[00:00:34] Speaker 01: Our next case is Eli Lilly versus Haspera, 2018, 21-26, and 21-27. [00:00:57] Speaker 01: Mr. LaIrela. [00:01:06] Speaker 00: Good morning, your honor. [00:01:07] Speaker 00: Did I get that right? [00:01:08] Speaker 00: You did, your honor. [00:01:09] Speaker 00: Good morning, and may it please the court. [00:01:12] Speaker 00: I'll speak first about literal infringement and come back to infringement under the doctrine of equivalence later on. [00:01:21] Speaker 00: The district court erred in finding that Haas Spiro literally infringes the 209 patents. [00:01:28] Speaker 00: It did so because it did not give the claims their plain and ordinary meaning. [00:01:36] Speaker 02: One question I have for you is, if we were to affirm the court on the doctrine of equivalence, I can't tell if there's any reason we would then need to reach this question of literal infringement. [00:01:50] Speaker 02: Am I wrong about that? [00:01:51] Speaker 02: And I guess it would probably be vice versa, that you have to overcome both of these findings to prevail. [00:01:59] Speaker 02: Am I right? [00:02:00] Speaker 00: Well, I agree that in order for me to prevail, I have to win on both points. [00:02:04] Speaker 00: I do agree with that. [00:02:05] Speaker 02: Well, but I don't see all of the same products are covered either way. [00:02:10] Speaker 02: So if I were to affirm on DOE, for example, I would never reach this literal infringement question. [00:02:16] Speaker 02: It would be not relevant. [00:02:17] Speaker 00: Well, that's true, but the reverse is also true. [00:02:20] Speaker 00: If we infringe literally, then you don't have to reach the doctrine of equivalence as to my clients. [00:02:25] Speaker 02: I just wanted to make sure that I wasn't missing anything. [00:02:28] Speaker 02: Go ahead. [00:02:28] Speaker 00: You're not. [00:02:30] Speaker 00: As I said, the district court failed to give the claims that are ordinary in plain meeting. [00:02:36] Speaker 00: There's a claim term. [00:02:38] Speaker 00: And I'm going to turn to the claim, and I invite you to do the same. [00:02:42] Speaker 00: It's on page 22 of the appendix. [00:02:48] Speaker 00: There's a claim term, administration of pemetrexid disodium, and that's the claim term where the district court went wrong. [00:02:55] Speaker 00: The claim is instructive. [00:02:58] Speaker 00: In claim 12? [00:02:59] Speaker 00: Claim 12. [00:03:00] Speaker 00: And I'm focusing on claim 12, because it's the only independent claim that Aspera was found to have infringed. [00:03:07] Speaker 03: The court said you can administer it as long as you find a relevant ratio in the solution of the sodium ions and the active ingredient. [00:03:16] Speaker 00: That is correct. [00:03:17] Speaker 00: But that's not the plain meaning of the claim. [00:03:19] Speaker 00: What the court did and where the court went wrong. [00:03:22] Speaker 03: That was not, just to double check since these two cases, yours and the next one, are related. [00:03:29] Speaker 03: That construction was not relied on in the other case. [00:03:34] Speaker 00: There's no literal infringement found in the other case. [00:03:36] Speaker 00: That's correct. [00:03:37] Speaker 03: And the DOE was based on a construction that started with the compound together. [00:03:44] Speaker 00: That is correct. [00:03:48] Speaker 00: I like to start at the claim, because the claim is a straightforward, simple claim that provides a recipe for practicing the method that's set out in the claim. [00:04:02] Speaker 01: Counsel, I want to interrupt you. [00:04:04] Speaker 01: Time is fleeting, and I want to get to the equivalence issue. [00:04:09] Speaker 00: Yes, Your Honor. [00:04:11] Speaker 01: Why isn't it fairly clear that the surrender of subject matter [00:04:17] Speaker 01: It was merely tangential to Pematrexid disodium. [00:04:27] Speaker 01: It cut back from anti-folate to Pematrexid disodium, and the particular salt was not the point. [00:04:36] Speaker 00: Well, what makes the particular salt the point, Your Honor, is that again and again and again in the remarks that the prosecuting attorney [00:04:47] Speaker 00: made to the patent examiner, the point of differentiating the prior art is always the change in terminology from antifolate to pimexifreddisodium. [00:05:06] Speaker 00: So the problem that Lilly has in providing an explanation. [00:05:11] Speaker 03: But that way of putting it is, it seems to me, sort of exactly what the several exceptions [00:05:19] Speaker 03: that the Supreme Court set out near the end of FESTO are designed to say, no, no, no, no, we are not going to say that the point of the change is everything that you chose to include in your new terminology. [00:05:33] Speaker 03: There are further inquiries. [00:05:34] Speaker 03: There's a foreseeability inquiry separately [00:05:37] Speaker 03: There is a tangential relation inquiry, and that really brings one to what Judge Lurie said, that the particular salt used was not the point or the reason for the amendment. [00:05:55] Speaker 00: But that's not quite the inquiry. [00:05:57] Speaker 00: Once the presumption arises, and Lilly agrees that the presumption arises based on the amendment that was made, [00:06:02] Speaker 00: Once the presumption of a prosecution history estoppel arises, then the burden is on Lilly to explain why, in this case, because we're only relying on the tangential exception, the burden is on them to explain why it's tangential. [00:06:16] Speaker 00: And there's another requirement, and this is the key requirement in this case. [00:06:20] Speaker 01: I think what the Supreme Court says was only tangential, or merely tangential. [00:06:24] Speaker 01: In other words, it was a side issue, assault. [00:06:28] Speaker 00: Well, that's correct, Yvonne, but my point is a different point. [00:06:30] Speaker 00: My point is it's not just an explanation, but it has to be an explanation that was objectively apparent in the contemporaneous documents in the file history. [00:06:41] Speaker 00: And this is where the parties are at odds. [00:06:43] Speaker 00: They've offered an explanation. [00:06:44] Speaker 00: The explanation is they're changing the act of loyalty from [00:06:48] Speaker 02: Metotrexate to Pematrexate, and that's their explanation, but that's not what they told... No, no, their explanation and what they told the PTO, and I'm going to quote, is to reduce the toxicity associated with the administration of Pimentrexedisodium. [00:07:04] Speaker 02: Unless I'm mistaken, and my understanding of this technology is probably not up to the par of everyone else on this panel, but [00:07:11] Speaker 02: My understanding of that is it's the pametrax that is what causes the toxicity. [00:07:15] Speaker 02: It's not the salt. [00:07:17] Speaker 02: In fact, you don't get it until it's disassociated. [00:07:20] Speaker 02: So why isn't that conveying to an ordinarily skilled artisan exactly that? [00:07:24] Speaker 02: That what I'm going after is a cure or an improvement to the toxicity caused by the pametrax itself. [00:07:33] Speaker 02: The salt's not what causes it. [00:07:35] Speaker 02: So why isn't that, since that's the actual words that they used when they made this amendment, why isn't that explaining quite clearly to the whole world that it's the metrics, not the salt, that is the reason for the change? [00:07:47] Speaker 00: Well, because I think the remarks are not consistent with that. [00:07:50] Speaker 00: The remarks that can be found in the appendix on page 429, they continue on for a few pages. [00:07:57] Speaker 00: The remarks and the explanation offered by the prosecuting attorney during prosecution are not consistent with that. [00:08:03] Speaker 00: And in fact, the change wasn't simply a change of moiety. [00:08:08] Speaker 00: The change was, instead of cutting back the scope of the claim to the moiety, the scope of the claim was cut back to a specific species of Pemintrex. [00:08:23] Speaker 00: And that species is Pemintrex adisodium. [00:08:25] Speaker 01: And again, and again, and again, in the remarks, that's- It was a species of antifolic, right? [00:08:30] Speaker 00: Yes, it's a species of anti-folate. [00:08:34] Speaker 00: So, pematrexid would be a type of anti-folate, and we're talking now about a specific species of pematrexid. [00:08:44] Speaker 00: And the remarks again and again and again focus on pematrexid disodia. [00:08:48] Speaker 00: And I'm not going to read the whole thing, but if you look at the remarks section in the appendix, you will see again and again and again [00:08:58] Speaker 00: Pematrexid disodium is not disclosed in the prior art. [00:09:02] Speaker 00: And that's why we are avoiding the prior art. [00:09:05] Speaker 00: Pematrexid disodium fixes the problem with the written description issue. [00:09:12] Speaker 00: Pematrexid disodium avoids arsenium. [00:09:16] Speaker 00: Pematrexid disodium avoids obviousness of Omori in view of John, et cetera, et cetera. [00:09:24] Speaker 00: And that is not consistent with the explanation that Lily is offering. [00:09:28] Speaker 00: to justify application of the tangential exception. [00:09:33] Speaker 02: And it's the failure to find this objectively apparent and- I'm sorry, but you seem to be avoiding all of the portions of the remarks that focus on the reason actually being the reduction of the toxicity. [00:09:48] Speaker 02: On page 7880, in response to every single rejection, in a very short paragraph, they explain that [00:09:58] Speaker 02: This is to reduce the toxicity associated with the administration of the metrexed disodium. [00:10:06] Speaker 02: So I guess I'm confused because my understanding is a skilled artisan would know that it only happens when you have a disassociated product in the solution. [00:10:23] Speaker 03: Do the counter ions have anything to do with the reduction of toxicity when it's in the body? [00:10:28] Speaker 00: No, the counter ions do not as far as I understand. [00:10:36] Speaker 00: But perhaps I'm not articulating this as well as I wish I could. [00:10:41] Speaker 00: But the point is not the science in this particular instance. [00:10:45] Speaker 00: The point is squaring up the legal justification for invoking the exception with [00:10:52] Speaker 00: Statements that were made in the record, and I can't find judge more and I apologize. [00:10:57] Speaker 00: I'm Where is this language that you've been pulling to me eight eight zero? [00:11:03] Speaker 02: In the appendix yes, different appendix. [00:11:05] Speaker 02: Oh, I'm looking at the other appendix. [00:11:07] Speaker 02: Oh, I'm looking at the appendix in the other case. [00:11:09] Speaker 00: I'm Gee whiz I don't have that length. [00:11:13] Speaker 00: I can't find it right now. [00:11:14] Speaker ?: I [00:11:14] Speaker 02: I'm so sorry all right, would you say it again your honor seven eight eight zero? [00:11:29] Speaker 00: All right, so I'm on appendix 430, and it's this language that you're looking at [00:11:37] Speaker 02: Which appendix 430? [00:11:39] Speaker 00: Well, I'm sorry, our appendix 430. [00:11:42] Speaker 00: I didn't bring Mr. Aucoin's with me. [00:11:44] Speaker 00: At least not to the podium. [00:11:46] Speaker 02: That seems like a reasonable choice. [00:11:54] Speaker 01: The point is the anions make no difference to the toxicity. [00:11:59] Speaker 00: I agree that the anions make no difference to the toxicity. [00:12:03] Speaker 00: And so it's curious that the anions are so prominently referred to, the disodium is so prominently referred to again. [00:12:10] Speaker 00: In fact, I can't find, at least in what I'm looking at, I can't find an example of where pemotrexate is referred to not in any form except the disodium form in all the remarks that were submitted. [00:12:24] Speaker 00: Every single time, as far as I can tell, every single time, Pematrexid is referenced. [00:12:31] Speaker 00: It's always referenced in the form of disodium. [00:12:34] Speaker 00: And that's not explained. [00:12:35] Speaker 00: And that's not consistent with the explanation that's being offered to invoke the exception. [00:12:43] Speaker 02: And if it's not objectively apparent, and I still haven't found the language that Judge Moore thinks makes it objectively apparent, but I'm finding all this other language that... Page 4, page 430 of your appendix, in every single paragraph it talks about the purpose of the amendment being to reduce the toxicity. [00:13:00] Speaker 00: Oh, I see what Your Honor is saying. [00:13:01] Speaker 00: But it's saying that it's Pematrexidysodium that does that. [00:13:04] Speaker 02: Yes, but a skilled artisan knows it's the Pematrexid. [00:13:08] Speaker 02: It's not the Dysodium. [00:13:09] Speaker 02: So you're right. [00:13:10] Speaker 02: A skilled artisan would read that and say it's the disassociated form in which it's going to reduce the toxicity. [00:13:15] Speaker 00: But a skilled artisan would also read this prosecution and understand that [00:13:21] Speaker 00: that pemetrexid disodium does not include pemetrexiditromethamine, for example, and would understand that prosecution history estoppel would prevent Lilly from making this kind of distinction, making these sorts of arguments, and then later on arguing equivalence. [00:13:39] Speaker 00: against trimethamine, which was clearly not part of what the prosecution history of Staple would forfeit. [00:13:53] Speaker 00: And there isn't anything that would allow someone to understand that they could engineer a round in the way that Haspera believed it had engineered a round by going to a product assault [00:14:07] Speaker 00: form of ditromethamine. [00:14:09] Speaker 03: Can I ask you one quick question, and it may have a simple no answer. [00:14:13] Speaker 03: Do you happen to know from what source, whether it's an amicus brief or a prior precedent, the Supreme Court might have taken the tangential relation point in the FESTO paragraph? [00:14:26] Speaker 03: I couldn't find it. [00:14:29] Speaker 00: I'm not aware of a case that does that. [00:14:30] Speaker 00: And there are only a few cases from this court that have done that. [00:14:35] Speaker 00: It is not litigated very often, as far as I can tell. [00:14:38] Speaker 00: And I should say by suppose the time I have left for rebuttal. [00:14:41] Speaker 01: We will save you two minutes. [00:14:43] Speaker 01: Thank you. [00:14:44] Speaker 01: Mr. Perlman. [00:14:52] Speaker 04: Good morning, Your Honor. [00:14:53] Speaker 04: May it please the court? [00:14:55] Speaker 04: I think I'll start with the doctrine of equivalence issue. [00:14:57] Speaker 04: That seems to be the focus. [00:14:59] Speaker 01: I'd like you to talk about the literal infringement. [00:15:02] Speaker 04: All right. [00:15:03] Speaker 01: Claim 12 recites pametrexadisodium four times. [00:15:10] Speaker 01: And why is it not clear that using another salt does not literally infringe that claim? [00:15:22] Speaker 04: And there are two direct answers to that question, Your Honor. [00:15:26] Speaker 04: The first is the undisputed point that the claim covers the intravenous infusion of pemotrexid disodium in solution. [00:15:35] Speaker 04: And two, the unrebutted expert testimony that was before the district court [00:15:40] Speaker 04: that we have it from our oncologist, and also from our pharmaceutical formulation slash chemist expert, that said that in this art, the ordinary meaning of a solution of Pematrexid disodium, which is covered by the claim, would include disassociated Pematrexid insodium. [00:15:57] Speaker 01: We're talking about administration of Pematrexid disodium. [00:16:01] Speaker 01: Correct. [00:16:01] Speaker 01: Which sounds like a specific compound. [00:16:04] Speaker 01: That's aside from what it might turn into in solution. [00:16:10] Speaker 01: as a cation with a bunch of anion with a bunch of sodium ions. [00:16:18] Speaker 04: Well, so that would certainly be covered by the claim. [00:16:21] Speaker 04: And the point that I am making is, in its ordinary usage in this field, the phrase, Pematrexid disodium, in the context of an administration phrase, is not so limited. [00:16:31] Speaker 04: We put in expert testimony as to the ordinary usage in the field, which the district court relied upon. [00:16:37] Speaker 04: Haspira had the opportunity to say, no, no, it's clear as day that that's wrong. [00:16:41] Speaker 04: And here's our expert. [00:16:42] Speaker 04: Here's our reference book. [00:16:43] Speaker 04: Here's our anything that says that's wrong. [00:16:46] Speaker 04: They didn't do any of that. [00:16:48] Speaker 02: I don't think that this is a sort of unusual... Is it your view that if the claim says administration of Pematrex at disodium, [00:17:01] Speaker 02: that if the solution that's administered is not disodium, but trisodium, or quadsodium, or set sodium, whatever other sodium it can be, that it's automatically covered? [00:17:12] Speaker 02: Yes, because when disassociated, there's at least two sodium items for every one Pematrex set. [00:17:19] Speaker 02: I don't know if I'm saying this right. [00:17:21] Speaker 04: But you understand my point. [00:17:22] Speaker 04: I understand exactly your point. [00:17:23] Speaker 04: And Dr. Chavner and Dr. Prenant both addressed this point directly in unrebutted expert testimony. [00:17:28] Speaker 04: And they said that, [00:17:30] Speaker 04: And look, we're the first to acknowledge this phrase is used in somewhat a colloquial or informal fashion in the field, but that's not unusual. [00:17:38] Speaker 03: When they gave that testimony, did they point to any writings so using it or just their usage in their memory? [00:17:45] Speaker 04: They pointed to their own experience and usage in the field. [00:17:49] Speaker 03: So the answer is no. [00:17:50] Speaker 03: Correct. [00:17:50] Speaker 03: They didn't point to anything. [00:17:51] Speaker 04: They pointed to, I mean, they give general background about acids and bases and salt, but yes. [00:17:57] Speaker 04: That's a fair point. [00:17:58] Speaker 04: And if there were contrary references, you would expect how spiritorial put them in. [00:18:01] Speaker 01: I want to get back to... Let's be clear. [00:18:03] Speaker 01: What we're talking about when we're talking about literal infringement is whether administration of hematrexid ditromethylamine, that particular salt, literally impinges a claim reciting hematrexid disodium. [00:18:22] Speaker 04: I understand that point. [00:18:23] Speaker 04: And the answer is that [00:18:25] Speaker 04: The unrevoted expert testimony is that the usage in the field is when that is dissolved in saline, it would be considered administration of Pematrexed disodium. [00:18:33] Speaker 04: Now, there's no legal rule that says a solution can be labeled one thing and one thing only. [00:18:39] Speaker 04: If you want to call it a solution of Pematrexed ditromethamine, that's not inconsistent with it also being a solution of Pematrexed disodium as used in this patent claim. [00:18:47] Speaker 02: Would you go back to my question now? [00:18:49] Speaker 04: I was attempting to get back to answering it. [00:18:52] Speaker 04: Pematrexed has a negative 2 charge. [00:18:54] Speaker 04: This is true when you start with solid Pematrexate disodium and dissolve it in saline, or you start with something else and dissolve it in saline. [00:19:02] Speaker 04: Pematrexate has a negative two charge when dissolved. [00:19:04] Speaker 04: And the testimony from Dr. Pinal, which is unrebutted, is that means it takes two positive charges to balance that Pematrexate. [00:19:12] Speaker 04: And so when scientists think about [00:19:14] Speaker 04: What you would call this relationship between the Pematrexid and the sodium, they would say that is Pematrexid disodium because there are two positive charges to balance the two negative charges of the molecule. [00:19:26] Speaker 04: That is unrebutted in the record as to the usage in the field. [00:19:30] Speaker 04: Olymptah, which starts as the solid salt, is dissolved in saline and is administered to the patient. [00:19:36] Speaker 04: And there is a vast excess of sodium because it's dissolved in saline. [00:19:40] Speaker 04: And it's common ground that that is covered by the claim. [00:19:44] Speaker 01: You wanted to start out on equivalence. [00:19:46] Speaker 01: Why don't you head for equivalence? [00:19:47] Speaker 04: I happily head for equivalence. [00:19:49] Speaker 04: And I think that much of what I have to say, the court has already said, but let me sort of hit the highlights. [00:19:56] Speaker 03: Do you happen to know [00:20:00] Speaker 03: where this tangential relation phrase in Festo might have come from? [00:20:03] Speaker 03: I do not. [00:20:05] Speaker 04: I don't have any basis to say that the justices of the Supreme Court didn't come up with it on their own. [00:20:11] Speaker 04: I simply don't know. [00:20:13] Speaker 04: So the issue before, what you heard essentially is we said Pematrix and disodium lots of times in the amendment, which is of course true because that was the claim language that we inserted and in the tangentiality case [00:20:27] Speaker 04: The patentee always inserts claim language that narrows the claim and excludes the accused equivalent. [00:20:34] Speaker 04: But that's not the inquiry under the tangentiality exception. [00:20:36] Speaker 04: The question is, what is the reason that the claim was narrowed? [00:20:40] Speaker 04: Here, the file history shows that the reason it was narrowed is because of the rejection over the Arsenian reference, which disclosed methotrexate, which is a different antifolate. [00:20:50] Speaker 04: We narrowed down to specify that [00:20:53] Speaker 04: We were not covering all active antifolates. [00:20:56] Speaker 04: We were covering pametrexate as the active antifolate, and we claimed it in the disodium form. [00:21:02] Speaker 04: There are two facts in the intrinsic record that demonstrate that the designation of the salt is tangential to that amendment. [00:21:10] Speaker 04: The first is what Judge Moore pointed out. [00:21:12] Speaker 04: The discussion of the purpose of this invention is to reduce the toxicity of pametrexate disodium. [00:21:18] Speaker 04: And every skilled artisan knows and knew, and it's undisputed, [00:21:22] Speaker 04: Pematrexid disodium has no toxicity. [00:21:26] Speaker 04: When the sodium and the Pematrexid are bonded together, they don't do anything. [00:21:29] Speaker 04: They don't bond to an enzyme. [00:21:30] Speaker 04: They don't cause any toxicity. [00:21:32] Speaker 04: It is the Pematrexid itself in dissociated form that causes the toxicity. [00:21:37] Speaker 04: The second point, and this gets lost a little bit, the specification in column four defines what it means by an antifolate. [00:21:45] Speaker 04: And the definition that it gives is [00:21:47] Speaker 04: the compound that interacts with the folate-requiring enzymes and has various effects. [00:21:54] Speaker 04: That is pematrexate. [00:21:56] Speaker 04: That would be understood in the art to be pematrexate. [00:22:00] Speaker 04: If you didn't have that in specification, the analysis would be the same, but combined with the reference itself that was the rejection, the discussion of the toxicity, and the definition of antifolate, the district court was correct in holding that the reason for the amendment [00:22:16] Speaker 04: was tangential to the claimed equivalent. [00:22:18] Speaker 03: Is extra analysis required for the amendment to claim five, for which that particular piece of prior art, if I'm remembering right, doesn't appear in your explanation? [00:22:31] Speaker 04: I don't think there is any extra analysis required, because I think you can't look at claim five with blinders on, which is what I think Hussbeer is asking you to do. [00:22:41] Speaker 04: The same phrase, antifolate, was narrowed to the same phrase, pametraxid disodium, [00:22:46] Speaker 04: at the same time, in all the claims, when Lilly responded to the rejection over Arsenian. [00:22:52] Speaker 04: That, as the district court found, from the face of the file history, the Arsenian issue is the reason for the amendment. [00:22:59] Speaker 04: And if you ask yourself, well, how do we know there isn't some different reason for claim five, one of the references in claim five discloses pematrixid disodium. [00:23:07] Speaker 04: So amending to pemotrexid disodium couldn't be to address that set of rejections. [00:23:13] Speaker 04: The other point I'll point out is if you look in the file history at the page that Judge Moore was talking about. [00:23:18] Speaker 03: And which is the reference? [00:23:19] Speaker 03: There's one that begins with- John is the one that- John and not the- Omori is the vitamin. [00:23:23] Speaker 04: John is the pemotrexid disodium. [00:23:26] Speaker 04: If you look at the page discussing the response to the anticipation rejection, [00:23:33] Speaker 04: Lilly argues that in light of the amendments, the claims are not anticipated. [00:23:37] Speaker 04: When it comes to obvious, Lilly doesn't rely on the claim amendments to respond to any of those rejections. [00:23:42] Speaker 04: It argues the merits of the references about whether you would expect to reduce toxicity, which is further confirmation that the amendment was due to what, of course, it was due to, the Arsenian rejection under 102. [00:23:56] Speaker 04: The final thing I will say here is the patent makes clear that the issue is the active anti-folate. [00:24:04] Speaker 04: The discussion of toxicity in the file history makes clear that the issue is the active anti-folate. [00:24:10] Speaker 04: And the real world that we're all living in makes clear that the issue is the active anti-folate. [00:24:14] Speaker 04: The only reason we're here is because Haspera and DRL are using Lilly's clinical data and Lilly's clinical trials with Pematrexid disodium [00:24:23] Speaker 04: to say that different salts of Pematrexed will be the same thing when you sell them to treat cancer. [00:24:29] Speaker 01: Do they have a paper NDA, not an ANDA? [00:24:32] Speaker 01: Paper NDA. [00:24:33] Speaker 04: Paper NDA. [00:24:34] Speaker 02: Yes. [00:24:35] Speaker 02: You suggested that the amendment was only mentioned with regard to anticipation and Yersinian reference. [00:24:44] Speaker 02: Respectfully, that's not correct. [00:24:46] Speaker 02: It's mentioned with regard to obviousness on 47880. [00:24:51] Speaker 02: That's when you again say the combination would reduce the toxicity associated with the administration from the Tetrix disodium. [00:25:01] Speaker 02: You use the exact same language between both. [00:25:04] Speaker 02: I apologize. [00:25:04] Speaker 04: I'm in the different appendix. [00:25:06] Speaker 02: It's the same page. [00:25:07] Speaker 02: It's the same page. [00:25:08] Speaker 02: 430 or whatever. [00:25:09] Speaker 04: So show me on the page where. [00:25:12] Speaker 04: Alone or in combination with John? [00:25:15] Speaker 04: Suggests or motive? [00:25:16] Speaker 04: I'm not seeing. [00:25:17] Speaker 02: part that you're reading. [00:25:18] Speaker 04: Oh, clearly we recite the phrase Pematrexadisodium. [00:25:23] Speaker 02: I didn't mean to... No, you recite the phrase, reducing the toxicity associated with Pematrexadisodium, and that is the exact same language you contain, that you have in the prior, in the explanation with regard to the 102 record. [00:25:35] Speaker 04: That is 100% correct, and that's not what I was intending, that's not what I was suggesting. [00:25:39] Speaker 02: If you want me to look at that language for anticipation and credit it, then the same [00:25:44] Speaker 02: applies for the obvious. [00:25:45] Speaker 04: I think I was not articulating my point well enough, Your Honor, so I appreciate the chance to clarify it. [00:25:50] Speaker 04: All of the rejections discuss the toxicity associated with hematrexit disodium, and the skilled artisan would know that that's about hematrexit itself. [00:25:58] Speaker 04: The language I was talking about was in the second to last line of the anticipation rejection, where it says, in view of the present amendments and the comments above, [00:26:06] Speaker 04: applicants respectfully request withdrawal of this rejection. [00:26:10] Speaker 04: And there is no such reliance of, in view of the amendments, we now believe we are patentable in the obviousness rejection. [00:26:16] Speaker 04: That's the only point I was making. [00:26:18] Speaker 04: I was not making it. [00:26:19] Speaker 02: I don't understand, because the amendment itself is to add the word, pemetritic disodium, and you refer to the word in the obviousness rejection. [00:26:28] Speaker 02: So the fact that you don't call it the amendment, instead just use the name of the word that you amended with. [00:26:33] Speaker 04: It's not a critical point, Your Honor. [00:26:34] Speaker 04: I take your point. [00:26:36] Speaker 04: I think I'm making a slightly different one. [00:26:38] Speaker 04: But I take your point that even if we are relying on Pematrexid disodium in the obviousness section, the association of the vitamins to reduce the toxicity of Pematrexid disodium is related to Pematrexid itself. [00:26:51] Speaker 04: It's the same rationale. [00:26:52] Speaker 02: My clerk just clarified it for me. [00:26:54] Speaker 02: He did a better job than you did. [00:26:55] Speaker 02: The obvious rejection is different. [00:26:57] Speaker 02: The prior art disclosed Pematrexid disodium. [00:26:59] Speaker 02: That's why they referred to it. [00:27:00] Speaker 02: That might have been a better answer. [00:27:03] Speaker 04: Well, I appreciate that, Your Honor. [00:27:06] Speaker 04: If I could get a screen, I could probably do it faster. [00:27:09] Speaker 02: Well, especially if you had my clerk feeding you the answers. [00:27:12] Speaker 04: I'm happy to take all of the assistance that the court would allow. [00:27:18] Speaker 04: If there are no other questions, I'll reserve. [00:27:21] Speaker 04: And if I don't reserve, I'll be done. [00:27:22] Speaker 01: You won't reserve? [00:27:23] Speaker 04: I won't reserve, but I'll see you again shortly. [00:27:25] Speaker 01: Thank you, Mr. Perlman. [00:27:28] Speaker 01: Mr. Laierle has two minutes for rebuttal. [00:27:31] Speaker 00: Thank you, Your Honor. [00:27:33] Speaker 00: If I may, let me go back to literal infringement. [00:27:36] Speaker 00: Where I think the district court went wrong is in failing to give the claim term its ordinary meaning. [00:27:43] Speaker 00: And that led it to read into the claim term a lot of information and a lot of what turned out to be what I believe argument concerning. [00:27:58] Speaker 00: Well, let me say it this way. [00:28:01] Speaker 00: The claim term has a plain meaning. [00:28:03] Speaker 00: And the plain meaning is to dispense or apply Pematrexid disodium to a patient. [00:28:09] Speaker 00: That's all it means. [00:28:11] Speaker 00: The claim term is neutral with respect to, in fact, the entire claim, claim 12 is a good one to look at, is neutral with respect to route of administration. [00:28:20] Speaker 00: It mentions, for example, vitamin B. We know from reading the patent, vitamin B can be injected through an intermuscular injection. [00:28:29] Speaker 00: It mentions folic acid. [00:28:31] Speaker 00: We know from reading the patent that folic acid can be administered orally. [00:28:35] Speaker 00: And then it mentions pemotrexid disodium. [00:28:39] Speaker 00: It doesn't mention any particular route of administration. [00:28:42] Speaker 00: The claim is neutral. [00:28:43] Speaker 00: It uses the word administration neutrally in discussing, in avoiding any discussion of route of administration. [00:28:54] Speaker 00: So what the claim term means, [00:28:56] Speaker 00: is giving, and it's as simple as this, it means giving a patient pemetrexid disodium. [00:29:03] Speaker 00: Full stop. [00:29:04] Speaker 00: That's what it means. [00:29:05] Speaker 00: And so if that's what the claims mean, and I believe that is the correct meaning, if that's what the claims mean, then hospira does not infringe. [00:29:14] Speaker 00: Because hospira never gives anyone pemetrexid disodium. [00:29:18] Speaker 00: Disodium never exists if you use the pemetrexid product. [00:29:25] Speaker 00: There's a very simple response on the infringement question in view of the misconstruction of that particular claim term. [00:29:38] Speaker 00: I think I've used up all my time. [00:29:39] Speaker 00: I won't respond further on the doctrine of equivalence. [00:29:42] Speaker 00: I expect the speaker to come. [00:29:45] Speaker 00: We'll cover that. [00:29:46] Speaker 00: very thoroughly and trust the court with the question. [00:29:51] Speaker 00: Thank you very much. [00:29:52] Speaker 01: Thank you, counsel. [00:29:54] Speaker 01: We will take that case under advisement.