[00:00:10] Speaker 04: We had five cases on our panel this morning. [00:00:15] Speaker 04: One from the district court, and one took from ETAB, two from the yard systems protection work that had been submitted on the brakes from the local market argue. [00:00:27] Speaker 04: Our first case was spent on the cynicals from Bosh Health, as you know, which had the cynicals. [00:00:36] Speaker 04: Two thousand twenty-two, twenty-one fifty-three, and nineteen fifty-two. [00:00:55] Speaker 04: Do you just want to take six minutes to say no? [00:00:58] Speaker 01: Yes, Your Honor, given that it's a cross-exam. [00:01:00] Speaker 04: You can be seconded. [00:01:02] Speaker 01: Thank you. [00:01:03] Speaker 01: May it please the Court, although I'll be pleased to answer questions regarding the polymorph claims. [00:01:09] Speaker 01: The polymorph patents expire later this year. [00:01:12] Speaker 01: The IBSD patents expire in 2029, so I'd like to focus my opening argument on the district court's two errors regarding the IBSD claims. [00:01:21] Speaker 01: First, misallocating the burden of the truth regarding the press release. [00:01:26] Speaker 01: And second, misreplying the court's prior art range cases and holding the claims invalid as obvious. [00:01:32] Speaker 01: The error with respect to the press release is straightforward. [00:01:36] Speaker 01: Norwich, as the challenger, bore the burden of proof by clear and convincing evidence on all issues related to the status of the press release as prior art. [00:01:46] Speaker 01: This includes whether the press release was by others [00:01:49] Speaker 01: for going to visit 3AIA, Section 102A. [00:01:53] Speaker 01: Norwich failed to carry that burden. [00:01:55] Speaker 01: It does not argue to this court that it did carry that burden. [00:01:58] Speaker 03: For these two IBS patents, the listed co-inventors for each one is a different overall entity. [00:02:06] Speaker 03: One is Forbes and Forte, and the other one is Forbes and Johnson. [00:02:10] Speaker 03: I don't think Forte or Johnson are identified anywhere in the press release. [00:02:14] Speaker 03: Is that right? [00:02:15] Speaker 03: That's correct, Your Honor. [00:02:16] Speaker 03: So just on the face of the press release, what is wrong with concluding that there's no indication that the actual co-inventors were the ones that produced the press release? [00:02:34] Speaker 01: That's why framing the question matters so much. [00:02:37] Speaker 01: There's nothing inconsistent with the face of the press release to include that the co-inventors were involved either. [00:02:43] Speaker 01: That's why this issue ultimately comes down to a question [00:02:47] Speaker 01: I'm not arguing that Salix carried or bore a burden to show that the press release was reporting the work of the inventors. [00:02:56] Speaker 01: My argument is that Norwich bore the burden to prove by clearing convincing evidence that the press release was not reporting the work of the inventors. [00:03:04] Speaker 00: Was there any possible sort of shifting of the burden to Salix once Norwich stayed a case for arbitrage? [00:03:11] Speaker 01: There might have been had Norwich made out a prima facie case [00:03:16] Speaker 01: that the press release was reporting the work of individuals other than the inventors. [00:03:21] Speaker 03: So weren't the press releases never quoted for it? [00:03:25] Speaker 03: So it was just a bland press release saying, we have some exciting results we wanted for it. [00:03:32] Speaker 03: Here are our results from this time period. [00:03:36] Speaker 03: Would that have been enough to say, look, there's no indication of who in this very large company [00:03:44] Speaker 03: actually produce the content of this press release that was responsible for it, so we can at least initially conclude that it's not necessarily from these specific co-inventors. [00:03:56] Speaker 01: I certainly don't think that would have been enough. [00:03:58] Speaker 01: I think it's the burden of the challenger, as the court has said, to prove all of the facts related to the status of a reference prior to art. [00:04:05] Speaker 01: The challenger would need to come in and provide enough evidence [00:04:08] Speaker 01: usually this is accomplished on the basis of reference, except the press releases by the company where the inventors work. [00:04:15] Speaker 01: I certainly don't think it's enough just to come into it and say, well, it doesn't tell us whose work was being reported on. [00:04:22] Speaker 04: Therefore, you can find it's not in the event. [00:04:24] Speaker 04: Do you want to, do you want to just fly around against you for a minute? [00:04:26] Speaker 04: We've got time until, and time until this closes. [00:04:34] Speaker 04: this, this, this journal and this treatment. [00:04:39] Speaker 04: And it also says that you can use the hydro dose. [00:04:49] Speaker 01: Yes, Your Honor. [00:04:49] Speaker 01: But as you see from the District Court's analysis, the District Court placed heavy reliance throughout on the RFID 2001 press release, particularly in overcoming Salix's evidence of skepticism. [00:05:01] Speaker 01: Pimentel was, in his own words, a lone voice in the wilderness. [00:05:05] Speaker 01: Pimentel 2006 was a deeply flawed reference. [00:05:08] Speaker 01: It was published accompanying the Grossman editorial, noting methodological issues with it. [00:05:13] Speaker 01: The question here is not whether the district court could have reached the same result, not relying on delay. [00:05:17] Speaker 00: Do you agree that there was other evidence before the district court, such as Viscami 2005, that could have allowed the district court to reach the conclusion regarding the claimed range? [00:05:27] Speaker 01: Well, potentially, but there's a key fact finding the district court didn't make that it would have needed to rely on some of the other evidence, such as Viscami 2005. [00:05:36] Speaker 01: There was a hotly disputed issue between the parties about the relationship between SIBO, that's small intestinal bacterial overgrowth, and IBSD. [00:05:47] Speaker 01: My friends' arguments primarily said, well, we can treat SIBO using certain dosages. [00:05:53] Speaker 01: and SIBO is a symptom of IBSD. [00:05:55] Speaker 01: Our expert testified precisely to the contrary. [00:05:59] Speaker 01: I point you to Appendix H, essentially 3260 to 3262. [00:06:04] Speaker 01: He said, no, SIBO is a different disease than IBSD. [00:06:07] Speaker 01: A diagnosis of SIBO is inconsistent with a diagnosis of IBSD. [00:06:11] Speaker 01: So it's critical to us that when you look at what the district court actually relied on in finding an expectation of success, [00:06:17] Speaker 01: That's appendix pages 34, and again appendix pages 39. [00:06:21] Speaker 01: The only prior art references that he looked to were those prior art references that actually reported success in treating IBSD. [00:06:30] Speaker 04: He did not rely on any of my friend's references. [00:06:34] Speaker 04: And this is not a cult. [00:06:34] Speaker 04: This is not a cult. [00:06:36] Speaker 04: It's not people thought to have an invention. [00:06:38] Speaker 04: People have found before all of these activities. [00:06:42] Speaker 04: It's all a creation of this far out. [00:06:44] Speaker 01: But your honor, with the protocol, the protocol was simply a test plan. [00:06:48] Speaker 01: And that's my second issue with respect to particular claimed doses. [00:06:52] Speaker 01: Well, the protocol suggests that the range between 1,100 and 1,200 milligrams per day might be tested. [00:07:00] Speaker 01: In fact, it went even lower, 550 to 2,200 milligrams. [00:07:04] Speaker 01: But the protocol alone didn't give an expectation of success across that entire range. [00:07:09] Speaker 01: And in fact, even looking at the press release, it doesn't justify finding an expectation of success. [00:07:15] Speaker 04: We argued to the district court... You mean, you put this compound in human beings without expecting it to do something useful? [00:07:24] Speaker 01: The testimony in this record, appendix page 13 to 3314, is to be, treatment literature is right with examples of drugs [00:07:32] Speaker 01: that might look good in a case study and then be unsuccessful in phase two. [00:07:36] Speaker 01: We certainly hoped it would be successful, but we did not have an expectation of success across the entire dosage range. [00:07:43] Speaker 03: Do you have some kind of, I don't know, rifle that's expected to be met before you start engaging in phase two trials with humans and drugs? [00:07:56] Speaker 01: There's no indication of that in the record, your honor. [00:07:59] Speaker 01: Certainly nothing here. [00:08:01] Speaker 01: I think it probably depends on [00:08:04] Speaker 01: I guess first, are there alternative treatments available? [00:08:06] Speaker 01: Are you potentially depriving patients of known successful treatments? [00:08:11] Speaker 01: As we pointed out in our statement of facts here, this was an area in which there were no known good treatments for IBSD. [00:08:18] Speaker 01: The second question might well be, how harmful is it likely to be to the patients? [00:08:21] Speaker 01: Are we giving them something like chemotherapy? [00:08:23] Speaker 01: There's no evidence here that this was a particularly harmful or risky treatment for the patients involved in the study. [00:08:29] Speaker 01: Our expert testified he had used it to some patients, but did so as an experiment without an expectation of success. [00:08:35] Speaker 03: There was widespread use by gastroenterologists using this particular drug or IDS. [00:08:42] Speaker 03: Something like 74% of all gastroenterologists interviewed said that they prescribed [00:08:49] Speaker 01: many of them had but I'll again I'll point you to our expert's testimony as he said appendix page 3319 he was trying it as an experiment out of hope and desperation just because there were no other options available and remember this is a drug, I'm sorry about that. [00:09:05] Speaker 00: So I was going to say do you believe that we have to reach the issue of whether or not the press releases prior are in order to resolve the issues relating to the IVFD patent? [00:09:14] Speaker 01: Well, if you agree with us on my second issue, which is that Norwich failed to show reasonable expectation of success in the claimed dosage, I don't believe you need to reach the issue of the press release as prior ARD. [00:09:25] Speaker 01: But the point there is that when you look on appendix page 39, this is the evidence credited by the district court of prior ARD reporting successful results for the treatment of IBSD, he's crediting references that teach the use between 1,100 and 1,200 milligrams a day. [00:09:41] Speaker 01: This plain dosage is nearly 40 percent higher. [00:09:45] Speaker 01: The only dosage, he cites, that is greater than 1,200 milligrams today is the 2,200 milligrams that I mentioned in the protocol. [00:09:53] Speaker 01: We argued on appendix page 40 to the district court that protocol is just protocol that doesn't carry with it an expectation of success. [00:10:00] Speaker 01: The district court did not make a finding that says [00:10:03] Speaker 01: I find that merely because something is tested, there would be an expectation of success. [00:10:08] Speaker 01: In response to that, as the appendix pages 41 to 42, the district court said, well, it doesn't matter that the protocol doesn't include results because skilled artisans would have known press release. [00:10:20] Speaker 01: But critically, when you look at the press release, the press release does not say everything we tested worked. [00:10:26] Speaker 01: The press release says, [00:10:27] Speaker 01: we succeeded at 1,100 milligrams a day. [00:10:31] Speaker 01: Not only is that violent as to the success of 2,200 milligrams a day, but the uncontroverted evidence is that skilled artisans would have understood that meant 2,200 milligrams per day didn't work. [00:10:43] Speaker 01: And in fact, that's the truth. [00:10:45] Speaker 01: 2,200 milligrams a day did not do any better than placebo in the RFID 2001 study. [00:10:51] Speaker 01: You'll see that at appendix page 3042 and the testimony that skilled artisans would have understood it didn't work was appendix page 3314. [00:11:01] Speaker 01: So when you look at what the district court credited here, the district court said positive results for a range of dosages, but the only positive results to keep credits on appendix page 39. [00:11:10] Speaker 03: I assume 1650 did better than 1100 milligrams. [00:11:14] Speaker 01: That was not tested as part of the RFID 2001 protocol. [00:11:18] Speaker 01: That was tested in our phase three clinical trial when we eventually adopted that. [00:11:23] Speaker 01: But I'll point out what the FDA was saying about that in 2011. [00:11:26] Speaker 01: This is about two and a half years after the critical date after our first phase three trial. [00:11:32] Speaker 01: The FDA is still looking at that saying, I'm concerned about how we figured out this almost magical 550 three times a day dose. [00:11:40] Speaker 01: We still don't know much about IBS. [00:11:42] Speaker 01: We're treating a disease which we know nothing or very little about, but the drug we know little or nothing about. [00:11:48] Speaker 01: We went through tremendous work to demonstrate to the FDA that this was the right dosage. [00:11:52] Speaker 01: This was actually successful. [00:11:53] Speaker 00: What page were you just reading from? [00:11:55] Speaker 01: You'll see that appendix page 5245. [00:11:57] Speaker 01: It's an FDA committee that was Dr. Pizricha discussing at that committee there. [00:12:04] Speaker 01: But the key for us is, it's not enough simply to say there is some expectation of success in using refractionment to treat IBSD. [00:12:11] Speaker 01: You have to find a reasonable expectation of success in the claimed dosage. [00:12:15] Speaker 01: And on that issue, the press release not only doesn't hurt us, but the press release can help us. [00:12:20] Speaker 01: Because the press release tells skilled artisans that 1,100 milligrams per day worked in the RFID 2001 study, but that 2,200 milligrams per day was unsuccessful. [00:12:31] Speaker 01: and nothing in the district court's opinion supports the finding that 1,650 milligrams per day is within the known range. [00:12:39] Speaker 04: Do you want to save considerable time? [00:12:43] Speaker 04: Do you want to save it or continue? [00:12:46] Speaker 01: No, Your Honor. [00:12:47] Speaker 01: I had hoped to save time for rebuttal. [00:12:49] Speaker 01: Right. [00:12:50] Speaker 04: You've got some. [00:12:51] Speaker 04: Mr. Landmark. [00:13:03] Speaker 02: Thank you, Your Honor. [00:13:04] Speaker 02: May it please the court, I'd like to spend a few minutes on Salix's appeal and then spend the remainder of my time on our cross appeal. [00:13:11] Speaker 02: Starting with the IBSD patent, even if Salix could have shown that there was some error in the district court's finding that the press release was prior art, the district court [00:13:23] Speaker 02: The district court could not only rely on that single document in finding reasonable expectation of success. [00:13:29] Speaker 02: In fact, the district court found that I'd quote, widespread off-label use in prior art. [00:13:35] Speaker 02: I can't think of more compelling evidence of reasonable expectation of success than actual poses at the time administering the drug for the claimed purpose. [00:13:43] Speaker 02: It was also supported by other pieces of prior art, including Pimentel 2006, Cuoco, Yang, and Barrett. [00:13:52] Speaker 02: But the district court didn't err with respect to its finding on finding the press release of prior art. [00:13:57] Speaker 02: In fact, it was issued by Salix, not a named inventor. [00:14:00] Speaker 02: It's undisputed it was publicly accessible. [00:14:03] Speaker 02: And it credits the protocol not to an inventor, but to Salix in consultation with FDA. [00:14:09] Speaker 02: And there's nothing on the face that credits the inventor with anything invented. [00:14:14] Speaker 00: And in fact... What is your response to the press release referencing Forbes? [00:14:19] Speaker 02: So obviously, Forbes is mentioned or quoted as an officer of the company. [00:14:25] Speaker 02: Notably, as was already noted by the panel, the patents mentioned two different groups of inventors, not just Forbes. [00:14:32] Speaker 02: It doesn't say that Forbes actually came up with anything. [00:14:34] Speaker 02: And in fact, most of the information on the press release was already publicly disclosed in the RFID 2001 protocol. [00:14:41] Speaker 02: So in addition to the [00:14:45] Speaker 02: The method steps were there, the end points were there, the dosages were there, and you can't simply repeat prior art in something and then try and keep that to another time. [00:14:55] Speaker 02: It's really just the results question, about 1,100 milligrams and how long it's there. [00:15:00] Speaker 02: Correct, the disclosure of the inherent results. [00:15:03] Speaker 00: What is your response to your opposing councils pointing us to appendix page 5245 in terms of the statements made there about the dosages? [00:15:13] Speaker 02: Uh, was that the FDA statement, Your Honor? [00:15:15] Speaker 00: Yes. [00:15:16] Speaker 00: It's on page 5245. [00:15:17] Speaker 00: He was just discussing it towards the end of his argument. [00:15:20] Speaker 02: Sure. [00:15:20] Speaker 02: Thank you, Your Honor. [00:15:21] Speaker 02: There's a few things on that. [00:15:22] Speaker 02: There's no evidence that anyone who made that statement at FDA is an actual POSA. [00:15:27] Speaker 02: That was not put before the court. [00:15:29] Speaker 02: But in addition, there was plenty of evidence that of the dosing range in the yard. [00:15:35] Speaker 02: First, Pimentel 2006 had 1200 milligrams per day, as was mentioned. [00:15:39] Speaker 02: The RFID 2001 protocol itself discloses up to 2,200 milligrams per day. [00:15:45] Speaker 02: But there were other prior references as well. [00:15:47] Speaker 00: This only 2,000... I thought that we were just talking about that the 2,200 might not work any better than a placebo. [00:15:53] Speaker 02: Is that... So the evidence doesn't... The press release doesn't mention the results of the 2,200 milligrams in the press release. [00:16:03] Speaker 02: But there was other prior evidence as well. [00:16:05] Speaker 02: For example, in 2005... Can you respond to my specific question? [00:16:09] Speaker 00: I thought that I heard opposing counsel point us to something that said 2200 didn't work better than placebo. [00:16:16] Speaker 00: I'm sorry. [00:16:17] Speaker 00: greater than 1,100 doesn't work. [00:16:19] Speaker 00: I'm just trying to get your response on that aspect. [00:16:21] Speaker 02: Yeah, I'm sorry, Your Honor. [00:16:22] Speaker 02: There was expert testimony from their expert. [00:16:24] Speaker 02: That expert testimony was pure edgy dicks. [00:16:27] Speaker 02: There was nothing more behind that except the expert statement. [00:16:30] Speaker 03: There was nothing at the time of the invention where it was disclosed that 1,200 milligrams is not working. [00:16:37] Speaker 02: Was not working? [00:16:38] Speaker 02: Was not working, yeah. [00:16:39] Speaker 02: Correct, Your Honor. [00:16:40] Speaker 02: In fact, other prior art, the Viscomi 2005 was 1,800 milligrams a day working. [00:16:46] Speaker 02: Scarbellini disclosed up to 1,600 milligrams per day. [00:16:50] Speaker 02: And the court found widespread off-label use. [00:16:53] Speaker 02: And I'd like to mention one of those uses was a use by a Dr. Weinstock. [00:16:57] Speaker 02: He actually communicated to one of the named inventors two years before the filing date that he was successfully using 1,800 milligrams per day to later publish a retrospective study showing that use. [00:17:09] Speaker 03: So the Weinstock and Jolly reports were posted [00:17:14] Speaker 03: priority dates, so those reports don't count as priority dates. [00:17:18] Speaker 02: Well, so they are post-priority dates, but they're reporting activities that happened pre-priority dates, so there were actual uses that they were doing as prescribers pre-priority dates, is what the evidence showed. [00:17:30] Speaker 02: Well, how do we consider that? [00:17:33] Speaker 02: The reference is still not priority. [00:17:36] Speaker 02: So this court's allowed to look at post-priority documents, [00:17:40] Speaker 02: that show uses or activity that was happening in the pre-priority time frame. [00:17:45] Speaker 02: So what kind of prior art is that? [00:17:49] Speaker 03: Is that 102A or 102B art? [00:17:52] Speaker 03: What do you designate that? [00:17:54] Speaker 02: It's a public use. [00:17:56] Speaker 03: It's a use by others. [00:17:58] Speaker 03: Right, but Judge Andrews didn't make a ruling that Jolly or Weinstock did prior to public use. [00:18:09] Speaker 02: He made a ruling that there was widespread off-label use. [00:18:13] Speaker 02: And this was prior art that was before him in the record. [00:18:16] Speaker 02: So this prior art evidence is the widespread off-label use. [00:18:19] Speaker 02: Even if you didn't go through and catalog all that use, it is still evidence that was before him that showed that widespread off-label use. [00:18:27] Speaker 02: And the widespread off-label use was the foundation of his determination on reasonable expectation of success. [00:18:34] Speaker 03: Your present counsel said something about how some of these other references, I don't know, [00:18:39] Speaker 03: aren't really useful and reliable for you because there were big arguments at the time as to whether bacteria overgrowth was in any way related to IBS. [00:18:58] Speaker 03: Did you comment on that? [00:18:59] Speaker 02: Yeah. [00:18:59] Speaker 02: The district court weighed all that evidence, the district court considered all that evidence, and the district court still said that it was a [00:19:06] Speaker 02: would have still had a reasonable expectation of success administering work vaccine. [00:19:10] Speaker 02: And the widespread awful use is probably the best evidence of that. [00:19:14] Speaker 02: And the district court weighed that and came to that conclusion after weighing the evidence. [00:19:17] Speaker 02: And I don't think anything Salix has been doing on appeal has demonstrated that that is clearly erroneous. [00:19:26] Speaker 02: So, Your Honors, if I may turn to our cross appeal. [00:19:29] Speaker 02: The district court's 271E order should be vacated as improper, because it blocked FDA from approving Norwich's amended ANDA, despite the fact that that amended ANDA does not contain the Imprisonation Indication. [00:19:43] Speaker 02: In fact, as FDA's regulations specifically permit, Norwich amended the ANDA to have only Section 8 statements to the A2 patents, which cannot be the basis for Imprisonment Undertakings. [00:19:54] Speaker 03: Just so I understand, your argument right now is about [00:19:59] Speaker 03: how your 60B motion was not granted. [00:20:01] Speaker 03: Is that the argument you're making? [00:20:03] Speaker 02: So there are two components to that. [00:20:05] Speaker 02: First is because you didn't have the amended ANDA until after final judgment. [00:20:09] Speaker 02: Correct. [00:20:10] Speaker 02: But the scope of the original ANDA expanding out beyond the AHE invitation was improper itself under the statute under 271A4. [00:20:19] Speaker 02: So we are challenging both the scope of the original ANDA and challenging the court's denial of our 60B motion. [00:20:26] Speaker 02: OK. [00:20:26] Speaker 03: So which one are you focusing on right now? [00:20:29] Speaker 03: You can just focus on one and then the second one later. [00:20:33] Speaker 02: Thank you, Your Honor. [00:20:34] Speaker 02: Yes, I can focus on the first one, which is the original scope of the court's order isn't proper. [00:20:39] Speaker 02: It's absurd for Norwich's Nanda to be blocked by a 271-E order that stems from infringement of a patent that Norwich only has a Section 8 statement to and is not seeking approval for. [00:20:49] Speaker 02: Norwich is in this unfair position because the court simply used the Nanda number in its 271-E order [00:20:56] Speaker 02: and gave it a much broader scope than its limited infringement findings, which was focused on the AG patents. [00:21:02] Speaker 02: That's contrary to patent law principles, which say that the scope of injunction should not exceed the scope of an infringement finding. [00:21:10] Speaker 04: Clearly, Your Honor, if a court... This is an abusive discretion, is it not? [00:21:16] Speaker 02: No, Your Honor, I don't think the court [00:21:19] Speaker 02: It's not a discretion issue because of what the statute says and what 271E4 says. [00:21:24] Speaker 02: And this court's determination of the scope of injunction. [00:21:29] Speaker 04: Rule 60 issue isn't discretion? [00:21:34] Speaker 02: No. [00:21:34] Speaker 02: Well, the rule 60 issue, it separately shows adjusting the first issue. [00:21:38] Speaker 02: But no, the rule 60 issue also wasn't within the court's discretion, again, kind of given the scope of the statute. [00:21:44] Speaker 03: I guess, as I understand, the district court said [00:21:48] Speaker 03: He was, at the time of final judgment, stuck with the form of the ANDA that you had submitted. [00:21:55] Speaker 03: And at that time, it did include the H.E. [00:21:57] Speaker 03: indication. [00:21:58] Speaker 03: And so that application had to be blocked. [00:22:03] Speaker 02: Not only that line of thinking. [00:22:06] Speaker 02: Sure. [00:22:06] Speaker 02: A few different things, Your Honor. [00:22:07] Speaker 02: First, from the plain language of the statute, the statute says under 271E4A that the order should be directed to the drug involved in the infringement. [00:22:17] Speaker 02: And here, Norwich's drug refaxonin is only involved in the infringement when it's used to treat HE. [00:22:24] Speaker 02: And that was the limited scope of the court's infringement finding. [00:22:27] Speaker 02: Under the construction applied by the court and by Selig, the words involved in the infringement would be deemed superfluous. [00:22:34] Speaker 02: And that's improper under the Supreme Court's canon of construction that every word of the statute should be given meaning. [00:22:42] Speaker 02: But also statutes need to be construed to fulfill their congressional purpose. [00:22:47] Speaker 02: And here we know that Hatch-Waxman was enacted, and this court has recognized it. [00:22:50] Speaker 02: Hatch-Waxman was enacted with the goal of bringing generic drugs to market as quickly as possible. [00:22:56] Speaker 02: And both this court and the Supreme Court have recognized that the Section 8 mechanism fulfills this purpose to enable generic companies to get approval for products that are only directed to methods that are not covered by a valid patent. [00:23:10] Speaker 02: It's important here, too, that Congress didn't put it temporal. [00:23:13] Speaker 04: Doesn't the statute talk about the effective date of the approval of the drug? [00:23:22] Speaker 02: So it then says it goes on to stay, Your Honor. [00:23:25] Speaker 02: It starts with the effective date of any approval of the drug, but then goes on to stay involved in the infringement. [00:23:33] Speaker 02: And our position here is the district court [00:23:35] Speaker 02: didn't give any value to the involved in the infringement and essentially rendered that part of the statute meaningless. [00:23:48] Speaker 02: So it's important Congress didn't put a temporal limitation on Section 8 statements. [00:23:52] Speaker 02: In fact, the FDA has a regulation that says you can submit a Section 8 statement after refining of infringement. [00:23:58] Speaker 02: but the district court's order and sale of his construction of the statute basically eviscerates the statute and FDA's regulation. [00:24:06] Speaker 02: But it also conflicts with basic patent law. [00:24:09] Speaker 02: As this court knows, injunctions are supposed to be tailored to the act of infringement. [00:24:13] Speaker 02: And just imagine a situation where a Ford F-150 is found to have infringed a patent directed to intermittent windshield wipers [00:24:20] Speaker 02: and a court issues an injunction that says Ford can't sell any Ford F-150 model, regardless of whether they have the infringing wipers. [00:24:33] Speaker 02: Well, it's a drug case, but the same principles of patent law apply. [00:24:37] Speaker 02: And in fact, when Congress was to opted 271E4A, Congress knew what those principles were. [00:24:42] Speaker 02: And Congress intended for this court and for courts generally to apply those principles in 271E4A orders. [00:24:49] Speaker 03: I guess in your court at 450, I had to call, for it to just remove the intermittent visual wipers and then step with, you know, [00:25:02] Speaker 03: cause the plaintiff to then attempt to sue the plaintiff. [00:25:08] Speaker 03: That's what would happen. [00:25:09] Speaker 02: If the district court issued an order as broad as saying, court can't work it in F-150, that's what would happen. [00:25:15] Speaker 02: And here, Hatch Black can't make users sell the infringing product. [00:25:21] Speaker 02: Well, so that's the problem is the district court should have said, Norwich can't make users sell the infringing product for H-E, because that would have been tailored to a finding of infringement. [00:25:32] Speaker 02: Instead, the court just said Norwich can't, and it's not going to do itself in the context, it's get FDA approval. [00:25:37] Speaker 02: But Norwich can't get FDA approval for the ANDA number full stop without addressing the scope of infringement. [00:25:44] Speaker 02: And the scope of infringement was limited to one ANDA. [00:25:47] Speaker 03: The other side says you can just find a new ANDA without the agency. [00:25:52] Speaker 02: So a couple things about that. [00:25:54] Speaker 02: I'm not sure exactly how FDA would handle that, but maybe more importantly, [00:25:58] Speaker 02: That's not required under the statute. [00:26:00] Speaker 02: The statute required the district court to tailor its 271E4A decision or order to the scope of infringement. [00:26:09] Speaker 02: And that's why the statute refers to the drug involved in the infringement. [00:26:13] Speaker 03: And isn't there some likelihood the FDA would abstract a new ANDA that did not have each communication? [00:26:23] Speaker 02: I don't know that that's the case, Your Honor, but, you know, I guess more importantly is the district court was required to follow the statute and follow the law on tailoring its finding, tailoring its 271E order to the drug involved in the infringement, and the district court didn't do that. [00:26:41] Speaker 02: I may reserve the remainder of the time. [00:26:42] Speaker 00: Can I ask you one housekeeping question? [00:26:44] Speaker 00: So do you agree with opposing counsel about respect to the polymorph patents? [00:26:48] Speaker 00: They were expired earlier this year. [00:26:51] Speaker 00: We have very limited argument on that, so I assume you're in agreement on that. [00:26:54] Speaker 03: Yes, ma'am. [00:26:55] Speaker 03: If I could ask you a question about type F's again. [00:26:59] Speaker 03: Yes. [00:26:59] Speaker 03: You know, the other side is making a big deal about the fact that Mr. Deggander's wrongfully relied on protocol, and protocols disclose range because there's just, it's not correct. [00:27:16] Speaker 03: And the need is for you to make this point as well, to rely on a disclosed range for a child to be undergiven as evidence of reasonable expectation of success. [00:27:32] Speaker 03: We're satisfied with reasonable expectation of success. [00:27:33] Speaker 03: And I'd like to hear your thoughts about that. [00:27:36] Speaker 02: So I guess a couple things. [00:27:39] Speaker 02: Following this court's decision in cases like Galderma, I think it is proper to lie on a discoped closed range. [00:27:47] Speaker 02: I would also point the court to all the evidence in the record that I mentioned before about the different other disclosures. [00:27:52] Speaker 03: Right, we're just talking about the protocol. [00:27:55] Speaker 02: Yeah. [00:27:55] Speaker 02: So in the Galderma case, it was a very similar factual situation, and that the disclosure had a broader range than it was actually [00:28:04] Speaker 02: demonstrated to be effective, at least for the claim used. [00:28:06] Speaker 02: And this court said it was a disclosure of the entire range. [00:28:10] Speaker 02: I'd also point this court has never required a clinical study to be performed to rely on something in the base of the prior art for reasonable expectation of communication. [00:28:23] Speaker 04: We'll give you two minutes for another one. [00:28:25] Speaker 02: Thank you, Your Honor. [00:28:36] Speaker 01: Thank you, Your Honor, all the two submissions they can. [00:28:41] Speaker 01: Judge Cunningham, with respect to the polymorph claims, we're happy to stand on the briefs for them, but please don't take that as a concession that we think the district court was correct. [00:28:49] Speaker 01: Turning to the RFIB, I'm sorry, 2001 protocol in the IDSD claims, there is one mention in the district court's opinion and analysis of a dosage exceeding 1,200 milligrams a day. [00:29:00] Speaker 01: That one mention in the district court's analysis [00:29:03] Speaker 01: is in the RFID 2001 protocol. [00:29:06] Speaker 01: Judge, can you ask for evidence that 2200 milligrams per day did not work? [00:29:10] Speaker 01: You have the testimony of our expert on 3314 who says skilled artisans reading the press release would read that and say, they're reporting only 1100 milligrams a day. [00:29:20] Speaker 01: That means to skilled artisans 2200 milligrams a day did not work. [00:29:25] Speaker 01: There was no contrary evidence that was introduced. [00:29:28] Speaker 01: So the only evidence in front of the court was that skilled artisans would understand correctly [00:29:33] Speaker 01: The 2200 was unsuccessful. [00:29:35] Speaker 01: And with respect to our experts' testimony, the 2200 milligrams today was in fact unsuccessful. [00:29:40] Speaker 01: Our expert, Dr. Schoenfeld, was one of the experts brought in by Salix to review the results of the RFID 2001 study and help Salix understand what's going on here with these results. [00:29:51] Speaker 01: Because there were strange results. [00:29:54] Speaker 01: We had success at 1100 milligrams today for 14 days. [00:29:57] Speaker 01: We were unsuccessful at 2200 milligrams today for 14 days. [00:30:01] Speaker 01: We were unsuccessful at 1,100 milligrams a day for 28 days. [00:30:04] Speaker 01: Saywit said, this is weird. [00:30:06] Speaker 01: We're going to bring in experts to help us understand this. [00:30:09] Speaker 01: So there's no evidence in the record that would support a finding that skilled artisans would understand. [00:30:14] Speaker 01: that the entire range from 1,100 to 2,200 milligrams a day tested in the protocol tested in the RFIB 2001 study was successful. [00:30:22] Speaker 01: The district court here didn't make a finding that said skilled artisans would have expected success across the entire range. [00:30:29] Speaker 01: With respect to the other prior art, the district court found that it was prior art. [00:30:34] Speaker 01: You see this on page 33. [00:30:35] Speaker 01: But in the expectation of success analysis, and this report is saying, wood-skilled artisans have an expectation of success in using refraxin to treat IBSD generally, or more importantly, using 1,650 milligrams a day to treat IBSD. [00:30:49] Speaker 04: Yes, Your Honor. [00:30:51] Speaker 01: I'm just going to say, you don't see Vascomi 2005. [00:30:54] Speaker 01: You don't see Scarpolini there. [00:30:55] Speaker 01: Scarpolini is not about treating IBSD. [00:30:57] Speaker 01: It's a SIBO reference. [00:30:59] Speaker 01: Vascomi lists treatment for a lot of different conditions, not including IBSD, including [00:31:05] Speaker 01: To cross the field briefly, at the time of judgment, Norwich's ANDA included the portions of the label that Norwich now acknowledges induced infringement of the aging indication. [00:31:16] Speaker 01: In accordance with Section 271E4A, the district court properly entered an order that restricted approval of the drug for which Norwich sought approval, that is the drug involved in the infringement, and a number 214369. [00:31:30] Speaker 01: This is the ordinary form [00:31:32] Speaker 01: of Section 271E4A orders. [00:31:34] Speaker 01: We've cited about two dozen examples for you in our brief. [00:31:37] Speaker 00: What about the fact that the district court didn't appear to address nor which is argument on the 60B6 motion? [00:31:44] Speaker 01: So I don't think Norwich adequately pressed that argument. [00:31:47] Speaker 01: We certainly looked at Norwich's motion and didn't understand Norwich not really to be pressing 60B6. [00:31:53] Speaker 01: In any event, the district court's discussion of the equities with respect to rule 60B motions generally would apply equally both to 60B5 and 60B6. [00:32:02] Speaker 01: This certainly doesn't rise to the level of extraordinary circumstances. [00:32:05] Speaker 01: Review is for abuse of discretion. [00:32:07] Speaker 01: And the right route for an orgy is to file under ANDA. [00:32:10] Speaker 01: Keep in mind, the facts have changed for both sides, following the entry of judgment in the case. [00:32:15] Speaker 03: What if the district court had specifically referenced the AT&T issue in its final judgment? [00:32:23] Speaker 03: Would that have been acceptable under 271? [00:32:28] Speaker 01: That's a difficult question, Your Honor. [00:32:30] Speaker 01: Potentially, a district court might have discretion to do so. [00:32:33] Speaker 01: I think it's questionable. [00:32:34] Speaker 01: I think Farron v. Watson Laboratories probably tells us throughout that Norwich should have followed if it wanted to do this. [00:32:41] Speaker 01: It should have made the amendment, not post judgment. [00:32:45] Speaker 01: It shouldn't have come in with a hypothetical we may want to amend at some point in the future. [00:32:50] Speaker 01: It should potentially have asked the district court to please delay entry of judgment [00:32:54] Speaker 01: Here is a particular amendment that we are making to our ANDA with this particular language. [00:32:59] Speaker 01: And that would let the district court under the fairing framework say, would this be unfair or? [00:33:04] Speaker 03: Norwich also pointed out in the briefings that it would be unfair to be subjected to another ANDA litigation over again with the new ANDA where you would get to enjoy another third month exclusion. [00:33:20] Speaker 01: Is that right? [00:33:21] Speaker 01: that we would get another 30 months. [00:33:24] Speaker 01: Keep in mind, 30 months is a maximum stay, not a minimum stay. [00:33:28] Speaker 01: So if there were no valid claims that could be asserted against a new ANDA, then it would certainly not be a 30-month long stay. [00:33:36] Speaker 03: The reason it might be a 30-month... If they filed a new ANDA without the HEE invitation and you tried to sue them for infringement, would that be a divorce? [00:33:43] Speaker 01: Absolutely not, particularly in light of the fact that we have now had two additional issued patents for which Norwich has given us paragraph four certifications with respect to this ANDA, and now that Norwich has changed its indications of use, the stipulated judgment in the first litigation no longer applies. [00:34:01] Speaker 01: That was limited to the ANDA with amendments or supplements so long as they didn't change the indications of use. [00:34:08] Speaker 01: Norwich has put itself in a position where we actually have good, viable, strong claims that could be asserted against a new ANDA. [00:34:16] Speaker 01: And that's why Norwich is working so hard to avoid following the new ANDA route and instead hoping to go directly to market without the opportunity for scrutiny of Norwich's label in the ANDA pre-market, which is exactly what the HACFLAX NAC gives to branded pharmaceutical companies. [00:34:32] Speaker 04: Thank you, Constance, for having arrived in this. [00:34:37] Speaker 04: And Mr. Brown, why don't you give us a few minutes. [00:34:43] Speaker 02: Thank you, Your Honor. [00:34:44] Speaker 02: So I just wanted to address a few issues. [00:34:46] Speaker 02: First, of course, Salix wants the filing of a new ANDA because it would get a new 30-month stay. [00:34:51] Speaker 02: You've also heard the mention of new kinds, which would, again, rise to the level of a 30-month stay. [00:34:57] Speaker 02: Counsel also mentioned the ordinary form of 271E judgments. [00:35:01] Speaker 02: And I know there are a lot that were cited in the papers. [00:35:04] Speaker 02: The issue is that the issue in our case doesn't come up in most cases. [00:35:09] Speaker 02: Most cases deal with the finding of infringement of a product claim [00:35:13] Speaker 02: you know, or a compound claim. [00:35:15] Speaker 02: And of course, that extends to the end of that patent. [00:35:18] Speaker 02: Or if there are varying methods of use, the court has come to the same conclusion. [00:35:22] Speaker 02: We did provide this court with an order. [00:35:25] Speaker 02: It was a consented judgment where there were two different indications, and the court properly set two different dates for which FDA [00:35:34] Speaker 02: would approve the ANDA based on the two indications because, again, it doesn't make any sense under 271E4A or this court's normal patent law provisions [00:35:45] Speaker 02: to not allow a product to go to market when it doesn't infringe, when it won't infringe one of the patents. [00:35:51] Speaker 02: And that's why the court in that case, I guess by stipulation the parties came out that way. [00:35:56] Speaker 02: And then lastly in our Rule 60B, you know, we've explained on our brief why it was an abuse of discretion, the way the district court ruled first. [00:36:05] Speaker 02: And today, actually, it hasn't tried to defend the court's incorrect application of the case law. [00:36:10] Speaker 02: on the grounds we moved under 60B5. [00:36:13] Speaker 02: It's indisputable that the district court was wrong to hold that the rule only applies to money judgments or that it only applies when a change is unforeseen or unanticipated. [00:36:21] Speaker 02: And the court was also clearly wrong not to address Norwich's raising of rule 60B6 in its brief and the brief that we pointed to in our brief showed that we did use that. [00:36:34] Speaker 04: The court doesn't have any questions.