[00:00:06] Speaker 01: We have a full morning of arguments before the court this morning. [00:00:12] Speaker 01: We have four cases that are documented for argument. [00:00:18] Speaker 01: First case is Philgenics, Inc. [00:00:20] Speaker 01: versus Genitech, Inc. [00:00:24] Speaker 01: Mr. Thompson, you reserved four minutes of your time for rebuttal, correct? [00:00:28] Speaker 00: Yes, Your Honor. [00:00:29] Speaker 01: And Ms. [00:00:31] Speaker 01: Maynard, you reserve three minutes of 15 minutes, three minutes for the cross appeal? [00:00:38] Speaker 01: Yes, Your Honor, thank you. [00:00:39] Speaker 01: OK. [00:00:40] Speaker 01: You may proceed. [00:00:45] Speaker 00: May it please the court. [00:00:47] Speaker 00: Good morning. [00:00:47] Speaker 00: Ben Thompson from Fish and Richardson for Phigenics. [00:00:52] Speaker 00: Phigenics' appeal concerns two summary judgment grounds. [00:00:55] Speaker 00: The below court entered adverse to Phigenics. [00:00:58] Speaker 00: I'd like to begin with the court's judgment stemming from its decision to strike Phigenix's expert's infringement report. [00:01:06] Speaker 00: Now, Phigenix's expert's opinion, it was not a new theory. [00:01:10] Speaker 00: At most, it was a subset or targeting a subset of the theories plainly disclosed in Phigenix's infringement contentions. [00:01:21] Speaker 00: The infringement contentions expressly accused catcilla usage in patients that had been pretreated with two chemotherapy agents, Trasumasab, let me try that again, Trastuzumab and Taxane. [00:01:36] Speaker 00: The experts infringement theory accused the same treatment, treatment with catcilla following pretreatment with these two other chemotherapy agents. [00:01:45] Speaker 04: Why is it that you narrowed your infringement contentions? [00:01:50] Speaker 00: So my firm was not involved at that specific time in this case. [00:01:54] Speaker 00: We came along after the infringement contentions, sorry, after the motions for summary judgment were ordered. [00:02:00] Speaker 00: It was Phigenix's position that there was no narrowing. [00:02:03] Speaker 00: The theory the whole time was [00:02:05] Speaker 00: administration of cadzilla following treatment with trace is a map and a taxane is the infringement and That's what the that's what the infringement contention say they don't mention other compounds Granted the infringement contention is didn't say and nothing else they also did not say at least trace is a map in a taxane What is the percentage of patient population? [00:02:27] Speaker 04: That would receive [00:02:31] Speaker 04: the drug with just those two other drugs, I think I read somewhere, I'm not expressing myself well, but I think I read somewhere that the narrowed, if you don't mind me using that phrase, but the narrower infringement contentions would only cover 4% of the people who take this medication. [00:02:48] Speaker 04: Is that an accurate statement? [00:02:51] Speaker 00: I believe that was the prognostication that Phigenics is expert made based on the data before them. [00:02:59] Speaker 00: Yes, it would be a small percentage. [00:03:02] Speaker 00: However, we're willing to adopt the assumption that phigenics as expert was proceeding on a narrower subset. [00:03:09] Speaker 01: Are you arguing that adding the limitation and nothing else, that that's not, that did not develop a new theory of infringement? [00:03:15] Speaker 00: We're willing to assume that it is a narrower theory than what was disclosed in the infringement contentions. [00:03:19] Speaker 00: And even adopting that assumption that Phigenix's expert was pursuing this narrower theory against a subclass of the patients that would be encompassed by Phigenix's infringement contentions, the district court nevertheless abused this discretion. [00:03:32] Speaker 00: And I'll tell you why. [00:03:34] Speaker 00: The district court found that disclosing the broader contention of administering cadcilla to all patients meeting the criteria required by the cadcilla label, meaning at least trace through the map in a taxane before cadcilla, does not adequately disclose a narrower theory of administering cadcilla to a specific subpopulation of patients. [00:03:54] Speaker 00: But we believe that's factually inaccurate. [00:03:56] Speaker 00: By definition, if I say in my infringement contentions, I'm accusing A, B, C, and D, these classes of patients, and my expert proceeds only on subclass of patients A, nevertheless, the defendant was on notice of that theory. [00:04:10] Speaker 04: You think that it's sufficient that the subclass was identified every time? [00:04:16] Speaker 04: I mean, in every infringement contentions, it doesn't matter so long as at least some [00:04:21] Speaker 04: subclasses identified, even if it's 96% and then only 4% are the ones that are actually accused of infringement? [00:04:29] Speaker 00: I'm not willing, in case I have to come back here later and argue something different, I'm not willing to say every time. [00:04:34] Speaker 00: But in this case, we can't forget that the infringement contention specifically said, Pax 2 is inhibited when you give cadcilla following pretreatment with trisuzumab and ataxane. [00:04:44] Speaker 00: It wasn't this hidden subclass that was not articulating the infringement contentions. [00:04:48] Speaker 00: It was the only combination of drugs [00:04:50] Speaker 00: that was specifically identified in the infringement contentions. [00:04:55] Speaker 01: Despite the degree of narrowness that we're talking about here, it is the addition of a new limitation, and that limitation was not included in the infringement contentions. [00:05:07] Speaker 00: I respectfully disagree. [00:05:10] Speaker 00: The infringement contentions say what they say. [00:05:14] Speaker 00: It's Catzilla following pre-treatment with Tracetuzumab in a taxi. [00:05:17] Speaker 01: It doesn't say anything else. [00:05:19] Speaker 00: Correct, but even if they could be read to include that broader subclass, again, there's no real prejudice to Genentech when they're on notice that Phigenics' infringement contentions are also targeting the infringing subclass. [00:05:32] Speaker 02: It's a negative limitation, really, is what it is, right? [00:05:35] Speaker 00: Correct, but if I'm in Genentech's shoes and I know that there's this broader class of patients who are accused of infringement, [00:05:41] Speaker 00: I have to develop infringement theories for all of the various subclasses. [00:05:45] Speaker 00: This is not the same as a new infringement theory where you're ambushing someone late in litigation with new infringement theories that they were not aware of. [00:05:53] Speaker 00: And what made this error worse is when the court applies case law directed only to new infringement theories, not narrower theories. [00:06:03] Speaker 00: And there's no dispute that the court relied only on case law concerning new theories. [00:06:08] Speaker 00: The district court, not the district court and not Genentech, has anyone identified a case where a district court properly struck an infringement theory for being narrower than what was in the infringement contingency? [00:06:21] Speaker 01: It was struck because of the prejudice that it caused to the defendant. [00:06:25] Speaker 01: This is after the fact discovery had closed. [00:06:28] Speaker 01: I believe Genentech had even conducted some experimentation to prove its case. [00:06:34] Speaker 01: And all of that kind of went into the wastebasket, didn't it? [00:06:37] Speaker 00: It did not. [00:06:38] Speaker 00: If Genentech was conducting experiments to disprove infringement, it should have conducted experiments to disprove infringement with respect to the entire class of patients accused in the infringement contingents. [00:06:48] Speaker 00: If it didn't do that, that was Genentech's mistake. [00:06:51] Speaker 04: What about the abuse of discretion standard that we have to apply? [00:06:57] Speaker 04: How do you see that the district court abused its discretion? [00:07:01] Speaker 04: It's obviously a very deferential standard. [00:07:04] Speaker 00: Yes, it is, Your Honor. [00:07:06] Speaker 00: First, reaching the factual mistake that the broader contentions don't disclose the narrower contention. [00:07:14] Speaker 00: That was an error that led the court to apply an apposite case law. [00:07:18] Speaker 00: And given the time I have, I'd like to shift over to the inducement issue, if I may quickly. [00:07:24] Speaker 00: The district court also found that there was not sufficient evidence of Genentech's intent to prescribe Casilla to this subset of patients. [00:07:36] Speaker 00: The Catzilla label plainly indicates it should be administered to patients pre-treated with trastuzumab and ataxane, and that is the specific combination that is accused in this case. [00:07:47] Speaker 00: Further, Genentech admitted that it expects Catzilla to be administered in accordance with these instructions. [00:07:53] Speaker 00: That was in response to an RFA at appendix 729. [00:07:57] Speaker 00: The district court even found that the Catzilla label instructs physicians to administer Catzilla to all patients that have previously received Trastuzumab and Ataxane. [00:08:07] Speaker 00: That's in the district court's opinion at Appendix 12. [00:08:11] Speaker 00: Given the express instructions on the Catzilla label, [00:08:14] Speaker 00: In combination with Genentech's admission that it's encouraging Catsilla's administration in accordance with that label, those two things alone should have provided sufficient circumstantial evidence on the intent element of inducement to get past summary judgment. [00:08:30] Speaker 00: Now, where things went awry here is the court looked past the instructions on the Catsilla label and proceeded to apply case law concerning off-label administration or off-label prescription of drugs. [00:08:44] Speaker 00: And although the court said that's a distinction without a difference, that's not actually true. [00:08:50] Speaker 00: In these on-label cases, such as the Sanofi case, you can infer the drugmaker's intent purely by the instructions on the label. [00:08:58] Speaker 00: And that's where we are here. [00:08:59] Speaker 00: The Catzilla label, and we can look at it, it's in Appendix 2252, specifically says, here's Catzilla. [00:09:07] Speaker 00: You should give it to patients that have been previously treated with Tracism Avanitaxine. [00:09:12] Speaker 00: That's the infringement theory. [00:09:13] Speaker 00: That's what the label says you should do. [00:09:15] Speaker 04: Do you think the Sanofi case makes it so the district court erred in relying on the substantial non-infringing uses? [00:09:25] Speaker 00: Exactly, Your Honor. [00:09:26] Speaker 00: Because in off-label cases where you don't have a label that specifically instructs infringement, you start to look other places to try and infer the drugmaker's intent, because you don't have the label to point to. [00:09:38] Speaker 00: And in that situation, like Judge Freeman did at the district court, [00:09:43] Speaker 00: She looked at the prevalence of the drugs used in this specific infringing scenario and other factors that were not appropriate to look at when you're in a situation in an on-label case. [00:09:58] Speaker 00: And Sanofi actually says that. [00:10:00] Speaker 00: Says, well, even if there are substantial non-infringing uses or there's a low prevalence of the specific infringing subclass, that's immaterial when the intent can be inferred from the drug label itself. [00:10:16] Speaker 00: Now Genentech's response to the Sanofi case is that the Sanofi case is not applicable because that case involved instructions sorry that case involved instructions that were encompassed the infringing use. [00:10:32] Speaker 00: I have to disagree with Genentech where it says there's a complete absence of any language encouraging Cattzilla's use among the infringing class that's in Genentech's brief that there is a complete absence of any language encouraging Cattzilla's use among the infringing class. [00:10:46] Speaker 00: The Catcilla label itself specifically encourages the infringing use among the subclass. [00:10:53] Speaker 00: It says, give Catcilla after pretreatment with Trasuzumab and ataxine. [00:10:59] Speaker 00: That was more than enough circumstantial evidence to find intent to get beyond summary judgment in this case. [00:11:08] Speaker 00: I'll reserve the rest of my time for a bottle. [00:11:11] Speaker 01: Thank you. [00:11:17] Speaker 01: Counselor Maynard. [00:11:21] Speaker 03: Good morning, Your Honors, and may it please the court. [00:11:23] Speaker 03: Deanne Maynard on behalf of Genentech. [00:11:25] Speaker 03: The district court acted well within its broad discretion in striking Figenitz's late-disclosed theory here, and that's all the court would need to decide to affirm this case. [00:11:34] Speaker 03: The district court also correctly granted summary judgment of non-infringement. [00:11:38] Speaker 03: And on top of that, this patent does nothing but express a plan and a hope [00:11:43] Speaker 03: Look for something that might work with breast conditions, and it's therefore invalid for three different reasons. [00:11:48] Speaker 02: That's your cross-appeal. [00:11:49] Speaker 02: That's our cross-appealing I Don't know whether it's appropriate to deal with the cross-appeal now or whether we should wait into this way But I do have a question for you on the cross-appeal, so okay. [00:12:02] Speaker 03: Thank you just right so I'd like to start with the the striking of the expert because obviously it gets a a [00:12:08] Speaker 03: very deferential standard of review from this court, which defers to a district court's both application and understanding of their local rules and their understanding of what was going on in their courtroom. [00:12:18] Speaker 03: This district court had presided over this case for several years. [00:12:22] Speaker 03: At the time she struck this expert, she'd heard a tutorial, a claim construction hearing. [00:12:26] Speaker 03: She'd heard argument on rule 11. [00:12:28] Speaker 03: She'd heard argument on two summary judgment motions. [00:12:31] Speaker 03: And she recognized that this was a marked change in the infringement theory. [00:12:35] Speaker 03: and correctly so, and that it would prejudice us. [00:12:39] Speaker 03: And I can explain how. [00:12:40] Speaker 03: Where is the prejudice? [00:12:42] Speaker 03: The prejudice, it's both in invalidity and infringement, Judge Stoll. [00:12:46] Speaker 03: So this was before the infringement contentions basically were based on the Catz-Isla label. [00:12:53] Speaker 03: If you're taking in accordance with the Catz-Isla label, then somehow that triggers [00:12:58] Speaker 03: this inference upon inference upon inference that infringes these patent claims. [00:13:03] Speaker 03: And throughout the litigation, pre-suit, to complaint, rule 11, motion, everything, Genentech's position had been, if your theory is right, if giving cadcyla to patients according to the label, i.e. [00:13:16] Speaker 03: those who have had trastusumab in a taxing before they get cadcyla, triggers this inference upon inference upon inference that is your infringement theory, then Genentech's own clinical trials [00:13:27] Speaker 03: anticipate your patent claim, inherent anticipation, what infringes now, anticipates before. [00:13:35] Speaker 03: And that was Genentech's constant refrain. [00:13:39] Speaker 03: And the district court was aware of that. [00:13:41] Speaker 03: Our expert in infringement contentions, our expert on invalidity in his report, relies on their infringement contentions. [00:13:49] Speaker 03: At page A190, Spressley says, I'm assuming your infringement contention theory. [00:13:54] Speaker 03: At A192, our expert lays out, [00:13:57] Speaker 03: a comparison between the, there's a chart at the bottom of A192 that lays out, that compares what Genentech studied versus, and the label, versus their infringement contingent. [00:14:23] Speaker 03: And so the district court found [00:14:26] Speaker 03: that only after the court rejected their priority date claim to 2005 did they change their theory. [00:14:35] Speaker 03: And that debunks any notion they didn't change their theory. [00:14:37] Speaker 03: They did change their theory. [00:14:38] Speaker 04: It's about three months between the time that the court issued its order on the priority date and the time that the expert made their position clear in a deposition. [00:14:49] Speaker 03: She issued her opinion on February 24 of 2017. [00:14:53] Speaker 03: The expert announced we found out about the change theory in the expert's deposition on May 31, 2017. [00:14:59] Speaker 03: That was after the close of fact discovery, after export reports and rebuttal reports had been exchanged, and in the midst of expert depositions. [00:15:07] Speaker 03: And the district court found that that was the cause and effect, that they didn't tell anybody either. [00:15:12] Speaker 03: So they didn't comply with the local rules in trying to change it. [00:15:15] Speaker 03: And they knew how to comply with the local rules, because previously in the case, they had moved to amend their infringement contingents after they did testing. [00:15:24] Speaker 02: I think there's a distinction between narrowing your theory of infringement and adding a negative limitation. [00:15:34] Speaker 02: Or is that, do you think, just a semantic distinction? [00:15:36] Speaker 03: No. [00:15:36] Speaker 03: I think it's critical. [00:15:37] Speaker 03: And it's what matters here. [00:15:40] Speaker 03: And so to the infringement theory, what they did here was add a negative limitation. [00:15:45] Speaker 03: And the upshot of that was, before it had been, the entire cat sila population infringes when you give cat sila according to the label. [00:15:53] Speaker 03: Now, it's affirmatively at least 95% of the patient population does not infringe. [00:16:00] Speaker 03: And this supposed subpopulation, which at best is less than 5% if it exists at all, is the infringing population. [00:16:08] Speaker 03: Now, Genentech does need to do different studies and different tests. [00:16:12] Speaker 03: And we need to do discovery from them. [00:16:14] Speaker 03: Why now do you think? [00:16:15] Speaker 03: What's different? [00:16:16] Speaker 03: What's different about a patient who only receives Trastusumab and Ataxine and nothing else? [00:16:21] Speaker 03: that makes them infringing when you don't think a patient who has received other chemotherapy agents infringes. [00:16:29] Speaker 03: We need to know from them why that's different. [00:16:32] Speaker 03: And now the 95% is effectively a control group, right? [00:16:35] Speaker 03: They say it doesn't infringe. [00:16:36] Speaker 03: We would need to test that. [00:16:37] Speaker 03: And we had no reason. [00:16:38] Speaker 03: So he says we should have tested the whole. [00:16:40] Speaker 03: We had no reason to test any subpopulation. [00:16:41] Speaker 03: They had never. [00:16:42] Speaker 03: And even if we thought they were breaking it up into subpopulations, which ones would we have chosen? [00:16:47] Speaker 03: Gender? [00:16:48] Speaker 03: Age? [00:16:48] Speaker 03: you know, prior other conditions, health factors? [00:16:51] Speaker 02: Suppose that I'm struggling to try to distinguish between the narrowing that one would regard as being sort of in the ordinary course of things. [00:17:03] Speaker 02: You drop a few claims or you drop out several patents. [00:17:06] Speaker 02: Those are narrowing that no one would even blink an eye at. [00:17:09] Speaker 02: That happens all the time. [00:17:10] Speaker 02: It's perfectly fine versus the kind of prejudicial [00:17:15] Speaker 02: negative limitation or other changes that you're saying really do change the whole ball game in a potentially prejudicial way. [00:17:24] Speaker 02: I mean, if I added that our claims only extend to people with gray eyes, let's say, that's not technically a negative limitation, but it is a strong restriction of the class of potential infringing conduct. [00:17:45] Speaker 02: in a way that, I suppose, would you say that something like that had the potential for prejudice in it? [00:17:51] Speaker 02: It could. [00:17:52] Speaker 02: For the same reason that you're saying? [00:17:53] Speaker 03: It could. [00:17:54] Speaker 03: And let me try another way to explain why this is prejudicial here. [00:17:57] Speaker 03: All along, we were taking their infringement theory, their broad infringement theory that the whole cat silo patient population infringes, as a concession that any art that covered that population would therefore anticipate if it predated the patent. [00:18:12] Speaker 03: They took away that concession. [00:18:14] Speaker 03: That would change how we would frame our invalidity defenses. [00:18:18] Speaker 03: They also then added a concession, which is 95% of your patient population does not infringe. [00:18:24] Speaker 03: And the district court entered summary judgment on that, and they haven't appealed that. [00:18:27] Speaker 03: That's at A4 and A21. [00:18:30] Speaker 03: they're conceding something different. [00:18:32] Speaker 03: They've taken away the concession we were relying on for our invalidity case. [00:18:36] Speaker 03: So we need to retool our invalidity defenses. [00:18:38] Speaker 03: And they're adding a concession that we didn't know about that now we need to figure out, well, why is it you think those people don't infringe? [00:18:45] Speaker 03: And what is it about your claims and the cat silo drug that makes it act differently in these two sets of populations? [00:18:52] Speaker 03: And so whatever may be in the case in other cases, and you can think of all different kinds of hypotheticals, this case, it was prejudicial. [00:19:00] Speaker 03: The district court, who was very familiar with this case and the theories the parties had advanced in it, recognized it was a change, recognized it prejudiced Genentech, recognized that in laying prejudice aside that separate and apart, [00:19:14] Speaker 03: The district court concluded they violated the local rules by not moving to amend, which would have required them to show diligence in doing so, like they moved timely. [00:19:24] Speaker 03: And she concluded they hadn't moved timely. [00:19:25] Speaker 03: She concluded that if they wanted to change their opinion after her February order, they needed to do so right away. [00:19:30] Speaker 03: And instead, as Your Honor mentioned, they waited until May, and they didn't exactly directly tell us. [00:19:35] Speaker 03: We had to confirm with them that their expert had meant to change their theory. [00:19:39] Speaker 03: And she said that prejudice, Genentech, it was too far along the case. [00:19:42] Speaker 03: Trial was set for November of that year. [00:19:44] Speaker 03: Trial was set for months away. [00:19:46] Speaker 03: And the judge said in her order that their [00:19:50] Speaker 03: Failure to comply with the local rules had affected her ability to potentially accommodate the schedule I could if I could shift I would have to ask each more questions I would just shift to inducement for just a second. [00:20:00] Speaker 04: Could you just talk about the Sanofi case? [00:20:03] Speaker 03: Yes Yes, your honor be glad to so this is different than the Sanofi case because in the Sanofi case I [00:20:07] Speaker 03: this court recognized that the label there expressly called out the subclass that was infringing. [00:20:13] Speaker 03: This case is different in two ways from Sanofi. [00:20:16] Speaker 03: This case is in some ways not like anything you've ever had, because what they're claiming is that the label, which says, gives to somebody who's had trastusumab in a taxane, it's totally silent as to two things in a way that is different from Sanofi. [00:20:32] Speaker 03: It's completely silent. [00:20:34] Speaker 03: Absolutely nothing about [00:20:37] Speaker 03: encouraging, actively promoting, inhibiting PACS-2 or expressing DEF B1, which is what their claims cover. [00:20:45] Speaker 03: So most of your cases, there's no space or leap of faith between, well, are you or are you not encouraging giving this drug to somebody who has the hospitalization risk factors that are covered in the claims? [00:20:56] Speaker 03: The question in Sanofi was, does the label do that in this court? [00:21:00] Speaker 03: said, yes, it does, because it says give the drug. [00:21:02] Speaker 03: And then the only example of people who would give the drug for that purpose were in the Athena trial, which was there. [00:21:08] Speaker 03: And it laid out the factors. [00:21:10] Speaker 03: That's not this case. [00:21:11] Speaker 03: There's nothing in this case that directly where the label here is silent, both as to the claims. [00:21:19] Speaker 03: It says nothing to the claims. [00:21:20] Speaker 03: And it's also silent as to this supposed subclass. [00:21:22] Speaker 03: There's no active inducement with respect to those who have [00:21:26] Speaker 03: received and nothing else. [00:21:29] Speaker 03: And then, unlike Sanofi as well, the district court concluded that this is a hidden noncompliance subclass at best with the standard of care. [00:21:37] Speaker 03: And in Sanofi, the facts were the opposite, that it was a vast majority. [00:21:41] Speaker 02: Do you think that the same analysis would apply? [00:21:44] Speaker 02: And again, to go back to my [00:21:46] Speaker 02: example with gray eyes. [00:21:47] Speaker 02: If the additional limitation were people give this drug only to people with gray eyes, that's the infringement contention. [00:21:58] Speaker 02: And the label says nothing about gray eyes. [00:22:01] Speaker 02: It just says give the drug to people who satisfy the two precursor drug requirement. [00:22:08] Speaker 02: Would there be inducement in that case because [00:22:10] Speaker 02: The theory would be, of course you would have expected the gray-eyed people would be among the category of people that would take it since you didn't have any indication that it would be limited to people with particular color dyes. [00:22:22] Speaker 03: Under the Supreme Court's case law and this court's case law, I don't think you could infer from the label that was silent about gray eyes [00:22:30] Speaker 03: the level of promotion and encouragement that would be required to allow a case based solely on the label, as this one is. [00:22:38] Speaker 03: And here, there's the added fact that they don't dispute that, at best, this supposed subclass is less than 5%. [00:22:48] Speaker 03: There's a very small, the vast majority of the patients. [00:22:52] Speaker 03: And that's backed up. [00:22:52] Speaker 03: They would be receiving it contrary to the standard of care. [00:22:55] Speaker 03: The ASCO standard of care is that you should receive a third agent per JETA. [00:22:58] Speaker 02: Would your answer be different if the class that was identified was not 5%, but was 95%? [00:23:05] Speaker 03: It would be perhaps a harder case, Your Honor. [00:23:08] Speaker 03: But no, I think the label would still be silent. [00:23:11] Speaker 03: The label is silent. [00:23:12] Speaker 03: And again, the gulf here between what the label says at all and what the claims cover. [00:23:18] Speaker 03: And you get into the willful blindness here. [00:23:23] Speaker 03: There's no evidence that Genentech knew that encouraging anybody to take cadcyla was causing the inhibition of Pax 1 and the expression of DEF B1. [00:23:35] Speaker 04: Do you think willful blindness has any application at all to intent? [00:23:39] Speaker 04: I mean, the Supreme Court talks about it in terms of knowledge in global tech, but not intent. [00:23:46] Speaker 04: And from the criminal law from which it drives, [00:23:49] Speaker 04: It's really talking about knowledge, not intent. [00:23:51] Speaker 04: So do you think willful blindness is a place where we're analyzing intent? [00:23:55] Speaker 03: Well, I think, you know, one can like break it down into sort of too many buckets that not matter. [00:24:01] Speaker 03: The question is, do we meet the statute, which requires active inducement, and you have to have the specific intent to promote or encourage [00:24:09] Speaker 03: someone to infringe the claims, not just take an act. [00:24:13] Speaker 03: And when you look at it here, we had no knowledge that giving Katsala to anyone, much less this subpopulation that they've come up with very late, late, late into the case, was infringing their patent claims. [00:24:29] Speaker 02: Could I ask you about the cross-appeal? [00:24:30] Speaker 02: Yes, please. [00:24:32] Speaker 02: I'm wondering why we have jurisdiction over the cross-appeal. [00:24:35] Speaker 02: Now, you've correctly, I think, identified this as [00:24:38] Speaker 02: a cross-appeal case, perhaps in excess of caution. [00:24:43] Speaker 02: But in any event, the problem I see is that this is the denial of summary judgment, which normally we don't have jurisdiction to review. [00:24:53] Speaker 02: So why is it that we have jurisdiction to review the denial of summary judgment, which is in the posture of a cross-appeal, not in the posture of defending a judgment on an alternative ground? [00:25:06] Speaker 02: Because it seems to me, and I'm [00:25:08] Speaker 02: We have a couple of cases that talk about this. [00:25:11] Speaker 02: It seems to me that there's no jurisdiction in that setting unless I'm missing something. [00:25:15] Speaker 03: So we did not raise a counterclaim. [00:25:19] Speaker 03: This is just a defense in this case. [00:25:22] Speaker 03: And so it is an affirmative. [00:25:24] Speaker 03: Go ahead. [00:25:25] Speaker 03: So I think your appellate jurisdiction, Judge Bryson, stems from the 1291 judgment on non-infringement. [00:25:30] Speaker 03: That's the judgment. [00:25:31] Speaker 03: It's properly in this court. [00:25:33] Speaker 03: They and if but are you suggesting we have pending appellate jurisdiction here over the cross-appeal no No, I'm suggesting that so there's only there's only one claim here in this case. [00:25:45] Speaker 03: There's we did not make a declaratory judgment Okay, well, maybe let me make myself clear. [00:25:49] Speaker 02: Okay, the thing that's bothering me either. [00:25:53] Speaker 02: It's not a cross-appeal or [00:25:54] Speaker 02: which I thought was where you were kind of going. [00:25:58] Speaker 02: Or it is a cross-appeal. [00:25:59] Speaker 02: If it is a cross-appeal, it does seem to me that you have to satisfy all the requirements for jurisdiction for an appeal, which would mean that you couldn't appeal from the denial of summary judgment. [00:26:09] Speaker 02: If it's not a cross-appeal, i.e. [00:26:12] Speaker 02: for some reason such as that you didn't file a counterclaim, but rather you filed a defense, and therefore your judgment isn't going to be broader than simply a non-infringement judgment, then it seems to me you have to deal with the problem [00:26:25] Speaker 02: that the judgment, if it's predicated on your defense of invalidity, it actually is broader in its effect on the plaintiffs, right? [00:26:34] Speaker 02: Because in a later proceeding, for example, the collateral estoppel effect of a judgment that it's predicated on invalidity would bar them in a way that a judgment predicated on non-infringement would not. [00:26:48] Speaker 02: So it seems to me that suggests that it does have to be a cross appeal. [00:26:52] Speaker 02: And if so, where do we have jurisdiction? [00:26:55] Speaker 03: So I think you have jurisdiction over the case. [00:26:58] Speaker 03: The only claim in the case is their claim. [00:27:00] Speaker 03: The only claim in the case is their claim for infringement. [00:27:03] Speaker 03: The judgment on that claim was entered in our favor on [00:27:08] Speaker 03: grounds that we don't infringe and that they have no evidence of infringement. [00:27:11] Speaker 03: And that's the 1291 judgment. [00:27:13] Speaker 03: That judgment's on appeal. [00:27:15] Speaker 03: I think there are two separate issues. [00:27:17] Speaker 03: I agree with your analysis, complete, but I think except the conclusion. [00:27:23] Speaker 03: Because I think the questions are separate. [00:27:25] Speaker 03: Do you have appellate jurisdiction over the judgment? [00:27:27] Speaker 03: Yes, I think you do under 1291. [00:27:28] Speaker 03: The only claim is their claim. [00:27:30] Speaker 03: Judgment is entered. [00:27:30] Speaker 03: There's a final judgment in this case. [00:27:32] Speaker 03: That case is properly in this court. [00:27:34] Speaker 03: If we want to defend the judgment of non-infringement on the alternative grounds that the claims are invalid, because that would, I think you could conclude two things. [00:27:44] Speaker 03: Because it can't be that you can't reach it. [00:27:47] Speaker 03: Because it's an alternative ground to the judgment that's properly before you. [00:27:50] Speaker 03: So I think you could conclude one of two things. [00:27:52] Speaker 03: We didn't need to keynote across appeal. [00:27:54] Speaker 03: And we did so out of an abundance of caution. [00:27:55] Speaker 03: And we wrote our opening brief within the word limits of a regular brief, in case you decided we were mistaken. [00:28:02] Speaker 03: And then you can strike our reply brief. [00:28:04] Speaker 03: And I still hope you would address the invalidity because these issues are important. [00:28:08] Speaker 03: Or you can conclude that you have jurisdiction, appellate jurisdiction, over the whole case. [00:28:12] Speaker 03: And we properly noted a cross-appeal because, as you note, affirming in the alternative ground on invalidity would lessen their rights and enhance ours. [00:28:21] Speaker 03: And so we've properly noted an appeal on that basis. [00:28:27] Speaker 02: Sounds like what you're saying is there's pending an appellate jurisdiction. [00:28:30] Speaker 03: OK, I'm happy for you to label it that way. [00:28:33] Speaker 02: Well, except that we have cases that say that you can't use appellate jurisdiction in this setting. [00:28:40] Speaker 03: But this is an alternative ground to affirm the only claim in the case and the only judgment in the case. [00:28:48] Speaker 02: But it's an alternative ground which you're required to bring as a cross appeal by hypothesis. [00:28:56] Speaker 03: Right. [00:28:59] Speaker 03: Unlike in Cardinal Chemical, unlike if we had brought a declaratory counterclaim, this court's not required to reach our invalidity claim. [00:29:07] Speaker 03: And so you could, as if I had appealed a claim construction issue, for example, in the midst of their appeal, for which there was also, that's an example for which there's also no separate appealable. [00:29:17] Speaker 03: I couldn't appeal a claim construction issue, but I can raise it in my red brief as an alternative ground. [00:29:21] Speaker 02: This is a conditional cross-appeal in your view? [00:29:29] Speaker 03: No, because I think a conditional cross-appeal has a different meaning. [00:29:32] Speaker 02: I think it's... Well, in other words, if we rule in your favor on the issue on which you're appellee, are you saying we nonetheless should deal with the cross-appeal? [00:29:42] Speaker 03: I think you don't have to. [00:29:43] Speaker 02: Well, do you want us to? [00:29:44] Speaker 03: I think we would like you to hold these patents invalid because just as a public service, like these patents are [00:29:51] Speaker 03: They are just merely a plan to hunt for something. [00:29:53] Speaker 03: They lack utility. [00:29:54] Speaker 03: They aren't enabled. [00:29:55] Speaker 03: They are hugely broad. [00:29:57] Speaker 03: They don't specify any compounds that, if you just look at the indirect inhibition, and they tell no one how to do it, and they certainly don't sow possession of the breadth of their planets. [00:30:06] Speaker 01: So if we rule in favor of that plea, you withdraw what you've called your cross claim? [00:30:11] Speaker 03: Well, so I think you can affirm, I think it's [00:30:15] Speaker 03: It's up to the court's discretion whether to go on and decide the invalidity if you affirm the judgment on either of the grounds given by the district court. [00:30:21] Speaker 02: In the course of your research on this, you do cite the Type Right case, which seemed to me to be appropriate. [00:30:30] Speaker 02: Did you run across Advanced Software Design Corporation? [00:30:35] Speaker 02: Standing here, I don't recall. [00:30:37] Speaker 02: All right. [00:30:37] Speaker 02: And Semcon against Micron. [00:30:40] Speaker 02: Those are two cases that deal with this problem now. [00:30:43] Speaker 02: Advanced software is like this case with one exception, which is an exception you've pointed out, that it had a counterclaim in it. [00:30:51] Speaker 02: So other than that, it's a cookie cutter of this case. [00:30:55] Speaker 02: So I'm wondering, is that enough to convert this from a case in which, as in the advanced software case, we dismissed the cross appeal into a case in which we don't? [00:31:07] Speaker 03: I think that- Your suggestion earlier was yes, that's an important factor. [00:31:11] Speaker 03: I think it is an important factor because I think the only claim in this case, there was final judgment under 1291, and that case is properly before the court. [00:31:19] Speaker 03: And we have noted across appeal out of an abundance of caution in case you perceived that ruling for us on this alternative ground to get to the same judgment of non-infringement would enhance our rights or lessen theirs. [00:31:30] Speaker 03: But I don't think you need separate appellate jurisdiction over that cross-appeal, given that there's only one claim in the case, and the final judgment's under 1291. [00:31:39] Speaker 03: But I'd be happy to submit a letter on those cases if you would like, Your Honor. [00:31:43] Speaker 03: If, I think, have I run over my time? [00:31:47] Speaker 03: Yes, you've run all the time. [00:31:48] Speaker 03: I apologize. [00:31:49] Speaker 03: Thank you, Judger. [00:31:50] Speaker 03: We were to press that you affirm. [00:32:00] Speaker 02: Do you have anything to say on the viability of the cross appeal? [00:32:08] Speaker 00: I do not. [00:32:08] Speaker 00: I trust this panel will make the right decision. [00:32:12] Speaker 00: We're willing to talk about the invalidity issues. [00:32:14] Speaker 00: You may have too much confidence in us. [00:32:19] Speaker 00: I would like to talk about a couple of things Ms. [00:32:22] Speaker 00: Maynard raised. [00:32:24] Speaker 00: One of them was there's this narrative about how this alleged change or narrowing of Phigenix's infringement theory stemmed from the court's decision on a priority date issue. [00:32:37] Speaker 00: As Ms. [00:32:37] Speaker 00: Maynard recognized, that decision came down in February of 2017. [00:32:42] Speaker 00: The month before that, in open court, Phigenix's former counsel made it clear that the infringement theory concerned a combination of trastuzumab and ataxane with catcilla and nothing else. [00:32:56] Speaker 00: And that is at appendix page 429 and 430. [00:33:01] Speaker 00: Specifically, there was discussion of some potentially invalidating prior art. [00:33:06] Speaker 00: Phigenix's counsel said that well this this previously clinical trial. [00:33:09] Speaker 00: They're being given a much different cocktail here That's not just trace through some avana taxing In the end I think that Phigenix agrees with the district court's initial impression of this issue Which the judge announced at a hearing on these motions. [00:33:28] Speaker 00: That's an appendix 349 the district court said [00:33:30] Speaker 00: I'm loathe to strike the infringement contention because the way it's worded I don't think it needs to say Herceptin, Ataxin and nothing else when it says Herceptin and Ataxin that's what the contention is and just to be clear Herceptin is a brand of Trastuzumab. [00:33:51] Speaker 00: On the prejudice issue [00:33:54] Speaker 00: Dentek recognizes that the district court did find there could be some prejudice. [00:33:59] Speaker 00: However, the actual prejudices were never really explained. [00:34:04] Speaker 00: Again, if the infringement contention say I'm targeting people with gray eyes, blue eyes, and green eyes, and then later the expert says, well, sorry, I can't support those theories on the latter two, the defense still has to prepare its non-infringement position with respect to the gray eyes. [00:34:20] Speaker 04: What about what we heard from [00:34:23] Speaker 04: miss Maynard about how with the broader infringement contentions, there was some ability to rely on those for proving validity or invalidity in this case? [00:34:37] Speaker 00: And theoretically speaking, there could be a case where the infringement theory is narrowed and necessarily the claim interpretations that the plaintiff is adopting have narrowed. [00:34:48] Speaker 00: And some piece of prior art that would have applied to the broader theory doesn't apply. [00:34:52] Speaker 00: However, I haven't seen from Genentech any specific prior art that falls into that bucket. [00:34:57] Speaker 04: I think their position is that they were practicing the prior art. [00:35:00] Speaker 04: And so they were practicing the part that was then not included in the more narrowed infringement contentions. [00:35:10] Speaker 00: Again, I didn't see that argument being made in the briefing or any specific instance of a piece of prior art. [00:35:16] Speaker 04: But if that were the case, would that be prejudice then? [00:35:19] Speaker 00: It could be. [00:35:22] Speaker 00: And on the abuse of discretion point, applying an apposite law, I believe as court has told us, is an abuse of discretion. [00:35:29] Speaker 00: I will hit the validity issues with the time I have remaining. [00:35:33] Speaker 00: Some common themes across the validity issues is that invalidity has to be shown by clear and convincing evidence. [00:35:40] Speaker 00: These specific invalidity issues we're dealing with in Genentech's cross-appeal are highly factual in nature, utility is a question of fact, written description is a question of fact and enablement is a question of law but the real dispute here pertain to whether there was undue experimentation which is also a factual inquiry. [00:36:00] Speaker 00: On enablement the real question came down to was the was any [00:36:09] Speaker 00: There was no real quantifying evidence or evidence quantifying the amount of this experimentation that would have been required. [00:36:16] Speaker 00: PyGenics' expert analyzed the WANS factors and said no undue experimentation. [00:36:20] Speaker 00: Genentech's expert says, well, it looks like the number of compounds you'd have to identify would be enormous. [00:36:26] Speaker 00: I don't know what enormous means. [00:36:27] Speaker 00: The district court didn't either. [00:36:28] Speaker 00: This case is not like the Wyeth case, where there was evidence showing that the experimentation would have had to have been performed on tens of thousands of compounds, each of which would have taken weeks to assay. [00:36:39] Speaker 00: That's a lifetime of undue experimentation. [00:36:41] Speaker 00: We don't have any such quantifying evidence here. [00:36:46] Speaker 00: On written description, Phigenics presented expert testimony on the issue, extensive expert analysis saying the person of ordinary skill in the art would have understood that the inventor was in possession of the invention. [00:37:01] Speaker 00: Genentech countered that with attorney argument only. [00:37:04] Speaker 00: And for utility, this court has told us that utility is not a high bar. [00:37:09] Speaker 00: There's no debate that the patent discloses utility with respect to prostate cancer. [00:37:16] Speaker 00: Phigenics is expert provide a testimony indicating that you could correlate those findings and understanding with respect to prostate cancer Over to breast cancer showing the utility there, and I believe I'm out of time. [00:37:27] Speaker 01: Thank you. [00:37:27] Speaker 03: Thank you I'm going to give you back your three minutes Thank you, Judge Rania, I really appreciate that and I'll limit my comments to the cross appeal the [00:37:46] Speaker 03: But this patent, as I indicated in my opening remarks, really just sets forth a plan to hunt for something that may or may not work with breast cancer. [00:37:56] Speaker 03: Every working example is about prostate cancer, and there's nothing in. [00:38:03] Speaker 03: So basically, for the same reasons, it lacks utility. [00:38:08] Speaker 03: It's not enabled, and it lacks written description. [00:38:11] Speaker 03: I'm happy to focus on any one of those theories, if your honors would like. [00:38:16] Speaker 03: But as far as utility, our expert gave unrebutted testimony that a person of skill in the art would not just infer from the fact, the prostate working examples, that they would work with breast cancer. [00:38:34] Speaker 03: And the patent only says what could be done, what might be done. [00:38:38] Speaker 03: The examples beginning with example 12 will be determined, might be considered. [00:38:43] Speaker 03: The district court held that [00:38:44] Speaker 03: There was nevertheless a dispute of fact because she felt like there was analytical reasoning in the patent to go from the one to the other. [00:38:53] Speaker 03: But as this court held in Rasmussen and Jansen, mere analytical reasoning is not enough unless a person of skill in the art would consider it to be obviously correct. [00:39:01] Speaker 03: And as I said, [00:39:02] Speaker 03: There's unrebutted testimony from our expert at Appendix 168, paragraph in Appendix 2300 to 2301 that an expert wouldn't expect it to work. [00:39:14] Speaker 03: In terms of enablement, that's a question of law. [00:39:18] Speaker 03: And this court can decide here the claims are extremely broad. [00:39:21] Speaker 03: It's a method of treating compositions that are defined only by their function. [00:39:27] Speaker 03: And under the claim construction order, it doesn't encompass [00:39:30] Speaker 03: just things that directly affect PACS2 or DEFB1, but also anything that indirectly affects the pathways upstream from them in such a way that it affects them. [00:39:42] Speaker 03: And that, as it's undisputed, is an enormous subset. [00:39:46] Speaker 03: And they say, well, it would be routine. [00:39:50] Speaker 03: All they say is, well, it would be routine to test. [00:39:52] Speaker 03: But one, all they say is it would be routine to test for PACS2. [00:39:57] Speaker 03: But there's not a single example of a class of compounds or any compound within them that you could use to treat breast conditions. [00:40:06] Speaker 03: So at column 8 through column 12, there's just a laundry list of large molecules and small molecules. [00:40:13] Speaker 03: But they point to nothing in the patent. [00:40:15] Speaker 03: And nothing in the patent teaches anything about treating [00:40:17] Speaker 03: which even an example of something that treats breast conditions or breast cancer. [00:40:21] Speaker 03: And then there's no examples of how to affect DEF B1, which the claims cover as well. [00:40:25] Speaker 03: Instead, they focus on, well, it would be routine to test for what affects Pax 2. [00:40:30] Speaker 03: But even under YF, the enormous number of compounds that would need to be treated, especially given their infringement theory now, that it matters what you've had before. [00:40:38] Speaker 03: So not only do you have to figure out which compounds are in this set, [00:40:42] Speaker 03: You have to figure out, and under what conditions would it matter? [00:40:46] Speaker 03: And nothing in the patent teaches someone of skill in the art how to do that. [00:40:50] Speaker 03: Written description, it's a similar problem. [00:40:53] Speaker 03: They say it's a question of fact, but under this course decision in Rochester, a patent can invalidate itself. [00:40:59] Speaker 03: And that's the situation here as a matter of law. [00:41:02] Speaker 03: And I think the shortest path from the specification here to invalidity on written description is the claim to the indirect inhibitors. [00:41:09] Speaker 01: Can you conclude your argument? [00:41:11] Speaker 03: Oh yes, I'm sorry. [00:41:11] Speaker 03: I apologize. [00:41:12] Speaker 03: Thank you Judge Rainier for your patience and we request that you affirm the judgment. [00:41:16] Speaker 01: We thank the parties for their arguments.