[00:00:00] Speaker 01: Our next case for argument is 22-1461, Faxulta versus Genentech. [00:00:08] Speaker 01: Mr. Peterson. [00:00:09] Speaker 02: Thank you. [00:00:09] Speaker 02: Good morning. [00:00:10] Speaker 02: May it please the Court. [00:00:12] Speaker 02: The key issue in this appeal is whether the Supreme Court's decision in Angen overruled this Court's decision [00:00:21] Speaker 02: A reasonable jury could find that the hybridoma and screening process that enables the claims at issue is indistinguishable from the process found enabling in wands. [00:00:30] Speaker 05: Before you get there, I know you want to talk about the facts of wands and the analysis of what happened to that claim in wands. [00:00:40] Speaker 05: But what about the wands factors? [00:00:42] Speaker 05: Is it your view that the Supreme Court's opinion did not disturb our existing precedent applying the wands factors [00:00:51] Speaker 05: context of enablement? [00:00:53] Speaker 02: Yes, Your Honor. [00:00:53] Speaker 02: That's certainly our view. [00:00:54] Speaker 02: We look at Amgen as a rather case-specific decision that affirmed this court's reasoning. [00:01:00] Speaker 02: I'm sorry. [00:01:01] Speaker 05: When you said, yes, Your Honor, did you mean, yes, the Supreme Court's opinion did disturb our wands factors? [00:01:08] Speaker 02: Oh, I apologize. [00:01:09] Speaker 02: No, our view is that the Supreme Court left the wands factors in place and left this court's enablement jurisprudence in place, that Amgen. [00:01:17] Speaker 03: I find it strange that the Supreme Court didn't mention wands. [00:01:23] Speaker 03: Oddly enough, Amgen itself was... The case that went up to the Supreme Court from our court was totally based on Wands and says, you know, under Wands there is undue experimentation required. [00:01:37] Speaker 03: The Supreme Court doesn't use the words undue experimentation at all. [00:01:43] Speaker 02: I did find that slightly odd. [00:01:45] Speaker 03: Only time they referred to our court at all was in two cases where they said, we're not exactly sure what the Federal Circuit thought it was saying, but we think whatever it was saying was OK. [00:01:59] Speaker 03: Do you think if wands were in front of the Supreme Court today, it would survive? [00:02:08] Speaker 02: I believe it would. [00:02:09] Speaker 02: The Supreme Court did not hold that [00:02:13] Speaker 02: screening as a matter of law is undue experimentation. [00:02:17] Speaker 02: The Supreme Court did not hold that testing as a matter of law is undue experimentation. [00:02:22] Speaker 02: The Supreme Court held that the Amgen claims required undue experimentation to practice. [00:02:28] Speaker 02: And we certainly agree with that. [00:02:30] Speaker 02: This court's decision in Amgen [00:02:32] Speaker 02: didn't see any inconsistency between the outcome in its case and the outcome of Wands. [00:02:38] Speaker 02: It noted that Wands involved different facts, a different record, and that the decision that the Amgen claims were not enabled was consistent with the earlier decision in Wands that those claims were. [00:02:49] Speaker 02: The facts of our case resemble Wands far more closely than Amgen. [00:02:54] Speaker 05: The key to Amgen... The Federal Circuit Amgen opinion, I believe, distinguished the claims in the Amgen case from the [00:03:03] Speaker 05: from, I guess, the arguments and analysis in the Wands case by pointing out that in Wands, there was no argument about the scale of experimentation that would have to be undertaken to do all the making and screening there. [00:03:20] Speaker 05: And so to that extent, the Wands case doesn't speak to that question. [00:03:26] Speaker 05: Whereas in Amgen, that argument, that line of attack against the claims was on the table. [00:03:33] Speaker 05: as it was in Wyeth, Adenyx, Enzo, et cetera. [00:03:37] Speaker 05: And so for that reason, even though the outcome of WANs, of upholding those claims, it was different from all these other cases, that's the reason why you reached diversion outcomes. [00:03:51] Speaker 05: What do you think about that? [00:03:52] Speaker 02: I think the specific line from Amgen to which you're referring is the statement that we stated that no evidence was presented by either party on how many hybridomas [00:04:02] Speaker 02: would be viewed by those in the art as requiring undue experimentation to screen. [00:04:08] Speaker 02: And that's the same on this record here. [00:04:10] Speaker 02: Genentech has not suggested that there's a certain number of hybridomas that would be viewed by those of skill in the art as requiring undue experimentation to screen. [00:04:19] Speaker 02: And we think Wands correctly described the art in this area. [00:04:22] Speaker 02: That the art, the experiment, is conducting the entire hybridoma and screening process to make an antibody with the desired characteristics. [00:04:31] Speaker 02: That experiment, Wands pointed out, succeeded every time the inventor there tried it. [00:04:36] Speaker 02: That experiment requiring routine experimentation that Wands recognized was routine. [00:04:41] Speaker 05: I guess what I'm trying to figure out is why would it be wrong to reconcile Wands with [00:04:47] Speaker 05: our more modern-day case law by pointing out that WANs only look to the question of whether this hybridoma making and screening process was something that was a repeatable, known, understandable process to do making and testing. [00:05:07] Speaker 05: And that's it, and that's the only line of inquiry that happened in WANs, whereas all of our modern-day cases were not just looking at whether [00:05:16] Speaker 05: that the means of making new candidates was a known possible definite thing. [00:05:22] Speaker 05: But in addition, ask the extra question of whether the scale of that kind of work and the indeterminacy of knowing ahead of time which candidates would likely prove to be good versus duds is an angle of analysis that just never occurred in Wands. [00:05:41] Speaker 05: And that's why you can reconcile all these cases together, even though the facts [00:05:46] Speaker 05: tend to look very similar. [00:05:48] Speaker 02: We would suggest reconciling them by pointing out that neither Wyeth, Idenex, Enzo, or Amgen involved any reliable predictable process like the hybridoma and screening process in wands. [00:06:02] Speaker 02: Those cases truly did involve trial and error with no way using routine technology to generate new embodiments. [00:06:10] Speaker 01: Well, I guess I don't understand. [00:06:12] Speaker 01: In Amgen, it [00:06:13] Speaker 01: It seems like it was a known process. [00:06:16] Speaker 01: It's just that process as it was applied to the various antibodies would discover some that worked and some that didn't work. [00:06:26] Speaker 01: And that's what your process does as well. [00:06:29] Speaker 01: Each time you apply your screening process, you result in some that meet the two functionality limitations. [00:06:40] Speaker 01: Some that don't. [00:06:41] Speaker 01: In fact, most don't. [00:06:42] Speaker 01: I think only 1.6% of those that get analyzed do meet the two sets of functional criteria. [00:06:49] Speaker 01: So I don't know how you're not in the same trial and error scenario. [00:06:54] Speaker 02: What our court explained, and this is appendix page 19-202 to 204, we attached it to our 28-J letter, is that the problem with the Amgen claims was the requirement that they bind to specific residues. [00:07:07] Speaker 02: That is very difficult to identify what residues and antibody binds to, and it's very difficult to find antibodies that bind to the particular 15 out of the nearly 700 residues at issue. [00:07:21] Speaker 02: This court explained that it was that [00:07:23] Speaker 02: Excuse me, that it was that binding limitation itself that was enough to require undue experimentation. [00:07:30] Speaker 02: Our expert testified that it was that particular requirement that made generating antibodies binding to specific residues so unpredictable in Amgen. [00:07:39] Speaker 04: What about the funk? [00:07:40] Speaker 04: Go ahead. [00:07:42] Speaker 03: When are we going to talk about the elephant in the room? [00:07:45] Speaker 03: The elephant in the room is the size of the genus, in my judgment. [00:07:49] Speaker 03: The Supreme Court said, the more you claim, the more you have to enable. [00:07:54] Speaker 02: Right? [00:07:55] Speaker 02: Yes, Your Honor. [00:07:56] Speaker 03: The more vast your claim, the more species within the range of that claim you're going to have to enable. [00:08:06] Speaker 02: Yes, Your Honor. [00:08:08] Speaker 03: Clearly, the Supreme Court is saying, oh, and Justice Gorsuch is sort of enamored of some of his phrases, but he says, [00:08:15] Speaker 03: The more you claim, the more you have to enable, right? [00:08:18] Speaker 03: Doesn't that clearly always bring in the question, what's the size of the genus? [00:08:23] Speaker 02: Yes, Your Honor, it does. [00:08:24] Speaker 03: How big is your genus? [00:08:25] Speaker 02: Focused and small. [00:08:26] Speaker 03: How many possible antibodies can fall in your genus? [00:08:30] Speaker 02: The number of possible antibodies that are claimed has not been quantified. [00:08:34] Speaker 02: To be clear, it was Genentech's burden of proof. [00:08:35] Speaker 02: I thought the lower court opinion said there were millions of candidates, not the number of actual antibodies claimed within the genus. [00:08:45] Speaker 02: He was discussing simply potential antibodies. [00:08:48] Speaker 03: Yeah, it was potential antibodies. [00:08:50] Speaker 03: The way you've drawn your claim covers a whole range of potential antibodies, right? [00:08:56] Speaker 03: Some will. [00:08:58] Speaker 03: Bind to the protein and some will have their desired a functional effect some won't Yes, your honor and as we view the law of enablement and the same was true in Amgen wasn't it? [00:09:10] Speaker 02: That is correct. [00:09:11] Speaker 03: Okay, so and the Supreme Court said in Amgen Well, you've spent a lot of time doing this and you've come up with 11 or whatever the number was And the Supreme Court is saying that's not enough [00:09:25] Speaker 02: The key difference though, Your Honor, is we see it. [00:09:27] Speaker 03: You were able to identify a very small number of species that meet the limitations of your claim out of a world range of many hundreds of thousands or millions that might possibly qualify. [00:09:40] Speaker 03: And the only way you can find out is by a known method of testing. [00:09:45] Speaker 03: Anybody who's skilled in the art knows how to produce the test. [00:09:48] Speaker 03: Does the person have the time and the interest? [00:09:53] Speaker 03: What are we supposed to do with a rule for enablement for this class of cases that says the more you claim, the more you have to enable? [00:10:06] Speaker 02: I would go back to first principles of enablement and say the question is whether the claims can be practiced by one of skill and the art without undue experimentation and to adhere to the holding of wands and the court's first decision in Amgen that routine screening can constitute. [00:10:20] Speaker 03: You're viewing undue experimentation [00:10:23] Speaker 03: as meaning is the test to find out whether or not the one you're testing meets some additional complicated or difficult. [00:10:32] Speaker 03: Is it undue? [00:10:33] Speaker 03: Is it a hard thing to do? [00:10:35] Speaker 03: And that's a little bit what Wands was talking about and how hard is the test. [00:10:42] Speaker 03: Well, I would point you. [00:10:43] Speaker 03: But it's admitted in both MGen and in your case that, I mean, I don't mean to deprecate the significance and the importance of the scientists, but I'm a history major, not a chemist. [00:10:57] Speaker 03: It's easy. [00:10:57] Speaker 03: The test, as you've pointed out, the test your people use is easy. [00:11:01] Speaker 03: I mean, still American know how to do it. [00:11:04] Speaker 03: It's just that they aren't sure when they look at, they pick [00:11:10] Speaker 03: an antibody, they say, this antibody falls within the limitation of the claim. [00:11:13] Speaker 03: We want to know if it binds and it does anything. [00:11:18] Speaker 03: They run a simple test. [00:11:19] Speaker 03: And a few times when you ran it, you found them. [00:11:23] Speaker 03: But now there's a whole world of potential candidates, right, that may or may not meet the specific limitation of the claim. [00:11:32] Speaker 02: That's correct and the best we can do is distinguish Amgen factually and look at the testimony of our expert who said that the process for identifying new embodiments in Amgen was more difficult and less certain than the process for identifying new embodiments as here and as it wants. [00:11:48] Speaker 02: And I look at page 12 of the slip opinion in the Supreme Court's decision in Amgen talking about the incandescent lamp case and it says that [00:11:57] Speaker 02: Had Sawyer and Mann disclosed a common quality to fibrous and textile substances that made them adapted, others would have known how to select among such materials to make an operable lamp. [00:12:07] Speaker 02: But we don't read the Supreme Court as saying that is the only way to teach others how to select among such operable materials. [00:12:15] Speaker 02: Wands holds that routine screening can be a way of teaching skilled artisans of how to select among new operable embodiments. [00:12:23] Speaker 02: We believe [00:12:23] Speaker 02: that our process involves routine screening as in wands and not the sort of trial and error, painstaking experimentation required by Amgen. [00:12:36] Speaker 03: Your case turns on the difference of the testing method? [00:12:40] Speaker 02: Yes, Your Honor, it does. [00:12:41] Speaker 02: And this court emphasized in Amgen that facts matter and the standard. [00:12:45] Speaker 03: So undue experimentation only deals with the [00:12:48] Speaker 03: complications of the testing methodology? [00:12:51] Speaker 02: The certainty, the reliability, the difficulty, all of these are important factors for whether experimentation is undue. [00:12:58] Speaker 02: And the facts of our case and the testing required resemble wands far more closely. [00:13:03] Speaker 03: Why is your testing methodology materially different than the one that was in the Supreme Court case in Hampton? [00:13:10] Speaker 02: It is because of the [00:13:11] Speaker 02: unpredictability in finding antibodies that actually bind to the specific 15 claimed binding sites, and it relates to the difficulty in actually identifying to which binding sites an antibody binds. [00:13:25] Speaker 02: Our process is essentially indistinguishable from the hybridoma and screening of wands. [00:13:29] Speaker 02: Amgen says you can't simply screen. [00:13:32] Speaker 02: You have to, after going through the assay, [00:13:35] Speaker 02: proceed to identify what particular residues these antibodies bind to, which is difficult to do, and then, fingers crossed, hope that you find them. [00:13:44] Speaker 02: We accept that Amgen was trial and error. [00:13:46] Speaker 01: Okay, so I guess I'm just, I want to follow what you're saying, but I'm having a little trouble. [00:13:50] Speaker 01: Are you focusing on the screening process itself and saying that application of the screening process in Amgen, every time it was used, took way longer and was way more complicated [00:14:02] Speaker 01: than the one here in this case, and that there's evidence in this record to show that. [00:14:08] Speaker 01: The process, not the likelihood of identifying, not the results of the process, the process, the screening process itself. [00:14:17] Speaker 02: Your Honor, our experts spoke to this. [00:14:19] Speaker 02: It's paragraph 254, appendix pages to 202 to 203, talking about the different processes that need to be followed in Amgen, [00:14:28] Speaker 02: compared to this case. [00:14:30] Speaker 02: It's attached to our Rule 28J letter discussing the Amgen decision. [00:14:34] Speaker 02: And he also notes the difficulty in identifying the particular region on PCSK9 to which the antibody is bound. [00:14:42] Speaker 05: But what about the difficulty of determining whether a given candidate in your situation has the desired pro-coagulant activity? [00:14:51] Speaker 02: Your honor, that's accomplished simply by using the hybridome and screening process that Wands recognized was routine. [00:14:59] Speaker 05: come up with some new-fangled scheme in order to figure out whether a given candidate has the desired pro-coagulant activity. [00:15:06] Speaker 02: That's true. [00:15:07] Speaker 02: Our inventors taught modifications to a commercially available chromogenic assay process, but those modifications change it from minutes to hours. [00:15:16] Speaker 02: They don't materially increase the experimentation involved in the chromogenic assay process, viewing the facts and drawing all inferences in the light most favorable to facts ultimately. [00:15:25] Speaker 03: I still don't understand your answer to the question of what it means when the Supreme Court says the more you claim, the more you have to enable. [00:15:34] Speaker 03: And that clearly in my mind deals with the breadth of the claim, i.e. [00:15:38] Speaker 03: the size of the genus. [00:15:40] Speaker 02: And Your Honor, I'll just say the evidence here is that the actual claimed genus is focused and small. [00:15:46] Speaker 02: That's appendix page 16417. [00:15:48] Speaker 05: How can we even say that though? [00:15:51] Speaker 05: We have no idea. [00:15:53] Speaker 05: We literally have no idea. [00:15:54] Speaker 05: Your position is that every time you run one of these massive screens, you're going to come up with a few working candidates every single time. [00:16:05] Speaker 05: I mean, that just means you have an ever-expanding limitless scope of the genus, because every single time, you're going to find a few more. [00:16:14] Speaker 05: Every single time, you're going to find a few more. [00:16:17] Speaker 05: And nobody knows when you're going to actually exhaust [00:16:20] Speaker 05: you know, the entire constellation of possible candidates which, as we all know, runs at least into the millions. [00:16:29] Speaker 02: That's true. [00:16:30] Speaker 02: The Supreme Court did make clear in Amgen, though, that the time and effort required to exhaust a genus is not the test for enablement. [00:16:36] Speaker 05: It's not alone the test, but what is very, very helpful for the patent owner who wants the kingdom of all compounds that work is when you have ex ante, some understanding of some common quality of all the working [00:16:52] Speaker 05: compounds or antibodies, and in that instance there wasn't any kind of ex ante understanding. [00:16:58] Speaker 05: And likewise here, we don't have any ahead of time appreciation of some kind of structural feature or something else that's going to run through the entire line of working compounds. [00:17:09] Speaker 02: That's certainly true. [00:17:10] Speaker 02: That was also equally true in wands and its predecessor, hybrid tech. [00:17:14] Speaker 03: What was your page 16? [00:17:16] Speaker 02: 16417. [00:17:21] Speaker 03: Well, I got the question on, in your joint appendix, a number of things are marked as confidential. [00:17:30] Speaker 03: And yet, those things are referred to in the brief not being marked as confidential. [00:17:35] Speaker 03: Are we bound in the record by the confidentiality markings? [00:17:40] Speaker 02: Your Honor. [00:17:41] Speaker 03: We're going to write an opinion. [00:17:42] Speaker 03: I mean, for example, I've owned [00:17:45] Speaker 03: Page 47 of your brief, you refer to Dr. Marasco and his deposition. [00:17:51] Speaker 03: And none of the brief matter is marked as confidential. [00:17:56] Speaker 03: Nothing from the district court opinions is marked as confidential. [00:18:00] Speaker 03: And yet, you have in your appendix a bunch of stuff marked as confidential. [00:18:04] Speaker 03: And here at page 47, you're citing those things in the blue brief without being marked as confidential. [00:18:10] Speaker 03: My question is, [00:18:11] Speaker 03: Can we write an opinion that refers to something that's marked as confidential in the appendix without worrying about it? [00:18:19] Speaker 02: Your Honor, I apologize. [00:18:19] Speaker 02: I need to consult with my client trial counsel on that. [00:18:22] Speaker 02: Certainly anything discussed in the briefing and by the district court. [00:18:25] Speaker 03: Well, if it's written in the brief or it's written in the district court opinion and marked as confidential, then we're not going to rely on what's in the brief. [00:18:31] Speaker 03: But under our new rules now, there's a big burden on the court in writing an opinion to try to respect your marking of confidential in the record. [00:18:41] Speaker 03: And it's hard for me to know. [00:18:42] Speaker 03: It doesn't seem to me it should be the court's job to have to go through your blue brief and go back and look at every single page to see whether it was marked with yellow. [00:18:51] Speaker 02: Certainly, Your Honor. [00:18:52] Speaker 02: I'll confer with my opposing counsel, and we'll see what we can do in that regard. [00:18:56] Speaker 01: All right. [00:18:56] Speaker 01: Let's hear from your opposing counsel, please. [00:18:59] Speaker 06: Thank you. [00:18:59] Speaker 06: Good morning, Your Honors, and may it please the court. [00:19:02] Speaker 06: Judge Chen, I want to pick up with the last thing that Your Honor asked about something disclosed ex ante in the patent that would allow [00:19:10] Speaker 06: a skilled artisan to determine what is in the genus and what is not without having to make and screen or conduct the research assignment that the Supreme Court now has given us as the standard for what is and what is not acceptable. [00:19:26] Speaker 06: It is undisputed on this motion that the patent does not disclose a structure that differentiates [00:19:34] Speaker 06: those antibodies that bind factor 9A and increase its procoagulant activity from those that do not, what Your Honor referred to as the good ones and the don'ts. [00:19:43] Speaker 06: There is no structure. [00:19:44] Speaker 06: There is also no mechanism of action disclosed. [00:19:47] Speaker 06: One doesn't know why the ones that work do work. [00:19:50] Speaker 06: What about the size of the genus? [00:19:53] Speaker 06: Absolutely, Judge Clevenger. [00:19:54] Speaker 06: The size of the genus is, I believe Judge Ten is right, unknowable. [00:19:59] Speaker 06: What we all agree on is that there is some vast number [00:20:03] Speaker 06: of antibodies. [00:20:04] Speaker 03: I'm looking at the testimony that is marked as confidential, but is no longer confidential. [00:20:09] Speaker 03: There's a statement that the genus is actually pretty small. [00:20:12] Speaker 03: It's focused in small, not unusually large. [00:20:15] Speaker 06: Yes, Your Honor. [00:20:17] Speaker 06: What Dr. Morasko is referring to, and that is their confidentiality, I have no objection to the court relying on it, but that's their witness. [00:20:24] Speaker 03: Well, they've waved it off now. [00:20:26] Speaker 06: Understood, Your Honor. [00:20:27] Speaker 06: What Dr. Morasko is saying is that ultimately there are not very many antibodies in the genus. [00:20:33] Speaker 06: He agrees that you have to start by screening a vast process. [00:20:37] Speaker 03: There are not many antibodies that actually meet the limitations of the claim? [00:20:40] Speaker 06: Correct. [00:20:41] Speaker 03: What he is saying is that the number of antibodies... His genus is the genus of the ones that actually meet the limitations. [00:20:50] Speaker 06: That's correct, Your Honor. [00:20:51] Speaker 06: And the argument that they are making is, yes, you would have to screen a very, very large number of candidates, but you would ultimately find that there are not many of them. [00:21:03] Speaker 06: That's exactly the argument that this court and identics rejected as backwards. [00:21:07] Speaker 06: The work done to screen to find those antibodies is the undue experimentation, that it turns out that there are not many of them. [00:21:17] Speaker 01: Should the work done, which is what you said is the undue experimentation, [00:21:23] Speaker 01: Should it matter how hard it is to do that work, how long it takes, how complicated? [00:21:28] Speaker 01: Let me give you, for example, suppose a supercomputer could run all of the testing on a million antibodies in 1.7 minutes, and we would now know the complete universe of that genus. [00:21:41] Speaker 01: Would that be undue experimentation just because it had to analyze millions of samples to determine the 1.6 percent that fall within the claims? [00:21:51] Speaker 06: I think the answer may be yes after the Supreme Court's decision in Amgen. [00:21:54] Speaker 06: I think that law is going to happen. [00:21:56] Speaker 01: It's really scary for me. [00:21:57] Speaker 01: That's a really scary proposition. [00:21:58] Speaker 01: I mean, then you're saying undo hardship isn't a thing anymore. [00:22:02] Speaker 06: Well, and to be clear, Your Honor, on the facts of this case, Your Honor's hypothetical is very, it hasn't come yet. [00:22:08] Speaker 06: We don't have computers that can do that. [00:22:10] Speaker 06: I think in this instance, a lab person has to actually do it. [00:22:13] Speaker 06: But to answer, but I don't want to avoid the question. [00:22:16] Speaker 06: The Supreme Court [00:22:17] Speaker 06: seems to be saying, and I think this is consistent with what this Court has always said, the patent has to teach you how to make the invention, not how to make things that aren't the invention and sift to find the things that are. [00:22:31] Speaker 05: That distinction may matter. [00:22:32] Speaker 05: But just to follow up on what the Chief is asking, the Supreme Court's opinion does seem to acknowledge [00:22:39] Speaker 05: there's more going on here than just looking at the scale of the make and screening and wants to know about the nature of invention and the state of the art. [00:22:49] Speaker 05: And maybe the state of the art here is that the testing goes super fast, goes really easy. [00:22:55] Speaker 05: And so therefore it becomes so conventional and minor and [00:23:03] Speaker 05: in such a modest act that therefore it couldn't possibly be considered undue experimentation if the amount of time to undertake testing all the millions of candidates would only [00:23:17] Speaker 05: require a week or a day or something like that. [00:23:20] Speaker 06: I think that the law is going to have to evolve in that direction. [00:23:24] Speaker 06: I take your honor's point. [00:23:25] Speaker 06: On this factual record, however, what Max Salta's scientists recommend to the skilled artisan is exactly what Amjans did and which the Supreme Court rejected by saying [00:23:35] Speaker 06: calling on scientists to create a wide range of candidate antibodies and then screen each to see which happens to meet the claim limitations is a research assignment, it is not enablement. [00:23:47] Speaker 01: Is there evidence in this record about how long that screening process would take or how easy it is to perform, how routine, how much time it would take to go through these millions of things? [00:24:00] Speaker 06: there is evidence that the actual, and we've never contended otherwise, the actual screening process, making a hybridoma, which was at issue in wands, by the time of the priority date in this patent, is routine, absolutely. [00:24:14] Speaker 01: Screening the antibodies... But routine, it's also routine for me to make lasagna, but it takes me two days. [00:24:20] Speaker 01: Fair enough. [00:24:21] Speaker 01: The point I'm trying to get at is, I'm trying to figure out what is still on the table after [00:24:27] Speaker 01: AMGEN for WANs in the form of undue experimentation. [00:24:30] Speaker 01: What are the things that one might look at to assess whether there's undue experimentation in a case, even though that case involves starting with a large genus in order to narrow it to a functional genus? [00:24:44] Speaker 06: I think it's the inability, presumably if it could be done that quickly, one would come out [00:24:49] Speaker 06: in the patent with something that unites the successful candidates. [00:24:53] Speaker 06: And I think what the Supreme Court is saying is if the only thing you know from doing your own work is that there is gold in them their hills, and you tell people that they can go find it, it doesn't matter how easy it is to find it. [00:25:05] Speaker 06: That's not enablement. [00:25:06] Speaker 06: I think what the court is telling us is that the ease by which one can find it may very well lead to a patent that tells you what it is you're looking for before you go screening. [00:25:18] Speaker 06: but that an instruction to go screen and find it yourself is no longer enablement. [00:25:22] Speaker 06: That's a research assignment. [00:25:23] Speaker 03: Well, what is enablement? [00:25:26] Speaker 03: If you were writing the test, what would it take to enable a broad genus clean? [00:25:34] Speaker 06: I think that there would have to be some form of uniting structure. [00:25:39] Speaker 06: You think it has to be structure-based as a common quality? [00:25:43] Speaker 03: And aren't you just saying the genus has to be narrower? [00:25:48] Speaker 06: I don't think I'm saying it has to be narrower. [00:25:50] Speaker 03: What happens if you add these other limitations? [00:25:52] Speaker 03: What are you doing? [00:25:53] Speaker 03: Aren't you shrinking the size of the genus? [00:25:55] Speaker 06: I think the genus, to take this in one place, the genus of lasagnas all have pasta in them. [00:26:01] Speaker 06: If it doesn't have pasta, I don't care what the menu says, that's not a lasagna. [00:26:04] Speaker 06: That's a structure that unites the genus. [00:26:06] Speaker 06: There could be lots of them, but they have a common structure. [00:26:09] Speaker 06: is structure the only way? [00:26:10] Speaker 06: I don't know the answer to that question. [00:26:12] Speaker 06: And the Supreme Court says, for example, when it introduces structure, I think it is telling us that structure is not the only way. [00:26:18] Speaker 06: But I think the point of the Sawyer and... It can't possibly be the only way. [00:26:22] Speaker 01: Or you've just said there could be no functional claiming for genuses. [00:26:26] Speaker 01: Because not every genus is going to have [00:26:29] Speaker 01: what is apparent to any skilled artisan and necessarily common structural component. [00:26:33] Speaker 06: I agree with that, Your Honor, and I don't think structure can be the only way. [00:26:36] Speaker 06: And I don't know how you can have a genus of antibodies that are defined only by what they do at this point without any structural limitation. [00:26:48] Speaker 06: I think that's a difficult question. [00:26:49] Speaker 06: I think this case doesn't present that difficult question because it is squarely on point with the facts of Amjad. [00:26:55] Speaker 06: But I think Your Honor is right. [00:26:56] Speaker 06: There has to be more than merely structure that unites the genus. [00:27:00] Speaker 06: But to answer the breadth of the genus, if you look at claims 6, 8, and 10 of this patent, which are not asserted, but they are certainly in the patent, those are genus claims to antibodies in which the antibody or the antibody fragment [00:27:14] Speaker 06: has the variable region of one of their three antibodies. [00:27:17] Speaker 06: You can take 193-AD3, which is a murine antibody, take the binding region, the part that matters, and put it into a camel antibody or a humanized antibody or a chimeric antibody. [00:27:28] Speaker 06: That's a broad genus, but the reason that you know in advance that that genus will work [00:27:33] Speaker 06: is because the patent tells you that the part that matters works. [00:27:36] Speaker 06: And so a skilled artisan reading the patent can differentiate in advance. [00:27:40] Speaker 05: So you think those claims are enabled? [00:27:44] Speaker 05: I think those claims are... Because, you know, putting that one variable region into all these different formats, you think there's enough confidence that [00:27:55] Speaker 05: it's going to work in all those different formats. [00:27:57] Speaker 06: I don't think summary judgment of no enablement would enter in that claim. [00:28:00] Speaker 06: I think the person you asserted that claim against would have an expert who would come in and say camels are different, and this is different, and it might be a tribal issue of fact. [00:28:07] Speaker 06: But I don't think that you could get summary judgment that that claim is not enabled. [00:28:11] Speaker 06: I think there'd be a fact dispute. [00:28:12] Speaker 05: Right. [00:28:12] Speaker 05: But I guess getting to just moving forward, we have to always worry about what's around the corner for the system. [00:28:21] Speaker 05: Are we really left in a [00:28:24] Speaker 05: all or nothing proposition. [00:28:25] Speaker 05: There is no all proposition anymore. [00:28:29] Speaker 05: Now it's just we're reduced down to just the one very sequence that you figured out accomplishes the binding and then also gets you the desired pro-coagulant activity in this case. [00:28:43] Speaker 06: I don't think that's necessarily true, Your Honor. [00:28:45] Speaker 06: Imagine, for example, if it had turned out [00:28:48] Speaker 06: that all of Bexalto's antibodies that succeed have two leucines followed by an orginine followed by a serine. [00:28:54] Speaker 05: Let's assume that's not the way the science works. [00:28:56] Speaker 05: That there is something quite random about the ultimate physical sequence that makes things work versus not work. [00:29:05] Speaker 06: Then I think where that would take the court, if anywhere, is to revisiting the overruling of Noel. [00:29:09] Speaker 06: It is the thing that we need to look at, the target, not the antibodies. [00:29:13] Speaker 06: But where the law exists right now, I don't think you can claim all the antibodies that have a particular functional outcome. [00:29:20] Speaker 06: I think that's what this court said in Amgen faces high hurdles. [00:29:24] Speaker 06: And I think what the Supreme Court is saying is that's a research assignment. [00:29:27] Speaker 06: I think you do need something more than that. [00:29:29] Speaker 06: I'm not smart enough to know whether there could be something that isn't structure. [00:29:33] Speaker 06: I see how you can do it with structure. [00:29:36] Speaker 04: Some people talk about using means plus function claims. [00:29:41] Speaker 04: Do you think that makes sense here? [00:29:44] Speaker 06: I think that might very well devolve down into being limited to the individual means that are in your patent. [00:29:49] Speaker 06: That might be just another way of getting a claim to the, to the 26. [00:29:52] Speaker 05: Right. [00:29:52] Speaker 05: But then there'd be some knife fight over what is the structural equivalent of that? [00:29:57] Speaker 06: I think that's right, your honor. [00:29:58] Speaker 06: And I think that might be one way of doing it. [00:30:00] Speaker 06: I think that that takes you to the same place, I think as a doctrine of equivalence fight around the antibody sequence itself. [00:30:07] Speaker 06: But I think means plus function is certainly one way that people are going to start trying to solve this riddle. [00:30:13] Speaker 06: What Emgen makes very clear you cannot do, however, is solve it the way Bexalta did, which is, I found 11 antibodies that work. [00:30:21] Speaker 06: I don't know why they work. [00:30:23] Speaker 06: But I know that you will find more if you make more. [00:30:25] Speaker 06: And if you do, I own them. [00:30:27] Speaker 06: That is no longer. [00:30:28] Speaker 06: I don't believe that was cognizable after Aidenics or Wyeth or Enzo or Emgen in this court. [00:30:34] Speaker 05: But it certainly isn't. [00:30:35] Speaker 05: I don't remember if we asked you the question, do you think the Supreme Court opinion disturbed any of the Federal Circuit [00:30:43] Speaker 05: pre-existing case law on the scope of enablement and Wands Factors. [00:30:47] Speaker 06: I don't think it did. [00:30:48] Speaker 06: I think I granted it doesn't mention Wands, and I certainly have the same curiosity that everyone else does of why is that. [00:30:54] Speaker 06: But I think that the things that the Wands Factors are getting at are part of what the Supreme Court is getting at as well. [00:31:00] Speaker 06: And to Judge Clevenger's point, there are the places where the Supreme Court [00:31:04] Speaker 06: takes on some of Amgen's characterizations of this court's jurisprudence and says, we don't know that that's what the jurisprudence said, but we agree with you that if it did, it would be wrong. [00:31:13] Speaker 06: But I don't see anything in it that is saying the law was fundamentally wrong. [00:31:19] Speaker 06: I do think, however, that under the law, as it existed before the Supreme Court decision, this case was Afar Shorai from Amgen not enabled. [00:31:29] Speaker 06: And I just want to make sure I say two things. [00:31:32] Speaker 06: The testimony of their expert, and I'm quoting from A17341, apart from trial and error, nothing in the patent will tell a person of ordinary skill what other different antibodies and fragments would exhibit the factor VIII-like activity shown by these ones. [00:31:48] Speaker 06: That's undisputed on summary judgment, and under this court's precedent even beforehand, that's insufficient. [00:31:54] Speaker 06: And the second is that there is a debate in the, and this may be a place in which I think the Supreme Court clarified the law as opposed to changed it, [00:32:01] Speaker 06: There's a debate in the briefing about whether it matters that the patent claims antibodies that increase the procoagulant activity, not only by a little bit, like the ones in the patent, but by much more than that, up to factor eight's level of activity. [00:32:16] Speaker 06: The Supreme Court answered that question not only in the more one claims the broader the monopoly it demands, the more one must enable, which it says three times, but also in this passage, [00:32:28] Speaker 06: If a patent claims an entire class of compositions of matter, the patent specification must enable a person skilled in the art to make and use the entire class. [00:32:38] Speaker 06: There's no dispute between us that antibodies that increase the procoagulant activity of factor 9 by as much as factor 8 do are within the scope of the claim. [00:32:48] Speaker 06: If they are covered by the claim, they have to be enabled. [00:32:50] Speaker 06: And there is no dispute that they are not enabled. [00:32:52] Speaker 01: How do the WANs factors continue to exist? [00:32:54] Speaker 01: Or how do you perceive them to operate [00:32:57] Speaker 01: in light of the sentence in the Supreme Court's Amgen that says, while we agree with Amgen, that enablement is not measured against the cumulative time and effort it takes to make every embodiment within a claim. [00:33:09] Speaker 06: Because, Your Honor, I believe that the point that Amgen was making there is that the question was, how long would it take me to make every single one cumulatively? [00:33:17] Speaker 06: How long would it take me to, for example, sing all of the Beatles songs? [00:33:21] Speaker 06: And what the Supreme Court is saying is that, and I don't think [00:33:24] Speaker 06: The Federal Circuit, there was a debate in Amgen about whether this court had ever said that and the dissent from denial of panel rehearing or says no. [00:33:32] Speaker 01: It's an undue experimentation. [00:33:33] Speaker 01: I've always understood it to include an assessment of how much work it would take a skilled artisan to do. [00:33:41] Speaker 01: Am I wrong? [00:33:41] Speaker 06: No, you're not wrong about that, but I don't think the Supreme Court is disagreeing with that. [00:33:45] Speaker 06: What it is saying is how long would it take to make every single one of them cumulatively? [00:33:50] Speaker 06: is not the test. [00:33:52] Speaker 06: And I don't think there's anything inconsistent with saying the test is not how long will it take to make all of them. [00:33:58] Speaker 06: The test is how long will it take to make each of them, how much work goes into making the full range of them. [00:34:04] Speaker 05: Maybe what it's trying to say is if there was a known common structural quality that runs through the good candidates, then even if it takes you a super long time to test all those [00:34:20] Speaker 05: good candidates with the common structural feature, that's okay, because you've pre-identified at least one feature of what is good from the bad. [00:34:30] Speaker 06: I think that's exactly right, and that's his discussion of some sands might not work in one of the prior cases about making clay. [00:34:37] Speaker 06: There may be individual sands that don't work, but the patent taught you how to make the clay. [00:34:41] Speaker 06: I think that's exactly right, Your Honor. [00:34:43] Speaker 06: I see that I'm over my time. [00:34:44] Speaker 05: No, you need to answer for Wands, because the other side, the big thrust of their [00:34:49] Speaker 05: case here is that the facts here, the hypodomas, that kind of testing and screening was blessed, endorsed in wands. [00:34:59] Speaker 05: And why can't it likewise be this case here? [00:35:02] Speaker 05: And that's factually the key distinction between whatever making screenings going on here versus all these other cases, Amgen, Enzo, Identis, Wyeth, et cetera. [00:35:13] Speaker 06: And I'm happy to do that, Your Honor. [00:35:14] Speaker 06: I appreciate the time. [00:35:15] Speaker 06: The Wands case was asking the question whether hybridoma technology at the time was undue. [00:35:21] Speaker 06: Cohen and Milstein had gotten the Nobel Prize for it 12 or 13 years earlier. [00:35:25] Speaker 06: And the question, the answer there was factually no, it's not. [00:35:29] Speaker 06: Wands was not claiming the antibodies. [00:35:31] Speaker 06: Wands was claiming using the antibodies in the sandwich assay. [00:35:34] Speaker 06: Wands was not trying to exercise dominion over the full range of IgM antibodies that bind hepatitis cell surface protein. [00:35:41] Speaker 06: It was answering factually a very different question. [00:35:44] Speaker 06: That is why when you get to later cases that are talking about, I own the antibodies themselves. [00:35:50] Speaker 06: If there are antibodies out there and you make them their mind. [00:35:54] Speaker 06: That is a different question factually than what was being presented in WANS. [00:35:58] Speaker 06: And then there is the point your honor made earlier that none of the debate in WANS was really about how hard is it or how long would it be. [00:36:05] Speaker 06: The debate in Wands is really about mathematically how well did Wands do? [00:36:09] Speaker 06: Is it 44%, which this court said is a reasonable percentage, or did the board miscalculate the 2.8%? [00:36:16] Speaker 06: Wands is not really asking the question that any of the subsequent cases ask. [00:36:21] Speaker 06: And I think that it's impossible to square the facts of this case with Enzo, Wyeth, Idenix, and Emgen itself and come out in favor of Bexel. [00:36:29] Speaker 01: Okay, well, just to be very precise, because I'm just trying to figure out what to do with wands, or in what way, shape, or form it continues to have meaning following Amgen. [00:36:41] Speaker 01: And there are the wands factors discussed in wands. [00:36:43] Speaker 01: Yes. [00:36:43] Speaker 01: Quantity of experimentation necessary. [00:36:47] Speaker 01: Do you think that factor has been eliminated by the Supreme Court in Amgen? [00:36:52] Speaker 06: No, Your Honor, I don't think so. [00:36:53] Speaker 01: So how would the quantity of experimentation necessary? [00:36:56] Speaker 01: You're saying if there were like two or three tests that could identify the entire genus, like if it wasn't going to take a million different attempts, it would be enough. [00:37:05] Speaker 01: How would you suggest, as applicable to this case, to measure the quantity of experimentation necessary? [00:37:10] Speaker 06: I think you're exactly right, Your Honor. [00:37:13] Speaker 06: I think that, and in some ways it's the point that Judge Chen is making, even if you had a common structural feature or some other thing that you knew a priori united the members of the genus, you might still ask how hard would it be, how much experimentation is needed. [00:37:27] Speaker 06: to then go find them. [00:37:29] Speaker 06: And you could imagine a patent that tells you something where the experimentation would still be undue. [00:37:33] Speaker 06: I think that factor survives. [00:37:35] Speaker 01: I don't think anything in... So my problem is your predicate. [00:37:39] Speaker 01: Your predicate is still, and I see where you're coming from with it, but your predicate is that there has to be some common structural feature. [00:37:46] Speaker 01: And I just don't think that the Supreme Court meant in Amgen to eliminate the possibility of functionally [00:37:53] Speaker 01: claimed genuses. [00:37:55] Speaker 01: And that's why they said, for example, with regard to structure. [00:37:57] Speaker 01: So I feel like there has to be other stuff, but I'm having a tough time wrapping my head around or identifying what that other stuff is. [00:38:04] Speaker 06: I agree with you, Your Honor, and I apologize. [00:38:06] Speaker 06: I did not mean to say structure is the only way. [00:38:08] Speaker 06: I think if you look at the lock analogy in the Supreme Court case, I think it perfectly summarizes what the Court is saying. [00:38:15] Speaker 06: You have a lock with 100 tumblers, each with 20 positions. [00:38:19] Speaker 06: The patentee finds 26 that work and says, go find the rest of them. [00:38:24] Speaker 06: I know they're out there. [00:38:25] Speaker 06: And the court says, quote, sure enough, that would produce functional combinations. [00:38:30] Speaker 06: You could spin the tumblers and you could find more of them. [00:38:32] Speaker 06: But it wouldn't enable others to make and use functional combinations. [00:38:37] Speaker 06: Why are those two things different? [00:38:39] Speaker 06: Because what the court is telling us is that the patent has to enable you to make the ones that work, not to trial and error and hunt and peck. [00:38:47] Speaker 06: To find the ones that work. [00:38:49] Speaker 06: Structure might be one way of doing that. [00:38:51] Speaker 06: There might be other ways of doing it. [00:38:53] Speaker 06: I'm in no way negating that. [00:38:54] Speaker 06: But I think that the amount of work you would need to do to find the combinations that open the lock, all of the things in the wands factor, state of the prior art, skilled artisans, working examples, those all still matter. [00:39:07] Speaker 03: Enablement requires you to make the wands that work? [00:39:13] Speaker 06: To make the invention. [00:39:14] Speaker 06: If the invention is the antibodies that work, it has to enable a skilled artisan to make it. [00:39:19] Speaker 03: And hasn't your adversary done that? [00:39:23] Speaker 03: Has he made 14 or whatever? [00:39:26] Speaker 06: He made 11 and he's entitled to patent those and in fact he did patent three of them. [00:39:29] Speaker 06: What he can't patent is the other ones that exist out there that someone else has to first make without identifying what they are. [00:39:37] Speaker 06: We have no dispute that they could patent their 11 antibodies. [00:39:40] Speaker 01: And they could also patent, if it were novel, the screening techniques to identify the other antibodies. [00:39:44] Speaker 01: Absolutely. [00:39:46] Speaker 03: You just said that in order to [00:39:48] Speaker 06: claim his entire genius he has to have made them all or he has to have that uh... i apologize your honor or issues that which is that no i don't think you can only claim the ones that he made i did not mean to say that your honor i guess uh... she can claim the ones he made [00:40:05] Speaker 06: The Supreme Court leaves open the idea that if the patent teaches the reader which are the other ones that will work, not how to find them, but which are they, you can claim that as well. [00:40:17] Speaker 03: The reason that Sawyer and Mann... If the claim has narrowed itself to a different class of species. [00:40:23] Speaker 06: Right. [00:40:25] Speaker 03: In this, all it's done is shrink the size of the genes. [00:40:29] Speaker 06: I think it may be the case that vast broad functional genera are not possible after Amgen, but I don't think they were possible after Amgen in this court or Wyeth or Adenyx or Enzo either. [00:40:40] Speaker 06: I don't think that's new, but I do think it's clear. [00:40:43] Speaker 01: Okay. [00:40:44] Speaker 01: Thank you very much. [00:40:44] Speaker 01: Thank you, Your Honor. [00:40:46] Speaker 01: Well, we went over by quite a bit, so you definitely have some extra time. [00:40:51] Speaker 02: Thank you, Your Honor. [00:40:52] Speaker 02: First, I think my friend misspoke with respect to the WANS case as involving only method claims or for the assays. [00:41:01] Speaker 02: You'll note claims 19 and 25 through 27 on the application are in WANS for the monoclonal IgM antibodies themselves. [00:41:11] Speaker 02: Claim seven in the issued patent begins monoclonal high affinity IgM antibodies. [00:41:17] Speaker 02: WANS was not simply claiming [00:41:19] Speaker 02: the assays, Wands was claiming the particular antibodies. [00:41:24] Speaker 05: Chief Judge Moore, the Supreme Court had every opportunity in Amgen to hold... I guess in Wands, the opinion, it shows the method claim, right? [00:41:38] Speaker 05: I mean, it copies in the method claim in there. [00:41:41] Speaker 05: How do we know that it's also analyzing something else beyond the method claim? [00:41:50] Speaker 02: Your Honour, the concluding paragraph refers to all of Wands' claims. [00:41:56] Speaker 02: All of Wands' claims were issued, and it's my understanding that all of Wands' claims, including the antibody claims, had been held invalid for lack of enablement. [00:42:06] Speaker 02: So all of those were reversed, even though it was specifically the method claim that was quoted in the opinion. [00:42:13] Speaker 02: But the Supreme Court had every opportunity in Amgen to hold that functional genus claims of antibodies are simply impermissible. [00:42:20] Speaker 02: The Supreme Court had every opportunity in Amgen to hold that screening is as a matter of law, non-enablement, to hold that you must always identify- But the Supreme Court hates clear, black-letter rules in patent law, and it won't give them to us. [00:42:36] Speaker 01: But then it writes an opinion in which there's no other way to come out. [00:42:40] Speaker 01: 101 is a prime example. [00:42:41] Speaker 01: What diagnostic method claim has been found to be patent eligible post Mayo and all of that? [00:42:47] Speaker 01: Zero. [00:42:48] Speaker 01: But nowhere in the Supreme Court does it say diagnostic method claims are off the table. [00:42:52] Speaker 01: Why isn't it similar here? [00:42:54] Speaker 01: Yeah, they didn't say. [00:42:54] Speaker 01: And possibly it's because they know enough to know they don't know everything, especially in this dense technology. [00:43:01] Speaker 01: And perhaps someone could identify something other than structure that is a common feature [00:43:05] Speaker 01: to them that might allow someone to identify them. [00:43:08] Speaker 01: But I don't see post-MGen how you can functionally claim a broad genus unless there's some common [00:43:14] Speaker 01: thing that you can point to with regard to it. [00:43:17] Speaker 02: I look at page 17 of the opinion, where the Supreme Court, I think, is making clear that it's writing a narrow opinion on the facts of the case. [00:43:24] Speaker 01: Where are they making it clear they're writing a narrow opinion? [00:43:26] Speaker 01: I mean, his voice doesn't read that way to me. [00:43:28] Speaker 02: Whether methods like a roadmap or conservative substitution might suffice to enable other claims and other patents, perhaps because, as this court suggested in incandescent lamp, the inventor identifies a quality common to every functional embodiment they do not hear. [00:43:43] Speaker 02: They leave a scientist about where Sawyer and Mann left Edison forced to engage in painstaking experimentation to see what works. [00:43:51] Speaker 02: And if you remove the word, perhaps, from that sentence in the M dashes, I think the opinion reads very differently. [00:43:59] Speaker 02: But the Supreme Court made clear it was reaching a holding on the facts of the case that were presented to it. [00:44:04] Speaker 02: This case and this court in its Amgen decision [00:44:07] Speaker 02: didn't see any inconsistency between its outcome on the facts of Amgen and the facts of Wands. [00:44:14] Speaker 02: We agree. [00:44:15] Speaker 02: We don't see any inconsistency between the Supreme Court's decision in Amgen and the outcome on the facts of Wands and hybrid tech. [00:44:23] Speaker 02: And I would add another perhaps. [00:44:24] Speaker 01: But I'm having trouble seeing any daylight between your facts and Amgen. [00:44:29] Speaker 02: And the difference, I think, is the painstaking experimentation that is... What was the painstaking experimentation in Amgen? [00:44:35] Speaker 01: The painstaking... Why was it just... because Justice Gorsuch is being his clever self. [00:44:39] Speaker 01: That wasn't... I mean, what the heck? [00:44:41] Speaker 01: Well, what's the painstaking experimentation in Amgen? [00:44:43] Speaker 02: It is identifying the binding sites for the antibodies. [00:44:47] Speaker 02: which is technologically more difficult, I think everyone would agree, than identifying the pro-coagulant activity at issue here and creates greater unpredictability in terms of whether they will be found. [00:44:58] Speaker 02: And that, in our mind, is what separates us from Amgen. [00:45:02] Speaker 02: Like WANs, when you follow a routine process each time, [00:45:06] Speaker 02: you create new embodiments within the scope of the claims. [00:45:10] Speaker 02: I agree with my friend that the relevant question is the work and the experimentation required. [00:45:15] Speaker 01: The painstaking experimentation that Justice Gorsuch points to doesn't seem to be the amount of difficulty of each stage of the screening process, but rather the trial and error that must occur by virtue of having to look at everything in the genus to figure out what is in the claim function of the genus. [00:45:36] Speaker 01: I mean, hunting license, he goes on and on. [00:45:38] Speaker 01: All of his analogies are about the number of things you have to sort through to get to the genus that will fit the functional description. [00:45:45] Speaker 01: It doesn't seem to me, and where do you see and hear that he is discussing, wow, in Amgen, boy, this screening method is really hard, and that's what matters. [00:45:54] Speaker 02: I think you see, and we quoted, I believe, Sanofi's arguments discussing the level of experimentation and the fact that it was a trial and error process. [00:46:07] Speaker 05: And so are you. [00:46:08] Speaker 02: But I would say I like the Locke analogy, because I think the Locke accurately describes identics, Wyeth, Enzo, [00:46:17] Speaker 02: and Amgen. [00:46:18] Speaker 02: In those cases, you truly were testing combination by combination, fingers crossed, I hope I find something that works. [00:46:24] Speaker 02: What I would say is, our claims, like Juan's, knock three times on the side of the safe, and it is going to spin to a new combination that will open it. [00:46:33] Speaker 02: Do you know in advance what that new combination is going to be? [00:46:37] Speaker 02: No. [00:46:37] Speaker 02: But can you go through a very simple process? [00:46:39] Speaker 01: The problem is you claimed all of them, and you're going to have to go through that process over and over and over again, a million or so times, in order to identify the ones that work. [00:46:47] Speaker 01: That's exactly trial and error. [00:46:49] Speaker 01: You identified all of them. [00:46:51] Speaker 01: So it's not a matter of does our process get you to one that will fit within the claim. [00:46:57] Speaker 01: It's does our process without undue experimentation or have we articulated a way without undue experimentation to get you all of them, the full scope of the claim. [00:47:07] Speaker 02: Your Honor, I recognize I'm over time. [00:47:10] Speaker 01: I'll simply say that. [00:47:11] Speaker 01: No, but answer please. [00:47:13] Speaker 02: And that's not how we view undue experimentation in light of Amgen, that it's not about identifying the full scope of the genus, but it is about the level of experimentation required to create new embodiments. [00:47:25] Speaker 01: I don't want to find that your claims are not enabled, but I don't see daylight between your case and Amgen. [00:47:31] Speaker 03: Doesn't the would-be infringer have to search the entire genus, a big part of it, to find out whether the one they want to use is going to infringe? [00:47:41] Speaker 02: No, Your Honor. [00:47:42] Speaker 03: How does somebody decide whether or not their particular product is going to infringe your claim? [00:47:52] Speaker 02: If a would-be infringer wanted to practice these claims, they would simply follow the hybridoma and screening process taught, and within a short period of time, crediting the testimony of our experts would have a new embodiment within the scope of the claim. [00:48:04] Speaker 03: What if somebody just comes in their lab and says, here's this antibody, and we think maybe we ought to build it into something to know whether or not it's going to bind and have the effect that your claims require. [00:48:19] Speaker 03: They have to test it, right? [00:48:25] Speaker 03: You were a competitor, right? [00:48:27] Speaker 03: If you wanted to design a product, design a round, you want to get your claimed species that lies within your broad genus, how does the competitor know whether it's safe? [00:48:44] Speaker 02: So as a competitor, I would first have to be, I assume, finding antibodies that bind [00:48:50] Speaker 02: to factor 9, 9A. [00:48:54] Speaker 02: Once I have created antibodies that bind to factor 9, 9A, then the question would be whether they also result in procoiculum activity. [00:49:01] Speaker 02: You can determine that through screening. [00:49:03] Speaker 02: You're not going to just stumble across an antibody that binds to factor 9, 9A by accident. [00:49:09] Speaker 02: These are created through the hybridoma process. [00:49:13] Speaker 03: and that you have to do that just the way you did it to prove the ones that met the limitations of the claim, right? [00:49:19] Speaker 02: Yes, Your Honor, that's correct. [00:49:21] Speaker 02: You would verify that antibody in those circumstances through the screening process. [00:49:25] Speaker 05: The defendant's antibody, do you know if they use the hybridoma process? [00:49:31] Speaker 05: I mean, their antibody is [00:49:34] Speaker 05: very different looking than your discovered antibodies. [00:49:39] Speaker 02: They followed slightly different steps. [00:49:41] Speaker 03: They took 10 men 10 years, 100 men years. [00:49:47] Speaker 05: It's not like you go through the standard garden variety hybridoma process and out pops their, I don't know even how to pronounce it, but their antibody. [00:49:58] Speaker 02: So I think we discussed this on page 19 of our opening brief. [00:50:02] Speaker 02: What they did was first generated hybridomas making the monospecific antibodies against factor 9a and factor 10. [00:50:14] Speaker 02: They then combined those together into a bispecific antibody, then screened for pro-coagulant activity. [00:50:21] Speaker 02: So rather than beginning with the factor 9, 9A arm, screening it for pro-coagulant activity, and then combining it to create a bispecific antibody, our understanding is they were creating the bispecific antibodies first, followed by screening them. [00:50:35] Speaker 01: Well, we are way over. [00:50:37] Speaker 01: I'm sure this is going to fall flat, but I'm going to try channeling my punster colleague and say, boy, this case is requiring undue experimentation on our part. [00:50:46] Speaker 01: Thank you.