[00:00:13] Speaker 01: The next case for argument is 15-1-7-1-6, Spear Intellectual Property versus Warner Tilcock Company. [00:00:44] Speaker 00: Good morning, Your Honor. [00:00:45] Speaker 00: Make sure everyone's settled here. [00:00:46] Speaker 00: I apologize. [00:00:48] Speaker 00: All right. [00:00:48] Speaker 00: I think we're ready, Mr. Ford. [00:00:50] Speaker 02: Thank you, Your Honor. [00:00:51] Speaker 02: First, I forgot to check in. [00:00:53] Speaker 02: I want to apologize for any inconvenience to the court. [00:00:56] Speaker 02: My name is Matt Ford. [00:00:58] Speaker 02: I'm an attorney for the Bayer Appellants. [00:01:00] Speaker 02: This appeal turns on the differences between the hierarchy of evidence and the burden of proof of indefiniteness and claim construction. [00:01:08] Speaker 02: Warner-Chilcott moved below for summary judgment of indefiniteness based only on the District Court's claim construction of the terms of the Whereby Clause in the 940 Pat. [00:01:17] Speaker 02: In opposition to Warner-Chilcott's motion, Bayer submitted expert and other extrinsic evidence that the terms in the Whereby Clause had a reasonably certain meaning to those of skill in the art, but the District Court found [00:01:28] Speaker 02: that its prior claim construction order satisfied Warner and Chilcot's burden, despite Bayer's evidence of meaning. [00:01:33] Speaker 01: Maybe I'm confusing this with another case. [00:01:35] Speaker 01: My understanding was you're correct that that's what the district court decided, but then he had an alternative holding, which said, even if I consider all the evidence, I looked at all the evidence, and here's what I conclude, that the evidence was insufficient, even if he considered it. [00:01:50] Speaker 01: Am I wrong about that? [00:01:51] Speaker 02: No, you're not, Your Honor. [00:01:52] Speaker 02: The primary holding is based on the intrinsic record. [00:01:56] Speaker 02: Excuse me, it's based on the claim construction order. [00:01:58] Speaker 02: The court then held for three reasons that even if it had considered the extrinsic evidence, that it would have granted Warner-Chilcot's motion. [00:02:08] Speaker 02: The argument here on appeals, the court did not give adequate weight to that evidence, did not consider the evidence as completely set forth, and that more importantly, Warner-Chilcot offered or had offered no evidence in opposition, proving either the knowledge of those of skill in the art [00:02:24] Speaker 02: or that the terms in the whereby clause would not have had a reasonably certain meaning to those of skill in the art. [00:02:30] Speaker 02: In so doing, he switched the burden over to Bayer, and Warren and Chilcot had not met its burden. [00:02:38] Speaker 02: The district court, as part of the claim construction hearing, was not resolving the indefiniteness of the patent at suit. [00:02:49] Speaker 02: The court confirmed in the subsequent conference after [00:02:52] Speaker 02: claim construction argument, that generally it's his practice not to treat indefiniteness in claim construction as part of the same proceeding. [00:03:01] Speaker 01: OK, and he didn't hear. [00:03:02] Speaker 01: He asked for a motion for summary judgment. [00:03:04] Speaker 01: And he did not. [00:03:04] Speaker 01: He didn't decide the indefiniteness in the context of claim construction, right? [00:03:07] Speaker 02: That's correct, Your Honor. [00:03:08] Speaker 02: He did not. [00:03:10] Speaker 02: And there was, we don't think a dispute, should be a dispute, that that is what occurred. [00:03:17] Speaker 02: At the time of claim construction, neither Warren Chilcot had sought permission [00:03:21] Speaker 02: to move for summary judgment, which was the district court's rules. [00:03:26] Speaker 01: I guess I'm not really clear what point you're making here. [00:03:28] Speaker 02: Well, the point, Your Honor, there's been an argument that in the claim construction argument, Bayer had waived reliance on extrinsic evidence as part of the indefiniteness inquiry. [00:03:40] Speaker 02: And that during the claim construction argument, when the district court asked why extrinsic evidence should be considered under vitronics, when [00:03:50] Speaker 02: Council for Bayer said that it was not necessary as part of claim construction. [00:03:54] Speaker 02: But that subsequently meant that it was not necessary as part of indefiniteness either, that it resolved the issue on indefiniteness as well. [00:04:01] Speaker 02: So the point here is simply that... All right. [00:04:03] Speaker 01: So let's assume there's no waiver here. [00:04:05] Speaker 02: Assuming there's no waiver, then we move on to the indefiniteness question. [00:04:09] Speaker 02: And the district court posed the question in his claim construction order as having continued questions regarding the plain meaning of the claim language and the terms of degrees set out in [00:04:19] Speaker 02: the claim language itself. [00:04:21] Speaker 01: And you posed different theories for how the language in the claim should be construed in your claim construction versus your response to the motion for summary judgment, right? [00:04:36] Speaker 02: No, Your Honor. [00:04:36] Speaker 02: No. [00:04:37] Speaker 02: The theories, what you're referring to, I believe, are two declarations by Dr. Schulman. [00:04:43] Speaker 02: The first declaration submitted as part of claim construction was regarding the [00:04:50] Speaker 02: the construction that, for example, high contraceptive reliability is assessed compared to a population of healthy women not taking hormonal contraceptive. [00:05:00] Speaker 02: The district court rejected, that was Bayer's construction, the district court rejected that construction and rejected Lorne and Chilcot's alternative construction. [00:05:07] Speaker 02: The question then turned to indefiniteness where the district court asked in its opinion that it had continued questions regarding the plain language of the claim language, plain meaning of the claim language. [00:05:18] Speaker 02: In particular, the terms of degree. [00:05:20] Speaker 02: How high is high? [00:05:21] Speaker 02: How low is low? [00:05:23] Speaker 02: What does reliable mean? [00:05:25] Speaker 02: Dr. Schulman's second declaration assesses those questions. [00:05:28] Speaker 02: And those were the questions that were the basis for the court's concerns over indefiniteness of the patent. [00:05:33] Speaker 02: And there, Dr. Schulman said that a person of skill and the art knows reliability is high when the reliability is comparable to other marketed oral contraceptives. [00:05:41] Speaker 02: And in his original declaration, he had said that even when comparing oral contraceptives, the comparison of oral contraceptives, [00:05:48] Speaker 02: The question is still, what is the effect of the oral contraceptive on a population of healthy women? [00:05:54] Speaker 02: Although compare is used in both, the comparison is not different. [00:05:59] Speaker 02: It's simply answering two different questions at two different phases of the proceeding. [00:06:03] Speaker 04: I don't even understand, though, how you can say the whereby clause is as compared to a woman not taking contraceptives. [00:06:13] Speaker 04: A woman not taking contraceptives [00:06:16] Speaker 04: High contraceptive reliability. [00:06:19] Speaker 04: Well, if you're not taking contraceptives, how do you have any contraceptive reliability? [00:06:24] Speaker 04: It doesn't make sense as a point of comparison. [00:06:27] Speaker 04: Like, the way the language is written, I don't understand your proposed construction. [00:06:32] Speaker 02: And you're right that women not taking contraceptives, by definition, that there is no contraception occurring. [00:06:40] Speaker 02: As explained in Dr. Shulman's declaration, when these are tested, when oral contraceptives are tested, they are tested on a population of healthy women. [00:06:46] Speaker 02: The assessment is the effect of the drug on a population of healthy women not taking hormonal contraception. [00:06:53] Speaker 02: And that is how the construction being high contraceptive reliability as compared to a population of healthy women not taking hormonal contraception. [00:07:01] Speaker 02: It's part of the test of the contraceptive itself. [00:07:05] Speaker 02: to see the effect on the body, the pharmacologic effect. [00:07:08] Speaker 01: What about low incidence of follicular development? [00:07:10] Speaker 01: What is the measure of that? [00:07:12] Speaker 01: What is the standard of that? [00:07:15] Speaker 02: Low incidence of follicular development, as part of claim construction, Bayer's proposed construction was low incidence of follicular development, again, based on the normal menstrual cycle. [00:07:26] Speaker 02: It would be evaluated based on the normal menstrual cycle. [00:07:28] Speaker 03: Can I ask you a question for all of these different terms? [00:07:32] Speaker 03: Wasn't it your claim construction position that [00:07:35] Speaker 03: it was compared to a woman who is not taking contraceptives? [00:07:39] Speaker 02: Yes, Your Honor. [00:07:40] Speaker 02: Because the assessment of the drug itself is done on a population of healthy women who are not taking contraceptives. [00:07:47] Speaker 03: And then later, in response to the summary judgment motion, you said it was compared to other contraceptives on the market. [00:07:58] Speaker 02: Is that correct? [00:08:01] Speaker 02: Assessment, the question at summary judgment was how would a person of ordinary skill know that contraceptive reliability was high, for example. [00:08:10] Speaker 02: And Dr. Schulman's declaration is that he would know, excuse me, a person of skill in the art would know that contraceptive reliability was high based on the knowledge of how contraceptives perform, marketed oral contraceptives. [00:08:22] Speaker 02: That the level of performance, the degree of contraceptive reliability is assessed against the knowledge of the market and how these products [00:08:31] Speaker 03: What's your position today on how this should be construed? [00:08:35] Speaker 02: How it should be construed? [00:08:36] Speaker 02: How the language? [00:08:36] Speaker 02: Today we have the plain language. [00:08:40] Speaker 02: And the district court was at an impasse with respect to construction of both, rejected both parties constructions, and we have the plain language. [00:08:48] Speaker 02: We think that language can go forward in the case, and it becomes a question first of indefiniteness, which we think should occur on a full record, and then of infringement. [00:08:56] Speaker 04: But you need to answer her question directly, because your circular answer, which doesn't respond to it, only makes the whole indefiniteness finding more appealing. [00:09:06] Speaker 04: So can you answer her question directly? [00:09:08] Speaker 04: What is your construction? [00:09:10] Speaker 04: Don't just say, oh, plain language. [00:09:11] Speaker 04: That doesn't help, because the district court found the plain language to be indefinite. [00:09:15] Speaker 04: So high contraceptive reliability as compared to what? [00:09:20] Speaker 04: Low incidence of follicular development as compared to what? [00:09:23] Speaker 04: Baer's position appears to me to be a moving target in this litigation. [00:09:28] Speaker 04: I understand why. [00:09:28] Speaker 04: District Court rejected your first construction. [00:09:30] Speaker 04: Got to go to your fallback position. [00:09:33] Speaker 04: I get it. [00:09:33] Speaker 04: But what is your argument now on appeal regarding how this claim should be construed? [00:09:39] Speaker 02: And if I could answer it in two parts. [00:09:41] Speaker 02: The first is we would go with, we would continue with what we've put forward as part of the indefiniteness case. [00:09:49] Speaker 02: That high is understood based on the performance of oral contraceptives. [00:09:53] Speaker 02: and how those are the performance of oral contraceptives generally. [00:09:57] Speaker 02: That is the knowledge of those of skill in the art when assessing high. [00:10:00] Speaker 03: Although... Does that include products that are currently on the market? [00:10:05] Speaker 02: Currently, but of course the questions at the time of the patents. [00:10:08] Speaker 03: It was 1995. [00:10:10] Speaker 02: That's correct. [00:10:10] Speaker 01: Over 10 years. [00:10:11] Speaker 02: That's correct. [00:10:12] Speaker 02: It would be at the time of the patent. [00:10:13] Speaker 03: So the comparison would be products that were on the market in 1995? [00:10:18] Speaker 02: Yes, because the meaning is as of the time of the patent. [00:10:23] Speaker 02: That would be the comparison that the person would have to make. [00:10:30] Speaker 02: But, Your Honor, if I could, one point with respect to your question, which was the difference between the construction. [00:10:40] Speaker 02: When Dr. Schulman said in his first declaration, or Bayer's first construction, which was high compared to a population of healthy women, the next question became, how does a person of ordinary skill know what high means? [00:10:53] Speaker 02: That was a term that had not been defined, had not been construed. [00:10:56] Speaker 02: And so the question necessarily then turned to, as part of indefiniteness, whether a person of skill in the art would understand this term. [00:11:06] Speaker 02: And Dr. Schulman's statement was that they would, because they wouldn't be able to compare this, understand the performance of the contraceptive against the performance of other contraceptives. [00:11:17] Speaker 02: the knowledge of those of skill in the art. [00:11:20] Speaker 01: Before you run out of time, can I just take you somewhere else, which is back to the prosecution history? [00:11:24] Speaker 01: Because the other side says in the prosecution history, to a certain extent, bears out that the reason for introducing this whereas clause was in the face of a rejection for obviousness, right? [00:11:36] Speaker 02: It was, yes. [00:11:37] Speaker 01: And your argument in putting it in is this shows the superiority of the product we're claiming, of what we're claiming, right? [00:11:47] Speaker 02: It shows the distinction from the prior art with respect to being able to have a very low estrogen amount, yet still achieve this profile. [00:11:59] Speaker 03: It says contrasted with the superior results of the present regimen. [00:12:03] Speaker 02: Yes. [00:12:04] Speaker 02: And the question of superiority was raised directly as part of claim construction and part of claim disavowal. [00:12:15] Speaker 02: And it was found not to have been [00:12:17] Speaker 01: I didn't ask you about this but I just asked you, is that correct? [00:12:20] Speaker 01: So you were claiming the reason for putting this language in in the first instance was to in the face of an obviousness rejection. [00:12:26] Speaker 01: Why? [00:12:27] Speaker 01: Was it because it was obvious and this is an unexpected, it's just a little odd to me. [00:12:31] Speaker 01: This was so you had to put in unexpected results and that's what got you the claim? [00:12:36] Speaker 02: Well the teaching was that as you lower the amount of estrogen you begin to sacrifice, for example, cycle control. [00:12:47] Speaker 02: The point, I believe, prosecution history that was being made was that even though you continue to lower estrogen with this regimen, you are able to achieve these effects in a way that if you were to lower estrogen in other contexts, you would not. [00:13:00] Speaker 02: So yes, in that sense, it is the differentiating effect. [00:13:03] Speaker 01: But just the lowering of estrogen was found to be obvious by the examiner. [00:13:07] Speaker 01: And that's why you had to put in this whereas clause, which described unexpected results in the face of lowering the estrogen. [00:13:16] Speaker 01: Is that what you're saying? [00:13:17] Speaker 02: Yes, there was an obviousness finding with respect to the regimen itself, excluding the whereby force. [00:13:22] Speaker 01: So you're saying your use of the word superior wasn't in connection with products currently on the market, it was for products that might use lower estrogen levels? [00:13:37] Speaker 02: Yes, Your Honor. [00:13:38] Speaker 02: It's not a good question, I'm really just trying to understand what you're saying. [00:13:40] Speaker 02: No, there were two prior art regimens cited for the basis of obviousness, and it was with respect to those two regimens. [00:13:49] Speaker 01: All right. [00:13:51] Speaker 01: We're into rebuttal. [00:13:52] Speaker 01: Why don't we save your rebuttal and we'll hear from the other side. [00:14:07] Speaker 05: Good morning, Your Honor. [00:14:08] Speaker 05: Christopher Sipes here on behalf of the respondent, Warner Chilcot. [00:14:12] Speaker 05: I think the key point to begin with, although there are several defects, I believe, with Petitioner's argument, is that what we're talking about here is claim construction. [00:14:20] Speaker 05: And in particular, a claim construction that Bayer did not present during the Markman proceeding to the district court. [00:14:27] Speaker 05: And the district court specifically found that and found waiver on that basis. [00:14:31] Speaker 05: They did not argue comparable to other marketed plural contraceptives during Markman. [00:14:37] Speaker 03: Once somebody makes a claim construction argument and it's rejected by the district court, aren't they allowed to go ahead and make a different argument? [00:14:46] Speaker 05: Your Honor, that's up to the district court's ability to manage the docket and the case. [00:14:50] Speaker 05: This court has held, for example, in central admixture that where a proposed claim construction is not presented, they cannot then pursue it later. [00:14:58] Speaker 05: And that makes sense. [00:14:59] Speaker 05: This is a matter of what do the claims mean before it moves on to the next proceeding. [00:15:04] Speaker 05: And that is, of course, the first step even in indefiniteness. [00:15:07] Speaker 05: is what do the claims mean? [00:15:09] Speaker 05: What is the scope and understanding of the claims? [00:15:12] Speaker 05: And the court needs a procedure to resolve that before moving on. [00:15:17] Speaker 05: And the well-established procedure for that is Markman. [00:15:21] Speaker 05: And they came in with one meaning at Markman. [00:15:23] Speaker 05: And to be clear, it's not that they then refined it. [00:15:27] Speaker 05: In Markman, they said specifically that it was a comparison to women not on contraceptives, not [00:15:34] Speaker 05: other, not women, not in comparison to other oral contraceptives. [00:15:38] Speaker 05: At JA505, for example, in their opening market paper, they said, assessing satisfactory cycle control requires comparing the cycle control of an oral contraceptive to the menstrual cycle of healthy women. [00:15:52] Speaker 04: And what did you argue the claim should be construed as? [00:15:56] Speaker 05: We argued that it was indefinite, but the degree that it had any meaning, and we believed comparisons could not be done, it was superiority. [00:16:03] Speaker 05: based on the intrinsic evidence. [00:16:05] Speaker 05: And as I can go through, even their current kind of instructions, they argue on appeal, and the argument of summary judgment is inconsistent with the intrinsic evidence. [00:16:13] Speaker 05: But the court first found, before moving on to that. [00:16:16] Speaker 04: Then why aren't you right that it's superiority? [00:16:18] Speaker 05: We are correct it is not comparability. [00:16:21] Speaker 05: But the problem with superiority is one cannot compare superiority either. [00:16:27] Speaker 05: One could say, for example, a man who is of height comparable to other men, or a man who is taller than other men. [00:16:33] Speaker 05: But that all remains subjective. [00:16:36] Speaker 05: How much taller compared to what men? [00:16:38] Speaker 04: And the intrinsic evidence makes even... Well, superiority, I mean, there were a number of prior art references before the examiner, at least two different oral contraceptives when he issued his obviousness rejection. [00:16:52] Speaker 04: They added this clause and they said this would demonstrate this product's superiority. [00:16:58] Speaker 04: Why isn't it sufficient to infer from that, as you all suggested, a claim construction [00:17:03] Speaker 04: that it is this product's superiority as compared to the prior art at the time of the patenting. [00:17:11] Speaker 05: To be clear, even at some point in time, they did not suggest that there were specific products called out that could be compared. [00:17:17] Speaker 05: They said generally the market of products. [00:17:19] Speaker 04: The district court at J&I... Okay, fine, maybe it'd be all the products, all the prior art that existed. [00:17:23] Speaker 05: And the problem, of course, is that prior art products vary as the intrinsic evidence itself teaches. [00:17:28] Speaker 05: For example, it references Mercellin as one prior art product that has [00:17:33] Speaker 05: less good cycle control than other products. [00:17:36] Speaker 05: But it doesn't say whether that cycle control is satisfactory or not. [00:17:41] Speaker 05: So we have intrinsic evidence that's teaching that all of these vary even as to marketed products, but doesn't tell you how to do the comparison, either for comparability or superiority. [00:17:53] Speaker 04: What if one of skill and the art would understand what satisfactory cycle control is? [00:17:58] Speaker 05: The problem with that, Your Honor, is that it is a subjective, we're back into data mimes. [00:18:03] Speaker 05: Each individual person might have their own yardstick. [00:18:06] Speaker 04: No, not each individual person. [00:18:08] Speaker 04: What if one of skill in the art understood what the industry meant when it said satisfactory cycle control in the context of birth control? [00:18:19] Speaker 04: I'm Catholic, so I'm not so good on all this. [00:18:22] Speaker 04: However, I think even I [00:18:25] Speaker 04: can venture a guess as to what is meant by satisfactory cycle control and probably be right simply as a woman. [00:18:31] Speaker 05: Well, you're right. [00:18:32] Speaker 05: Cycle control is different, for example, than contraceptive reliability. [00:18:35] Speaker 05: And so, for example, there may be different degrees of amenorrhea. [00:18:39] Speaker 05: How much amenorrhea, which is avoidance of bleeding in between, is satisfactory. [00:18:46] Speaker 05: There is spotting or intercyclic bleeding as part of cycle control. [00:18:51] Speaker 05: How much is satisfactory? [00:18:52] Speaker 05: How much is better than the other products? [00:18:54] Speaker 05: Well, the other products vary. [00:18:55] Speaker 05: Take the reliability clauses, reliable avoidance of undesirable side effects. [00:19:00] Speaker 05: Well, how do you compare superiority with regard to headaches versus cardiovascular versus breast tenderness? [00:19:06] Speaker 05: They all vary. [00:19:08] Speaker 05: At what point is it comparable if one is better avoiding headaches but produces more breast tenderness or greater cardiovascular results? [00:19:16] Speaker 05: Which is superior? [00:19:17] Speaker 05: Which is comparable? [00:19:19] Speaker 05: It is impossible to answer that question. [00:19:22] Speaker 05: Each one of these terms, every one of the five terms [00:19:25] Speaker 05: has degree. [00:19:26] Speaker 05: Low incidence of follicular development. [00:19:29] Speaker 05: Well follicles grow and then one gets recruited. [00:19:31] Speaker 05: Maybe it grows to 10 millimeters. [00:19:33] Speaker 05: Maybe it grows to 13. [00:19:34] Speaker 05: If you have one regime in which a certain percentage of women, they get to 10. [00:19:39] Speaker 05: If you have another regime where it's fewer women, but it gets to 13 millimeters, which is superior? [00:19:46] Speaker 05: You can't know. [00:19:47] Speaker 05: The district court knew all things. [00:19:49] Speaker 05: And the key point here is twofold. [00:19:51] Speaker 05: These are each one of these. [00:19:53] Speaker 05: is manifold issues of degree. [00:19:55] Speaker 05: There's no dispute. [00:19:55] Speaker 05: These are issues of degree. [00:19:58] Speaker 05: And they are ones that are subjective. [00:20:00] Speaker 04: We've never suggested that subjective words or issues of degree necessarily render a claim indefinite. [00:20:08] Speaker 04: It all depends on what one of skill and the art would understand about the subject matter. [00:20:13] Speaker 04: So why isn't that a fact question that ought to go to a fact finder? [00:20:18] Speaker 05: Your Honor, it's a legal question. [00:20:19] Speaker 05: And the court has said that [00:20:23] Speaker 05: Without objective boundaries, the claims are indefinite. [00:20:27] Speaker 05: It's said in data mice, some objective standard must be provided in order to allow the public to determine the scope of the claimed invention and an interval licensing. [00:20:36] Speaker 05: It is not enough, as some language in our prior cases may have suggested, to advise some standard for measuring the scope of the phrase. [00:20:42] Speaker 05: The claims, when read in light of the specification of prosecution history, must provide objective boundaries for those skilled in the art. [00:20:49] Speaker 04: Yes, and that all turns on whether one of skill in the art [00:20:52] Speaker 04: would understand them to provide objective boundaries. [00:20:56] Speaker 04: So high contraceptive reliability. [00:21:00] Speaker 04: Why wouldn't one of skill in the art understand what that means? [00:21:02] Speaker 04: They don't end up pregnant. [00:21:04] Speaker 04: It seems like a pretty straightforward concept to me. [00:21:07] Speaker 04: So I don't know what I'm missing, and I'm not certainly not one of skill in the art. [00:21:12] Speaker 04: However, I mean, if one of skill in the art could provide that information, why isn't that relevant to deciding whether the words high [00:21:21] Speaker 04: contraceptive reliability, even though you're correct they have a degree of subjectivity to them, would nonetheless provide objective boundaries in terms of how one of ordinary skill in the art would understand them. [00:21:32] Speaker 05: Your Honor, these are not light switches. [00:21:34] Speaker 05: In other words, high contraceptive reliability can't be 100%. [00:21:37] Speaker 05: Or if it is 100%, then there's nothing but that. [00:21:40] Speaker 05: But the problem with contraceptive reliability is that it varies. [00:21:43] Speaker 05: What percentage of women, what is the risk of pregnancy, taking this? [00:21:49] Speaker 05: Cycle control, follicular development, [00:21:52] Speaker 05: avoidance of intercyclic menstrual bleeding, reliable avoidance of undesirable side effects. [00:21:57] Speaker 05: Each one of these are degrees. [00:21:59] Speaker 05: It's not a matter of light switch on or off. [00:22:02] Speaker 05: Every one of them is degrees. [00:22:04] Speaker 05: And there is no objective standard for any one of them. [00:22:07] Speaker 05: The plaintiff here has come in with two different inconsistent standards in an effort of claim construction, a legal question. [00:22:14] Speaker 05: First comparing it to healthy women, then comparing it to other marketing contraceptives. [00:22:18] Speaker 05: The intrinsic evidence not only refutes what they've come in with, [00:22:21] Speaker 05: but shows the variance, shows, for example, in talking about Mercellin, that the cycle control, the follicular development varied, but doesn't even say whether that marketing product, Mercellin, meets the requirements of the whereby clause. [00:22:37] Speaker 01: What if we had a situation, I mean, taking now their claim construction of comparable to other combined oral contraceptives on the market, what if [00:22:46] Speaker 01: We had clear evidence, and there was no dispute, that if you took all the products on the market in 1995, this is where they would be on all these indicia, on what is high, what is low, et cetera. [00:22:59] Speaker 01: And what if we could easily determine what those comparable markets, comparable products consisted of with respect to each of these categories? [00:23:08] Speaker 01: Would that be sufficient? [00:23:09] Speaker 05: It might well be if you had a single one take contraceptive reliability, and there was a benchmark, 90%. [00:23:15] Speaker 05: That would be the sort of objective boundary, or 99% reliability. [00:23:20] Speaker 05: That might be. [00:23:21] Speaker 05: The problem here is some of them are not amenable to bench books at all. [00:23:25] Speaker 05: Reliable avoidance of undesirable side effects. [00:23:28] Speaker 05: Why? [00:23:28] Speaker 05: Because you have a variety of undesirable side effects, which are independent. [00:23:33] Speaker 05: Headaches versus breast tenderness versus cardiovascular events, for example. [00:23:40] Speaker 05: So they may vary, both in their incidence and their severity for each one. [00:23:45] Speaker 05: It's impossible even to think about how one would have a benchmark. [00:23:48] Speaker 05: But there has been no suggestion for any of these that there is such a benchmark. [00:23:52] Speaker 05: And as I say, the intrinsic evidence specifically says that it varies. [00:23:57] Speaker 05: And the district court observed that in rejecting even comparability as a definite term. [00:24:03] Speaker 05: There is no, in fact, benchmark products, benchmark levels to compare to. [00:24:09] Speaker 05: And for some, follicular development is another one. [00:24:11] Speaker 05: There is no such a benchmark, because it varies. [00:24:14] Speaker 05: in terms of the women who experience levels of follicular development, how far developed it goes. [00:24:21] Speaker 05: And again, the intrinsic evidence says specifically about Myrcelon that there was greater follicular development without saying whether or not that was a low incidence of follicular development or not. [00:24:33] Speaker 05: So not only do we know that there's no benchmark, that is that products vary, and they vary by degree and amount, but the patent provides absolutely no guidance [00:24:43] Speaker 05: And the executive evidence provides absolute no guidance onto what any benchmark is for any one of them, let alone all five of them. [00:24:50] Speaker 05: And we're beginning here, comparability with a construction. [00:24:54] Speaker 05: That's clearly claim construction. [00:24:57] Speaker 05: What do these terms mean? [00:24:58] Speaker 05: That the patent holder did not present during the claim construction phase of the case. [00:25:05] Speaker 05: So the court began with the point, we've had our opportunity for claim construction. [00:25:09] Speaker 05: You've not presented this as claim construction. [00:25:11] Speaker 05: You've waived this. [00:25:12] Speaker 05: And then said, and even if I took it up, one, it's the wrong client construction, which seems right, and two, it doesn't provide me a benchmark. [00:25:19] Speaker 05: And just as comparability doesn't provide a benchmark, neither would superiority, because you can't judge superiority any more than comparability without a benchmark and a way of measuring it. [00:25:30] Speaker 05: And the district court found all of those problems step by step and correctly did so. [00:25:35] Speaker 05: These are terms that are subjective terms without fixed meaning. [00:25:39] Speaker 05: They've been unable to construe the claims. [00:25:41] Speaker 05: Which means, without construction, that there is no objective boundaries, that they are in their nature subjective, without objective boundaries. [00:25:50] Speaker 05: And the court has held repeatedly, in datumized, in interval, in howitiva, that subjective terms are, without objective boundaries, are legally indefinite. [00:26:05] Speaker 05: And that it's not a matter of sending it to a jury with subjective terms to figure out whether the jury can sort through that. [00:26:11] Speaker 05: That this question of indefinite is a legal question. [00:26:15] Speaker 05: And where claim terms are not subject to construction to have objective boundaries, they are by law indefinite. [00:26:23] Speaker 05: Your Honor, if there are no further questions. [00:26:24] Speaker 05: Thank you. [00:26:25] Speaker 05: Thank you, Your Honor. [00:26:32] Speaker 02: Very briefly, thank you to the court. [00:26:34] Speaker 02: One, I want to return to a question from Chief Judge Proce. [00:26:36] Speaker 02: I don't think I answered it particularly helpfully [00:26:39] Speaker 02: The prosecution history is at 1317 and says the deficiencies of the prior multi-phasic combination preparations, including two of the prior art regimens used on the obviousness rejection, are discussed in the specification and contrasted with the regimen itself. [00:26:58] Speaker 02: That was the statement made as part of the prosecution history. [00:27:02] Speaker 02: I want to make sure that I answered your question was clear on that. [00:27:05] Speaker 02: And finally, just very briefly, unless the court has any other questions, [00:27:09] Speaker 02: The statements regarding what a person of the skill in the art would or would not understand were not before the district court as part of the summary judgment on Warner Chilcot's side. [00:27:20] Speaker 02: The only evidence at that time put forward was that by Bayer's expert, as well as the extrinsic evidence that showed, as Judge Moore pointed out, that these terms are used in the art. [00:27:32] Speaker 02: They are understood by those in the art as clinical assessments regarding what are essentially very important design elements of an oral contraceptive itself. [00:27:39] Speaker 02: So to the extent that there is a question, a factual question, over the scope of knowledge of one of skill in the art, the record as it currently stands on summary judgment is Bayer's evidence and the claim construction order on the other side. [00:27:52] Speaker 02: We think that that is sufficient to create at least an issue of material fact and justify a reversal here. [00:27:59] Speaker 02: And unless the court has any other questions, I would surrender my time. [00:28:03] Speaker 01: Thank you. [00:28:03] Speaker 01: I think both counsel and the case is submitted.