[00:00:01] Speaker 00: The first case for argument this morning is 18-1658, Isutica v. Lupin. [00:00:08] Speaker 00: Mr. Richards, good morning. [00:00:10] Speaker 01: Good morning, Your Honors, and may it please the Court, Oliver Richards, for repellence. [00:00:14] Speaker 01: Unless the Court has questions otherwise, I'd like to focus this morning on amendment-based estoppel. [00:00:19] Speaker 01: And on that question, we basically have two questions we have to answer. [00:00:23] Speaker 01: First, does the prosecution history evidence an objective intent behind the amendments made? [00:00:28] Speaker 01: And if so what is that intent? [00:00:30] Speaker 01: And second, we have to analyze whether that intent is directly relevant. [00:00:34] Speaker 01: to the equivalent issue here. [00:00:37] Speaker 00: Well, and there's an interesting discussion of policy back and forth on this case. [00:00:41] Speaker 00: And this is kind of an unusual case. [00:00:44] Speaker 00: But with the backdrop of knowing that there's a real strong notice function in patent world, even if we credit everything you say about why the patent owner in this circumstance is what his motivations were, her motivations, [00:01:01] Speaker 00: If you choose with specific language changes to expressly claim a range in furtherance of that motivation, why does the fact that the motivation may have been a little different or not directly related get you a pass on DOE? [00:01:19] Speaker 01: Well, I think that when we're considering this public notice function, we have to consider who is being noticed. [00:01:25] Speaker 01: So here, this is a drug patent. [00:01:29] Speaker 01: supposed to provide notice to competitors. [00:01:31] Speaker 01: And we have to kind of consider here that we've got sophisticated competitors. [00:01:34] Speaker 01: This is not Joe off the street looking at this patent saying, I need to make some meloxican. [00:01:40] Speaker 01: And as this court said in Intervet, we have to fully consider the record. [00:01:45] Speaker 01: It can't just be plucking statements out of the prosecution history. [00:01:51] Speaker 01: We've got to consider the prior art. [00:01:52] Speaker 04: We've got to consider it. [00:01:53] Speaker 04: It's very clear that you gave up less than $1,200. [00:01:57] Speaker 01: Well, as a matter of literal infringement, I agree that the claims were amended to... Well, that's why you were stopped to recapture it. [00:02:09] Speaker 01: Well, I disagree that simply because we amended, we can't recapture any of that ground. [00:02:15] Speaker 01: I mean, if we look at what happened in Intervet, you know, there was an amendment in that case [00:02:19] Speaker 01: to recite of porcine circovirus 2, right? [00:02:22] Speaker 01: And that, you know, the original scope of the claim would have included the accused product in that case, and the amendment took it out. [00:02:28] Speaker 01: But they were allowed to recapture some of that ground. [00:02:31] Speaker 01: Because both in intervet and in institute, institute, I can't, institute form, or whatever that case was, there's, you know, you have to look at the rationale behind the amendment. [00:02:42] Speaker 01: That's what this case law says, is we have to look at the rationale. [00:02:45] Speaker 04: The rationale was to avoid the reference. [00:02:47] Speaker 01: Yeah, but how would it avoid that reference? [00:02:51] Speaker 01: So like in the Institute Forum case, there was an amendment added to specify one suction cup, but the rationale wasn't necessarily to avoid prior art based on [00:03:04] Speaker 01: the one suction cup in that vacuum device, and I can provide some background if you all like, but the rationale was to distinguish prior art based on the source of the vacuum. [00:03:15] Speaker 01: And just because the claim was amended in a way that read out as a matter of literal infringement, the particular equivalent doesn't mean they weren't able to recapture that ground. [00:03:29] Speaker 01: So on that, this question, you know, the prosecution history here, and I think the panel seems to be, you know, I'm sure is aware of it, seems to be replete with evidence that the rationale here was about the particle size distribution and not the... But sometimes you choose. [00:03:47] Speaker 00: Even the rationale is to accomplish one thing. [00:03:49] Speaker 00: There are options you have in terms of choosing how to implement or achieve what your goal is. [00:03:56] Speaker 00: And if the patent owner [00:03:58] Speaker 00: chooses one of those options, and it's quite clear from the language what's at stake here. [00:04:05] Speaker 00: I mean, I see a distinction to be drawn between the cases you've cited and the one here. [00:04:11] Speaker 00: So how do we get by that here? [00:04:13] Speaker 00: There's no question the language is clear. [00:04:17] Speaker 00: So if you're on the receiving end, notwithstanding that, yeah, drug companies may be pretty sophisticated, and you're looking at the prosecution history, [00:04:27] Speaker 00: It just seems like an unreasonable amount of effort to require a future business holder to look at the motivation and then compare it to the claim language. [00:04:38] Speaker 00: Here, there were several stages of the amendment, right? [00:04:41] Speaker 00: Some amendments were rejected. [00:04:44] Speaker 00: And it just seems to me striking how much effort and speculation it will take on the receiving end to get to where you want to go. [00:04:56] Speaker 01: I mean, I disagree that there's much speculation required. [00:04:59] Speaker 01: I mean, we look here, I mean, there's a single prior art reference, right, which is Cooper, and Cooper expressly says particle size can range up to 2,000, right, and we look at, you know, it is, I will acknowledge that there is some complication that the examiner didn't seem to understand the argument we were making throughout the prosecution. [00:05:20] Speaker 01: But if you look at the record, the record says the examiner rejected because she said, okay, Cooper goes up to 2,000, you all are within 2,000. [00:05:28] Speaker 01: But then the final amendment didn't actually cure that objection, right? [00:05:31] Speaker 01: There's still an overlap between the range taught by Cooper and the final range. [00:05:36] Speaker 01: competitor and you're looking at this and you say okay I look at the Cooper and that's not that challenging it's right there and on the first page of Cooper it says up to 2000 and the examiner cited it. [00:05:45] Speaker 01: We look at the final claims and they still overlap you know I think at least reasonable inquiries to what what's actually going on here is not that much to ask of a competitor here. [00:05:56] Speaker 01: You know, and again, particularly considering that this is a sophisticated company that is investing time and money into developing a maloxicam formulation. [00:06:13] Speaker 00: It's challenging, right? [00:06:14] Speaker 00: I mean, claim construction by itself in the context of literal infringement is hard enough under Philips and in light of the spec. [00:06:23] Speaker 00: And now we're at a level of granularity [00:06:26] Speaker 00: beneath that, right? [00:06:28] Speaker 00: I mean, it's interpreting the prosecution history and looking the back and forth. [00:06:32] Speaker 00: And there's a lack of position. [00:06:35] Speaker 00: And then again, the bottom line is irrespective of your goal, you have choices on how to achieve that. [00:06:44] Speaker 00: So perhaps there was a way that you could have amended the claim narrowly to exclude Cooper and not to have gotten you to where you are. [00:06:53] Speaker 00: But this is a challenge, right? [00:06:56] Speaker 01: Yeah, I mean, I agree as a litigator. [00:06:59] Speaker 01: I mean, I think that every litigator wishes they had a time machine and they could go back in time and rewrite claims later on, you know, and every prosecutor wishes they had a crystal ball to look into the future. [00:07:09] Speaker 01: But like the Supreme Court said in Festo, is that we, you know, there's no reason, you know, we don't expect prosecutors to be prescient. [00:07:16] Speaker 01: That's the whole reason behind the doctrine of equivalence. [00:07:18] Speaker 01: And, you know, another thing to remember here is that [00:07:22] Speaker 01: All we're asking for is an opportunity to try this case. [00:07:26] Speaker 01: There's a reason why there are trials. [00:07:28] Speaker 01: Even with claim construction, you've got that stage. [00:07:30] Speaker 01: There's a whole judicial process. [00:07:32] Speaker 01: And that's why the ANDA process exists, is that they can test claims beforehand in declaratory judgment. [00:07:39] Speaker 01: There's a whole process that exists here. [00:07:43] Speaker 00: But the jury plays no role. [00:07:44] Speaker 00: I mean, you agree this is an issue of law, a question of law, that the jury is not going to be making assessments of whether this was tangential or not, or so forth, right? [00:07:55] Speaker 01: Correct, but just because we get to try the case doesn't mean that there's equivalence. [00:08:00] Speaker 01: There still has to be later on a determination as to whether it is or is not equivalent. [00:08:05] Speaker 00: And that is the function by result test? [00:08:08] Speaker 00: Yes, correct. [00:08:12] Speaker 01: Okay, so now in reading through Lupin's briefs, Lupin seems to suggest this [00:08:20] Speaker 01: This broad, narrow thing is litigation-inspired. [00:08:23] Speaker 01: To your question from earlier, all we do is read the examiner's reasons for allowance. [00:08:31] Speaker 01: You just have to really, even as a competitor, read that. [00:08:35] Speaker 01: The examiner lays it out very clearly. [00:08:37] Speaker 01: She says, look, Cooper teaches up to 2,000, but Cooper teaches a narrow range. [00:08:42] Speaker 01: These claims are different because they teach a broad range. [00:08:44] Speaker 01: We're not just making this up, you know, later on. [00:08:47] Speaker 01: This is what the examiner's words actually said, you know, in Appendix 258. [00:08:52] Speaker 01: The examiner said it. [00:08:53] Speaker 01: The examiner said it again, allowing the 734 in Appendix 625. [00:08:59] Speaker 01: You know, and even in the examiner's statement of the interview, this appears all throughout the prosecution. [00:09:03] Speaker 01: It's the 627, you know, that the district court focused on. [00:09:08] Speaker 01: She said this amendment still, you know, demonstrate the broad particle size range. [00:09:16] Speaker 01: I mean, it's all throughout the prosecution history. [00:09:20] Speaker 01: There's certainly some statements that are challenging, but you don't have to look that hard to find the rationale here. [00:09:31] Speaker 01: So let's go ahead, and we can go ahead and turn to, I guess, directly relevant if the court wishes, or if you all have additional questions on the record, we can obviously address those. [00:09:46] Speaker 01: But so let's turn to the second question here, is the objective rationale directly relevant to the equivalent at issue? [00:09:54] Speaker 01: And so on that, we actually have to look at the equivalent at issue here. [00:10:00] Speaker 01: Lupin's product uses a broad distribution range like the patents. [00:10:04] Speaker 01: So if we look to, you know, they didn't specify D50 in the ANDA, and I'll cite to the district court's public order so it's not revealed confidential, but just look at the appendix 28, you know, the D50 that some of the test data shows, the D50 is around 200 nanometers. [00:10:22] Speaker 01: The D90 is less than 800 nanometers, and certainly, [00:10:26] Speaker 04: Lupin's 90% data was 800, right? [00:10:31] Speaker 01: That's their target, correct. [00:10:32] Speaker 04: And that's directly relevant to the retreat giving away 0 to 1,200. [00:10:40] Speaker 01: I think the question we have to ask is it directly relevant to the rationale behind the amendment, right? [00:10:48] Speaker 01: I don't think that the equivalent at issue here is 200, 800 is directly relevant to the rationale, which was to avoid a very narrow distribution taught by Cooper. [00:11:00] Speaker 01: So in Cooper, we have to remember, if we look at Cooper's actual data, I mean, Cooper instructs us, consistent with the common knowledge at the time, is that you wanted to have a narrow spread of very small particles. [00:11:13] Speaker 01: Because the concern was about all small ripening, these things growing, and potentially [00:11:17] Speaker 01: being harmful or not being absorbed. [00:11:20] Speaker 01: And what Cooper shows, their data shows, is that the difference between D50 and D90 was always less than 100 damage. [00:11:29] Speaker 01: And if we look at the patents here, they defied that common knowledge. [00:11:35] Speaker 01: We've got a very broad spectrum. [00:11:36] Speaker 01: So this court has certainly said that whether the equivalent issue is within the prior art is not necessarily answer the question, but it's certainly a relevant inquiry here. [00:11:46] Speaker 01: And if we look at the prior art and Lupin's [00:11:50] Speaker 01: and a product compared to the patents. [00:11:53] Speaker 01: They're certainly a lot closer to us than they are to, and they're not within the prior art certainly, and they're a lot closer, you know, they have this broader particle size range. [00:12:03] Speaker 00: And you would have to prevail on both the amendment estoppel issue and the argument estoppel issue. [00:12:11] Speaker 01: That's correct. [00:12:12] Speaker 01: Either one would preclude us from certain doctrinal quotes. [00:12:20] Speaker 00: You want to save your – you're in your rebuttal time, so you want to – [00:12:36] Speaker 03: Good morning, your honor. [00:12:37] Speaker 03: May it please the court? [00:12:38] Speaker 03: Bill Zimmerman on behalf of Lupin. [00:12:40] Speaker 03: The district court correctly held, as a matter of law, that argument-based estoppel and amendment-based estoppel separately and independently preclude application of the doctrine of equivalence. [00:12:52] Speaker 00: I'd like to turn first to the- But what about this argument about how there is little dispute as to what their motivation was and what they were trying to achieve, which is to avoid Cooper? [00:13:02] Speaker 03: They were trying to avoid Cooper, but I'd like to directly address the rationale that they claim that they were focused on the difference between D50 and D90, the size of the particle limitation. [00:13:13] Speaker 03: But if you look at the prosecution history, that's not what happened. [00:13:17] Speaker 03: If you look at Joint Appendix, page 183, this is where the D90 limitation is first introduced into the independent claims, and it's during prosecution of the 318 patent. [00:13:28] Speaker 03: They introduced the lower limit of 900, but there is no D50 limitation. [00:13:34] Speaker 03: They're not arguing the difference between D90 and D50. [00:13:37] Speaker 03: It's D90 alone. [00:13:39] Speaker 03: And then if you turn to page 190. [00:13:41] Speaker 04: But the avoidance of Cooper was imperfect, though, wasn't it? [00:13:47] Speaker 04: Because Cooper said less than 1,200. [00:13:49] Speaker 03: It may have been imperfect, but we have to look for the rationale of the amendment, not the rationale on which the patent may have ultimately been allowed. [00:13:58] Speaker 03: At the time of the amendment, if we look at page 190, what did they argue to the Patent Office? [00:14:04] Speaker 03: They told the Patent Office that the D90 of Cooper is 300. [00:14:09] Speaker 03: and the D-90 of their claims was 900. [00:14:13] Speaker 03: The sole argument for patentability that they made over Cooper at the time of the amendment was a difference in D-90. [00:14:21] Speaker 03: This broad particle size distribution that they're alleging now doesn't come until way later in the prosecution history. [00:14:28] Speaker 03: When they make the subsequent amendments to 1200 at page 241 of the appendix, they make the same argument. [00:14:36] Speaker 03: They focus solely on D90, no argument about broad versus narrow particle size distribution. [00:14:43] Speaker 03: It's only that the difference in their claims in D90 is allegedly different from Cooper. [00:14:49] Speaker 03: So the rationale for the amendment was to distinguish Cooper based solely on the D90 limitation. [00:14:56] Speaker 03: They do it again at page 606 and 607 of the Joint Appendix. [00:15:01] Speaker 03: So throughout the prosecution history, they tried to distinguish Cooper solely on the basis of D90. [00:15:07] Speaker 03: And so that was the rationale for the amendments. [00:15:10] Speaker 03: Now, those amendments sequentially didn't work. [00:15:14] Speaker 03: And they ultimately have to make other amendments, [00:15:17] Speaker 03: But we look at it on a limitation by limitation basis, and the D90 limitation was expressly added to Distinguished Cooper based on D90 alone. [00:15:27] Speaker 03: Even when the examiner allows the claims, though, the examiner doesn't say, oh, it's a broad particle size distribution. [00:15:35] Speaker 03: If you look at page 625 of the joint appendix, [00:15:38] Speaker 03: The examiner is very clear that it's not any broad distribution. [00:15:43] Speaker 03: It's a broad distribution where they fall within these specific ranges. [00:15:49] Speaker 03: And the examiner three times refers to the specific D90 particle size limitations. [00:15:55] Speaker 03: And so any objective reading of the prosecution history is that the D-90 limitation, that lower limit of 1200, first 900, then 1200, was made in an effort to overcome Cooper. [00:16:08] Speaker 03: It's directly relevant to the Lupin product, which has a much lower D-90 value. [00:16:13] Speaker 03: Turning to argument-based estoppel, it's not just that they made the amendment. [00:16:19] Speaker 03: On pages 190, 241, and 606 of the Joint Appendix, they specifically say, it's a minimum. [00:16:28] Speaker 03: And they argue that it's a minimum, and that minimum distinguishes Cooper. [00:16:32] Speaker 03: So you can't represent to the public throughout the prosecution history that the lower $1,200 value is a minimum, and then say during litigation, that representation doesn't apply. [00:16:44] Speaker 00: Well, your friend's a bit of an answer is that we're not really looking at representation to the public, that we're looking at Lupin, which is a sophisticated player in the market with an understanding of particle size and distribution and all this stuff. [00:16:59] Speaker 00: Is that right in your view? [00:17:01] Speaker 03: I believe you look at an objective standard and what would a person of skill in the art view the prosecution history as reading. [00:17:09] Speaker 03: So it would be a skilled artisan in the pharmaceutical art. [00:17:13] Speaker 03: And unlike the policy of most doctrine-equivalent cases where you have vagaries of language and you may not be able to capture your invention, that's not the case when you're dealing with numbers. [00:17:25] Speaker 03: The numbers are expressed. [00:17:27] Speaker 03: 900 is always less than 1200, and the value that was picked in the Lupin product, 800, is always below what they seeded. [00:17:36] Speaker 03: There wasn't some ambiguity in the range they picked. [00:17:40] Speaker 03: They now just don't like the range they picked, because objectively reading it, someone was able to design around the patent. [00:17:48] Speaker 03: And when you make a clear representation as to what your minimum is, the public should then be free to design around in the area that was surrendered. [00:17:57] Speaker 00: Do none of the cases your friend relies on deal with the numbers, right? [00:18:03] Speaker 03: There is not, at least in our research, an express numerical range case that we were able to find. [00:18:11] Speaker 03: The closest case, and it's not cited in the brief, Your Honor, it just came out on May 31st, is the non-precedential opinion in Cobalt Boats versus Brunswick. [00:18:25] Speaker 03: And the statement there is, in particular, when claims are amended to include a specific numeric boundary, we have held that the patentee cannot later recapture what is beyond that boundary through the doctrine of equivalence. [00:18:39] Speaker 03: So there isn't a precedential case that we were able to find dealing directly with numerical ranges. [00:18:44] Speaker 00: Well, did that sentence end in a cite to a precedential case? [00:18:47] Speaker 00: Because it says, what you read to me says, we have held. [00:18:51] Speaker 03: Usually, we would include a citation at the end. [00:18:53] Speaker 03: It did. [00:18:54] Speaker 03: The case that was cited was Wang Laboratories, 103 F3rd, 1571. [00:19:01] Speaker 03: But that case was the number of units, eight versus nine. [00:19:06] Speaker 03: It wasn't a numerical range case. [00:19:08] Speaker 03: So this would be the closest precedent in terms of a numerical range. [00:19:13] Speaker 02: But here- There must be a little bit of wiggle room on the numerical range, right? [00:19:16] Speaker 02: I mean, if their patent said, and I don't know the science, so maybe [00:19:22] Speaker 02: This might have a big difference, practically, but just bear with me on the hypothetical. [00:19:27] Speaker 02: Their patent said 1,200, and you designed around with 1,195, even though the specific range was 1,200, assuming that had no practical difference. [00:19:37] Speaker 02: Then you might see the doctrine of equivalence come in, no? [00:19:40] Speaker 03: Then you would have a much harder case, and you can use words of approximation, and this claim doesn't, but even if we gave them that wiggle room, we're in a scenario where they amended to add the 900, the patent office said you can't have 900, then they amend to 1200, [00:19:59] Speaker 03: They certainly can't get back far enough to recapture 900, and Lupin's product is so far below that at 800 that the hypothetical, you might get some range of equivalents, but that's not the scenario we're dealing with here. [00:20:13] Speaker 03: So the district court correctly found both argument-based and amendment-based to stopple, and respectfully, we would ask the court to affirm. [00:20:22] Speaker 03: Thank you. [00:20:22] Speaker 03: Does the panel have any further questions? [00:20:24] Speaker 03: Then I will cede my time. [00:20:25] Speaker 03: Thank you. [00:20:32] Speaker 01: So I just want to pick up where opposing counsel left off with the numerical range. [00:20:36] Speaker 01: I just want to point out in Intervet, I think it is pretty analogous, and there was a numerical range in that case, because in that case there was a dispute as to what PCV2. [00:20:44] Speaker 01: But the patent itself said that PCV2 was defined by 95% similarity to these five strains they had deposited with the patent office, and roughly 73% homogeneous with the previous PCV1. [00:20:59] Speaker 01: There was a numerical range in that case as to how similar the strains had to be. [00:21:05] Speaker 01: Just briefly, I also want to kind of address a general theme that I've seen come through, which is the idea behind the effect of the amendment versus the purpose behind the amendment. [00:21:16] Speaker 01: If you look at the effect of the amendment here, obviously, is to recite a particular range for T90. [00:21:23] Speaker 01: And the effect of the amendment, what actually was done, can be evidence. [00:21:26] Speaker 01: I certainly agree it can be evidence of the intent. [00:21:28] Speaker 01: But what we have to look at here is the intent, not necessarily the effect. [00:21:33] Speaker 01: Because if the effect is automatically the intent behind it, there would be no point to being able to rebut. [00:21:40] Speaker 01: the presumption of Doctrine of Equivalence, it would collapse down because if [00:21:47] Speaker 01: You know, you just look at the amendment made, you say, okay, you gave up between 900 and 1,200 per se, and you could never recapture that. [00:21:54] Speaker 01: The whole analysis would be, is there a presumption because there was an amendment? [00:21:58] Speaker 02: And then yes, but there's... Why wouldn't what's left over for equivalents be what I just discussed with your friend, something not quite 1,200 but essentially equivalent to it, like 1,150? [00:22:11] Speaker 02: or even 1,100. [00:22:13] Speaker 02: Whereas, which, you know, you specifically gave up 900 and they're at 8. [00:22:18] Speaker 02: It seems to me that that's kind of a hard line once you specifically, you know, whatever reason you gave it up for, you gave it up. [00:22:32] Speaker 01: Well, I mean, how much that [00:22:35] Speaker 01: Wiggle Room would depend on the specifics of the case, the technology. [00:22:39] Speaker 01: These are all factual issues that I think would be appropriate for a determination of whether their product is or is not equivalent. [00:22:46] Speaker 01: But as a matter of judicial, where would you draw the line? [00:22:51] Speaker 01: $1,195, $1,150, $1,100? [00:22:53] Speaker 02: Well, I would think you would at least draw the line at you tried to get a certain amount, $900, and they said no, and you went up to $12. [00:23:04] Speaker 02: And so it at least has to be anything below 900 can't be equivalence. [00:23:09] Speaker 02: And then we can talk about between 9 and 12. [00:23:13] Speaker 01: Well, I mean, so that again is, I mean, we look at subsequent amendments here. [00:23:17] Speaker 01: The original claims did not specify a D90 range. [00:23:20] Speaker 01: So we're going from nothing to 9 to 12. [00:23:23] Speaker 01: But if we look at 9 to 12, that is the ground seeded by that particular amendment. [00:23:28] Speaker 01: The law says there is a presumption of estoppel for that ground that we gave up. [00:23:33] Speaker 01: We have to be able to at least have an opportunity to rebut that presumption. [00:23:40] Speaker 01: But just simply because we went from 9 to 12 doesn't mean we automatically lose everything between 9 to 12. [00:23:46] Speaker 02: We're not talking about 9 to 12, we're talking about 8, aren't we? [00:23:52] Speaker 02: Maybe you didn't give up everything between 9 to 12 and you might have had a stronger equivalency argument there. [00:23:57] Speaker 04: Isn't it 0 to 12? [00:24:00] Speaker 01: I mean, there was nothing recited. [00:24:02] Speaker 01: It's, I guess, everything to 12 or 0 to 12, depending on how you want to think about it. [00:24:06] Speaker 01: But yes, there was certainly something to 9 to 12, correct. [00:24:11] Speaker 01: But again, that's the effect of the amendments. [00:24:13] Speaker 01: The law says we have to look at the rationale behind why those amendments were made, which is not the same thing as the effect. [00:24:22] Speaker 00: Your time has expired. [00:24:24] Speaker 00: So if you have a final thought, we'll take it. [00:24:27] Speaker 01: No. [00:24:28] Speaker 01: I rest. [00:24:29] Speaker 01: And thank you all very much. [00:24:30] Speaker 01: Thank you. [00:24:31] Speaker 01: We thank both sides in the cases.