence of water? [00:02:55] Speaker 04: So Cygnus discloses the absence of water. [00:02:57] Speaker 04: Example 15 of Cygnus uses water, but Cygnus specifically teaches that you can replace the water with ethanol. [00:03:06] Speaker 04: That's at 5709 of the appendix is where that is in Cygnus. [00:03:10] Speaker 04: And the district court found that you could make that type of substitution. [00:03:14] Speaker 04: Cygnus' disclosure, of course, of replacing water with ethanol is also presumed to be enabled. [00:03:19] Speaker 04: And again, as Dr. Ling testified, what works is the free base. [00:03:24] Speaker 04: not the assault. [00:03:25] Speaker 04: So that should be the end of the matter. [00:03:28] Speaker 04: That requires reversal as to claim one, based on anticipation. [00:03:32] Speaker 04: And obviousness should follow as to the other claims. [00:03:34] Speaker 04: Now, unless there are further questions on those issues, let me turn to the doctrine of equivalence. [00:03:41] Speaker 04: And the court should reverse the finding of infringement as a matter of law, because UCB is not entitled to a range of equivalence that includes polyisobutylene, given the narrowness of its claims [00:03:52] Speaker 04: intentional decision to pursue acrylates and silicones, but not PIBs, as well as the election it made in response to the examiner's restriction requirement. [00:04:01] Speaker 04: In other words, no matter how you slice it, this is not an appropriate case for the doctrine of equivalence. [00:04:07] Speaker 04: It's not what it was meant for. [00:04:08] Speaker 04: Instead, as Festo holds, the doctrine of equivalence is premised on the limits of language, and here there is no doubt that they had the words [00:04:17] Speaker 04: for a PIB-based system. [00:04:20] Speaker 04: And you know that for several reasons. [00:04:22] Speaker 03: In Gravertank, the manganese and the magnesium were, I think, understood at the time of filing to be substitutes for each other. [00:04:32] Speaker 03: Why does that not decide this? [00:04:34] Speaker 04: Well, I think, Judge Toronto, a few things. [00:04:36] Speaker 04: First, subsequent to Gravertank, you have the Supreme Court clarifying the doctrine of equivalence in [00:04:43] Speaker 04: Warner Jenkinson and Festo. [00:04:45] Speaker 04: And in Warner Jenkinson. [00:04:47] Speaker 03: But not specifically addressing any kind of circumstance in which the alleged equivalent was a mean equivalent before or in circumstances where there was a mere restriction requirement, et cetera. [00:05:03] Speaker 03: That is, circumstances like this. [00:05:05] Speaker 04: So certainly the Supreme Court didn't address exactly the details of a case like this. [00:05:10] Speaker 04: But I think it said a few things that are instructive. [00:05:13] Speaker 04: In Warner Jenkinson, it said that the time that's relevant for known interchangeability is the time of infringement, number one. [00:05:21] Speaker 04: Number two, when you look at Festo, Festo is premised, and the decision there is premised on the notion that there are limits to language. [00:05:32] Speaker 04: And Festo says, when you have a situation where there has been a narrowing, then you know a forciari that they had the words. [00:05:40] Speaker 02: Now the question would be- I'm getting a little confused. [00:05:42] Speaker 02: Are we talking about prosecution history estoppel right now, your prosecution history estoppel argument, or your what you call narrow claiming argument? [00:05:50] Speaker 04: Sure, Judge Chen. [00:05:51] Speaker 04: So first, the point that I'm making doesn't depend on the prosecution history estoppel point. [00:05:58] Speaker 04: I think that here, you have a situation not only where PIB was foreseeable by the inventors, it was foreseen. [00:06:06] Speaker 04: And so this is a situation where, as Festo puts it, [00:06:09] Speaker 04: when the inventor turned their attention to the subject matter in question, they knew the words for both the broader and the narrower claim and affirmatively chose the latter. [00:06:18] Speaker 04: And I don't think that that reasoning is necessarily or should be limited to the context of where you have prosecution history estoppel. [00:06:26] Speaker 04: Now, here the case is even easier because prosecution history estoppel should apply based on the restriction requirement. [00:06:34] Speaker 04: And I think this Court's decision in Pacific Coast Marine [00:06:38] Speaker 04: Yes, that was a design patent rather than a utility patent, but there's nothing in the reasoning of this Court's decision that suggests that that should make any difference. [00:06:47] Speaker 04: And in fact, if you look at the reason for the restriction requirement in Pacific Coast Marine, it was that you could only have one invention because you can only have one claim in a design patent. [00:06:59] Speaker 04: The same is true here. [00:07:00] Speaker 04: The restriction was because you could only have one invention. [00:07:03] Speaker 04: And you have the same policy concerns, which is this. [00:07:07] Speaker 04: The restriction requirement and the election that follows still rebuts the inference that the thing that was not described was indescribable. [00:07:18] Speaker 04: Which, again, gets back to the premise of prosecution history estoppel in FESTO. [00:07:22] Speaker 03: Isn't there this difference? [00:07:25] Speaker 03: One thing that a restriction requirement does not do, implicitly or otherwise, is say that this identical claim on this identical specification is not patentable. [00:07:36] Speaker 03: Everything else, the indefiniteness and obviousness in Honeywell Sunstrand, whatever the rejections that led to the changes in FESTO and everything else, [00:07:47] Speaker 03: involve the examiner saying you cannot have this broad claim on this specification and now your attention is focused on how much you're going to narrow. [00:07:59] Speaker 03: Restriction just says we want two different patents. [00:08:02] Speaker 04: So two points in response to that Judge Toronto. [00:08:04] Speaker 04: First, that was entirely true in Pacific Coast Marine as well. [00:08:10] Speaker 04: Nothing that would have prevented them from pursuing a different patent on the other claims. [00:08:16] Speaker 04: the point that I think that that case ultimately turns on, and I think that point is even stronger here where you're dealing with words as opposed to pictures, is the fact that they had claims to an adhesive and chose not to pursue those claims, at least for purposes of this patent, means that they can have no argument that they didn't have the words. [00:08:36] Speaker 04: And that gets back to Festo and the idea that the doctrine of equivalence is premised on the limits of language, or as Sage Products put it, [00:08:44] Speaker 03: I wonder if you're making too much of this idea premised on the limits of language. [00:08:49] Speaker 03: Yeah, it is premised, but that's not synonymous with saying every time language is available, we will forbid you to find equivalence when you don't use available language. [00:09:01] Speaker 04: Sure, and there are other scenarios as well. [00:09:03] Speaker 04: I think Sage Products puts it best where it found no equivalence there. [00:09:07] Speaker 04: saying that there was quote no subtlety of language or complexity of the technology or any subsequent change i.e. [00:09:14] Speaker 04: in the in the technology [00:09:15] Speaker 04: that would have prevented them from seeking the claim that covered what they... Wouldn't this position have the following consequence? [00:09:22] Speaker 03: Suppose you know that there are a number of different adhesives out there, but you don't know, except for the two that you've tested, that they work for this particular purpose. [00:09:32] Speaker 03: And now I have to delay my filing of my application on the two that I know work in order to test others that are used for other purposes as adhesives. [00:09:44] Speaker 03: Why would [00:09:45] Speaker 03: forbidding the availability of the dock general equivalence be a good rule that would force you to delay the application in that circumstance? [00:09:55] Speaker 04: Well, Judge Tarantuo, I think if you look at the claims that they actually pursued here, these are claims to an acrylate-based or silicone-based polymer adhesive system. [00:10:07] Speaker 04: And what they effectively are now asking for is just a polymer adhesive system. [00:10:12] Speaker 04: They didn't have to include the words. [00:10:15] Speaker 03: The fact that they're asking to cover the PIB, is it? [00:10:18] Speaker 03: Yes. [00:10:18] Speaker 03: PIB doesn't mean that they're asking for any old adhesive. [00:10:23] Speaker 03: We don't know that on this record. [00:10:24] Speaker 04: Well, Judge Toronto, I would submit, given the differences that were documented, indeed, by the district court at appendix 128 between PIBs and silicones and acrylates and how they do their bonding, [00:10:39] Speaker 04: that on this it effectively vitiates the claim term. [00:10:44] Speaker 04: Because at that point, given the differences that were disclosed or that were known, if you're going to say that equivalence applies here, it's hard to see where it would not apply. [00:10:58] Speaker 02: But I guess if I could just follow up on what Judge Toronto was asking. [00:11:03] Speaker 02: It seems like I have that same concern, which is what do you do as an inventor when you know a couple options work and maybe there's a third option you're aware of that could also work for the same purpose, same goal, but, you know, that's going to require work, it's going to require experimentation, and are we going to require applicants to go forward with that additional work and experimentation [00:11:32] Speaker 02: to see whether or not that other potential option also works and then claim it as opposed to just allowing the applicants to go ahead and start applying for claims directed at things they know works under their experiments at the time. [00:11:51] Speaker 04: I appreciate the question Judge Chin and I think that here if you look for example at appendix 5916 you see that not only was it foreseeable [00:12:00] Speaker 04: that PIBs were known and were commonly interchangeable with these others. [00:12:07] Speaker 04: It was foreseen by the inventors. [00:12:09] Speaker 04: 5916 is their feasibility study. [00:12:13] Speaker 04: They specifically identify this as one of the three. [00:12:15] Speaker 02: So would it be fair to say you're not demanding that an applicant or an inventor go ahead and do that additional experimentation in order to write a claim broadly enough to cover polyisobutylene? [00:12:30] Speaker 02: The premise of your argument is they knew it already. [00:12:32] Speaker 04: That's exactly right, Judge Chen. [00:12:33] Speaker 04: That's my point, is that not only was it foreseeable, it was foreseen. [00:12:38] Speaker 04: And I'm not saying that they had to go off and do it. [00:12:41] Speaker 03: And the it here is they knew that it would work in for this particular process of delivering an effective dose of the underlying medication for treatment of Parkinson's. [00:12:56] Speaker 04: Well, what they knew and what the district court found at Appendix 127 is that PIBs were long known, along with silicones and acrylates, as pressure-sensitive adhesives that were well-suited for use in transdermal systems. [00:13:11] Speaker 04: And there's no suggestion by them that there would be a difference vis-a-vis ritigatine versus anything else. [00:13:20] Speaker 04: And I think that when you have that situation, you have a situation much like Tenaube versus ITC. [00:13:25] Speaker 04: where the inventors chose to define their invention in that case in terms of a specific base solvent combination, rather than in terms of categories of solvents and bases. [00:13:38] Speaker 04: And a person skilled in the art would have known that the patentee could have used a broader term. [00:13:43] Speaker 03: I want to change the topic before you sit down, and we'll restore your rebuttal time. [00:13:49] Speaker 03: And I want to ask you about the 414. [00:13:53] Speaker 03: What fact? [00:13:56] Speaker 03: about the completion of the inventive activity was not already part of this litigation when the issue was tried under the derivation heading that would have been part of it had it been tried under the essentially let's call it the priority heading [00:14:19] Speaker 03: I'm trying to get a sense of what concretely was missing or whether this is just you didn't say the right label. [00:14:28] Speaker 04: Well, I understand. [00:14:31] Speaker 04: And with respect to the latter part, I don't think that's any small thing in terms of the waiver here. [00:14:37] Speaker 04: But let me address the first part of your question. [00:14:40] Speaker 04: And that's this. [00:14:42] Speaker 04: Evidence of derivation doesn't answer the question of whether or not there's been sufficient communication for joint invention. [00:14:50] Speaker 04: So you don't have just a single inventor here who allegedly did everything. [00:14:54] Speaker 04: You have different inventors having different roles. [00:14:57] Speaker 04: And you can see, for example, at appendix 3952, one of the inventors, Wolf, testifies that it was Queer who did the analytical work. [00:15:08] Speaker 04: It was Reidner who did the chemical synthesis. [00:15:10] Speaker 04: And there's no suggestion that they were all doing it together. [00:15:13] Speaker 04: They were doing this independently. [00:15:16] Speaker 04: And the question then is, where does [00:15:19] Speaker 04: does conception actually get communicated among the joint inventors? [00:15:26] Speaker 04: Because you can only be a joint inventor, as Eli Lilly says at 376. [00:15:30] Speaker 04: I'm sorry. [00:15:31] Speaker 03: I thought that there was a quite full record about what happened between the awful event of either early August or July or something of the precipitate and the eventual filing of November 30th, where [00:15:48] Speaker 03: Everything was detailed about the communications between UCB and the LTS. [00:15:55] Speaker 03: I'm sorry, what was missing? [00:15:57] Speaker 04: So two different things. [00:15:59] Speaker 04: I guess there are two different sets of communications that your question is referencing, Judge Toronto. [00:16:04] Speaker 04: Yes, there were a number of elaborate communications between UCB and LTS. [00:16:10] Speaker 04: And of course, that actually gave rise to our derivation argument. [00:16:15] Speaker 04: And we've briefed that, of course, and you can see that on the papers. [00:16:18] Speaker 04: But that wasn't about the communications among the inventors themselves. [00:16:23] Speaker 03: So Queer and Wolf are UCB. [00:16:25] Speaker 03: Where's Reitner? [00:16:26] Speaker 04: He is UCB as well, I believe. [00:16:29] Speaker 04: And about the communications among them and the different roles that they had. [00:16:33] Speaker 04: And yes, there was testimony about what they did in their respective roles in order to say that what they did was not derived from LTS, but not about the communications between them. [00:16:45] Speaker 04: So when you have that, and then you have, of course, [00:16:48] Speaker 04: In the pretrial order itself, UCB is identifying the invention, the November 28, 2007 is the date that it's relying on and saying that what it's going to show is that there was no use, not that there was earlier invention. [00:17:04] Speaker 04: And similarly, the expert in his testimony at trial, Appendix 4336, is relying on November 28, 2007. [00:17:13] Speaker 04: And that's what he's asked about in his rebuttal exam after our cross-examination. [00:17:19] Speaker 04: He specifically asked about whether or not there was use before November 28, 2007. [00:17:25] Speaker 04: If they were going to argue that there should be, that the invention was before that, they needed to say something about that before their post-trial brief. [00:17:34] Speaker 04: And the district court was right and well within its discretion to find that was waived, just as it had found that we had waived a non-infringement argument as well. [00:17:42] Speaker 04: sauce for the goose and sauce for the game. [00:17:44] Speaker 02: Can I just pivot you back to the Doctrine of Equivalence? [00:17:47] Speaker 02: Yes, Judge Chen. [00:17:50] Speaker 02: I'd like you to speak to ring and pinyon. [00:17:52] Speaker 02: Sure. [00:17:53] Speaker 02: In 834, the court said excluding equivalents that were foreseeable at the time of patenting would directly conflict with these holdings that known interchangeability supports infringement under the Doctrine of Equivalence. [00:18:07] Speaker 02: So what are we supposed to do with that statement? [00:18:11] Speaker 02: as to your narrow claiming argument. [00:18:14] Speaker 04: Right. [00:18:14] Speaker 04: So with respect to Ring and Pinyon, I think you have to look at the context in which that case came to this Court, which was on a stipulation from the parties below, in which they had literally stipulated if foreseeable equivalents are barred by the doctrine of equivalents, then party X wins, and if they're not, party Y wins. [00:18:35] Speaker 04: And the Court was answering the question, is there a per se bar [00:18:41] Speaker 04: to the doctrine of equivalence based on foreseeability. [00:18:44] Speaker 04: And this court answered that question, no. [00:18:46] Speaker 04: And I'm not relying just on foreseeability for purposes of our narrow claiming argument. [00:18:52] Speaker 04: I'm also principally relying on the idea of the limits of language. [00:18:56] Speaker 04: That is, Sage Products itself acknowledges that you might have something that would have been foreseeable, but subtlety of language or complexity of the technology would be a reason that you wouldn't expect it to have been specifically claimed. [00:19:10] Speaker 04: They can't argue that here, particularly given their own feasibility study at appendix 5916. [00:19:16] Speaker 04: This is a case of buyer's remorse. [00:19:18] Speaker 04: They knew about it. [00:19:19] Speaker 04: They chose not to claim it. [00:19:21] Speaker 04: And particularly when you add on top of that the fact that you do have the restriction requirement here in which they elected and then ultimately voluntarily canceled their claims. [00:19:32] Speaker 04: And this court in Festo 9 on remand from the Supreme Court said voluntary cancellation gives rise to a presumption of [00:19:38] Speaker 04: of prosecution history of Staple. [00:19:42] Speaker 03: I think we should hear from the other side and we'll restore your rebuttal time. [00:19:45] Speaker 04: Thank you, Judge Tarantino. [00:19:50] Speaker 03: Mr. Blumenfeld. [00:19:51] Speaker 01: Thank you, Your Honor. [00:19:54] Speaker 01: I want to briefly start where Mr. O'Quinn started and that is with Cygnus claim one and then hopefully move on to the doctrine of equivalence issues. [00:20:05] Speaker 01: The Cygnus patent, which they are arguing anticipated claim one, was raised in the patent specification and specifically distinguished on the basis that it was not the free base and it was in water. [00:20:21] Speaker 01: It was the main reference that was distinguished throughout prosecution on the same basis. [00:20:31] Speaker 01: uh... examples of rutigotine in the Cygnus application are examples fifteen and sixteen both of them are in water they're in a phosphate buffer which the record is not disputed. [00:20:46] Speaker 03: So did Judd Stark reject the anticipation idea or yes the anticipation idea that you could take the piece of Cygnus that says you can use ethanol instead of water and [00:21:00] Speaker 03: essentially combine it with the particular examples of rigatine in water? [00:21:06] Speaker 01: What Judge Stark said was that, correctly, that in another part of the Cygnus patent application, it refers to using other polar solvents than water. [00:21:20] Speaker 01: There's no example of it, and more importantly, he specifically found that there was nothing in the record [00:21:28] Speaker 01: that of what would happen if you put the rotigatine into ethanol or into another polar solvent. [00:21:38] Speaker 01: He said there was just no evidence of what form the rotigatine would take. [00:21:42] Speaker 01: And that's because activists didn't make any record of that. [00:21:46] Speaker 01: They put in no evidence of what would happen [00:21:50] Speaker 02: So then are we supposed to take from Cygnus when it says you can use a lot of other different solvents, including ethanol, that Cygnus was just being speculative and it wasn't actually teaching the use of ethanol as a replacement for water? [00:22:07] Speaker 02: I mean, why would Cygnus say what it said unless it contemplated that there were a number of different solvents that could be used, including ethanol, and then here are some [00:22:18] Speaker 02: examples we've made, but nevertheless, the scope of the disclosure encompasses using many different solvents, including ethanol. [00:22:29] Speaker 01: Well, what the Cygnus patent application says, if you read it, is that the drugs, and it's not only ritigatine, but the other drugs that are in there, are placed in an aqueous phase with hydrated silicate. [00:22:48] Speaker 01: And that is that there is water there. [00:22:51] Speaker 01: Those are the only examples it gives. [00:22:54] Speaker 01: That's the only teaching it has. [00:22:56] Speaker 01: There is a statement, or maybe two, in the specification that say you could use a polar solvent such as ethanol. [00:23:04] Speaker 01: There's no example. [00:23:06] Speaker 01: But there's nothing, I take your honest point, but there's nothing that tells you what you would get if you put ritigatein into ethanol. [00:23:17] Speaker 01: There's no conditions. [00:23:18] Speaker 01: There's no information. [00:23:20] Speaker 01: And that's where Judge Stark went. [00:23:22] Speaker 01: He said, yes, they're pointing to ethanol. [00:23:27] Speaker 01: And I think, as a basic matter, you don't take one part of the patent application and plug it into an example for another part. [00:23:35] Speaker 02: Sometimes you can. [00:23:36] Speaker 01: Well, sometimes you can. [00:23:37] Speaker 01: But here, there was really no information which would lead you to do that. [00:23:41] Speaker 01: And what he said was, if you did it, [00:23:44] Speaker 01: There's no record as to what you would get. [00:23:46] Speaker 02: There's no record. [00:23:47] Speaker 02: Where did Judge Stark say that about ethanol? [00:23:52] Speaker 00: Somewhere in A154 to 158, if that was the section. [00:24:04] Speaker 01: Excuse me. [00:24:06] Speaker 01: It is at A158. [00:24:26] Speaker 02: I see. [00:24:33] Speaker 01: What he said was, it's possible that ritigantine would be present primarily in its neutral base form, but activist has presented no evidence to that effect. [00:24:53] Speaker 01: If I [00:24:53] Speaker 01: can turn to the doctrine of equivalence unless there are more questions about Cygnus. [00:25:01] Speaker 01: There is no issue here that activists' system using PIB is substantially equivalent to the claim to mention. [00:25:15] Speaker 01: That was something [00:25:17] Speaker 01: that there was a lot of evidence on Judge Stark found and there is no appeal on that point. [00:25:22] Speaker 01: No claim anywhere that anything he found was clearly erroneous. [00:25:28] Speaker 01: There's also no disclaimer or disavowal, never has been an issue of disclaimer or disavowal, never came up at claim construction or anywhere else. [00:25:39] Speaker 02: Can you explain what happened in the Wrigley opinion? [00:25:42] Speaker 02: The Wrigley opinion seems like the closest [00:25:47] Speaker 02: case for the other side to describe that when an inventor is aware of a possibly broader class of compounds that can be claimed, but for whatever reason chooses to recite a subset of that genus of compounds, [00:26:07] Speaker 02: then therefore the patent owner now is stuck with a scope limited to that subset of compounds per side in the claim and doesn't get to employ the doctrine of equivalence to capture the broader genus. [00:26:21] Speaker 01: Judge, I think there is more to Wrigley than that because when you read the Wrigley opinion and the lower court opinion, that case involved the chemical structure of a chemical compound. [00:26:37] Speaker 01: And during claim construction, the district court held that there was a disclaimer of non, I think it was carboxamides of that structure, that there was an express disclaimer based on the information both in the claim and in the specification. [00:26:57] Speaker 01: And it held that. [00:26:59] Speaker 02: But what do we mean there was an expressed disclaimer? [00:27:03] Speaker 02: Because neither the claim nor the spec ever referred to that larger genus and said, but we really like and prefer this particular subset of compounds, and that's why we're claiming the subset only and not the broader genus. [00:27:18] Speaker 01: As I understand the spec, it was completely silent as to that broader... I don't... I mean, I have to say I haven't read the specification of the patent at issue there, but from reading the opinion and Judge Bryson's opinion on appeal, certainly they both said that the non-Carboxamids that were claimed had been disclaimed and that had come up, unlike here, that had come up during claim construction. [00:27:47] Speaker 01: And the defendant, or the counter-defendant, I guess it was there, specifically asked to have that excluded, and it was excluded. [00:27:57] Speaker 01: And under those circumstances, the Court said you can't go in and claim that by equivalence. [00:28:04] Speaker 01: We have a very different situation here where there was no disclaimer and no argument that there was a disclaimer, no amendment, [00:28:17] Speaker 01: disclosure dedication. [00:28:18] Speaker 02: Inventors knew about PIB, though, right? [00:28:21] Speaker 02: There's no question that... And they had reported out that PIB was known to be used as a possible polymer for design of these transdermal patches. [00:28:33] Speaker 01: There is no question, Your Honor, that there is evidence in the record that Dr. Mueller, who was the inventor that was involved here, knew that [00:28:46] Speaker 01: PIB could be used as an adhesive in transdermal patches. [00:28:53] Speaker 01: Getting back to a point that Judge Serrato made, when they applied for the patent, they had only done work on transdermal patches using silicone or acrylate adhesives. [00:29:07] Speaker 01: That's all they had done. [00:29:08] Speaker 01: That was their experience. [00:29:09] Speaker 01: And it was kind of refreshing that they applied for a patent application, which was based on the work that they had done [00:29:15] Speaker 01: and didn't include work they hadn't done. [00:29:17] Speaker 01: What Dr. Mueller said was that he had used PIP. [00:29:23] Speaker 02: Would the group two claims that got restricted out of the application encompass PIP? [00:29:28] Speaker 02: Would the group two claims that got restricted out during the prosecution encompass PIP? [00:29:35] Speaker 01: That's an interesting question, Honor, because that was a different question. [00:29:40] Speaker 02: It's either a yes or no answer, I think. [00:29:42] Speaker 01: Well, the reason I would say that [00:29:45] Speaker 01: it, based on the prosecution history, would not cover PIV. [00:29:50] Speaker 01: And this is in the judges. [00:29:53] Speaker 01: The judges would not literally cover PIV because it included PVP, as the examiner said, and therefore would only include the silicone and not the acrylate. [00:30:10] Speaker 01: But that, you know, whether there would have been equivalents [00:30:14] Speaker 01: uh... will never know i mean that's an interesting issue because there was never an amendment the limitation that we're talking about here during any prosecution rejection [00:30:29] Speaker 03: Actually, I would say the restriction... Can I get back to something I think we were discussing just a little bit earlier about Mr. Mueller and others? [00:30:40] Speaker 03: What evidence is there that even though he and others knew that PIB was a candidate for transdermal patch adhesive, that there was... is there evidence that [00:30:57] Speaker 03: Nevertheless, there might have been some doubt about whether it would work for this particular transthermal factor. [00:31:03] Speaker 01: Your Honor, I don't know. [00:31:05] Speaker 01: I think the answer to that is that Dr. Mueller hadn't tested it, didn't know. [00:31:11] Speaker 01: His experience with PIB here was in a liquid form as a tachifier. [00:31:16] Speaker 01: That he did testify to. [00:31:19] Speaker 01: But the claim limitation that we're talking about here is not simply [00:31:26] Speaker 01: the polymer adhesive system, it also has to have a solubility of at least 5 percent for the free base of retigatine. [00:31:39] Speaker 01: That is part of the claim and that was a key part of the claim in getting the application. [00:31:46] Speaker 03: And I guess what I'm trying to understand at least one better level of concreteness [00:31:55] Speaker 03: is Mr. Elquin's description of a situation in which the inventor knows full well that A and B are substitutes. [00:32:08] Speaker 03: Both of them absolutely could work in this claim, claims only A. It's troubling to say, even though with all of that knowledge and not even any doubt about whether B would work, you left B out. [00:32:23] Speaker 03: And now you're going to get it. [00:32:26] Speaker 03: Why is this case different from that case? [00:32:29] Speaker 01: Well, I mean, for a couple reasons. [00:32:32] Speaker 01: One, because there is no evidence of the this would work just the same. [00:32:38] Speaker 01: I mean, there's no evidence that Dr. Mueller knew that when they were applying for the patent. [00:32:45] Speaker 01: He applied for what he knew worked because they had tested it. [00:32:47] Speaker 03: What was Mr. O'Quinn referring to when he said he did foresee it? [00:32:51] Speaker 03: He gave a side I didn't write. [00:32:53] Speaker 01: I'm sorry. [00:32:54] Speaker 03: Mr. O'Quinn said, not only was this foreseeable, it was foreseen. [00:33:00] Speaker 03: And I think he referred to a specific document. [00:33:03] Speaker 01: And I think that is an overstatement. [00:33:06] Speaker 01: There certainly was a technology report at LTS where they listed before the application was filed, where they listed different types of polymer adhesives. [00:33:19] Speaker 01: And it was in the list. [00:33:20] Speaker 01: Was it ever tested with retigatine freebase [00:33:24] Speaker 01: which is what's claimed here, no. [00:33:28] Speaker 01: Was there any information about the solubility of the free base in PIB as there was with silicone and with acrylate? [00:33:39] Speaker 01: No, there wasn't. [00:33:40] Speaker 01: But to get back to your question, there are lots of limitations on the doctrine of equivalence. [00:33:46] Speaker 01: Amendment is one, and I think there was never an amendment here of this term. [00:33:52] Speaker 01: Disclaimer is one. [00:33:54] Speaker 03: They've been pretty careful to avoid the ones that are obviously not present and to point to the prosecution history rationale statement in Festo and the kind of sage products kind of notion of you chose this language, you're stuck with it, and that they're making arguments that are available to them. [00:34:21] Speaker 01: Right. [00:34:21] Speaker 01: But as to the argument that there is some kind of limitation on the doctrine of equivalence as a result of what's in someone's head, there is no authority that I know for that. [00:34:35] Speaker 01: And, in fact, that is exactly opposite to this Court's decision in Ring and Pinyon. [00:34:41] Speaker 01: And as for the kind of that was old law, that was a 2014 opinion, and the issue [00:34:50] Speaker 01: in Ring and Pinyon was exactly the issue here. [00:34:55] Speaker 01: And I don't know how you could find a clearer statement from this court. [00:35:03] Speaker 01: There is not nor has there ever been a foreseeability limitation on the application of the doctrine of equivalence. [00:35:09] Speaker 01: Getting back to the policy issue, here we have a situation where the inventor knew that [00:35:17] Speaker 01: silicone and acrylate polymer adhesives would work, had never tested PIB, and the solubility was unknown, at least from the point of view of having tested it. [00:35:31] Speaker 01: The notion that they had to claim something or lose it by equivalence, even though they hadn't made it, hadn't tested it, really, I think, puts the incentives in the wrong place. [00:35:43] Speaker 01: You want to encourage people. [00:35:45] Speaker 01: to apply for patents on the work that they've done and not on things that might work in the future. [00:35:52] Speaker 03: Before your time runs out, can you turn to the 414 issue? [00:35:59] Speaker 03: Why was Chief Judge Stark wrong to say that this particular issue was not flagged and maybe the record would have been different? [00:36:13] Speaker 01: Your Honor, I would start off by asking that the panel look at Appendix 2426, which is a page from the pre-trial order, which specifically says that on September 23rd, 2007, that UCB, Dr. Carre, defined the structure. [00:36:38] Speaker 03: Let me just get to the focus that is in my mind. [00:36:43] Speaker 03: there's material to work with probably both sides about whether you raised it enough or not. [00:36:49] Speaker 03: Put that aside. [00:36:50] Speaker 03: Why is Mr. O'Quinn wrong in saying it made a difference in what would have happened in the litigation had you, that you did not raise it more clearly than you did? [00:37:04] Speaker 03: Some issue would have been tried, that wasn't an issue. [00:37:07] Speaker 03: I think the one that he focused on was [00:37:09] Speaker 03: the relation among the three named inventors or co-inventors, and I forget whether he was referring also to unnamed co-inventors, but something about communication. [00:37:20] Speaker 01: Your Honor, on the derivation point, I don't think there are any other facts that weren't tried, if that's what you're asking about. [00:37:28] Speaker 01: The communications between UCB and LTS [00:37:31] Speaker 03: The issue from our point about intra-UCB communications, I think is what he was considering. [00:37:36] Speaker 01: The intra-UCB communications are fine too. [00:37:38] Speaker 01: There was never any issue involving inventorship or derivation as between different UCB. [00:37:45] Speaker 03: Isn't that effectively his point? [00:37:48] Speaker 01: I don't think that is his point. [00:37:50] Speaker 01: I think his point from the briefs is that there were communications between the LTS people, like Dr. Mueller, [00:37:59] Speaker 01: and the UCB people like Dr. Wolf. [00:38:03] Speaker 01: If there was an issue on any of this, of course, there could be a 256 inventorship correction, but we never got to that point. [00:38:11] Speaker 03: Just to try to create a concrete version of what I thought Mr. O'Quinn was arguing. [00:38:20] Speaker 03: In order for there to be a [00:38:23] Speaker 03: completion of the invention by the three co-inventors, we actually would have to know when Mr. Reidner, what he did and when. [00:38:32] Speaker 03: That was actually completely irrelevant to the derivation question. [00:38:37] Speaker 03: And so there would have been something more to try had this issue been identified more clearly. [00:38:45] Speaker 01: I don't think there was anything more to be tried. [00:38:47] Speaker 01: We know exactly when Dr. Reidner made the 42. [00:38:52] Speaker 01: There is a report that's in the record dated November 14, 2007. [00:38:56] Speaker 03: Do you do the first one or the second one? [00:39:00] Speaker 03: There were two methods, right, for making the Form 2. [00:39:03] Speaker 01: One was ethanol and one was the ethanol. [00:39:05] Speaker 01: Yes, the second one. [00:39:07] Speaker 01: And at that time, the memo spelled out that there had been a conception and there had been a reduction to practice, and it involved [00:39:20] Speaker 01: the identification of the structure of the polymorph by Dr. Carré in September, and then the making of the Form 2 by Dr. Reidner in October. [00:39:34] Speaker 01: The three of them were not at the same location, but they were working together on this project. [00:39:40] Speaker 01: And I don't think there's any question, and I didn't understand before just now that Mr. Okun was raising an issue as between these inventors. [00:39:50] Speaker 01: Our issue [00:39:51] Speaker 01: as you know from our brief is a little different, and that is that we felt like we were sandbagged on the prior user defense where they didn't even put on a case prior user defense in their case in chief, and it was only during cross-examination of our expert that they brought out a document that had never been put in their exhibit list in the pretrial order. [00:40:17] Speaker 01: That's why we think we haven't waived anything about the conception reduction to practice dates because they didn't raise it until they were into our case. [00:40:27] Speaker 01: We had no reason to have earlier dates until they raised a date of alleged public use before the application date. [00:40:39] Speaker 01: Unless you have anything else, I will. [00:40:42] Speaker 01: Thank you. [00:40:47] Speaker 03: in five minutes. [00:40:48] Speaker 04: Thank you, Judge Toronto. [00:40:49] Speaker 04: Let me respond on the last point that my friend said, and that's this. [00:40:53] Speaker 04: This idea that they were sandbagged, at trial, you can look at appendix 4379. [00:40:58] Speaker 04: They didn't object to the admission of the exhibit that he's talking about. [00:41:01] Speaker 04: They didn't object to its use at trial at all. [00:41:04] Speaker 04: And as far as the point that Your Honor was having the colloquy with him a moment ago, that is exactly my point. [00:41:10] Speaker 04: The issue of when inventorship actually occurred was not litigated. [00:41:15] Speaker 04: precisely because they didn't put us on notice that that was an issue that they were contesting. [00:41:20] Speaker 04: Now, there may have been other issues as well. [00:41:23] Speaker 03: Maybe my memory isn't very good. [00:41:26] Speaker 03: I don't remember in your brief here when responding to the challenge to Judge Stark's waiver issue. [00:41:39] Speaker 03: waiver ruling that you identified this joint inventorship issue. [00:41:46] Speaker 03: Tell me if I'm just wrong. [00:41:48] Speaker 03: I remember coming away from the briefing thinking I don't have a single concrete point in my mind about why this made any difference. [00:41:59] Speaker 04: Yeah, Judge Toronto, I [00:42:04] Speaker 04: Of course, the way this got briefed, we're responding to them as part of our, you know, our consolidated reply. [00:42:11] Speaker 03: No, I understand. [00:42:14] Speaker 04: And I don't recall off the top of my head whether we made this precise point or not. [00:42:19] Speaker 04: The point that we did make was that it would obviously have prejudiced us from the ability to contest issues at trial, including when this purported conception and reduction of practice actually happened among the joint inventors. [00:42:33] Speaker 04: and that we had been led down the Primrose path because of every single step, whether it was in the pretrial order or at trial with their expert's affirmative testimony or the questions that their expert was asked on rebuttal when we had raised the issue of use and they were on notice. [00:42:48] Speaker 03: Didn't Chief Judge Stark find in the course of rejecting the derivation argument that there was conception and reduction to practice by October 30th? [00:43:00] Speaker 04: I don't recall Judge Sorrento that he made a specific finding that there was conception and reduction to practice by that date. [00:43:06] Speaker 03: I do recall that he found that what they did was separate from... That they identified using the right form of crystallography and then reproduced it by October 30th. [00:43:21] Speaker 03: What else is there? [00:43:23] Speaker 04: But that goes again to there being different individuals having different roles at different points in time. [00:43:29] Speaker 04: And if they're going to then say, OK, well, that gives rise to an earlier priority date, this business that they were not on notice of that we were arguing of use prior to November 28 is simply not true. [00:43:40] Speaker 04: You can look in the joint pretrial statement. [00:43:43] Speaker 04: We specifically identified that as of November 12, they were telling the FDA that these things were being used in the United States from Lot 47808, which necessarily contained these crystals. [00:43:56] Speaker 04: Let me, if I may, turn to our affirmative appeal. [00:43:59] Speaker 04: I think the Wrigley case here is indistinguishable. [00:44:03] Speaker 04: And I think what's telling about Wrigley and its reasoning, number one, is obviously there's no limit on language there that would have prevented the claiming. [00:44:11] Speaker 04: And number two, it specifically distinguished other cases, like Abraxis, where it was unknown at the time of patenting that an alleged equivalent was a suitable substitute. [00:44:22] Speaker 04: And so when my colleague says, well, there's no case that looks at what would have potentially been in the inventor's head, [00:44:29] Speaker 04: Well, maybe not in their head specifically, but what would have been known to a person of ordinary skill of the art at the time of patenting? [00:44:37] Speaker 04: Wrigley is directly on point, and I think Judge Bryson's decision, joined by Judge Newman, is indistinguishable in this regard. [00:44:45] Speaker 04: And very much like what was at issue in Tanabe versus ITC as well. [00:44:52] Speaker 04: And Judge Chin, you asked sort of a policy question here. [00:44:57] Speaker 04: Shouldn't we be concerned about inventors in new fields having to run out and test lots of different things before they submit their patent application? [00:45:06] Speaker 04: Don't we want to encourage them to go ahead and submit it? [00:45:10] Speaker 04: I think it's worth taking a step back and just recalling the context in which they pursued this patent. [00:45:15] Speaker 04: This is a patent where they tried to claim narrowly to get around the Cygnus prior art. [00:45:21] Speaker 04: I don't think they did that, and I'll come back to that as my final point, but to try to get around [00:45:25] Speaker 04: the Cygnus prior art. [00:45:26] Speaker 04: They had worked with Cygnus, and now what they were essentially doing was replacing water with a different solvent. [00:45:34] Speaker 04: And they knew full well that these were the three most common adhesives. [00:45:42] Speaker 04: This is not just some long laundry list. [00:45:44] Speaker 04: The site that I referenced, Judge Toronto, that you were asking about a moment ago is 5916. [00:45:49] Speaker 04: It is the feasibility study by inventor Mueller. [00:45:53] Speaker 04: And the strategies, it says, for the formulation of matrix systems with a self-adhesive matrix formulation, the following adhesives are most commonly used. [00:46:01] Speaker 04: Silicone-based adhesive, polyacryl resin-based adhesives, polyisobutylene-based adhesives. [00:46:08] Speaker 04: They chose to claim the first two and not the third, and they gave up claims that would have reached the third in their election under the restriction requirement. [00:46:17] Speaker 03: We're going to require pollining to this now. [00:46:19] Speaker 04: All right. [00:46:20] Speaker 04: Thank you, Judge Troncett. [00:46:21] Speaker 03: Thank you. [00:46:21] Speaker 03: All counsel, the case is submitted.