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We have four argued cases this morning.

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The first of these is number 22-1194.

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H. Lundbeck versus Lupin Limited.

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Ms.

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Barkata, I guess.

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Am I pronouncing that right?

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Barkata?

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Barkata.

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Barkata.

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OK.

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Go ahead.

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Good morning, Your Honors, and may it please the court.

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Breanne Barkata on behalf of Lundbeck and Takeda.

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The district court here erred in finding that the defendants were not liable for infringing plaintiffs' method of treatment patents.

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The district court's conclusions on non-infringement cannot be reconciled with its own fact finding regarding defendants' underproducts, their approved uses, and their labeling.

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The record in this case firmly establishes defendants' infringement on three different grounds.

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First, defendants' infringe as a matter of law under Section 271E2A.

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Second, defendants infringe because even though they were permitted to omit some information from their labels about treatment emergent sexual dysfunction, their labels still contain extensive and detailed information and data that would encourage the claimed uses.

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And the information must be in the label because it's considered critical and essential to the safety and the effective use of the drug.

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And third, defendants are liable for contributory infringement

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And the court's conclusion to the contrary was based on legal error.

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So defendants infringe under section 271E2A because the district court correctly found.

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Should people be liable for inducement because they include in the label something that was required?

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They couldn't have gotten approval without the label that they had, right?

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Your Honor, I believe this court's case law establishes firmly that inducement

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can and should be found in that instance.

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For example, in the AstraZeneca V Apotex case from 2010, there was a specific instance where

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The defendant Apotex in that case was required to include information that told physicians to titrate down to the lowest effective dose for each patient, even though that was required by FDA for inclusion.

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This court said that that can still be the basis for infringement.

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And very often, when we are talking about drug labels, the information is in there exactly because it is required for physicians to understand the safe and effective use of a given product.

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And that can still, of course,

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If that leads to physicians to prescribe the drug for the claimed use, that is inducement under this court's case law.

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And here, the district court correctly found also that defendant's underproducts will be approved for the uses that are claimed in the 096 and 910 patents, and that physicians will prescribe defendant's underproducts for those uses.

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Now, based on the text and structure of the Hatch-Waxman statute itself, that alone is sufficient to find infringement here.

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The statute is clear.

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Why didn't you list the 96 and the 910 patent in the Orange Book until after you had modified the label?

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to include this carved out data.

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So why did you do that?

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The record actually doesn't contain evidence about the reason for the timing of the listing.

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However, I don't think that actually affects the analysis here, because really the question, first of all, the patent certainly was listed for this patent in the Orange Book.

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And the ultimate question of whether or not

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the information in a label will induce infringement or encourage the prescribed use is determined by the court's assessment.

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FDA and listing requirements do not determine ultimately the infringement of a patent.

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And here, the district court correctly found that the drug will be used in this way by physicians.

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And so the question is, what does the label say?

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What will the physicians

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be encouraged to do based on the contents of the label.

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I think that's the key question.

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The timing of the listing is really not relevant to that particular question.

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So what could they have done to avoid inducement, in your view, and to secure approval for the marketing of a drug which wasn't covered by the patent?

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What could they do?

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There may have been, there could, in theory, have been attempts to negotiate with FDA for a narrower indication, for narrowing label language that perhaps was different from what ultimately got included in the label.

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Well, what would it say?

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How would it be different?

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There could have been a narrowing for, for example, first line treatment, treatment naive patients.

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with MDD, for example, which would have eliminated treatment of patients who have previously received an SSRI, SNRI, or tricyclic antidepressant and then are switched due to sexually-related adverse events.

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For example, that would have been one way.

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As the district court found, the defendants here made no attempt to narrow the indication or narrow the approval that they were seeking.

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the ultimate approval that they are seeking will be constant.

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So let's assume hypothetically, if something is not covered, clearly is not covered, would there still be a need or a requirement to affirmatively disavow everything else or other steps?

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If something is clearly not covered by the label, it would seem that that wouldn't be necessary.

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But that's not the situation we have here, because I think the district court correctly found that the use of

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Defendants products is in fact within the scope of the approval that defendants are seeking it is an approved use of the product and this court's case law has said that The other remedy would be that once you realize that you are going to have a label that infringes the patent You could not seek approval or wait until after the patent expires to launch the product.

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What you're basically saying is if you can get a new patent on

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single use, you can borrow them from selling the drug for uses that aren't covered by the patent.

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There's nothing they can do about it.

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Assuming that the FDA insists on including this material in the light, there's nothing they can do, right?

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I think that's what the statute contemplates, although I don't think... Yes, actually.

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I think, for example, it's often the case that method of use patents or other patents that cover a product are, in fact, narrower than the full scope of the indication.

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For example, the Sanofi v. Watson case, a broad cardiac

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indication, and the method of treatment that was infringed there was for patients who had that particular cardiac problem, but also a specific set of risk factors that were not all of the treated patients.

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That's not that unusual.

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I'm not suggesting gamesmanship should occur, and there may be other arguments, in fact.

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You seem to be completely contrary to the purpose of the statute.

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The idea is that you should be able to have an end allowing you to sell things for non-patented uses, and you're saying

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no no you can't do that because you happen to encompass within the uses that people use it for something which is subject to another path.

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I mean that really seems perverse.

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I think that the way that one obtains a patent and then the way that one obtains FDA approval means that those two things don't always line up perfectly.

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Usually patents are obtained actually before you get FDA approval.

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And oftentimes, they may be narrower for various reasons than the ultimate indication that you get for a drug.

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If there is a situation, for example, where you can eliminate an indication or carve out the information fully from the label such that

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what remains on the label will not encourage the infringing use, then you can get yourself.

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I'm just saying that if the FDA doesn't permit that, there's nothing they can do.

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They're stuck.

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They can't sell it, even though they're selling it for legitimate purposes.

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I believe that is what is not only appropriate, but called for by this court's case law.

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If FDA requires the information to be in the label, and it would nonetheless induce infringement of a valid patent, that would be infringement under the Hatch-Waxman Act.

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Can you say the intent requirement is satisfied just because they have knowledge that some physicians would prescribe it for the uses covered by your patent?

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Well, it's not simply the knowledge piece.

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It's the knowledge piece, but then also proceeding to attempt to market the drug prior to the expiration of the patent nonetheless.

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For example, in Sunovion, the court said that if the defendant there did not have intent required by the statute, then it would not seek and would not accept approval

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for a use that was claimed in the patent.

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And I think that is the case here.

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That's also echoed in AstraZeneca via Apotex from 2010.

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Are you saying that the mere fact that they know that some doctors are going to prescribe it for the patented use is sufficient?

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It's that they know that the label will encourage at least some doctors to prescribe the drug for the claim to use.

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And how does the label do that?

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How does the label work?

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The label does that here both because of the broad indication coupled most importantly with the information in section 6.1 of the label.

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that contains extensive data about treatment emerging sexual dysfunction, showing that it is quite low for vortioxetine, and therefore doctors who are looking to treat a patient who has experienced sexually-related adverse events on another antidepressant would be encouraged to prescribe vortioxetine for that specific use.

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There's ample testimony on that in the record.

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The data here is extensive.

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There's voluntarily reported adverse event data from seven pooled clinical studies.

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Those are the six to eight week MDD studies that are in section 14 of the label.

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And those are thousands of patients.

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That's reflected in the data.

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Is this all data that the FDA required?

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So there was some attempt by certain defendants, not all, to remove some of it from the label.

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And FDA said, no, we're requiring all of this.

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That makes sense, because this was data that was originally... Well, that's what... I mean, it seems like that's a problem.

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If the generic wants to market this for non-patented uses,

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And it submits a label that doesn't cover any of the patented uses.

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It doesn't intend to market it for patented uses.

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It doesn't intend to tell the doctors.

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We all know that doctors prescribe stuff off label all the time.

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If the only thing that brings us within infringing these patents is data that the FDA requires, then why does that show intent by the generic to infringe?

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That is what this court's case law says.

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Because if you can't carve it out, that's the issue.

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If you can't carve it out, then one has to make a decision between going to market with data or information on the label that you know will encourage the infringing use, which I think

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certainly does show intent.

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That's encouraging it.

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At best it's the FDA's intent to signal to these doctors that they can prescribe it off use.

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But you're not trying to go after the FDA obviously, you're trying to go after the generic.

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To be clear, this is not an off-label use case.

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This use is on-label.

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This is not an instance where we're talking about the drug being prescribed for off-label uses or uses that are not approved in the label.

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And here, the question of-

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I don't think that that, well I'm not sure, in terms of targeting, I think the issue is will the label encourage doctors to prescribe the product for these specific uses?

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I believe it is.

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What in the label, apart from the information that FDA requires, would induce infringement?

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I'm sorry, Judge Hughes, can you repeat that?

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Yeah, sorry, it was a little muddled.

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What in the label

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apart from the parts that the FDA required would encourage infringement?

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I'll point you to specific sections if you bear with me for one moment.

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So there is both the indication, which the court found it covers the claimed use, and then there is the section 6.1 data, which is the voluntary related adverse event reporting, and then there's the- That was all required by the court.

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The it's because it's critical safety information of course it's going to answer my question and maybe you can't maybe my question makes no sense and if it doesn't tell me but the FDA required certain information to be put on here take all of the information that the FDA require is there anything left that encourages infringement.

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The key information that encourages the infringement here is in 6.1.

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It's the safety data.

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There's also other labels, other portions of the label, for example, and I just want to be comprehensive on that.

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In the opinion, so this is Appendix 150, paragraph 604, the court pointed to some other portions of the label that also taught certain things to physicians.

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But the critical piece is 6.1.

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And I think as a practical matter here,

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This is the consequence of the way that the scheme works.

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For example, as I was mentioning before, let's take the Sanofi v. Watson case.

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Of course, the label, for example, might identify a critical patient population or information about a particular patient population that aligns with a claimed use or a claimed patent.

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In that instance, of course that information is going to be required.

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It's critical and it's important.

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It can still be infringed and there can still be intent to

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induce infringement.

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This is the way it works, because FDA determines ultimately what's in the labels.

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And the generic companies must sometimes make a difficult decision about whether or not to move forward with attempting to market a product that has a patent covering that use.

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But it's the interaction between the FDA approval process, what's required for safety and effective use, and making sure that doctors have the right information, and the inducement case law, which is what

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the statute, that's how the statute contemplates that this will work.

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Okay.

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If there are no other questions, I think I'm in my rebuttal time, so I shall reserve.

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You're out of your rebuttal time.

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We'll give you a few minutes.

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Okay.

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Let's see.

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Who's going to go first here?

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Good morning, Your Honours.

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May it please the Court, David DeBramowitz.

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I'll be arguing on behalf of the defendant, Annalise, on the 096 and 910 method of use patents.

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I'd like to address three issues today.

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Plaintiffs' infringement targets under 271E2A induce infringement and contributory infringement.

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Now, since we spent most of our time with your colleague dealing with inducement, why don't you start with the inducement and the arguments you heard today being made?

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Defendants carved everything related to the 096 patent out of their labels.

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This is not a case where FDA actually rejected the carve-outs.

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Their section 8 submissions carved out the clinical studies and

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the adverse event data associated with those clinical studies.

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They're arguing that you could have asked the FDA to allow you to carve out even more and to leave out six-minute walk, right?

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Plaintiffs appear to be arguing that we could have done a larger carve-out.

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Right.

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Defendants' carve-out actually mirrors the Trentelix label from before the clinical studies

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were done for the 096 and 910 patent, and from the Gentelix label as it was approved originally.

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Address the question of whether their premise is correct.

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I mean, is there a possibility that the FDA would have allowed you to carve out the 6.1 data?

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No, Your Honor.

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We cannot carve out 6.1 data or change the indication.

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As a generic, we have to apply for the same indication.

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The only indication for which vortioxetine was approved, which is the treatment

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of patients with major depressive disorder, MDD, with vortioxetine.

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Well, is it your view that 6.1 is enough to establish inducement or encouragement?

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6.1 is not enough to establish inducement, as the district court found.

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6.1 simply tells you the adverse events that you'd suffer if you took vortioxetine.

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The 096 patent requires three steps.

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First, the patient takes an antidepressant from one of four classes.

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Then that patient suffers TESD on that antidepressant, which has to be ceased to reduced.

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And third, the patient then takes Vordioxetine for the treatment of MDD.

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Section 6.1 of the finance labels does not include any information about any product other than Vordioxetine.

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Only discusses TESD a patient would suffer while taking Vordioxetine, not some other medication, and instructs physicians not to compare

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results for bordeoxetine with other products explicitly, as the district court found.

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Defendants have engaged in no activity encouraging, recommending, or suggesting to a physician that the use of generic bordeoxetine should be in concert with the method described in the 096 patent.

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In fact, the method described in the 096 patent may intersect

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with the approved use, which is treating Bordioxin with MDD.

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But as the district court found it, it's a separate and different use that simply intersects with the approved indication.

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It is not the same.

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And was there expert testimony on both sides on that point, or was there a record?

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There was expert testimony on both sides, and the court had ample evidence

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substantial evidence to find that the uses were different and that physicians may prescribe vortioxetine in concert with the 096 patent based on the brand Trimtelex label, but not in concert with the generics carved out label.

[00:19:35] Speaker 06:
I don't understand.

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What does that mean, in concert?

[00:19:38] Speaker 00:
So looking at the brand label, a physician might prescribe Trimtelex

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for a use that would be covered by the ONXX patent.

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And eventually, that prescription.

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And the district court found that they would have been aware of that, right?

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Defendants are aware of that.

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But under this court's case law, that's not enough.

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As far back as Warner Lambert, simply knowing that an infringing use might occur is not enough to establish intent.

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That's especially true in a situation like this, which is similar to the Grunenthal and HCMP cases, where

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There is an approved indication, but the use in the patent is at best intersecting or a subset of those of the approved indication.

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And that particular use or indication has been carved out of the label.

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So even though there is knowledge that the generic product might be used in an infringing manner, that's not enough to simply prove intent.

[00:20:36] Speaker 00:
There has to be more than that.

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Some suggestion or recommendation or encouragement in the label to prescribe for that specific use in that manner.

[00:20:46] Speaker 00:
Here, we don't have that.

[00:20:49] Speaker 06:
I mean, would that be true, for example, if they knew that half the uses wouldn't be infringing?

[00:20:57] Speaker 00:
I think Warner Lambert's actually really instructive on that.

[00:21:00] Speaker 00:
In the Warner Lambert case,

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The approved indication for which the generic site was a minor use you caught a minor use because it was something like less than five percent of all prescriptions were for that use and the generics knew that it would be described for other uses And I think that's why I was going your honor I think that in Warner Lambert

[00:21:32] Speaker 00:
they knew that those other uses were going to be.

[00:21:34] Speaker 00:
The defendants knew that.

[00:21:35] Speaker 06:
But you said it was minor use there.

[00:21:37] Speaker 00:
No, the use they sought approval for was the minor use.

[00:21:40] Speaker 00:
They knew that the other 95% of uses would be prescribed for Neurontin gallopetin.

[00:21:47] Speaker 00:
But this court found that even that knowledge, that only 5% of patients would actually be taking for the indication of generic SADA, was enough under section 8.

[00:22:00] Speaker 00:
those labels, they're only seeking intent for those 5% of the patients, even if they know 95% of patients would be substituted for some other use.

[00:22:12] Speaker 00:
I'd also just like to address for a second the contributory argument that plaintiffs have made.

[00:22:19] Speaker 00:
And there is no statute or case law that a substantial amount of infringing use can't be covered by some other patent.

[00:22:28] Speaker 00:
The statute's patent specific as noted.

[00:22:30] Speaker 06:
Does Warner Lambert tell us that it doesn't make any difference that it's 95%?

[00:22:41] Speaker 00:
I do not recall whether that's in the appellate opinion or in the district court opinion that the use is only 5%.

[00:22:50] Speaker 00:
What Lambert tells us is it doesn't matter whether the use is small or not.

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if they've carved out the intent of the indication for which the defendants are seeking approval, not for some other use that's not described in the label.

[00:23:11] Speaker 00:
I think Grunenthal might be particularly instructive on that, because in that case, the approved indication that the generic sought was chronic pain, and the patent was for neuropathic pain, which was a separate indication.

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which have been carved out.

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And plaintiffs clearly proved in that case that defendants were aware that a lot of the chronic pain prescriptions would be for neuropathic pain.

[00:23:38] Speaker 00:
But this court found that even though the generics were aware that many, if not a majority of those prescriptions would be for neuropathic pain, that the fact they carved out that from the label showed a lack of specific intent.

[00:23:54] Speaker 03:
Can I go back to inducement?

[00:23:57] Speaker 03:
It's my recollection that the other side represented to the FDA that the section 6-1, as it existed in the original label and as it exists in the carve-out and the label, would actually discourage prescription of whatever for TESD.

[00:24:19] Speaker 03:
Am I right about that?

[00:24:20] Speaker 00:
That is correct.

[00:24:21] Speaker 00:
The district court found that.

[00:24:23] Speaker 00:
filing their citizen petition, plaintiffs told FDA that the information 6.1, because of the rate of TSD on Vodaxine, might discourage prescribers from prescribing for that purpose.

[00:24:36] Speaker 00:
And in response to that, in the citizen petition decision, the FDA actually found that the carve-outs defendants had made not only got past the use code that was listed in the orange book, which is broader than the 096 patent, but also the 096 patent.

[00:24:52] Speaker 00:
FDA found in a footnote, that the Fennis Carbons were broad enough to meet that lack of intent for that particular use.

[00:25:04] Speaker 06:
Was there any evidence that the 6.1 data in the Carved Out label was the cause of physicians willingness to prescribe this for the patented use?

[00:25:20] Speaker 00:
There was conflicting expert testimony on that.

[00:25:23] Speaker 00:
The defendant's expert noted that the high rates of TESD in 6.1 would have discouraged prescribers and that plaintiff's own evidence demonstrated that physicians were not very familiar with the ASEX criteria used in 6.1, and such physicians wouldn't necessarily use that as a comparator with other products.

[00:25:50] Speaker 06:
So I guess the question is, do we have a finding?

[00:25:56] Speaker 06:
Was that finding referenced by Judge Proves just now?

[00:25:58] Speaker 06:
Do we have a finding by the district court that the label didn't cause, wouldn't cause these patented uses?

[00:26:07] Speaker 00:
Judge Stark specifically found that the CAR.LABEL would not

[00:26:11] Speaker 00:
would not induce these specific uses because the eliminated material prohibits comparison with other products and encourages a physician not to try.

[00:26:23] Speaker 06:
Where is that finding?

[00:26:24] Speaker 00:
So that, if we look at its appendix 145 to 46, paragraphs 5, 85 to 89,

[00:26:41] Speaker 06:
585 to 89 maybe you should look at

[00:27:10] Speaker 00:
I may be wrong about that, but that seems... You could also look at Appendix 147, Progress 595, and Appendix 226-28, where the district court came to its legal conclusions apart from the factual findings.

[00:27:52] Speaker 00:
226 I think I'm over my time and yeah unless there are further questions thank you

[00:28:21] Speaker 01:
Thank you, Your Honors.

[00:28:22] Speaker 01:
Deepa Mukherjee on behalf of the cross-appellant Lupin.

[00:28:26] Speaker 01:
Your Honors, I'm cognizant of the limited time I have, so I will try to be as brief as possible.

[00:28:31] Speaker 01:
The singular issue in this portion of the appeal deals with the district court's construction of the term reacting as it appears in the city.

[00:28:39] Speaker 06:
Your contention is that this compound has to be a starting material lab in the intermediate.

[00:28:46] Speaker 06:
That's basically your argument.

[00:28:47] Speaker 01:
That's correct, Your Honor.

[00:28:49] Speaker 01:
So if you look at the 626 patent, in every instance, whether we're talking about the claims, whether we're talking about the specification disclosures, and every single example as well, compounds 2, 3, and 4, which are seminal to the process, are always referred to as

[00:29:06] Speaker 01:
starting material or used as starting materials and that goes through even in the prosecution history because it's very limited but in the one office action that was even issued which I believe was a non-final one the 2015 office action the examiner

[00:29:22] Speaker 01:
always refers to compounds two, three, and four as starting compounds.

[00:29:27] Speaker 01:
It's never, anywhere in the intrinsic record, ever referred to as an in situ intermediate type compound or something that'll just start in the process or somewhere in the process.

[00:29:40] Speaker 06:
But that's not enough to limit it, is it?

[00:29:42] Speaker 01:
I don't believe that anything that I am trying to say is to limit something.

[00:29:48] Speaker 01:
It is just simply that as used in the patent, the term reacting is always referring to the usage of compounds 2, 3, and 4 as the starting material.

[00:29:58] Speaker 01:
That's how the reaction can even take place.

[00:30:02] Speaker 01:
by always having those three compounds either in a one pot, like one chamber type reaction, or in a two chamber reaction.

[00:30:10] Speaker 01:
It's always put in as starting material.

[00:30:12] Speaker 01:
It's never an intermediate.

[00:30:14] Speaker 01:
It's never midway into the process.

[00:30:17] Speaker 01:
It's always how it starts.

[00:30:19] Speaker 01:
And in some ways, even I think in one aspect, plaintiffs in some way kind of acknowledge that too.

[00:30:25] Speaker 01:
Or I should say Lundbach acknowledged that.

[00:30:26] Speaker 01:
Because in the yellow brief, I believe even in page 14, Lundbach calls when they characterize claims two and three, they actually state that, well, claims two and three specify the introduction of compounds two, three, and four.

[00:30:41] Speaker 01:
And so in that way, whether we call it introduction or we call it starting material, it's always consistently the starting material that actually starts the reaction.

[00:30:52] Speaker 01:
And that's it, Judge Dyke.

[00:30:54] Speaker 01:
That is essentially the construction.

[00:30:57] Speaker 01:
It is not a far-fetched type construction.

[00:31:00] Speaker 01:
It's just in keeping with the actual teachings and all of the intrinsic record.

[00:31:06] Speaker 01:
In every instance, it's the starting material.

[00:31:08] Speaker 01:
And where I think I take some issue with the district court's ultimate adoption of the construction that Lundbach proposed was simply that it was the usage of

[00:31:20] Speaker 01:
extrinsic evidence in the form of expert testimony and a dictionary definition not for reacting, but for the noun reaction to come up with the proper construction of just a reaction being changing a reactant to products.

[00:31:36] Speaker 01:
But that broad a definition is just not supported anywhere in the intrinsic record.

[00:31:41] Speaker 01:
And the intrinsic record, obviously, is the first best place that we go to when we're trying to determine even a term like reacting, which everyone, I can concede that it's a fairly common term that is used.

[00:31:55] Speaker 01:
But its definition is context dependent, always.

[00:31:59] Speaker 01:
It's not like the straight path case that this court ruled on on the definition of is.

[00:32:05] Speaker 01:
Reaction may be known or I'm sorry reacting might be known, but it's always context dependent and here your honor to go back to your seminal question reacting is always in reference to those compounds as starting compounds and Lupin of course does not use compound to as its starting compound in its process and so

[00:32:27] Speaker 01:
The adoption of Lundbach's construction is what led to the infringement finding against Lupin.

[00:32:35] Speaker 01:
And as this court does de novo review of the construction, we submit that under the proper construction, there can't possibly be any finding of infringement.

[00:32:48] Speaker 01:
Are there any other questions?

[00:32:52] Speaker 01:
Thank you.

[00:32:52] Speaker 01:
All right.

[00:32:52] Speaker 01:
Thank you, Ron.

[00:33:04] Speaker 06:
Okay, so I gave you two minutes.

[00:33:05] Speaker 06:
Well, we'll make that four, since you have one.

[00:33:09] Speaker 06:
Thank you.

[00:33:11] Speaker 02:
Would Your Honor like me to address the 626 process patent and reacting?

[00:33:16] Speaker 02:
On that front, I will say I think the Court did a textbook fill-up analysis, adopted the plain and ordinary meaning of the term because there was no basis.

[00:33:23] Speaker 02:
to limit it by definition, disavowal, or disclaimer.

[00:33:26] Speaker 02:
And Lupin offers none here today or in its briefing.

[00:33:29] Speaker 02:
I think the court clearly got that right, as it did with respect to its determination on infringement of the 626 patent.

[00:33:37] Speaker 02:
So if there are no questions, I'll respond to some of Mr. Abramowitz's points and some of the questions you asked as well.

[00:33:44] Speaker 02:
There was a question regarding, I want to distinguish Werner Lambert and Grunenthal, because in both of those cases,

[00:33:52] Speaker 02:
Those were off-label uses where an entire indication and all of the relating data was carved out of the patent, or the patent that was asserted in the case covered a use that was not an approved use or indication of the product.

[00:34:06] Speaker 02:
So I think those are wholly inapplicable to the situation that we have here.

[00:34:11] Speaker 02:
Also, FDA did not, and neither did the court, describe the use claimed in the 096 patent as an off-label use.

[00:34:21] Speaker 02:
The court actually expressly found that it is an approved use of defendant's antiproducts, and that the products will be used for the claimed use prescribed that way by physicians.

[00:34:32] Speaker 02:
I would point to paragraph 557 of the court's opinion, also, where the court specifically found that defendants had not narrowed the indication that they were seeking.

[00:34:42] Speaker 02:
I think, Judge Prost, you asked.

[00:34:45] Speaker 06:
I mean, this is pretty troublesome, isn't it?

[00:34:48] Speaker 06:
You have a situation where there's a compound, an expired patent on the compound, and the statute conflates, the generics under those circumstances, I'll be able to file a hand and to market the product.

[00:35:02] Speaker 06:
And you're saying, no, no, that can't happen because we get a new patent on some sliver

[00:35:10] Speaker 06:
And because some people will prescribe for that purpose, then you can't sell the generic for the expired patent abuse.

[00:35:24] Speaker 06:
I mean, that doesn't seem right.

[00:35:27] Speaker 02:
The patent law expressly contemplates, especially in the chemical arts... Expressly contemplates?

[00:35:31] Speaker 06:
Contemplates that people will... How does the Hatch-Waxman Act contemplate that?

[00:35:37] Speaker 06:
That patent applicants will do additional research on known or existing compounds that they will be able to obtain method... How does the Hatch-Waxman Act contemplate that additional research and the additional patents will prevent the sale of the product for the expired patent?

[00:35:53] Speaker 02:
Well, there, Section 271E2A says...

[00:35:57] Speaker 02:
that it includes expressly patents that claim a product or a method of using the product.

[00:36:03] Speaker 02:
And the remedy that it specifically prescribes for infringement of a method of use patent covering a product is that the FDA cannot approve the application until expiration of the patent, actually.

[00:36:14] Speaker 02:
It is expressly in there that that is what's contemplated.

[00:36:18] Speaker 02:
And in this court, in Eli Lilly Viteva and also in Lucent, has said there isn't a prevalence requirement for inducement if there is

[00:36:27] Speaker 02:
at least some induced activity, if there is at least one act of infringement that is caused by the label, then you get the 271E4 remedy.

[00:36:37] Speaker 02:
And therefore, I think it is actually expressly contemplated by the statutory scheme.

[00:36:43] Speaker 02:
I wanted to address Judge Prost's question about the issue of the citizen petition and

[00:36:51] Speaker 02:
the issue that was raised by Lundbeck with respect to concerns that removing the information from section 14 from the label might

[00:37:01] Speaker 02:
lead doctors to misunderstand the section 6.1 data that it could potentially cause them to misunderstand or think that the TESD rate was high, FDA rejected that.

[00:37:13] Speaker 02:
They said, no, doctors will fully understand this.

[00:37:16] Speaker 02:
They will contemplate that.

[00:37:18] Speaker 02:
They will know how to placebo adjust.

[00:37:19] Speaker 02:
They will understand all of this data and the rates.

[00:37:22] Speaker 02:
And that was confirmed by the experts at trial.

[00:37:24] Speaker 02:
And on that issue,

[00:37:25] Speaker 02:
I think there was a question posed about whether there was expert testimony on both sides.

[00:37:32] Speaker 02:
And I disagree with the idea that there was in two specific instances.

[00:37:36] Speaker 02:
First of all, defendant's FDA expert never offered the opinion that this was an off-label use of any kind.

[00:37:43] Speaker 02:
And then also, Dr. Rothschild, their physician expert, which is the only testimony that the court relied on in finding no induced infringement, did not in any way address the 5, 10, or 15 milligram doses of the product.

[00:37:58] Speaker 02:
His opinions were solely related to Trump.

[00:38:01] Speaker 02:
Thank you, Anna.

[00:38:01] Speaker 06:
Thank you.

[00:38:03] Speaker 06:
Now, I guess, Mukherjee, there wasn't much mention of your cross-appeal bid, but if you have anything

[00:38:11] Speaker 06:
Why did you say that?

[00:38:14] Speaker 01:
Thank you, Your Honor.

[00:38:15] Speaker 01:
I appreciate that.

[00:38:16] Speaker 01:
All I would just say is that I heard my colleague on the other side say that the district court's analysis was a textbook Phillips analysis.

[00:38:23] Speaker 01:
I disagree.

[00:38:24] Speaker 01:
I think a textbook Phillips analysis would look at the intrinsic record and see how it uses compounds 2, 3, and 4 as part of this process.

[00:38:32] Speaker 01:
And there I just return to that simple fact.

[00:38:34] Speaker 01:
It is always the starting material.

[00:38:36] Speaker 06:
Okay, thank you.

[00:38:37] Speaker 06:
And there was no mention of a contingent cross appeal, so we don't have any further argument on that, so the case is submitted.

[00:38:44] Speaker 01:
The cross appeal on invalidity you're talking about, Your Honor, I'm sorry, or just on to the situation.

[00:38:48] Speaker 01:
Yes, yeah, there was no mention of that.

[00:38:50] Speaker 01:
Right.