[00:00:00] Speaker 02: Our next case for argument is 23-2434, Baer v. Mylan. [00:00:06] Speaker 02: Mr. Crossman, please proceed. [00:00:09] Speaker 00: Good morning, Your Honors, and may it please the Court, on behalf of Appellant Baer, we respectfully request that the Court reverse the final written decision of the Board, and to the extent needed, vacate and remand. [00:00:20] Speaker 00: I'd like to start with the claim limitation clinically proven effective. [00:00:24] Speaker 00: Because the narrow exception under Bristol Myers Squibb does not apply on this record, and because the Foley reference relied upon by Miland does not inherently anticipate that limitation, the final written decision of the board must be reversed. [00:00:41] Speaker 02: I'm confused. [00:00:41] Speaker 02: How would that result in a reversal? [00:00:46] Speaker 00: Well, if clinically proven effective is in fact limiting and not inherently anticipated, [00:00:54] Speaker 00: The board decided all of the grounds at a minimum on clinically proven effective being either non-limiting or inherent. [00:01:03] Speaker 02: How do we know what clinically proven effective means? [00:01:06] Speaker 02: Even if it is in fact a limitation, it's not clear to me that this record is [00:01:10] Speaker 02: fully developed on what it means to be clinically proven effective. [00:01:13] Speaker 02: For example, does it require a p-value showing statistical significance? [00:01:18] Speaker 02: Does it require human testing? [00:01:20] Speaker 02: As we all know, FDA testing involves multiple stages. [00:01:23] Speaker 02: It can be in vitro, in vivo, or in human testing. [00:01:27] Speaker 02: Each of those are clinical trials, at which point is something clinically proven effective. [00:01:32] Speaker 02: I don't feel like we have a developed record on this point. [00:01:36] Speaker 02: I've read everything, all of the expert testimony. [00:01:39] Speaker 02: So I don't see how we would reverse, because if we decide something's a limitation, don't we have to send it back for some development and argument from the parties on what that limitation means? [00:01:51] Speaker 00: Certainly, Your Honor, I would agree that if the court were to determine that clinically proven effective is a limitation and that further development of what that limitation meant should be decided by the board, then the decision of the board should be vacated and remanded. [00:02:06] Speaker 02: Well, I mean, I didn't see a very fulsome argument in your brief or in any briefs about what the exact meaning of that term should be. [00:02:14] Speaker 02: It was like a fly-by. [00:02:16] Speaker 00: I believe we did an argument. [00:02:17] Speaker 02: And by the way, it differed. [00:02:18] Speaker 02: What you said here on appeal to us about what that term means differed than some of the arguments you made below about what the term differed. [00:02:25] Speaker 02: Sometimes you argued that clinically proven effective meant it had to be proven to be better than or more effective than [00:02:34] Speaker 02: the administration of Rivaroxaban itself, that this combination had to be more effective than that. [00:02:41] Speaker 02: On appeal, you seem to have adopted the position that just means it has to be more effective than, I think, a placebo, though you didn't call it that. [00:02:48] Speaker 02: So I'm not even sure that you've consistently argued if that was a limitation exactly what it means. [00:02:56] Speaker 00: I do believe, Your Honor, that, as we noted in our briefing, the board construed, clinically proven effective in the institution decision, that it needed to be, the combination therapy needed to be shown to be clinically effective. [00:03:12] Speaker 00: We, before the board, in reference to that, I believe in our briefing here, [00:03:16] Speaker 00: that it did need to be shown clinical efficacy in the clinic, meaning in a patient, and that there needed to be a statistically significant improvement relative to the standard of care, which in this case was aspirin given alone, which were the arms of the COMPASS trial. [00:03:31] Speaker 00: So if I would submit we did make that argument below, and we did reference that argument here in our briefing as the construction that we are operating on, I don't think that [00:03:43] Speaker 00: whatever the construction is, I don't think on this record the Foley trial can actually inherently anticipate that limitation because the Foley trial did not disclose the Compass trial. [00:03:57] Speaker 00: It was actually conducted. [00:03:59] Speaker 00: And so when you do not actually have the method that was being performed that supposedly leads to the result in the claim. [00:04:07] Speaker 04: What supports your argument that clinically proven effective changes how the claim method is performed? [00:04:12] Speaker 00: So I would say two things. [00:04:13] Speaker 00: First of all, as a practical matter, it does change it because in the prior art, the doses of rivaroxaban and aspirin that had been given were not clinically proven effective. [00:04:25] Speaker 00: But I will also add, [00:04:27] Speaker 00: that I think the question of whether the limitation changes the manipulative steps of the method is not the dispositive question under this court's decision in Allergan for whether or not a limitation in the body of a claim should be deemed to be limiting. [00:04:43] Speaker 00: Allergan looked at the BMS case as well as the Copaxone case. [00:04:47] Speaker 00: And the question that that addressed was, was this limitation material patentability? [00:04:51] Speaker 02: But this is a method of treatment [00:04:54] Speaker 02: And so I want to pick up on Judge Cunningham's point, which is, what does clinically proven effective have to do with the method of administering precise quantities of precise drugs to a particular end? [00:05:10] Speaker 00: I think that what it does is it shows the distinction between what the claim is, what the invention is, which is that the method was in fact clinically proven effective and the prior art. [00:05:22] Speaker 02: I will note on this point... No, but the method isn't... The method here is administering a method of reducing myocardial infarction. [00:05:30] Speaker 02: Whether something was clinically proven effective or not doesn't actually affect whether this does improve myocardial infarction. [00:05:40] Speaker 02: and reducing risk of myocardial infarction, right? [00:05:45] Speaker 02: Okay, let me give you a third example, because I think this will be helpful. [00:05:48] Speaker 02: You might not perceive it as helpful, but I think it will be helpful to me. [00:05:52] Speaker 02: So instead of clinically proven effective, because I'm worried about clawback. [00:05:55] Speaker 02: I'm just going to be clear. [00:05:56] Speaker 02: I'm worried about clawback. [00:05:57] Speaker 02: Do you know what I mean by clawback? [00:05:58] Speaker 02: I'm not sure I understand what you mean. [00:06:00] Speaker 02: Okay. [00:06:00] Speaker 02: I'm worried that y'all want to develop a method, Bayer or anyone else, precise dosages, put it out there, [00:06:09] Speaker 02: And then later, come back and say, now I want to claim it, even though it's been in the public domain for a very long time, because I'm going to add in this clinically proven effective language. [00:06:19] Speaker 02: And that's how I'm going to claw it back from the public domain. [00:06:23] Speaker 02: I understand. [00:06:23] Speaker 02: Now you understand my clawback? [00:06:25] Speaker 02: Wait, hold on. [00:06:26] Speaker 02: Questions still coming. [00:06:27] Speaker 02: What if instead of clinically proven effective, what if you said, voted best new drug of 2026? [00:06:35] Speaker 02: So wait, wait. [00:06:37] Speaker 02: Administering to the human patient riboviraxin and aspirin in amounts that reduce risk and it's been voted best new drug of 2026 wherein riboviraxin is administered in an amount equal to two point. [00:06:50] Speaker 02: You see my point, right? [00:06:51] Speaker 02: You've just added a thing that isn't really a meaningful limitation in terms of the method of treating myofardial infarction. [00:07:00] Speaker 02: You've added a descriptor or something. [00:07:03] Speaker 00: I understand your question, Your Honor, and I think this is where the Allergan case is very instructive, because if you look at the claim there, it was a method of administering a particular pharmaceutical combination wherein the method was as effective as the prior ART method and reduced the incidence of side effects as the prior ART method. [00:07:25] Speaker 00: That falls directly into, squarely into this clawback hypothetical [00:07:29] Speaker 00: And the court, in that circumstance, this court concluded that nevertheless, the language there, the two wherein clauses about efficacy and safety, were in fact limiting because they were material to patentability. [00:07:42] Speaker 00: There could be a future case where there is language clinically proven effective, but [00:07:47] Speaker 00: On that record, it wasn't determined to be material to patentability for one reason or another. [00:07:53] Speaker 00: Or it could be obvious in that case. [00:07:55] Speaker 00: It could be based on the clinical trial, based on the information of the public. [00:07:58] Speaker 00: That limitation, that method might not be deemed by the post-it to be something that would be unexpectedly clinically proven effective. [00:08:07] Speaker 00: But that is the record we have here. [00:08:09] Speaker 01: I don't know that that answers the question, though, because in the case you cite, you're looking at a level of effectiveness. [00:08:16] Speaker 01: It's got to be better than the prior method. [00:08:19] Speaker 01: And it's got to not cause a certain downside. [00:08:23] Speaker 01: If something just wins a prize, as Chief Judge Moore's hypothetical states, that doesn't add anything to the method treatment at all. [00:08:33] Speaker 00: But I do think, Your Honor, that goes back to Judge Moore's original question, which is how does someone demonstrate clinical proof of efficacy? [00:08:40] Speaker 00: And to show something is to be clinically proven effective. [00:08:44] Speaker 00: It has to be shown relative to some standard, which is what happened in the Compass trial. [00:08:49] Speaker 00: So I think for purposes of the case here, that type of a concern is not a reason not [00:08:57] Speaker 00: either reverse or vacate the decision of the board. [00:09:00] Speaker 02: Well, I don't understand. [00:09:02] Speaker 02: I mean, my concern was callback. [00:09:04] Speaker 02: Taking something from the public domain and now patenting it because you've added a descriptive label that isn't at all relevant to the actual method of administration. [00:09:16] Speaker 02: This is a method of administering claim. [00:09:21] Speaker 02: Whether it's clinically proven or effective or not has no bearing on the method of administering. [00:09:26] Speaker 00: Well, what I would submit, Your Honor, is that it's not the same method as in the prior art. [00:09:32] Speaker 00: Because now, whatever method was being carried on in the prior art, that had not been clinically proven effective. [00:09:37] Speaker 00: Now there was a method that, in fact, was clinically proven effective. [00:09:41] Speaker 00: And that should allow the distinction, again, under the Allergan case. [00:09:45] Speaker 04: Let me just do kind of an add-on or a similar hypothetical to what the chief started you with. [00:09:54] Speaker 04: So what if you found another patent today with the limitation as proven clinically effective in a study started on May 6, 2025? [00:10:03] Speaker 04: Can you get 20 more years of patent protection? [00:10:06] Speaker 00: What I would suggest in that, Your Honor, is the answer is no, because in that case, it's hard to see how that particular limitation would be material to patentability or have anything to do with the allowance, the novelty of the non-obviousness of the claim. [00:10:18] Speaker 00: However, in a circumstance where it does, which it clearly does here, which was the case in the allergan, and that's also the case in how it's distinguished capaxone, such a limitation as we have in these claims would be material to patentability. [00:10:30] Speaker 00: I would like just before, while there's time, to also address some of the other claims. [00:10:34] Speaker 00: Because even if this court were to determine that clinically proven effective is either non-limiting or is inherently anticipated, I don't think that addresses claims three through eight. [00:10:50] Speaker 02: And let me start at least with claims- Do you mean three through eight or five through eight? [00:10:53] Speaker 02: Sorry. [00:10:53] Speaker 00: Three through eight. [00:10:55] Speaker 00: Because I don't believe it addresses claims three and four because of the combination of Foley and Plotsker. [00:11:01] Speaker 00: And I don't believe it addresses five through eight for the first product reason, as well as six and seven for the other reason. [00:11:08] Speaker 01: Before you do this, I just wanted to tease out one point on Foley. [00:11:10] Speaker 01: You said it didn't inherently disclose this effectiveness because it seems like the main distinction you have is that there's a different number of individuals in the trial. [00:11:24] Speaker 01: How is that enough to take away the inherent disclosure in full? [00:11:31] Speaker 01: Why is that so important? [00:11:33] Speaker 00: Because a clinical trial needs to be sufficiently powered in order to demonstrate the results. [00:11:38] Speaker 00: P-value. [00:11:39] Speaker 02: You have statistical significance. [00:11:40] Speaker 00: Correct. [00:11:41] Speaker 00: Correct. [00:11:41] Speaker 00: Which the patent talks extensively about. [00:11:42] Speaker 02: Small population won't give you a reliable P-value. [00:11:45] Speaker 02: Correct. [00:11:45] Speaker 00: Correct. [00:11:46] Speaker 00: That's your idea? [00:11:46] Speaker 00: Right. [00:11:47] Speaker 00: And the patent talks extensively about confidence intervals and statistical significance, hazard ratios, all of that which goes to the statistical analysis, whether something is clinically proven effective or not. [00:11:57] Speaker 00: So if Foley didn't have the right number of patients, then it couldn't disclose [00:12:04] Speaker 00: efficacy, even if the clinical trial could, assuming a clinical trial could disclose that, Foley is the wrong reference to rely on it. [00:12:09] Speaker 01: So you're packing a lot into clinically proven effective. [00:12:12] Speaker 01: And clinically proven effective means it's got to be proven with a significant statistical value. [00:12:19] Speaker 00: Yes. [00:12:19] Speaker 00: And that is what we argued for the board, and we note that argument here in our briefing. [00:12:23] Speaker 00: But on claims three and four, the ground that Mylan raised was Plotsker and Foley in combination. [00:12:32] Speaker 00: the arguments that it presented in its petition were about Foley and Plotsker in combination. [00:12:37] Speaker 00: The board and the institution decision said the salient question here is whether the post would have a reason to combine Foley and Plotsker with a reasonable expectation of success. [00:12:47] Speaker 00: However, then in its final written decision, it avoided that question and decided Foley in combination with commercial dosages of aspirin. [00:12:55] Speaker 00: And the only discussion of commercial dosages of aspirin [00:13:00] Speaker 00: in the petition was a single sentence buried in the discussion about the combination of Foley and Plotsker, which in part reference our own patent. [00:13:11] Speaker 02: And I would submit, Your Honors, that the fact that the board... I think your problem is the board found persuasive Dr. Zussman's explanation that a skilled artist would have this good reason to modify Foley's 100-milligram aspirin with Plasker's 75 to 100-milligram, because Plasker not only teaches such a dosage regime, but also teaches its success in reducing the risk of myocardial infarction. [00:13:38] Speaker 02: So why isn't that a motivation? [00:13:41] Speaker 00: Well, what the board in its decision said was that the post-it would have a reason to modify Foley because the dosages of 75 milligrams and 81 milligrams of aspirin were publicly available, and Plotska is consistent with that. [00:13:56] Speaker 00: But that's not answering the question. [00:13:58] Speaker 00: I don't think the board addressed its final written decision. [00:14:01] Speaker 00: why the POSA would have had a reason to be looking at Plotskir in the first place because Foley and Plotskir address two different clinical trials, Compass and Atlas, directed to two different groups of patients. [00:14:12] Speaker 02: So the problem with that is that's a fact argument. [00:14:14] Speaker 02: You're weighing facts. [00:14:15] Speaker 02: You're pointing out reasons that maybe [00:14:18] Speaker 02: statement ought not to be a motivation to combine but it's a fact that's a fact question we review for substantial evidence so you're up against a hard challenge you're almost out of time and I really want to give you enough time to address the other issues why don't you turn to first product okay I believe that's a legal issue because I believe the board didn't address the correct standard but moving on to first product [00:14:41] Speaker 00: The board, Mylan proposed a construction of first product whereby a first product comprising A and B is actually not a first product comprising A and B. It can be two separate products given around the same time. [00:14:53] Speaker 00: And it proposed a construction for first product that allowed rivaroxaban aspirin to be given around the same time. [00:14:59] Speaker 02: Okay, just help me understand something because I get this argument. [00:15:03] Speaker 02: A first product that is the rivaroxaban and aspirin [00:15:07] Speaker 02: Does that have to be encapsulated in a single capsule, or can it just be take, you know, here, take these two pills, but you have to take them at the same time? [00:15:15] Speaker 00: I think a first product has to have the two in the same product. [00:15:18] Speaker 00: I mean, that's from the language a first product comprising. [00:15:20] Speaker 00: And the only place the specification speaks of a product is when it talks about a pharmaceutical product containing all the components along with additional pharmaceutical excipients. [00:15:31] Speaker 01: But the specification describes it as a combination dosage, right? [00:15:35] Speaker 00: The specification talks about a pharmaceutical product. [00:15:38] Speaker 00: It also talks about a combination dosage. [00:15:41] Speaker 01: And when it refers to a single pill that has both components in it, it calls that a combination dosage. [00:15:49] Speaker 00: It does, Your Honor. [00:15:50] Speaker 00: And then also in column 12, it talks about a pharmaceutical product. [00:15:55] Speaker 00: containing rivaroxan and aspirin in a single form. [00:16:00] Speaker 01: But either way, even whether... Are you arguing that the patentee [00:16:08] Speaker 01: define product other than its ordinary meaning? [00:16:12] Speaker 00: Well, I think the ordinary meaning of product, I don't think there's a different definition from the ordinary meaning, but I don't think a product could be satisfied by what Mylon argued is that one could give rivaroxaban and aspirin separately at the same time, and that satisfies the first product. [00:16:27] Speaker 01: What about the blister pack idea? [00:16:30] Speaker 00: So this was, this was, what Mylon argued later was not that O fully discloses a blister [00:16:38] Speaker 00: that contains all three. [00:16:40] Speaker 00: And by the way, all three wouldn't satisfy the limitation either, because it needs to be a first product with rivaroxan and aspirin, and then a second product with rivaroxan. [00:16:49] Speaker 00: So you really need two packs under the pack theory. [00:16:52] Speaker 00: But Mylan never argued that Foley disclosed any of that. [00:16:55] Speaker 00: Mylan's argument was Foley supported giving these two agents at the same time, as long as they were given closely together. [00:17:03] Speaker 00: We disputed the claim construction they proposed to accept that. [00:17:08] Speaker 00: double down on their claim construction. [00:17:09] Speaker 04: OK, so just to confirm, and I think it follows up on Joe Scorsese's question, you're not contending any lexicography with respect to first products, is that right? [00:17:18] Speaker 00: We're not. [00:17:19] Speaker 04: And then what would you say is your best intrinsic support for what you think first product needs? [00:17:24] Speaker 04: You point us to column 12. [00:17:25] Speaker 04: Do you have a line number as well? [00:17:27] Speaker 00: Sure, yes. [00:17:28] Speaker 00: It is column 12 line. [00:17:34] Speaker 00: I'm sorry, I'm going to need my reading glasses for this. [00:17:40] Speaker 00: line 40, the paragraph beginning line 43. [00:17:47] Speaker 00: In one embodiment, the venturing concerns a safe and effective pharmaceutical product, et cetera, et cetera, et cetera, wherein the pharmaceutical product comprises 2.5 milligram rivaroxaban [00:17:58] Speaker 02: You said line 43, is that right? [00:18:00] Speaker 00: Yes, correct. [00:18:01] Speaker 02: Okay, I'm going to ask a really stupid question now. [00:18:04] Speaker 02: When we talk about separate dosage forms versus combined dosage forms, can you help me understand is a combined dosage form always mean in the same capsule or can a combined dosage form mean two pills given at the same time so that you're receiving [00:18:22] Speaker 02: both of them. [00:18:23] Speaker 00: I don't think a combined dosage form would encompass the latter of your two hypotheticals. [00:18:29] Speaker 00: I don't think if you hand someone [00:18:31] Speaker 00: two pills that is a first product comprising A and B just based on the plain language of a first product comprising A and B. There has to be a single product that comprises the two A and B, which we believe in this circumstance is a pharmaceutical product. [00:18:47] Speaker 00: It could be literally mixed up in a pill. [00:18:49] Speaker 00: It could be a capsule that contained two different pills within it. [00:18:53] Speaker 00: It could be [00:18:54] Speaker 00: Even taking Mylan's hypothetical, which they didn't even really run, is how Foley disclosed it, but a pack that just had rivaroxan and aspirin, and it was some second pack for the second product, none of that has to do with, oh, here's rivaroxan and aspirin in two separate pills, but my hand is somehow the product. [00:19:16] Speaker 04: So just to kind of sum up, let's say we disagree with you [00:19:19] Speaker 04: on the arguments you're making with respect to clinically proven effective, but agree with you on your first product arguments. [00:19:25] Speaker 00: What do you contend would need to be done in terms of the relief granted? [00:19:33] Speaker 00: Those would need to be reversed, because I don't think there was any evidence to support under the correct construction of first product. [00:19:45] Speaker 00: I don't think Mylon proffered evidence to satisfy that correct construction. [00:19:50] Speaker 00: And therefore, that would need to be reversed. [00:19:53] Speaker 00: The case would need to be, I suppose, remanded for a further consideration of grounds one and two, which were not decided by the board in light of five and eight. [00:20:04] Speaker 00: And I would also submit again that I think that even if clinically proven effective were decided in Mylan's favor, that claims three and four, because the board did not conduct the correct analysis that was necessary under that ground, looking at the combination of Foley and Plotsker and looked instead at Foley on its own, that that should be at a minimum reverse. [00:20:27] Speaker 00: But certainly if the court is [00:20:29] Speaker 00: remanding for consideration of grounds one and two, could remand it to the board to say, why don't you make some findings as to whether the post would have had a reason to combine Foley and Plotsker with a reasonable expectation of success, as was proposed by Myland and argued before the board. [00:20:45] Speaker 02: OK, thank you, Mr. Grossman. [00:20:47] Speaker 02: Let's hear from also, how do I say your name? [00:20:51] Speaker 02: Mr. Fine. [00:20:51] Speaker 02: Mr. Fine. [00:20:52] Speaker 02: That's what I thought it was going to be. [00:21:00] Speaker 03: May it please the court, Wendy Devine? [00:21:03] Speaker 03: If I could just answer Your Honor's question about combinations with reference to the specification of the 310 patent. [00:21:11] Speaker 03: The 310 patent actually tells us what, in the scope of this patent, is a combination at column 9, line 9. [00:21:20] Speaker 03: It defines combination. [00:21:22] Speaker 03: It says, combinations means, for the purpose of this invention, not only dosage forms which comprise all the components, so-called fixed dose combinations, which is what Bayer contends is a first dose, a fixed dose combination. [00:21:40] Speaker 03: But it goes on to say, it also includes combination packs or kits. [00:21:48] Speaker 03: which comprise the components separate from one another but in a single package. [00:21:52] Speaker 03: It goes on and says, later, and this is the part cited by the board, it also includes components administered simultaneously or sequentially, as long as they are employed for prophylaxis and or treatment of the same disease. [00:22:07] Speaker 02: OK, so that is excellent. [00:22:09] Speaker 02: I'm really glad you pointed me right to that. [00:22:10] Speaker 02: That's very helpful. [00:22:12] Speaker 02: And I'm sure, on the bottle, he's going to have some answers to that because he needs one. [00:22:16] Speaker 02: Can you tell me now how that language links up with first product? [00:22:21] Speaker 02: Because I'm not positive I see that the first product can be a combination dosage. [00:22:31] Speaker 02: First product seems to me, if we're not giving it lexicography, I think of that as a product, i.e. [00:22:38] Speaker 02: a single thing. [00:22:39] Speaker 02: Sure. [00:22:40] Speaker 02: First product versus the second product. [00:22:42] Speaker 02: So I tend to think that he's right, that unless you show me something in the specification otherwise, I think a first product has to be a capsule or a caplet or a pill that has those two things combined in it. [00:22:54] Speaker 02: And so I'm not sure. [00:22:55] Speaker 02: I totally see what you're saying about column nine. [00:22:58] Speaker 02: And when I'm trying to figure out what the words combination dosage mean, I think the patentee did the finding, and you're right. [00:23:02] Speaker 02: But I'm not sure that is equated to first product in the spec. [00:23:07] Speaker 03: Sure. [00:23:07] Speaker 03: And the SPECT does not actually define first product. [00:23:11] Speaker 03: What it does is it talks about products of the invention, and then it talks about the therapeutic impact of the invention. [00:23:17] Speaker 03: And then it says one thing you can do is combination therapy. [00:23:21] Speaker 03: And if you look at claim five versus claim one, what claim one says [00:23:25] Speaker 03: is that you're administering the rivaroxaban twice daily, and you're administering the aspirin once daily. [00:23:32] Speaker 02: And that one doesn't have a limitation in it about where in, you know, whether it needs to be in one product versus two products. [00:23:40] Speaker 03: Right, right. [00:23:40] Speaker 03: So from a claim differentiation perspective, if you then look at claim five, what it says is that the rivaroxaban and the aspirin come together as a first product, and then there's another dose of rivaroxaban separately as a second product. [00:23:54] Speaker 03: So putting that in the context of the specification, what you have is combination therapy. [00:24:00] Speaker 02: No, no, no. [00:24:02] Speaker 02: I don't think that's right. [00:24:03] Speaker 02: I mean, I think it says in a first product. [00:24:06] Speaker 02: So I think we have to give those words first product meaning. [00:24:09] Speaker 02: So I'm not sure. [00:24:10] Speaker 02: You've got to show me where in the specification I am supposed to derive that that means combination therapy as defined in claim nine. [00:24:19] Speaker 02: That's what you're missing. [00:24:19] Speaker 02: I feel like you're reading out the words first product. [00:24:23] Speaker 03: Sure. [00:24:24] Speaker 03: If I can come at this from a slightly different angle, A first product, A meaning one or more. [00:24:29] Speaker 03: So one or more products that has these two drugs in them. [00:24:33] Speaker 02: No, it doesn't mean one or more products. [00:24:35] Speaker 02: It says A first product as compared to A second product. [00:24:40] Speaker 02: So I think [00:24:43] Speaker 03: I don't know what you... So it only has the two APIs in it, right? [00:24:48] Speaker 03: And it doesn't say one pill. [00:24:49] Speaker 03: It doesn't say one dosage form. [00:24:51] Speaker 03: It doesn't say a combination dosage form. [00:24:53] Speaker 04: It does not... What is your response to opposing counsel pointing us to column 12 beginning at around line 43? [00:25:00] Speaker 04: So that was where opposing counsel said we should look to further understand what first product means. [00:25:05] Speaker 04: How do you respond to that? [00:25:06] Speaker 03: Sure. [00:25:06] Speaker 03: So the only thing that that portion of the specification says is that it's an invention that concerns a safe and effective pharmaceutical product for this particular purpose wherein the pharmaceutical product comprises these two active ingredients in this amount. [00:25:24] Speaker 03: It doesn't say it's a combination dosage form. [00:25:26] Speaker 03: It doesn't specify the dosage form at all. [00:25:29] Speaker 03: So it [00:25:31] Speaker 03: It doesn't shed any further light than the actual language of the claim. [00:25:34] Speaker 03: But if I could just address counsel's contention that we did not develop the record in response to this construction, that's not accurate. [00:25:42] Speaker 02: I don't know. [00:25:43] Speaker 02: I don't want you to miss whether the records develop. [00:25:46] Speaker 02: You're losing on this point. [00:25:47] Speaker 02: I don't know if you perceive that. [00:25:48] Speaker 02: And so I want you to continue drilling down on it. [00:25:52] Speaker 02: The pharmaceutical product, I don't know how that could, the pharmaceutical product, I don't know how that can be multiple pills. [00:26:00] Speaker 03: If I could just talk about the record for just a moment, this claim construction issue actually doesn't impact the ultimate outcome, because Bayer did not develop any evidence that this claim construction leads to a different result, and we did. [00:26:19] Speaker 02: But the board hasn't addressed that evidence. [00:26:22] Speaker 02: And that would, it seemed to me, be a factual question, not a legal question. [00:26:27] Speaker 02: Correct, Your Honor. [00:26:27] Speaker 02: So I don't know how that helps you. [00:26:29] Speaker 02: I guess maybe it helps you because you say then we would vacate, not reverse. [00:26:32] Speaker 03: And if you vacated and remanded, the only evidence before the board supports invalidity. [00:26:37] Speaker 03: There is no evidence to support that this construction leads to a different conclusion by the board. [00:26:45] Speaker 02: I mean, are you thinking I'm going to make that decision in the first instance? [00:26:50] Speaker 03: No, I'm not asking, Your Honor, to make an actual decision. [00:26:53] Speaker 02: OK. [00:26:56] Speaker 02: OK, so are you just crying uncle on this one? [00:27:00] Speaker 02: No, I'm not. [00:27:00] Speaker 02: I still think that there are consequences. [00:27:06] Speaker 03: If I could go back to column nine. [00:27:11] Speaker 03: If I could go back to column nine. [00:27:14] Speaker 03: I understand your honor is focused on the language specifically first product, which isn't called out in column nine. [00:27:20] Speaker 03: But column nine is the only place in the specification that talks about combining therapies together. [00:27:26] Speaker 03: And it is deliberately expansive in how those therapies are combined together. [00:27:31] Speaker 03: It says that it includes any possible way of giving those therapies together, including simultaneous administration. [00:27:39] Speaker 04: But just following up on what Chief Judge Moore asked you, I'm not seeing the link between combinations and first product that you're, I think, arguing for. [00:27:48] Speaker 04: Is there anything else that you can show us to allow me to maybe see the link you're arguing for? [00:27:55] Speaker 04: Sure. [00:27:55] Speaker 04: It's just the actual text of the claim. [00:27:57] Speaker 04: So first product. [00:27:58] Speaker 04: I'm with you on the text of the claim, but I don't think it supports what you're saying. [00:28:01] Speaker 04: But go ahead. [00:28:02] Speaker 03: So first product is not defined at all in the specification. [00:28:04] Speaker 03: The claim chose to use language that is not defined in the specification. [00:28:09] Speaker 03: But what the claim goes on to say is that first product has two drugs in it. [00:28:14] Speaker 03: And those are given in combination. [00:28:16] Speaker 03: And then the second product is given a single drug. [00:28:19] Speaker 03: So if we look for what does the specification say is a combination therapy? [00:28:24] Speaker 03: How are drugs given in combination? [00:28:28] Speaker 03: The only place that is discussed, it begins at the bottom of column eight, and it goes to column nine. [00:28:33] Speaker 03: And it is expansive. [00:28:34] Speaker 03: It says that you can give them as a single dosage form. [00:28:37] Speaker 03: It says that you can give them as a combined dosage form. [00:28:40] Speaker 04: But I'm looking at claim five, and I'm not seeing the word combination. [00:28:43] Speaker 04: I don't know if it's just because I'm tired. [00:28:46] Speaker 04: But could you look at claim five and show me? [00:28:48] Speaker 03: Yes. [00:28:49] Speaker 03: Claim five does not contain literally the word combination, but it does say two different drugs together. [00:28:56] Speaker 03: A combination of drugs would be the plain and ordinary meaning of that. [00:29:00] Speaker 04: OK, so you are importing the word combination to claim five. [00:29:03] Speaker 04: I'm not seeing it. [00:29:04] Speaker 04: You don't see it either, right, when we both look at it? [00:29:06] Speaker 03: The literal world is not there. [00:29:07] Speaker 03: I agree. [00:29:07] Speaker 04: Thank you. [00:29:08] Speaker 03: I agree. [00:29:08] Speaker 03: Why don't you move on to one of your other arguments? [00:29:10] Speaker 03: Sure. [00:29:10] Speaker 03: I just wanted to make one last point. [00:29:11] Speaker 03: The board did find in the final written decision that Bayer had waived any arguments related to application of their claim construction by not separately arguing these claims. [00:29:21] Speaker 03: Moving to clinically proven effective. [00:29:24] Speaker 03: One thing that I want to level set on clinically proven effective is that the claim language is amounts that are clinically proven effective. [00:29:32] Speaker 03: And then there is a wherein clause that specifies what those amounts are. [00:29:36] Speaker 03: And what the board found is supported by the literal language of the claims, which is that the amounts that are specified later define the scope of the claim. [00:29:45] Speaker 03: And that is all that is covered by the claim. [00:29:47] Speaker 01: In order to get to the argument you made in the briefing, we have to read proven out of the phrase clinically proven effect, correct? [00:29:56] Speaker 03: No, Your Honor, you do not need to read it out. [00:29:58] Speaker 03: You do not need to read it out. [00:29:59] Speaker 03: Proven, the past tense proven, just simply indicates that the treatment has been characterized through a clinical trial. [00:30:07] Speaker 03: And this court actually faced a very similar situation in the titanium metals case. [00:30:13] Speaker 03: In titanium metals, there was a claim to an alloy [00:30:16] Speaker 03: that was characterized by corrosive resistance in certain hot brine circumstances. [00:30:22] Speaker 03: And this court found that that characterization, that functional description of the claimed prior art composition, did not confer novelty. [00:30:30] Speaker 03: The same thing applies here. [00:30:31] Speaker 03: It's a characterization of how certain clinical endpoints were met that were set by Bayer in their clinical trial. [00:30:38] Speaker 01: But I guess what I'm wondering is, what would be the difference in claim scope if the claim were clinically effective as opposed to clinically proven effective? [00:30:45] Speaker 03: In this particular claim, it would not make a difference because it is amounts clinically effective, amounts clinically proven effective. [00:30:51] Speaker 03: And then it tells you that those amounts are 2.5 and 75 to 100. [00:30:55] Speaker 03: So it doesn't further limit those 2.5 and 75 to 100. [00:30:58] Speaker 03: It doesn't change the scope of those amounts. [00:31:00] Speaker 03: And it's undisputed that those amounts are in the prior art. [00:31:03] Speaker 01: So your argument is that proven adds nothing to the claim. [00:31:06] Speaker 01: The word proven. [00:31:08] Speaker 03: to the actual limits of the claim? [00:31:10] Speaker 03: It does not. [00:31:11] Speaker 03: Are we reading out of the claim, though? [00:31:13] Speaker 03: No. [00:31:13] Speaker 03: It's simply a broader limitation, followed by a more narrow limitation. [00:31:17] Speaker 03: And we see claims written like that all the time. [00:31:19] Speaker 02: It's not negating. [00:31:20] Speaker 02: But does it have to already be proven effective? [00:31:24] Speaker 02: So for example, could Bayer have filed this claim before they undertook any clinical trials? [00:31:31] Speaker 03: A clinical trial isn't required for patentability. [00:31:33] Speaker 03: So once they knew that this method, and to your honor's point earlier about Clawback, once they knew this method had promise, they could have filed their patent application. [00:31:42] Speaker 03: They chose not to. [00:31:43] Speaker 03: They chose to publish it. [00:31:45] Speaker 03: And they dedicated it to the public. [00:31:46] Speaker 02: And then once their clinical trial was done, they filed a patent application. [00:31:50] Speaker 02: Time out now. [00:31:50] Speaker 02: When you say they chose to publish it, doesn't the FDA require publication of clinical trials? [00:31:56] Speaker 03: Sure. [00:31:57] Speaker 03: And they could have filed their patent application before FDA made that requirement, but they chose not to. [00:32:03] Speaker 02: But wouldn't you here be arguing that they didn't have a reasonable expectation of success at that point? [00:32:08] Speaker 02: I mean, wouldn't you now be challenging the utility of their claim if they had done that? [00:32:12] Speaker 03: Well, here we're talking about anticipation. [00:32:14] Speaker 03: So we don't need to address reasonable expectation. [00:32:17] Speaker 02: I don't need to address the consequences of the rule of law you want me to adopt about this not having any meaning? [00:32:23] Speaker 03: Oh, for... I'm sorry. [00:32:25] Speaker 03: I don't understand your question, Your Honor. [00:32:27] Speaker 02: You want me to say clinically proven effective has no meaning in this claim, OK? [00:32:33] Speaker 02: But if I say that has no meaning, then I guess theoretically I'm creating a universe where they have to file claims before they know that those claims are going to be effective, potentially effective in reducing the risk of myocardial infarction. [00:32:52] Speaker 03: So we don't think that such a per se rule is necessary here. [00:32:55] Speaker 03: What this claim covers is amounts that are clinically proven effective and specification of those amounts. [00:33:01] Speaker 03: And those amounts and this entire method was published. [00:33:05] Speaker 03: well before the priority date of the patent. [00:33:07] Speaker 02: Well, no, what was published was the onset of a clinical trial. [00:33:12] Speaker 02: The results of the clinical trial weren't published. [00:33:14] Speaker 02: Right. [00:33:14] Speaker 03: And the claim doesn't cover the results of the clinical trial. [00:33:17] Speaker 03: The claim covers a method of treating this particular affliction. [00:33:20] Speaker 03: Wait a minute. [00:33:20] Speaker 02: No, if the words clinically proven effective have meaning, the word proven, you can't actually have that be a claim limitation until you've actually proven that they're effective. [00:33:30] Speaker 02: Not that I hope they're going to be effective. [00:33:32] Speaker 02: I'm preparing to see if they're effective. [00:33:34] Speaker 02: I'm in the process of determining if they're effective. [00:33:36] Speaker 02: Right. [00:33:37] Speaker 03: But what that is is an inherent property of these particular doses. [00:33:42] Speaker 03: When that was dosed before the patent and when that was dosed after the patent, that dosage, that method is the same. [00:33:49] Speaker 03: The impact of that method is the same. [00:33:51] Speaker 03: The only thing that was happening in between those two times was the characterization of the impact of that method. [00:33:58] Speaker 03: And under titanium metals, that characterization doesn't confer novelty or patentability. [00:34:03] Speaker 03: It's simply identifying a property of a prior art method. [00:34:08] Speaker 02: I don't understand the inherent anticipation argument. [00:34:11] Speaker 02: Can you try and explain to me again? [00:34:13] Speaker 02: Sure. [00:34:14] Speaker 03: So the claim itself is amounts clinically proven effective. [00:34:18] Speaker 03: Then it goes on and says, where in those amounts are 2.5 milligrams or 75 to 100 milligrams for rivaroxaban and aspirin respectively. [00:34:27] Speaker 02: Isn't it possible that somebody could attempt a clinical trial with those amounts and it would not in fact be effective? [00:34:37] Speaker 03: That it's possible that a clinical trial could fail is absolutely true, but it's not relevant in the scope of this claim in titanium metals. [00:34:46] Speaker 02: Stop. [00:34:46] Speaker 02: If it's possible, doesn't inherent anticipation require it's always the case? [00:34:51] Speaker 02: Always the case? [00:34:52] Speaker 02: Every time? [00:34:53] Speaker 03: Absolutely. [00:34:53] Speaker 03: And it is always the case that this trial that was run would have met its clinical endpoints, regardless of the time period when it was run. [00:35:04] Speaker 02: Well, how do you know that? [00:35:05] Speaker 02: Like, how do you know what the population was going to be? [00:35:08] Speaker 02: How do you know what the p-value was going to be? [00:35:10] Speaker 02: What if you had a bunch of elderly people that had a greater predisposition, and then it wouldn't have had a p-value that showed statistical significance? [00:35:17] Speaker 02: I don't know. [00:35:18] Speaker 02: How can you be sure? [00:35:19] Speaker 02: I mean, there's so many variables that go into a clinical trial. [00:35:23] Speaker 03: That go into a clinical trial, absolutely. [00:35:25] Speaker 03: But the fact of the matter is the only thing that is covered by this claim is giving a patient these two doses of these two medications. [00:35:32] Speaker 03: And if it had any impact today, it was going to have that same impact before the priority date. [00:35:41] Speaker 01: You're reading proven out of the claim though because I can see your argument that clinically effective might be inherent You know, it either works for it doesn't work and that's inherent in the actual doses itself But proven effective is a different story So in other words if someone hadn't run the clinical trial, this would have never been clinically proven effective, correct? [00:36:03] Speaker 03: It wouldn't have been characterized but it still would have had that [00:36:06] Speaker 01: would have had effectiveness, but it wouldn't have proven effectiveness, correct? [00:36:09] Speaker 01: Right. [00:36:10] Speaker 03: And the difference between this case and allergen, which is where that was the outcome of the case, is there, it was a wherein clause that characterized the method. [00:36:19] Speaker 03: Here, we're talking about clinically proven effective amounts. [00:36:22] Speaker 03: We're talking about specific amounts. [00:36:24] Speaker 03: We're not talking about, hey, you can have a composition that can have a bunch of different things in it, and we're characterizing it by its safety and efficacy. [00:36:30] Speaker 03: We're talking about what happens when you give a person 2.5 milligrams of rivaroxaban and 100 milligrams of aspirin. [00:36:37] Speaker 03: It was the same five years ago as it's going to be tomorrow. [00:36:41] Speaker 01: So let me ask a question just hypothetically. [00:36:44] Speaker 01: So someone could run another clinical trial on different dosages, and that method wouldn't infringe this claim because the dosages are different. [00:36:53] Speaker 03: The dosages are different. [00:36:54] Speaker 01: If somebody ran another clinical trial that disproved the first clinical trial, then taking these dosages wouldn't infringe the claim, correct? [00:37:04] Speaker 03: if somebody ran a different clinical trial that didn't meet a different clinical endpoint? [00:37:08] Speaker 01: So let's say somebody runs a new trial and determines in that new trial that the first trial was somehow a fault, or it somehow discovered that the first trial was faulty. [00:37:19] Speaker 01: Wrong data, glitch, something happened. [00:37:22] Speaker 01: And this is no longer proven clinically effective. [00:37:25] Speaker 01: Well, then taking the dosages wouldn't infringe the claim, correct? [00:37:28] Speaker 03: I would take that back to the titanium metals case where it was [00:37:32] Speaker 03: a decrease in corrosion resistance in a hot brine environment. [00:37:37] Speaker 03: You could run that hot brine environment in less hot, more hot, less salt, more salt. [00:37:42] Speaker 03: That's the point. [00:37:43] Speaker 03: It's a functional characteristic of a composition claim limitation. [00:37:48] Speaker 03: Here we're talking about 2.5 milligrams of rivaroxaban is 2.5 milligrams of rivaroxaban, no matter how you characterize it. [00:37:56] Speaker 02: Can I ask you, you haven't addressed the Allergan case and it's really important and it's probably your biggest hurdle in this case. [00:38:03] Speaker 02: So can you jump to that and tell me how we would distinguish Allergan? [00:38:08] Speaker 03: Sure. [00:38:08] Speaker 03: The key difference between Allergan and the present case is the claim language. [00:38:13] Speaker 03: So in Allergan, it's a method of treating a patient with glaucoma or ocular hypertension comprising [00:38:19] Speaker 03: In that method, topical administration of a composition comprising, and it lays out some of the elements of the composition. [00:38:27] Speaker 03: And then there's a where-in clause about efficacy and a where-in clause about side effect profile. [00:38:32] Speaker 03: Here, again, we have administration of 2.5 milligrams and 100 milligrams. [00:38:38] Speaker 03: That is the same claim language that you see in BMS, which is the case that the board applied. [00:38:44] Speaker 03: In BMS, the claim language was administering to a patient an anti-neoplastically effective amount of about 135 to 175 milligrams. [00:38:54] Speaker 03: There, the anti-neoplastically effective amount [00:38:59] Speaker 03: applied to specific milligram amounts. [00:39:01] Speaker 03: That's our case here. [00:39:03] Speaker 03: In Allergan, that was not the claim language. [00:39:06] Speaker 03: In BMS, that language, the anti-neoplastically effective amount, was not further limiting on the milligram amount. [00:39:13] Speaker 04: That's the case here. [00:39:14] Speaker 04: But following up on what Judge Scarzi's been asking you, I think in BMS, it doesn't have, for example, the comparable word proven. [00:39:22] Speaker 04: How do you say that it's precisely our case here [00:39:25] Speaker 04: if we have the additional language of proven? [00:39:28] Speaker 04: Or tell me what you think about that. [00:39:29] Speaker 04: Sure. [00:39:30] Speaker 03: Anti-neoplastically effective amount in BMS was indicating that it had some sort of therapeutic impact on cancer. [00:39:37] Speaker 03: Here, we're saying it has some sort of therapeutic effect on heart disease or preventing stroke or heart attack. [00:39:45] Speaker 03: It's absolutely analogous. [00:39:46] Speaker 03: The fact that it says proven just indicates that they did the characterization of the functional aspect of what they're trying to claim and pull back out of the priority. [00:39:59] Speaker 03: If your honors have no further questions, I see you. [00:40:12] Speaker 02: Three minutes. [00:40:12] Speaker 00: Mike, thanks. [00:40:14] Speaker 00: OK. [00:40:16] Speaker 00: A few points. [00:40:18] Speaker 00: First of all, on the inherency question, here, the uncontroverted expert testimony, including from Mylon's expert, was that proof of efficacy in a clinical trial is not inherent. [00:40:31] Speaker 00: That's at a minimum. [00:40:32] Speaker 00: But again, the Foley reference that Mylan relied upon did not actually disclose the clinical trial as it was conducted that provided the clinical proof of efficacy. [00:40:41] Speaker 00: So for purposes of a PTAP appeal where Mylan relied on a specific reference that didn't actually demonstrate that, they haven't proven an inherency for purposes of the PTAP proceedings. [00:40:52] Speaker 00: I'll also add that [00:40:55] Speaker 00: on Chief Judge Moore's question about publishing the results. [00:41:00] Speaker 00: This was, in fact, the case where the information was required to be put on clinicaltrials.gov. [00:41:07] Speaker 00: And if you look at Foley, that's not a buyer publication. [00:41:10] Speaker 00: That cites to the footnote 72 cites to clinicaltrials.gov. [00:41:14] Speaker 00: So that is one aspect of sort of whether this is truly voluntarily putting something out in climate fact. [00:41:20] Speaker 02: You're voluntarily putting it out. [00:41:22] Speaker 02: That's a stupid argument. [00:41:23] Speaker 02: That being, I mean, you had the power, you could have filed patent application promptly. [00:41:27] Speaker 02: You could have filed your patent application in order so as not to have your own publication become prior art. [00:41:35] Speaker 00: As Your Honor observed, 112 is a backstop on that because had they done that, they wouldn't have been able to say this is clinically proven effective, which is what they claimed. [00:41:42] Speaker 00: They couldn't claim something was clinically proven effective until the trial was actually completed and they had that data to prove it. [00:41:48] Speaker 02: I just don't understand this clinically proven effective. [00:41:50] Speaker 02: I don't understand how this is any different than, you know, safest car on the road voted in 2026 for my Land Rover. [00:41:57] Speaker 02: Like, I just don't understand how it isn't a superlative in a lot of ways that could be added to every claim to allow people to claw back things that are in the prior art. [00:42:06] Speaker 02: And this is bothering me because you used clinically proven effective. [00:42:10] Speaker 02: And yes, that sounds sciency. [00:42:11] Speaker 02: Wow. [00:42:12] Speaker 02: You know, but you could have used any superlative. [00:42:15] Speaker 00: As I said, Your Honor, I believe that that goes back to this question of material to patentability and something just about like best clinical trial of 2022, I don't think would fall into that category. [00:42:26] Speaker 00: Why? [00:42:27] Speaker 00: Because I couldn't imagine an examiner looking at that and saying, how does that language have anything to do with an invention? [00:42:34] Speaker 00: Whereas here, clinically proven effective was in fact relied on by both the applicant and the examiner. [00:42:39] Speaker 00: It's a particular set of facts that Allergan looked at, specifically to distinguish BMS [00:42:45] Speaker 00: and capaxone and is relevant, I think, here to the patentability of that limitation. [00:42:50] Speaker 02: What's your best argument that it was important to the patentability in the prosecution history? [00:42:57] Speaker 02: Because that's allergen. [00:42:58] Speaker 02: So what is your best argument that this parallels allergen from the prosecution history? [00:43:02] Speaker 02: I just want you to point me to the prosecution history and what you think is the strongest argument that clinically proven effective was necessary to secure the Lyme scope. [00:43:11] Speaker 00: If you look at, in the supplemental examination, [00:43:14] Speaker 00: in the appendix 3541 to 3542. [00:43:16] Speaker 00: That is where the board said the prior art does not disclose the results of the clinical trial. [00:43:24] Speaker 00: And that's why there's no substantial new question of patentability here. [00:43:28] Speaker 00: And we actually argued that in our supplemental examination petition at appendix 3221 to 22. [00:43:33] Speaker 02: I'm at 3541. [00:43:35] Speaker 02: Where are you at 3541? [00:43:37] Speaker 00: At 3541. [00:43:43] Speaker 00: The very bottom of the page, the carryover. [00:43:46] Speaker 00: Yes. [00:43:54] Speaker 00: None of the items of information discloses information regarding the efficacy of the claimed treatment methods, i.e. [00:44:00] Speaker 00: results of the clinical trial, which was available prior to the critical date. [00:44:04] Speaker 00: Therefore, none of the items of information raises a substantial new question of patentability. [00:44:09] Speaker 00: And the items of information were, in fact, those clinicaltrial.gov printouts disclosing the method of the clinical trial. [00:44:21] Speaker 00: And if one were to look back earlier at the other side I gave, again, appendix 3321 to 22, those are arguments that then the supplemental examination unit is responding to in that regard. [00:44:33] Speaker 00: Also, just so the court has in front of it some other citations on this question of claims three and four. [00:44:39] Speaker 02: No, no. [00:44:39] Speaker 02: Your time's up. [00:44:40] Speaker 02: You've more than extended your time. [00:44:42] Speaker 02: I've been gracious and gave you a lot of time back. [00:44:43] Speaker 02: We're not going to move on to a different point at this point. [00:44:46] Speaker 02: But thank you very much. [00:44:47] Speaker 02: This case is taken under submission.