[00:00:25] Speaker 04: The next case for argument is 161044 RV Pharmaceuticals Limited versus Bio Delivery Sciences. [00:01:11] Speaker 01: I want to focus on three errors that compel reversal and present the clearest path forward. [00:01:21] Speaker 01: First, on the issue of disclosure, the board apparently found that Lab Tech expressly discloses the claimed elements. [00:01:31] Speaker 01: This was error. [00:01:33] Speaker 01: The claims require a film with certain pharmacokinetics for its two active ingredients. [00:01:39] Speaker 01: buprenorphine and naloxone. [00:01:42] Speaker 01: The lab tech does not describe a buprenorphine naloxone film. [00:01:48] Speaker 01: It simply identifies a buprenorphine naloxone tablet as one of 19 drugs of interest known at the time and lists some of the pharmacokinetics of the tablet. [00:02:01] Speaker 01: The identification of 19 known drugs in a tablet form and their preferred pharmacokinetics [00:02:09] Speaker 01: along with a wish that each could be turned into a film with similar pharmacokinetic properties is not a disclosure of the claimed invention. [00:02:20] Speaker 01: Simply put, a wish is not a disclosure. [00:02:23] Speaker 04: Just to be clear, is this an enablement argument? [00:02:26] Speaker 01: No. [00:02:27] Speaker 01: We do have an enablement argument. [00:02:28] Speaker 01: This is a disclosure argument. [00:02:31] Speaker 01: This is much like the Apple case that we discussed in our brief. [00:02:35] Speaker 01: where there was a heading for future research. [00:02:39] Speaker 01: What we have in Table A of Lab Tech are known existing tablet products and a wish for a film with similar pharmacokinetics. [00:02:51] Speaker 01: So we don't have an example or a claim or anything of the sort to a film with those pharmacokinetics. [00:03:00] Speaker 01: And as your honors well know, anticipation is a strict standard. [00:03:04] Speaker 01: This is not a case where there's a disclosure of a film with those pharmacokinetics simply. [00:03:11] Speaker 02: But the law cannot be that you always have to have a disclosure of an actual reduction of practice of some product for that reference to then be anticipating the claim to that product. [00:03:23] Speaker 01: You need to have a disclosure, either express or inherent, of all of the elements of the claim. [00:03:30] Speaker 01: And the elements of the claim here are a film with these pharmacokinetics, a film with the claimed CMAX, with the claimed AUC for both buprenorphine and naloxone. [00:03:42] Speaker 01: We don't have that here. [00:03:43] Speaker 01: And as to one of those pharmacokinetics, the naloxone AUC of claim 17, you can look far and wide. [00:03:53] Speaker 01: In lab tech, you won't find a disclosure [00:03:57] Speaker 01: of the naloxone AUC of claim 17. [00:04:00] Speaker 01: It's just not there. [00:04:02] Speaker 00: What about in the PTO, as I understand it, you can argue your claims have rise and fall together, or you can argue claims separately. [00:04:13] Speaker 00: And I don't see where claim 17 was argued separately before the PTAP. [00:04:19] Speaker 01: Certainly claim 17 was treated separately before the PTAP, and there's been no argument [00:04:25] Speaker 01: by bdsi that we've waived any argument about claim 17. [00:04:28] Speaker 00: But the question is whether it rises and falls with other claims. [00:04:31] Speaker 00: I don't believe it would. [00:04:33] Speaker 00: Where is that site in the records or where it was argued before the p-tab separate from the claim from which it depends? [00:04:54] Speaker 02: Claim 19 appears to be argued separately at 388. [00:04:57] Speaker 02: But I don't see something for claim 17. [00:05:02] Speaker 01: And I'll have to give you that eyesight during my rebuttal time. [00:05:07] Speaker 01: But certainly as to claim 17, setting aside the issue of whether this was in the PTO, first, BDSI's made no argument as to waiver. [00:05:19] Speaker 01: There was an express finding. [00:05:22] Speaker 01: about naloxone AUC in the opinion. [00:05:24] Speaker 01: That seems to be erroneous. [00:05:27] Speaker 01: We had thought that it was an inherency discussion, but BDSI says, inherency has nothing to do with this. [00:05:34] Speaker 01: It's a red herring. [00:05:38] Speaker 01: So I've addressed the naloxone AUC, and I would add that BDSI, when it's looking for the naloxone AUC, it doesn't even point to anything in lab tech. [00:05:50] Speaker 01: It points to a different document. [00:05:53] Speaker 01: So this is at BDSI's brief at 26, exciting to A648, which is a European Medicines Agency study. [00:06:07] Speaker 01: The second issue that I'd like to focus on is of enablement. [00:06:11] Speaker 01: The board reversed the burden of proof on the issue of enablement, placing it on the patent owner instead of on BDSI. [00:06:20] Speaker 04: What does that mean? [00:06:21] Speaker 04: Sorry, go ahead. [00:06:22] Speaker 04: What does that mean? [00:06:23] Speaker 04: Is that your view is that the patent owner has the burden of production but not the burden of persuasion and that the board misapplied and put the burden of persuasion on you? [00:06:35] Speaker 01: Yes. [00:06:36] Speaker 04: OK. [00:06:36] Speaker 01: And that's clear from two places. [00:06:38] Speaker 01: These are examples in the opinion. [00:06:41] Speaker 01: At A19, the board concluded, we are not persuaded that lab tech is not enabled with respect to buprenorphine. [00:06:51] Speaker 01: And in 823, we are not persuaded that Lab Tech is not enabled with respect to Naloxone. [00:06:58] Speaker 04: So by the use of the word persuaded, that to you suggests or requires that we interpret what the board's analysis was to mean that they put the burden of persuasion on you? [00:07:08] Speaker 01: Yes, and BDSI doesn't contend otherwise. [00:07:11] Speaker 01: In BDSI's brief, what it said is that the board properly placed the burden [00:07:18] Speaker 01: on us, of persuasion. [00:07:20] Speaker 04: I thought it was the burden of production. [00:07:23] Speaker 01: No. [00:07:24] Speaker 01: I don't believe so, Judge Still. [00:07:25] Speaker 02: I think you're wrong about that. [00:07:28] Speaker 02: Well, what do we do about Amgen and impacts and those opinions? [00:07:35] Speaker 02: Let's assume that I read them on their face saying, when it comes to the enablement question of a prior art reference and an invalidity challenge, [00:07:46] Speaker 02: If the question of enablement gets invoked in the proceeding, the burden is on the patent owner to prove that the prior art reference is not enabled, that there is some presumption of enablement. [00:08:02] Speaker 02: Aren't we bound by those decisions? [00:08:05] Speaker 01: Carefully read, those decisions speak to the burden of production, not persuasion. [00:08:12] Speaker 01: MGen, I think, is a good case in point. [00:08:14] Speaker 01: The issue there was the applicability [00:08:17] Speaker 01: of a presumption of enablement. [00:08:19] Speaker 01: But 35 USC 116E, which is in the IPR setting, says that the burden of, it places the burden of persuasion on the petitioner on all issues. [00:08:32] Speaker 01: This is, I think, akin to the issue that arose with respect to Section 282 in the Inbray-Cyclobenza Green case. [00:08:41] Speaker 01: And dynamic drinkware, I think, to similar effect. [00:08:45] Speaker 01: The burden of persuasion, [00:08:47] Speaker 01: always, always rests with the petitioner. [00:08:51] Speaker 01: So there can't be any question here either as to whether or not the burden of production was met. [00:09:00] Speaker 01: There was a lengthy declaration by Dr. Johnston [00:09:05] Speaker 01: it addressed these issues, I think it's 833 through 404, and there's nothing on the contrary. [00:09:12] Speaker 02: I understand what your side argued to the patent board on this question of [00:09:21] Speaker 02: enablement of the lab tech reference. [00:09:24] Speaker 02: It was specifically scoped to two arguments. [00:09:28] Speaker 02: One is this must have been a mistake for lab tech to talk about suboxone. [00:09:34] Speaker 02: I'm not sure if that's the right pronunciation because suboxone is about sublingual absorption of the tablets and [00:09:44] Speaker 02: Lab tech is really geared towards GI tract absorption. [00:09:48] Speaker 02: So there must be some mistake. [00:09:49] Speaker 02: And then the second argument is this notion that the bioavailability of bupren and morphine, whether through GI tract versus sublingual absorption, is dramatically different. [00:10:04] Speaker 02: And so those were the issues that the patent board took on and made the findings that it made. [00:10:11] Speaker 02: And then what I saw in your briefing was, [00:10:14] Speaker 02: a fairly dramatic expansion of the enablement argument going into other issues, other areas, identifying perhaps other problems with whether the lab tech reference is enabling. [00:10:27] Speaker 02: And so my first question to you is, aren't we, as a court of review, restrained to look at the actual issues presented to the tribunal below and the findings that the tribunal made with respect to those specific arguments? [00:10:44] Speaker 01: The answer to the latter question is yes. [00:10:49] Speaker 01: At E399 through 404 though, I know that the issue of routine experimentation was addressed and certainly the issue of enablement generally was raised in the sections of the appendix that I cited to. [00:11:04] Speaker 01: So these issues were squarely raised. [00:11:07] Speaker 02: And again- I guess what I'm wondering is, should the patent board be charged with looking at any and all arguments that you made against the proposed 103 rejection in answer to a possible 102 rejection? [00:11:23] Speaker 01: It refused to even address the issue of undue experimentation in the context of obviousness. [00:11:30] Speaker 02: Well, that's a separate question for trying to- [00:11:33] Speaker 02: discern the correctness under the applicable standards of review of the patent board's decision on the anticipation rejection? [00:11:41] Speaker 01: Your Honor, again, I think the issue was fairly raised as to enablement generally. [00:11:47] Speaker 01: And routine experimentation, while under a heading of obviousness, was put forward. [00:11:54] Speaker 01: And the board refused to address it. [00:11:58] Speaker 01: It said enablement has nothing to do with obviousness. [00:12:02] Speaker 04: Well, except I thought here you were using the whole discussion that preceded this last set of questions dealt with you're using enablement for purposes of anticipation, not for obviousness, right? [00:12:13] Speaker 01: Yes, and 383 through 404. [00:12:15] Speaker 01: I'm into my time. [00:12:17] Speaker 01: That's okay. [00:12:18] Speaker 01: 383 through 404 of the appendix, we believe, relate to enablement and also to the [00:12:25] Speaker 01: issue of routine experimentation. [00:12:27] Speaker 01: And one other thing, BDSI hasn't raised any waiver issue. [00:12:31] Speaker 01: I don't know what else we would be citing to or have cited to in the appendix. [00:12:35] Speaker 01: There's not a word, not a word in BDSI's brief about waiver. [00:12:40] Speaker 01: In most instances, BDSI just didn't take on the arguments that we raised in our initial brief. [00:12:50] Speaker 01: So I think that given where we are, [00:12:54] Speaker 01: It seems to me that that ought to have been raised by BDSI. [00:13:00] Speaker 01: And again, there do happen to be, irrespective of their not having raised an issue of waiver, those 20 pages, 21 pages of the appendix speak to enablement and routine experimentation. [00:13:14] Speaker 01: I just wanted to get to the third issue. [00:13:16] Speaker 04: But before we get there, can I just sort of, before we got into the process questions, we were talking about the board's findings with respect to enablement. [00:13:24] Speaker 04: and notwithstanding that they used the word persuaded, I thought I understood, and I think Judge Chen alluded to this, that your main argument about, even under the burden of production, which you acknowledge you had, was that lab tech is limited to GI absorption films, and therefore it's not anticipatory. [00:13:44] Speaker 04: Right? [00:13:44] Speaker 04: I mean, wasn't that the main argument? [00:13:46] Speaker 04: Certainly there is that. [00:13:47] Speaker 04: OK. [00:13:48] Speaker 04: And the board concluded, and let's say for the sake of argument, correctly, [00:13:54] Speaker 04: that it's not, that lab tech uses the word predominantly, and that they also talk about orally disintegrating films, which means even if it's going to go primarily for the GI tract, some of it is going to be absorbed in the mouth just by definition. [00:14:11] Speaker 04: So why is the board incorrect in its conclusion? [00:14:15] Speaker 04: Leaving aside the burden question. [00:14:17] Speaker 01: Well, the issue of routine experimentation was clearly raised. [00:14:21] Speaker 01: And I pointed to those pages earlier. [00:14:24] Speaker 04: No, but can you just deal with what I'm saying? [00:14:26] Speaker 04: The issues that I think that were clearly raised and that the board dealt with, why was the board here? [00:14:31] Speaker 01: We haven't raised any issue as to whether it requires only use of gastrointestinal. [00:14:42] Speaker 01: That's not an issue that we've raised in this appeal. [00:14:45] Speaker 01: So that's a section of the board's reasoning that we haven't [00:14:50] Speaker 01: challenged in this appeal. [00:14:52] Speaker 04: Well, but you've challenged its conclusion. [00:14:54] Speaker 01: Correct. [00:14:55] Speaker 04: That there's anticipation, and the sub-part of that, which is that there can be no anticipation because the lab tech reference is not enabled. [00:15:07] Speaker 04: Isn't that part of this appeal? [00:15:09] Speaker 01: Certainly, that's part of the appeal. [00:15:11] Speaker 01: But the issue of routine experimentation, we believe, was raised. [00:15:14] Speaker 01: The issue of disclosure and this wish disclosure thing was also raised. [00:15:19] Speaker 01: I know, but I'm not. [00:15:21] Speaker 04: Okay. [00:15:21] Speaker 04: Well, I just want you to answer my question, which is on the point of whether or not lab tech is limited to GI absorption films. [00:15:29] Speaker 04: You're saying that you agree that it's not limited to GI absorption films. [00:15:33] Speaker 01: Well, I think our position is it's limited. [00:15:36] Speaker 01: It's focused on GI films, and this is even the other science expert said the general teaching is how to reduce absorption through the oral mucosa. [00:15:45] Speaker 01: What we're not contending is that [00:15:47] Speaker 01: All absorption need be through the oral mucosa. [00:15:51] Speaker 01: That is not a contention. [00:15:52] Speaker 04: So I guess I'm sorry. [00:15:54] Speaker 04: Maybe it's me. [00:15:54] Speaker 04: But is the answer to the question, is lab tech limited to GI absorption films? [00:16:00] Speaker 04: Your answer is it is limited or it's not limited. [00:16:04] Speaker 01: It's limited to films that are chiefly or predominantly through GI absorption. [00:16:10] Speaker 01: That's the best I can do, Your Honor. [00:16:13] Speaker 01: And the other side's expert, I think, was to the same effect as was [00:16:16] Speaker 01: Judge Andrews in the district court decision that we submitted as our 28-J level. [00:16:23] Speaker 01: May I proceed to the third? [00:16:25] Speaker 04: Sure. [00:16:27] Speaker 04: Just very briefly, because you've already run over your rebuttal time. [00:16:32] Speaker 04: But I understand that we've asked you a lot of questions. [00:16:35] Speaker 04: So just take another two minutes. [00:16:37] Speaker 04: OK. [00:16:38] Speaker 01: So the board, we believe, based on the evidence submitted, which was a copious declaration, it couldn't have concluded [00:16:46] Speaker 01: that there was enablement without undue experimentation. [00:16:49] Speaker 01: And we've pointed out all the variables in lab tech. [00:16:53] Speaker 01: There isn't any guidance how to get to a film with those pharmacokinetics. [00:16:59] Speaker 01: And the board recognized there's no embodiment of a film with buprenorphine and naloxone with these pharmacokinetics. [00:17:07] Speaker 01: And there was also agreement with BDSI that not every lab tech film would produce the clean pharmacokinetics. [00:17:16] Speaker 01: We think it's clear that it's not enabled. [00:17:18] Speaker 01: I also, just for a moment, wanted to mention obviousness. [00:17:22] Speaker 01: So the board didn't identify any element that was missing from Lab Tech that was supplied by Yang. [00:17:32] Speaker 01: He didn't provide a reason why the person of ordinary skill in the art would have combined them or why the person of ordinary skill in the art would have reasonably expected success in combining them. [00:17:45] Speaker 01: Those are things that ought to be in the board's opinion. [00:17:49] Speaker 01: They aren't. [00:17:50] Speaker 01: We're entitled to them as a matter of administrative law. [00:17:54] Speaker 01: We cite it to cases to that effect. [00:17:56] Speaker 01: And I think as recently as June in the Encino case, the Supreme Court said as much. [00:18:01] Speaker 01: So that we're entitled to decisions from an administrative body. [00:18:06] Speaker 01: For all these reasons, the board's findings should be reversed. [00:18:11] Speaker 04: OK. [00:18:11] Speaker 04: Thank you. [00:18:12] Speaker 04: We'll restore two minutes of rebuttal. [00:18:14] Speaker 04: And to keep it even, why don't we give the other side an additional four minutes, starting off. [00:18:19] Speaker 04: Don't feel compelled to use all of it. [00:18:21] Speaker 03: Thank you, Your Honor. [00:18:22] Speaker 03: Lee Bromberg for BDSI. [00:18:24] Speaker 03: I'm accompanied by Danielle Herath. [00:18:26] Speaker 03: And we believe that the record below provides substantial evidence for the anticipation finding by Lab Tech [00:18:35] Speaker 03: and certainly substantial evidence for the obviousness finding by lab tech in view of Yang, and therefore that those results should be affirmed by this court. [00:18:48] Speaker 02: What about the other side's expert report describing how it's somewhat tricky to make these films, and we shouldn't be so quick to presume that just because it exists in tablet form, we can get the exact same pharmacokinetics from a film version. [00:19:05] Speaker 02: and know how to build a film that will do that. [00:19:08] Speaker 03: Well, there was overwhelming evidence in support of the proposition that you could take the tablet and turn it into a film form based on the teaching of lab tech. [00:19:19] Speaker 03: And one of the most important was the admissions by Dr. Johnston himself, Arby's expert. [00:19:27] Speaker 03: Among those admissions, first of all, he said that the person of skill in the art, he set a very high bar. [00:19:33] Speaker 03: PhD in pharmacology, a couple years experience, familiarity with how to make film, as well as familiarity with the pharmacokinetics of buprenorphine and naloxone. [00:19:45] Speaker 03: So with that definition, you have a very highly educated person of skill in the art. [00:19:53] Speaker 03: Secondly, Dr. Johnston's declaration was all premised on the proposition that lab tech was limited to [00:20:03] Speaker 03: care oral administration for dissolution in the gut. [00:20:08] Speaker 03: What my colleague at the bar said, they don't stand by that. [00:20:14] Speaker 03: Because the board said, no, it's not. [00:20:16] Speaker 03: It's based upon both orally disintegrating film. [00:20:19] Speaker 03: Those are words Wright and Labdek, orally disintegrating film. [00:20:23] Speaker 03: And Dr. Johnston admitted that when you have orally disintegrating film, you get some absorption through the oral mucosa. [00:20:32] Speaker 03: even if you subsequently swallow the whole thing. [00:20:35] Speaker 03: In fact, he testified in his deposition, I don't think you would make a film just to be swallowed. [00:20:41] Speaker 03: I mean, so that was his own testimony. [00:20:45] Speaker 03: So his admissions really undermine the claim that you wouldn't know how to do it. [00:20:51] Speaker 04: And of course, if you look at- Well, it depends what the question is that you're asked, and I think your friend was suggesting that, that their position is that it was predominantly [00:21:00] Speaker 04: not dealing, it was predominantly dealing with GI absorption. [00:21:05] Speaker 03: Well, the lab tech reference does talk about GI absorption, but it has a specific section which says, now, admittedly, if you have a pharmaceutical film, you put it in your mouth, and it's an orally disintegrating film, you're going to have some absorption in the oral mucosa. [00:21:23] Speaker 03: But we're aiming to think of ways that we can reduce that to get more of it to go into the gut. [00:21:28] Speaker 03: Which is clearly different than this path. [00:21:31] Speaker 03: That is different from this patent, your honor. [00:21:34] Speaker 03: But the teaching, a reference teaches for everything that's in that reference. [00:21:38] Speaker 03: And it not only teaches you about how to adjust the pH so that you try to promote gastrointestinal absorption, but it also teaches you that if you have an orally disintegrating film, [00:21:52] Speaker 03: It's going to dissolve in your mouth, and you're going to have absorption through the oral mucosa. [00:21:56] Speaker 03: So we think that all of those things are fully disclosed in LAMP Tech. [00:22:02] Speaker 03: And indeed, the argument that it was just a wish is just not true. [00:22:07] Speaker 03: There is a table of references. [00:22:10] Speaker 03: There is a detailed discussion of how to make a film, all of the components of the film. [00:22:15] Speaker 04: There's an example given... There's no dispute that what's not disclosed is the particular number that are included in Claim 17. [00:22:23] Speaker 03: Okay, on that point, Your Honor, that is and was a well-known pharmacokinetic characteristic of naloxone that was part of the European Medicines Association study published in 2006. [00:22:39] Speaker 03: It's got a copyright date on it, which tells you the values for [00:22:44] Speaker 03: naloxone that are right in the range that CLAIM-17 calls for. [00:22:49] Speaker 03: So the person who organized... And that's outside of the disclosure, right? [00:22:53] Speaker 03: It's outside of the... I'm sorry, outside of the... It's not in lab tech. [00:22:56] Speaker 03: Those numbers are not in lab tech. [00:22:58] Speaker 03: All the other pharmacokinetic numbers are in lab tech. [00:23:01] Speaker 03: But with respect to that set of AUC numbers, those are in this study from 2006 based on the suboxone tablet. [00:23:11] Speaker 03: And that [00:23:12] Speaker 03: The characteristics of those tablets were replicated by RB itself. [00:23:20] Speaker 03: And that's the basis for the 832 patent claims. [00:23:23] Speaker 04: They made it into a film. [00:23:26] Speaker 04: Maybe someone could infer that or figure that out there. [00:23:28] Speaker 04: I don't think there's any dispute about that. [00:23:30] Speaker 04: The question is, in the context of anticipation, whether it works to not have disclosure in the reference you're relying on and have to look elsewhere [00:23:41] Speaker 04: to bolster, to clarify, to inform what we're talking about. [00:23:48] Speaker 03: OK. [00:23:49] Speaker 03: Well, in that context, Your Honor, I believe the law is clear that you don't have to provide a disclosure of things that are well known in the prior art. [00:24:02] Speaker 03: And there's the old... [00:24:06] Speaker 03: machine fabric case. [00:24:08] Speaker 02: So are we talking inherency with respect to claim 17? [00:24:11] Speaker 03: We're not talking inherency, we're talking about things that are well known. [00:24:14] Speaker 03: It's like saying the temperature has to exceed the boiling temperature of water. [00:24:20] Speaker 03: We all know what that means. [00:24:21] Speaker 03: That means it has to be over 100 degrees centigrade. [00:24:24] Speaker 03: That is fully disclosed from that phrase without putting that number in. [00:24:29] Speaker 03: And similarly here, and there's case law that supports this proposition, that if there's [00:24:35] Speaker 03: information that's known to technologists in the field, then that information does not have to be part of the disclosure that's going to anticipate. [00:24:46] Speaker 02: So what would be so clearly known to those of skill in the art that you would have a mean AUC in the range reciting the claim 17? [00:24:58] Speaker 02: Yes. [00:24:58] Speaker 02: For naloxone. [00:24:59] Speaker 03: Yes, you would know that from the 2006 study, from the tablet insert, [00:25:05] Speaker 03: from all of the information about the suboxone tablets, which when RB turned them into film, they had the identical pharmacokinetic characteristics. [00:25:14] Speaker 03: So contrary to the argument that RB makes about how difficult and strange this was, they were directly translated. [00:25:24] Speaker 03: And the lab tech reference itself talks about another sublingual product, Zofran, [00:25:31] Speaker 03: which is listed in table A, just like the Suboxone tablet, and talks about turning that into a film form with detailed discussion of how to make the film and what kind of characteristics you would get. [00:25:45] Speaker 03: In fact, the lab tech reference says you want to mimic the pharmacokinetics of the tablet product. [00:25:55] Speaker 02: So you're relying on the Suboxone tablet label or data sheet? [00:26:01] Speaker 03: Yes, we're relying upon the label, the data sheet, the EMEA study. [00:26:05] Speaker 02: That's where it says the specific claim range for Naloxone's mean AUC? [00:26:11] Speaker 02: Yes, Your Honor. [00:26:12] Speaker 02: Yes, Your Honor. [00:26:13] Speaker 04: Can you go back now to the discussion we were having with your friend Judge Chen and I, I guess, about the process kind of question. [00:26:21] Speaker 04: It seems that the board did not, if I'm reading it correctly, on the enablement question on anticipation, deal with undue experimentation. [00:26:32] Speaker 04: Right? [00:26:32] Speaker 04: And if that's the case, [00:26:35] Speaker 04: then isn't that a problem unless it really wasn't presented for square before the board in that way. [00:26:43] Speaker 04: So do you have any comments or information you can give us with that in that regard? [00:26:47] Speaker 03: With respect to that, Your Honor, of course the board went through the lab tech reference and took all of the teaching of that reference and said you would get there, you would get to the film with these characteristics and [00:27:04] Speaker 03: the comment that they made about were not persuaded that there's non-enablement here, which was the argument below, that was simply talking about all of the evidence they had that supported enablement and a limited amount on non-enablement. [00:27:21] Speaker 03: With respect to, and therefore they concluded that BDSI had sustained its provenance. [00:27:27] Speaker 03: However, you adjusted the burden of production and the burden of persuasion. [00:27:32] Speaker 02: Let me try to drill down a little more on this. [00:27:36] Speaker 02: As I saw what happened below in front of the board, when it came to the anticipation grounds for rejection, RB made an enablement argument. [00:27:48] Speaker 02: But its enablement argument was predicated on the great disparity in alleged bioavailability between GI tract absorption and sublingual absorption. [00:28:01] Speaker 02: So therefore Lab Tech doesn't enable these plans. [00:28:06] Speaker 02: When it came to the 103 proposed rejection, [00:28:10] Speaker 02: RB made a non-enablement type of argument again, but there they had related but different arguments about undue experimentation. [00:28:24] Speaker 02: I don't think they [00:28:26] Speaker 02: invoke in Ray Wands but it was the same idea of in Ray Wands and then had all kinds of evidence from their expert explaining how it's kind of tricky to figure out what is the right balance of various ingredients that you would need beyond the two active ingredients in order to make an effective film. [00:28:43] Speaker 02: So then the question is the patent board ultimately with respect to the one of two rejection that it adopted [00:28:50] Speaker 02: just focused in and addressed the enablement arguments the patent order made with respect to the 102, and did not address the additional undue experimentation or non-enablement arguments that are being made for the 103. [00:29:10] Speaker 02: So the question is, should the patent board have said to itself, aha, [00:29:16] Speaker 02: RB is making all kinds of enablement arguments throughout its brief, some with respect to 102, different ones with respect to 103. [00:29:27] Speaker 02: And we, as the Patent Board, really, in respect to addressing the enablement question in the context of either 102 or 103, need to address all of the full basket [00:29:42] Speaker 02: enablement arguments each time with respect for 102 and with respect to the 103. [00:29:48] Speaker 02: That is how I understand RV's position this morning. [00:29:52] Speaker 02: Is that correct or is that incorrect? [00:29:55] Speaker 03: Respectfully, Your Honor, I believe that is not a correct position. [00:29:58] Speaker 03: I think the board addressed everything that was put in front of them. [00:30:01] Speaker 03: And my colleague referenced a question of whether they waived the argument. [00:30:06] Speaker 03: Perhaps they did. [00:30:08] Speaker 03: But in any event, the board addressed everything in front of them and found really overwhelming evidence of both enablement and of no need for undue experimentation. [00:30:19] Speaker 03: And let me just articulate some of that. [00:30:21] Speaker 03: This record is full of it. [00:30:23] Speaker 03: But Dr. Johnston, again, Arby's own expert, said, [00:30:28] Speaker 03: that the bioavailability of buprenorphine in the gut was 5 to 15 percent. [00:30:38] Speaker 03: So when questioned at his deposition about the suboxone tablet label, which says bioavailability is an average of 13.6 percent, a range of 5 to 25 to 24.9 percent, the question was, don't those overlap? [00:30:56] Speaker 03: Yes, those overlap. [00:30:58] Speaker 03: So the Suboxone tablet is talking about oral mucosal absorption. [00:31:03] Speaker 03: His testimony is talking about what's going on in the gut. [00:31:08] Speaker 03: So the evidence was overwhelming that the lab tech reference would give you what you needed to make a film that would have the appropriate bioavailability characteristics. [00:31:21] Speaker 03: And similarly, on the question of the need for experimentation, [00:31:27] Speaker 03: The beef that RB presented to the board was, gee, it's telling us make a film that mimics the pharmacokinetic characteristics of these tablets. [00:31:41] Speaker 03: It's giving us a list of them. [00:31:43] Speaker 03: It's showing us what those PK characteristics are. [00:31:47] Speaker 03: It shows us how to make a film. [00:31:48] Speaker 03: And as an example, it takes the drug that [00:31:56] Speaker 03: that involves the active ingredient Ondansetron, and it says, here's how you do it with Ondansetron in great detail about how to do the film. [00:32:05] Speaker 03: So they're saying, we're still, geez, we still don't get it. [00:32:09] Speaker 03: How do you make a film? [00:32:10] Speaker 03: How do you make a film that has buprenorphine and no-on-soil? [00:32:14] Speaker 03: The board just didn't think there was any credibility to that position once Dr. Johnston's admissions were of record, and when our own expert, Dr. Feigl, said, [00:32:25] Speaker 03: I don't know what Dr. Johnson says is missing from lab tech that's in claim 15. [00:32:31] Speaker 03: And in fact, Dr. Johnson admitted he couldn't find anything in lab tech. [00:32:37] Speaker 03: in claim 15, I'm sorry, that was missing in Lab Tech. [00:32:41] Speaker 03: So there was just overwhelming evidence that it taught you how to do it, it showed you how to do it. [00:32:48] Speaker 03: Now, when we get to the obviousness analysis, Your Honor, the question becomes, well, what's left here? [00:32:56] Speaker 03: If Lab Tech teaches you everything you need to know, then how do you address that? [00:33:03] Speaker 03: Well, the Yang reference, which is RB's [00:33:07] Speaker 03: Arby's own partner's reference, which is incorporated by reference in the 832 patent. [00:33:14] Speaker 03: It says, if you want to know how to make a pharmaceutical film, here's how to do it. [00:33:18] Speaker 03: Look at the Yang reference. [00:33:20] Speaker 03: So the Yang reference tells you everything in detail about how to make a pharmaceutical film. [00:33:27] Speaker 03: That was why the board said, well, if you take lab tech, and to the extent there's anything missing, namely not an explicit example of putting these things together in a film that uses buprenorphine and naloxone, it's in Yang. [00:33:41] Speaker 03: So we believe that that was an adequate 103 determination that it would be obvious over those two references. [00:33:54] Speaker 04: Thank you. [00:33:55] Speaker 03: Thank you. [00:33:56] Speaker 03: May I make just one more point, which is that in the discussion of obviousness, there was reference to commercial values and a lot of a hewing cry about RB that they weren't addressed. [00:34:09] Speaker 03: Well, they were addressed. [00:34:10] Speaker 03: They were explicitly addressed. [00:34:11] Speaker 03: Our own expert, Dr. Meyer, an economist, testified that there's no evidence on this record that shows any nexus between the film form of [00:34:23] Speaker 03: Suboxone and the tablet and the commercial success. [00:34:27] Speaker 03: The tablet itself was very successful when they came out with the film with the identical characteristics. [00:34:34] Speaker 03: That continued to be successful but there was no evidence that the film itself contributed to the commercial success. [00:34:42] Speaker 03: And to put the frosting on that cake, Dr. Johnston's declaration says that [00:34:51] Speaker 03: The 16 milligram dosage of suboxone film is not within the claims at issue here. [00:35:01] Speaker 03: Not within the claims. [00:35:03] Speaker 03: And that was hard to figure out because he listed all the dosages in his declaration up to the 16. [00:35:09] Speaker 03: But at deposition he admitted it's not within the claims. [00:35:12] Speaker 03: What's the significance of that? [00:35:14] Speaker 03: That is the standard dosage. [00:35:17] Speaker 03: that RB recommends for its film product. [00:35:21] Speaker 03: So its standard dosage is not within the claims showing no commercial success nexus to the film form. [00:35:31] Speaker 03: Thank you. [00:35:39] Speaker 01: First, the maloxone you see, I don't have an A site. [00:35:42] Speaker 01: Again, though, BDSI did not raise any issue as to waiver [00:35:46] Speaker 01: So it's not surprising, I don't have an e-site of anything that would counsel for reman, were this the one issue. [00:35:53] Speaker 01: But there was something that my friend said about the pharmacokinetics of the Naloxone AUC. [00:36:01] Speaker 01: Naloxone AUC, and you can look at other references. [00:36:05] Speaker 01: This is formulation dependent. [00:36:07] Speaker 01: LabTex talks about a wish for a film with certain pharmacokinetics. [00:36:12] Speaker 01: There isn't any reason that a film with [00:36:16] Speaker 01: The listed pharmacokinetics, even were you able to obtain those, would have the naloxone AUC that's desirable. [00:36:24] Speaker 01: Which pharmacokinetics are achieved depend upon the formulation selected. [00:36:29] Speaker 01: And we have a citation in Lab Tech showing that very thing with different dissolutions resulting from the choice of different active ingredients, inactive ingredients, I'm sorry, I misspoke. [00:36:40] Speaker 01: That's at table 15. [00:36:42] Speaker 02: Is the mean AUS AUC this? [00:36:45] Speaker 02: listed in claim 17, is that also identified in a data sheet or some label with regard to Suboxone tablets? [00:36:53] Speaker 01: It's in the EMEA. [00:36:55] Speaker 01: It's not in the FDA labeling, I believe, for Suboxone tablets. [00:37:00] Speaker 01: But the person with ordinary skill in the art is able, if we disregard the fact that table A is about a tablet and lab tech generally about the wish to have film versions of those tablets, if the person with ordinary skill in the art goes there and tries to make a film, [00:37:15] Speaker 01: There's no reason why they're going to end up with the naloxone AUC of claim 17. [00:37:20] Speaker 01: Certainly, there was no evidence to that effect put on by BDSI. [00:37:24] Speaker 01: They don't argue that in their brief. [00:37:26] Speaker 01: They say, inherency is a red herring. [00:37:29] Speaker 01: And there's no argument either about incorporation. [00:37:32] Speaker 01: And certainly, we put the issue of disclosure at issue below. [00:37:37] Speaker 01: And I believe, as to all claims, there isn't disclosure [00:37:42] Speaker 01: of any film with these pharmacokinetics, which I believe is required under the net money case, where the requirement is that there be a disclosure in the prior art of as arranged in the claims. [00:37:56] Speaker 01: So the elements as arranged in the claim, they simply aren't there. [00:38:01] Speaker 01: There was something about overlap. [00:38:03] Speaker 01: I don't really think that this issue about paroral dosage forms [00:38:08] Speaker 01: is we're not arguing that every bit and speck of these active ingredients has to be absorbed transmucosally. [00:38:19] Speaker 01: There's clearly some if one follows lab tech. [00:38:23] Speaker 01: There's some that will be absorbed transmucosally, because that's the nature. [00:38:28] Speaker 01: This isn't a precise science. [00:38:31] Speaker 01: But clearly something that's designed for gastrointestinal delivery [00:38:37] Speaker 01: And by that, I mean not swallowing the film whole, which would be ludicrous. [00:38:40] Speaker 01: That was the question to Dr. Johnston. [00:38:43] Speaker 01: But when the film dissolves in the mouth, if you have a film that's designed to be delivered gastrointestinally, the contention was that you're not going to reach those pharmacokinetics that are claimed. [00:38:56] Speaker 01: The only way that the board reached a different conclusion was through the gymnastics about the Naloxone AUC that is in the opinion. [00:39:05] Speaker 01: And I think also that tells us that the board was concerned with the Naloxone AUC, because it went through what we believed in our initial brief had to have been an inherency analysis. [00:39:17] Speaker 01: But it's a deficient one at that. [00:39:19] Speaker 04: Thank you. [00:39:20] Speaker 04: We have your argument. [00:39:21] Speaker 04: Thank you. [00:39:21] Speaker 04: Thank both parties.