[00:00:00] Speaker 02: Our last case this morning is number 23-2254, Merck Sharp and Dome B.V. [00:00:09] Speaker 02: versus Ourobindo Pharma USA. [00:00:15] Speaker 02: Okay, Mr. Werlinger. [00:00:17] Speaker 03: Good morning, and may it please the court. [00:00:19] Speaker 03: Congress limits patent term extensions to a period of time beginning after the date the patent is issued, not the date of application, not the priority date, not some effective date, the issue date of the patent for which PTE is sought. [00:00:34] Speaker 03: Everyone agrees that the patent is the 733 patent, and we all agree that it issued on January 28, 2014. [00:00:41] Speaker 03: The issue here [00:00:44] Speaker 03: put it directly, is does Section 156C mean what it says? [00:00:50] Speaker 02: So why is it that Congress conceivably would want to treat the extension question differently depending on whether the same claim appears in the original application or a situation in which the same claim is continued as a result of a reissue? [00:01:12] Speaker 03: I think when we're looking at section 156C, it doesn't differentiate claim to claim. [00:01:16] Speaker 03: That's 252, and I'm happy to go there in a moment. [00:01:19] Speaker 02: No, no. [00:01:20] Speaker 02: But why is it that under 156, the Congress would want to have different results in those two situations? [00:01:27] Speaker 02: It's sort of counterintuitive. [00:01:29] Speaker 03: So I think what Congress was looking to do with 156C is to set a single bright line regimen that is applicable to all patents. [00:01:37] Speaker 03: It was looking for something that was very easy for folks to understand, for the PTO to administer, and it didn't want to get into claim-by-claim distinctions. [00:01:47] Speaker 03: And I think that's what it has accomplished with Section 156C, by pegging it to the issue date of the patent for which PTO is solved. [00:01:53] Speaker 02: So you can lose your patent term extension by seeking a reissue, and the same claim survives? [00:02:00] Speaker 03: There are ways. [00:02:01] Speaker 03: So this is Merck's point. [00:02:03] Speaker 03: It's a policy point. [00:02:04] Speaker 03: And I have two responses. [00:02:05] Speaker 03: The first is that if the text is plain, that's it. [00:02:10] Speaker 03: There might be policy reasons why the statute might have been written differently. [00:02:13] Speaker 03: But that is for Congress to determine. [00:02:15] Speaker 03: Specifically to the issue of losing the patent term, there are multiple ways that Merck could have avoided this outcome. [00:02:24] Speaker 03: The first thing they could have done was they could have sought reissue earlier. [00:02:29] Speaker 03: number of years before seeking the reissue of this patent despite knowing full and well that they did not have the species claim that they are asserting today. [00:02:38] Speaker 03: The other thing they could have done was to wait for the approval process of the drug to play out. [00:02:45] Speaker 03: They could have sought their patent term extension and then they could have sought the reissue. [00:02:49] Speaker 02: Well, I understand that, but that's not really responsive to the question of why Congress would want two different outcomes, one when there's been no reissue and when there has been a reissue. [00:03:00] Speaker 03: So I don't think it's necessarily that they wanted two different outcomes. [00:03:04] Speaker 03: I don't think that was an issue where they are expressing a policy here. [00:03:07] Speaker 03: I think what they wanted through 156C was to set a single regime that would allow for all patents to go through the PTP process without distinction. [00:03:20] Speaker 03: And if I may, again, the principle canon we have to apply here is that if the text is plain, that's what we apply, and that is it. [00:03:28] Speaker 03: It's a dangerous position for us lawyers to be sitting here and arguing about policy. [00:03:33] Speaker 03: That one belongs to Congress. [00:03:34] Speaker 03: And here, section 156 is plain on its face. [00:03:37] Speaker 02: And I'd like to make it clear. [00:03:38] Speaker 02: Well, if you look at 156A, where it refers to the term of a patent, it could be referring to the term of the original patent. [00:03:47] Speaker 02: And given the reference later in that same subsection to the original expiration date of the patent, maybe that's a reference to the original patent. [00:03:56] Speaker 03: So speaking of the term, well, first of all. [00:04:01] Speaker 02: But answer my suggestion that maybe when Congress used the phrase the term of the patent in 156A, they were referring to the term of the original patent. [00:04:15] Speaker 03: So the word original is used throughout 156, and I think that is in reference to the term before PTE is applied. [00:04:25] Speaker 03: So that's not necessarily making a distinction between original and reissued patents. [00:04:30] Speaker 03: There is no such distinction that is drawn in 156, and I think that's on purpose. [00:04:36] Speaker 03: Congress was aware of the peculiarities of reissued patents for over 150 years before they promulgated section 156 as part of the Hatch-Waxman Act. [00:04:45] Speaker 02: But you would lose if that were the right construction, if in 156A the term of the patent referred to the original patent, right? [00:04:59] Speaker 03: I don't think that's necessarily true, Your Honor. [00:05:01] Speaker 03: I think the question is [00:05:05] Speaker 03: When we're referring to the term, that's referring to what is being extended. [00:05:09] Speaker 03: The question here is, when do we start counting? [00:05:12] Speaker 03: And if I may, I think this goes to Merck's argument of the term of the reissue importing in the issue date of the original patent. [00:05:23] Speaker 03: And I have three responses to that argument. [00:05:27] Speaker 03: The first is that, so this is speaking of section 251. [00:05:31] Speaker 03: That's not what section 251 says. [00:05:34] Speaker 03: What section 251 says is that a reissued patent takes the unexpired part of the term of the original. [00:05:41] Speaker 03: It just takes a piece of it, not the full thing. [00:05:44] Speaker 03: If Congress intended reissued patents to take the full term from beginning to end of the original patent, they could have just said term, but they could have picked some other language without a qualifier, but they didn't. [00:05:57] Speaker 03: Second, Section 251C incorporates Sections 151 through 154 into the reissued regime, and 154 sets the beginning date of all patents, the terms of all patents at issuance. [00:06:14] Speaker 03: And third, the issuance of a reissued patent is a legally distinct and meaningful moment. [00:06:19] Speaker 03: And we know that by looking at the first sentence of section 252, which says that the surrender of the original patent takes effect on the issue date of the reissue. [00:06:33] Speaker 03: That is the point where the original patent is canceled in law and ceases to exist, and the reissued patent rises up in its place. [00:06:40] Speaker 03: So it has to have that distinct issue date. [00:06:47] Speaker 03: If there's no questions on 251, I'd like to turn to 252. [00:06:52] Speaker 03: And I think this is where Merck and the PTO spend the majority of their time. [00:06:57] Speaker 03: This court has twice before confronted this provision in Seattle Box and Fresenius. [00:07:04] Speaker 03: And it has made clear that Section 252 operates narrowly. [00:07:09] Speaker 03: It preserves litigation claims that would otherwise be defeated or die [00:07:14] Speaker 03: due to the mechanics of canceling out the original patent and issuing the reissued patent. [00:07:21] Speaker 03: PTE is not granted in litigation. [00:07:24] Speaker 03: Section 252 does not alter the operation. [00:07:29] Speaker 02: 251 and 252 were enacted long before 156, right? [00:07:33] Speaker 02: That is correct. [00:07:34] Speaker 02: So why would we look there to figure out what's meant by 156? [00:07:40] Speaker 02: Why isn't it just better to look at 156 and interpret it? [00:07:44] Speaker 03: So I think you do look at these provisions, but when we look at Section 156, what we have to consider is that Congress was aware of these provisions. [00:07:52] Speaker 03: It was aware of how reissued patents operate. [00:07:56] Speaker 03: So if it wanted to create a special PTE regime for reissued patents, it would have done so explicitly. [00:08:03] Speaker 03: Repeatedly throughout the history of our patent laws, when Congress has wanted to alter the operation of reissued patents vis-à-vis original patents, it has passed explicit text to do so. [00:08:14] Speaker 03: And it has not done anything to alter the operation of Section 156. [00:08:18] Speaker 03: It has not promulgated an alternative interpretation of the word issued as applied to reissued patents. [00:08:26] Speaker 03: And we have to view that silence as purposeful. [00:08:31] Speaker 03: Now, Merck does not [00:08:33] Speaker 03: I don't think they directly dispute anything I just said. [00:08:37] Speaker 03: But they say that because we're in litigation, we have to ignore it. [00:08:42] Speaker 03: And the problem I have with that is that reading section 252 in that manner would violate multiple cans of construction, at least three by my count. [00:08:52] Speaker 03: The first is that the argument, the point of their argument is that they're asking you to infer an alternative meaning of the word issue, which is the operative word in section 156C. [00:09:05] Speaker 03: And if you were to do that, if you read section 252 to do that, you're violating the candidate of construction that words are supposed to have a single meaning throughout the statute because you're creating this alternative definition through 252. [00:09:18] Speaker 03: Your second, you're creating an idiosyncratic interpretation of a word that's already appearing in the statute. [00:09:24] Speaker 03: And when Congress intends to do that, they do so explicitly. [00:09:28] Speaker 03: That has not been done here. [00:09:29] Speaker 03: And the third canon is the one we were just talking about, Judge Dyke, which is Congress is presumed to write the law with full knowledge of pre-existing law. [00:09:38] Speaker 03: Reissue patents have been around for a long time. [00:09:40] Speaker 03: 251 and 252 were there when 156 was written. [00:09:44] Speaker 03: So if Congress wanted to [00:09:46] Speaker 03: alter the operation of section 156 as applied to reissued patents, they would have passed an explicit regime. [00:09:53] Speaker 03: But they didn't do so. [00:09:56] Speaker 03: By keeping section 252 more to the historic meaning that has been recognized by this court multiple times, you avoid these construction problems while still giving meaning to the statute. [00:10:13] Speaker 03: So if there's no question on 252, [00:10:16] Speaker 01: What's your response to the argument that your position leads to absurd results or could lead to absurd results? [00:10:26] Speaker 03: Sure. [00:10:27] Speaker 03: So this is Merck and, to an extent, the district court walking through hypotheticals where a matter of days might make the difference between getting five years of PTE or no PTE at all. [00:10:41] Speaker 03: That might be the way that the bright line of this statute works, but that does not mean that it's absurd. [00:10:47] Speaker 03: Anytime you draw a bright line, there are different things that you can do, different circumstances that might put you on one side of the line or the other. [00:10:55] Speaker 03: That does not mean that we deviate from the otherwise plain text of the statute. [00:11:00] Speaker 03: the court confronted a situation very similar to this in YFD Capos, where it walked through a very similar exercise. [00:11:08] Speaker 01: Obviously, the statute is not plain in this case. [00:11:13] Speaker 03: Well, I disagree with that, Judge Raina. [00:11:15] Speaker 03: I think 156C is plain. [00:11:19] Speaker 03: And neither Merck nor the PTO identify a facial ambiguity on the text of the statute. [00:11:27] Speaker 03: to be sure they try to use 251 and 252 to ambiguate the text. [00:11:34] Speaker 03: But number one, we shouldn't be ambiguating plain text based off of a statute. [00:11:40] Speaker 02: If you take the text that says the patent, that's easily construed to mean the original patent. [00:11:49] Speaker 02: I beg your pardon. [00:11:50] Speaker 02: Could you repeat that, Your Honor? [00:11:51] Speaker 02: 156A says the term of a patent. [00:11:54] Speaker 02: If the reference there is to the original patent, the provision is clear, and we don't have to look to 251 or 252. [00:12:06] Speaker 03: So if I may, Your Honor, is there a sub-provision of 156A that you're looking at? [00:12:10] Speaker 02: He says the term of a patent which claims a product. [00:12:13] Speaker 02: Correct. [00:12:14] Speaker 02: Right? [00:12:15] Speaker 02: Right, the term of the patent. [00:12:17] Speaker 02: Shall be extended. [00:12:18] Speaker 02: Correct. [00:12:19] Speaker 02: So if the reference is to the term of a patent, meaning the original patent, then work is correct about it. [00:12:28] Speaker 02: I'm glad I asked that, Your Honor, because... And then C says the term of a patent. [00:12:32] Speaker 02: It's the same reference to the same patent. [00:12:35] Speaker 02: If that means [00:12:36] Speaker 02: the term of the original patent eligible for extension. [00:12:40] Speaker 03: So I apologize for not getting it earlier, but I now understand your question, Your Honor. [00:12:45] Speaker 03: And I want to point you, patent is a defined term in the statute. [00:12:49] Speaker 03: I want to point you to section 156F6 that says the term patent means a patent issued by the United States Patent Office. [00:12:59] Speaker 03: It's not necessarily saying original patent, issued patent. [00:13:03] Speaker 03: It's just saying a patent. [00:13:05] Speaker 02: and if we go back to section... I don't think the definition is inconsistent with the construction I'm suggesting. [00:13:11] Speaker 03: Well, if I may, your honor, section, let's come back to section 156. [00:13:15] Speaker 02: And interpreting that way avoids a situation where somebody tries to get a patent term extension for some new patent in a reissue patent. [00:13:25] Speaker 03: By defining it in that manner? [00:13:26] Speaker 02: A new claim in a reissue patent. [00:13:28] Speaker 03: Well, I'm not... [00:13:30] Speaker 03: I'm not entirely certain I agree with that one, Your Honor. [00:13:33] Speaker 03: And I want to come back to section 156C itself, because I think the context here is important. [00:13:38] Speaker 03: It says the term of a patent eligible for extension. [00:13:43] Speaker 03: So we all agree, all sides agree, that the patent eligible for extension is the 733 patent. [00:13:49] Speaker 03: At the time Merck applied for PTE, the original patent was already dead and canceled out in law. [00:13:59] Speaker 03: So the term of a patent eligible for extension cannot refer to the original patent, because under that circumstances, that patent doesn't exist anymore. [00:14:14] Speaker 03: And I think you were hitting at one of the major problems with Merck's interpretation by referencing the potential of a broadening reissue, where the original patent does not cover the product, but the broadening reissue does. [00:14:28] Speaker 03: That would be creating a problem in section 156 because the patents are only eligible for PTE if they claim the product. [00:14:37] Speaker 03: So to be using the issue date of an original patent that didn't even claim the product and using that as the marker for starting patent term exceeding... They couldn't do that because if the claim is cancelled and reissued, it's non-protonical, it doesn't exist. [00:14:52] Speaker 03: Well, I'm not suggesting that the claim was canceled. [00:14:55] Speaker 03: I'm suggesting a broadening reissue where the original patent said nothing about the product. [00:15:00] Speaker 03: It didn't claim it. [00:15:01] Speaker 03: And then you are allowed within two years of that point to seek a broadening reissue. [00:15:09] Speaker 03: And it is possible. [00:15:10] Speaker 03: And even Merck and the PTO can see this. [00:15:13] Speaker 03: It is possible to have a broadening reissue that claims a product that was not claimed in the original. [00:15:20] Speaker 02: Yeah, and you shouldn't get an extension for that. [00:15:22] Speaker 03: I agree with that, but under Merck's interpretation, you would, and that's a problem. [00:15:26] Speaker 03: I see that I am into my rebuttal time. [00:15:30] Speaker 03: I am happy to keep talking and answer any questions, but I did want to flag that for the bench. [00:15:36] Speaker 03: Okay. [00:15:37] Speaker 03: I'll answer the remainder of my time. [00:15:38] Speaker 03: Thank you. [00:15:44] Speaker 02: Mr. Krinsky. [00:15:44] Speaker 00: Thank you, Your Honor. [00:15:47] Speaker 00: May it please the court. [00:15:49] Speaker 00: I'd like to start, Your Honors, with the accusation that we are somehow avoiding the statutory text and making an argument based on policy. [00:16:00] Speaker 00: I think, Judge Dyke, you had it exactly right that the language of 156 is very helpful to us here. [00:16:06] Speaker 00: The defendant's argument assumes the conclusion that 156, when it refers to the date of the patent issued, must be referring to the reissued patent as a separate brand new entity, and referring to the date that the reissue occurred as the date. [00:16:23] Speaker 00: But that's not the best reading of the statute, and it's certainly not the best reading of the statute when, as this court is required to do, [00:16:31] Speaker 00: it looks at the broader statutory scheme, including sections 251 and 252, which dictate the operation of reissues and the relationship between an original patent and the reissuance of that patent, which, for some purposes, the reissue steps into the shoes of the original. [00:16:48] Speaker 00: And for other purposes, there are differences set forth in 251 and 252. [00:16:53] Speaker 01: So then why should we interpret [00:16:56] Speaker 01: 156 see the language the term of a pen that the original pen Your opponent says that that pen no longer exists instead So so the the original patents claims are dead. [00:17:12] Speaker 00: That's that's what the the case law Seattle box actually says there the patent in a sense is the same patent reissued in in this case and in every other case where this issue has been presented and [00:17:25] Speaker 00: the original patent claimed the drug, and the reissued patent also claimed the drug, in this case with claims that are identical throughout and under both section 252. [00:17:37] Speaker 01: I understand that, but it doesn't say patent claims, it says pen. [00:17:42] Speaker 00: Right, and to Judge Dyke's point, the patent ought to be construed to be the original patent, and if there's any doubt about that, [00:17:53] Speaker 00: look to section 251. [00:17:55] Speaker 00: Section 251 doesn't refer to two different patents. [00:17:59] Speaker 00: It refers to reissuing a patent. [00:18:02] Speaker 00: It is the same patent as this court explained in the Intel case. [00:18:07] Speaker 00: It doesn't refer to the issuance of a reissue patent for an invention. [00:18:11] Speaker 00: It specifically refers to the reissue of the inoperative or invalid patent for the invention disclosed in the original patent. [00:18:18] Speaker 00: In other words, [00:18:19] Speaker 00: Congress, when it referred to the patent in section 156, was referring to, in the case of reissues, one and the same patent, with one and the same term. [00:18:30] Speaker 00: It is not, unlike a divisional or a continuation or a wholly new patent on a different invention, it is the same patent that has been reissued with errors corrected. [00:18:41] Speaker 00: And to Judge Dyke's point about the operation of the statute, where [00:18:47] Speaker 00: where the drug is claimed originally and continues to be claimed in the reissued version of the patent the best and I'd argue only reading of section 156 A and C is that the patent [00:19:02] Speaker 00: refers to the one patent that's been here all along, and the date the patent issued is the original issue date. [00:19:11] Speaker 00: And that's the only reading that gives a sensible result in the Hatch-Watzman Act where a patentee [00:19:20] Speaker 00: gets credit for the period of time where they had a patent in effect, but they effectively couldn't make use of that patent because the FDA was still reviewing their drug, and that was the case here. [00:19:31] Speaker 00: Merck Segemedek's drug was under FDA review for longer than the maximum five years of credit. [00:19:38] Speaker 00: After this court decided the Inrei Tanaka case, Merck promptly sought a reissue, having been clarified that they could get narrower claims directed solely to this compound. [00:19:50] Speaker 00: But all along, they had claim four, which covered this compound expressly. [00:19:56] Speaker 00: And the fact that the reissue predated [00:20:00] Speaker 00: the FDA approval in the PTE application should not make a difference in terms of whether Mark gets full or only partial credit for that period of overlap between the patent's term, the period after the date the patent issued, and the regulatory review period. [00:20:21] Speaker 00: Sections 251 and 252 both confirm this result. [00:20:26] Speaker 00: Section 251, as I mentioned, refers to a single patent and a single invention. [00:20:31] Speaker 00: It also refers to a single term, which this court has always treated consistently across statutes as it must. [00:20:40] Speaker 00: The Yamazaki case emphasized that fact. [00:20:43] Speaker 00: And the term is defined based on the date the original patent issued. [00:20:48] Speaker 00: Today that goes to a date that is 20 years after the the filing date of the patent, but at the time section 156 was enacted that that term ran through 17 years after the date the patent issued that term remains the same upon re issuance it inherited that same period of time it didn't get an additional new 17 years of the brand new patent and [00:21:13] Speaker 00: And so the logical inference is that when Congress enacted section 156, it intended to refer to extending that one and only term. [00:21:22] Speaker 00: Likewise, section 252, as a district court properly recognized, explains how reissued patents should be treated in litigation. [00:21:33] Speaker 02: And the first clause is that this isn't litigation. [00:21:36] Speaker 00: This is litigation. [00:21:37] Speaker 02: Well, not the kind of litigation they were referring to. [00:21:40] Speaker 02: They were talking about infringement litigation. [00:21:42] Speaker 00: Well, but Your Honor, I think this is an important point, because this is an infringement litigation. [00:21:49] Speaker 00: And Section 252 provides for intervening rights when an act of infringement occurs prior to the reissuance of a patent. [00:21:57] Speaker 00: But that's not the act of infringement here. [00:21:59] Speaker 00: The abbreviated new drug applications that give rise to this cause of action and the filing of this complaint all occurred after the reissue and Section 252 therefore compels that the claims be treated as though they had been present all along. [00:22:21] Speaker 00: That's the language of Section 252. [00:22:23] Speaker 00: And were there any doubt on that, the continuous effect clause at the end of 252 [00:22:28] Speaker 00: applies that rule where there are substantially identical claims all along. [00:22:32] Speaker 00: And that, again, is this case here. [00:22:35] Speaker 00: I think Your Honor rightly expressed some concern with the situation where a broadening reissue, for the first time, the reissued patent covers the drug when it didn't cover the drug before that. [00:22:53] Speaker 00: Merck's position does not require that a patentee in that situation be given credit for that. [00:22:59] Speaker 00: That's not the facts of this case here. [00:23:02] Speaker 00: And it's not the facts of any case of the 40 cases that we and the director have been able to identify where there have been a PTE in an application where there was a reissued patent. [00:23:20] Speaker 00: In none of those cases, [00:23:22] Speaker 00: did this broadening reissue scenario occur. [00:23:24] Speaker 00: So I don't know that the court needs to decide the broadening reissue situation. [00:23:28] Speaker 00: I do think that the answer to that scenario probably lies in section 156A, because in 156A, you would not necessarily have a [00:23:38] Speaker 00: Patent covering the drug for the entire period of regulatory review, but again. [00:23:42] Speaker 02: That's not that's not the situation we have here But but we sort of have to come up with an interpretation that we make sense in other situations. [00:23:52] Speaker 02: I mean, I don't think we can view this with blinders on to the consequences of what we might be doing and [00:24:01] Speaker 00: And if the court wishes to decide it, that would compel affirmance either way. [00:24:06] Speaker 00: Section 156A and C, as Your Honor recognized in questions to my friend on the other side, can and should be read to refer to the original patent. [00:24:18] Speaker 00: And in a situation where there's a broadening reissue and the original patent doesn't claim the drug, [00:24:24] Speaker 00: At that point, there wouldn't be that period of overlap. [00:24:28] Speaker 00: But we don't have a problem with that. [00:24:30] Speaker 00: That would lead to an affirmance here. [00:24:35] Speaker 00: The continuous effect clause of section 252, I think, also reinforces that. [00:24:39] Speaker 00: I mean, if your honor is troubled by the notion that the PTE should be governed by a litigation statute, the final clause of 252 provides that where there is a substantially identical claim, as there is here, it should be given continuous effect [00:24:58] Speaker 00: To the extent its claims are substantially identical with the original patent, it shall constitute a continuation thereof and have effect continuously from the date of the original patent. [00:25:06] Speaker 00: So whereas here, you have a claim that survives re-issuance, the error correction doesn't make a substantial change to that claim. [00:25:16] Speaker 00: both the patent office when calculating PTE and courts when subsequently handling litigation thereafter. [00:25:23] Speaker 00: Everyone consistently treats that as though it had been issued in the first place. [00:25:27] Speaker 00: The fact that a patentee has gone to procure a reissue, a build itself of that mechanism that Congress created, doesn't change any of their statutory rights with respect to those claims that they have before and after the reissue. [00:25:46] Speaker 00: I think the policy point, too, does reinforce this. [00:25:54] Speaker 00: Merck, I think it's important to recognize, did not engage in any timing gamesmanship here at all. [00:26:00] Speaker 00: It simply obtained a reissue promptly after Inoue Tanaka clarified that it could get more specific claims. [00:26:08] Speaker 00: But there was a suggestion that maybe we should have sought reissue earlier. [00:26:12] Speaker 00: Tanaka hadn't been decided yet. [00:26:14] Speaker 00: There was a suggestion that perhaps we should engage in some kind of gamesmanship and save our reissue application. [00:26:20] Speaker 00: But at the time, Merck sought reissue. [00:26:23] Speaker 00: Nobody knew how long the FDA was going to take to review the drug. [00:26:26] Speaker 00: Nobody knew if the drug was even ever going to be approved. [00:26:31] Speaker 00: So Merck did the natural thing and in the ordinary course sought reissue as it was entitled to. [00:26:37] Speaker 00: And it doesn't, I submit it doesn't make any sense for to read section 156. [00:26:43] Speaker 00: And I don't think Congress intended for section 156 to lead to a result where if the reissue happens to occur prior to the conclusion of the regulatory review, the amount of compensation the patentee gets for that overlap is curtailed. [00:27:02] Speaker 00: But if the reissue just happens a little later, they get the full five years. [00:27:06] Speaker 00: I mean, neither the date the patent office concludes a reissue proceeding, nor the end of the FDA's regulatory review period, are within the patentee's control. [00:27:17] Speaker 00: And there's no conceivable reason why [00:27:21] Speaker 00: Relative ordering of those two dates should lead to a different result that I think distinguishes it from the cases that My friend on the other side highlighted where you know Sometimes if you miss a deadline there are adverse consequences days can matter at times in the law. [00:27:36] Speaker 00: That's true and [00:27:37] Speaker 00: But here, Congress enacted Section 156 essentially as a remedial statute to award patentees compensation for the time the FDA takes in a protracted regulatory review, give them more terms specifically with respect to the drug or indication at issue. [00:27:56] Speaker 00: And that compensation should not depend, and I would submit does not depend, as the statute's properly read, on the [00:28:07] Speaker 00: the timing of a reissue or the fact of a reissue. [00:28:11] Speaker 00: It's the same pattern all along. [00:28:18] Speaker 00: And I guess the one last clarifying point I'd make, if there are no other questions, is just this notion that we heard a lot of in the argument, and I think even more of in the briefs, that this court needs to treat a reissued patent as a separate patent, and that section 156 needs to refer to the [00:28:38] Speaker 00: to a different patent because the patent is dead. [00:28:43] Speaker 00: But the dead case law comes from Seattle Box. [00:28:49] Speaker 00: And Seattle Box went on to [00:28:53] Speaker 00: to articulate the same identity rule that I was highlighting in Section 1252. [00:28:59] Speaker 00: After saying, quote, the original claims are dead, Seattle Box went on to say, the statute permits that the claims of the reissue patent to reach back to the date the original patent issued, but only if those claims are identical with claims in the original patent. [00:29:14] Speaker 00: And in that case, which is presented here, the reissue shouldn't affect the calculation of patent term, and it should reach back. [00:29:23] Speaker 00: And for that reason, if the court has no other questions, I'll just say the consistent practice of the PTO, the PTO's position, you're going to hear from them momentarily, the PTO's codification of its practice in the MPEP, [00:29:36] Speaker 00: And the district courts very well reason decision all pointed in the same direction, which is how the statute should be read The the date the patent issued is the original issue date Okay, thank you [00:30:04] Speaker 04: Your Honors, and may it please the Court. [00:30:07] Speaker 04: The phrase the issue date in 156 for PTE is best interpreted in view of the Patent Act as a whole. [00:30:15] Speaker 04: And for a reissue date, that's in view of sections 251 and 252 and means the date the original patent was issued. [00:30:24] Speaker 04: This interpretation aligns the language of 156 with the statutory provisions governing the very patent that we're talking about, which is a reissue. [00:30:35] Speaker 04: With respect to 252 in particular, that demonstrates, and the language makes clear, that a reissue has the same effect as if originally granted in amended form. [00:30:48] Speaker 02: I'm not sure. [00:30:49] Speaker 02: I think 252 is dealing with infringement and validity questions. [00:30:54] Speaker 02: It's not obviously dealing with patent term extensions or anything like that, because those didn't exist when it was written. [00:31:02] Speaker 04: So with respect to the term the trial of action in there, I think it's counterintuitive to say that you're not going to give the reissue the same effect in an administrative proceeding that directly impacts a litigation and infringement action, which all depends on determining the expiration date of the patent. [00:31:20] Speaker 04: And this court in the Cooper case did look to 252 to decide how do we interpret language that governs reexaminations, which is an administrative proceeding. [00:31:31] Speaker 04: So the effect does impact trials of actions. [00:31:34] Speaker 04: You need to know what the expiration date is of a patent when it's in litigation. [00:31:39] Speaker 04: So it would not make sense to have PTE depend on the forum there. [00:31:45] Speaker 04: In addition, turning to 251, that also impacts the term of the patent. [00:31:53] Speaker 04: And as your honors have recognized, 251 tells you that a reissue patent has the unexpired term of the original patent. [00:32:01] Speaker 04: So that unexpired term is based on the original patent's issue date. [00:32:06] Speaker 04: That's the date it starts. [00:32:07] Speaker 04: Pre-URAA, it was also entirely based on the issue date. [00:32:11] Speaker 04: That's how much term you got. [00:32:14] Speaker 04: And then PTE, the PTE statute itself tells you, I'm going to put that PTE into the original patent. [00:32:23] Speaker 04: So everything is tied to the original patent. [00:32:25] Speaker 04: It would simply not make sense [00:32:27] Speaker 04: to say, although I'm putting this extension into the original patent, I'm going to base it on a different date, a reissue patent date. [00:32:36] Speaker 04: So using the original patent's date aligns all of the dates that what you're using to determine the expiration date of the patent for a reissue patent. [00:32:49] Speaker 04: With respect to the absurd results that Your Honors talked about earlier, I think one of the important things to realize are the absurd result [00:32:57] Speaker 04: PTO finds most persuasive is the fact that more FDA delay here leads to less PTE. [00:33:05] Speaker 04: And that simply does not align with the policy behind PTE, which is to compensate for agency delay. [00:33:12] Speaker 04: So it's just nonsensical to say, the longer the agency delayed, the less PTE I get. [00:33:19] Speaker 04: If Merck had filed on only the original patent and waited until after FDA approval to file for the reissue, there is no dispute they would have gotten the full amount of PTE. [00:33:34] Speaker 04: And so aligning all of those things together, the statutory context, the policy, and as I'll mention briefly, USPTO practice, they all go towards the best reading, which is using the original issue date, not the reissue issue date. [00:33:51] Speaker 01: Am I correct that this situation doesn't rise very often? [00:33:54] Speaker 01: That's correct, Your Honor. [00:33:55] Speaker 01: In fact, it's relatively rare, correct? [00:33:58] Speaker 04: That is very correct, Your Honor. [00:34:00] Speaker 04: Since USPTO records that I looked back to patent 3 million for PTEs, there's only been around 40 to 50 that have even addressed PTE on the reissue. [00:34:12] Speaker 01: And the resolution of those cases favored finding that the issue date is the original issue date? [00:34:20] Speaker 04: Yes, Your Honor. [00:34:21] Speaker 04: So the USPTO has been consistent with a reissue PTE application [00:34:27] Speaker 04: in using the date of the original patent for calculation of that PTE. [00:34:33] Speaker 02: So what happens if the original patent has a claim which is cancelled and reissued and that's the claim that covers the product? [00:34:41] Speaker 02: I mean obviously if the claim is cancelled you wouldn't think that you'd get the patent term extension and yet the statute provides for an extension not on a claim by claim basis but for the patent as a whole. [00:34:53] Speaker 02: So what's the result under those circumstances where [00:34:56] Speaker 02: where you have a claim in the original patent, which covers a product whose approval is delayed, but that claim is canceled in the reissue. [00:35:06] Speaker 04: So if that was the only claim covering the approved product, the other parts of the PTE statute say you can't get PTE on that patent because you do not have a claim covering the approved product. [00:35:18] Speaker 02: So one of the requirements of PTE... Wait, what provision says that? [00:35:22] Speaker 04: So that you have to have... [00:35:28] Speaker 04: So it's the term of a patent which claims a product that has been subject to a regulatory review period. [00:35:36] Speaker 02: So if you read section A. So if we're talking about that being the term of the original patent, but the claim gets canceled and reissued, somehow the construction of the language has to take account of that situation and not presumably give a patent term extension when there was no claim in the reissue that covered the product. [00:35:58] Speaker 04: So I'm interpreting. [00:35:59] Speaker 02: Do you agree? [00:36:00] Speaker 04: I agree that you cannot get a PTE extension on a patent that does not cover the approved product. [00:36:10] Speaker 02: After the reissue. [00:36:12] Speaker 04: I guess it depends on the timing. [00:36:13] Speaker 04: So if you had PTE on the original patent, [00:36:18] Speaker 04: and you filed a reissue, that would, under the terms of 251, that reissue would get the unexpired term of the original patent. [00:36:26] Speaker 02: OK, but we're talking about a situation in which the patent term extension comes up after the reissue occurs, and the reissue cancels the claim that covers the product. [00:36:39] Speaker 02: Do you agree that under those circumstances, there should be no PTE? [00:36:43] Speaker 04: My understanding is that that would be denied, because the reissue patent does not cover the approved product correctly. [00:36:49] Speaker 02: Yeah, so how do we get there under the language of the statute? [00:36:54] Speaker 04: So my understanding, so 156A, I read that differently than I believe your honor is. [00:37:00] Speaker 04: I'm reading the term of a patent in 156A in this case, in this scenario, to refer to the reissue patent. [00:37:08] Speaker 04: the term that the reissue patent has. [00:37:11] Speaker 04: And you know that because you have to look 156A just like you look at 156C in terms of what the reissue patent says. [00:37:20] Speaker 04: So you need the context. [00:37:21] Speaker 04: So 252. [00:37:22] Speaker 02: If you read that as referring to the reissue patent, then you could get patent term extension for a new claim that's in the reissue. [00:37:31] Speaker 04: Yes, Your Honor. [00:37:32] Speaker 04: And same thing would happen if you had an original claim, original patent that got PTE. [00:37:37] Speaker 04: And then you've got reissue that had a new claim. [00:37:39] Speaker 04: There's no dispute in this case. [00:37:41] Speaker 04: That term would transfer to the reissue. [00:37:43] Speaker 04: So a new claim and a reissue would get the same PTE that it had in the original. [00:37:49] Speaker 02: Well, and it could be the source of the PTE, is what you're saying. [00:37:53] Speaker 04: So I think that's a different question with respect to broadening reissue, if that's what Your Honor is talking about. [00:37:58] Speaker 04: If you file, if this case happens where the broadening reissue, or excuse me, the reissue patent has [00:38:06] Speaker 04: claim for the first time covering the approved product. [00:38:09] Speaker 04: So in that case, the USPTO has not set forth because we have simply never seen that happen. [00:38:15] Speaker 04: It is a theoretical and, I would admit, highly unlikely scenario given that I don't know there's a lot of pharma companies that have just one patent on a product going over FDA approval, and it doesn't happen to cover the approved product. [00:38:30] Speaker 04: So this theoretical, unlikely possibility [00:38:33] Speaker 04: We have not said we would treat it differently. [00:38:35] Speaker 04: And that's because we haven't been presented with arguments about under the statute why it should be treated differently. [00:38:42] Speaker 04: So what the PTO has said, and that's in the new MPP provision that they said in 2022, which is when you have a patent that has the same claims that cover the product between the original and the reissue, we're going to use the original date. [00:38:59] Speaker 04: And that's simply reflecting [00:39:01] Speaker 04: the situations that the PTO sees. [00:39:03] Speaker 04: We do not see and never have seen a broadening reissue covering an approved product for the first time. [00:39:11] Speaker 04: And I would submit that the theoretical and unlikely possibilities should not derail the statutory construction that is guided by 252 and 251, as well as policy, and as well as the consistent, longstanding US PTO practice, which [00:39:31] Speaker 04: we believe is informative, to your honors, as you obtain the best reading of this. [00:39:37] Speaker 01: I'm concerned about, in the area of gamesmanship or shenanigans, to what extent would there be a greater opportunity to game the system if we find the date to be the reissue date, not the original date? [00:40:00] Speaker 04: So I believe just my self-thinking of gamesmanship that could occur, it would be not seeking a reissue quickly and not, I guess, that would take away from the public the knowledge of the correction and the error and the patent. [00:40:17] Speaker 04: What you would do instead would be wait [00:40:20] Speaker 04: until you have the PTE on the original patent. [00:40:24] Speaker 04: And then you would file your reissue, knowing that under the statute, and it's undisputed, that that PTE would then transfer over the reissue. [00:40:31] Speaker 04: So it would be gainsmanship in either not filing the reissue or at the patent office taking certain steps to delay your reissue application until you get PTE on the original patent. [00:40:44] Speaker 04: On the contrary, there is no gainsmanship that would be [00:40:48] Speaker 04: under the interpretation using the original patent. [00:40:51] Speaker 04: And that goes back to the idea that there's no reason that you would want to file a reissue if you knew it would cut off PTE. [00:41:01] Speaker 02: OK. [00:41:01] Speaker 02: I think we're out of time. [00:41:03] Speaker 02: Thank you. [00:41:03] Speaker 04: Thank you, Your Honors. [00:41:07] Speaker 02: Mr. Werlinger? [00:41:16] Speaker 03: So Judge Dyck, Judge Raina, you all asked a lot of pointed questions about some inconsistencies in things that might occur with the PTO and Merck's position. [00:41:25] Speaker 03: So I'll note that those two positions are not identical, and I'll get to that in a moment. [00:41:30] Speaker 03: The best way to avoid those issues is to apply the text as Congress wrote it. [00:41:35] Speaker 03: I want to respond to the comment that we are assuming a definition of issue. [00:41:40] Speaker 03: We're not. [00:41:42] Speaker 03: It is an undefined term in the statute, and under the law, [00:41:46] Speaker 03: Undefined terms presumptively carry their ordinary meaning. [00:41:49] Speaker 03: That's the one you find in the dictionary. [00:41:52] Speaker 03: Merck and the PTO have not argued otherwise. [00:41:56] Speaker 03: I think my friend from representing Merck also mentioned several times that reissued patents and the original patents are the same patent. [00:42:03] Speaker 03: They're just one and the same. [00:42:05] Speaker 03: And that, too, is wrong as a matter of law. [00:42:08] Speaker 03: This court said as much in Seattle Box, and the Supreme Court has said it multiple times in cases going back nearly 200 years. [00:42:16] Speaker 03: I also want to point out in this respect that Merck amended its complaint to specifically plead the reissue patent, meaning it is a different bundle of rights. [00:42:28] Speaker 03: And they updated their orange book listing to reflect the fact that we have this new patent out there. [00:42:34] Speaker 02: Well, what they might think really doesn't bear on the statutory construction, right? [00:42:40] Speaker 03: On the statutory construction of what? [00:42:42] Speaker 03: 156. [00:42:44] Speaker 03: But well, again, but it does because what they're trying to say is that it's the same patent. [00:42:48] Speaker 03: It's the same patent term. [00:42:49] Speaker 03: It takes the issue date. [00:42:51] Speaker 03: This is kind of their oblique way of getting a separate definition of the word issued because they cannot give you a plain text interpretation of that word directly. [00:43:02] Speaker 03: And what I'm saying is that's wrong. [00:43:04] Speaker 03: That's the problem. [00:43:05] Speaker 03: It is a different patent. [00:43:06] Speaker 03: It is a different term. [00:43:08] Speaker 03: The term takes qualities of the original patent's term as defined. [00:43:12] Speaker 03: in Section 251. [00:43:14] Speaker 03: But as I noted during my presentation, it just takes the piece. [00:43:17] Speaker 03: It just takes that back hat. [00:43:19] Speaker 03: Reissued patents must have a distinct issue date. [00:43:23] Speaker 03: Otherwise, the reference to the incorporation of Section 154 doesn't make sense. [00:43:28] Speaker 03: The first sentence of Section 252 doesn't make sense. [00:43:32] Speaker 03: And again, that's what Congress wanted. [00:43:34] Speaker 03: They could have picked a different language, but they didn't. [00:43:38] Speaker 02: You assume that anybody was thinking about this problem, which is probably unlikely. [00:43:45] Speaker 03: Well, perhaps so, but we make that assumption in law, Judge Dyke. [00:43:48] Speaker 03: We assume that Congress is aware of these issues when it promulgated 156. [00:43:55] Speaker 03: And specifically on sections 251 and 252, Congress has amended the law multiple times over the years to address issues of concern. [00:44:04] Speaker 03: One I want to point out is that they created the definition of an effective application date under 100i2. [00:44:12] Speaker 03: That specifically backdates the application of the reissue to that of the original. [00:44:17] Speaker 03: If they wanted to do something like that for an issue date, they certainly knew how to, but they haven't. [00:44:23] Speaker 03: Regarding the PTO's practice, I do want to point out the disconnect between the two. [00:44:27] Speaker 03: Merck is saying [00:44:28] Speaker 03: Issue refers to the issue date of the original patent. [00:44:33] Speaker 03: We're talking about issue full stop, no limiting principle. [00:44:36] Speaker 03: I think you asked a couple of questions of my friend of how we stop the problems with broadening reissued. [00:44:41] Speaker 03: And he effectively punted. [00:44:43] Speaker 03: He did not give you a limiting principle. [00:44:45] Speaker 03: What the PTO is proposing through Section 2766 is that we only do this if the original and the reissue both cover the product. [00:44:57] Speaker 03: That might be a little bit more of a sensible policy, but it is even further unmoored from the text. [00:45:03] Speaker 03: And that is the problem with it. [00:45:05] Speaker 03: I also want to note very quickly on deference that we, for a number of reasons, we do not think Skidmore deference is appropriate here. [00:45:13] Speaker 03: Number one, we think you can resolve this case with the application of cannons of construction, which means you don't get to Skidmore. [00:45:20] Speaker 03: Number two, the PTO has not articulated [00:45:24] Speaker 03: a coherent interpretation of 156. [00:45:26] Speaker 03: They didn't even take a position on this until they promulgated MPEP 2766 during the pendency of this litigation. [00:45:35] Speaker 03: And even at that, there's still no articulation of how the statute supports that interpretation. [00:45:42] Speaker 03: We really didn't get that until they filed their amicus brief in this case. [00:45:46] Speaker 03: And for the reasons that we have laid out in our reply brief, that position [00:45:50] Speaker 03: is wrong. [00:45:51] Speaker 03: If there are no further questions, I think I'm about out of time. [00:45:55] Speaker 02: Okay, thank you. [00:45:56] Speaker 02: The Medical Council case is submitted. [00:45:58] Speaker 02: That concludes our session for this morning.