[00:00:00] Speaker 02: Okay, the next case before the court is 2010-98, Farring v. Allergan. [00:00:08] Speaker 02: Before we begin, I want to note that I just realized that of the six arguing counsel this morning, five are women, which makes me feel good. [00:00:18] Speaker 02: But in any event, we'll proceed with this case after my commentary there. [00:00:26] Speaker 02: And Ms. [00:00:27] Speaker 02: Bork, you have your five minutes for rebuttal. [00:00:29] Speaker 00: Judge O'Malley, I add my voice to your commenter. [00:00:35] Speaker 02: Oh, thanks. [00:00:36] Speaker 00: This is Judge Chen. [00:00:37] Speaker 00: I concur completely. [00:00:40] Speaker 01: Well, thank you, Your Honors. [00:00:42] Speaker 01: May it please the Court? [00:00:43] Speaker 01: The District Court's grant of summary judgment based on equitable stop in this case was improper for three reasons. [00:00:51] Speaker 01: The district court's application of equitable estoppel to Ferring's correction of his ownership claims under 256 based on pre-issuance conduct was an abuse of discretion and is in conflict with this court's precedent. [00:01:08] Speaker 01: Number two, there were disputed issues of material fact for each of the required elements of equitable estoppel. [00:01:16] Speaker 01: And number three, there were undisputed facts pertaining to Dr. Fine's intentional copying of Farrin's work that were not addressed by the court. [00:01:28] Speaker 01: As a preliminary matter, a cause of action under 256 does not accrue until the patent issues, based on the plain language of the statute. [00:01:39] Speaker 01: Judge Sweet's equitable estoppel finding was- This is Judge Jen. [00:01:45] Speaker 00: Yep. [00:01:46] Speaker 00: Do you think MCV is still good law? [00:01:51] Speaker 01: I think MCV is a pre-offerment case. [00:01:55] Speaker 01: I think it is sort of what I would call the exception to the rule, which is where you have, you know, equitable estoppel is an equitable doctrine. [00:02:07] Speaker 01: We must take into account the equities as between the parties. [00:02:11] Speaker 01: And in MCV, it was a very different factual situation in which there was affirmative misconduct, affirmative misrepresentation, the... But you concede in your brief, I mean, while you're arguing that there may be different facts, but you conceded in your brief that, yes, MCV does stand for the proposition, that you can look to pre-assurance conduct. [00:02:41] Speaker 01: It does. [00:02:42] Speaker 01: I mean, unless this court overrules it, I don't know that it has been overruled. [00:02:46] Speaker 01: It is the exception where there is. [00:02:49] Speaker 00: So then we can't necessarily say that no pre-issuance conduct is relevant in an equitable estoppel case. [00:02:59] Speaker 01: I'm not saying that. [00:03:01] Speaker 01: I'm saying based on the facts. [00:03:02] Speaker 00: Oh, maybe I misunderstood. [00:03:03] Speaker 00: OK, go on. [00:03:05] Speaker 02: Yeah, because it sounded like you were arguing for a per se rule until you got to MCV and then sort of conceded that, [00:03:11] Speaker 02: that there can't be a per se rule. [00:03:16] Speaker 01: What I am saying is that when the scope of the issued patents are different than what was before the parties that led to the alleged misleading conduct or inaction, then the defense of equitable estoppel cannot apply to pending claims [00:03:39] Speaker 01: during the examination of a patent application. [00:03:42] Speaker 01: That's the precedent that was set forth in Radius Systems and John Bean. [00:03:49] Speaker 02: Can I ask you a question, a procedural question? [00:03:52] Speaker 02: When I look at your opposition to the motion for summary judgment, while there are arguments that the dialogue back and forth that you argue that there wasn't a complete [00:04:06] Speaker 02: obviously meeting of the minds on the dialogue back and forth, and that you didn't understand that Dr. Fine was talking about something beyond the sub-lingual administration route. [00:04:21] Speaker 02: I understand that, but I don't see anywhere that you really argue these legal points about pre-issuance conduct as never relevant. [00:04:31] Speaker 01: I do not believe that. [00:04:34] Speaker 01: Let me back up a minute. [00:04:36] Speaker 01: In the opposition brief, there was a reference to the fact that the correspondence between the fines and Ms. [00:04:49] Speaker 01: Barkley-Ferrin was sort of limited to the sublingual administration route and the enablement of low dosage possibilities thereby. [00:05:00] Speaker 01: And that was different from what the scope of the claims were that issued. [00:05:04] Speaker 01: And I do believe there was an argument that was made in our opposition brief, and it's on page appendix 1163, that Allergan does not even attempt to argue that the letter in exhibit 18, which is one of the Sparanza letters [00:05:29] Speaker 01: evidence a threat of formal action to correct inventorship, which is the substantive legal claim at issue here, nor could it the statute and case law requires that a patent issue before it. [00:05:42] Speaker 01: So that was the extent of it that was in the opposition brief and I believe [00:05:53] Speaker 01: was discussed in the facts that I referred to earlier in Appendix 1148 and 1149. [00:06:00] Speaker 01: But the issue was recognized by the defendant in their reply brief when they submitted an Exhibit B where they compared the patent application claims [00:06:16] Speaker 01: to the patent claim. [00:06:19] Speaker 02: I'm not sure you understood my question. [00:06:21] Speaker 02: I'm saying your opposition brief almost is entirely based on the argument that Allergan couldn't prove its own reliance or prejudice. [00:06:33] Speaker 02: You do go into a discussion about the back and forth on the letters, but I don't see a legal discussion about this per se rule that you're proposing or almost per se rule [00:06:44] Speaker 02: that you can't consider pre-assurance conduct in the context of an equitable stable analysis? [00:06:53] Speaker 01: I do not believe that that issue was specifically addressed in the opposition brief. [00:06:57] Speaker 01: I believe radio systems was raised and argued that you had to look at each of the patents separately, but I do not believe that [00:07:07] Speaker 01: the legal issue that I'm raising right now was raised completely in the opposition brief below. [00:07:12] Speaker 01: But it was certainly the issue that the judge, Judge Sweep, made his decision on in his opinion, which is as he analyzed the law, he came down to radio systems and he states that [00:07:32] Speaker 01: He looked at the scope of the claims, but if you look at what was written in the opinion, what he states is, and this is Appendix 54, the low dosage invention as described in the PCT at issue in the Sparanza correspondence is the same subject matter detailed in the patent in suit down to the specific numerical quantity of desmopressin to be used. [00:07:58] Speaker 01: and thereby he distinguishes it from radio systems. [00:08:01] Speaker 01: So that's the issue that we have on appeal, whether that was correct or not. [00:08:05] Speaker 01: And what we're saying is he erroneously analyzed, if he did, the scope of the claims. [00:08:13] Speaker 01: It seems to me, from that language, he was looking at the specification and the description in the PCT and the patent institute. [00:08:22] Speaker 02: Well, let me get to that, your scope argument. [00:08:25] Speaker 02: I mean, it's pretty [00:08:27] Speaker 02: clear that what the Judge Sweet found was that it doesn't, in his view, it didn't really matter what the scope of the claims were when the applications were provided to you in advance. [00:08:40] Speaker 02: So the question was, what did you have? [00:08:43] Speaker 02: There was silence in the face of what information? [00:08:48] Speaker 02: And I think his conclusion was there was a silence in the face of information that said these are the claims that we're going to assert. [00:08:56] Speaker 02: And isn't that the point he was making? [00:09:04] Speaker 02: Hello? [00:09:09] Speaker 02: Hello? [00:09:11] Speaker 01: Convention in the correspondence, which is sublingual administration enabling load dosage possibilities. [00:09:20] Speaker 02: We had about the application itself. [00:09:23] Speaker 01: Right, we had the PCT and the 100 application claims, which at that point in time, we had told Dr. Fine that we were not relinquishing any claim as to ownership of any material that he may intend to include or claim later until we saw what he argued or presented for novelty and inventiveness. [00:09:48] Speaker 02: But you knew what was in the application, right? [00:09:51] Speaker 01: But the application claims are different in scope from what the claims are in the patents in suit. [00:09:58] Speaker 01: And that comes very clearly when we look at, for example, claim one of the 321 patent, which is at appendix 190. [00:10:12] Speaker 01: And that claim, first off, has no limitation as to dose. [00:10:18] Speaker 01: There is no low dose in that, and there is [00:10:20] Speaker 01: no reference to sublingual administration. [00:10:24] Speaker 01: And it is a method for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia, comprising delivering to the bloodstream of the patient an amount of desmopressin no more than about 2 nanograms. [00:10:41] Speaker 02: I think you must have misstated because the application claims don't reference sublingual administration either. [00:10:50] Speaker 01: That's correct. [00:10:51] Speaker 01: What the application claims mention are low doses for a pharmaceutical composition claims and low plasma concentrations, but what they don't... You had those application claims in front of you, right? [00:11:09] Speaker 01: We did, but those are not the claims that issued in the patents in suit, and if they are [00:11:15] Speaker 01: Inventorship is determined by the claims and element by element of the claims. [00:11:21] Speaker 01: And the elements that were ultimately claimed in the patents in suit are different. [00:11:27] Speaker 01: There were additional limitations directed to duration of action. [00:11:32] Speaker 01: There were [00:11:33] Speaker 01: Were claims directed to delivering to the bloodstream in the patient an amount of desmopressin of a certain amount? [00:11:41] Speaker 01: There were claims directed to, this is claim eight. [00:11:45] Speaker 00: Ms. [00:11:45] Speaker 00: Bork, this is Judge Chen. [00:11:46] Speaker 00: I know right now in an oral argument at the Federal Circuit, you're going line by line through various patent claims and trying to compare them to the 2004 application claims. [00:11:59] Speaker 00: To what extent did you argue any of this [00:12:03] Speaker 00: line item type arguments to Judge Sweet below? [00:12:07] Speaker 01: That issue was not specifically argued, but the issue was before him, that the patents in suit were different from what the invention that was claimed by Dr. Fond. [00:12:28] Speaker 00: Where's that in the briefing in front of Judge Sweet? [00:12:33] Speaker 01: It's on the opposition page, appendix 1148 and 1149. [00:12:38] Speaker 02: I read that to say that the patent claims ended up being different than the ones that were first discussed in the earliest correspondence going back and forth, the sub-legal administration claims. [00:12:56] Speaker 02: But I don't see any argument that the patent claims actually differed [00:13:02] Speaker 02: in material ways as it relates to this issue, not as it relates to whether there's some other issue that could be presented, but as it relates to the estoppel issue, I don't see any argument that the application that was submitted to you was stuck to the sub-lingual administration route. [00:13:26] Speaker 01: It was, that statement that I referred to in our opposition brief was addressed by the defendants in the reply brief, and that's Appendix 4937, where they addressed exactly this issue, the scope of the claims in the PCT and the 100, the pending applications with the scope of the claims in the patents in suit, and submitted an Exhibit B, [00:13:55] Speaker 01: to their brief, which, of course, we could not respond to because it was the reply brief. [00:14:01] Speaker 01: But it certainly was the issue was before Judge Sweet, and he was aware of it when he wrote his opinion because the issue was squarely presented in at least the reply brief of the defendant. [00:14:15] Speaker 01: So there was no surprise on that. [00:14:17] Speaker 02: Let me ask you. [00:14:20] Speaker 02: I understand that we are facing [00:14:25] Speaker 02: this record. [00:14:26] Speaker 02: We can't consider all the things that were submitted in more detail in the later record. [00:14:35] Speaker 02: But what is the impact of the decision that you submitted to us in the 28-J letter? [00:14:47] Speaker 01: So that decision found that the claims, all claims, [00:14:54] Speaker 01: Two of the patents that are at issue in this case were invalid for three different reasons, written description, enablement, and 102F. [00:15:04] Speaker 01: That decision, however, is not final. [00:15:10] Speaker 01: I am told by defendants that they intend to appeal that decision. [00:15:15] Speaker 01: So this decision is, this case is still important because to the extent [00:15:23] Speaker 01: that the Chief Judge McMahon's judgment of invalidity is overturned in all respects, then it is always been and has been Faring's position that these patents contain Faring's work and they should not be allowed to be used as a sword against [00:15:49] Speaker 01: fairing when they were our work and he derived the information from us. [00:15:55] Speaker 01: So that to the extent that the patents are valid, we have always taken the position that they are ours and they belong to us. [00:16:04] Speaker 00: This is Judge Chen. [00:16:05] Speaker 00: I've got a quick follow-up question. [00:16:07] Speaker 00: To what extent do the claim scope from the fairing patents overlap with the claim scope of these three Dr. Fine patents? [00:16:18] Speaker 01: The fairing patents were directed to pharmaceutical compositions. [00:16:22] Speaker 01: They related to an oral dispersable dosage form. [00:16:26] Speaker 01: They are different from the fine patents, which these are directed to methods of treating individuals with a dose of desmopressin to achieve certain functional limitations, functional pharmacokinetic and pharmacodynamic limitations. [00:16:48] Speaker 01: different and Judge Costell in this case has already found that Dr. Fine is not an inventor or a joint inventor on Ferens patents. [00:17:04] Speaker 01: I can see my time is running out. [00:17:05] Speaker 01: I would just like to emphasize one other important thing. [00:17:08] Speaker 01: And this is very important because this is an equitable doctrine. [00:17:13] Speaker 01: There was undisputed facts that were submitted by Farrin to the district court showing Dr. Fine's intentional copying of Farrin's work and which were, they can be found at appendix 1172 through 1206. [00:17:39] Speaker 01: They were accompanied by a declaration from Dr. Danhoff [00:17:43] Speaker 01: And that's at Appendix 1473 to 1514. [00:17:47] Speaker 01: So that intentional copying by Dr. Fine was not addressed by Judge Sweeney. [00:17:58] Speaker 02: But you were aware of the copying back in 2004, isn't that right? [00:18:03] Speaker 01: No. [00:18:04] Speaker 01: No. [00:18:06] Speaker 00: No. [00:18:07] Speaker 00: I thought Fine's counsel, Mr. Speranza, [00:18:13] Speaker 00: you know, gave you a copy of the CIP application in addition to the PCT application. [00:18:18] Speaker 00: So, and then he proclaimed to Fairing's council that everything in example eight was Dr. Fine's work. [00:18:27] Speaker 00: And so that gave you the opportunity to see that and understand whether you agreed or disagreed with that. [00:18:34] Speaker 01: My understanding as to what occurred was it was not until there were documents produced in corresponding litigation in the Netherlands where we found out that Dr. Fine had access to and had fairing documents in his possession and that he had in fact copied fairing [00:18:59] Speaker 01: clinical trial CS009, he had taken that protocol and copied it and re-ran it as his own and submitted that data to the Patent Office as Example 8 and represented it as his own. [00:19:19] Speaker 01: Those facts did not come to light. [00:19:21] Speaker 01: We were not aware of those facts in 2004. [00:19:26] Speaker 00: I'm sorry. [00:19:27] Speaker 02: Can I just ask one question on that? [00:19:28] Speaker 02: Yeah. [00:19:28] Speaker 02: Wasn't it a fairing employee who sent Dr. Fine the CS009 protocol by email? [00:19:38] Speaker 02: How can fairing say they weren't aware of it? [00:19:43] Speaker 01: Well, what happened was a fairing employee, fairing workers in Copenhagen drafted the CS009 protocol. [00:19:54] Speaker 01: They sent it to Dr. Fine. [00:19:56] Speaker 01: for him to execute it here in the U.S. [00:19:59] Speaker 01: Dr. Fine was shortly after that when the results were published, or once he had unblinded and knew the results, he was fired or terminated. [00:20:10] Speaker 01: And what was not known to us until later was that he had taken fairing documents with him and he had actually copied the fairing protocol to rerun his own study. [00:20:23] Speaker 01: We were not aware that he was [00:20:25] Speaker 01: it during the entire time of the Speranza correspondence, we were not aware that he was running these two proof of concept studies, that he had formed his own company, CNF, to repeat the work that was done at Farin and to use it in his patent application. [00:20:41] Speaker 01: That was never brought to our attention at any time in that period. [00:20:44] Speaker 00: Okay, here's my final question and what I'm trying to understand is why after [00:20:51] Speaker 00: In December 2004, after Mr. Sparanza sent his two letters explaining Dr. Fine's position that he is the true inventor of everything that's being claimed in these two patent applications and this is his work, it's not any of Behring's confidential information. [00:21:15] Speaker 00: And so he really plants his flag in the sand with this proclamation [00:21:22] Speaker 00: and why doesn't fairing ever write back? [00:21:29] Speaker 01: I don't know the answer to that other than to say that what preceded that was fairing's council saying we cannot now say that we will not ever challenge ownership or inventorship until we see [00:21:42] Speaker 01: whether or not you get any claims will be allowed. [00:21:46] Speaker 01: It was Farron's position. [00:21:47] Speaker 00: Well, as I understand it, that one letter said, well, of course, we don't know until we see the content of the application, until we see the text. [00:21:57] Speaker 00: And now in 2004, you plainly saw the text of both applications and then said no more after Dr. Speranza made his proclamation. [00:22:08] Speaker 00: So I'm just trying to understand what is the [00:22:12] Speaker 00: plausible alternative reading of that other than, well, seven years of silence is, it was very, very reasonable for Dr. Fine to believe that Ferring was walking away from this and not going to bother Dr. Fine in his attempt to get patents and everything else. [00:22:37] Speaker 01: I think it's quite clear that we reserved our right to challenge inventorship, depending on what claims ever issued. [00:22:46] Speaker 01: It was also clear that we didn't believe that what Dr. Fine said he was pursuing patent protection for, sublingual administration enabled by low dose, would be patentable. [00:22:57] Speaker 01: We did not believe low dose in and of itself was a patentable invention, and so therefore [00:23:03] Speaker 01: We had to wait. [00:23:05] Speaker 01: We could not bring a cause of action. [00:23:07] Speaker 01: We had no recourse at that time. [00:23:08] Speaker 01: There were no issued patent claims. [00:23:11] Speaker 01: So we made our position clear that we were still reserving our rights to see what he did and what claims ultimately became allowed. [00:23:23] Speaker 01: And until we had issued patent claims, we couldn't bring a cause of action under 256. [00:23:33] Speaker 01: And quite frankly, remember, the important thing here, this was a grant of summary judgment. [00:23:40] Speaker 01: And in those circumstances, the evidence must be perceived in the light most favorable to Sparing. [00:23:47] Speaker 01: And inferences must be drawn in Sparing's favor, not against it. [00:23:53] Speaker 01: And it is our position that Judge Sweet, quite frankly, drew inferences against Sparing, and the evidence was not [00:24:01] Speaker 01: perceived in the light most favorable to Farrin. [00:24:04] Speaker 01: And at the very least, we should have been allowed to present the evidence to the court with a full record, which I think is what Judge McMahon said in her footnote 11 in her opinion that she recently issued, where she said, I now, knowing what I know now, not so sure I would have agreed with that decision. [00:24:31] Speaker 01: And I can see I'm way over my time. [00:24:33] Speaker 02: We'll give you two minutes for rebuttal, Council. [00:24:36] Speaker 01: Thank you. [00:24:40] Speaker 02: Ms. [00:24:40] Speaker 02: Spires? [00:24:50] Speaker 02: Hello? [00:24:53] Speaker 01: Sorry, Your Honor. [00:24:54] Speaker 01: I stay on mute. [00:24:55] Speaker 01: The purpose of the doctrine of equitable estoppel is well laid out. [00:24:59] Speaker 01: As you all have mentioned, this court held in MCV that it is impermissible for a party to lie low for four years and then invoke a claim of erroneous inventorship against the patent when the matter could have been resolved from the start. [00:25:14] Speaker 01: And that is the case whether the misleading conduct occurs prior to the patent issuance as it did in MCV or otherwise. [00:25:23] Speaker 01: And that's exactly what Faring did here. [00:25:25] Speaker 00: Ms. [00:25:26] Speaker 00: Byers, this is Judge Chen. [00:25:27] Speaker 00: I just want to try to understand the larger landscape here and what's in play, because now we have this equitable estoppel decision here to correct inventorship, but at the same time, now we have the district court's decision after a trial finding at least two of these three patents invalid for among other reasons [00:25:54] Speaker 00: failure to correctly identify the inventor. [00:25:57] Speaker 00: Is that right? [00:25:59] Speaker 01: That's correct, Your Honor. [00:26:01] Speaker 00: And what is your plan? [00:26:04] Speaker 00: Your plan is to appeal that decision? [00:26:06] Speaker 01: Yes, Your Honor. [00:26:07] Speaker 01: We are going to appeal that decision. [00:26:10] Speaker 01: And I would like to note a misstatement related to this in Farron's reply brief. [00:26:16] Speaker 01: It said that we misstated the decision when we said that [00:26:24] Speaker 01: Judge McMahon had said that fairing was not allowed to pursue its declaratory judgment claims for inventorship and that she had reversed herself on that issue. [00:26:33] Speaker 01: She actually did not. [00:26:34] Speaker 01: She reversed herself on the issue of, she saw a distinction, whether correct or not, that'll be an issue for appeal, but she saw a distinction for an actual claim for correction of inventorship, 256 claim versus defenses. [00:26:50] Speaker 01: And while she applied equitable estoppel to Judge Sweets [00:26:54] Speaker 01: decision, and so did not consider Farrings' equitable claims, or Farrings' 256 claims, she did consider Farrings' defense. [00:27:04] Speaker 01: But I will note that in that case, although she did, in our opinion, wrongly, but you guys will see that opinion come to you soon enough, determine that two of the three patents are invalid, she did not, despite Farrings' best efforts, [00:27:21] Speaker 01: decide that any fearing employee was the inventor. [00:27:25] Speaker 01: And so the case that Farron's trying to bring here, even in Judge McMahon's decision, they did not win. [00:27:32] Speaker 02: Well, she didn't correct inventorship, but what she said is that Dr. Fine either wasn't the inventor [00:27:41] Speaker 02: or to the extent that he was an inventor, he wasn't the sole inventor. [00:27:46] Speaker 02: So she did find that the patent was invalid because of improper inventorship, correct? [00:27:53] Speaker 01: He did. [00:27:53] Speaker 02: She did find... So what does it matter if it's not a fairing employee that's been left off? [00:28:02] Speaker 01: Well, for this particular action, this was a 256th action to correct inventorship, not an action to invalidate the claim. [00:28:09] Speaker 01: And so for correcting inventorship, here, in this case, what Farring was trying to prove was that its employees were inventors. [00:28:19] Speaker 01: They were not trying to invalidate the patent. [00:28:21] Speaker 01: They were trying to get the patent. [00:28:23] Speaker 01: And so the distinction matters there. [00:28:25] Speaker 02: OK, but even if you're going to appeal that, you've got an uphill climb because you would have to establish that Judge McMahon was wrong on everything, and written description enablement, [00:28:39] Speaker 02: and inventorship. [00:28:41] Speaker 02: So given that, why shouldn't we hold this case in abeyance pending consideration of that case on appeal to see if there's anything even left of this patent? [00:28:56] Speaker 01: Well, in all honesty, if your honors wanted to do that, you could. [00:29:00] Speaker 01: I think there's nothing improper about holding this case in abeyance to see if there is anything left. [00:29:08] Speaker 01: However, there is, in this case, the one problem that would resurface no matter what is the third patent. [00:29:15] Speaker 02: This case... And so, yeah, that's what my follow-up question is. [00:29:19] Speaker 02: So what's difference, what is different about the third patent as it relates to the specific factual findings and the other determination? [00:29:32] Speaker 01: The third patent has quite a few claims that Fairing has never claimed ownership of. [00:29:37] Speaker 01: And so, Judge McMahon never looked at to determine whether Dr. Fine was the inventor. [00:29:46] Speaker 01: And so, that one would have to be decided on its own in another case. [00:29:52] Speaker 01: That was not asserted against fairing in the other litigation, which is why it was not at issue here. [00:30:00] Speaker 01: And one point that I would like to make, I know you mentioned that it would be an uphill battle. [00:30:06] Speaker 01: In our view, when you all see the record and you see that Judge McMahon came in honestly with her mind already made up and said, pardon the language, it's a direct quote from Judge McMahon that she came in with an opinion from Judge Castell saying that Dr. Fine was lying his expletive off and said that on the record. [00:30:28] Speaker 01: It was clear that her mind was made up and she did not approach the case as a neutral impartial fact finder. [00:30:36] Speaker 01: And so in light of that, I think when one domino falls, the rest will fall in terms of showing that Judge McMahon's findings were improper in that case. [00:30:49] Speaker 01: Okay. [00:30:54] Speaker 01: I do agree with counsel's statement earlier that the scope of the fairing patents that you all mentioned are different than the scope of the patents at issue here. [00:31:05] Speaker 01: And that is one of the reasons that the castellating in that Judge McMahon relied on so heavily should not have influenced her the way it did. [00:31:17] Speaker 02: Well, each case, yes, has to be decided on its own record. [00:31:20] Speaker 02: But she also heard testimony, correct? [00:31:24] Speaker 02: She heard from the same people. [00:31:27] Speaker 01: She did. [00:31:27] Speaker 01: But she said in closing argument that she came into this case [00:31:32] Speaker 01: with an opinion from Judge Castell that said that Dr. Fine is lying his expletive off. [00:31:38] Speaker 01: And so that she admitted that that's how she came into the case and she wanted to be proved otherwise. [00:31:44] Speaker 01: She was just looking for us to prove otherwise. [00:31:46] Speaker 01: And so that is not deciding the case on its own record by any means. [00:31:52] Speaker 02: Well, I mean, she developed the full record to give you an opportunity to show that Judge Castell was wrong, right? [00:32:01] Speaker 02: I mean, it's kind of shocking what you're accusing her of. [00:32:05] Speaker 02: It's kind of surprising. [00:32:09] Speaker 01: And I appreciate that, Your Honor. [00:32:11] Speaker 01: But I'm giving you a direct quote of what she said, leaving the expletive. [00:32:14] Speaker 02: I'm sure there's some other context that we'll hear about. [00:32:19] Speaker 01: It was actually shocking to us, the way that she approached this case. [00:32:25] Speaker 01: And so we were shocked as well, I assure you. [00:32:28] Speaker 02: OK, does that have anything to do with [00:32:30] Speaker 02: enablement or written description? [00:32:34] Speaker 01: We believe that everything rose and fell together. [00:32:38] Speaker 01: Yes, Your Honor. [00:32:41] Speaker 01: Yes, that everything was approached with the very same mindset. [00:32:46] Speaker 02: I want to address the copying. [00:32:49] Speaker 02: It was a glaring omission from Judge Sweets' opinion. [00:32:54] Speaker 02: It doesn't even mention the copying in its factual recitation. [00:32:57] Speaker 02: How do you get around that [00:33:00] Speaker 02: gap in the equitable analysis? [00:33:05] Speaker 01: Well, because of the purpose of an equitable estoppel, what Farring says in its opening brief at page 50 is that the evidence of unclean hands is that Dr. Fine, quote, incorporated the data into example eight of the fine patents and intentionally misrepresented it as his own original work by claiming he was the sole named inventor. [00:33:29] Speaker 01: That is the inventorship dispute. [00:33:30] Speaker 01: That is the dispute that equitable estoppel is designed to foreclose. [00:33:37] Speaker 01: If we're getting into the inventorship dispute as to whether or not Dr. Fine was the sole named inventor of what he included in his patent, if that counts as unclean hands, then there's no purpose for equitable estoppel. [00:33:50] Speaker 01: It would always apply because it's always the case when equitable estoppel is applying to an inventorship dispute [00:33:58] Speaker 01: that you're going to have someone that is representing that they are an inventor and there's a dispute about that. [00:34:03] Speaker 01: So if we're getting into the facts of the dispute, then we're getting into facts that are foreclosed by equitable estoppel. [00:34:12] Speaker 01: And I think that Judge Sweet was correct in saying that he had considered that evidence and did not find it persuasive. [00:34:21] Speaker 01: And so he did not. [00:34:22] Speaker 02: It's not a situation where they're saying, [00:34:24] Speaker 02: you know, okay, this same information in this patent where you've got like an interference where both parties say that they invented simultaneously. [00:34:34] Speaker 02: This isn't, it's not a question of whether there's similarities between the two. [00:34:39] Speaker 02: It's a question of whether he actually took documents that didn't belong to him and copied a protocol for purposes of testing. [00:34:47] Speaker 02: Now I understand he says I did my own tests afterward, but [00:34:51] Speaker 02: But I think that's a different circumstance than the one you're saying that says would make equitable stop will always apply. [00:35:01] Speaker 01: Respectfully, what opposing counsel represented are the facts actually are not the facts. [00:35:06] Speaker 01: There is nothing in the record here, or frankly, in the trial that we just conducted, which has a much fuller record. [00:35:11] Speaker 01: There is nothing in the record that Dr. Fine took fairing documents with him, copied them, and conducted this test again. [00:35:21] Speaker 01: What did Judge McMahon find? [00:35:23] Speaker 02: Didn't she find that? [00:35:26] Speaker 01: Not that he took the documents with him, no. [00:35:30] Speaker 01: The facts are that Dr. Fine was the author of, or was one of the authors of that protocol. [00:35:40] Speaker 01: And so he had the Covance Clinical Research Unit, which is what is in evidence here, that he outsourced the [00:35:51] Speaker 01: or contracted with the same outside research organization to perform the studies. [00:35:56] Speaker 01: And so that outside research organization, Dr. Fine gave or someone at his organization sent the protocol, which Dr. Fine was not under any confidentiality obligation, which is in the trial testimony there. [00:36:13] Speaker 01: But again, none of that is in the record here, which is why council's representations about all of these [00:36:20] Speaker 01: how they found all of this is entirely improper in this case. [00:36:24] Speaker 01: That is not in the record and that was not in the record before Judge Sweet. [00:36:28] Speaker 01: That's what counsel has been trying to do this entire time today is talk about facts that they did not bother to put into evidence. [00:36:36] Speaker 01: They want to say now that there's a disputed fact issue about this and about that, about the scope, about unclean hands, but they did not make a factual issue because they did not put that evidence in the record. [00:36:49] Speaker 01: all the evidence that they put in the record before Judge Sweets, it was very minimal in fact, and it was that there were similarities between the two studies, acknowledging that both studies were done by the same outside research organization, who likely has the same template, and then [00:37:14] Speaker 01: They also acknowledged that Dr. Fein's example eight was based on another study, PK 2004-01, which Fein has never alleged has any similarity to any study Fein conducted. [00:37:29] Speaker 01: And so this example eight that is the part of Dr. Fein's patent does not have, well, we will give that there are similarities between one of the studies that led to example eight. [00:37:43] Speaker 01: and studies conducted at Faring. [00:37:46] Speaker 01: There are additional studies that went into example eight, and all of the data that came from example eight was the property of Dr. Fine and CNS Pharma. [00:37:55] Speaker 01: They did not use the data from Faring to come up with example eight. [00:37:58] Speaker 02: But the protocols were nearly identical, were they not? [00:38:02] Speaker 01: They were nearly identical, yes, Your Honor. [00:38:05] Speaker 01: For the 2003 protocol, the CNS-09, the other protocol that was the [00:38:13] Speaker 01: PK 2004-01 was not. [00:38:17] Speaker 01: And that's the one that Farring omits in its discussion. [00:38:21] Speaker 01: And as Your Honors mentioned, this is something that Farring had in its possession in 2004. [00:38:26] Speaker 01: So whether or not they thought there was an issue about unclean hands, the fact that they sat on that, it's the same problem. [00:38:38] Speaker 01: They're sitting there saying, OK, we're going to lie and wait. [00:38:41] Speaker 01: and allow our competitor to do this, and then maybe we can swoop in and take the competitor's patent. [00:38:47] Speaker 01: They knew in 2004, as Your Honors mentioned earlier, that Dr. Fein had this protocol. [00:38:56] Speaker 01: They emailed it to him. [00:38:57] Speaker 01: So they knew that he had had this protocol, he'd used it. [00:39:00] Speaker 01: So that was not a secret. [00:39:02] Speaker 01: They knew the data in example eight. [00:39:05] Speaker 01: They could see what was done in the protocol or in the patent, and they could see [00:39:11] Speaker 01: what the data that Dr. Fein came out with. [00:39:16] Speaker 01: If they wanted to come up with any inventorship argument or any other here, it was incumbent upon them to do so. [00:39:22] Speaker 01: As this court has held in MCV, an assertion of right followed by silence can give rise to equitable estoppel. [00:39:32] Speaker 01: The fact that Fein may have objected at one point in 2003 saying, well, there might be additional subject matter, [00:39:41] Speaker 01: that is rendered moot when in 2004 they see the claim. [00:39:46] Speaker 01: And as Judge Rayna has discussed in his concurrence in 4 versus 2, it actually is the case that where is here the scope issues that counsel talked about earlier, the only differences in scope between the patent claims that Dr. Fine had sent to fairing at the time in 2004 and the issued claims [00:40:11] Speaker 01: or additions to claims. [00:40:13] Speaker 01: And what Judge Raina Stamhorst versus Chiu is that if claims are narrowed during examination, the scope of the patent here, or limitations are added, the scope of the patent becomes narrower, not broader. [00:40:27] Speaker 01: And shrinking patent scope does not give rise to previously non-existent inventorship claims. [00:40:33] Speaker 01: So since an omitted inventor would know whether he or she has a cognizable inventorship claim from the very beginning, [00:40:40] Speaker 01: There is no rational reason to wait until the patent issues. [00:40:45] Speaker 00: This is Judge Shen. [00:40:46] Speaker 00: Are you saying that when you add limitations, those limitations can never be separate inventive concepts and so therefore there's no basis to claim inventorship over specific limitations? [00:41:06] Speaker 01: I won't go as far as to say never. [00:41:08] Speaker 01: I think what Judge Raina said correctly in her concurrence was that shrinking patent scope does not necessarily give rise to previously non-existent inventorship claims. [00:41:18] Speaker 01: And I think here we are in a case where it did not give rise to previously non-existent inventorship claims. [00:41:25] Speaker 01: And as your honors has mentioned earlier, fairing did waive that issue. [00:41:31] Speaker 01: They have never gone line by line or done anything more than about a two-line summary saying that the patent claims were different in scope until their reply brief. [00:41:41] Speaker 00: In your summary judgment paper below, your opening summary judgment brief, we don't have a copy of that in the Joint Appendix. [00:41:52] Speaker 00: Did you in fact, [00:41:54] Speaker 00: say in that brief, hey, look at the claim scope of our 2004 application claims versus our subsequently issued patent claims. [00:42:04] Speaker 00: Same claim scope, same subject matter. [00:42:07] Speaker 00: So therefore, fairing was completely on notice and relinquished any rights to the ultimately issued patent claim scope because they had full notice of that very claim scope in the content of our 2004 application. [00:42:24] Speaker 00: Does your summary judgment brief say anything like that? [00:42:28] Speaker 01: Your Honor, I believe it does. [00:42:29] Speaker 01: But to be honest, right this second, I can't confirm that for certain. [00:42:34] Speaker 01: But I can submit a letter brief if that would be helpful to the court to provide that information later. [00:42:38] Speaker 02: Well, can you submit the summary judgment, the full summary judgment briefing from the parties? [00:42:44] Speaker 02: Because much of it is heavily redacted on the district court docket. [00:42:51] Speaker 01: Yes, Your Honor. [00:42:52] Speaker 01: We'd be happy to do that. [00:42:53] Speaker 00: Getting back to the 2004 colloquy between Barclay and Speranza, is it possible to read Barclay's opening December 2004 letter saying, hey, you have some information in this PCT application that is fairing proprietary and confidential information. [00:43:17] Speaker 00: So that really bothers us, and it surprises us that you went and did that, Dr. Fine. [00:43:22] Speaker 00: And then Dr. Fine says, no, no, that's not confidential at all. [00:43:28] Speaker 00: Is that enough to say that on summary judgment, necessarily fairing took an act that basically abandoned the claim scope that was contained in the 2004 application when Ms. [00:43:50] Speaker 00: Barclay never actually said, [00:43:52] Speaker 00: The claims that you have drafted in these 2004 applications belong to Ferring, not Dr. Fine. [00:43:59] Speaker 00: We are the inventors, not you. [00:44:03] Speaker 00: Given the absence of a statement like that, can we really say that there's no reasonable inference that the Barclay letter wasn't necessarily about inventorship, per se, but really more just about [00:44:22] Speaker 00: some information it believes was proprietary information to fairing, which is a different question than inventorship. [00:44:31] Speaker 01: Your Honor, I don't think that's a permissible reading. [00:44:33] Speaker 01: As you're aware, I'm sure, this Court has held many times that when there is a threat of action, of immediate legal action, and then silence, that that is sufficient to constitute misleading conduct. [00:44:51] Speaker 01: And here, there is no possible reading that that is all that Dr. Barclay was referring to. [00:44:59] Speaker 01: If you look at her letter, it's a short letter of appendix 544. [00:45:07] Speaker 01: And in one sentence, she gives the issues. [00:45:09] Speaker 01: And she gives two issues, not one. [00:45:11] Speaker 01: And she says that she was surprised to see Dr. Fine had proceeded with this application containing an invention to which we believe he has no entitlement and [00:45:20] Speaker 01: which in particular discloses information confidential and proprietary to fairing, like you're talking about. [00:45:26] Speaker 01: So, two issues with the conjunctive and. [00:45:30] Speaker 01: And then the next paragraph says fairing will take all necessary steps to protect its rights and interests and goes on, if I do not receive a full, and that word is key, and satisfactory explanation within 14 days of this letter, we will commit formal action. [00:45:45] Speaker 01: There's no reading that an issue, that a response that only addresses one of only 10 issues discussed in this short letter could be a full explanation. [00:45:54] Speaker 01: So she is threatening immediate legal action within 14 days if she does not receive a full explanation. [00:46:01] Speaker 01: And full meaning, that can only mean addressing both issues that are discussed. [00:46:08] Speaker 01: The issue before the end, which is the inventorship issue, and the issue after the end, which is the confidential information. [00:46:15] Speaker 00: Okay, so where is the inventorship issue? [00:46:17] Speaker 00: Because she doesn't exactly say the word inventorship. [00:46:21] Speaker 01: She says the application containing an invention to which we believe he has no entitlement. [00:46:28] Speaker 01: And then if we look at Dr. Fine's interpretation of this, and I believe your honor's [00:46:38] Speaker 01: will recall that Dr. Fine's interpretation of this is key. [00:46:44] Speaker 01: In the Wafer-Shape case, this court held that you look at this from the perspective of the person asserting equitable estoppel. [00:46:52] Speaker 01: So from Dr. Fine's perspective, he comes in and at appendix 546 addresses this issue and the belief of no entitlement and says at the bottom of that page, [00:47:05] Speaker 01: If your characterization is somehow intended to suggest that Dr. Fine is not the inventor of the claimed low-dose invention and or that Dr. Fine cannot assert ownership rights to it, we respectfully yet emphatically disagree. [00:47:18] Speaker 01: Our dealings and communications throughout 2003 has made clear and he goes on and he talks about that his email prior had said Dr. Fine was proceeding with his patent application for low-dose desmopressin [00:47:32] Speaker 01: with the understanding that Farring relinquishes any ownership claims to. [00:47:37] Speaker 01: And that's key because that is Dr. Fine showing Farring that he is relying on their representation here, that they have relinquished ownership claims to this. [00:47:47] Speaker 00: And so... To me, one alternate reading of these two letters is that Dr. Fine cannot be sure and cannot tell exactly what it is that Ms. [00:47:59] Speaker 00: Barclay intended with her very short brief letter. [00:48:02] Speaker 00: So maybe it's possible that this short brief Barclay letter isn't necessarily devoted to an inventorship claim of saying that, you know, all patent rights on these applications on these claims belong to Ferrin. [00:48:23] Speaker 00: I guess that's the concern I have as to whether this is something that can be kicked off on summary judgment. [00:48:31] Speaker 01: Well, Your Honor, respectfully, because this correspondence was conducted quite a while ago, and I know Dr. Ferranda has passed away, this record is not going to be any more fulsome than it is here. [00:48:45] Speaker 01: And so it's not going to be any better later. [00:48:51] Speaker 01: But what she said and what Dr. Fine references here is that the next sentence on appendix 547 [00:48:59] Speaker 01: is that in your responsive letter of April 29th, you confirm that Ferring would not be pursuing any claim with respect to low-dose desmopressin while reserving possible claims as to ownership only of any other material Dr. Fine may include in his patent application. [00:49:14] Speaker 01: By this time now, Ferring has the, is on notice that this is what Dr. Fine believes, and believes this based on their own representation, that they were not, [00:49:26] Speaker 01: going to pursue ownership of anything that Dr. Fine has claimed and only of any other material. [00:49:33] Speaker 01: And this is exactly the MCV case, which is- Wouldn't you agree that- I'm sorry. [00:49:40] Speaker 00: Oh, wouldn't you agree that- Go ahead. [00:49:42] Speaker 02: You go ahead. [00:49:44] Speaker 00: I was just going to ask this statement in the Sparanza letter summarizing the Barclay April 29 letter. [00:49:53] Speaker 00: Wouldn't you agree that's actually a misstatement of it? [00:49:57] Speaker 00: That April 29 letter never said that fairing would not be pursuing any claim with respect to low dose desmopressin. [00:50:04] Speaker 00: It said that fairing wouldn't be pursuing any claim for sublingual administration enabling a low dosage of desmopressin. [00:50:14] Speaker 00: So it wasn't just a blanket statement that fairing is going to be out of the business on any form of a low dose desmopressin. [00:50:22] Speaker 00: It was a very specific form, sublingual administration. [00:50:26] Speaker 01: Isn't that right? [00:50:27] Speaker 01: Respectfully, no. [00:50:29] Speaker 01: That letter is at Appendix 542. [00:50:31] Speaker 01: And when Thering is talking about sublingual administration, the second paragraph of that page, they are only talking about what they believe is in the public domain. [00:50:41] Speaker 01: And so they said that the low-dosage possibilities enabled by the sublingual administration route. [00:50:46] Speaker 01: So they're talking about both low-dosage possibilities that are enabled by the sublingual administration route. [00:50:52] Speaker 01: So there's kind of a mixture here. [00:50:54] Speaker 01: that's fairly broad as to what is enabled by the, and the possibilities enabled by the sublingual administration rule. [00:51:00] Speaker 00: But said those are available in... Those are linked, right? [00:51:03] Speaker 00: It's a sublingual administration that enables a low dosage possibility. [00:51:10] Speaker 01: Correct. [00:51:10] Speaker 01: That's what they are talking about being in the public domain. [00:51:14] Speaker 01: And here they're not talking about [00:51:17] Speaker 01: the entirety of Dr. Fine's invention, which he had given a much more fulsome explanation as to what his invention was in his initial communications with them in November 2002. [00:51:29] Speaker 01: But at this point, they're talking about the, what they believe is in the prior art and the, apologies on the pronunciation, but the Fjeldstad-Pulsen's doctor's thesis published in 1996. [00:51:41] Speaker 01: And so for that, that is what they're talking about with respect to sublingual administration. [00:51:45] Speaker 01: But then they're saying, [00:51:47] Speaker 01: They cannot, of course, say now that fairing will not make any claim as to ownership of any other material Dr. Fine may include in any patent application without seeing the text. [00:51:58] Speaker 02: But the November 2002 letter, it goes directly to what Judge Jen was talking about. [00:52:06] Speaker 02: It asserted his inventorship [00:52:11] Speaker 02: because it added something important, particularly a sublingual transmucosal route of delivery. [00:52:19] Speaker 02: So, I mean, it was, he was saying that that's where he contributed, was the sublingual administration. [00:52:28] Speaker 02: Right? [00:52:30] Speaker 01: Um, respectfully, the letter it said, [00:52:34] Speaker 01: at Appendix 49 that Dr. Fine asserted that he invented a sublingual transmucosal route of delivery, which is broader than just sublingual, which affords a number of advantages, including enabling the effective use of formulations, having reduced concentrations of desmopressin. [00:52:53] Speaker 01: And that's where a lot of these inventions come in, the effective use of formulations that have reduced concentrations. [00:53:02] Speaker 01: And that's what Dr. Fine does ultimately end up claiming. [00:53:06] Speaker 01: And so what Ms. [00:53:11] Speaker 01: Barclay states in this letter is that she can't say at that time whether they're going to make any claim of ownership of other material. [00:53:20] Speaker 01: But then by the time she makes her threat, she has all of the information of what all of the other material is that Dr. Fine is claiming. [00:53:28] Speaker 01: She has his statement in his letter. [00:53:31] Speaker 01: that he is relying on the understanding that Farring has relinquished any ownership claims to and his interpretation of her statement. [00:53:42] Speaker 01: And in light of the fact that she is the one that made the threat, she was in the driver's seat of her letter, she made the threat, he responded and is showing very clearly, laying his cards on the table saying, [00:53:55] Speaker 01: This is what I am relying on. [00:53:57] Speaker 01: This is my interpretation of your letter which under way for shave is the perspective that must be relied on and He's saying this is my interpretation of your letter It is now incumbent upon her under way for shave and MCV To not be silent and she was okay. [00:54:15] Speaker 02: Okay. [00:54:15] Speaker 02: Thank you council. [00:54:16] Speaker 02: We've gone way over time Thank you. [00:54:18] Speaker 02: I hear from Ms. [00:54:19] Speaker 02: Bork again [00:54:29] Speaker 01: Sorry, thank you, Your Honor. [00:54:31] Speaker 01: I will be brief. [00:54:32] Speaker 02: Can I first start where we just left off? [00:54:35] Speaker 02: I mean, do you agree that sublingual transmucosal route of delivery is much broader than sublingual route of delivery? [00:54:48] Speaker 01: I agree that transmucosal route of delivery encompasses more than sublingual, yes. [00:54:55] Speaker 02: Okay, so how do you respond to that? [00:54:59] Speaker 02: right in the very beginning, he was actually saying that his contribution was broader than just sublingual route of delivery. [00:55:10] Speaker 01: Because he ultimately claims far more than just transmucosal routes of administration. [00:55:16] Speaker 01: He claims, let me get my claim, he claims conjunctival, he claims [00:55:27] Speaker 01: subcutaneous, intravenous, transdermal, intradermal, et cetera, et cetera, et cetera. [00:55:35] Speaker 01: So yeah, what he claims is far broader than what he claimed his invention to be. [00:55:46] Speaker 01: And even if you look at his declaration that he submitted in support of the summary judgment brief, which is Appendix 1122, [00:55:56] Speaker 01: He still describes his invention as, and what he relied on, as claiming a low dose desmopresent or desmopresent adapted for sublingual administration. [00:56:12] Speaker 01: He believed that if Bering was aware of my application and would not be entitled, I would not dispute that I was entitled to pursue patents for my low dose and adapted for sublingual administration invention. [00:56:25] Speaker 01: What he claimed is far broader than that. [00:56:30] Speaker 01: So, let me just say this. [00:56:35] Speaker 01: At a minimum, the arguments here have shown that there are disputed issues of fact that summary judgment was improper. [00:56:46] Speaker 01: As to the sporangic correspondence, there are inferences that can be drawn [00:56:51] Speaker 01: as to what was being discussed there in terms of entitlement. [00:56:56] Speaker 01: What was the threat of action? [00:57:00] Speaker 01: Was that related to the stealing of confidential information? [00:57:06] Speaker 01: It could not have been an action for correction of inventorship because that cause of action did not exist. [00:57:14] Speaker 00: So there are... [00:57:17] Speaker 00: Getting back to unclean hands and copying, the other side, you just heard them say that you're trying to create fact questions that you didn't actually present below. [00:57:27] Speaker 00: And so therefore, you don't really have a leg to stand on with your specific accusations about copying. [00:57:36] Speaker 00: In your opening argument, you tried to very broadly cite chunks of the JA. [00:57:42] Speaker 00: But do you have something a little more specific? [00:57:45] Speaker 01: I can be quite specific, Your Honor. [00:57:50] Speaker 01: What I'm referring to is a section called, it begins, the cover page is Appendix 1172. [00:57:58] Speaker 01: It's variance response to Defendant's Rule 56.1 statement and statement of additional material facts. [00:58:08] Speaker 00: What follows? [00:58:08] Speaker 01: What's the pinpoint? [00:58:09] Speaker 00: Do you have a pinpoint? [00:58:11] Speaker 00: Do you have a paragraph number? [00:58:13] Speaker 01: Well, it starts on 1204 with the Roman numeral 3 heading, and it is all of the evidence that goes through to Roman numeral 4. [00:58:30] Speaker 01: In addition, there is a declaration from Dr. Danhoff, which he has, and that's [00:58:41] Speaker 01: Well, that begins at Appendix 1473, but at Appendix 1499, he has an entire section, Roman numeral six, that goes quite some pages about the copying of the CS009 study. [00:59:00] Speaker 01: It goes all the way to, well, excuse me, 1514. [00:59:06] Speaker 01: And what I would say is that those facts [00:59:11] Speaker 01: And Dr. Danhoff's declaration was never responded to by the defendants below and was never addressed by the court. [00:59:21] Speaker 01: Those are clearly disputed facts. [00:59:24] Speaker 01: They are clearly something that we should have been able to present to the trier of fact. [00:59:30] Speaker 01: It goes to Dr. Fine's reliance and was it reasonable or not? [00:59:37] Speaker 01: Because if he has bad faith, [00:59:40] Speaker 01: and he has his own misconduct, and he's utilizing data fairings, not data, protocol, rerunning it, submitting his data, representing it as his own to the patent office, utilizing that data to add additional claim limitations, including the duration of action to his patent claims, it's highly material to whether or not [01:00:09] Speaker 01: equitable estoppel was even proper on a motion for summary judgment in this case. [01:00:17] Speaker 01: And I would also say that I think this court's president, when it talks about misleading conduct in terms of silence, there generally is, there's got to be something more. [01:00:30] Speaker 01: It's just not silence. [01:00:32] Speaker 01: There has to be some course of dealing between the parties where there was [01:00:37] Speaker 01: some sort of expectation that they would speak up, or some sort of affirmative misrepresentation during that violence period. [01:00:46] Speaker 02: And you don't have to... Council, before you sit down, can I ask you about the 761 patent? [01:00:53] Speaker 02: What is different about that patent in terms of these specific facts for purposes of our analysis here? [01:01:04] Speaker 01: Well, I would say that 761 patent also includes the same duration of action time limitations. [01:01:12] Speaker 01: These are additional claims that were added. [01:01:15] Speaker 01: They're claims 13 to 17. [01:01:17] Speaker 01: So again, this is different than what was ever presented in the pending applications. [01:01:26] Speaker 01: And the route of administration is not transmucosal. [01:01:30] Speaker 01: It's intranasal, transdermal, or intradermal. [01:01:34] Speaker 01: So different routes of administration. [01:01:40] Speaker 02: Okay. [01:01:42] Speaker 02: Any last words? [01:01:44] Speaker 01: No, I thank you, Your Honor, for the time. [01:01:46] Speaker 01: I would just say that I do not believe waiver exists here. [01:01:50] Speaker 01: Under this court's precedent, and I have Pfizer versus Lee, 811, Fed 3rd, 466. [01:02:00] Speaker 01: I'm citing from page 471. [01:02:04] Speaker 01: Waiver exists to ensure that the lower court be fairly put on notice as to the substance of the issue. [01:02:10] Speaker 01: Here, it cannot be disputed that the district court was put on notice of the substance of the issue because that was the central focus of part of his finding on misleading conduct. [01:02:29] Speaker 01: And I don't have anything further. [01:02:30] Speaker 01: Thank you for your time. [01:02:31] Speaker 02: Okay. [01:02:32] Speaker 02: Thank you. [01:02:32] Speaker 02: The case will be submitted. [01:02:34] Speaker ?: you