[00:00:09] Speaker 02: The next case for argument is 141671, Clawson v. Leon Pharmaceuticals. [00:00:56] Speaker 02: Good morning, Your Honor. [00:01:05] Speaker 05: This case presents, it's under Rule 271B, as to whether or not the safe harbor applies to the activities that are accused of infringement. [00:01:17] Speaker 05: important key point of our appeal, it's the activities that are actually accused of infringement. [00:01:22] Speaker 02: And what are those activities? [00:01:23] Speaker 02: I'm a little unclear on your infringement theory here. [00:01:26] Speaker 05: And I understand that, Your Honor. [00:01:29] Speaker 05: There's the activities that were done in the clinical study. [00:01:34] Speaker 02: Are you referring to something in the appendix? [00:01:36] Speaker 05: Yes, I'm looking at appendix A 1539, 1541, [00:01:48] Speaker 05: And 1651, for example. [00:01:51] Speaker 02: So this is the clinical study report. [00:01:54] Speaker 05: Correct. [00:01:56] Speaker 02: And the clinical study was done by... Well, what is... Maybe I didn't ask the question clearly enough. [00:02:01] Speaker 02: What is your infringement theory? [00:02:03] Speaker 02: What conduct is infringing? [00:02:04] Speaker 02: Is it filing the patent application that's infringing? [00:02:08] Speaker 02: Yes. [00:02:10] Speaker 02: Are there sales that are arguably infringing here? [00:02:14] Speaker 05: There is a sale of the product that was patented. [00:02:18] Speaker 05: and the patents itself. [00:02:20] Speaker 05: It's not the sale of the product. [00:02:23] Speaker 05: It's important that I start in this direction, and I'm getting right exactly to your question because that's the confusion. [00:02:31] Speaker 05: The clinical study done by a dozen doctors is not being accused of infringement. [00:02:37] Speaker 05: The clinical study itself would fall under the safe harbor. [00:02:41] Speaker 05: The clinical study is the activity that creates the database. [00:02:47] Speaker 05: If you look at the first clause of the claim, which is found on our brief. [00:02:55] Speaker 03: Which claim are you talking about? [00:02:56] Speaker 05: Claim 33, which is in our brief at page 25. [00:03:03] Speaker 05: The claim says, accessing the data source. [00:03:08] Speaker 05: So that activity is necessarily after the clinical study. [00:03:13] Speaker 03: But isn't it pursuant to filing a supplemental NDA and therefore falls within 271E1? [00:03:21] Speaker 03: No, it's not. [00:03:24] Speaker 03: The clinical study... But that's what the court found. [00:03:27] Speaker 05: What? [00:03:28] Speaker 03: That's what the court found, right? [00:03:30] Speaker 05: Right, because the court found that the clinical study was involved in the NDA and it was filed with the FDA. [00:03:37] Speaker 05: We don't disagree with that. [00:03:39] Speaker 05: But the clinical study and conducting the clinical study is not accused of infringement. [00:03:43] Speaker 05: This was done, again, by a dozen doctors at Elon. [00:03:49] Speaker 05: Subsequent to the conclusion of the clinical study on October 1st, and I'm looking at page A, 1539, after October 1st... Could you please stop showing that to us? [00:03:59] Speaker 03: We really can't read it. [00:04:03] Speaker 05: Correct. [00:04:03] Speaker 05: In November, there was a pharmaceutical product lifestyle strategy meeting held where Dr. Klassen presented a paper which included [00:04:13] Speaker 05: reference to the patent in dispute in the back, and this is at A1505, where he taught what is the patented process, which has nothing to do with the clinical study, which had already been completed prior to, in October, completed prior to the November meeting, that was attended by Ms. [00:04:37] Speaker 05: Pellegrini, as well as Ms. [00:04:40] Speaker 05: Santelli from Elon. [00:04:43] Speaker 05: Miss Pellegrini then, at the end of November, filed one of the patents in suit, one of the patents that are the infringing activity, accused of infringement, not the patent that's being asserted. [00:04:58] Speaker 03: Filing a patent application isn't an infringing act, no matter what the claims say. [00:05:04] Speaker 03: It's not making, using, or selling an invention. [00:05:09] Speaker 05: Actually, filing the patent application is one of the steps of the claimed invention. [00:05:14] Speaker 05: So actually filing the patent application and getting the patent is an active infringement of Dr. Klassen's patent. [00:05:22] Speaker 05: So it seems counterintuitive, but it is. [00:05:25] Speaker 03: Because if you practice the steps... Which claim says, file a patent application? [00:05:29] Speaker 05: Well, it's claim 131 is the one example we have in here. [00:05:32] Speaker 05: There's a couple of them that say that. [00:05:36] Speaker 05: The method of claim 36. [00:05:37] Speaker 05: You're saying it's a step of the method. [00:05:38] Speaker 05: What? [00:05:38] Speaker 05: You're saying it's a step of the method. [00:05:40] Speaker 02: Step of the method. [00:05:40] Speaker 02: I thought the commercialization was the step of the method. [00:05:43] Speaker 05: Well, claim 131 is a dependent claim from claim 36, which depends from claim 33. [00:05:49] Speaker 02: Was that one of those that was canceled, or is that still alive? [00:05:52] Speaker 05: That's still alive. [00:05:53] Speaker 05: The ones we have in here are still alive. [00:05:54] Speaker 05: Actually, 131 was added during the re-examination. [00:05:57] Speaker 03: So you're saying that filing a patent application is commercialization? [00:06:03] Speaker 05: Yes. [00:06:05] Speaker 03: And we're also... You don't get any money out of filing a patent application. [00:06:08] Speaker 03: In fact, it costs money. [00:06:10] Speaker 03: So commercialization is usually selling something or offering a service, not entering a government agency for which you pay a fee. [00:06:22] Speaker 05: Investing is a commercial transaction. [00:06:26] Speaker 05: You're taking your money and you're investing it in something. [00:06:29] Speaker 05: You're commercializing that money. [00:06:31] Speaker 05: When you buy inventory, that's a commercial transaction. [00:06:34] Speaker 05: When you sell inventory, you make profit. [00:06:37] Speaker 05: Profit and loss are both parts of commercialization. [00:06:41] Speaker 05: No company exists without expenditures and then returns. [00:06:45] Speaker 05: That's all part of the commercialization process. [00:06:47] Speaker 05: So no, I would disagree. [00:06:49] Speaker 05: Paying your patent attorney is a step of commercializing whatever your invention is. [00:06:53] Speaker 05: It's not a profitable step. [00:06:54] Speaker 05: It costs you money. [00:06:56] Speaker 02: In this case, it was a very profitable step. [00:07:00] Speaker 05: then you have, it's still part of the commercialization. [00:07:03] Speaker 05: It was just a bad idea, just as you buy inventory that you later have to sell off below cost. [00:07:09] Speaker 05: It's still part of your process. [00:07:10] Speaker 05: It's still part of your commercial enterprise. [00:07:12] Speaker 05: Commercialization doesn't mean successful commercialization. [00:07:15] Speaker 05: It could be unsuccessful commercialization. [00:07:18] Speaker 05: Not all commercial enterprises are successful. [00:07:20] Speaker 02: Do you have a definition of commercializing? [00:07:22] Speaker 02: Is there an ordinary meaning to commercializing? [00:07:24] Speaker 05: It's actually found in the patent where it gives the examples of [00:07:28] Speaker 05: of getting a patent intellectual property and the like are described in the patent as commercializing. [00:07:34] Speaker 02: So just back to the infringement theory. [00:07:40] Speaker 02: There are three steps. [00:07:43] Speaker 02: You're saying that the first three steps if you do it are not within the safe harbor. [00:07:48] Speaker 02: You recognize the first three steps are in the safe harbor and it's only if you perform those steps and then do the commercializing step that's the infringement theory? [00:07:58] Speaker 05: No, the first step is accessing the data source, not creating the data source. [00:08:08] Speaker 05: Once again, the data source was created and already reported to the FDA before the infringing activity began. [00:08:17] Speaker 02: So this is what we call a second look, right? [00:08:19] Speaker 02: You're saying the FDA stuff is already done, but then when you access it afterwards, it's for another purpose. [00:08:27] Speaker 02: And so all of that is infringing. [00:08:29] Speaker 05: Correct. [00:08:29] Speaker 02: Well, I mean, looking at the claims there, and I'm looking at what you describe as the claims. [00:08:35] Speaker 02: So under step two, it says at least [00:08:40] Speaker 02: one adverse event, step three says at least one new adverse event. [00:08:44] Speaker 02: So if you've already done it before and we're now on the second round, how can you have a new adverse event? [00:08:50] Speaker 02: Is that different than the other adverse event you encountered when you were getting ready for the FDA submission? [00:08:56] Speaker 05: Correct. [00:08:57] Speaker 05: This is new as in novel as in patentable. [00:09:01] Speaker 05: It's the same event, but you look at it to determine whether or not you can get intellectual problems. [00:09:06] Speaker 05: Not necessarily patenting. [00:09:08] Speaker 05: any intellectual property. [00:09:09] Speaker 02: Well, so you're saying a new adverse event could be the same event, but if you're going to use it for a different purpose, that makes it new? [00:09:15] Speaker 02: Correct. [00:09:16] Speaker 02: You think that's a fair interpretation of new? [00:09:18] Speaker 05: It's the interpretation that's claimed in the patent. [00:09:21] Speaker 05: Again, the patent describes this all in detail of this is not a patent on how to conduct a clinical study. [00:09:28] Speaker 05: It's not a patent on how to recognize when there's been an adverse event. [00:09:32] Speaker 05: It's a patent to recognize how you commercialize that. [00:09:36] Speaker 05: Again, it's the [00:09:37] Speaker 05: It was part of the pharmaceutical policy's life cycle strategies, which is how do you continue to retain intellectual property protection for old pharmaceuticals. [00:09:47] Speaker 02: Just going back to another question. [00:09:48] Speaker 02: I'm sorry if I'm redundant, but I'm confusing myself here, perhaps. [00:09:52] Speaker 02: But we know your position with respect to filing a patent application. [00:09:57] Speaker 02: Does your infringement theory also include sales and things that happen subsequent to the patent issuance? [00:10:06] Speaker 05: If you're talking about the damages theory, yes, because we have a product by process or kit claim, which says every time you sell this newly patented, whatever it is, whenever you sell this newly patented or intellectual property protected commercial product, you are now, that's an active infringement of not the method claims, [00:10:29] Speaker 05: but the product by process. [00:10:31] Speaker 05: You created a commercial product. [00:10:32] Speaker 03: With respect to the kit claims, if we don't agree with you, with respect to the exemption from infringement of accessing and analyzing, but if the kit has that information appended to it, [00:10:52] Speaker 03: Once exempt, is it always exempt or is it no longer exempt because it's part of a kit and that is being sold which is commercializing? [00:11:03] Speaker 05: Absolutely not. [00:11:04] Speaker 05: It is absolutely not always exempt once exempt and that is not something we're arguing. [00:11:08] Speaker 05: That's fundamental to the law. [00:11:10] Speaker 05: It's the second look issue. [00:11:12] Speaker 05: If I do my clinical studies and I get my drug approval and I have my FDA approved drug, my pharmaceutical [00:11:21] Speaker 05: manufacturing facility has to look back at that information to make sure they make the drug that is now subject to infringement and the like. [00:11:30] Speaker 05: They have to make it the same way it was made for the clinical study. [00:11:34] Speaker 05: So one doesn't forget everything in the clinical study when one manufactures a pharmaceutical. [00:11:39] Speaker 05: So it's fundamental in pharmaceutical law that that activity is exempt while it's being used and done. [00:11:45] Speaker 05: The activity is exempt. [00:11:47] Speaker 05: And the activity never becomes unexempt. [00:11:49] Speaker 05: That clinical study always remains exempt. [00:11:52] Speaker 05: But if you then manufacture a pharmaceutical that infringes somebody else's patent, you of necessity must be using some of the information from your clinical study, otherwise you're not complying with the FDA. [00:12:03] Speaker 05: Let me ask you this, Counselor. [00:12:05] Speaker 05: If we were to agree that the District Court extended the safe harbor protections further than they should have gone, and we were to send this case back, in light of the Supreme Court's recent guidance in Alice, how does this survive a 101 challenge? [00:12:23] Speaker 05: That issue has not been raised. [00:12:25] Speaker 05: I understand, but you yourself said this is taking an old idea and sending it around again. [00:12:31] Speaker 05: Well, not an old idea. [00:12:34] Speaker 05: Taking an existing patent and re-patting. [00:12:37] Speaker 05: Taking an existing pharmaceutical. [00:12:40] Speaker 05: Right. [00:12:40] Speaker 05: And finding new intellectual property that applies to that existing pharmaceutical because of the discovery of something new about that pharmaceutical. [00:12:50] Speaker 05: So it's not on the same clinical study that existed before. [00:12:53] Speaker 05: based upon a clinical study that already existed, it's already been reported to the FDA. [00:12:57] Speaker 05: We're not going back. [00:12:59] Speaker 05: We're not saying that study itself had anything to do with imprinting. [00:13:02] Speaker 05: That's still protected by the safe armor, not removing that protection. [00:13:06] Speaker 05: That protection lasts. [00:13:07] Speaker 05: But again, the information from pharmaceutical, protected pharmaceutical studies are used every day in the manufacture of non-protected drugs. [00:13:16] Speaker 05: They're being used here in the manufacture of intellectual property. [00:13:21] Speaker 05: So it's the information [00:13:22] Speaker 05: that you're taking a second look at and reusing in the manufacture of intellectual property that covers it. [00:13:28] Speaker 05: And what the district court got incorrect, and you can see it in their decision, is they said, you're accusing the study of infringement. [00:13:39] Speaker 05: And that's what's been repeated in Elon's brief. [00:13:40] Speaker 05: You're accusing our study of, we're not accusing the study of infringement. [00:13:44] Speaker 05: It's after that study. [00:13:46] Speaker 05: And the background and the history is in here, where the study ended, they came, they listened to Dr. Klassen, [00:13:53] Speaker 05: They had exchanges of email of information. [00:13:55] Speaker 05: We got them quoted in here with Dr. Klassen. [00:13:57] Speaker 05: Said, oh, that's great. [00:13:58] Speaker 05: And then individuals who were not participants in the study filed the intellectual property because they identified protection that was available based upon not conducting a study, not doing a clinical study. [00:14:14] Speaker 05: They didn't report any of this. [00:14:16] Speaker 05: None of these patents were reported to the FDA. [00:14:18] Speaker 05: The documenting and mentorship wasn't reported to the FDA. [00:14:20] Speaker 05: It was all reported to the PTO. [00:14:22] Speaker 05: is not covered over the safe harbor. [00:14:25] Speaker 05: How does it survive Alice? [00:14:30] Speaker 05: If you look at Alice Corp as a different way of looking at novelty versus looking at Alice Corp as a different way of looking at Section 101 patentability, I'm not trying to ignore it. [00:14:42] Speaker 05: Those are two very different questions. [00:14:44] Speaker 05: It certainly survives 101, this is patentable subject matter. [00:14:48] Speaker 05: Does it survive Alice Corp's [00:14:51] Speaker 05: uh... reinterpretation of whether novelty exists or not yes it does it's kind of likely to go into that at this point these patents were re-examined there were two patents the one patent survived was re-examined and the re-examination looked at huge amounts of information about [00:15:19] Speaker 05: earlier looks at repatting have been done. [00:15:23] Speaker 02: And as you know about half of... The re-exam was like a decade ago, right? [00:15:26] Speaker 02: I mean the re-exam clearly preceded Alice in all of the cases with the Supreme Court. [00:15:32] Speaker 05: Barely preceded Alice. [00:15:33] Speaker 05: The decision was 2006, re-examination included in 2011. [00:15:38] Speaker 05: So yes, it preceded Alice. [00:15:40] Speaker 05: But that doesn't... Alice didn't say nothing is novel any longer. [00:15:47] Speaker 02: Well, the patent here is essentially running a clinical trial, looking at the data from the clinical trial, and then discovering new information that could give it commercial value from looking at the data and doing something to commercialize. [00:16:01] Speaker 02: That doesn't sound to you like the kind of steps of a patent that the Supreme Court might have a problem with? [00:16:08] Speaker 05: Let me first correct that the first step you said is not actually a step. [00:16:11] Speaker 05: Running a clinical trial is not a step in the patent. [00:16:13] Speaker 02: It's in the preamble. [00:16:14] Speaker 02: I thought you said the preamble was limiting, but I may be wrong about that. [00:16:17] Speaker 02: I thought your precision was the preamble was limiting, no? [00:16:24] Speaker 05: The method of creating and using data, so you mean the creating part? [00:16:28] Speaker 01: Yes. [00:16:30] Speaker 05: You're not creating data that's in the clinical trial. [00:16:38] Speaker 05: You're creating the data that's used to make the path. [00:16:43] Speaker 05: You're looking at the data in the clinical trial. [00:16:44] Speaker 05: The data you're creating is the information or knowledge. [00:16:48] Speaker 02: Yeah, but I take that. [00:16:50] Speaker 02: I'm talking about alopecia and the steps of a patent. [00:16:53] Speaker 02: So I don't think it matters whether we're talking about first looks or second looks with regard to the steps of this patent. [00:16:59] Speaker 05: I guess my first response is I'd like to be able to brief that. [00:17:02] Speaker 05: But that said, there was nothing, after a thorough re-examination, there was nothing in the prior art [00:17:13] Speaker 05: that included the last step, identifying the potential commercial value of the second to last step, and commercializing the newly identified product information based upon the analyzed data. [00:17:26] Speaker 05: It wasn't in the prior art. [00:17:27] Speaker 05: Now this requires that not that it sounds familiar to you, but that it actually be found in the prior art. [00:17:35] Speaker 05: We have to remember that the patents were filed, I believe, in 2000 or 2001. [00:17:39] Speaker 05: There's a family of these patents. [00:17:43] Speaker 05: last week. [00:17:44] Speaker 05: In 2000, 2001, evergreening was not even a concept in the pharmaceutical field. [00:17:50] Speaker 05: Nobody evergreened anything. [00:17:51] Speaker 05: Patents, your original patent on your blockbuster drug expired and you moved on to the next blockbuster drug. [00:17:57] Speaker 05: Evergreening wasn't a concept when these patents were filed. [00:18:00] Speaker 05: So if you take Alice, go back to when these patents were filed, it sounded completely unknown to everyone in the pharmaceutical industry. [00:18:07] Speaker 05: And again, remember, by [00:18:09] Speaker 05: 2001, Dr. Klassen, who has never been employed by a large pharmaceutical company, was the invited final speaker at this conference, attended by every pharmaceutical company, including Elon. [00:18:22] Speaker 05: It was a brand, evergreening was a brand new concept. [00:18:26] Speaker 02: Okay, I think we're beyond your time. [00:18:27] Speaker 02: Why don't we hear from your friend and we'll record two minutes of your talk. [00:18:38] Speaker 04: May I please support? [00:18:39] Speaker 04: I'm James Monroe on behalf of the Lawn Pharmaceuticals. [00:18:42] Speaker 04: Given the conversation, I'd like to focus on the claims, given some of the questions. [00:18:48] Speaker 04: There was a reexamination. [00:18:49] Speaker 04: At the beginning of the reexamination, claim 33, which is at A81, did exist. [00:18:56] Speaker 04: It was canceled. [00:18:57] Speaker 04: That claim 33 has a last step, commercializing the newly identified product information based upon the analyzed data. [00:19:05] Speaker 04: That was canceled. [00:19:06] Speaker 04: The PTO required [00:19:08] Speaker 04: to limit the commercializing step to what was in Claim 36 at that time. [00:19:15] Speaker 04: Claim 36 reads, commercializing comprises formatting the data relating to at least one new adverse event associated with exposure to or use of the product or documenting saying such as a manufacturer or distributor of the product must inform consumers, users, or individuals responsible for the user, physicians, or prescribers about [00:19:38] Speaker 04: at least one new adverse event associated with exposure to the use of the product. [00:19:42] Speaker 04: So the commercializing was limited to that particular type of commercializing, which reads on a product label. [00:19:49] Speaker 02: That reads on a... So you're saying filing a patent application has nothing to do with what's claimed here? [00:19:56] Speaker 04: That is correct. [00:19:56] Speaker 04: In fact, if you look at claim 35 at that same spot, which precedes claim 36, it says the commercializing, again, depending upon original claim 33, [00:20:08] Speaker 04: It says commercializing step comprises protecting the intellectual property interest in the newly identified product information. [00:20:16] Speaker 04: The PTO canceled that claim. [00:20:18] Speaker 04: In fact, the PTO canceled all claims that dealt with protecting intellectual property rights. [00:20:24] Speaker 04: So it's unfair to go back and look at- Based on 101? [00:20:29] Speaker 04: Based on prior art, the reasons for allowance, the reason the examiner gave for allowing claim 36 [00:20:35] Speaker 04: was that the examiner did not, in that particular examiner, did not find in the prior art informing the users of at least one new adverse event. [00:20:45] Speaker 04: And that's the reasons for allowance or a 1484. [00:20:50] Speaker 04: To the question about Alice, we would contend it's not patentable under Alice. [00:20:59] Speaker 04: In fact, Elon contends that if the examiner who handled the 674 patent application [00:21:04] Speaker 04: that went all the way to the board, that went all the way to the board and then was affirmed here, that entire patent was canceled. [00:21:12] Speaker 04: If the same examiner had handled this case, it's our contention that this would have been canceled also. [00:21:17] Speaker 03: And of course the 101 Alice issue wasn't before us, right? [00:21:21] Speaker 04: That is correct. [00:21:22] Speaker 04: And nor is the issue of can one, is patenting, the idea, can one get a patent on the idea of patenting something provided under a Particle 8 of the Constitution? [00:21:33] Speaker 04: And if that is the point of novelty is that you figured out you could file a patent application on something, we would argue. [00:21:40] Speaker 03: Now, what about the idea of once exempt, always exempt? [00:21:44] Speaker 03: If information is exempt under 271E1, if it's then embodied in a PIP, which is sold, is it still exempt or not? [00:22:00] Speaker 04: I think that would depend on the particular facts of your case. [00:22:02] Speaker 04: I think in this case, absolutely, because what was embodied in the kit that was the product label, which the FDA requires one to include with one's product in order to maintain [00:22:16] Speaker 04: approval for your product. [00:22:18] Speaker 03: So that is... So if we agree with you and the District Court that anything relating to filing the supplemental NDA was exempt, we would have to send it back on the Kitt claims? [00:22:33] Speaker 04: No, Your Honor. [00:22:35] Speaker 04: We would argue that... But you said that was a fact question. [00:22:38] Speaker 04: No, I'm saying if there was a different factual scenario than our case. [00:22:41] Speaker 04: In our case, the Kitt [00:22:44] Speaker 04: that is accused, and the element that's accused in the kit is the product label, which is something that the FDA requires. [00:22:51] Speaker 04: So it still falls under the Safe Harbor provision. [00:22:53] Speaker 04: It still falls under the once exempt, always exempt, because the activity... In other words, once exempt, always exempt, in your view. [00:22:59] Speaker 04: Correct. [00:23:00] Speaker 04: In the context of you then using the product label, which is that activity of including a product label to maintain approval is required by the FDA and therefore is exempt. [00:23:10] Speaker 04: There could be other fact patterns and other kit claims, but under the facts of this case, Alon's activity of selling the product with that label is under the Safe Harbor provision. [00:23:23] Speaker 02: What about his argument about the second look? [00:23:28] Speaker 02: He wants to say you did all of this for the FDA approval, put that in the door, and then you're going through all of this again for purposes of commercial sale. [00:23:38] Speaker 04: Your Honor, Alon agrees with your earlier question, which is when you were asking Klassen about the issue of second look, that his claims, the Klassen claims, preclude the second look theory. [00:23:53] Speaker 04: Once you've gone through the process before the FDA of identifying the purported adverse event and how you should use the product differently, the new use and view of that adverse event, [00:24:05] Speaker 04: It's no longer a new if you come back later and look at that exact same data and come to the exact same conclusion. [00:24:12] Speaker 04: You're not identifying a new adverse event that identification of the new adverse event occurred during the original clinical trial study. [00:24:20] Speaker 04: And on that point I think it's important to also look at the study report that class and identify at a one five four zero which was provided to the FDA on that [00:24:34] Speaker 04: page of the report a one five four zero it with it document the people analyze the clinical study it also identified the date they did that two of those people jim and shaw and michael skates that are on that page were the identified inventors on the later so i wanted to clear up it was the same people who did that uh... and there are some to dependent claim but i don't want to leave the court there are two dependent claims that survived [00:25:04] Speaker 04: of the re-examination. [00:25:06] Speaker 04: One claim said the commercialization step, which I noted was limited to informing the public of your adverse event, it said further comprises documenting inventorship. [00:25:21] Speaker 04: And then there's another claim from that one that says documenting date of invention. [00:25:26] Speaker 04: It's unclear what those mean in the abstract referring upon the product label notice claim 36. [00:25:33] Speaker 04: but the disclosure at 8154-0 clearly covers the documenting who analyzed the study and when they did it, and so therefore falls under the safe harbor. [00:25:45] Speaker 04: One other factual issue I would like to point out, Klassen identified the November 15, 2001 conference, which is reportedly the date that Klassen first gave notice [00:26:02] Speaker 04: of Claussen's reported rights. [00:26:05] Speaker 04: As of November 15, 2001, the patent that issued that still exists following re-examination did not exist. [00:26:15] Speaker 04: The 472 patent that survived the re-exam did not issue until 2003. [00:26:20] Speaker 04: That patent did not issue until after the clinical trial, the FDA submissions, the approving of the label, and the filing of the patent application. [00:26:30] Speaker 04: All of those activities occurred [00:26:31] Speaker 04: before the 472 patent issued. [00:26:35] Speaker 04: I wanted to point that out, given the reference to the November 2001 date. [00:26:39] Speaker 04: Keep in mind, at the time of the district court proceedings, the 674 patent still existed, which it did issue prior to that date, prior to Alon's activity. [00:26:50] Speaker 04: My point being, at this stage, there will be no, even if there were a remand, there will be no 271A infringement case still in play, because the 472 patent [00:27:01] Speaker 04: did not exist so all of the activities filing the patent application and all of the other activities occurred prior to the issuance of the patent with respect to 154-D which was never claimed in class and complaint but anticipating it will be claimed. [00:27:17] Speaker 04: I will note all the clinical trials and the submission of the FDA information to the FDA that also occurred before the November 15th date. [00:27:27] Speaker 03: How does 271-G fit in here if at all? [00:27:29] Speaker 04: Alain's position is the precedent is very clear that for 271G to apply, made means manufactured. [00:27:37] Speaker 04: That you actually manufacture the process used to make the product needs to be a manufacturing process, not... Outside the country. [00:27:47] Speaker 04: That too. [00:27:48] Speaker 04: But adding a label wouldn't satisfy the process limitations that are in the product by process claim would not satisfy the manufactured requirement of 271G. [00:28:00] Speaker 04: and I have no other comment on the question. [00:28:08] Speaker 05: Thank you. [00:28:18] Speaker 05: First dress page a fifteen forty. [00:28:21] Speaker 02: Before you do that, I'm sorry to interrupt, but could you address the first point your friend made, which is about the claims that are still alive and in suit? [00:28:30] Speaker 02: Certainly. [00:28:31] Speaker 02: And 36, how 35 and the others might include intellectual property and patent applications. [00:28:36] Speaker 02: Claim 36, which does not refer to the patent application stuff. [00:28:47] Speaker 02: You understand his argument, right? [00:28:49] Speaker 05: Claim 36. [00:28:50] Speaker 05: refers to the labeling issue. [00:28:52] Speaker 05: Claim 131, which depends from claim 36, incorporates the documenting inventorship. [00:28:59] Speaker 05: So that's correct. [00:29:02] Speaker 05: Claim 36, doesn't it? [00:29:04] Speaker 05: I've got claim. [00:29:06] Speaker 02: Documenting invent, OK. [00:29:07] Speaker 05: OK, claim 30. [00:29:08] Speaker 05: I just use that as an example. [00:29:10] Speaker 05: There are four now independent claims, 1736, 73, and 98, [00:29:19] Speaker 05: which were dependent claims, but those are the ones that have fought. [00:29:22] Speaker 02: Do any of those refer to what 35 says with just protecting intellectual property interests? [00:29:33] Speaker 01: What if you mean original claim 35? [00:29:42] Speaker 03: And that claim 35 didn't survive re-examination, did it? [00:29:46] Speaker 05: The claim 35 did not. [00:29:50] Speaker 05: One of them did that had that. [00:29:53] Speaker 02: Thirty-six did, right? [00:29:55] Speaker 02: That's my understanding. [00:29:56] Speaker 02: Thirty-three went down, thirty-five went down, and thirty-six is what you're asserting. [00:30:01] Speaker 05: Right. [00:30:03] Speaker 05: Thirty-six is the one that uses the exemplary claim. [00:30:10] Speaker 02: My question, are there any, I know you've got, you retain like thirty out of a hundred thirty-seven claims. [00:30:15] Speaker 02: Do any of the claims that you're asserting here explicitly talk about intellectual property? [00:30:21] Speaker 02: or were those claims all gone? [00:30:24] Speaker 05: I believe that the ones talking about documenting inventorship are the ones that are intellectual property related. [00:30:35] Speaker 05: They don't say obtaining intellectual property. [00:30:38] Speaker 02: Right. [00:30:38] Speaker 02: I mean, I'm not talking about documenting inventorship. [00:30:41] Speaker 02: I'm talking about protecting intellectual property interests. [00:30:44] Speaker 02: I understood you were talking about commercialization includes filing the patent application. [00:30:50] Speaker 02: And I'm wondering what's left of the claims that are left. [00:30:53] Speaker 02: It seems your friend, I think, was saying that those all went down. [00:30:58] Speaker 02: And so you're left with 36, which does not have the references to anything dealing with protecting intellectual property. [00:31:08] Speaker 02: I didn't mean to take up your time, but I thought it was an important point. [00:31:19] Speaker 05: Only to the extent that the commercializing step, if you look in the patent, includes getting intellectual property as a commercializing step. [00:31:30] Speaker 05: So to the extent that it's in the definition in the patent, it is in there in the commercializing step. [00:31:37] Speaker 05: There's no patent [00:31:38] Speaker 02: claims that remain that specifically call you need to be the definition of commercial i think that you're going to come definition to the specification yes specifically you happen to have that you can count twenty two at the end of the column twenty two [00:32:04] Speaker 02: Why don't we, I don't want to take up all your time on rebuttal. [00:32:07] Speaker 05: I'm sorry to... Well, the only other point I wanted to make in rebuttal was the issue of once exempt, always exempt. [00:32:20] Speaker 05: Once exempt, always exempt cannot be the rule. [00:32:23] Speaker 05: And it simply is not the rule. [00:32:26] Speaker 05: Once again, the particular, let's take it out of the context of this patent. [00:32:31] Speaker 05: Just go to a regular pharmaceutical patent. [00:32:33] Speaker 05: During your clinical trials, you add element A, element B, and element C together, and you determine the proper ratio and the proper dosing. [00:32:42] Speaker 05: That's protected because it's a clinical trial. [00:32:45] Speaker 03: If those three, if using those three components was... What's protected is the act of generating the information, which is using an invention, arguably. [00:32:56] Speaker 03: Right. [00:32:57] Speaker 03: That's what's protected, using the invention, so that you can submit the data to the FDA. [00:33:03] Speaker 05: Right. [00:33:04] Speaker 05: So you use the invention, use some sort of invention to mix these chemicals and figure out the right formula, and you submit it to the FDA. [00:33:10] Speaker 05: That's all protected. [00:33:11] Speaker 05: Now, that list of chemicals and their [00:33:14] Speaker 05: constituent percentages is information that was submitted to the FDA. [00:33:19] Speaker 05: If you use that information, it's no longer protected. [00:33:21] Speaker 05: You can't now go make a pharmaceutical using the exact same formula from your study. [00:33:27] Speaker 05: Doing your study, you are protected using that formula. [00:33:30] Speaker 05: That formula loses its protection when you go commercial. [00:33:34] Speaker 05: Otherwise, there will be no such thing as a pharmaceutical patent. [00:33:36] Speaker 05: That's the basic pharmaceutical patents are, what's the formulation? [00:33:41] Speaker 05: That formulation is protected when you're doing the study and generating the information. [00:33:44] Speaker 05: Once you figure out what that formulation is, if you then go and sell it, you're infringing the brand names packed on it. [00:33:51] Speaker 05: So it's not once protected, always protected. [00:33:55] Speaker 05: The activity once protected is always protected and that activity is done. [00:33:58] Speaker 05: The information from activity is once protected and then never again protected. [00:34:04] Speaker 05: You can't argue that. [00:34:05] Speaker 05: And that's the same thing with the label. [00:34:08] Speaker 05: Yes, the activity that generated that label [00:34:11] Speaker 05: is protected because we want to promote action. [00:34:13] Speaker 03: Information isn't protected by a patent. [00:34:18] Speaker 03: The product is protected by a patent or a method of making it, but not information relating to it. [00:34:25] Speaker 03: That's copyright material. [00:34:28] Speaker 05: Well, except that the labeling is the element of claim 36. [00:34:34] Speaker 05: And so it is part of the kit, the final product that's out there. [00:34:38] Speaker 05: just as each of the ingredients is part of that product. [00:34:42] Speaker 05: And if we had a formulation patent, no one would argue that using the same ingredients as a clinical study is still protected. [00:34:48] Speaker 05: It's not. [00:34:49] Speaker 05: Using the same label generated in a clinical study is now no longer protected. [00:34:54] Speaker 05: The argument that, oh, wait, the FDA requires us to put a label on there, so therefore it's still protected. [00:35:00] Speaker 05: The FDA requires you to put certain chemicals in that pharmaceutical, and that's not protected. [00:35:04] Speaker 03: Just because the FDA requires you to do it while you sell it doesn't go back to protecting it. [00:35:12] Speaker 05: If the FDA requires you in a limited case where the FDA requires you to continue to practice a method to continue to certify and verify that your pharmaceutical satisfies the FDA requirements, and that requirement was imposed by the FDA beforehand, [00:35:32] Speaker 05: In a limited factual circumstance, the Supreme Court has said that yes, and this Court has said that yes, that would be covered. [00:35:39] Speaker 05: But that's not what we have here. [00:35:41] Speaker 05: The activity is done. [00:35:42] Speaker 05: It's finished. [00:35:43] Speaker 05: It's over. [00:35:44] Speaker 05: They found that. [00:35:44] Speaker 05: They developed a label. [00:35:47] Speaker 05: The fact that the FDA requires the label on the package doesn't mean it's protected, because the FDA requires all the ingredients in the patent, and they're not protected if we add a formula patent. [00:35:56] Speaker 05: So it's simply another piece of our formula patent, which is the [00:36:01] Speaker 05: The pharmaceutical in the jar and the label on the outside of the jar are the two parts of the product, the kit. [00:36:07] Speaker 05: And those two parts are required by the FDA, but that doesn't mean they're protected by the full part of that protection. [00:36:15] Speaker 02: Time is expired. [00:36:16] Speaker 02: We have the argument that we thank both councils and we'll take just a minute.