[00:00:00] Speaker 03: The case for argument is 17-2109, FWP versus biologic. [00:00:31] Speaker ?: Thank you. [00:00:54] Speaker 00: We're sitting out here talking about how much fun tax is. [00:00:57] Speaker 00: Really, seriously. [00:00:58] Speaker 03: Finally, we get to a patent case. [00:01:00] Speaker 03: I never thought I'd be happy to see a patent case, but here we are. [00:01:04] Speaker 02: Good morning, Your Honors. [00:01:05] Speaker 02: Well, I'm happy to see you too. [00:01:07] Speaker 02: Kathleen Sullivan for Forward Pharma. [00:01:09] Speaker 02: The sole issue on appeal is whether Forward's application contained adequate written description to support the asserted claim. [00:01:19] Speaker 02: It does, and the board erred in finding otherwise. [00:01:22] Speaker 02: The claim is very simple. [00:01:24] Speaker 02: It has three elements, a dose, a drug, and a disease. [00:01:29] Speaker 02: 480 milligrams a day. [00:01:31] Speaker 00: As mentioned, expressly three times in the disclosure. [00:01:35] Speaker 02: Exactly, Your Honor. [00:01:37] Speaker 02: Of dimethyl fumarate to treat multiple sclerosis. [00:01:40] Speaker 02: And Your Honor, I'll go right there. [00:01:41] Speaker 02: The board found it was expressly disclosed three times in the disclosure. [00:01:45] Speaker 02: Let's look to what the board found about the upscale table. [00:01:49] Speaker 02: which appears in the appendix at pages 160 to 162. [00:01:53] Speaker 00: Where does the 871 application explicitly say that that dosage, 480, or any of the dosages in the upscale table are relevant generally to every condition listed in the application? [00:02:10] Speaker 02: Your Honor, the board found that it did. [00:02:13] Speaker 02: The board finds at A22. [00:02:16] Speaker 02: that one skilled in the art would have recognized that the inventors had considered those fumarates to be significant in treatment of the listed conditions and diseases. [00:02:26] Speaker 02: So, Your Honor, let me go through it in steps, if I could. [00:02:29] Speaker 02: Dose. [00:02:29] Speaker 02: The dose is there. [00:02:31] Speaker 02: As you said, the dose of 480 milligrams a day is expressly mentioned three times in the disclosure, including in the upscale table. [00:02:38] Speaker 02: That's the board's finding at A22. [00:02:40] Speaker 02: It also [00:02:42] Speaker 02: finds at A14 that the dosage of 480 milligrams a day was specified in the upscale table. [00:02:47] Speaker 02: There's no ambiguity. [00:02:48] Speaker 02: The dose is there. [00:02:49] Speaker 00: Second, 8.71 says the daily dosage depends on a number of factors, including the condition or disease to be treated. [00:02:57] Speaker 02: That's not right, Your Honor. [00:02:59] Speaker 02: If you reread that clause, it says a number of factors, including age, weight, and the underlying causes of the condition to be treated. [00:03:08] Speaker 02: And the fact that a physician might vary the dosage for somebody based on their being too old or too thin or having multiple comorbidities has nothing to do with whether the 481 milligram a day dose was disclosed. [00:03:20] Speaker 02: Now, Your Honor, the drug is disclosed. [00:03:23] Speaker 02: Let's go to the second one of the board's findings. [00:03:25] Speaker 02: I want to show you that the board's factual findings are all there, and it's a legal error that led them not to see the disclosure. [00:03:30] Speaker 01: Can we just stay with the upscale table? [00:03:32] Speaker 01: Yes, Your Honor. [00:03:33] Speaker 01: Because I'm concerned about the reliance on the upscale table [00:03:37] Speaker 01: being a therapeutically effective amount of this particular drug for treating any of the conditions when, as I see it, it seems like it's an intermediate level of a drug that you're ramping up so that you're, through this controlled administration, you're helping someone to get used to the drug and avoid any GI side effects. [00:04:05] Speaker 02: That's exactly right. [00:04:06] Speaker 01: So that's why I'm worried about any choice of any of these intermediately disclosed dosages before you ramp up to the maximum level. [00:04:18] Speaker 01: They're not actually dosages that are therapeutically effective. [00:04:24] Speaker 01: They're more designed to get the patient to get acclimated to the particular drug. [00:04:28] Speaker 01: Why am I misreading that? [00:04:30] Speaker 02: You're not, Your Honor, but there's no inconsistency between that acclimation schedule [00:04:35] Speaker 02: and 480 milligrams a day being therapeutically effective. [00:04:39] Speaker 02: Here's why. [00:04:40] Speaker 02: The claim has no temporal limitation. [00:04:43] Speaker 02: It doesn't say therapeutically effective for X result within Y time. [00:04:48] Speaker 02: And in fact, therapeutically effective was never construed by the board. [00:04:52] Speaker 02: The board didn't say it was an additional limitation. [00:04:55] Speaker 02: And in fact, the claim here defines 480 milligrams a day as therapeutically effective. [00:05:00] Speaker 02: It says wherein 480 milligrams a day is a therapeutically effective dose. [00:05:05] Speaker 01: That's the claim. [00:05:06] Speaker 01: Now we're talking about the upscale table. [00:05:08] Speaker 02: Yes, Your Honor. [00:05:09] Speaker 02: But the upscale table is, let me go to the third step. [00:05:13] Speaker 02: So this first step is 480 is there. [00:05:16] Speaker 02: Second step is the drug is there. [00:05:17] Speaker 02: There's no question that DMF and MMF are called out, as the board says, in significant detail in the disclosure. [00:05:25] Speaker 02: Now, Your Honor, if you go to 160 and 162, you see that the kits here, the kits for administration of the drug over the up-titration schedule, getting the patient used to the drug over many weeks, the kits tie together the dose, the drug, and the disease by saying that the kits are used to contemplate it to be suitable for use in the treatment of multiple sclerosis. [00:05:48] Speaker 02: Now, Your Honor, therapeutically effective is perfectly consistent. [00:05:54] Speaker 02: with getting the patient used to the drug. [00:05:57] Speaker 02: There's no question that reducing the side effects only matters if you're treating the patient in a way that is therapeutically effective. [00:06:06] Speaker 02: That's the point. [00:06:11] Speaker 01: We have to give difference to the board on these written description matters. [00:06:16] Speaker 01: And if the board says, well, we read this upscale table differently than Ms. [00:06:22] Speaker 01: Sullivan, we read it more as [00:06:24] Speaker 01: this acclimation schedule, this ramp up to before we get to the therapeutically effective amount in order to avoid gastrointestinal side effects due to, I don't know, the strength or relative toxicity perhaps of this given drug, these fumarates. [00:06:42] Speaker 01: And so the board concludes, well, this upscale table is not disclosing therapeutically effective amounts. [00:06:49] Speaker 01: Why would we say that that was an unreasonable reading of the upscale table? [00:06:54] Speaker 02: So two answers, Your Honor. [00:06:55] Speaker 02: The board did not find that. [00:06:57] Speaker 02: The board, if you look to A27, found that this was therapeutic use. [00:07:01] Speaker 02: It found that the upscale table is consistent with therapeutic use. [00:07:05] Speaker 02: And we cite in the gray brief at page 11 and multiple times where the board talked about therapy and treatment in connection with the upscale table. [00:07:13] Speaker 01: Can you point me to the quote that you're referring to at A27? [00:07:19] Speaker 02: I'm sorry. [00:07:19] Speaker 01: 827, I think is what you said. [00:07:22] Speaker 02: I'm sorry. [00:07:22] Speaker 02: I didn't mean 827, Your Honor. [00:07:24] Speaker 01: I meant that the board refers to therapy. [00:07:28] Speaker 01: Well, I guess what I'm wondering is I thought I heard you say that the board made a fact-finding that the upscale table discloses therapeutically effective amounts of [00:07:37] Speaker 01: dosage forms for this particular fumarate. [00:07:40] Speaker 01: And I'm wondering, where did the board say that? [00:07:42] Speaker 02: So, Your Honor, on appendix 11, the board says, with respect to the treatment of specific diseases and conditions, FD's specification lists uses of the described fumarate formulations as well as possible doses. [00:07:56] Speaker 02: So it refers to look at the paragraph. [00:07:58] Speaker 00: At A22, it says, with respect to treatment of MS with a dose of 480 milligrams a day, [00:08:07] Speaker 00: The written description does not indicate 480 milligrams a day is a therapeutically effective dose with respect to any condition or disease, or is otherwise of any particular significance with respect to treatment of MS or any other disease. [00:08:24] Speaker 02: And Your Honor, that's my second answer to Judge Chen's question. [00:08:27] Speaker 02: That line about particular significance was legal error. [00:08:30] Speaker 02: And you do not need to defer to the board on legal error. [00:08:33] Speaker 02: You should overturn the board on its legal error. [00:08:36] Speaker 00: Why doesn't that indicate that the PTAB's written description decision doesn't turn on the construction of therapeutically effective amount? [00:08:46] Speaker 02: It doesn't turn on it, Your Honor. [00:08:47] Speaker 02: It doesn't turn it on at all. [00:08:48] Speaker 02: What the statute requires is written description. [00:08:51] Speaker 02: The claim isn't for therapeutic. [00:08:53] Speaker 01: So there's no reason to reach that issue. [00:08:54] Speaker 02: That's right, Your Honor. [00:08:55] Speaker 02: That's absolutely right. [00:08:56] Speaker 01: So I guess going back to what Judge Wallace quoted, the written description does not indicate [00:09:02] Speaker 01: 480 milligrams per day is a therapeutically effective dose with respect to any condition or disease. [00:09:12] Speaker 01: Why is that an unreasonable reading of the application? [00:09:16] Speaker 02: Well, Your Honor, the application discloses to the person of skill in the art that all of the listed doses in the upscale table are effective for all of the listed diseases. [00:09:29] Speaker 02: Eight doses, 24 diseases. [00:09:31] Speaker 02: And there's no question that if you had any doubt about all the diseases, a person of skill in the prior art would certainly know that they're effective for psoriasis and for multiple sclerosis. [00:09:42] Speaker 02: The prior art was overwhelming. [00:09:43] Speaker 02: The board erred in ignoring the prior art. [00:09:46] Speaker 02: So to the extent the board made a factual finding, it was clear error. [00:09:51] Speaker 02: The disclosure has the three ingredients. [00:09:54] Speaker 02: And if you have any doubt about therapeutically effective, biogen's own patent, the 514 patent, [00:10:00] Speaker 02: defines therapeutically effective as anything between 0.1 and 1 gram, 0.1 and 1 gram, 100 milligrams and 1,000 milligrams. [00:10:10] Speaker 02: The 480 is in that range. [00:10:11] Speaker 01: But maybe that's something they invented, not something that these inventors invented. [00:10:17] Speaker 02: Well, it's most definitely not, Your Honor. [00:10:18] Speaker 02: We were the first to claim and disclose 480 milligrams a day as a therapeutic treatment [00:10:25] Speaker 02: for multiple sclerosis. [00:10:27] Speaker 02: And I want to go back to the legal error here, because I think it's crucial. [00:10:30] Speaker 02: I think the most important point is this court has two very well-developed lines of cases. [00:10:36] Speaker 02: And the court put us in the wrong line. [00:10:39] Speaker 02: They thought this was a Ruschig-Novizheim case, in which there's a disclosure of the forest, and there need to be blaze marks through the unmarked trees. [00:10:48] Speaker 02: This is not a Ruschig-Novizheim situation. [00:10:52] Speaker 02: We disclosed, [00:10:53] Speaker 02: a set of marked trees. [00:10:56] Speaker 02: This is a species claim. [00:10:57] Speaker 02: It's not a genus claim. [00:10:59] Speaker 02: It would be a genus claim if we had said, let's claim, let's disclose fumarates as a treatment for inflammatory conditions. [00:11:10] Speaker 02: And then Biogen came along and said, oh, DMF works for MS at 480 milligrams a day. [00:11:16] Speaker 02: That's not what happened. [00:11:17] Speaker 02: We disclosed [00:11:19] Speaker 02: DMF at 480 milligrams a day for multiple sclerosis. [00:11:26] Speaker 02: We just disclosed it with several other titrated amounts. [00:11:29] Speaker 00: A 67-page application mentions MS five times. [00:11:35] Speaker 00: Three times in the spec, twice in the original claim. [00:11:38] Speaker 02: Well, Your Honor, let me go back. [00:11:39] Speaker 00: Each time it listed as one of 11 autoimmune diseases. [00:11:45] Speaker 00: Autoimmune diseases are only [00:11:49] Speaker 00: one out of 10 of the wide-ranging conditions. [00:11:53] Speaker 00: Forest is growing all over the place. [00:11:55] Speaker 02: It's not a forest, Your Honor. [00:11:56] Speaker 02: It's eight dosages or six preferred dosages in the original claims and 24 conditions out of thousands of conditions, inflammatory conditions. [00:12:05] Speaker 02: The scientists in our patent had found that these inflammatory and autoimmune conditions were linked. [00:12:10] Speaker 02: They had common disease mechanisms. [00:12:11] Speaker 02: So it's not surprising that fumarates in these specific dosages [00:12:15] Speaker 02: were helpful in the therapeutic treatment of those diseases. [00:12:18] Speaker 02: But Your Honor, I want to get to what you just said doesn't matter. [00:12:21] Speaker 02: And it's your decisions or your predecessor court's decisions. [00:12:24] Speaker 00: Oh, what I say always matters. [00:12:25] Speaker 02: What you say matters more than anything, Your Honor. [00:12:27] Speaker 02: But in your predecessor court's decisions in Snitzer and Driscoll, they decide this case. [00:12:33] Speaker 02: We are a Snitzer-Driscoll case in which we list several trees, marking them all. [00:12:40] Speaker 02: We did not list a forest and then claim an unmarked tree. [00:12:43] Speaker 02: And Schnitzer and Driscoll are precisely on point for your question, Judge Wallach. [00:12:47] Speaker 02: And that is because in Schnitzer, too, the party you lost tried to say, well, there's so many different disclosures here. [00:12:58] Speaker 02: And Schnitzer said, it may be that were there boundless speculation, evident a different result would be reached, but not in that case and not here. [00:13:09] Speaker 02: In other words, this isn't a case where somebody [00:13:11] Speaker 02: walked through every dosage amount in the universe and claimed every treatment for every disease in the universe. [00:13:17] Speaker 02: It's a narrow list, eight specific doses for 24 diseases. [00:13:23] Speaker 02: And I want to point out that there's no need to pick and choose among the dosages precisely because it's an upscale table, Your Honor. [00:13:29] Speaker 02: What the upscale table teaches the person of skill in the art is every one of these doses is to be used to treat the disease. [00:13:40] Speaker 01: What if we disagree on the upscale table? [00:13:47] Speaker 01: Then where are we? [00:13:50] Speaker 01: If the court disagrees with your preferred reading of the upscale table. [00:13:54] Speaker 02: Your honor, you wouldn't be disagreeing with me. [00:13:57] Speaker 02: You'd be disagreeing with the board. [00:13:58] Speaker 02: The board has three factual findings. [00:13:59] Speaker 01: Let's say we interpret the board's decision as saying what it said at page 22, that the written description does not indicate 480 milligrams a day as a therapeutically effective dose with respect to any condition or disease. [00:14:13] Speaker 01: And then there's other places where they say they look at the upscale table [00:14:16] Speaker 01: really more as a way and a means disclosed and contemplated to acclimate a patient to a given drug, not to actually provide therapeutically effective amounts. [00:14:26] Speaker 01: So if we find that, then where are we with your case? [00:14:30] Speaker 02: Your Honor, we still win under the original claims, which can be sufficient for the disclosure. [00:14:35] Speaker 02: And we win under the original claims because claim 44, original claim 44 discloses multiple sclerosis as a disease to be treated. [00:14:44] Speaker 02: Original claim 37 discloses 240 milligrams as a preferred dose. [00:14:51] Speaker 02: Original claim 30 discloses two times a day, which with respect to 240 would get you to 480 as a preferred administration. [00:14:59] Speaker 02: And original claim 27 discloses the use of DMF. [00:15:04] Speaker 02: So we went on the original claims where I'm going. [00:15:06] Speaker 01: Those original claims, they were bizarrely complex to me. [00:15:12] Speaker 01: explosion of cross-referencing of all the different claims against each other. [00:15:17] Speaker 01: I don't know. [00:15:19] Speaker 01: It would take the patience of a yogi to try to map your way all the way through the different iterations when you have a claim 44 depending on any one of the earlier 43 claims. [00:15:33] Speaker 02: Not at all, Your Honor. [00:15:34] Speaker 02: First of all, it's a Danish patent. [00:15:36] Speaker 02: They don't follow our multiple dependency rules. [00:15:38] Speaker 02: But putting that aside, remember, your law is that each claim is its own invention. [00:15:43] Speaker 02: And we claimed the invention in the original claims. [00:15:47] Speaker 02: But I want to say why you shouldn't disagree with me on the upscale table. [00:15:50] Speaker 02: I think you would be changing this circuit's law in a dramatic way that would weaponize Section 112 as a new weapon against conventional pharmaceutical claiming practices in which multiple doses for multiple diseases are applied. [00:16:03] Speaker 02: And you rejected that approach. [00:16:05] Speaker 02: at your predecessor court in Snitzer and Driscoll, you reaffirmed it in ScriptPro, you said you're allowed to disclose a species among several species. [00:16:15] Speaker 02: You're allowed to disclose, if you expressly disclose, even if it's among several species, expressed disclosure ends the 112 inquiry. [00:16:25] Speaker 02: And we are a case that just as in Snitzer and Driscoll, we are [00:16:30] Speaker 02: The invention is expressly disposed as a unified whole on the upscale table based on the board's findings. [00:16:35] Speaker 02: The board made no factual finding to disagree with me. [00:16:38] Speaker 02: It made a legal error of saying, oh, well, you still need blaze marks, and you need to call out particular significance. [00:16:44] Speaker 02: And that's what you rejected in ScriptPro. [00:16:47] Speaker 02: That's what you rejected in Snitzer. [00:16:48] Speaker 02: And if you impose a new blaze marks requirement on patents where there is an express disclosure, even if it is as Novazymes itself conceded would be fine, [00:16:58] Speaker 02: individually described as one of several possibilities, you're going to throw 112 law into a very different situation. [00:17:05] Speaker 02: Your Honor, I say I'm passing my time. [00:17:07] Speaker 02: Thank you very much. [00:17:08] Speaker 00: I don't want to use up any of your time, Ms. [00:17:10] Speaker 00: Sullivan, but what I said when you said it doesn't matter and I said what I say always matters is not out of hubris, but because it gives counsel an opportunity to correct. [00:17:21] Speaker 02: Your Honor, I'm happy to take additional time to go back if I didn't give adequate response. [00:17:27] Speaker 00: I'm not asking for that. [00:17:28] Speaker 00: I'm explaining why I said what I said. [00:17:30] Speaker 02: I understood exactly, Your Honor. [00:17:32] Speaker 02: Thank you. [00:17:32] Speaker 02: Thank you. [00:17:33] Speaker 02: Thank you. [00:17:43] Speaker 04: May it please the court? [00:17:44] Speaker 04: The judgment below should be affirmed for at least three reasons. [00:17:48] Speaker 04: The first has already been alluded to, which is the fact finding that there was no written description here is supported by substantial evidence. [00:17:56] Speaker 04: And indeed it was clearly correct. [00:17:58] Speaker 04: Secondly, it is never legal error to do a blaze marks analysis. [00:18:03] Speaker 04: That analysis has been sanctioned for more than 50 years in this court since Ruschig. [00:18:08] Speaker 04: When there is an express disclosure, when it is present, it is the ultimate blaze mark. [00:18:14] Speaker 04: It wasn't present here. [00:18:16] Speaker 03: So you don't think the blaze mark is another standard or a standard above and beyond what was said in your answer? [00:18:22] Speaker 04: No. [00:18:22] Speaker 04: It is the basic standard. [00:18:23] Speaker 04: And if you've got to express disclosure, you have a really clear blaze mark. [00:18:27] Speaker 04: But that's the way, an appropriate way to do it. [00:18:30] Speaker 04: It is not very clear. [00:18:31] Speaker 04: What about Ms. [00:18:32] Speaker 03: Sullivan's final point, which is that numerous pharmaceutical patents [00:18:41] Speaker 03: include this kind of picking and choosing between them, and that this would have a terrible effect if we were to... Well, that's not what the decided cases say. [00:18:49] Speaker 04: I admit there are a number of patents like that, and many of them have been struck down by this court. [00:18:55] Speaker 01: Are there claims for a compound where at this position it could be one of any 30 different things, and then at the next position it could be one of 40 different things, and then yet at a third position it could be one of 25 things? [00:19:08] Speaker 01: Would you say that [00:19:09] Speaker 01: There's a lack of written description. [00:19:12] Speaker 01: If at position number one, it's element seven, and position two is element 14 of that list of 30, and then at position three, it's element 24 of the possible 25 possibilities. [00:19:24] Speaker 01: Would that lack written description? [00:19:26] Speaker 04: Indeed it would. [00:19:27] Speaker 04: That's a perfectly legitimate way to describe a genus and claim a genus, but you cannot talk the individual. [00:19:34] Speaker 01: In the genus, you list all 25 at position one. [00:19:39] Speaker 01: and all 30 position 2 and all 25 position 3. [00:19:43] Speaker 01: And then if you ultimately claimed, at a later date, a specific composition that's inside all those different lists, that would lack written description? [00:19:57] Speaker 04: Indeed it would. [00:19:57] Speaker 04: And that's exactly what the Fujikawa case held. [00:20:01] Speaker 01: Fujikawa. [00:20:02] Speaker 01: I'm sorry. [00:20:03] Speaker 01: Let me go to another one. [00:20:03] Speaker 01: What about a bicycle? [00:20:05] Speaker 01: where it was, I claim a bicycle, and here are three really important elements. [00:20:10] Speaker 01: I want a tire, and here's a list of 20 different kinds of tires. [00:20:15] Speaker 01: I want a good bicycle seat. [00:20:16] Speaker 01: Here's one of 20 bicycle seats. [00:20:19] Speaker 01: And I want a good braking system. [00:20:21] Speaker 01: Here's a list of 20 braking systems. [00:20:25] Speaker 01: And then I later claim a particular braking system, bicycle seat, and tire that I had listed and contemplated. [00:20:35] Speaker 01: That would lack written description? [00:20:38] Speaker 04: And the short answer is? [00:20:41] Speaker 04: You're going to say yes? [00:20:42] Speaker 04: No. [00:20:43] Speaker 04: OK. [00:20:45] Speaker 04: I'm going to say, well, we don't have decided cases that deal specifically with that. [00:20:50] Speaker 04: The cases we have are in the pharmaceutical area where things are much less predictable. [00:20:57] Speaker 01: So what's the problem? [00:20:58] Speaker 01: I mean, what is the problem with the pharma example I gave and the bicycle example I gave? [00:21:06] Speaker 04: Well, in the pharma example, as the court said in Fujikawa, laundry lists like that don't lead to particular combinations. [00:21:14] Speaker 04: And indeed, it was the holding in Novozymes as well. [00:21:17] Speaker 01: Well, let's just think about that out loud. [00:21:19] Speaker 01: I mean, unless you are necessarily reaching a conclusion that someone [00:21:28] Speaker 01: didn't possess everything that was listed because of some reason. [00:21:35] Speaker 01: And that reason must be because you don't believe that those different combinations would actually work for its intended purpose. [00:21:43] Speaker 01: And that sounds more like a, I don't know, an enablement defect or something like that than a written description defect. [00:21:50] Speaker 01: You've actually literally described in your lists the different possibilities at those different positions. [00:21:57] Speaker 01: whether it's for a bicycle or a compound. [00:22:00] Speaker 04: What you've described is a generic invention. [00:22:04] Speaker 04: And you can have generic inventions that coexist with more specific inventions. [00:22:09] Speaker 04: Because very often, the broad generic claim doesn't describe, doesn't anticipate, doesn't even render obvious the narrower invention. [00:22:18] Speaker 04: And the case we have here is the classic written description case, where somebody with a broad blender bus disclosure [00:22:26] Speaker 04: realizes that somebody else, Biogen, has made and developed a very valuable, specific invention who goes back with the benefit of hindsight and picks one from column A and one from column B and one from column C and says, aha, I had it all along. [00:22:41] Speaker 04: And that is exactly what the Ruchig, Fujikawa, Perdue, and Novizheim's cases say is wrong. [00:22:47] Speaker 04: You can have a written description of a genus that does not guide the woodsman to specific trees. [00:22:53] Speaker 04: And that's exactly the problem here. [00:22:55] Speaker 04: The idea that I've got this broad disclosure of vast numbers of three different things, and therefore I've described all combinations that was specifically rejected in Fujikawa, specifically rejected in Novozymes. [00:23:10] Speaker 04: Novozymes specifically said that the Schnitzer analysis falls apart when you have multi-component inventions. [00:23:17] Speaker 04: Schnitzer had picking one out of 14. [00:23:20] Speaker 01: But then your answer to my bicycle hypothetical ought to be that there's no written description for that particular claimed bicycle with the tire, the seat, and the brakes. [00:23:34] Speaker 01: Right? [00:23:35] Speaker 01: Or wrong? [00:23:37] Speaker 01: Because I don't know if there's anything in Nova Zimes or Fujikawa that rests its holding on the notion that, well, this is a farmer world. [00:23:48] Speaker 01: Tricky science, we're not really sure whether any of this is actually enabled. [00:23:54] Speaker 04: It's not necessarily a question of enablement. [00:23:57] Speaker 04: In all these cases, say, once you tell the person the name, sure, they could make it. [00:24:03] Speaker 04: But there's nothing in your patent that even calls that name to mind, that directs them to make that, that causes them to think about it, that shows that you as an inventor even envisioned it specifically. [00:24:13] Speaker 04: And this is why your bicycle question [00:24:16] Speaker 04: is why these written description cases are questions of fact. [00:24:21] Speaker 04: And I could imagine a bizarre circumstance where the answer to your bicycle hypothetical might be, perhaps they are all described. [00:24:30] Speaker 04: If there was nothing, they were all described. [00:24:33] Speaker 00: Well, they were all described because it was done by name. [00:24:36] Speaker 00: And there were 20 categories and 40 categories. [00:24:39] Speaker 00: And 40 different names of types of tires were named. [00:24:46] Speaker 04: There was nothing what the scenario would be. [00:24:49] Speaker 04: Suppose instead of having a generic bicycle when you pick a tire 15 and brake 43 and seat 59, all of a sudden the bicycle goes 10 times faster than any other bicycle described there. [00:25:06] Speaker 04: That person had no possession of that invention. [00:25:09] Speaker 04: And that's the sort of reaping where you didn't sow that the written description requirement is intended to prevent. [00:25:15] Speaker 04: And the fact of the matter is the fact finding here that it wasn't there is supported by substantial evidence. [00:25:22] Speaker 04: And blessedly, we don't have to decide the bicycle scenario since that was not before the board. [00:25:31] Speaker 04: To talk just a minute about the, you look like trouble. [00:25:35] Speaker 01: No, I want you to get to the upscale table because in some way, this case might not be the [00:25:42] Speaker 01: the selection of one from different columns of the menu and combine them all together to get your claim to intervention. [00:25:50] Speaker 01: Instead, this is maybe just lack of any disclosure that reveals the inventors contemplated that 480 milligrams per day would be therapeutically effective for anything. [00:26:02] Speaker 04: That is exactly what the board held, and that is exactly the core failing of the upscale table. [00:26:09] Speaker 04: The upscale table [00:26:11] Speaker 04: is for side effects. [00:26:12] Speaker 04: It's not for efficacy. [00:26:13] Speaker 04: The two MS clinicians who testified, Dr. Swin and Buckle, said that people would not view a one-week interim dose in that sort of situation as therapeutic. [00:26:25] Speaker 04: They never said that 480 milligrams per day was therapeutically effective for MS. [00:26:31] Speaker 04: Their upscale table blasts right through it on its way to 720. [00:26:36] Speaker 04: And that's the core failing with the upscale table. [00:26:38] Speaker 04: By not identifying a therapeutically effective dose for MS, they don't tell you where to stop in treating MS. [00:26:45] Speaker 04: All that discloses is adjusting for side effects up to a dose of 720. [00:26:51] Speaker 04: They never did disclose that the 480 milligram daily dose was therapeutically effective for MS. [00:27:01] Speaker 04: And indeed, the suggestion that [00:27:04] Speaker 04: The same doses are effective for everything that's listed in there. [00:27:07] Speaker 04: It's just strange credulity. [00:27:10] Speaker 04: Our witnesses testified that these 24 different diseases affect disparate organs with differing pathophysiologies, including generalized pain, which has nothing to do with multiple sclerosis. [00:27:23] Speaker 04: And Dr. Nguyen testified at paragraph 47A, 18 and 298, there's no expectation [00:27:31] Speaker 04: that one dose would be effective for all of those diseases. [00:27:37] Speaker 04: One point worth noting is reference was made to page 162 in the FP application saying that the compositions and kits, they could be used for everything. [00:27:49] Speaker 04: That doesn't say that. [00:27:50] Speaker 04: It says the compositions and kits, according to the invention, are contemplated to be suitable to use in the treatment of one or more of the following conditions. [00:28:00] Speaker 04: And they never identified which the one or more was. [00:28:07] Speaker 01: Does one or more mean all? [00:28:09] Speaker 04: One or more does not mean all. [00:28:11] Speaker 04: One or more means one or more, at least one, possibly more. [00:28:17] Speaker 01: I seem to recall that the other side's relying on the fact that perhaps by 2005, it was known in the art or through clinical trials that [00:28:29] Speaker 01: these particular fumarates were effective for multiple sclerosis? [00:28:35] Speaker 01: So does that somehow color our understanding of the written description here? [00:28:42] Speaker 04: Retreat to the prior art is the last bastion of the inadequately described invention. [00:28:47] Speaker 04: We see it in all of the cases. [00:28:49] Speaker 04: Now let's talk about the facts of this case. [00:28:50] Speaker 04: OK. [00:28:52] Speaker 04: But just to set the legal framework, the board said [00:28:59] Speaker 04: You can't reach into the prior art to do an obviousness type analysis to fill the voids in the specification. [00:29:07] Speaker 04: The Purdue case we cited says the blaze marks have to be in the specification. [00:29:12] Speaker 04: And the Lockwood case and the Goodell case and the Ariad case all stand for that proposition that it's not a question of what a person of ordinary skill in the art might, looking at the application, [00:29:25] Speaker 04: say, gee, I wonder if they thought of this, even though they didn't disclose it. [00:29:29] Speaker 04: That's not the right analysis. [00:29:31] Speaker 04: And that's what they're trying to do. [00:29:34] Speaker 04: There's nothing here. [00:29:36] Speaker 04: And indeed, it isn't helpful. [00:29:37] Speaker 04: The prior art isn't helpful. [00:29:38] Speaker 04: Dr. Ravitch confirmed at paragraph 37 of his declaration, A-7383, that in the prior art, there's no disclosure of 480 milligrams per day of DMF and or MMF [00:29:52] Speaker 04: as a therapeutically effective dose for MS. [00:29:55] Speaker 04: And that's what's missing from this application. [00:29:57] Speaker 04: That is the key essential failure of this application that makes the board's decision that there was no written description supported by substantial evidence and that it should be a firm. [00:30:08] Speaker 01: What about the original claims? [00:30:09] Speaker 01: If you're patient enough to trace through the original claims, you could locate claim scope that is [00:30:22] Speaker 01: directed to treating multiple sclerosis with these particular fulmarates, I guess at a daily dosage of 480 milligrams? [00:30:34] Speaker 04: Well, to start at the very end, the original claims don't describe a daily dosage, because they don't tell you how many pills you take at each administration. [00:30:44] Speaker 04: And page 161 of their own application shows that it can be different at different times in the day. [00:30:49] Speaker 01: There's nothing in the claims that tells you a daily dose, but more importantly... There's one claim that says 240, and then there's another claim that says twice a day. [00:30:57] Speaker 04: It says the amount that's in the pill, and it says how many times a day. [00:31:01] Speaker 04: It doesn't tell you how many pills you take each time, and that's what you need to get the daily dosage. [00:31:07] Speaker 04: But more importantly than that, that backward march through that nested maze of improperly, multiply dependent claims [00:31:17] Speaker 04: is the sort of thing that you can only do with foreknowledge of the claimed invention. [00:31:23] Speaker 04: And in Novozymes and the other cases, they made clear you can't do it with hindsight. [00:31:27] Speaker 04: You have to look at the disclosure, including the original claims, and unguided by later knowledge of the invention, you've got to see that the inventor envisioned that particular thing as his invention. [00:31:40] Speaker 04: And we had testimony from Dr. Ravitch. [00:31:44] Speaker 04: from counsel pretty well acknowledging that they were shaping their review of the claims based on looking for the dose. [00:31:51] Speaker 04: And that is just a blatant hindsight reconstruction of the invention of the sort that's routinely rejected here. [00:32:02] Speaker 04: I would like to make one point before I sit down. [00:32:08] Speaker 04: I think it is correct, two points, [00:32:11] Speaker 04: Further claim construction isn't required. [00:32:13] Speaker 04: They construed the claim to the extent they needed to. [00:32:15] Speaker 04: There simply isn't any description anywhere on the patent of 480 milligrams being a therapeutically effective dose for MS. [00:32:24] Speaker 04: And therefore, under any reasonable construction of that term, they would fail. [00:32:29] Speaker 04: And lastly, my friend did correctly state the issue. [00:32:34] Speaker 04: The issue here is only [00:32:37] Speaker 04: forward pharma's specification and the written description there. [00:32:41] Speaker 04: There is some intimation in their reply brief trying to draw comparisons to biogen specification. [00:32:47] Speaker 04: Biogen specification is not before the court. [00:32:49] Speaker 04: It is irrelevant. [00:32:51] Speaker 04: And more importantly, those arguments were waived by not having been raised below in connection with this motion and not having been raised in the opening brief. [00:33:05] Speaker 00: I have a quick question. [00:33:06] Speaker 00: Sure. [00:33:07] Speaker 00: You referenced 7383, the Ravitch declaration, for prior art purposes. [00:33:15] Speaker 00: What was your exact utilization of it? [00:33:21] Speaker 04: He stated very carefully that in the prior art, there was no disclosure of 480 milligrams per day for therapeutically effective dose for MS. [00:33:34] Speaker 04: Thank you. [00:33:35] Speaker 04: Thank you very much. [00:33:45] Speaker 02: Thank you, Your Honors, very briefly. [00:33:46] Speaker 02: We are Judge Chen's bicycle hypothetical. [00:33:49] Speaker 02: There's express disclosure. [00:33:50] Speaker 02: Even though there's a list of eight and a list of 24, we are express disclosure. [00:33:55] Speaker 02: We are not Novozymes. [00:33:57] Speaker 02: My friend likes Novozymes. [00:33:58] Speaker 02: He won Novozymes. [00:34:00] Speaker 02: This is not Novozymes. [00:34:01] Speaker 02: Novozymes would have come out the other way if there had been express literal disclosure of the claim. [00:34:09] Speaker 02: Novozyme turned on the fact that the substitution [00:34:12] Speaker 02: at location 239 in the alpha amylase enzyme, the substitution that was in the description was a substitution at 239 of tryptophan. [00:34:24] Speaker 02: The claim was for a substitution of glutamine. [00:34:28] Speaker 02: Had there been expressed disclosure of the substitution of glutamine for serine at location 239, no designs would have come out the other way. [00:34:38] Speaker 02: That would have been your exact pedal in the bicycle. [00:34:41] Speaker 02: So we are not Novozymes. [00:34:42] Speaker 02: Novozymes would have come out the exact opposite way if there had been expressed literal disclosure, even if it had been in a list. [00:34:49] Speaker 02: That's Schnitzer. [00:34:50] Speaker 02: Lists are OK, even if it's disclosed among several possibilities. [00:34:53] Speaker 02: Second, we're not a hindsight case. [00:34:56] Speaker 02: We didn't go out and troll later backwards to a generic claim for using fumarates to treat inflammatory conditions. [00:35:03] Speaker 02: We were the first to claim 480 milligrams a day of DMF to treat MS. [00:35:09] Speaker 02: And we did it. [00:35:10] Speaker 02: We disclosed that in the upscale table. [00:35:12] Speaker 02: And the upscale table tells POSA it's mandatory to give all the doses. [00:35:16] Speaker 02: You give all the doses. [00:35:18] Speaker 02: The doses are listed in an upscale precisely because each of them is mandatory to treat all the listed diseases. [00:35:24] Speaker 02: As to the prior art, Your Honor, it was error to completely ignore the prior art. [00:35:30] Speaker 02: The prior art is overwhelming in 2005 that DMF is effective to treat. [00:35:36] Speaker 02: MS. [00:35:38] Speaker 02: You can look to the Joshi patents. [00:35:39] Speaker 02: There's three of them. [00:35:40] Speaker 02: We made a reference to the 376 patent, which plainly taught the use of fumarates to treat MS. [00:35:47] Speaker 02: Quick question. [00:35:47] Speaker 02: Should 2004 be the right frame of reference? [00:35:50] Speaker 01: Because the priority date for this PCT was 2004. [00:35:54] Speaker 02: Yes, Your Honor. [00:35:55] Speaker 02: But we cite to prior our pre-2004 Joshi patents, the Schimrick studies in particular, which we're using up titration of DMF to treat MS in particular. [00:36:06] Speaker 02: And one of the Joe Sheep patents was filed in 2002. [00:36:08] Speaker 02: So we're citing the prior art that plainly predates 2004. [00:36:11] Speaker 02: And it was an additional error to completely ignore it. [00:36:14] Speaker 02: We think with the express description we had, even though it was in a list, we're plainly in Snitzer and Driscoll. [00:36:20] Speaker 02: We're not in Novozymes. [00:36:21] Speaker 02: And Your Honor, my friend is right that we all thought the point of novelty was the 480 milligrams, that that particular [00:36:29] Speaker 02: That's the point of novelty. [00:36:31] Speaker 02: That 480-milligram dose that we called out in our application, and then they later patented under the 514, that was novel. [00:36:39] Speaker 02: But it was not novel to connect DMF to MS, which is what the board seemed to be finding missing. [00:36:51] Speaker 02: And finally, Your Honor, one or more is a red herring. [00:36:54] Speaker 02: One or more, if you look at it, simply means a patient might have one or more conditions at the same time. [00:36:58] Speaker 02: If you look at A163, it references the comorbidity problem. [00:37:03] Speaker 02: And in fact, if you look in the record at A18747, you'll see that Biogen's expert admitted that he commonly treats people who have MS, and psoriasis, and Crohn's, and Hajimoto's syndrome at the same time. [00:37:18] Speaker 02: We disclosed the use of eight doses to treat all 24 diseases. [00:37:23] Speaker 02: It was mandatory. [00:37:24] Speaker 02: A person of skill in the art would have known it from the prior art. [00:37:27] Speaker 02: You should reverse. [00:37:28] Speaker 02: Thank you. [00:37:28] Speaker 02: Thank you. [00:37:28] Speaker 02: We thank both sides and the case is submitted.