[00:00:25] Speaker 05: Okay, the next argued case is number 17-1671, Jazz Pharmaceuticals Incorporated against Amnial Pharmaceuticals, LLC. [00:00:36] Speaker 05: Now, Ms. [00:00:37] Speaker 05: Sullivan, we asked you both on very short notice. [00:00:42] Speaker 05: Let's start with anything that might be pertinent that we need to decide in connection with the effect of the [00:00:51] Speaker 05: recent decision in the SAS case. [00:00:55] Speaker 05: So let's talk about that, and we won't count that against your time on the merits. [00:01:00] Speaker 01: Thank you very much, Your Honor. [00:01:01] Speaker 01: And good morning, and may it please the Court. [00:01:03] Speaker 01: Kathleen Sullivan for Appellant Jazz Pharmaceuticals. [00:01:06] Speaker 01: In answer to the Court's question whether the new Supreme Court decision in SAS has any bearing on this appeal, the answer is no as to six of the seven patents at all, because all of those patents involved [00:01:20] Speaker 01: the institution of proceedings on all claims. [00:01:23] Speaker 01: So the only patent it could possibly affect is the 963, which was the only one which involved partial institution. [00:01:30] Speaker 01: And as to the 963, we respectfully submit that you have no need to send it back first, because our principal argument is that as to all seven patents, including the 963, the advisory committee art was not a publication publicly [00:01:48] Speaker 01: available and therefore was not appropriate prior art as to any of the claims. [00:01:53] Speaker 04: That's the merits. [00:01:55] Speaker 01: Exactly, Your Honor. [00:01:56] Speaker 01: That's the merits. [00:01:57] Speaker 01: If we succeed on the merits of that claim, Your Honor, there'd be nothing to send back. [00:02:00] Speaker 05: And what if you lose on the merits on that point? [00:02:03] Speaker 05: Are you waiving any further review of the other claims? [00:02:08] Speaker 01: We are not, Your Honor. [00:02:08] Speaker 01: We are not waiving. [00:02:10] Speaker 05: Well, that's what we need to know. [00:02:11] Speaker 05: Where do we stand if, in fact, you're entitled to a remand? [00:02:18] Speaker 05: To that review. [00:02:20] Speaker 01: Yes, Your Honor. [00:02:20] Speaker 01: So we believe that you should not remand because Amniel, the only petitioner before you, will waive. [00:02:27] Speaker 05: You're asking us to decide the non-instituted claims? [00:02:33] Speaker 05: We can't do that. [00:02:34] Speaker 01: Your Honor, we believe that as to the non-instituted claims, they waived their right to appeal in light of SAS by failing to ask the board to reconsider. [00:02:43] Speaker 01: The petitioners in SAS filed a motion for reconsideration on the ground that the non-instituted claims should have been reached and given them a right to appeal. [00:02:52] Speaker 01: The Amniel petitioners here did not ask for reconsideration before the board. [00:02:58] Speaker 01: So we respectfully think they waived their right to an appeal in light of SAS. [00:03:02] Speaker 03: Second, Your Honor, it's not clear to us that SAS... What about a waiver by not preserving the right to appeal the SAS decision? [00:03:13] Speaker 03: I noticed in your blue brief that you preserve the oil states issue. [00:03:19] Speaker 01: We did, Your Honor. [00:03:20] Speaker 03: But you don't preserve the SAS issue. [00:03:22] Speaker 01: Well, Your Honor, we think it would have been up to Amnial to preserve the SAS issue, and they failed to do so. [00:03:27] Speaker 01: They did not include in their red brief a paragraph as to SAS [00:03:31] Speaker 01: the way we included in our blue brief a paragraph as to oil states. [00:03:35] Speaker 01: So they had the opportunity at two junctures, one to seek reconsideration before the board, which they failed to exercise as the SAS petitioners had done before the board. [00:03:44] Speaker 01: And second, they failed to preserve their right to appeal in line with SAS. [00:03:48] Speaker 03: So your argument, and this is a preliminary issue that's before the court with respect to SAS, and that's whether we even have jurisdiction to hear the issues brought up [00:04:00] Speaker 03: if there hasn't been a preservation of the right to appeal, similar to what was done in this case for all states. [00:04:08] Speaker 01: That's right, Your Honor. [00:04:09] Speaker 01: We think that were Amniel to press you to give them a remand in light of SAS, that you should decline that on the ground that they waived twice. [00:04:19] Speaker 01: They didn't seek reconsideration as to the non-instituted claims before the board. [00:04:23] Speaker 01: And as Judge Raina, you point out, they didn't seek a contingent appeal in light of a potential claim for their side in SAS. [00:04:30] Speaker 03: We're gathering information, so I don't mean to be facetious by this question. [00:04:34] Speaker 03: But if you were on the other side, would your argument be the same? [00:04:37] Speaker 01: Your Honor, if I were on the other side, I would say SAS gives us a do-over. [00:04:41] Speaker 01: But on my side, I have to say I'm sorry it's too late. [00:04:44] Speaker 01: You didn't ask for anything that would have preserved your right to a do-over. [00:04:48] Speaker 01: You didn't seek reconsideration of the non-institutional claims before the board when you had the opportunity to do so. [00:04:53] Speaker 01: And you didn't preserve a contingent appeal right in your red brief. [00:04:58] Speaker 01: So I think they're one and done, Your Honor. [00:05:00] Speaker 01: If you do, however, disagree with us. [00:05:02] Speaker 03: Do you see something in the SAS Supreme Court decision that supports your position? [00:05:06] Speaker 01: Your Honor, unfortunately, the Supreme Court decision is cryptic on prospective versus retroactive effect. [00:05:12] Speaker 01: We do, however, know what the board thinks about prospectivity. [00:05:15] Speaker 01: The board issued guidance on April 26 in which the board said, faced with a backlog of cases, that it will regard SAS as binding prospectively on new proceedings in which they will have to institute on all claims or none. [00:05:29] Speaker 01: But the board expressly said that as to pending claims in the docket in which final trial resolution has not occurred, they may take into account the need to institute on... Well, we don't take our instructions from the board. [00:05:45] Speaker 05: I know you don't, Your Honor. [00:05:46] Speaker 05: Let's hear from the other side on this point. [00:05:57] Speaker 05: Let's see, you're not Mr. Maddox? [00:06:00] Speaker 05: Okay. [00:06:04] Speaker 02: With respect to SAS, it seems to us that we've come this far on the claims that it was instituted on. [00:06:13] Speaker 02: We should rule on those. [00:06:14] Speaker 02: Those are properly before you. [00:06:16] Speaker 02: And that the world would just have to go on with the non-institution and the district court litigation will continue. [00:06:25] Speaker 02: That would be ours. [00:06:26] Speaker 04: Did the PTO have jurisdiction [00:06:29] Speaker 04: to act contrary to what the Supreme Court now says the statute means. [00:06:37] Speaker 02: In partially instituted? [00:06:40] Speaker 04: Yes. [00:06:41] Speaker 02: Did they have authority to do it? [00:06:46] Speaker 02: It would seem to suggest the statutory authority wasn't there if the Supreme Court says that. [00:06:52] Speaker 02: But we didn't. [00:06:54] Speaker 02: They didn't do it. [00:06:55] Speaker 02: We did go through the litigation process before the board. [00:06:58] Speaker 02: They did issue an opinion on these three claims from 936. [00:07:02] Speaker 02: And we've all briefed it up to here. [00:07:04] Speaker 02: There comes a point when you can't retroactively undo what's done and fully briefed and already litigated. [00:07:11] Speaker 02: So that's what we're doing. [00:07:13] Speaker 04: What about Ms. [00:07:14] Speaker 04: Sullivan's assertion that you waived the SAS issue? [00:07:21] Speaker 02: We don't agree with that. [00:07:22] Speaker 02: It came down when it came down. [00:07:25] Speaker 02: It doesn't really matter to us. [00:07:28] Speaker 02: It seems that we should finish this litigation that came out of the PTO. [00:07:32] Speaker 02: And there's a district court litigation that's been state pending this. [00:07:36] Speaker 02: And then when this is done, we go with what we got. [00:07:39] Speaker 03: Let's look at this. [00:07:40] Speaker 03: There's a district court litigation pending, awaiting the decision in this case. [00:07:46] Speaker 03: Yes. [00:07:47] Speaker 03: But apparently, the Supreme Court has said to the PTO, you have to institute on all the claims that are raised, correct? [00:07:56] Speaker 02: That's what the Supreme Court said, yes? [00:07:57] Speaker 03: Well, if that's true and we send it back for the PTO to look at all the claims that were raised and to issue a final written decision on all the claims that were raised, what is there left for the district court to do? [00:08:13] Speaker 02: If you do that, then the district court will be hearing non-infringement of these patents and Section 112 issues on these patents. [00:08:22] Speaker 02: But there would be nothing left to do on obviousness. [00:08:29] Speaker 02: I'm sorry, you seem dissatisfied. [00:08:32] Speaker 03: How can I... No, I wasn't satisfied by your answer. [00:08:35] Speaker 03: If all the claims that are raised have to be decided by the PTO and they have to issue a final written decision, and that's another question, whether they do or not, then why is a district court litigation still pending? [00:08:54] Speaker 02: Because there's non-imprisonment defenses to these patents. [00:08:59] Speaker 03: That's the only reason? [00:09:07] Speaker 05: Yes. [00:09:08] Speaker 05: Okay. [00:09:08] Speaker 05: Okay, we'll figure it out. [00:09:09] Speaker 05: Thank you. [00:09:10] Speaker 05: Okay, so let's proceed with the merits of the appeal. [00:09:19] Speaker 05: Ms. [00:09:19] Speaker 05: Sullivan. [00:09:20] Speaker 01: Thank you, Your Honors. [00:09:21] Speaker 01: I hope maybe we can moot the SAS problem by persuading you to agree with us on the merits of the [00:09:28] Speaker 01: ACA, the advisory committee, art materials failing to constitute publicly accessible prior art and therefore failing to provide a basis for the obvious misconduct here. [00:09:41] Speaker 04: Well, there was notice in the Federal Register and there was an FDA website. [00:09:45] Speaker 04: And isn't the Federal Register exactly the place where you want to give notice to the world? [00:09:51] Speaker 01: Well, Your Honor, the question is notice of what? [00:09:57] Speaker 01: Let's go back to this court's decision in Inray Lister, which I think is very helpful. [00:10:02] Speaker 01: And that's the case about a copyright reference not being publicly accessible, even though the deposit copy was on file with the Copyright Office. [00:10:11] Speaker 01: And you might think you go to the Copyright Office to find notice to the world. [00:10:15] Speaker 01: But importantly, Lister breaks the inquiry down into several steps. [00:10:19] Speaker 01: When we're looking for publication prior art, first we ask, does it exist? [00:10:23] Speaker 01: Second, we asked, does a person of interest and ordinary skill in the art have a motivation to look for it there, an incentive to look for it there? [00:10:32] Speaker 01: And crucially, Lister said, we don't stop at step two. [00:10:35] Speaker 01: We go on to step three. [00:10:37] Speaker 01: And step three is, could the person of ordinary skill in the art have located it there? [00:10:42] Speaker 04: That's even more than Mayo. [00:10:44] Speaker 01: Step three. [00:10:45] Speaker 01: Well, you're right. [00:10:46] Speaker 01: Break it down into two. [00:10:46] Speaker 04: But look, someone goes to the FDA website if they're interested in this field. [00:10:52] Speaker 01: Your Honor, I hear you on that. [00:10:53] Speaker 01: But we're not disputing the factual question of whether a person of ordinary skill would go to the Federal Register or go to the FDA website. [00:11:03] Speaker 01: We're focusing solely on the legal error the board committed. [00:11:07] Speaker 01: When it got to the step, Lister said, we don't stop the inquiry with is it there and would POSA go there. [00:11:13] Speaker 01: We ask whether it's POSA could have located it there. [00:11:17] Speaker 01: And just because it's on a single page of the Federal Register, [00:11:20] Speaker 01: page 24,391 out of the 67,702 pages. [00:11:23] Speaker 01: It doesn't mean you can find it. [00:11:28] Speaker 03: We all live and work in Washington, DC. [00:11:30] Speaker 03: And we're all familiar with the Federal Register. [00:11:32] Speaker 03: Yes, Your Honor. [00:11:33] Speaker 03: And if you want to know what's going on with a particular agency, you consult the Federal Register. [00:11:39] Speaker 03: I'm sure you have people in your law firm that are dedicated to looking at every Federal Register notice that comes out every day so that you may inform your clients. [00:11:50] Speaker 01: Your Honor? [00:11:50] Speaker 01: Let's go back to the cases. [00:11:52] Speaker 01: I'd ask you to look at appendix pages 33 and 34 and look what the court did. [00:11:58] Speaker 01: The court didn't say that the person of skill has a way to find that reference to the FDA website in the register. [00:12:04] Speaker 01: And by the way, we're back in 2001. [00:12:07] Speaker 01: Internet is still in its infancy. [00:12:09] Speaker 01: There was no evidence in the record that the federal register was online. [00:12:14] Speaker 01: or was indexed or searchable in a way that could have led you? [00:12:16] Speaker 03: Well, the Federal Register, part of the Federal Register are its indexes. [00:12:22] Speaker 03: And in 2001, now I'm just saying this from my own personal experience, I can go back to 1992 maybe or even earlier and know that the Federal Register had alphabetical and subject matter indexes. [00:12:37] Speaker 01: Your Honor, there's no evidence in the record about indexability or searchability of the Federal Register. [00:12:42] Speaker 01: It's a chronological document. [00:12:43] Speaker 01: It goes by page. [00:12:44] Speaker 01: And there was no evidence that there was evidence that a person of skill in the art might look to the Federal Register. [00:12:50] Speaker 01: But the Federal Register is like the library in the old library cases. [00:12:54] Speaker 01: You still need a card catalog or an index to get you to the single page where the FDA website was referenced. [00:13:00] Speaker 01: And there was no evidence in the record that there was indexability or searchability [00:13:05] Speaker 01: as of 2001. [00:13:06] Speaker 01: I'm sure that Amniel's expert would have put in such evidence if it existed, but there wasn't. [00:13:11] Speaker 01: So what did the court do? [00:13:14] Speaker 03: Sorry, what did the board do? [00:13:15] Speaker 03: Since we're dealing with a federal publication that's widely distributed and has a long established history of providing governmental notices, is this something we could take judicial notice of? [00:13:28] Speaker 01: Your Honor, you could take judicial notice of the existence of this page. [00:13:31] Speaker 03: No, the indexes. [00:13:34] Speaker 03: That there were indexes to the Federal Register in 2001. [00:13:40] Speaker 01: That the fact that there were indexes, Your Honor, if there were, of course you could. [00:13:44] Speaker 01: But there is no evidence of which you could take judicial notice that somebody looking for a risk management hearing about the drug Zyrem, an important narcolepsy treatment that has to be controlled because it's subject to abuse and diversion. [00:13:57] Speaker 03: But you would be looking for FDA advisory committee meetings. [00:14:02] Speaker 01: So Your Honor, there was no evidence of index searchability in the Federal Register as of 2001 in the record. [00:14:09] Speaker 01: If you take judicial notice of the availability of indexing of FDA proceedings, that's still not enough, because it doesn't get you to ZIRM. [00:14:16] Speaker 01: It doesn't get you to risk management. [00:14:18] Speaker 01: There's a lot of things about the FDA that happened. [00:14:20] Speaker 01: It doesn't get you to this page. [00:14:22] Speaker 03: Does it get you to the ACA materials? [00:14:24] Speaker 01: It does not, Your Honor. [00:14:25] Speaker 01: The ACA materials themselves. [00:14:27] Speaker 01: Let me break it into two parts. [00:14:29] Speaker 01: Our main argument, and here I really do want the court to focus on the one page in the board's reasoning about locatability. [00:14:37] Speaker 01: You can find it, for example, on appendix pages 33 to 34. [00:14:42] Speaker 01: And when you get there, you're not going to find any law of this court. [00:14:45] Speaker 01: You're going to find references to regional circuit law about constructive notice the Federal Register gives to stop people from making due process claims against the government. [00:14:57] Speaker 01: The one site to this court's predecessor court in the Aris Gloves case is not a patent case. [00:15:03] Speaker 01: It's a case about a customs tariff announcement. [00:15:06] Speaker 01: So what the court did, and this is the key argument, Your Honor, they skipped the crucial step, would a person of ordinary skill exercising reasonable diligence, which is a fact question, find this one page in the Federal Register? [00:15:21] Speaker 01: And there's no evidence. [00:15:22] Speaker 01: a person of ordinary skill exercising reasonable diligence would have found this page. [00:15:28] Speaker 01: None. [00:15:29] Speaker 01: What the court substituted was a legal presumption that you take constructive notice of the Federal Register for due process purposes against the government. [00:15:39] Speaker 01: Therefore, let's transpose that over to patent law to Section 102 and Section 103 for purposes of prior publication, prior art, and obviousness. [00:15:48] Speaker 01: And let's just say anything that ever showed up anywhere in a link anywhere in the Federal Register satisfies reasonable diligence. [00:15:55] Speaker 01: With respect, we think this court's requirement, Kyocera, Lister, unbroken line of cases, this court's requirement that to be prior rendering a patent obvious, the publication has to have been locatable through reasonable diligence. [00:16:12] Speaker 01: And that's a fact. [00:16:13] Speaker 03: Wasn't there evidence that the internet archive [00:16:16] Speaker 03: had links to the ACCA materials that were posted on the FDA website in June of 2001? [00:16:21] Speaker 01: The board found, as a matter of fact, that there was an existence on the internet as of June of 2001. [00:16:29] Speaker 03: There was a link to the ACCA materials. [00:16:31] Speaker 01: Correct, Your Honor. [00:16:32] Speaker 03: And so what I am arguing... Is that a factual finding? [00:16:36] Speaker 03: It is. [00:16:36] Speaker 03: That we would review for substantial evidence? [00:16:38] Speaker 01: You would, Your Honor. [00:16:39] Speaker 03: Why is that not substantial evidence? [00:16:41] Speaker 01: That is substantial. [00:16:42] Speaker 03: I want you to... Was this disputed? [00:16:45] Speaker 01: Yes, it was disputed, Your Honor, but I'm not contesting that up, as a matter of fact. [00:16:49] Speaker 01: I'm not going to take on that fight. [00:16:50] Speaker 01: I'm not going to take on the fight. [00:16:51] Speaker 01: Let's break it. [00:16:52] Speaker 01: If three steps is too many, Your Honor, let's make it two. [00:16:56] Speaker 01: Would a person of skill in the art have wanted to find it in the Federal Register where it exists? [00:17:00] Speaker 01: And second, would the person of skill in the art have been able to find it in the Federal Register if he went there? [00:17:05] Speaker 01: Is there a library and it's on the shelf? [00:17:08] Speaker 01: And is there a catalog and an index that leads him to find it? [00:17:11] Speaker 01: We're fighting only on step two. [00:17:13] Speaker 01: I'm not going to fight you on step one, substantial evidence, leave it to the board. [00:17:16] Speaker 01: But I am fighting you on step two, because what the board did was a legal error. [00:17:20] Speaker 01: It substituted constructive notice from the due process context for reasonable diligence of the person of skill. [00:17:27] Speaker 01: And it ran reasonable diligence out of your patent law. [00:17:30] Speaker 01: And you should not be the first panel to decide that as a matter of patent law, constructive notice. [00:17:35] Speaker 03: This isn't constructive notice the way [00:17:38] Speaker 03: this court has viewed constructive notices. [00:17:40] Speaker 03: This is an actual printed publication that appears daily, wherein important meetings of federal agencies are noted, including the FDA. [00:17:53] Speaker 01: That's correct, Your Honor. [00:17:54] Speaker 01: And by the way, the prior art isn't, of course, the notice. [00:17:57] Speaker 01: The asserted prior art is the ACA materials. [00:18:00] Speaker 03: So how is this constructive notice then? [00:18:02] Speaker 01: Well, because if you look at pages 33 and 34, [00:18:07] Speaker 01: trouble, Your Honors, just to read you. [00:18:11] Speaker 01: All six opinions are identical on this point, so we can just take any one of them to find the error. [00:18:17] Speaker 01: The error happens on the carryover from Appendix 33 to 34, where the board says, the Federal Register provides notice to interested individuals of the actions of federal agencies [00:18:29] Speaker 01: And therefore, that is legally sufficient notice, page 34, legally sufficient notice to satisfy reasonable diligence. [00:18:37] Speaker 01: We think that's not right. [00:18:38] Speaker 01: We think reasonable diligence for a person of skill in the art, here a person with pharmaceutical background and some computer skill who understands controlled distribution systems, a person of skill in the art doesn't live every day to look at the Federal Register, which is chronological [00:18:55] Speaker 01: No evidence it was indexed or searchable in the record. [00:18:58] Speaker 01: Your honor may decide to take judicial notice, but you still won't find a judicially noticeable availability of this hearing out there in the world, Xiram Risk Management. [00:19:09] Speaker 01: The other side's expert admitted he was thumbing through a paper copy, and he didn't actually know of other risk management references involving this drug, Xiram, elsewhere in the 2001 list. [00:19:21] Speaker 01: What we are asking you to do is correct the board's legal error. [00:19:25] Speaker 01: of substituting constructive notice of the Federal Register for reasonable diligence standard. [00:19:30] Speaker 01: And Your Honor, this is not a case where the prior art was disseminated in the Federal Register. [00:19:36] Speaker 01: All that was disseminated in the Federal Register, we would argue without an ability to find it, was a treasure map clue that said X marks the spot. [00:19:46] Speaker 01: Go find the prior art in the FDA website. [00:19:49] Speaker 01: And I want to be very clear on one thing. [00:19:51] Speaker 01: Before you is not a possible alternative argument [00:19:55] Speaker 01: that the ACA materials themselves were available in a prior publication. [00:20:00] Speaker 01: There was no evidence in this case, none, much less substantial, that the ACA materials themselves, the transcript of the June 6 hearing, the materials that Jazz Pharmaceutical's predecessor submitted to the hearing, there's no evidence that that was available in a way that a post-it could have located. [00:20:18] Speaker 01: None. [00:20:18] Speaker 01: In fact, Amiel's expert conceded, if you look at the key evidence the board relied on, [00:20:25] Speaker 01: The board on A33 to A34 refers to the amnial expert Dr. Vallek's declaration, exhibit 1007 at paragraph 47. [00:20:36] Speaker 01: You can read it yourself on appendix 9292 to 9293. [00:20:39] Speaker 01: He said, the only thing I'm saying was published was the Federal Register. [00:20:45] Speaker 01: And in fact, the District of New Jersey has found that the ACA materials themselves were not prior publication. [00:20:52] Speaker 01: So this case all comes down to whether the Federal Register itself gives rise to constructive notice of a clue to find the prior art. [00:21:01] Speaker 04: Was there a German thesis that was not readily retrievable? [00:21:08] Speaker 01: Is it like a German thesis? [00:21:10] Speaker 04: Yeah. [00:21:10] Speaker 04: I mean, do we have an old case like that? [00:21:12] Speaker 01: You have a lot of them, Your Honor. [00:21:13] Speaker 01: I would say that this is exactly like Bayer. [00:21:15] Speaker 01: You're thinking of the buyer case. [00:21:16] Speaker 04: The buyer case, yeah. [00:21:17] Speaker 01: The buyer case. [00:21:18] Speaker 01: It's just like the buyer case. [00:21:19] Speaker 04: That's in your favor, aren't you? [00:21:20] Speaker 01: In our favor. [00:21:21] Speaker 01: It's just like Cronin. [00:21:22] Speaker 01: And crucially, Your Honor, it's just more recently in the web world, it's just like Blue Calypso against Groupon. [00:21:28] Speaker 01: It's just like that because there the board found there was no public accessibility to a document that wasn't obtainable. [00:21:36] Speaker 01: It might have been on the web somewhere, but there was no way to locate it. [00:21:38] Speaker 01: And you affirmed the findings of the board on that. [00:21:41] Speaker 04: And your point is that [00:21:43] Speaker 04: Maybe the Federal Register is public notice, but it didn't have the reference in it. [00:21:48] Speaker 01: That's right. [00:21:49] Speaker 01: It had no way to find the reference, Your Honor. [00:21:52] Speaker 05: Well, it had the links. [00:21:53] Speaker 05: Did it not? [00:21:54] Speaker 05: It had the links to the information in the Federal Register. [00:21:58] Speaker 01: That's correct, Your Honor. [00:21:59] Speaker 01: It did have the links. [00:22:01] Speaker 01: But there was no way to find the single page. [00:22:04] Speaker 01: It's a needle in the haystack problem. [00:22:06] Speaker 01: It's a German thesis. [00:22:06] Speaker 03: You're not arguing that the ACA materials were not in the Federal Register. [00:22:10] Speaker 03: You're arguing that it's difficult or impossible to find them. [00:22:14] Speaker 01: That's exactly right. [00:22:15] Speaker 01: You're right. [00:22:16] Speaker 03: Where X marks a spot, that X is the ACA materials. [00:22:21] Speaker 01: No, it's not the materials. [00:22:22] Speaker 01: It's a link to the materials, Your Honor. [00:22:24] Speaker 01: But assuming that the link to the materials is enough, you couldn't find X marks the spot. [00:22:29] Speaker 01: And the reason is there's no substantial evidence that the Federal Register was online, indexable, or searchable. [00:22:34] Speaker 01: We have a back to the future problem here. [00:22:37] Speaker 03: Does it have to be online? [00:22:40] Speaker 01: Oh, no, Your Honor. [00:22:40] Speaker 01: We're not suggesting any categorical rule here that it has to be online or that it has to be indexable or searchable. [00:22:46] Speaker 01: What we are suggesting is, [00:22:47] Speaker 01: This record is devoid of substantial evidence of locatability. [00:22:52] Speaker 01: We're in the German, the thesis in the German library, or the thesis in the Reed College library, or the private blog page that wasn't accessed. [00:23:01] Speaker 01: We're in that world. [00:23:02] Speaker 01: We're not in a world where you can leap that chasm of locatability by constructive notice of the Federal Register. [00:23:09] Speaker 03: So assuming that indexes are available, is it your argument that [00:23:14] Speaker 03: had you used those indexes that you would not have found the material? [00:23:18] Speaker 01: Our argument is there's no evidence that those indexes existed or that had you used them, you could have found them. [00:23:23] Speaker 01: So yes, that is our argument. [00:23:24] Speaker 01: Our argument is that Amniel would have had to show not the mere existence of the Federal Register page. [00:23:30] Speaker 01: Thesis existed in the German Library. [00:23:32] Speaker 01: Thesis existed in Reed College. [00:23:34] Speaker 01: Private blog posting was up. [00:23:36] Speaker 01: There has to be some method the person of skill and the art would have been able to use to find it. [00:23:41] Speaker 01: There wasn't here. [00:23:42] Speaker 01: And where I really think the key is, Your Honors, is it would be a major change in the law for this panel to announce for the first time that constructive notice of the Federal Register, look at those pages on A, cases cited on A34. [00:23:55] Speaker 01: They're out of circuit cases about due process. [00:23:58] Speaker 01: Somebody says, I didn't know you were going to have the train go across my property. [00:24:02] Speaker 01: And the courts say, out of circuit. [00:24:04] Speaker 01: Yes, you did. [00:24:05] Speaker 01: It was in the Federal Register. [00:24:06] Speaker 01: Those due process cases should not be used. [00:24:09] Speaker 01: to eliminate the reasonable diligence requirement that your court has established, as a matter of fact. [00:24:14] Speaker 01: That would be a major change in the law, and you should reverse. [00:24:17] Speaker 01: I'll leave the other arguments to the briefs unless the court has questions. [00:24:21] Speaker 01: Thank you. [00:24:22] Speaker 05: Well, not at the moment. [00:24:23] Speaker 05: We'll save you a bit of time to solve it. [00:24:25] Speaker 01: Thank you, Your Honor. [00:24:34] Speaker 05: Mr. Maddox? [00:24:40] Speaker 02: We're not asking you to hold the constructive notice. [00:24:45] Speaker 02: It's the same thing as something that's publicly accessible by a motivated person of ordinary skill in the art, exercising reasonable diligence. [00:24:53] Speaker 02: The board didn't hold that. [00:24:55] Speaker 02: We're not asking you to hold that. [00:24:57] Speaker 02: The area of what is a printed publication is, of course, a question of law with underlying questions of fact. [00:25:05] Speaker 02: One of those questions of fact, as Ms. [00:25:07] Speaker 02: Sullivan said, [00:25:08] Speaker 02: is whether you meet the standard that it's either disseminated or otherwise made available to the extent the person's interested and skilled in the art. [00:25:17] Speaker 04: But doesn't it have to be locatable? [00:25:19] Speaker 04: And what about the German thesis? [00:25:22] Speaker 02: Well, there's two different bunches of cases there, as you have recognized most recently in the Suffolk case. [00:25:29] Speaker 02: You've got, on the one hand, what this court continually refers to as the library cases. [00:25:35] Speaker 02: And that's where a thesis is sitting on a shelf or not yet quite on the shelf in a pile somewhere. [00:25:40] Speaker 02: And the person of ordinary skill in the art has the great good fortune for no reason whatsoever to have wandered into Freiburg, Germany and wandered into that university and then said, gee, now I'll look for this. [00:25:55] Speaker 02: That's where it's in one place. [00:25:57] Speaker 02: There's no dissemination. [00:25:59] Speaker 02: And those cases stand that if you don't disseminate and you're in one place, [00:26:04] Speaker 02: Frankly, it can even be, even if you're in Germany, it's enough if you have an index when the person stumbles in there. [00:26:11] Speaker 02: But if you don't have an index, and you're in one library, and you haven't told anyone about it, and you haven't disseminated it, then no. [00:26:19] Speaker 02: So the cases handle it both sometimes as a question of fact, as public accessibility, and sometimes as a question of law. [00:26:24] Speaker 02: It's a bit mixed up. [00:26:26] Speaker 02: The board did it both ways. [00:26:30] Speaker 02: Well, one way. [00:26:31] Speaker 02: The discussion [00:26:34] Speaker 02: that Ms. [00:26:34] Speaker 02: Sullivan's pointing you to actually starts, the two pages we're dealing with, starts with under the heading, whether APOSA exercising reasonable diligence would have been capable of locating the exhibits. [00:26:47] Speaker 02: The board took this as a factual inquiry, and it did. [00:26:49] Speaker 02: And it started, you can look at Appendix 255. [00:26:53] Speaker 03: What do you say to your opponent's claim that there's no substantial evidence here that a façade would have been able to find the information because [00:27:02] Speaker 03: There were no indexes. [00:27:04] Speaker 03: There's no evidence that indexes. [00:27:06] Speaker 02: Right. [00:27:06] Speaker 02: I would say what you said in the Suffolk case, that a printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time. [00:27:20] Speaker 02: And dissemination, frankly, is a fairly low standard under Klopfenstein and MIT. [00:27:25] Speaker 02: You've held that a poster at a conference followed by the distribution of six copies is dissemination. [00:27:30] Speaker 02: As Your Honor indicated, [00:27:31] Speaker 02: The Federal Register is widely disseminated, always has been. [00:27:35] Speaker 02: And there are people who, the idea that a person of ordinary skill in the art, which the board found factoring, would be motivated to go to the Federal Register to keep tabs on what's going on in this area, that that person, motivated to go to the Federal Register, then would have been stymied because he couldn't look through the FDA notices as they [00:27:59] Speaker 02: came out or as they were collected over the year. [00:28:01] Speaker 02: I mean, if the New York Times comes out daily, if that wasn't searchable, would we say it's something published in the New York Times? [00:28:09] Speaker 03: So was there or was there not evidence that the Federal Register was indexed in a way that made it searchable in 2001? [00:28:16] Speaker 02: I'm not aware of that evidence. [00:28:19] Speaker 02: I don't think so. [00:28:21] Speaker 02: I think the whole case was litigated on it was not searchable by keyword and so forth. [00:28:29] Speaker 02: It was referred to throughout the papers as indexed, but I don't believe there was evidence to record that. [00:28:35] Speaker 02: You asked about judicial notice. [00:28:36] Speaker 02: You can certainly take judicial notice that the Federal Register is widely disseminated, and it always has been since 1934 when it started. [00:28:45] Speaker 02: They say on page 13 that the Federal Register is equivalent to the bearer. [00:28:50] Speaker 02: And we say it's for the important reason of dissemination [00:28:58] Speaker 02: This court has held that dissemination can be enough even just giving a talk at a conference. [00:29:05] Speaker 02: Even putting something up on a server for seven days could be dissemination. [00:29:11] Speaker 02: And it's in Suffolk that you really sort of systematize what's going on here. [00:29:15] Speaker 02: You've got the library cases. [00:29:17] Speaker 02: Come and get it. [00:29:18] Speaker 02: Hope you find the right library. [00:29:19] Speaker 02: But once you're there, you're entitled to some indexing. [00:29:24] Speaker 02: If you're sitting in a library and you don't have it, that's Hall case. [00:29:27] Speaker 02: That's the German University case you asked about to explore it. [00:29:31] Speaker 02: And that's also where Lister was. [00:29:34] Speaker 02: And Lister itself was very clear, excuse me, not very clear, said, listen, while we have, here's the quote, while cataloging and indexing have played a significant role in our cases involving library references, this is Lister, we have explained that neither cataloging [00:29:53] Speaker 02: Nor indexing is a necessary condition for reference to be publicly accessible. [00:29:58] Speaker 02: And that was picked up on in Suffolk, where you said it need not be easily searchable after publication if it was sufficiently disseminated. [00:30:05] Speaker 02: And then you turn to what is sufficiently disseminated. [00:30:08] Speaker 02: And you looked at Klopfenstein and MIT. [00:30:12] Speaker 02: And you have had one or two cases where you said, and this is, for instance, SRI International, which you remanded summary judgment, so it wasn't quite a decision. [00:30:22] Speaker 02: where you said, look, this is somewhere in between the thesis sitting in Germany and a published paper. [00:30:33] Speaker 04: You mentioned the New York Times, something published in the New York Times. [00:30:36] Speaker 04: Yes. [00:30:39] Speaker 04: Before the internet. [00:30:41] Speaker 04: Yes. [00:30:43] Speaker 04: And before you could go up to the upper right-hand corner of their website and pick out search. [00:30:49] Speaker 04: Right. [00:30:51] Speaker 04: Papers as of 2001, things published in the New York Times, searchable. [00:30:58] Speaker 04: And if not, they still were accessible to the public, right? [00:31:01] Speaker 02: That's my point. [00:31:02] Speaker 02: I don't know if they're searchable. [00:31:04] Speaker 02: But to say a daily publication with a wide dissemination comes out daily, and the people who are motivated to look at it for their area. [00:31:13] Speaker 04: As to what it says. [00:31:14] Speaker 02: As to what it says, right. [00:31:15] Speaker 04: And what does it say with respect to this? [00:31:18] Speaker 04: Was it ACA prior off? [00:31:21] Speaker 04: ACM? [00:31:21] Speaker 02: Right. [00:31:22] Speaker 02: It says there's going to be this meeting of the advisory committee. [00:31:24] Speaker 02: It's going to be about risk management, distribution control, safety, the sponsor is going to be presenting things. [00:31:33] Speaker 02: Here's the course from here, the materials from this link, click this link and go there. [00:31:37] Speaker 02: That, by the way, is not being challenged here. [00:31:40] Speaker 02: That was challenged below. [00:31:41] Speaker 02: They litigated and lost. [00:31:42] Speaker 02: The fact is, when the Federal Register wants to make available big documents, it doesn't shove them all in the Federal Register. [00:31:50] Speaker 02: except for the Microsoft settlement. [00:31:52] Speaker 02: But, so that's not, the fact that it was said what was going on, and everyone agrees that the person with more than a skill, as the board found it, which was motivated to go to the Federal Register into these things, everyone agrees that when they saw that notice, they would click those things, those links, and get these documents. [00:32:15] Speaker 02: There's no difference there. [00:32:17] Speaker 03: Well, it begins to sound like your argument is that [00:32:20] Speaker 03: The information was out there, and Posita would have known. [00:32:26] Speaker 03: But there's no bridging that gap. [00:32:30] Speaker 03: So it seems like you, are you arguing that this was constructive notice? [00:32:35] Speaker 03: No. [00:32:36] Speaker 03: Then, and your opponent is, why is this not constructive notice? [00:32:41] Speaker 02: Because first of all, it was dealing with declaration testimony from Dr. Beluk, which [00:32:48] Speaker 02: court cited in this section saying that a post exercising reasonable diligence would have been able to locate the ACA. [00:33:00] Speaker 02: And it goes on. [00:33:00] Speaker 02: And there's a whole bunch of declaration testimony that the board relied on. [00:33:04] Speaker 02: They said, here's what the petitioner's saying. [00:33:06] Speaker 02: Here's their evidence. [00:33:07] Speaker 02: Then they said on the next page, we are not persuaded by the attacks that JAS has made on this testimony. [00:33:14] Speaker 02: And then they're saying, so it's publicly accessible. [00:33:19] Speaker 02: In terms of constructive notice, that's something different. [00:33:25] Speaker 02: Yes, the Federal Register is used for constructive notice. [00:33:29] Speaker 02: It is in the statute. [00:33:31] Speaker 02: Other things in that statute, by the way, say it's a presumption that it was publicly available. [00:33:36] Speaker 02: So that's 44-1507-2, publication in the Federal Register. [00:33:45] Speaker 02: But we don't need to go there. [00:33:47] Speaker 02: It's the Federal Register. [00:33:50] Speaker 02: The person who had any skill in the art here is motivated to go to the Federal Register and find it. [00:33:56] Speaker 02: There was expert testimony that the person would have located. [00:33:59] Speaker 02: There was some attacks on that, similar to the attacks being made now. [00:34:05] Speaker 02: But the board on the factual issue said, no, we're not persuaded by that. [00:34:10] Speaker 02: This is something that's a factual issue. [00:34:12] Speaker 02: Ms. [00:34:13] Speaker 02: Sullivan said that public access is a factual issue. [00:34:15] Speaker 02: It is. [00:34:16] Speaker 02: The board took the evidence, the expert opinion, [00:34:20] Speaker 02: POSA would have found it, was motivated to, and would have found it, and looked at it. [00:34:25] Speaker 02: There was no expert evidence the other way, because all their expert evidence was based on this POSA being a new hire behind the CBS counter. [00:34:37] Speaker 02: And so it would be substantial evidence, even if there had been countervailing evidence, but there was not. [00:34:44] Speaker 02: And so it was at least substantial evidence for that factual finding. [00:34:50] Speaker 02: We have here fundamentally. [00:34:52] Speaker 02: Also, as we did in Suffolk, there's some overstating of the difficulty. [00:34:57] Speaker 02: On this one page in 17,000, as the court knows and can take judicial notice of, the register comes out every day. [00:35:03] Speaker 02: It's divided by departments and their notices. [00:35:06] Speaker 02: And no one interested in what the FDA is doing would look at anything other than the FDA notices, the Department of Health and Human Services. [00:35:14] Speaker 02: You can see it at page 9797 in the appendix. [00:35:18] Speaker 02: That's where the page is. [00:35:19] Speaker 02: You can see Pettig's Department of Health and Human Services. [00:35:21] Speaker 02: But as in Suffolk, it doesn't really matter that they're overstating, because we have dissemination here. [00:35:27] Speaker 02: We have wide dissemination, and we have a motivated person of ordinance going yard. [00:35:33] Speaker 02: And if you think it's somewhere in between, you would look to the Klopfenstein track. [00:35:40] Speaker 02: I beg your pardon. [00:35:41] Speaker 02: Klopfenstein Factors, which is from the Klopfenstein decision, 380 at 3rd at 1350. [00:35:48] Speaker 02: He clapped for the scene and said, well, it's not quite pure library. [00:35:51] Speaker 02: It's not quite pure publication. [00:35:53] Speaker 02: You have to take into consideration all the facts. [00:35:59] Speaker 02: And it looked at four factors and said, first one is length of time that the reference was available. [00:36:04] Speaker 02: Well, it was put in the Federal Register and stayed in the Federal Register for, I don't know if it's still there, but if the links are still active, but certainly for a very long time. [00:36:15] Speaker 02: The second factor, expertise of target audience for the reference. [00:36:19] Speaker 02: Yeah, the way the person of ordinary skill in the art was found by the board. [00:36:23] Speaker 02: This is someone who is interested in that subject and has some abilities in that subject, and would look at that notice and click that link, because this is what they're all about. [00:36:34] Speaker 02: Third factor, expectation of no copy. [00:36:37] Speaker 02: Well, the whole point of the Federal Register is to get things out there, and the whole point of making documents available to those who want to participate in this meeting is to get things out there. [00:36:48] Speaker 02: One CFR 2.6 specifically says the federal registry is subject to unrestricted use and copying. [00:36:55] Speaker 02: There's no expectation of secrecy or no copying. [00:36:58] Speaker 02: And then the fourth factor is the simplicity of copying the reference. [00:37:02] Speaker 02: Well, that's pretty easy. [00:37:05] Speaker 02: I'd like to just point out that in Suffolk, which is your most recent case from the period 2014, excuse me. [00:37:21] Speaker 02: In Suffolk, you had a user post, a news group post involved. [00:37:28] Speaker 02: And one of the things this court pointed out was, hey, the whole purpose of this Usenet group is to have dialogue, have people involved in dialogue. [00:37:39] Speaker 02: This is not like a thesis, the whole purpose of it. [00:37:43] Speaker 02: No thesis is put in a library with a view towards getting dialogue going with the public. [00:37:50] Speaker 02: The Federal Register is only about getting information to the public. [00:37:55] Speaker 02: And by the way, if you have a motivated person with ordinary skill in the art, and he is motivated to look in the Federal Register, which is finding a fact with the board set, the idea that that person couldn't find the notice in the Federal Register is going to cast quite a shadow over the workings of the executive agencies which function using the Federal Register to get out the proposed rules [00:38:21] Speaker 02: and hearings, et cetera. [00:38:25] Speaker 02: Do you have any questions? [00:38:29] Speaker 05: Thank you. [00:38:30] Speaker 05: Thank you, Mr. Maddox. [00:38:34] Speaker 01: Thank you, Your Honor. [00:38:35] Speaker 01: To be very clear, the question of public availability is a question of law. [00:38:39] Speaker 01: I did not say it was a question of fact. [00:38:41] Speaker 01: It's based on subsidiary facts. [00:38:43] Speaker 01: And my argument to you is here there were no subsidiary facts on locatability. [00:38:47] Speaker 01: And I believe my friend on the other side just confirmed [00:38:50] Speaker 01: our argument. [00:38:51] Speaker 01: He said, it's the Federal Register. [00:38:53] Speaker 01: And the court said, it's the Federal Register. [00:38:55] Speaker 01: But with respect, saying it's the Federal Register is not enough unless there's some way, once I get to the Federal Register, to find a ZIRM risk management proceeding. [00:39:07] Speaker 01: And there's no evidence that there was that. [00:39:09] Speaker 01: My friend on the other side actually just conceded. [00:39:12] Speaker 01: There was no evidence, Your Honor, of indexability. [00:39:15] Speaker 01: And in fact, you can look at a particular page in the record where counsel [00:39:20] Speaker 01: the board conceded that there was no evidence one way or the other on indexability. [00:39:27] Speaker 01: That concession is at A, 18,175. [00:39:30] Speaker 01: There's no evidence either way. [00:39:32] Speaker 04: You're distinguishing between findability and accessibility. [00:39:37] Speaker 01: I believe findability is required for accessibility under Lister, Your Honor, because remember, Lister has that crucial language that says even if there's [00:39:48] Speaker 01: the existence of something out there in the world. [00:39:50] Speaker 01: That does not end our inquiry. [00:39:52] Speaker 01: That was the exact language that Listed Decision uses. [00:39:55] Speaker 01: That does not end our inquiry. [00:39:57] Speaker 01: We must ask whether a person of skill interested in finding the information is capable of finding it. [00:40:03] Speaker 01: And there's no evidence here that they were capable of finding it. [00:40:07] Speaker 01: There was no evidence that the expert on the other side had a search term. [00:40:11] Speaker 01: Your Honor, what would you do when you got to the Federal Register? [00:40:15] Speaker 01: What search terms would you use? [00:40:16] Speaker 01: There were 67,702 pages in the 2001 Federal Register. [00:40:23] Speaker 01: And there's no indication in the record that there was any way to find ZIRAM, the name of our drug, or find risk management proceedings, or control distribution proceedings. [00:40:34] Speaker 01: In fact, the expert on the other side just admitted he was paging through a paper copy. [00:40:43] Speaker 03: Aren't these minutes of [00:40:46] Speaker 03: an advisory group meeting? [00:40:50] Speaker 03: Isn't that what we're talking about, an FDA advisory council? [00:40:53] Speaker 01: That's right, Your Honor. [00:40:54] Speaker 01: And let me be, I want to be clear, I believe. [00:40:56] Speaker 03: Why can't you search FDA advisory council? [00:41:00] Speaker 01: Your Honor, there was no evidence that in 2001, remember it's the internet's in its infancy, that there was any searchability on the FDA website. [00:41:09] Speaker 01: In fact, I believe my friend on the other side has conceded that the materials themselves, the treasure, were not publicly available. [00:41:16] Speaker 01: They are resting their whole case, and the board rested its whole holding, on the idea that public availability of X marks the spot on page 9797. [00:41:25] Speaker 01: And if you look at nothing else around, or look at page 9797, to this supposed great public dissemination, it just says background material from the sponsor will be posted on the following website. [00:41:37] Speaker 01: It's typically available in three weeks. [00:41:40] Speaker 01: This one page is the supposed public availability. [00:41:43] Speaker 01: My friend's reliance on suffix technologies should be disregarded. [00:41:46] Speaker 03: But there was evidence that it was available within two weeks after that, exactly where that map pointed. [00:41:53] Speaker 03: X marks a spot in two weeks. [00:41:56] Speaker 01: You're right. [00:41:56] Speaker 03: There was evidence that showed exactly that was true. [00:41:59] Speaker 01: And Your Honor, there is no evidence that on the FDA website there was index ability or search ability to find it on the FDA website. [00:42:06] Speaker 01: So the whole case comes down to whether the Federal Register gave enough to locate. [00:42:10] Speaker 01: It did not. [00:42:11] Speaker 01: There's no evidence that it did, and you should not substitute constructive notice. [00:42:15] Speaker 01: Just to answer, Your Honor, you said it was the board relying on constructive notice. [00:42:18] Speaker 01: It was. [00:42:18] Speaker 01: If I can get you to just focus on one other page in the record, look at page appendix 34. [00:42:24] Speaker 01: It's an exemplary of the holding here. [00:42:27] Speaker 03: On a broad general level, is that the crux of your argument that this was constructive? [00:42:31] Speaker 03: If it was noticed at all, it was constructive notice? [00:42:34] Speaker 01: Yes, exactly, Your Honor. [00:42:36] Speaker 01: And as a matter of law, [00:42:37] Speaker 01: Constructive notice should not be substituted by this court on an issue of first impression for the reasonable diligence inquiry that this court's precedents require. [00:42:48] Speaker 01: And you know it's constructive notice, Your Honor, because look at Williams v. Mukasey, the cited Ninth Circuit case. [00:42:54] Speaker 01: Publication in the Federal Register is legally sufficient notice to all interested or affected persons. [00:42:59] Speaker 01: That was a constructive notice due process case. [00:43:02] Speaker 01: The board relied on constructive notice. [00:43:04] Speaker 01: You should not. [00:43:05] Speaker 01: You should insist on the reasonable diligence standard being satisfied by anyone who seeks to invalidate an important patent that protects the public health. [00:43:12] Speaker 01: And you should not change the law in this case. [00:43:14] Speaker 01: Your Honor, if you disagree with me, we have three alternative arguments amply documented in the briefs for why you should still reverse on claim construction. [00:43:22] Speaker 01: I won't repeat them if Your Honors have any questions. [00:43:25] Speaker 04: It's not proper rebuttal. [00:43:27] Speaker 01: Understood, Your Honor. [00:43:28] Speaker 01: I just wanted to be clear I wasn't waiving them. [00:43:30] Speaker 05: Thank you very much for considering our ordinance.