[00:00:02] Speaker 03: We have four argued cases this morning. [00:00:04] Speaker 03: The first is number 191172, Bowinger-Inglehime versus Mylam Pharmaceuticals Inc. [00:00:13] Speaker 03: Ms. [00:00:13] Speaker 03: Bennaby. [00:00:20] Speaker 00: Good morning. [00:00:21] Speaker 00: May it please the court? [00:00:23] Speaker 00: With the court's permission, I would like to start with the issue of 101 and the 156 patent. [00:00:29] Speaker 00: As the court is aware, in the district court, the district court found that the method of treatment claim was an abstract idea. [00:00:37] Speaker 00: On appeal, I believe the appellees are now saying that it is a law of nature. [00:00:43] Speaker 00: And today we have a body of case law that the district court didn't have, which should be helpful. [00:00:50] Speaker 00: Those cases date. [00:00:53] Speaker 00: very strongly that you look at what the claim is directed to. [00:00:57] Speaker 00: The claim is directed to a method of treatment. [00:01:00] Speaker 00: Method of treatments are not natural. [00:01:03] Speaker 00: The compound that's being used is not natural. [00:01:08] Speaker 00: And therefore, step one of the 101 analysis should allow this claim to go forward as patent eligible. [00:01:18] Speaker 00: Should the court consider that we need to understand that on this case, this was decided as a motion on the pleadings without fact finding? [00:01:29] Speaker 00: Should the court consider that we need to go to step two, saying the claim as a whole may be patent ineligible, but is there something inventive in it that directs you away? [00:01:43] Speaker 00: Is there something that's [00:01:45] Speaker 00: not routine or conventional. [00:01:48] Speaker 00: That's a question of fact that would have to go back to the district court. [00:01:52] Speaker 00: And that has not happened here. [00:01:55] Speaker 00: Moreover, the only prior art is that we have that would be considered would be the prior art of a paper patent. [00:02:05] Speaker 00: These are not the drug at issue. [00:02:07] Speaker 00: Lineglyptin, these type of DPP4 inhibitors, did not, weren't in conventional use. [00:02:13] Speaker 00: They weren't even approved by the FDA yet. [00:02:15] Speaker 00: And therefore, that issue should be resolved by the district court in the first instance. [00:02:22] Speaker 00: If the court doesn't have any questions on that issue, I will go to the second part. [00:02:29] Speaker 00: And that relates to the trial decision, which is the decision of obviousness type double patenting and obviousness. [00:02:40] Speaker 00: For the purpose of my discussion, I'm going to focus on the 859 patent. [00:02:46] Speaker 00: because the 859 patent relates to oral tablets, method of treatment using oral tablets. [00:02:55] Speaker 00: And to consider this issue, I'd like the court to consider the following facts that are not in dispute. [00:03:03] Speaker 00: Those facts include that there are many factors that affect a dose besides the IC50 value. [00:03:14] Speaker 00: And that is in the appendix at 103.85. [00:03:16] Speaker 00: There is a listing of all the factors, and all the experts agreed with this. [00:03:23] Speaker 00: The second fact is that the IC50 value does not correlate alone to dose. [00:03:28] Speaker 00: It cannot. [00:03:30] Speaker 00: The third fact is that all the experts agreed that in the reference patent, the 510 publication, the range, the 1 to 100, 1 to 1,000, [00:03:43] Speaker 00: one to four times a day was for 7,000 compounds and dozens of different diseases. [00:03:54] Speaker 00: So given that, those facts, I'd like to turn to this issue of whether there was a presumption, a presumption of obviousness from the range. [00:04:04] Speaker 01: I understand that you want to address the Galderma issue, but I'd rather have you move to [00:04:10] Speaker 01: what I think is the court's alternative finding on obviousness, that even if I agreed with you on Galderma, you still have to demonstrate that the court was wrong in finding that there was a reasonable expectation of success in using this drug at 2.5 and 5 milligrams. [00:04:35] Speaker 01: Apart from the presumption because you know even if I agree with you on the presumption you can still lose this case Yes, I understand and that's what I'd like you to address. [00:04:45] Speaker 00: I'll be happy to address that There's a fundamental disconnect in the district court decision which relates to both fact and law When you look at the evidence that is in the record [00:05:01] Speaker 00: Dr. Grass, the expert who testified on this routine experimentation, talked about doing a dose ranging study. [00:05:09] Speaker 00: The district court found that dose ranging studies were routine because all the witnesses said they're subject to FDA guidelines. [00:05:20] Speaker 00: So the FDA says do dose ranging studies. [00:05:23] Speaker 00: That's fine. [00:05:25] Speaker 00: But what the district court did not take into account [00:05:29] Speaker 03: That fine meaning they would do it. [00:05:32] Speaker 00: I'm sorry? [00:05:32] Speaker 03: When you say that's fine, you mean they would do it. [00:05:35] Speaker 00: No, I think that's what they said. [00:05:38] Speaker 03: Would they do it? [00:05:39] Speaker 00: Would they? [00:05:40] Speaker 00: No. [00:05:40] Speaker 00: Not in this instance, and for several reasons. [00:05:44] Speaker 00: What the district court did not credit, and this is very important, is that all the experts stated that to do the dosing study, you must first do animal studies. [00:05:59] Speaker 00: The O'Grady reference, and this is the state of the art reference. [00:06:05] Speaker 00: Dr. Gress said, state of the art is the O'Grady reference. [00:06:09] Speaker 00: And this is Appendix 1387. [00:06:11] Speaker 00: That reference says, first you do animal studies, and then based on the animal studies, you go ahead and you evaluate. [00:06:24] Speaker 00: of what the dose ranging study should be. [00:06:27] Speaker 00: So you would never do a dose ranging study based on a disclosure in a patent. [00:06:33] Speaker 00: You might do animal testing based on that. [00:06:36] Speaker 00: But you would not, remember, the district court said, I'm finding it routine because the FDA says, [00:06:43] Speaker 00: You do dose-ranging studies. [00:06:45] Speaker 00: The FDA says, first you do animal testing. [00:06:49] Speaker 00: And here we have evidence of what happens when you do animal testing. [00:06:53] Speaker 00: When you do animal testing, and this is in the opinion where the district court credits what Behringer scientists actually did. [00:07:03] Speaker 00: There, they did the correct studies in accordance with the FDA. [00:07:09] Speaker 00: And from that, they found [00:07:11] Speaker 00: that the range was supposed to be between 50 and 200. [00:07:17] Speaker 00: So if one were to follow routine studies, then one must get, and the only evidence in the record on what one would get with the first dosing studies, the animal studies, which are required by the FDA, is 50 to 200. [00:07:39] Speaker 00: Interestingly, that range is consistent with the examples for oral tablets. [00:07:52] Speaker 01: There are so many issues in this briefing and its complex technology, so maybe I missed it. [00:07:58] Speaker 01: But all of this stuff that you're saying right now about these animal studies, I don't remember. [00:08:03] Speaker 01: Did you argue this? [00:08:05] Speaker 00: We did argue the whole list that's in that [00:08:08] Speaker 00: The whole list, and it says including dosages in animals. [00:08:11] Speaker 03: Yes. [00:08:11] Speaker 03: Where did you argue the animal studies point in your blue brain? [00:08:16] Speaker 00: We didn't argue it specifically except for as part of the general point. [00:08:22] Speaker 00: I've been perfectly honest with you. [00:08:28] Speaker 00: But when you look at this in totality. [00:08:31] Speaker 01: I guess, putting aside the animal studies thing, since it's not in your blue brief, and to be honest, I don't even understand what you're really saying about it. [00:08:38] Speaker 01: And it's not in your blue brief, which makes it hard for me to think that I ought to decide a case on that basis. [00:08:44] Speaker 01: I guess for me, what it came down to was the district court found that through routine experimentation, someone would arise at this. [00:08:55] Speaker 01: You're talking about dosing ranges from, say, 1 to 100 milligrams. [00:08:59] Speaker 01: And it seems reasonable. [00:09:00] Speaker 01: I didn't understand the start from the top and double down stuff. [00:09:03] Speaker 01: That seemed confusing to me a little bit. [00:09:06] Speaker 01: But what I do understand is the notion [00:09:09] Speaker 01: which seems clearly articulated that there are lots of good reasons, like side effect profiles and things, to start at the low end and then work your way up from there. [00:09:20] Speaker 01: And to be honest, 2.5 doesn't seem very far from 1 to me. [00:09:24] Speaker 01: So I have to review this under a clear error standard, because these are all fact findings we're talking about. [00:09:30] Speaker 01: And there's expert testimony that says you would start at the low end for side effect reasons. [00:09:35] Speaker 01: And that, you know what, just makes good common sense to me. [00:09:37] Speaker 01: And I'm not a skilled artisan. [00:09:38] Speaker 01: But when I take medicine, I don't start at the highest dose usually. [00:09:42] Speaker 01: So it seems like it makes sense. [00:09:45] Speaker 01: And it's all in the record and supported by expert testimony. [00:09:48] Speaker 01: And so I guess under the standard of review, [00:09:50] Speaker 01: I really don't understand your argument about animal studies, but I don't think I'm likely to try to figure it out since it's not in your blue brief. [00:09:58] Speaker 01: So what, if anything, do you have to say to respond to what I just said? [00:10:01] Speaker 00: A few things. [00:10:03] Speaker 00: Number one, the dose range is 1 to 100, 1 to 1,000 for 7,000 compounds. [00:10:11] Speaker 00: And under that scenario, one would [00:10:14] Speaker 00: start for all 7,000 compounds at one? [00:10:17] Speaker 03: Wait, no, that's not the case if you're talking about double patenting, right? [00:10:21] Speaker 03: You have lindaglipton in the 541 patent. [00:10:26] Speaker 00: You do, but you still need to consider the 510 reference for what it teaches. [00:10:32] Speaker 03: You are correct that the person would say, for double patenting purposes, once you've got the 541, the question becomes dosage, right? [00:10:41] Speaker 00: It does. [00:10:41] Speaker 00: But you still need to say, what does the 510 patent teach about dosage? [00:10:45] Speaker 00: And the 510 patent doesn't say, for linoglyptans, start at 1. [00:10:49] Speaker 00: The 510 patent says, I want you to look at 7,000 compounds. [00:10:54] Speaker 00: It's a very broad disclosure. [00:10:57] Speaker 00: And so then you have to say, what about the examples? [00:11:01] Speaker 00: Because on the 859 patent, and the court did not distinguish on the 859 patent, the court recognized it had to consider the examples. [00:11:11] Speaker 00: And the examples for oral tablets are 75, 100, and 150. [00:11:17] Speaker 00: That's an important point because for oral tablets, 75 and 100 are within [00:11:28] Speaker 00: the preferred range, that 1 to 100 range, Your Honor. [00:11:32] Speaker 00: The examples on oral tablets, two of them are in the preferred range. [00:11:38] Speaker 00: The third is outside the preferred range. [00:11:41] Speaker 00: Therefore, for the preferred compounds, the examples are 75 and 100. [00:11:47] Speaker 00: The district court recognized those examples were important. [00:11:54] Speaker 00: And to get around them, he developed this concept of [00:11:58] Speaker 00: He called it doubling in reverse. [00:12:00] Speaker 00: It's just dividing by two. [00:12:01] Speaker 00: There's no evidence in the record to support that. [00:12:04] Speaker 00: That doesn't really exist. [00:12:07] Speaker 00: So you look at that and you have to say, all right, now I have a real example, real examples for oral tablets. [00:12:17] Speaker 00: It says 75 and 100. [00:12:19] Speaker 00: And then you need to look at unexpected results and things of that nature. [00:12:24] Speaker 00: And you look at the fact that when the inventors themselves did the animal testing, it was consistent with the examples. [00:12:33] Speaker 00: So this is a very unexpected result. [00:12:42] Speaker 00: Furthermore, what we need to consider [00:12:47] Speaker 00: is that when we consider this issue of dosing, we have no evidence that you will get to 2.5 and 5. [00:13:00] Speaker 00: The only evidence stated was you would get to 1, you would get to 2, you'd get to 4, you'd get to 8. [00:13:07] Speaker 00: There's no testimony that says then you would go backwards and look at 2.5 and then you would go backwards and look at 5 and you would do that. [00:13:15] Speaker 00: They did not put any evidence into the record that specifically talks about how you get to 2.5 and 5. [00:13:24] Speaker 00: And the- You're into your remodel. [00:13:25] Speaker 03: Do you want to say that? [00:13:26] Speaker 00: I'm sorry? [00:13:27] Speaker 03: You're into your remodel. [00:13:28] Speaker 00: Oh, yes. [00:13:28] Speaker 03: Thank you. [00:13:30] Speaker 03: We're just going to pause for one moment here. [00:13:36] Speaker 04: Your Honor, may I just- Yes. [00:14:11] Speaker 01: Thank you. [00:14:11] Speaker 01: I'm all set. [00:14:12] Speaker 04: Thank you, Your Honor. [00:14:13] Speaker 04: Good morning. [00:14:18] Speaker 04: Good morning, Your Honor, and may it please the Court. [00:14:20] Speaker 04: I'll be happy to address some of the issues that my colleague on the other side ended with a little bit further down. [00:14:28] Speaker 04: I think we can see on the obviousness type double patenting and the obviousness issues, these are really coming down to factual issues as opposed to legal error. [00:14:36] Speaker 04: and I'll be happy to go into them more. [00:14:39] Speaker 02: What's your specific factual evidence addressing your friend's last point that the arc shows dosage ranges up in the 75 and 100 milligrams and we're way down in the 2.5 to 5? [00:14:53] Speaker 04: So Judge Hughes, I think two things there. [00:14:56] Speaker 04: One, I think it [00:14:57] Speaker 04: is also conflating obviousness-type double patenting with obviousness. [00:15:01] Speaker 04: So where those numbers are coming from, they're coming from examples in the patent that relate to numerous DPP4 inhibitors, not linoglutin specifically. [00:15:12] Speaker 02: But there's nothing, is there anything in any of the linoglutin-specific patents that we can use for the obvious-type double patenting analysis that talk about dosage range at all? [00:15:24] Speaker 04: Well, so for obviously this type of double patenting, we're looking at the reference claims, which are coming from the 541 patent. [00:15:31] Speaker 04: And the 541 patent, as your honor knows, specifically claims lenaglutin specifically for the treatment of type 2 diabetes mellitus. [00:15:38] Speaker 02: Sure. [00:15:38] Speaker 02: But my question was, does it actually do any of these references show dosage? [00:15:43] Speaker 04: So for the 541, I believe it's a pharmaceutically effective amount. [00:15:47] Speaker 04: And then the 510 patent, of course. [00:15:49] Speaker 03: But in the specification of the 541, it talks about the 1 to 100 also. [00:15:54] Speaker 04: It does. [00:15:55] Speaker 04: Well, the specifications are the same. [00:15:57] Speaker 04: And I was just about to get to that, is that the 510 and the 541 actually share a specification. [00:16:03] Speaker 04: So that preferred range of 1 to 100 is there. [00:16:06] Speaker 04: Listing linoglyptin as one of the six most potent compounds, that's there as well. [00:16:12] Speaker 04: That disclosure is there as well. [00:16:13] Speaker 02: Right. [00:16:13] Speaker 02: I get all that. [00:16:14] Speaker 02: And like I said, your friend said it starts off in these higher ranges. [00:16:19] Speaker 02: I just want to know, it seemed to me the district court [00:16:22] Speaker 02: relied on a specific factual finding that it would be obvious to start at the lower end and go up. [00:16:28] Speaker 02: What's the actual evidence supporting that factual finding? [00:16:31] Speaker 04: Well, I mean, there was there was expert testimony on on both sides that even said that you would be starting from a low dose in a typical dose ranging study. [00:16:40] Speaker 04: That's where you start. [00:16:41] Speaker 04: Boringer's own documents, and this is in the brief, as I'm sure the court knows, Boringer's own documents talks about the potency of linoglyptin and how you would start with a low dose. [00:16:53] Speaker 04: So there was numerous evidence in the record as to why [00:16:57] Speaker 04: one would go from the low dose and go up. [00:17:00] Speaker 04: And I believe even Judge Moore, even from a common sense perspective, Judge Moore commented that that is typically how it was. [00:17:05] Speaker 01: You just basically told Judge Hughes in response to the question that there's a lot of evidence in the record when we started a low dose. [00:17:10] Speaker 01: And you gave none of the reasons. [00:17:12] Speaker 01: Why not? [00:17:12] Speaker 01: Why aren't you walking through the reasons? [00:17:13] Speaker 01: There were three reasons articulated in the trial transcript, none of which you've mentioned. [00:17:17] Speaker 01: I can't imagine why. [00:17:19] Speaker 01: Low dose is a smaller pill, makes it easier to swallow. [00:17:22] Speaker 01: Sure. [00:17:22] Speaker 01: Is easier to formulate in combination pills low dose may result in a lower risk of drug to drug Interaction and number four low low dose has lower side effects and be more precise in your argument Give us reasons and facts and cite the record. [00:17:36] Speaker 01: Don't just answer his question by telling him. [00:17:38] Speaker 04: Well, there's lots of evidence that says so I Understand any rationale or pointing to any I understand and appreciate that Judge more and thank you for bringing up those four points those four points are actually [00:17:48] Speaker 04: testified to by one of the named inventors. [00:17:52] Speaker 04: And so to Judge Moore's point, yes, even their own inventors stated that. [00:17:57] Speaker 04: Their own slides stated that. [00:17:59] Speaker 04: 30B6 testimony stated that. [00:18:01] Speaker 04: So there is ample evidence in the record to suggest, or not just suggest, but actually state that you would start from the low and go to the high. [00:18:10] Speaker 04: Your Honors, I do want to, since my colleague also started with 101, why don't I revisit 101 and we can, of course, talk about [00:18:19] Speaker 04: the obviousness type double patenting issues here. [00:18:23] Speaker 03: Is there also a obviousness and obviousness type double patenting issue with respect to 156 coins? [00:18:32] Speaker 04: Is there an obviousness and obviousness type argument you're saying with respect to that? [00:18:38] Speaker 04: Yes, Your Honor, there might very well be. [00:18:41] Speaker 04: Obviously, you know, that issue isn't what's up. [00:18:45] Speaker 03: Has that been raised in the district court? [00:18:48] Speaker 04: So that specific issue wasn't raised because, remember, it was on a motion to dismiss, a 12C motion. [00:18:54] Speaker 04: So the whole 12C motion was based upon the 101 issues. [00:18:58] Speaker 04: And so that was granted. [00:19:01] Speaker 04: And so as a result of that, [00:19:03] Speaker 04: That's it. [00:19:04] Speaker 04: That's where we are procedurally. [00:19:05] Speaker 02: So if we disagree with you on 101, it has to go back. [00:19:08] Speaker 02: But I assume you have a 103 and obviousness double patenting type argument. [00:19:16] Speaker 04: There are certainly other arguments there, Judge Hughes. [00:19:19] Speaker 04: I would argue, though, that there isn't a basis for remand. [00:19:22] Speaker 04: And we can discuss that a bit. [00:19:24] Speaker 04: But to answer your question head on, yes, there would be other arguments with respect to invalidity. [00:19:30] Speaker 04: But the 101 was included. [00:19:32] Speaker 04: obviousness and obviousness type double patenting, right? [00:19:37] Speaker 04: Correct. [00:19:37] Speaker 04: There would be other types of arguments. [00:19:39] Speaker 04: Correct. [00:19:41] Speaker 04: But going back to then the 101, and I'm fully cognizant of how versed this panel is on those issues, Mayo and now this court's more recent decision in INO at least make clear that with respect to method of treatment patents, [00:19:56] Speaker 04: There isn't a per se rule that says method of treatment patents are patent eligible. [00:20:04] Speaker 04: Now, guided by Mayo, the district court properly concluded that the 156 patent was ineligible because it failed the two-step Mayo test insofar as the claimed advance was nothing more than a natural law. [00:20:21] Speaker 04: The natural law actually being the recognition [00:20:25] Speaker 04: that lineglyptin is preferentially excreted by the liver. [00:20:28] Speaker 04: That's an inherent property. [00:20:30] Speaker 04: And with respect to the second step, the district court also properly found that the other elements of the claim, individually or in the ordered combination, did not in any way create an inventive concept that then rescued eligibility. [00:20:47] Speaker 01: Well, there certainly are no black letter rules. [00:20:49] Speaker 01: As I wrote recently in a dissent [00:20:53] Speaker 01: We've never held a diagnostic claim eligible since Mayo. [00:20:56] Speaker 01: Likewise, since Vanda was decided, we've held a number of treatment claims eligible, and I've never seen us hold a method of treatment claim ineligible. [00:21:04] Speaker 01: So while I'm not suggesting there is a black-letter rule, why don't you start, instead of trying to tell me how this may or may not be like Mayo, tell me why it's not exactly like Vanda? [00:21:15] Speaker 04: Oh, sure, Your Honor. [00:21:16] Speaker 04: Vanda had a specific dosage regimen. [00:21:21] Speaker 04: It was an outline actual dosage regimen. [00:21:24] Speaker 04: There had to be a genotypic identification of a particular type of marker that would indicate whether or not that subject is a metabolizer of a certain functional group. [00:21:37] Speaker 04: And based on that, based on that information, which arguably is a natural law, [00:21:42] Speaker 04: But based on that information, a specific dosage regimen was actually constructed. [00:21:47] Speaker 02: It's not a very specific dosing regimen, though. [00:21:50] Speaker 02: If you have this marker, give one dose. [00:21:53] Speaker 02: If you don't have this marker, give the other dose. [00:21:55] Speaker 04: But that is a specific dosage. [00:21:59] Speaker 02: Certainly, this is a little bit more general. [00:22:02] Speaker 02: Similarly, if you suffer from a number of conditions and also have diabetes, use this class of drugs. [00:22:11] Speaker 02: Why isn't that exactly like Vanda? [00:22:13] Speaker 04: Well, first of all, there is no dosage here. [00:22:16] Speaker 01: That's not true. [00:22:17] Speaker 01: In claim 10, which is one of the two claims at issue, it says, and do it at the same dose as a patient for normal renal failure. [00:22:24] Speaker 01: So actually, it tells you exactly what dose to do. [00:22:25] Speaker 04: But there's no articulation, first of all, of what that dosage is. [00:22:29] Speaker 04: And to your point, though, to your question, Judge Moore, if we read that to its logical conclusion, all it's saying is, keep doing what you're doing. [00:22:37] Speaker 04: So, Judge Hughes, if I recall your question correctly, the question is how is there not a specific dose given in the claims issue here. [00:22:52] Speaker 04: There is no dose, no instruction to do anything in this particular patent. [00:22:57] Speaker 04: All it says is, linearly. [00:22:58] Speaker 02: It's not true. [00:22:59] Speaker 02: The plain language of the patent says it's a method of treating things, and then one of the steps is orally administering a dosage. [00:23:09] Speaker 02: Again, these are incredibly broad patents. [00:23:12] Speaker 02: I don't understand how they will stand up under any kind of obviousness analysis at all, if we affirm on the other two. [00:23:22] Speaker 02: I don't see how you can read a method of administering a drug. [00:23:29] Speaker 02: And I agree with Judge Moore. [00:23:33] Speaker 02: Claim 10 actually tells you the exact dosage. [00:23:35] Speaker 02: It may be not the exact dosage, but the type of dosage you can do. [00:23:41] Speaker 02: And that's specific method of administering drugs. [00:23:48] Speaker 02: It's not a diagnostic path. [00:23:50] Speaker 04: But Your Honor, we have to focus on the claim in advance, though, right? [00:23:53] Speaker 02: No, we don't. [00:23:54] Speaker 02: We have to look at what the claim is directed to. [00:23:58] Speaker 02: You're not. [00:23:58] Speaker 02: True. [00:23:59] Speaker 02: You're plucking out one small part of the Mayo Alice test and say, this is the dispositive step. [00:24:06] Speaker 02: But the first critical step in Alice and Mayo is look at what the patent is directed to. [00:24:12] Speaker 02: And if the claim is directed to administration of a drug, we have almost universally held, post Mayo and Vanda and other cases, that that's patent eligible. [00:24:24] Speaker 04: Every single other element in that claim, Judge Hughes, is conventional and was known. [00:24:29] Speaker 02: Every single one. [00:24:29] Speaker 02: I don't care. [00:24:30] Speaker 04: So even if we look at it from even a- That's not the test under Alice. [00:24:35] Speaker 02: So respectfully, Your Honor, I mean- The first step is what is the claim directed to? [00:24:40] Speaker 02: What is the claim here directed to? [00:24:42] Speaker 04: Correct. [00:24:43] Speaker 02: You tell me. [00:24:44] Speaker 04: It is directed to a method of treating type 2 diabetes mellitus using lineglyptin. [00:24:51] Speaker 04: That's ultimately the treatment regimen. [00:24:54] Speaker 02: All the claimed- Is a method of treating a condition using a drug a natural law? [00:25:04] Speaker 04: Is a method of treating with a drug a natural law? [00:25:07] Speaker 04: No, no, Your Honor, it's not. [00:25:07] Speaker 02: Well, doesn't that answer the question here? [00:25:09] Speaker 02: No, so I would respectfully- I mean, all pharmaceutical compositions and method of treatment claims at some point have to have a natural law in them, don't they? [00:25:20] Speaker 02: I mean, I'm an English major. [00:25:21] Speaker 02: I don't understand chemistry and medicine like this, but the reason the body reacts in certain ways to certain drugs with certain conditions is all based in some sense on natural laws. [00:25:32] Speaker 02: But the distinction here is it's not claiming that natural law. [00:25:39] Speaker 02: You know, the whole idea, it is a method of treatment claim. [00:25:42] Speaker 04: It is a method of treatment claim, but the claimed advance itself, Judge Hughes, is nothing but a recognition of the fact that linoglyptan gets excreted through the liver. [00:25:54] Speaker 02: What's your support for the notion that the claimed advance, as opposed to reading the patent as a whole, is the proper test to determine what the patent is directed to? [00:26:07] Speaker 04: Mayo itself says, Your Honor, that this court is charged with determining what the claimed advance is. [00:26:16] Speaker 02: Does it say that's what the patent is directed to? [00:26:21] Speaker 02: Can you cite to me any case that says the initial step one analysis at what the claim is directed to only narrows in on the advance over the prior art, not the claim as a whole? [00:26:34] Speaker 04: That seems to me to be a remarkable proposition. [00:26:38] Speaker 04: I think then you are a little bit misunderstanding what I'm saying. [00:26:42] Speaker 04: I am not disputing the fact that the claim ultimately is going to be looked at as a whole. [00:26:47] Speaker 04: But to determine patent eligibility for a claim like this, we do have to look at what the claimed advance is. [00:26:54] Speaker 04: Treatment of diabetes with linoglyptin was conventional well-known. [00:26:57] Speaker 02: Boringer has a patent that goes- Which is why you have a really good obviousness case. [00:27:06] Speaker 04: Think about it also from a preemption perspective. [00:27:09] Speaker 04: And maybe that'll make the point. [00:27:10] Speaker 04: I know I'm running out of time. [00:27:12] Speaker 02: These are all questions that occur after step one about whether it's actually directed to a natural law or not. [00:27:22] Speaker 04: Correct. [00:27:23] Speaker 02: And we have to get past that step. [00:27:25] Speaker 02: And if we don't get past that step, because we determine it's a method of treatment claim, [00:27:31] Speaker 02: then whether it preempts, whether it is an advance or is just used as conventional techniques, none of that stuff matters if it's a method of treatment claim. [00:27:41] Speaker 04: But the natural law here, Your Honor, because the natural law here is simply the fact that linoglyptan gets excreted through the liver. [00:27:48] Speaker 04: And that's why doctors don't need to do anything. [00:27:51] Speaker 04: That is literally what this claim is saying. [00:27:54] Speaker 04: Because linoglyptan goes through the liver, someone who has a renal impairment, some type of renal problem, of course, [00:28:00] Speaker 04: you can give it to them without worrying about what the dose will be. [00:28:03] Speaker 04: Because primarily drugs get excreted through two ways, the kidney and the liver. [00:28:08] Speaker 04: And so if this goes through the liver, then it won't matter if that patient has renal failure or renal impairment. [00:28:14] Speaker 04: It can, you can give it to that person and you don't have to worry about the dosage. [00:28:19] Speaker 04: That's the, but the natural law itself is that it is something that is inherent in linoglutin, which is that linoglutin inherently goes through the liver. [00:28:29] Speaker 04: That's the natural law. [00:28:30] Speaker 04: So I understand your point and it's well taken. [00:28:32] Speaker 04: that you don't just parse out each individual element. [00:28:36] Speaker 04: But even taken together, the only advance you are talking about is the excretion through the liver. [00:28:42] Speaker 04: And that as a result of that, the doctor can just give the same type of dosage or do whatever it was doing before to this person with a kidney impairment. [00:28:53] Speaker 04: And why I even mentioned on preemption very briefly is the fact that Boringer has the exact same type of patent [00:29:00] Speaker 04: that goes out to 2023. [00:29:01] Speaker 04: Now imagine that patent expires and a doctor is administering the lineaglyptin. [00:29:07] Speaker 04: The patient walks in. [00:29:08] Speaker 04: The patient has some form of renal impairment. [00:29:10] Speaker 04: The doctor doesn't know that. [00:29:11] Speaker 04: That doctor has now infringed that 156 patent, no matter what. [00:29:15] Speaker 01: Well, possibly not. [00:29:15] Speaker 01: That's why several members of this panel have repeatedly told you it's possible you have obvious mistype double patenting arguments you can make on this patent. [00:29:25] Speaker 01: So no, we don't need to turn 101 into a cure-all and deviate from our existing precedent because you want to suggest there might be long-term problems. [00:29:35] Speaker 01: Go raise other defenses. [00:29:36] Speaker 01: Don't limit yourself to just one. [00:29:38] Speaker 04: 101 is certainly not a panacea, Judge Moore. [00:29:41] Speaker 04: But 101 does have a separate gatekeeping function, as this Court has recognized, than 102 and 103. [00:29:48] Speaker 04: And there can certainly be sometimes conflation of the two. [00:29:52] Speaker 04: But 101 is still the gatekeeper on should it even get a patent in the first place, as opposed to should it be invalidated, and it shouldn't. [00:30:01] Speaker 01: Really, I didn't think it was, should it get a patent in the first place? [00:30:04] Speaker 01: I guess I mistakenly thought 101 is, are these claims directed to an abstract idea or a natural law? [00:30:10] Speaker 01: And if they are. [00:30:11] Speaker 01: And you'd like us to say, should it get a patent in the first place? [00:30:13] Speaker 01: And you're giving us hypos and scenarios of how awful it would be because they get to extend their patent protection because they already had patent protection. [00:30:21] Speaker 01: Gosh, if only there was a doctrine that could address that. [00:30:26] Speaker 04: I take your point, Judge Moore. [00:30:29] Speaker 04: If it is directed to a natural law, then it's not eligible for a patent. [00:30:33] Speaker 04: And I think that was my point. [00:30:34] Speaker 04: And here, no matter what, the only discovery is that. [00:30:38] Speaker 04: The only discovery is that linoglyphin goes through the liver. [00:30:41] Speaker 04: And that's why it does fail step one. [00:30:43] Speaker 04: And if we were to quickly move to step two, just for that purpose, every other step was conventional. [00:30:49] Speaker 04: Everything was known. [00:30:50] Speaker 03: So all we are left with is that. [00:30:52] Speaker 03: I think we're about out of time. [00:30:54] Speaker 03: Thank you. [00:30:54] Speaker 03: Thank you, Your Honor. [00:30:58] Speaker 03: The enemy got about two minutes. [00:31:00] Speaker 00: Thank you, Your Honor. [00:31:02] Speaker 00: I'm going to focus once more on the oral tablet claims. [00:31:05] Speaker 00: Council said look at the evidence from BI where they found that it worked at this very low dosage. [00:31:15] Speaker 00: That was years later after the fact. [00:31:18] Speaker 00: What we have here is the district court recognized that you had to consider the examples. [00:31:28] Speaker 00: That is his finding, that you have to consider them. [00:31:31] Speaker 00: But he then determined that you would go backwards from that, which is without any evidence in the record. [00:31:40] Speaker 00: What you then have to understand is that for an oral tablet, 75 and 100 is a low dose, because [00:31:51] Speaker 00: The dosage range, that 1 to 100, is for oral. [00:31:56] Speaker 00: It is not for oral tablet. [00:31:58] Speaker 00: It's broader, like oral liquid. [00:32:02] Speaker 00: So for oral tablet, the reference is making a distinction and saying there's a 75 dose and a 100 dose, which are in that preferred range of 1 to 100. [00:32:16] Speaker 00: And there is 150 outside. [00:32:18] Speaker 00: So if you look at the preferred compounds, it's telling you for an oral tablet, it's 75 to 100. [00:32:25] Speaker 00: Then all the witnesses agreed that if you did IV, it would be lower. [00:32:32] Speaker 00: And when you look at the examples for IV, the ampule, it says 10 milligrams preferred. [00:32:41] Speaker 00: 30, less preferred. [00:32:43] Speaker 00: So when you look at the examples, when you read a reference for all it teaches, which is required, when you read a reference for all it teaches. [00:32:54] Speaker 01: And how do you comport? [00:32:55] Speaker 01: I mean, the district court gave four reasons someone would start at a low dose. [00:32:59] Speaker 01: And he cited portions of expert testimony. [00:33:02] Speaker 01: And I've got it right in front of me, where the expert says, the question is, do you recall what dose that was, 100 milligrams? [00:33:09] Speaker 01: And was that the first dose you tried in humans? [00:33:11] Speaker 01: No. [00:33:11] Speaker 01: You would typically start with a dose you may believe would be subtherapeutic. [00:33:15] Speaker 01: And why would you do that? [00:33:15] Speaker 01: And he goes through and tells all the reasons you'd start at subtherapeutic and work your way up from there. [00:33:20] Speaker 01: So you want us to start at the examples. [00:33:22] Speaker 01: But the district court said there was reasons to start at the lowest end. [00:33:25] Speaker 01: That's what he held as a fact finding. [00:33:27] Speaker 01: And he cited this exact trial transcript where this expert said you wouldn't even start at the example. [00:33:33] Speaker 01: You would start subtherapeutic below the example and work your way up from there. [00:33:38] Speaker 00: That's exactly the point. [00:33:41] Speaker 00: The B.I. [00:33:42] Speaker 00: inventors started with five as the subtherapeutic, not supposed to work. [00:33:51] Speaker 00: They then used [00:33:52] Speaker 00: 50, 100, et cetera, going up. [00:33:56] Speaker 00: These were their animal studies. [00:33:57] Speaker 00: And the judge did point to that. [00:34:00] Speaker 00: It's in his opinion that this is what BI did. [00:34:03] Speaker 00: And when they did the animal studies, they said 50 to 200. [00:34:08] Speaker 00: Then they go to the human. [00:34:10] Speaker 00: Now they're saying, we're doing five as it's not going to work. [00:34:14] Speaker 00: Five's not going to work. [00:34:15] Speaker 00: We're doing 50. [00:34:16] Speaker 00: We're doing 100. [00:34:17] Speaker 00: We're doing 200. [00:34:18] Speaker 00: And unexpectedly, completely contrary to what all their research said, they got to five. [00:34:26] Speaker 03: OK. [00:34:26] Speaker 03: I think we're about out of time. [00:34:27] Speaker 03: Thank you. [00:34:28] Speaker 03: Thank you. [00:34:28] Speaker 03: Thank both counsel. [00:34:29] Speaker 03: The case is submitted.