[00:00:18] Speaker 00: Okay, the next argued case is number 18, 1925. [00:00:22] Speaker 00: OSI Pharmaceuticals, LLC against Apotex, Incorporated. [00:00:28] Speaker 05: Mr. Saunders. [00:00:29] Speaker 05: Good morning, Your Highness, and may it please the Court. [00:00:32] Speaker 05: This is not a run-of-the-mill IPR appeal. [00:00:35] Speaker 05: The Board here invalidated OSI's groundbreaking claims to treating non-small cell lung cancer. [00:00:42] Speaker 05: based on references that disclose no data regarding erlotinib and non-small cell lung cancer, not even in a pre-clinical trial. [00:00:52] Speaker 04: Based on... Can I just double check something? [00:00:55] Speaker 04: The briefs seem to agree with each other that the only indicated condition that needs to be discussed is the non-small cell lung cancer, even though there are a couple of others in the claim. [00:01:07] Speaker 04: Is that because nobody has suggested there's prior art on those other conditions? [00:01:12] Speaker 05: Correct. [00:01:12] Speaker 05: The challenge below is solely about non-small cell lung cancer. [00:01:16] Speaker 05: And so that was the focus. [00:01:17] Speaker 05: And so you have no data about that, even in preclinical models. [00:01:22] Speaker 05: The board then tried to backfill [00:01:24] Speaker 05: with speculation based on the mere initiation of clinical trials, that there must have been hypothetical preclinical evidence. [00:01:33] Speaker 01: Can I ask you something about that? [00:01:35] Speaker 01: On the preclinical evidence, I think the only thing that it's in the records for that is expert testimony that there would be animal studies or mammal studies before phase one studies could occur. [00:01:49] Speaker 01: Is there any evidence at all on what those studies were seeking, what they would have sought to treat? [00:01:55] Speaker 01: For example, would they be for other conditions other than non-small cell lung cancer? [00:02:01] Speaker 01: Or, I mean, do we know? [00:02:03] Speaker 01: Do you know what the criteria is for those kind of clinical testings that would allow the phase one testing to occur? [00:02:12] Speaker 05: Right. [00:02:13] Speaker 05: It doesn't have to be testing in non-small cell lung cancer. [00:02:16] Speaker 05: Phase one trials can be done in healthy volunteers, [00:02:19] Speaker 05: or in a mix of cancer patients? [00:02:20] Speaker 01: I was thinking about the preclinical mouse studies. [00:02:22] Speaker 05: Right, but I'm saying, because that's what you're going towards, you don't need to do preclinical mouse studies in non-small cell lung cancer to be advancing there. [00:02:31] Speaker 05: And in fact, there's no evidence anywhere in the record that such studies were done. [00:02:36] Speaker 04: And on this point, I gather there was some testimony or declaration or something that says, when you have a phase one study, [00:02:49] Speaker 04: we think there should have been some kind of preclinical testing. [00:02:55] Speaker 04: There is that kind of declaration, right? [00:02:58] Speaker 05: deposition of our expert. [00:03:01] Speaker 05: He said you'd have a lot of things you'd show, pharmacology, toxicology, preclinical efficacy. [00:03:07] Speaker 04: But then your point is that is there any evidence that somebody declare or say in a deposition that there would have been or we would expect there to have been in the preclinical testing leading to the phase one [00:03:26] Speaker 04: testing of non-small cell lung cancer. [00:03:30] Speaker 04: Absolutely not. [00:03:31] Speaker 05: No evidence on that whatsoever. [00:03:33] Speaker 05: So it's a huge speculative leap that the board is making here that isn't grounded in any evidence. [00:03:41] Speaker 04: And that's the basis on which principally, maybe even solely, you attack the reliance on the 10K. [00:03:47] Speaker 05: Right, that was the basis on which the board actually relied on the 10K, and so focusing on its reasoning under January, we say that reasoning can't stand. [00:03:57] Speaker 01: Is that also the basis for which the board relied on the table in Gibbs? [00:04:02] Speaker 05: Yes, so Gibbs has a table that just says phase two, doesn't even say what's being tested in phase two. [00:04:09] Speaker 05: And so all that leaves, when you take out this leap about the preclinical trials, all that leaves is the statement in Gibbs, which the board latched on to the idea that this statement begins with the term these compounds. [00:04:27] Speaker 05: And this is on Appendix 14.06. [00:04:33] Speaker 05: The actual reference to non-small cell lung cancer in that statement was in an exemplary clause at the end. [00:04:41] Speaker 05: begins with the word particularly. [00:04:43] Speaker 05: It's singling out a particular attribute here and not necessarily even on its face applying to both compounds. [00:04:50] Speaker 05: And more importantly, statements like that, and this course has been very clear, need to be read in context. [00:04:57] Speaker 05: And Gibbs, in that paragraph, cites two references. [00:05:01] Speaker 05: The Woodburn reference, which is about gefidinib, an entirely different compound, [00:05:06] Speaker 05: discloses anti-tumor activity in non-small cell lung cancer. [00:05:11] Speaker 05: The Moyer reference, which is actually about erlodinib, is entirely about head and neck and colorectal cancer. [00:05:18] Speaker 05: And it's undisputed that there's no disclosure of activity in non-small cell lung cancer in the Moyer reference. [00:05:25] Speaker 04: And the reason that you think context for the relevant sentence, the however sentence, [00:05:31] Speaker 04: would look to Moyer and the other one is that, what, those are 12 and 13 in the two sentences above it? [00:05:40] Speaker 05: the two references that are cited in that section. [00:05:44] Speaker 05: And a person of ordinary skill who has this statement that's ambiguous, what are they talking about for non-smell-cell lung cancer, is naturally going to say, well, what is the evidence for this before forming a reasonable expectation of success? [00:05:57] Speaker 05: And you look at those references, and one's about another compound and talks about non-smell-cell lung cancer. [00:06:03] Speaker 05: The one about our lotinib doesn't talk about non-smell-cell lung cancer. [00:06:07] Speaker 05: pretty strong context saying this statement is not giving you an expectation of success in non-special non-claims. [00:06:14] Speaker 04: Are you asking us to clarify the legal meaning of reasonable expectation of success to say that a person of skill in the art would not have, as a matter of law, a reasonable expectation of success based on a sentence [00:06:36] Speaker 04: that points to two references without going and looking what those references say to make sure that the sentence is read one way rather than another. [00:06:48] Speaker 05: I think that is an available route here. [00:06:52] Speaker 05: It could be phrased in those terms. [00:06:54] Speaker 05: It could also just be presented in substantial evidence terms, getting to the same result. [00:06:59] Speaker 05: In terms of that bare sentence, where these references are [00:07:03] Speaker 05: are pointing to saying, well, this isn't a disclosure about erlondinib and non-small cell lung cancer. [00:07:08] Speaker 05: That isn't substantial evidence to support this. [00:07:12] Speaker 05: And at the very least, as a procedural ground, the board can't do what it did here, which is it looked at Gibbs. [00:07:21] Speaker 05: Gibbs actually had a hole in it. [00:07:23] Speaker 05: And the board says, well, we have to look at Gibbs in context. [00:07:27] Speaker 05: And it relies on the Moyer article to [00:07:30] Speaker 04: fill that. [00:07:31] Speaker 04: What was the hole? [00:07:31] Speaker 05: The hole was the Gibbs used the chemical code name. [00:07:34] Speaker 04: Oh, right. [00:07:35] Speaker 05: Never disclosed what it was. [00:07:37] Speaker 05: So they said, oh, of course we would read this in the context of the underlying references. [00:07:40] Speaker 05: They looked to more to fill that hole, but then it wouldn't look to the underlying references to understand the key sentence. [00:07:47] Speaker 01: In your brief, you have a suggestion that they erred legally in how they interpreted the reference by not interpreting it as a [00:07:59] Speaker 01: whole, I guess, or interpreting that language in context. [00:08:03] Speaker 01: And you contrast with the situation where it was the code name for Latinib. [00:08:08] Speaker 01: Is that really a legal error? [00:08:10] Speaker 01: I mean, how does that operate when we know that our law says that what a prior reference teaches one of ordinary scale in the art is a question of fact? [00:08:23] Speaker 05: You said it's a question of fact, but you also said that the reference has to be read in context. [00:08:31] Speaker 05: The reference is read for everything that it teaches. [00:08:35] Speaker 05: when the board looks at that one isolated portion and isn't considering that context, then it's put itself in a position where it doesn't have a fact finding to be deferred to there. [00:08:49] Speaker 05: And by the way, this is all reinforced by the fact that Gibbs, at the beginning of the article, also says, [00:08:57] Speaker 05: to the extent you want to learn more, look at the proceedings, these two 1999 proceedings and the abstracts there. [00:09:06] Speaker 05: And we asked Apotex's expert, [00:09:12] Speaker 05: about those proceedings. [00:09:14] Speaker 05: And he said, this is Appendix 4571, question, so you looked at these proceedings and did not find anything that you relied on to support your opinion. [00:09:23] Speaker 05: Is that right? [00:09:25] Speaker 05: Answer, correct. [00:09:26] Speaker 05: So again, it's reinforcing. [00:09:28] Speaker 05: Not only is there this clear contrast between Woodburn and Moyer, but when you look to the background of the only other proceedings that are cited there, there's also not showing any evidence [00:09:42] Speaker 05: Non-small cell lung cancer and in fact their expert. [00:09:46] Speaker 05: We have a we have a straight-up Concession in this case that he is not aware of any preclinical or clinical data before the priority date Regarding non-small cell lung cancer now regarding the data you lead with that issue in your brief, but you're not suggesting [00:10:05] Speaker 01: Oh, this is my question. [00:10:06] Speaker 01: Are you suggesting that the only way that they could have shown reasonable expectation of success was data because of the nature of treatment of cancer? [00:10:17] Speaker 05: No, I'm not sure it's the only way, but it's undisputed that this is a highly unpredictable art. [00:10:27] Speaker 05: I mean, they're experts. [00:10:29] Speaker 05: Admitted quote the odds of finding a successful treatment for non small cell lung cancer at least as of the 2,000 time period We're not good. [00:10:39] Speaker 01: It's appendix four six one five So do I understand that maybe your argument is that? [00:10:44] Speaker 01: All these references have holes and one way they could have filled it up is with data and they haven't done that here [00:10:50] Speaker 01: or is it more that they had to have data? [00:10:53] Speaker 05: That's what I'm trying to understand. [00:10:55] Speaker 05: We're not arguing a per se rule, but in the context of a highly unpredictable art here. [00:11:02] Speaker 05: And when we talk about data, whether it's the underlying data itself or whether it's the disclosure of the results, that's what a medical oncologist here, making these decisions, is going to need some sort of scientific evidence before being able to reasonably conclude. [00:11:22] Speaker 04: But not necessarily to see the evidence. [00:11:25] Speaker 04: There could be a highly reliable representation that such evidence exists. [00:11:32] Speaker 04: If I thought that the board said something like, that's kind of what that sentence from Gibbs is, standing alone, a highly reliable indication of what's being asserted, until you go and look at the two citations that clarifies that actually that couldn't really be what he was saying. [00:11:58] Speaker 05: Right. [00:11:59] Speaker 05: And so that doesn't, you have to look at, [00:12:01] Speaker 05: all of those together as a package. [00:12:04] Speaker 05: And when you look at the actual testimony that they're relying on. [00:12:10] Speaker 04: But if there's an article in the New England Journal of Medicine at the beginning of phase three studies that says, we expect this to happen based on information we have, that might well be a sufficient basis for finding a reasonable expectation of success, even if the skilled artisan [00:12:31] Speaker 04: had no access to that data. [00:12:33] Speaker 05: Right. [00:12:33] Speaker 05: If someone's reporting on their own experiments, for example, and they're not reporting the underlying data. [00:12:38] Speaker 05: But what we have to remember here is Gibbs here was a review article. [00:12:42] Speaker 05: Gibbs was canvassing what other people had reported and wasn't saying, I have undisclosed knowledge here about erlotinib. [00:12:52] Speaker 05: And so that has to be read in light of those references. [00:12:55] Speaker 05: And Gibbs cites Moir Woodburn and these abstracts. [00:12:58] Speaker 05: And you don't see any of the [00:13:00] Speaker 05: results here regarding non-small cell lung cancer. [00:13:04] Speaker 05: And so their expert, when pressed about this, admitted, said, well, I think Gibbs would be saying something important here, but then admitted that he would look to the underlying references being cited. [00:13:19] Speaker 05: And then his final line of argument was he said, well, I would call it. [00:13:24] Speaker 05: I would call Dr. Gibbs. [00:13:26] Speaker 05: And so to check that box, we did call Dr. Gibbs, and he came and testified as a fact witness in this case and confirmed, you know, I didn't do the testing here. [00:13:35] Speaker 05: I didn't have any knowledge that this was going to have an effect in non-small cell lung cancer. [00:13:41] Speaker 05: And the board's only response to that [00:13:43] Speaker 05: was the circular argument. [00:13:45] Speaker 05: They said, well, you didn't correct your article. [00:13:48] Speaker 05: But that assumes that we have an unambiguous disclosure here. [00:13:53] Speaker 05: And as we've talked about from the beginning, this is an ambiguous sentence that gets read in light of these other references. [00:14:01] Speaker 05: There's nothing there that needs to be corrected. [00:14:05] Speaker 01: This is like your analogy in your brief to the baseball players with the opening pitcher and the closer. [00:14:11] Speaker 05: Yes, exactly. [00:14:11] Speaker 05: And I haven't, I mean, there was no response in the responsive brief to that basic point that you can't just say on the face of that sentence necessarily, this is a lot in him. [00:14:22] Speaker 05: And particularly when you're not talking about, no offense, you're not talking about a lawyer's game here. [00:14:27] Speaker 05: We're talking about what is a medical oncologist going to rely on to say, I expect this is going to treat [00:14:34] Speaker 05: non-small cell lung cancer. [00:14:37] Speaker 05: And in that circumstances, that ambiguous statement on the face of the reference isn't going to be enough. [00:14:44] Speaker 05: And when it's read in context with the underlying references, you're going to say there isn't the evidence here about non-small cell lung cancer. [00:15:00] Speaker 00: Have you divided your time? [00:15:04] Speaker 00: Have you divided your issues? [00:15:06] Speaker 03: Yes, your honor. [00:15:07] Speaker 03: I will take 10 minutes, and the government is going to take five minutes. [00:15:12] Speaker 03: May it please the court, OSI's argument that a person of ordinary skill in the art would need clear, vetted scientific evidence, and that the board misapprehended the reasonable expectation of success requirement is predicated on [00:15:29] Speaker 03: too high of a standard for reasonable expectation of success. [00:15:35] Speaker 03: OSI is requiring absolute vetted data, which would be an absolute predictability of success. [00:15:41] Speaker 03: I'm sorry. [00:15:42] Speaker 04: What's absolute vetted data? [00:15:44] Speaker 04: I thought their point was there turns out to be actually no evidence of any clinical testing on humans or animals of this compound for this condition. [00:16:01] Speaker 03: There is evidence that there was data that was done. [00:16:04] Speaker 03: In fact, when we read Gibbs, the Gibbs reference, the Gibbs reference refers to these compounds were tested in preclinical models. [00:16:12] Speaker 04: Let's just assume for purposes of this question that that sentence is [00:16:19] Speaker 04: on its face, obviously imprecise. [00:16:21] Speaker 04: And so you would, in fact, look at the two expressly cited references, 12 and 13 by number, and Moyer and Woodburn by name. [00:16:33] Speaker 04: And you would immediately see that's not actually what it meant. [00:16:36] Speaker 04: So what evidence is there that when checked in the most minimally responsible way would show that there was preclinical testing of this compound for this condition? [00:16:49] Speaker 04: in humans or animals? [00:16:50] Speaker 03: Looking at Gibbs, the way that that particular paragraph is laid out, the two specific references that are addressed there address a completely different sentence. [00:17:02] Speaker 03: And those specific references actually modify a sentence that demonstrates that these two compounds were in clinical trials. [00:17:12] Speaker 03: It's not until two sentences later where we see that Dr. Gibbs is referring to [00:17:19] Speaker 03: these compounds, only talking about two. [00:17:22] Speaker 01: Can I say something? [00:17:23] Speaker 01: So the only evidence is Gibbs. [00:17:28] Speaker 01: I think that's the only evidence of any clinical testing of this drug for this condition. [00:17:34] Speaker 03: I actually think that not only the Gibbs, but I also think that the board is allowed to make inferences based off of the testimony that Dr. Bunn and Dr. Giacconi both gave. [00:17:46] Speaker 03: When we look at OSI's 10K and we look at the Gibbs reference, what we see is that they finished the phase one trials and began phase two trials. [00:17:56] Speaker 03: Now, when asked about that, [00:17:58] Speaker 03: asked about investigational new drug applications and investigator brochures, Dr. Bonds said, yes, there would have been preclinical data that would have been submitted, and there would have been targeted conditions. [00:18:11] Speaker 04: Did he say that that preclinical data would have been about using this compound for this condition? [00:18:19] Speaker 03: I think his overall statement was, and you have the pre-clinical efficacy data. [00:18:26] Speaker 04: And I think the answer is no, he did not say that. [00:18:29] Speaker 03: But I also think that he said that the therapeutic conditions would have been listed in there as well. [00:18:35] Speaker 03: Where did he say that? [00:18:37] Speaker 03: I have to look at the record. [00:18:50] Speaker 03: 2023 What line are you looking at? [00:19:24] Speaker 03: So here we go. [00:19:48] Speaker 03: I'm sorry, APPX1992. [00:19:52] Speaker 03: And we look at lines five, or we look at lines eight through five. [00:20:04] Speaker 03: I think there's testimony about the therapeutic indications. [00:20:06] Speaker 03: Eight through what? [00:20:07] Speaker 03: Eight through, and they go on to 33.5. [00:20:13] Speaker 03: Dr. Bun testifies that many drugs would not be called targeted. [00:20:16] Speaker 03: So generally, you would list the indications that you are going to study in the clinical trial that has to accompany [00:20:21] Speaker 03: would specify what patients are being included. [00:20:24] Speaker 01: So that's identifying what you're going to study in the phase two trials, right? [00:20:29] Speaker 01: It doesn't identify anything about what was previously done. [00:20:34] Speaker 03: I think that it identifies the pre-clinical data, but also identifies the therapeutic targets that they intend [00:20:43] Speaker 01: To study in those particular trials, but I think that looking at the looking for I'm just trying to understand sure understand how it works. [00:20:56] Speaker 01: Do you know of anything that says that? [00:20:59] Speaker 01: in the preclinical, and before you could have phase one trials, that you have to do preclinical work on particular, the particular conditions that you've, or targeted indications that you've identified in your investigator's brochure? [00:21:19] Speaker 03: As part of the record, I can't identify anything that says that specifically. [00:21:24] Speaker 03: But I would say that when we look at requiring data, [00:21:29] Speaker 03: I would say that that would be an absolute predictability of success. [00:21:35] Speaker 03: What we have here is that when we look at Schnurr and the board looking at Schnurr, [00:21:41] Speaker 04: The board found that Schnurr had... That seems to me to be a leap. [00:21:47] Speaker 04: That is, it's one thing to say I have some data or a reliable representation that some data exists and what that data reliably tells me is this looks, now I'm going to use some non-legal word, [00:22:02] Speaker 04: promising something like that, it doesn't mean absolute, you know, I've looked at this data and the data, maybe the data says this is spectacular, there's no doubt at all, but there's a large, a lot of room on the spectrum between that and there is some data that begins to give me some expectation, you know, using my reasonable scientific methodology in my head. [00:22:32] Speaker 03: I think that the board and its factual findings made a reasonable inference based off the testimony of Dr. Bond and Dr. Giacconi about pre-clinical data being done. [00:22:46] Speaker 03: But I'll also second that if we look at the Gibbs reference, the board made factual findings on the Gibbs reference and what a person of ordinary skill in the arts, how they would read that specific reference. [00:22:58] Speaker 03: And looking at that specific reference, [00:23:01] Speaker 03: When it says these compounds had been through preclinical studies, had good anti-cancer activity, and had a good therapeutic index, particularly in patients with NSCLC, the board looked at testimony from Dr. Giacconi. [00:23:15] Speaker 03: The board looked at testimony from Dr. Bunn, looked at testimony from Dr. Gibbs. [00:23:20] Speaker 03: And the board made factual findings saying, a person born to your skill in the art would know that [00:23:27] Speaker 03: pre-clinical trial, pre-clinical studies had been done, and that patients had been treated with Arlotinib to treat NSCLC successfully. [00:23:39] Speaker 03: And that's enough for reasonable expectation of success. [00:23:43] Speaker 01: Can I ask you about Shner? [00:23:44] Speaker 01: You were mentioning it earlier. [00:23:46] Speaker 01: I read Shner as disclosing at least 105 different compounds, most of which are described as being preferred. [00:23:55] Speaker 01: And then disclosing that there's a list of indications that could be treated. [00:24:02] Speaker 01: But I don't see anywhere where it says that a latinib could be used for lung cancer. [00:24:10] Speaker 01: Nowhere do I see it linking that. [00:24:11] Speaker 01: I'm just forgetting about the non-small cell lung cancer issue. [00:24:16] Speaker 01: But am I correct in my understanding of that? [00:24:19] Speaker 01: There's no place in that reference where it links the two at all. [00:24:25] Speaker 03: I think that the Schneur reference actually claims allotinib as one of, I think, probably 43 compounds. [00:24:34] Speaker 03: Schneur also claims that these compounds, in a therapeutically effective amount in mammals, can be used to treat high prolific disorders, including lung cancer. [00:24:45] Speaker 01: So you say that the claim that's directed to erlotinib also has within it somewhere along the chain of claim elements that it treats lung cancer? [00:24:55] Speaker 03: Is that how you're connecting them? [00:24:57] Speaker 03: I think if we look at the claims themselves, we see the therapeutically effective amount in mammals. [00:25:02] Speaker 03: And we also see that some of the conditions listed, one of those being lung cancer. [00:25:07] Speaker 03: We also have disclosure in several spots in Schnurr where the compounds could be used to treat lung cancer. [00:25:14] Speaker 03: The therapeutically effective amount that's given in Schnurr is the effective dosage amount that is given in the 2-2-1 patent for that particular. [00:25:23] Speaker 03: If we do a gram factor analysis and we look at the second gram factor and we look at the scope of the prior art compared to the challenge claims, if we look at what the challenge claims require, it only requires therapeutically effective amount in mammals. [00:25:38] Speaker 03: It doesn't require phase two, phase three studies. [00:25:42] Speaker 03: It doesn't require clinical efficacy in humans. [00:25:44] Speaker 03: If you look at the 2-2-1 specification itself, it only has preliminary data from a phase two trial where the inventors, the only conclusion they can make is that Orlatan is active in NSCLC. [00:25:58] Speaker 03: And when Dr. Bunn was asked about such preliminary data, he said, that's not enough information to a person with a skill in the art to determine whether it was effective in treating humans, NSCLC in humans. [00:26:11] Speaker 03: And so when we look at that second grand factor, and we look at what's required for disclosure of the prior art, we see that Schneer has everything you need except for the identification of NSCLC. [00:26:23] Speaker 03: And you have contemporaneous references. [00:26:26] Speaker 04: From a medical point of view, using the compound for the right condition seems like not a small thing. [00:26:35] Speaker 04: I'm sorry, using the compound for the right condition as opposed to a different condition seems like not a small detail. [00:26:44] Speaker 03: I think the compound among is a preferred compound that is listed as a therapeutically effective amount to treat lung cancer. [00:26:54] Speaker 03: And what the case law tells us is that Schnurr is enabled for everything it discloses. [00:27:01] Speaker 03: OSI never argued before the board that Schnurr was not enabled. [00:27:06] Speaker 03: So it's enabled for a therapeutically effective amount in mammals to treat lung cancer. [00:27:11] Speaker 03: The only thing missing is the NSCLC. [00:27:13] Speaker 03: And looking at GILBS, looking at OSIs 10K, they specifically point out NSCLC. [00:27:23] Speaker 03: And so in view of those, looking at Schneer, in view of those two references, it's right there, right there for a person of ordinary skill in the art, given what the challenge claims. [00:27:34] Speaker 00: It's there if you put them together, knowing what happened. [00:27:39] Speaker 03: So a person of ordinary skill in the art, looking at those three references, they would have combined those references because they all deal with EGF. [00:27:47] Speaker 00: But they didn't combine them. [00:27:50] Speaker 03: The person of ordinary skill. [00:27:51] Speaker 00: This patentee combined them. [00:27:53] Speaker 03: The Gibbs and OSI's 10-K were never before the patent office, only Schnurr. [00:28:00] Speaker 03: And when faced in prosecution with Schnurr, the only argument that OSI made against the Schnurr rejection was that Schnurr did not disclose an SCLC. [00:28:12] Speaker 03: Gibbs and OSI's 10-K give us that information, specifically about erlotinib. [00:28:18] Speaker 03: They give us the information that an SCLC is the cancer [00:28:22] Speaker 03: that is of two lung cancers. [00:28:24] Speaker 03: There's only two, SCLC and NSCLC. [00:28:27] Speaker 03: Not a big genus. [00:28:29] Speaker 03: Only two. [00:28:30] Speaker 03: And a person of ordinary skill in the art, knowing at that particular time that 80% of lung cancers are NSCLC. [00:28:38] Speaker 03: And the only one that overexpresses the EGF receptor is NSCLC. [00:28:44] Speaker 03: So you're looking at the disclosure of SNR and saying, hey, look at this as lung cancer. [00:28:49] Speaker 03: It's probably NSCLC. [00:28:51] Speaker 03: And then you get Gibbs and OSI's 10K, and they say, yes it is. [00:28:55] Speaker 03: It is an SCLC. [00:28:56] Speaker 03: That is what it is. [00:28:58] Speaker 00: But they didn't do the clinical trials. [00:29:00] Speaker 00: They didn't proceed with the FDA approvals. [00:29:04] Speaker 00: This is the problem, is it not? [00:29:07] Speaker 00: Where the line is drawn when there is such a significant distinction in terms of a combination of the public benefit and the cost of proceeding to serve the public. [00:29:23] Speaker 03: I think that the, from Gibbs, [00:29:26] Speaker 03: person with a skill in the art would look at that statement and say, pre-clinical trials were done, and patients were treated within SCLC successfully by an SCLC. [00:29:37] Speaker 03: That's enough for a reasonable expectation of success when you look at Gibbs and when you look at Schnurr together. [00:29:44] Speaker 03: And I think the fact that Schnurr is enabled for all that it discloses, has a therapeutically effective amount to treat mammals, the same disclosure as in the 221 patent, and it has lung cancer, [00:29:56] Speaker 03: that it can't be ignored, that it is enabled for everything it discloses, and that efficacy data is not required for looking at Schnur. [00:30:10] Speaker 00: And now you've exhausted your colleague's time. [00:30:13] Speaker 00: Do you still want us to hear from him for a couple of minutes? [00:30:19] Speaker 03: Yes, Your Honor, if that's OK. [00:30:22] Speaker 03: Thank you for your time. [00:30:23] Speaker 00: Thank you. [00:30:30] Speaker 00: That's good. [00:30:32] Speaker 02: Good morning. [00:30:32] Speaker 02: May it please the court? [00:30:33] Speaker 02: Dennis Vann on behalf of the United States on the constitutional issues in which we've intervened on. [00:30:39] Speaker 02: Obviously, this court has heard many of these issues a number of times already. [00:30:43] Speaker 02: And so if there are no questions, I'd just briefly like to address the waiver point. [00:30:50] Speaker 02: In many of these cases, in which... Waiver of what? [00:30:54] Speaker 04: waiver by not presenting arguments before the board, and of course it's the... And this is about the retroactivity of the IPR regime, how that fits with oil states and other issues. [00:31:07] Speaker 04: This is not the case-specific issue. [00:31:09] Speaker 00: You're telling us the official position of the United States is any argument that's not raised explicitly and fully developed is deemed waived as a matter of national policy or what? [00:31:24] Speaker 02: No, I mean every one of these questions is case specific. [00:31:28] Speaker 02: This court obviously has discretion to excuse waiver in any of these cases and the government has, you know, submitted a fully developed brief for the purpose of this court resolving these questions in any given one of these cases. [00:31:42] Speaker 00: Let me ask you a question about waiver in that case. [00:31:46] Speaker 00: Here we have a situation in which [00:31:50] Speaker 00: the government has granted a property right. [00:31:54] Speaker 00: We can debate whether it's personal property or a franchise or whatever. [00:31:58] Speaker 00: It is a federal grant. [00:32:00] Speaker 00: The same agency that granted it now comes forward and says, we made a mistake, that we shouldn't have done so. [00:32:09] Speaker 00: That's the decision, which is being appealed. [00:32:11] Speaker 00: We made a mistake. [00:32:13] Speaker 00: In that case, when the United States comes forward and [00:32:19] Speaker 00: confesses an error, concedes that they made a mistake on which the patentee relied to the tune of I don't know how many billions of dollars through the clinical phases. [00:32:34] Speaker 00: What is the government's responsibility for that mistake? [00:32:38] Speaker 00: We've crossed the bridge that there is an opportunity in the law for this agency to correct its mistake. [00:32:49] Speaker 00: Why is this any different from any other Fifth Amendment liability for government action that is obligatory? [00:33:02] Speaker 00: You mentioned it in your briefs, so obviously you've thought about it. [00:33:06] Speaker 02: I'm happy to address, and I take it to be some type of due process or takings, you know, concern that you're raising here, but of course there's Patlex in this court already controls both the due process and the taking. [00:33:19] Speaker 00: Patlex did not deal with, Patlex said that it was not forbidden for the agency to correct its mistake. [00:33:28] Speaker 00: Patlex did not raise the question of having corrected the mistake. [00:33:34] Speaker 00: shouldn't the government face the consequences of its error? [00:33:38] Speaker 02: Right. [00:33:38] Speaker 02: And I don't think there's any type of claim here that the government should somehow pay money or to face other types of... Then why did you brief it? [00:33:47] Speaker 00: If there's no claim, why did you brief the Fifth Amendment? [00:33:50] Speaker 02: Because in the opening brief in this case, they've raised constitutional challenges. [00:33:54] Speaker 02: This court [00:33:55] Speaker 02: issued a Rule 44 certification asking the government whether they would intervene to address the constitutional challenge in this case. [00:34:03] Speaker 02: Their theory is that because there would be some sort of due process or takings issue, that the government's IPR action couldn't proceed at all, that the government couldn't even go through inter partes review. [00:34:16] Speaker 02: not that there should be some back-end consequence against the government once Interparte's review is completed. [00:34:22] Speaker 00: We have a specific commitment that was made in reliance on the government action. [00:34:29] Speaker 02: And I understand that, of course, when somebody has issued a patent, they do have some type of, you know, they have a property interest, they use that, they've gained the benefit of that for a number of years, [00:34:42] Speaker 02: whenever a patent owner receives a patent, they have the benefit of that patent. [00:34:46] Speaker 02: And that patent is only finally taken away, if you want to call it in those terms, until- I think we can discontinue the argument. [00:34:57] Speaker 02: Thank you. [00:34:59] Speaker 02: If there are no further questions, please, the court should defer. [00:35:01] Speaker 00: Thanks. [00:35:04] Speaker 00: You have your rebuttal time. [00:35:08] Speaker 05: I want to circle back to a few points on the investigative brochure, this hypothetical evidence that's being relied on. [00:35:15] Speaker 05: I mean, we're talking about something that's not in the record and wouldn't even be in the prior art. [00:35:21] Speaker 05: And so the backfilling that's being done, this testimony from our expert Dr. Bunn, as I think has been clearly revealed here, is not in any way saying there were [00:35:34] Speaker 05: pre-clinical evidence regarding non-small cell lung cancer. [00:35:39] Speaker 04: And there isn't a... I've got, I think, two questions, like a little bit of clarification on, probably unrelated to each other. [00:35:49] Speaker 04: So by the time of this, by the time of the priority date here, there might have been, there would have been pre-clinical testing, but there was also the phase one testing. [00:36:01] Speaker 04: I understand, I think that there's an argument that was made that the preclinical testing would have had some relevant data. [00:36:13] Speaker 04: It was an argument made that the phase one process would have had relevant data. [00:36:20] Speaker 05: Right, an argument was made. [00:36:22] Speaker 05: The board didn't base its decision on that, and for good reason, which is there's no disclosure in the prior art that there were non-small cell lung cancer patients treated in phase one. [00:36:33] Speaker 05: The only evidence that was offered was the Hidalgo reference. [00:36:36] Speaker 04: The post-priority date thing. [00:36:38] Speaker 04: Exactly. [00:36:38] Speaker 05: The board said that's not prior art. [00:36:39] Speaker 04: All right, so my second point of clarification, and I may not quite understand, [00:36:47] Speaker 04: what the argument was on the other side, but I thought it was something like this. [00:36:54] Speaker 04: Schnurr says for some class of conditions, lung cancer, you can use this, presumptively enabled, put that aside for a minute, [00:37:11] Speaker 04: There are kind of two classes within that lung cancer, the small cell and the non-small cell. [00:37:18] Speaker 04: When you combine it with the 10K that says you're investigating the non-small cell, [00:37:27] Speaker 04: Isn't that enough all by itself, not only to put the idea in your head, in the skilled artisan's head, that you might use this for the, you know, the non-small cell lung cancer, but also when combined with what Schneer says or legally implies about enablement to give you a reasonable expectation of success? [00:37:52] Speaker 05: Is that coherent? [00:37:53] Speaker 05: No, right. [00:37:53] Speaker 05: I understand the question. [00:37:55] Speaker 05: And just to be clear on the contours of Schneer, [00:37:57] Speaker 05: The only disclosures in Schneer regarding treatment are the generic disclosures about compound 1. [00:38:05] Speaker 05: So you're talking about a genus of more than a thousand compounds and a list of at least 18 [00:38:12] Speaker 05: conditions. [00:38:14] Speaker 05: And so this court has recognized in the UCB case, we cite in our brief, that there still is a leap to be made from going from a presumption of enablement of a genus to a reasonable expectation of [00:38:30] Speaker 05: Success and I'd submit judge still your your opinion a few weeks ago in Novartis B. Westward had a similar dynamic there you had the 7-7-2 patent disclosed derivatives of rapamycin including everolumus and it disclosed that these would be useful in treating tumors, but the leap isn't made from [00:38:52] Speaker 05: from that fact to getting down to the specific treatment. [00:38:55] Speaker 05: And so what we have in Schneer is we have no disclosure, erlotinib is disclosed as a compound, and claimed as a compound. [00:39:04] Speaker 05: No disclosure specifically about erlotinib treating anything, and only this broad genus disclosure that's a prophetic disclosure. [00:39:14] Speaker 05: And their own expert, when talking about the disclosure in Schneer, [00:39:20] Speaker 05: said here that, well, you know, people quote, and this is Appendix 4541, people quote, cast a broad net so they would indicate, like in these cases, several tumor types, and then eventually they will test it. [00:39:34] Speaker 05: So when you're talking about how is someone who's making this decision about do I have a cancer treatment here going to Regener, [00:39:41] Speaker 05: that scene is just a prophetic genus claim that that's not it's hindsight to be drilling down specifically to her not nip and lung cancer and then as for OSI and the others to fill it in I think one thing we want to be clear on is [00:39:55] Speaker 05: OSI talks about potentially targeting. [00:39:58] Speaker 05: I'm sorry, the 10K? [00:40:00] Speaker 05: Sorry, the 10K, yes. [00:40:01] Speaker 05: Sorry, the 10K talks about potentially targeting a lot of conditions. [00:40:06] Speaker 05: Even in the 10K, when it talks about entering phase two, even that doesn't say we're going into phase two for non-small cell lung cancer. [00:40:16] Speaker 05: And so you can see this at 4562 in the appendix. [00:40:21] Speaker 05: This was questioning Aputex's expert question. [00:40:24] Speaker 05: And the OSI 10K does not specify which indication is being pursued in the phase two clinical trial for CP358774. [00:40:32] Speaker 05: That's our lot nip. [00:40:34] Speaker 05: Correct? [00:40:35] Speaker 05: Answer, that's correct. [00:40:38] Speaker 05: So it's a double dose of hindsight here to be reading that [00:40:45] Speaker 05: for more than it discloses and then to be working backwards on Schneur. [00:40:48] Speaker 05: And it's well established in this court that you can have species claims issue over genus claims. [00:40:56] Speaker 05: And so I think if we follow this path that is taking the leap from the presumption of enablement on the broad genus of [00:41:05] Speaker 05: SNR, that that's a position where I think you then presumptively don't have species claims over genus claims, which would run against a long line of precedent in this court. [00:41:19] Speaker 05: And particularly, again, when we're talking about SNR not being accompanied by any data. [00:41:25] Speaker 05: And we're not saying you have to finish your phase two clinical trials. [00:41:28] Speaker 05: We're talking about not even the most basic in vitro testing [00:41:33] Speaker 05: in an NSCLC cell line. [00:41:36] Speaker 01: You're saying in the context of the prayer here, there had to have been more testing, more data. [00:41:42] Speaker 05: Right. [00:41:42] Speaker 05: And just a final point on the expectation of success. [00:41:48] Speaker 05: The Supreme Court in KSR used the term anticipated success. [00:41:53] Speaker 05: And Judge Toronto, in your writing at the en banc denial stage in BMS Vitella, you talked about this issue and said that the phrase reasonable expectation of success requires the expectation to be reasonable, and said, quote, we've tied the reasonable expectation of success standard to the Supreme Court's use of predictable in KSR, [00:42:14] Speaker 05: That precedent suggests a higher rather than lower standard for reasonable expectation. [00:42:19] Speaker 05: And I think that's exactly right. [00:42:21] Speaker 05: And that's why you've seen in this court's cases a reference to a likelihood of success. [00:42:27] Speaker 05: Would the medical oncologist think here, I am likely to treat cancer with this compound? [00:42:34] Speaker 05: And in such an unpredictable art, with that dearth of scientific evidence we've talked about, you would not have that expectation here. [00:42:42] Speaker 05: And so the board aired its bottom line result. [00:42:45] Speaker 05: And then as we've discussed, also aired procedurally in reaching that result in terms of its approach to the prior references and what it was relying on. [00:42:58] Speaker 00: Thank you. [00:42:59] Speaker 00: Thank you all. [00:43:00] Speaker 00: The case is seconded under submission.