We'll hear argument next in Case 24-889, Hikma Pharmaceuticals versus Amarin Pharma. Mr. Klein. ORAL ARGUMENT OF CHARLES B. KLEIN ON BEHALF OF THE PETITIONERS
“This is a purely procedural announcement calling the next case and inviting counsel to begin argument. It contains no emotional valence, questioning, or evaluative content whatsoever.”
Thank you, Mr. Chief Justice, and may it please the Court: Under Section 271(b) of the Patent Act, selling a product suited for both infringing and substantial non-infringing uses is lawful unless the seller actively induces the infringing use. Congress later passed Hatch-Waxman Section viii to ensure that one infringing use will not foreclose selling a generic drug for a second non-infringing use. So public statements entirely consistent with selling skinny-label generic drug products under Section viii cannot actively induce infringement. Under our approach and the one advanced by the United States, "actively induce infringement" when dealing with statements 1 requires a clear message that necessarily promotes infringement. The Court applied this standard in Grokster and more recently in Cox. Active inducement cannot depend on whether doctors might read infringing instructions into product descriptions that, on their face, are entirely consistent with non-infringing use. Amarin argues that generic drug companies must constantly discourage infringement with disclaimers that are explicit. But that turns the statute on its head. Agreeing with Amarin, the Federal Circuit basically swapped the statutory term "active" for its antonym, "passive." And under the decision below, patent lawsuits filed after skinny-label product launches will routinely survive a pleading challenge. This shuts the Section viii pathway down. Generic companies won't choose that pathway if, at best, it means paying millions in legal fees and, at worst, a massive damages award. Reversal is needed to harmonize Section viii with Section 271(b) and to encourage legitimate competition that reduces 1 drug prices. I welcome the Court's questions.
Wouldn't it have been safe to just simply say that -- that the generic drug was -- was only approved for the SH indication and nothing more?
“The 'Wouldn't it have been safe to simply say...' framing suggests the Justice is probing whether there was a simpler, safer course of action available, implying skepticism about the petitioner's position or reasoning. It challenges the necessity or logic of the approach taken, while also carrying some engagement as it explores an alternative scenario.”
Your Honor, Hikma did say that when it launched its product in the November press release, and it did say that on the accused website. But the law does not require that. In Grokster and Cox, the Court made clear that failure to take affirmative steps to prevent infringement is -- is not what the standard --
But what if you -- what if Respondent had engaged in a certain degree of self-adulation and said that this is a great product for this, that, or the other, and you merely quoted it? Wouldn't that almost be baiting people into inducement -- or inducing people into using the product more broadly than the unpatented use?
“The Justice is exploring a hypothetical scenario about potential manipulation or 'baiting' through self-promotional quoting, showing both concern about the broader implications of the petitioner's argument and intellectual engagement in testing the boundaries of inducement liability. The word 'baiting' signals some worry about unfair outcomes, but the tone remains exploratory rather than hostile.”
The hypothetical is -- is a little vague, but if -- if Hikma or a generic were to send a clear message that --
Well, not using your language but using their language. They have patented uses that they think are great, but you could -- why didn't you -- you simply quote them. Wouldn't that be a way to induce?
“The Justice is probing the petitioner's argument by suggesting an alternative framing—using the patent holder's own language about 'great uses' as a basis for inducement—which challenges counsel's position with a rhetorical hypothetical. The phrase 'wouldn't that be a way to induce?' signals skepticism about whether counsel's distinction holds up, while the exploratory nature of rephrasing arguments maintains some engagement quality.”
If -- if Hikma quoted Amarin --
-- with regard to its cardiovascular use --
-- that could plausibly state a claim if -- if it's a clear message that necessarily promotes infringement. The -- the Grokster Court addressed a similar type of situation when distinguishing the Sony case and -- and -- and distinguished statements like "record favorite shows on your Betamax" and said that does not encourage conduct that necessarily infringes, and, therefore, that's not actively induced infringement. And if you don't actively induce infringement, you fall under Section 271(c) --
I -- I think what I'm 1 asking you is, is the only way to actively induce infringement is overstating or your own statements sound as though the patented use is covered by your product, as opposed to simply quoting the Respondent's website or statements about its product, which is patented?
“The Justice is seeking to clarify the precise boundaries of the petitioner's argument about what constitutes active inducement of infringement, specifically whether the standard requires the infringer's own affirmative statements versus merely quoting the patent holder's materials. While there is some skepticism embedded in the framing, the primary intent appears to be pinning down the exact legal standard being advanced.”
I -- I'm not saying there is any kind of magic words standard. And if -- if the generic basically adopts by reference statements by the -- the -- the brand that would -- that would encourage the infringing use, then that could plausibly state a claim.
Do you need any of the special rules that you're claiming we have to announce to win this case? Does this pass Twombly and Iqbal?
“The Justice is probing whether the petitioner's broad legal claims are even necessary to resolve the case, implying the argument may be overreaching. The question challenges counsel to justify why special rules are needed if standard Twombly/Iqbal pleading standards might suffice, reflecting skepticism toward the scope of the legal position being advanced.”
It does, and -- and our --
It passes Twombly and Iqbal?
“The terse, direct question 'It passes Twombly and Iqbal?' signals skepticism about the pleading standards being met, with the brevity and implied challenge suggesting doubt. However, it retains some clarifying quality as the Justice may be genuinely seeking confirmation before probing further.”
-- the complaint here --
“This appears to be a mid-sentence interruption or a fragment referencing 'the complaint here,' which is likely a procedural or administrative reference to the case at hand. The truncated nature suggests either an interruption or a transition, making it largely neutral with a slight hostility signal given the interruption pattern.”
-- is adequate under Twombly and Iqbal?
“This appears to be part of a larger question testing whether the pleading standard has been met, probing the adequacy of the complaint under the Twombly/Iqbal framework. The truncated nature suggests it's a continuation of a skeptical or clarifying inquiry about the legal sufficiency of allegations.”
Oh, I'm sorry. I'm sorry. I thought you -- I -- I misunderstood the question. The -- no, the -- the complaint does not pass the standard for plausibility under Twombly and Iqbal. Our argument --
That -- that -- that's the point --
“The fragmented, emphatic repetition of 'that's the point' suggests the Justice is either reinforcing or seizing upon a key argument, indicating active engagement. The stuttering could reflect interruption or excited agreement, but without more context it's difficult to determine clear approval vs. challenge.”
-- which is you're asking us to announce rules that -- that -- almost impossible in this area because determining whether or not there's active inducement is always contextual. I think Grokster said that one of the factors it used was that the name that the infringer was using was suggestive of the infringement. So that wasn't an express statement of any way to infringe. It was a suggestion. But, in context with other things, it reached active inducement. I'm asking a very simple question. You don't need all of the things you've been arguing about to win under Twombly and Iqbal, 1 correct?
“The Justice is pushing back on the petitioner's framing by pointing out the contextual nature of active inducement doctrine (referencing Grokster), while simultaneously trying to simplify the question to what's actually needed to win under Twombly/Iqbal—suggesting skepticism about the breadth of the argument being made. The directness of 'I'm asking a very simple question' signals mild frustration but is primarily aimed at narrowing and clarifying the legal issue.”
That is correct. The statements here, as the government called them, were anodyne. They -- they -- they were unoffensive. They were totally consistent --
Now I do know that we make life hard because we say we're not going to take on error correction, so you had to make up a rule of some sort, but it seems like everything you say, like somehow you need express statements as opposed to what we have said, you need active inducement. You want to change the words, but do we need to change any of our standards for you to win?
“The Justice is probing the petitioner's argument by questioning whether their position actually requires changing existing standards or just reframing the words, suggesting doubt about the necessity of the proposed rule changes. The phrase 'do we need to change any of our standards for you to win?' is a pointed challenge that exposes a potential weakness in the argument, indicating skepticism, though the tone remains intellectually engaged rather than hostile.”
No, Your Honor, because there are obvious alternative explanations in view of the anodyne statements. Every single accused statement has an -- has an explanation that is entirely consistent with non-infringement.
All right. Thank you, counsel.
“This is a standard procedural closing remark used to conclude counsel's argument time, with no emotional valence or substantive content beyond routine court administration.”
Can I ask you a similarly straightforward question? With 1 respect to Amarin's allegations concerning the label, I had understood that by statute, generics have to have a label that essentially, in all relevant circumstances, mirrors the brand label, except for just admitting the patented indication. Is that correct?
“The Justice is genuinely seeking confirmation of their understanding of the statutory framework regarding generic drug labeling requirements, using phrases like 'I had understood' and 'Is that correct?' which signal a clarifying intent. There is some intellectual engagement as the Justice probes the legal foundation of Amarin's labeling allegations.”
That is correct. It's called the sameness requirement. That's by statute. Now --
So it's -- so even if Amarin is right that it thinks that -- that Hikma could have or should have excluded a certain study or included the -- some other information, if those aren't on the original label, Hikma can't do that?
“The Justice is probing the logical implications of the petitioner's argument about label constraints, combining genuine clarification of the rule's boundaries with mild skepticism about whether Hikma is truly restricted from including or excluding certain information. The 'so even if' framing tests whether the argument holds under a challenging hypothetical.”
Hikma cannot change the label, but I want to be clear about something because Amarin supplied to the FDA the sections that Amarin thought pertained to its patent. And then the way the FDA, the -- the skinny-label process works is the FDA compares what Amarin says is patented in the label to the proposed skinny label, and it's a ministerial role. If -- if the generic carved out everything that the brand said is patented, 1 then the skinny label can be approved. And the generic can't add new disclaimers or -- or new language.
Or anything else. And it can't be accused of inducing infringement by refusing to put things on the label that the brand didn't have, right?
“The Justice is probing the logical extent of the argument ('Or anything else') and then posing a rhetorical question challenging how far liability can extend, suggesting skepticism about the petitioner's position while also partially clarifying the scope of the argument.”
That's true because of the statutory scheme. That's true because Grokster and Cox says there's -- they're -- the statute doesn't require active discouragement of infringement and for all of those reasons. I -- I also want to point out how Grokster warned against trenching on regular commerce, and that is exactly the situation here because the regular commerce we're talking about here is commerce that's encouraged by Congress. It's -- it's Section viii skinny-label products. And as a practical matter, under the decision below, you can get FDA approval of your skinny product label, but as soon as you put that product into commerce and you say anything about that product, anything, you call it a generic version, even if you have 1 disclaimers, you can be sued. And that lawsuit will survive a pleading challenge. And that sends a -- a terrible message to the generic industry. Hatch-Waxman was designed to resolve patent disputes before a product launch for the -- for the reason that it's the -- it's an economic reason. Once a generic launches its product, its profits will be much, much lower than the brand's profits. And so, if the generic gets hit for a lost profits damages award, it's devastating. This happened in the GSK case with Teva, and Teva got hit for hundreds of millions of dollars that dwarfed its actual profits. And that is what the decision below is encouraging, and that's why we -- we are urging the Court to reverse.
Anything else? Anything else? No? Thank you, counsel. Mr. Stewart. 25 1 ORAL ARGUMENT OF MALCOLM L. STEWART FOR THE UNITED STATES, AS AMICUS CURIAE, SUPPORTING THE PETITIONERS
“This is a purely procedural utterance involving the transition between speakers in oral argument. The Justice is wrapping up one counsel's time and introducing the next speaker, which is standard administrative court management with no emotional valence.”
Thank you, Mr. Chief Justice, and may it please the Court: I'd like to begin with two very brief observations. The first point is that although the Federal Circuit appropriately said that the label itself was not sufficient to get Amarin past 12(b)(6) in this case, we think the court of appeals erred in giving any weight at all to the label. The contents of a Hatch-Waxman skinny label are largely dictated by federal law, and to treat the generic manufacturers' compliance with those requirements as any evidence of intentional inducement to infringe would be wrong. The second thing is, when Respondents explain in their brief why they sued Hikma but haven't sued any of the other generic manufacturers of icosapent ethyl, their explanation is all of those other manufacturers included in press releases express disclaimers to the effect that their product is not 1 authorized for use to treat the CV indication. But it's a bedrock principle of inducement law that active inducement to infringe is required. The question is not whether the defendant has adequately warned people away from infringement. I welcome the Court's questions.
What would Respondent have to have alleged to survive a motion to dismiss?
“The Justice is asking petitioner's counsel to define what adequate pleading would look like, which is an exploratory question probing the legal standard being argued. This reflects genuine intellectual engagement and clarification-seeking about the boundaries of the petitioner's position, without clear hostility or skepticism.”
I think they would have had to --
In your world, not the Fed Circuit's world.
“The phrase 'In your world' signals skepticism by drawing a sharp distinction between the petitioner's position and the Federal Circuit's ruling, implying the Justice finds the argument idiosyncratic or potentially problematic. The slightly dismissive framing edges toward mild hostility, though it also serves a clarifying function by pinpointing which legal framework is being invoked.”
In -- in our world, the Respondent would have had to -- to identify statements or actions that had the clear purpose of induce -- of causing others to infringe as something that the -- the brand wanted to bring about. The Court in Grokster said it was with reference to copyright, but it was drawing on copyright -- on patent law principles. The Court said one who distributes a device with the object of promoting its use to 1 infringe copyright, as shown by clear expression or other affirmative steps taken to foster infringement, is liable for the resulting acts of infringement by third parties. And so they would have needed to point to statements or actions that clearly revealed a purpose to induce infringement.
What role -- what impact is it that occurs in states that encourage the use of the generics for the patented use? What does that have on the problem that the Respondent is having?
“The Justice is probing the practical implications of state policies encouraging generic use on the respondent's situation, combining genuine clarification-seeking with some concern about real-world impact. The question appears to be exploring a complicating factor in the case rather than directly challenging or approving the petitioner's argument.”
I mean, I -- I think one of the principles that emerges from this Court's cases and from Cox most recently --
No, I don't mean on this. I mean with the problems of the -- of the unpatented, the generic being used for uses that are still patented by Respondent.
“The Justice is correcting a misunderstanding and redirecting the counsel's attention to a specific issue about unpatented generics being used for still-patented uses, which is primarily a clarifying move. There is also an element of concern about the implications of this patent overlap problem.”
I mean, the preliminary point I would make is the perceived difficulty or the actual difficulty of going after the direct infringer or getting the direct infringement to start -- to -- to stop is not a justification for watering down inducement 1 principles. Now there are other things that Respondents could try to do and some of them they have tried to do. They sued Health Net in this case, and they separately alleged that the health insurer, through its reimbursement policies, was encouraging pharmacies to fill the drug fully.
But aren't some states doing that too?
“The 'But aren't...' phrasing signals mild skepticism, challenging the petitioner's implicit distinction between state and federal/other actors. It probes a potential weakness in the argument by suggesting the premise may not hold exclusively, while also carrying some genuine clarifying and exploratory curiosity.”
I mean, states certainly have these generic substitution laws. And I'm not sure to what extent states are regulating the health insurers, but, certainly, Amarin and similarly situated companies could urge state legislatures to take measures to prevent this from happening. The other thing they could do, I understand they don't want to sue the doctors, but they could attempt informational campaigns to doctors and tell the doctors our product is the only one that is authorized to be used for the CV indication. It would be infringement of patent to administer icosapent ethyl for the purpose of reducing cardiovascular risk. 1 And the doctor really is in the best position of any other -- any single actor to say for what purpose am I prescribing the drug and at least in theory could figure out is there a patent on one method of use and adjust prescribing practices accordingly.
I understood that the test that you articulated is that the -- what was required is that the generic person clearly reveal a purpose of infringement, is that --
“The Justice is restating and confirming their understanding of counsel's articulated legal test, using language like 'I understood that' to verify comprehension. This is a classic clarifying question seeking confirmation of the standard being proposed.”
Act -- acts or messages that reveal a clear intent to encourage infringement.
That's a pretty broad safe harbor. I mean, you really just have to have, you know, a seminar on your first day of work and say whatever you do, don't -- don't do that. It's pretty easy -- it -- it's a pretty high threshold -- or low threshold.
“The Justice is skeptically challenging the breadth of the proposed safe harbor, suggesting it would be trivially easy to satisfy (just a first-day seminar), which implies the standard is too low and potentially inadequate. The somewhat sarcastic, rhetorical framing signals skepticism about the petitioner's position, with concern about the practical implications of such a broad protection.”
I -- I mean, it is supposed to be a -- a difficult standard for the pleader to satisfy, but I think that's for design. That is, the Court has said in various 1 contexts that when a product is capable of both infringing and non-infringing use -- uses, it's important that a patent on one method of use not become a de facto monopoly on the product as a whole. And so it's supposed to be feasible for people in Hikma's position to market their product for the unpatented use without running afoul of liability for third parties who choose to use the product in infringing ways. Unless they have affirmatively encouraged that to be done, the mere knowledge that it will be done or the expectation that some people will infringe is not enough.
And the risk of liability and what it could do to a generic, I would think, would be pretty significant.
“The Justice is expressing worry about the practical consequences of liability exposure for generic drug manufacturers, signaling concern about potentially negative downstream effects. The phrase 'would be pretty significant' indicates the Justice is troubled by the implications of the argument being presented.”
It's very substantial in part because the generic is charging a lot -- typically, a lot less for the drug than the brand-name manufacturer is. And so, if the generic has to pay lost profits to the -- the brand name, the profits that the brand name would have earned on a particular volume of sales would -- would be much more than the 1 generic has actually earned.
And the product is substantially similar. I mean, that's why it's a generic. So, in other words, there's no defense that, well, we really have a different product here. We -- it's -- it's the generic of the drug, and so, if they're also liable absent active inducement for people taking their generic and using it in an infringing way, you would think that could happen a fair amount, and it would really be a risk to the bottom line of this generic company.
“The Justice appears genuinely concerned about the practical business implications for generic drug companies if they face liability without active inducement, noting the substantial similarity of generic products eliminates product-differentiation defenses. The utterance explores the downstream consequences of broad liability rules, combining concern about negative outcomes with engaged intellectual exploration of the issue.”
Yes. I mean, there -- there is an intimation -- more than an intimation in the Respondents' brief that Hikma was doing something wrong by describing its drug in press releases as a generic version or a generic equivalent of Vascepa. But, in fact, that's a normal thing to say. It really refers to two different things. One of them is, under the abbreviated new drug application process, the generic comes on the market not by conducting independent studies of safety and efficacy but by showing that it is equivalent to a drug that's already been found 1 safe and efficacious. And so, when Hikma says we're the generic version of Vascepa, they just mean Vascepa is what's called the reference listed drug. It is the drug as to which we established equivalence in order to get approval. The second thing is that the patents in these cases refer to methods of reducing cardiovascular -- risk of cardiovascular events or cardiovascular death, and the method they describe is the use of what the patent refers to as ethyl icosapent in various ways, a series of steps with certain types of patients. And everybody agrees, if Hikma's drug is used to reduce the risk of cardiovascular death or events through the performance of those steps, infringement will occur. The reason that's so is that Hikma's drug is ethyl icosapent. It's the same stuff. And it's the same stuff for infringement purposes, but it's also the same stuff for describing the product.
Can you explain the United States' concerns about the broader market implications of the decision?
“The question uses 'Can you explain,' which is a classic clarifying request seeking elaboration. However, the reference to 'broader market implications' suggests some concern about consequences, and the intellectual curiosity about the government's position adds an engagement dimension.”
I mean, I think we would divide the -- the -- what the Federal Circuit relied on into three categories. The one we were most concerned with was the skinny label because all of the things that Amarin is complaining about are things that were on the brand name's label, and the rule is the generic is supposed to use the same label as the brand unless there's a good patent-specific reason to take things off. And so the Federal Circuit, I think, thought it was being limited by saying the label by itself is not enough to get past 12(b)(6), but the flavor of its opinion was this is almost enough, and if you have some pretty ethereal stuff at the -- in addition, that will be enough to get you over the hump. And we think it shouldn't have attached any weight to the label. Hikma just did what it was supposed to do. And then the second thing is the description of the -- Hikma's generic product as the generic version --
I understand that, but the interest -- the implications of the 1 decision in the marketplace at large, I understood -- do you want to speak to that or not speak to that?
“The Justice is acknowledging the counsel's point while redirecting attention to broader marketplace implications, showing some concern about wider consequences. The offer to let counsel choose whether to address the topic reflects a clarifying, procedurally considerate approach rather than hostility or strong skepticism.”
Yes. I mean, I -- I think the FDA's view is it is too soon to tell exactly what the effects of the Federal Circuit's decision would be on the willingness of other generic manufacturers to enter the marketplace. And, in part, I assume that generics are waiting on this Court's decision in this case, but we certainly think that if the Federal Circuit's analysis were affirmed, that it would create a substantial disincentive to entering the generic market.
Your point -- no, go ahead.
“This is a brief procedural exchange where the Justice begins to interject, then yields the floor back to counsel. It carries no substantive emotional valence and is essentially administrative in nature.”
What if Hikma -- Hikma had -- had not just said its drug is generic Vascepa but went on to say that Vascepa is approved to treat cardiovascular risks?
“The Justice is positing a hypothetical variation of the facts to explore where the line of liability might be drawn, indicating intellectual engagement with the legal question. The modification of the scenario (adding explicit approval language) suggests the Justice is probing the boundaries of the argument rather than expressing hostility or strong skepticism.”
I think if it had said those two things in the -- in the same breath that you would have a pretty strong case of active inducement, that it would not take much 1 work to connect the dots that this is something Vascepa has been approved for and ours is the same stuff.
What if it had said studies have shown that icosapent ethyl, the active ingredient in our drug, reduces cardiovascular risks?
“The Justice is posing a specific hypothetical variation of the advertising claim at issue, exploring how a slight change in wording might affect the legal analysis. This is classic intellectual engagement—testing the boundaries of the argument through a 'what if' scenario rather than challenging or doubting it.”
I think that would be problematic as -- as well, although probably closer to the line, but one thing I would say about the label is, when Hikma prepared its skinny label in conformity with the rules, kind of the most obvious thing it took off of Amarin's label was the indication at the beginning. But a second thing that it took off of Amarin's label was, in the clinical studies section of Amarin's label, Amarin summarized the results of what they call the REDUCE-IT study, which was designed to test the efficacy of the product for reducing cardiovascular risks, and the study concluded that Vascepa was efficacious for this purpose. And --
I -- I see your red light is on.
“This is a purely procedural statement indicating that counsel's allotted time has expired, with no emotional valence or substantive legal content whatsoever.”
Justice Alito? Justice Sotomayor?
I asked the same question of you that I asked of Petitioners' counsel. Do we need your new definition that you gave the Chief or saying again that following the label alone, exactly what the Federal Circuit said, is not enough? Do we need any special rules --
“The Justice is pressing the respondent's counsel with the same question posed to the other side, challenging whether any special rules or new definitions are actually necessary beyond what the Federal Circuit already said. This combines genuine clarifying intent with skeptical probing about the need for the respondent's proposed legal framework.”
-- for Petitioner to win?
“This appears to be a fragment of a larger question asking what is necessary for the petitioner to win, which is a clarifying inquiry seeking to understand the standard or requirements. The partial nature suggests it's mid-sentence, likely probing the petitioner's legal theory in a genuinely exploratory way.”
I -- I don't think you need special rules. I -- you are interpreting Section 271(b), which is not specific to Hatch-Waxman. It's just the general inducement provision. And we think application of the general rules is sufficient.
And then, finally, 1 there's a whole lot of discussion about congressional policy, both in your brief and in Petitioners' brief, that they wanted to encourage this, and we should rule that what active infringement means in patent law is very narrow because of that. I always have problems when we use policy reasons to set a standard.
“The Justice expresses a principled methodological skepticism toward using policy arguments to define legal standards, signaling doubt about the validity of the policy-based reasoning in both briefs. The phrase 'I always have problems when we use policy reasons to set a standard' is a clear indicator of skepticism and mild concern about judicial methodology, without rising to outright hostility.”
That's not our job. If they're infringing a patent, they're infringing a patent. If they're not infringing a patent, they're not. But why should we change our rules, narrow them or expand them --
“The Justice firmly asserts 'That's not our job,' signaling strong pushback and resistance to the petitioner's argument about changing existing rules. The declarative, somewhat dismissive framing and the challenge 'why should we change our rules' reflects both skepticism toward the argument's premise and a degree of hostility in rejecting the Court's role as framed by counsel.”
-- to avoid either result?
“This appears to be a fragment of a longer question asking counsel how to avoid two undesirable outcomes, suggesting the Justice is probing for a solution or middle ground. The clarifying and engagement tones dominate as the Justice seems to be genuinely exploring the argument's logical structure.”
I -- I basically agree. I don't think it's a main -- matter of changing the rules. We have described the Hatch-Waxman scheme at some length because it's pretty complicated. But, in the end, Hatch-Waxman embodies the same basic principles as the Patent Act generally; namely, if you sell something that can be used either in an 1 infringing or a non-infringing way, then you still won't be held liable for others' infringement unless you've actively encouraged them to infringe.
That's the bottom line, correct? Thank you.
“The phrase 'That's the bottom line, correct?' is a brief confirmatory/clarifying question seeking agreement on a summary point, followed by a polite 'Thank you,' indicating a procedural close to the exchange. The overall tone is neutral and administrative with a slight clarifying element.”
Mr. Stewart, your point about not looking to the skinny label in a suit like this, I guess the reasonableness of that depends on how much patent review the FDA is doing when it approves the skinny label. So what's the answer to that question?
“The Justice partially acknowledges the petitioner's point ('your point about not looking to the skinny label') while immediately conditioning its reasonableness on an empirical question about FDA patent review, suggesting both genuine inquiry into the factual premise and mild skepticism about whether the argument holds up under scrutiny.”
I mean, I think the -- the Court discussed this in Caraco. The FDA has disclaimed patent expertise, and so it doesn't purport to read patents and determine what conduct would infringe them. But Respondents suggest that the result is we take the generics' word for what is and isn't infringing. And I think that that's not correct. As the Court explained in Caraco, the brand-name manufacturer will provide for the Orange Book what's called a use code, which will describe what it believes its 1 patents cover, and the FDA considers itself bound by the use code. And so, if the brand name is saying this wide range of uses would be patented, the FDA won't look behind that. There is a counterclaim mechanism by which the -- the generic can obtain judicial review of that determination -- of the brand's behavior in a suit between the two private parties. But the -- kind of the bottom line is, here, there was really no dispute about what was patented. If there had been a dispute, FDA would have deferred to the brand's own description of what its patent covered, and then the question would just be, has the generic carved out enough of the label to excise references to the patented use? And what I was saying before about the clinical studies, although Amarin's label had a description of the REDUCE-IT study that was about efficacy of the drug for treating cardiovascular -- or preventing cardiovascular events, Hikma omitted that from its own label. So it didn't just omit the indication. It omitted another part of the label that referred 1 to the efficacy of the drug for that purpose because the purpose was still patented.
Justice Gorsuch, anything further? Justice Kavanaugh? Justice Barrett? Justice Jackson?
“This is a purely procedural utterance where the presiding Justice is polling colleagues for additional questions. It contains no evaluative content, emotional valence, or substantive legal engagement whatsoever.”
Can I just ask you, what -- what is the relevance of the state laws that you cite permitting or requiring substitution of generics for brand-name drugs in this context? I would think those would be relevant to an Amarin lawsuit maybe against a third party, but I don't know why they matter here.
“The Justice is questioning the relevance of an argument the petitioner is making, signaling doubt about its applicability ('I don't know why they matter here'), while also genuinely seeking to understand how the argument fits the current context. The combination of probing the logic of the argument and requesting clarification reflects both skepticism and a clarifying intent.”
I -- I mean, I think the Court can decide the case without referring to them. The -- we had two basic reasons for including some discussion. The -- the first was we didn't want the Court to decide the case based on a misimpression of the facts or the way the world works. And I think portions of the court of appeals opinion are written as though, in -- in each case, the doctor who's 1 writing the prescription determines which version of the drug will be dispensed and that will carry the day. And we wanted to explain, in the real world, it's more complicated than that. And -- and kind of conceivably in some future case, that could matter given the way it was pleaded because you'd have to show, in light of these laws, how is it plausible that what we said would cause somebody to infringe.
Mr. Huston. ORAL ARGUMENT OF MICHAEL R. HUSTON ON BEHALF OF THE RESPONDENTS
“This is purely a procedural announcement introducing the next counsel to argue, with no emotional valence or substantive content whatsoever.”
Mr. Chief Justice, and may it please the Court: The implications of this Court's ruling in this case will go far beyond the pharmaceutical industry. This is not really a Hatch-Waxman case at all. It's not really a skinny-label case. Hikma got the full benefit of the 1 Hatch-Waxman compromise when it was permitted to sell its product for FDA -- with an FDA approved skinny label as a treatment for severe hypertriglyceridemia. But, in exchange, Hikma was required to promise not to promote its product for any still patented use of Amarin's branded drug. That limitation on generic marketing of their products is absolutely vital. It is the only thing that makes it economically rational for a branded company like Amarin to spend the $300 million that Amarin spent in the REDUCE-IT trial to discover that an existing drug, Vascepa, actually had life-changing implications to treat cardiovascular risk. And that rule of induced infringement liability is not unique to pharmaceuticals. This Court's interpretation in this case will be of Section 271(b) of the Patent Act. That is the statute that protects all patented innovations in this country of whatever kind. The standard for induced infringement liability is settled. In most cases, the key dispute is going to be whether the defendant 1 had the requisite intent to infringe. But Hikma has not contested its intent as this case comes to the Court because the case is at the pleading stage. Nor has Hikma disputed that there was substantial direct infringement of Amarin's patents using Hikma's product. So the only element that's in dispute here today is whether it is plausible that Hikma took active steps to encourage that infringement. It is plausible. There are seven other generic manufacturers of icosapent ethyl on the market, but Hikma alone was the one who described its product as AB rated for "hypertriglyceridemia," even though that product is not approved for that distinct medical condition. Hikma alone repeatedly used Amarin's brand name, Vascepa, just at the moment when that name was synonymous in the market with treating cardiovascular risk. Those statements and more by Hikma that other generics did not use state a plausible claim. I welcome the Court's questions.
Was there anything 1 inaccurate about that statement?
“This pointed question challenges the respondent to find fault with a prior statement, suggesting the Justice believes the statement was accurate and is probing the respondent's position. The rhetorical nature leans toward skepticism, though it could also be genuinely clarifying the accuracy of facts.”
Yes, there absolutely was, Your Honor. And I want to just say for -- it was inaccurate. I also don't think, frankly, it matters whether it was inaccurate. A statement can be absolutely true. Imagine a statement that Hikma said you can use and should use our product to accomplish exactly the same medical purposes as Vascepa, including cardiovascular risk, the kind of example that I think Justice Alito gave to my friend, Mr. Stewart. And I heard Mr. Stewart say that would state a claim for induce -- a strong claim for induced agreement. I agree with that. So truth is not a defense to liability in an induced infringement situation.
So what if they simply quote you?
“The brief hypothetical 'what if they simply quote you?' appears to be an intellectually curious probe exploring the boundaries of the respondent's argument, likely testing edge cases. It has elements of both clarification and engagement, with mild concern about implications, but lacks strong skepticism or hostility.”
I think they can't -- they cannot do that, Your Honor, because the whole point of the compromise is that Hikma is allowed to market its product but only for the unpatented use, only as a treatment for severe hypertriglyceridemia. 1 If Hikma comes on and quotes Amarin's marketing of its product to treat for the patented purpose, that's the most classic case of induced infringement. That's like the literal textbook definition of induced infringement. I -- I also do think it's important to say, though, that the -- the key statement on which we rely here, the statement on Hikma's website where it described what its drug is for, was not accurate. Hikma said its product was for treating hypertriglyceridemia. That's misleading, if not false, because Hikma's product was approved by FDA only to treat severe hypertriglyceridemia, and that's a distinct medical condition that presents distinct medical risks.
Well, if that's your best piece, and I think it probably is, that website, what do you do with -- there was a further disclaimer on the website saying that the product was -- Hikma's generic version is indicated for fewer than all approved indications of the reference listed drug?
“The phrase 'if that's your best piece' signals skepticism about the strength of the respondent's argument, suggesting the Justice doubts the website evidence is sufficient. The follow-up about the disclaimer further probes a potential weakness in the argument, though the question also has a clarifying dimension in seeking to understand how the respondent handles this contrary evidence.”
Sure, Your Honor. So two 1 points about that disclaimer, which is at JA 195. First, as you can see even on the blown-up version in the Joint Appendix, it really appears in quite tiny print, but even if the -- even if somebody read it, even if they saw the disclaimer, just as Your Honor read, all it says is Hikma's product is approved for fewer than all uses of Vascepa. It doesn't disclaim that Hikma's product can and should be used to treat the most famous use of Vascepa, the billion-dollar use, which is saving patients' lives by treating cardiovascular risk. So there's nothing -- the disclaimer is, I think, at best, carefully worded, it's sort of written by a clever lawyer to try to minimize Hikma's liability while still sending the fundamental message that is coming across by all the collection of Hikma's statements that says doctors can and should prescribe Hikma's product anytime they would prescribe Vascepa, including to treat cardiovascular risk, in a way that infringes Amarin's patents. So I --
I just think having rang the bell, Your Honor, having repeated -- when Hikma has come on to the market repeatedly and said we are generic Vascepa, generic Vascepa, generic Vascepa, a billion dollars in sales, our product is for hypertriglyceridemia, having made all of those offensive statements that are calculated that have the intent to induce infringing sales, that tiny little sort of cleverly worded disclaimer I don't think is sufficient to pull that back.
Mr. Huston, I just wondered, if you -- you started in your opening talking about the impact of this case that would be more broad, that it would extend beyond just the pharmaceutical industry. It seems to me this is a pretty fact-bound case about the plausibility standard. I don't know that we have to -- to reach any kind of greater issue. So do you see the case that way? Is this just kind of applying Twiqbal to this particular complaint?
“The Justice is gently pushing back on counsel's framing of the case as having broad implications, suggesting it may be a narrower, fact-bound application of the Twiqbal plausibility standard. The tone is curious and clarifying rather than hostile, essentially inviting counsel to reconsider the scope of the case while also signaling the Justice's own tentative view that the case may not need to reach broader issues.”
I do see the case that way, Your Honor. We -- we -- that's what we argued in our brief in opposition. 1 And I think that it's not this Court's typical practice to grant a case that asks merely whether the facts as pleaded under the -- you know, a settled legal standard states a claim. All that said, you know, of course, we -- we -- we -- we continue to think, and I -- I do want to think -- I do think it's very important to say, it is important, as I think the -- was the premise of Justice Sotomayor's questions, that the Court not adopt a new induced infringement standard with words like express promotion is required. I -- I -- I can't -- I just can't understate the extent to which that would be a transformation of the scope of patent law. So, if the Court is going to simply apply Twombly and Iqbal to the facts of this case, and I -- I do think that's the right approach to the case, then I continue to think that the key question in the case is in -- in -- as in most cases of induced infringement, what was the message that the doctors who read these Hikma statements took away? And that's typically a fact question.
I -- I agree that's the key question, it is a fact question, and, you know, Justice Alito observed the other day, I'm not sure why this case is here except four of my colleagues wanted it to be. But, if it is a fact-bound question, what I'm asking is, if the case is as you just described it, what's the broader impact? You know, in -- in your -- are you talking about broader impact solely if we reached some new rule?
“The Justice begins with partial approval ('I agree that's the key question'), but then expresses subtle frustration about the case being at the Supreme Court level (suggesting it may be fact-bound and not cert-worthy), while simultaneously seeking clarification about the broader impact of the argument. The mix of agreement, mild skepticism about the case's presence before the Court, and genuine inquiry about scope makes this a multi-layered utterance.”
Yeah. No, I -- I'm totally --
Let me -- I appreciate the opportunity to clarify. If the Court says that even though this case is at the pleading stage, even though it's only a plausibility pleading standard, these allegations of intentional -- intentional statements by Hikma where intent is undisputed, that that doesn't even state a claim for relief, I do think that's going to have serious implications. It's going to make it much, much harder to plead induced patent infringement. 1 And I think that's going to have implications both in the patent space more generally but even in the pharmaceutical space because, as I mentioned, if -- if -- if a -- if a branded drug like Amarin cannot get any kind of protection for a new -- this newly discovered use of its existing drug, it would just be economically irrational to make that kind of investment that discovers a lifesaving cure. And I think that's what we are really fighting for in this case, is the opportunity to say: We spent five years, we spent $300 million, and we discovered something that is literally saving people's lives. Hikma wants to come and, having spent no money basically at all, try to capture all of those gains. The patent law doesn't allow them to do that. They are allowed to sell their product for the unpatented use. But, when we have discovered this game-changing "new use," Hikma can't come in and try to capture those -- those -- those sales. That's what it did with its repeated statements by calling itself generic Vascepa over and over again by mis --
-- would you contest, Mr. Huston, that these press releases were really issued for investors, that they had nothing to do with -- this was not the way the company marketed itself to doctors?
“The Justice is probing whether the press releases were investor-directed rather than doctor-directed marketing, challenging the respondent's likely characterization of their purpose. The phrasing 'would you contest' signals skeptical pressure on a factual premise, while also seeking clarification on the specific nature and audience of the communications.”
I -- I would contest that, Your Honor, especially because we're at the pleading stage, where all inferences that are fair have to be taken in our favor. I think Hikma's claim that these were directed at investors is really just grounded in the fact that there's a "Contact Us" section of the press release that allows you to get in touch with the investor relations team, in addition to other kinds of, you know, phone numbers provided. So they're not consciously directed at investors, not expressly directed at investors. And I think two other points about that. First, Hikma spread these messages far and wide. It wanted --
I mean, is there any evidence at all that Hikma directed these to -- 1 to the medical community, that Hikma gave these press releases to doctors?
“The phrase 'is there any evidence at all' signals strong skepticism about whether the factual basis exists for the respondent's argument regarding Hikma's press releases being directed to the medical community. The Justice is probing the evidentiary foundation while also seeking clarification about what actually occurred.”
So I think the answer is yes in the sense that these -- this is advertising, Your Honor, which is, as Grokster said, a classic form of induced infringement since common law. Hikma, the -- our allegations are -- we don't have evidence; we're at the pleading stage -- but the allegations we have are that Hikma took these press releases and intentionally attempted to make them get distributed as far and widely as possible. It did want doctors to see these things. And evidence has come in in other cases where doctors have testified that they do pay attention to press releases and that they do pay attention to the announcements of when generics are coming online, and those kinds of announcements do affect doctors' prescription decisions. So that's all evidence that, you know, we're going to put on -- you know, that -- those -- we're going to use the Federal Circuit's established standards for pleading 1 induced -- or for proving induced infringement claims. It only has to be plausible at this stage. And I don't think it's a fair inference -- I don't think you can say the only fair inference from Hikma's statements is that they were directed solely at investors and were not going to reach doctors.
But I guess, to your initial statement when you started out saying this is not a Hatch-Waxman case at all, I think you said that, and to why this case is here, because I'm glad it's here, the federal -- Congressman Waxman filed an amicus brief. And I don't want to put too much faith in a former Congressman's brief about his own statute, but it says, "the Federal Circuit's decision threatens to decimate the compromise at the heart of the Hatch-Waxman Act, which, in turn, threatens to undermine the generic pharmaceutical industry if this kind of complaint's good enough." And it points out, you know, "generics have saved 3.4 trillion over the past 10 years, but the Federal Circuit's decision here leaves generic drug companies in the dark about what might expose 1 them to liability." All of which is to say I think the question is, you know, if this is good enough, then that's going to have some serious implications market-wide.
“The Justice expresses significant concern about the broader market implications of the Federal Circuit's decision, citing the Waxman amicus brief about potential decimation of the Hatch-Waxman compromise and generic drug savings. The statement 'I think the question is...going to have some serious implications market-wide' signals worry about systemic consequences rather than direct skepticism of the argument itself, though there is some engagement in exploring the issue intellectually.”
So, Justice Kavanaugh, maybe two or maybe three points if I might in response to that. First, when we say "if it's good enough," all we mean is good enough to get out of the starting gate, to get into discovery, where we're going to have the opportunity -- we're going to be held to the burden to prove everything that we allege. That's the first point. The second point about Hatch-Waxman is that the reason it's named Hatch-Waxman, of course, is that it was a fundamental compromise, and on the other side of that compromise was about protecting the need to encourage branded drugs to take existing products and invest massive resources to discover how those drugs can be used for new cures. The dark green briefs are replete with 1 examples of situations where that has happened. It can only happen, it's only economically rational to occur, if they can get patent protection for that subsequent use.
And then I think the last --
I don't dispute that there's a compromise. I was just making the point that, you know, I take it seriously when someone says this is upsetting the compromise.
“The Justice is expressing genuine concern about upsetting a legislative or constitutional compromise, while also partially validating the opposing argument. The tone is measured and serious, acknowledging the weight of the compromise argument without fully endorsing or challenging either side.”
Well, I think the -- the -- the last reason why the Court can have confidence that that is not going to come to pass, Your Honor, is the example of the many other generics who sell the very same product that Hikma does, and we haven't sued any of them. And you can look at what they say on their press release to know that generics have a ready roadmap to avoid induced infringement liability. All they have to do is accurately describe the limited purpose for which their drug is approved. 1 So, for example, Camber, one of the other generic manufacturers, it says, "Camber's press release is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia." It doesn't talk about generic Vascepa. It doesn't talk about the volume of sales of Vascepa and say this is a billion-dollar revolutionary drug. It doesn't say that it is in a therapeutic category of hypertriglyceridemia. And, again, that's a different medical condition. So Camber, Zydus, Dr. Ready's, they all -- none of them do the things that Hikma did.
Are you just saying --
“This appears to be an interruption mid-sentence, which research associates with hostility, but the phrasing 'Are you just saying' more strongly suggests the Justice is attempting to distill or paraphrase counsel's argument for clarification. The fragmentary nature makes definitive classification difficult.”
-- just -- are you just saying generic Vascepa would be enough?
“The Justice is seeking to pin down and clarify the respondent's precise argument—whether generic Vascepa alone would suffice—without any apparent hostility or skepticism. The repetition of 'just' signals a genuine attempt to simplify and confirm understanding of the position being advanced.”
I do not think, Your Honor, that merely saying one time generic Vascepa is enough to state a claim for liability. And that's not our allegation. Our allegation is that Hikma said it over and over and over again and that they did it at just the 1 key moment where there was a market -- a market -- key market association between Vascepa and treating cardiovascular risk. That was the context. Grokster says, of course, that induced infringement is a context-dependent analysis. That was the context into which Hikma launched these statements over and over and over again. But I take the point. I'm certainly not here to say that a company that one time says generic Vascepa is going to be held liable. As the Federal Circuit held, Hikma did much, much more. It made statements that no other generic manufacturer --
But, counsel, I guess it -- it seems to me you -- you do emphasize that we're talking about plausibility and this is early in the case and we're at the motion-to-dismiss stage. But that does highlight what has to be plausible, what is the focus of this. And the government here, the SG, says what we're looking for is an intent on the part of this manufacturer to be inducing people or to have doctors be using this drug for the 1 patented purpose. Your standard, as far as I can tell, is more just what message would the doctors have taken away from the marketing materials. And, as Justice Kagan pointed out, at least some of these marketing materials, I think, were directed to investors. So the -- if the intention of the generic is to mention Vascepa and the size of the market, et cetera, et cetera, for the purpose of getting investment, not for the purpose of inducing doctor infringement, what do we do with that in terms of understanding whether active inducement liability lies?
“The Justice is probing the respondent's legal standard by contrasting it with the government's stricter intent-based approach and highlighting a specific factual problem (investor-directed marketing materials), signaling doubt about the sufficiency of respondent's 'message received' standard. There is also concern about the broader implications of how to categorize marketing materials aimed at investors rather than physicians.”
A couple points about that, Justice Jackson. I think the first is that, of course, at this stage of the case, your own -- you can't just take Hikma's assertion that, oh, we put out that press release for the purpose of talking to our investors.
No, but it's your burden if we are supposed to be looking for intent. And I guess that's why I think we do have to kind of focus on what the legal 1 standard is here. If -- if -- if we are looking for intent to induce infringement, then I would think it's your burden to actually have statements and evidence that go to that. And if we look at those statements and we say, yes, we see them, but, really, those statements that you point to are indicative of an intent to encourage investors, then why have you stated enough of a claim in this circumstance?
“The Justice is pressing the respondent on whether they've met their burden of proof for showing intent to induce infringement, challenging the sufficiency of their evidence and questioning whether their cited statements actually demonstrate the required intent. This is primarily skeptical, probing the weakness of their claim while also showing intellectual engagement with the legal standard at issue.”
I understand the question, Your Honor, but I -- I -- I want to stress the Federal Circuit found that it was undisputed -- that's their word -- that in -- Hikma did not contest the requisite intent. That's at Pet. App. 15a. Hikma's motion to dismiss in this case did not say, unlike most other skinny-label cases where intent, along the lines of Your Honor's question, would very much be the focus and where I'm sure Hikma at trial will attempt to -- to prove exactly the kinds of things that Your Honor --
But is -- is the Federal Circuit right about that?
“The Justice is directly questioning the correctness of the Federal Circuit's ruling, signaling doubt about the lower court's holding. The phrasing 'But is -- is the Federal Circuit right about that?' with its halting repetition and use of 'But' suggests probing skepticism toward the respondent's position as supported by the Federal Circuit.”
I don't know that we can disaggregate. I mean, they've -- they -- they might have -- Hikma might have said, we're not really focused on our intent to induce something or our intent to have people buy more of this product. But, if the active inducement element of this is what we're all focused on and active inducement requires an intent to induce doctors to use this product, then I don't know that their concession about intent really covers this particular circumstance.
“The Justice is probing the adequacy of Hikma's concession about intent, questioning whether it truly covers the active inducement element at issue. This reflects both skepticism about the argument's logical coherence and intellectual engagement as the Justice thinks through the disaggregation problem aloud.”
So, Your Honor, I mean, the Court has always talked about those as distinct elements of induced infringement. There are three elements. There has to be direct infringement. Somebody has to do the infringing. And then the inducer has to both have the intent that that happen and take active steps.
I understand, but the United States today said the active inducement -- active steps prong of this is statements and acts that are -- that 1 demonstrate an intent to induce the doctors. So they brought intent into the very element we're talking about here.
“The Justice is pointing out that the government's own framing introduces intent into the element being debated, which serves both as a clarifying observation and a mild challenge to the respondent's position. The tone suggests the Justice is engaging with the legal argument while subtly noting a tension or inconsistency in the government's stance that may undercut the respondent's argument.”
There's no way to reconcile that conception of the -- of the standard with this Court's case after case after case --
So they're wrong about that?
“The terse, direct question 'So they're wrong about that?' probes the opposing party's position and implicitly challenges the respondent to confirm a contradiction, signaling skepticism. The brevity and pointed framing suggests doubt-testing rather than genuine clarification, though a mild clarifying element remains possible.”
They're just distinct elements --
-- and the intent element isn't part of this case at this stage.
I -- I'm sorry to interrupt. Go ahead and finish.
“This is a purely procedural, courteous remark where the Justice apologizes for interrupting and invites counsel to continue speaking. It carries no substantive judicial sentiment and is essentially administrative in nature.”
I'm just -- I just want to say that, I mean, the Court has always talked about them as distinct elements. The Federal Circuit found that Hikma had not contested the intent element. I think -- actually, I thought it was common ground between all of the parties that we're only here 1 talking about what constitutes active steps. These are active steps in the sense that Hikma put out statements. And then I think the only question we're left with is the one Justice Barrett flagged, which is how is a listener going to understand those statements? That's a fact question that's typically not suitable for resolution on summary judgment. That's the crux of our case. Justice? I'm sorry.
I'm not even sure I want to ask my question anymore, Mr. Huston. (Laughter.)
“This is a lighthearted, humorous remark that prompted laughter in the courtroom, suggesting the Justice is reacting playfully to something the counsel said that may have preemptively addressed or complicated the planned question. The tone is casual and collegial rather than adversarial, with no clear substantive sentiment direction.”
Let me come at it this way. I understand your -- your -- your point about this case being a little different, but, you know, Twombly/Iqbal talking about whether you have an antitrust conspiracy versus maybe what is entirely rational independent conduct, right?
“The Justice is probing the argument by drawing an analogy to Twombly/Iqbal pleading standards, acknowledging the counsel's distinction while pushing back with a competing framework. The 'Let me come at it this way' signals intellectual engagement and reframing, while the rhetorical question about rational independent conduct introduces skepticism about the argument's strength.”
Are not to compete in one another's territory.
“This utterance appears to be a Justice completing or restating a point about territorial non-competition agreements, likely paraphrasing or confirming an understanding of the argument being made. The phrasing suggests a clarifying restatement rather than a challenge, possibly seeking confirmation or helping to crystallize the legal issue.”
It seems like a whole different world. At any rate, there, the question was, hey, everybody knows that they're not going into each other's territory, but it could be explained by two possible intents, and it was the burden of the plaintiff to rule out, plausibly rule out, the non-problematic intent. And I -- I think what Justice Jackson is getting at is, why isn't this case just like that? Why isn't that the question? I understand your point that, well, they didn't contest it, but it is your burden on -- on a motion-to-dismiss stage to -- to rule out that lawful intent, hey, this is puffery for investors, and this can be plausibly explained by -- by that rather than infringement.
“The Justice is actively probing the respondent's argument by drawing a parallel to a prior case and questioning why the burden-of-pleading standard shouldn't apply similarly here, signaling skepticism of the respondent's position. There is also significant engagement as the Justice intellectually explores the analogy and helps articulate what a fellow Justice's concern is.”
I think I would say two things, Your Honor. The first is that it -- it's -- it's very hard for me sitting here in the Supreme Court of the United States to put myself in what arguments we would have made if 1 Hikma in a motion to dismiss had said we want to contest our unlawful intent the same way the defendant in Twombly contested its intent. You're absolutely right. Twombly was an intent case. That was where all the action in the case was. Did the defendants have an unlawful intent? Hikma did not contest its unlawful intent at this stage.
So I just think it's a different -- but, I mean, the other -- the other point I would make is, though -- even that kind of intuition, even a -- if you -- if you think, okay, there's a -- there's an alternative explanation for the press releases, which is what -- that they were aimed at investors, that cannot explain Hikma's website, where it's described its -- it describes its product as a treatment for hypertriglyceridemia, the infringing use, instead of, as all the other generic companies do, as a treatment --
-- for severe hypertriglyceridemia use.
So here again, I think you're -- you can't -- even that conception of the case cannot carve out all of the allegations we have made, all of which add up together to support Hikma's unlawful intent and their active steps that have the effect of inducing infringement. And that is fundamentally what we're going to be held to the burden to prove, as in all other cases of induced infringement. We're going to show that the infringing sales of our product happened faster and to a greater degree than would have occurred had Hikma not made these statements. And so, again, I -- I understand the Court's concern about the idea that, you know, and I think my friends have attempted to say this is going to devastate the generics market. Nobody wants to devastate the generics market. But it's just factually not true. And the surest reason you can know it's not true is because there's seven other generics in this market selling this product who know how to market their product lawfully. 1 And all that Hikma needed to do was follow that path and they wouldn't be here, just like the other generics aren't here.
Mr. Huston, my sense of your papers in this Court as compared maybe to your papers below is that you've really dialed down your reliance on the skinny label. So could you tell me why that is if I'm right about that, and -- and more to the point maybe, what is your view of the relevance of the skinny label? Would you go -- would you accept Mr. Stewart's proposition that that label has no relevance? And, if not, why not?
“The Justice is genuinely seeking clarification about a strategic shift in the respondent's argument regarding the 'skinny label,' while also probing the counsel's position relative to opposing counsel's proposition. The tone is inquisitive and intellectually engaged rather than hostile, but contains mild skepticism in noting the change in reliance between filings.”
Sure. So, Justice Kagan, I would not accept Mr. Stewart's proposition that that has no relevance, and I think the -- I think the reason for that is that this Court is not accustomed in pleading cases and in Section 271(b) cases to saying there's a category of evidence that's sort of fundamentally off the table. That to me sounds like the creation of a safe harbor, and I think that's a legislative task fundamentally. Now, to be sure, Hikma has -- you know, I -- I don't think Hikma could be held 1 liable -- or, you know, I -- I -- I -- I think that there is a protection in the statute in Hatch-Waxman for -- for Hikma to prepare a skinny label. That's why, as the Federal Circuit said, the skinny label is not the heart of our case by any means. It is one piece of evidence.
Well, why should it be one piece of evidence?
“The question 'Why should it be one piece of evidence?' directly challenges the respondent's characterization or framing of a legal standard, probing why their preferred treatment is justified. The 'why should it be' phrasing signals doubt and pushes back on the argument's premise, making skepticism the dominant sentiment, with some clarifying intent as the Justice may also be seeking a reasoned justification.”
Sure. Because, again, I don't think that the Court has generally said there's sort of evidence that's off the table. But the way I think about the label in this case, because keep in mind the label comes factually later in time. So it's really at the moment that Vascepa is all -- getting all of this amazing press attention that doctors are prescribing it en masse to -- for -- to -- for the first time really effectively treat patients with severe cardiovascular risk. It's into that market that Hikma launches all of its offensive statements about generic Vascepa, billion dollars in sales, hypertriglyceridemia and the 1 like. Then it comes out with its label. And the way I think about the label is the label was an opportunity for Hikma to try to -- to sort of mitigate the damage from its unlawful statements and it didn't take it. And in that sense, I think the Hikma -- the Hikma label maybe -- you know, probably, arguably, exacerbated our harm. But that's the way I think about the label. It's -- it is definitely not the -- the key contention that we rely on because, again, it's not the thing that distinguishes Hikma from all the other generic manufacturers. They were -- it was -- those generics made all of these statements that Hikma did not make, and I think that's why they're here -- that's why they're not here and Hikma is. The label just was an opportunity missed by Hikma to try to control the extent of the infringement after they had already rang the bell. I think I just want to spend one moment if I might talking about where the Court would go from here if it found that this is a 1 Twombly/Iqbal case and that the allegations in the current complaint did not suffice to state a claim for relief. I think, as we described in our brief, the Court's far and away most common practice in that situation would be to vacate the Federal Circuit's opinion and remand. It would not be to enter the form of judgment in this Court that Hikma requests, which would be to sort of declare the case over. And I think that disposition, again, I -- you know, obviously, we -- we hope that you will agree that the -- the -- the -- the complaint here does state a claim, but in the event the Court didn't, it would be especially important for the Court to allow the case to proceed back on remand because, since the Federal Circuit remanded the case and since Hikma did not stay the mandate, extensive discovery has occurred. Millions of documents have been exchanged, 12 depositions have -- have -- have come -- have been taken, and that has revealed substantial new evidence of Hikma's intent to infringe and the effect.
So are you saying 1 you'd amend your complaint?
“The Justice is directly seeking clarification about the respondent's intended course of action, using a 'So are you saying...' construction that signals a genuine attempt to confirm understanding of counsel's position rather than challenging it.”
Absolutely, Your Honor. We would -- we very much want the opportunity to amend. That would normally be the course under the Federal Rules of Civil Procedure, and all I'm trying to say is I think the case for our opportunity to amend is even stronger here given that there -- you know, there's been a material change in the case since the Federal Circuit's opinion. We've uncovered all of this new evidence.
Well, Judge Andrews granted a motion to dismiss, right?
“This is primarily a clarifying question seeking to establish a factual procedural point about the lower court's ruling. The 'right?' tag at the end suggests the Justice is confirming their understanding of the record rather than challenging the argument, though there is mild skepticism implied in establishing the procedural posture.”
But -- and we successfully appealed that judgment, so --
I understand. I'm just talking about what happened in the district court.
“The Justice appears to be narrowing or redirecting the discussion to the factual record below, signaling a clarifying intent to focus on what actually occurred in the district court rather than broader arguments. The tone is measured and procedural with no strong emotional valence.”
That's right. And so, again, the case has the same posture as all the cases cited on, I think, page 51 of our brief. A district court judge grants a motion to dismiss. We elect to appeal that judgment. We 1 successfully appeal it. The Federal Circuit reverses. There is no stay of the mandate by my friends on the other side. The case returns to district court. Judge Andrews opens discovery. And we take substantial discovery, and discovery does its job. It reveals that exactly what we allege about Hikma's intent and the effects of their statements is true. And we haven't yet had an opportunity to bring that out, but, you know, obviously, in -- in this situation, we very much want that opportunity to bring that evidence. And what I don't think is supported is Hikma's sort of very unusual ask that this Court would simply declare case over and --
Well, we wouldn't -- we wouldn't enter judgment, but we would reverse and remand for further proceedings, consistent, and I would take it the Federal Circuit, that when -- that would then send it back to the district court. The district court would say, okay, the -- the motion to dismiss is granted, as I said many years ago now --
“The Justice is walking through the procedural mechanics of what would happen on remand, essentially thinking aloud about the case's procedural path. This is largely neutral/procedural in nature, with some engagement as the Justice works through the logical sequence of events, and some clarifying intent as they articulate the steps for counsel's benefit.”
-- and -- and you could -- you could then file a motion for leave to amend. Is -- is that about right?
“The phrase 'Is that about right?' is a classic clarifying question seeking confirmation of the procedural sequence described. The Justice is verifying their understanding of the process with no apparent negative or positive valence toward the argument itself.”
I -- I think that -- I think -- I think that's about right, Your Honor, with a slight tweak. I think, actually, what would happen probably is the Federal Circuit would remand and we would then go to the district court and he would say, you know, there's -- I'm supposed to have further proceedings consistent with the Supreme Court's opinion. What should those proceedings be? Our proceeding -- our requested proceeding is going to be an amended complaint.
Yeah, yeah, of course. You'd move, yeah.
“This brief, casual affirmation ('Yeah, yeah, of course') suggests the Justice is quickly agreeing with or acknowledging a point made by counsel, likely in the context of a hypothetical or procedural matter. The tone is informal and agreeable, with no adversarial content.”
And that's what Hikma -- all I'm saying is I think Hikma is trying to tell you --
-- we shouldn't have that right. And I just don't think anything in the law supports that.
I just want to make sure the way I described it is how you'd 1 foresee it.
“The Justice is explicitly seeking confirmation that their understanding matches counsel's position, which is a classic clarifying move. The phrasing 'I just want to make sure' signals a neutral desire for accuracy rather than skepticism or hostility.”
You agreed with Justice Gorsuch, right?
“This is primarily a clarifying question seeking to confirm or pin down counsel's position by referencing a prior concession or agreement made during the argument. The justice is likely trying to establish a baseline before probing further, though mild skepticism is possible if the intent is to highlight an inconsistency.”
I agreed -- I -- I agreed with -- I -- let me -- let me try to be as clear as I can. I --
I shouldn't have asked it. I'm sorry.
“This is a rare moment of self-correction and apology from a Justice, withdrawing a question they found unhelpful or poorly framed. It carries no analytical or argumentative weight and is essentially a procedural/social remark, making it predominantly neutral with very slight warmth toward counsel.”
I thought you agreed with Justice Gorsuch.
“The utterance is primarily clarifying in nature, seeking to reconcile what counsel previously said with their apparent agreement with Justice Gorsuch. There is mild skepticism as the justice is probing for potential inconsistency or contradiction in counsel's position.”
I think I mostly agree, and I hope I -- I hope I don't -- I hope I agree in full. But I -- I think the right way to think -- I don't -- I don't -- I just want to make sure that there would be an opportunity -- the district court judge would entertain a motion to amend the complaint.
That's what we want an opportunity to do. That's what Hikma is telling you we should not have the opportunity to do. But, as long as we're --
Yeah. But this Court doesn't normally weigh in on whether --
“The 'Yeah. But...' construction signals acknowledgment followed by pushback, indicating skepticism about whether the Court should be weighing in on this issue at all. The incomplete sentence suggests the Justice is challenging the premise of the respondent's argument by invoking institutional restraint norms.”
We're not going to 1 weigh on in on that. We would just remand.
“This utterance reflects a procedural/institutional response about what the Court would do — simply remand rather than decide the merits. It is largely neutral and procedural, with some engagement as the Justice is exploring or suggesting a possible disposition of the case.”
You can argue to the district court, right, as Justice Gorsuch said?
“The Justice is referencing a point made by a colleague (Justice Gorsuch) and confirming that the respondent retains the ability to argue to the district court, which appears to be a clarifying question that may also carry mild approval of the earlier point made by Justice Gorsuch while seeking confirmation from counsel.”
I think that is your typical practice. Again, I'm trying to, you know, oppose the sort of extraordinary requests that I think my friends on the other side are asking.
I'm sure they'll address it on rebuttal. Okay.
“This is a purely procedural remark managing the flow of oral argument, acknowledging that a point will be addressed later in rebuttal. There is no emotional valence or substantive engagement with the legal arguments.”
Anything further? Is there anything further down there? No? Anything further? Okay. Thank you, counsel.
“This is purely procedural language used to close out oral argument, checking if any other justices have questions before dismissing counsel. The polite 'Thank you, counsel' carries minimal positive valence but the utterance is overwhelmingly administrative and neutral.”
Rebuttal, Mr. Klein. 1 REBUTTAL ARGUMENT OF CHARLES B. KLEIN ON BEHALF OF THE PETITIONERS
“This is a purely procedural statement inviting counsel to present rebuttal argument. It contains no emotional valence, questioning, or evaluative content whatsoever.”
Thank you, Your Honor. I want to start by addressing this -- this point with no specifics that somehow new evidence came up in discovery that supports a claim for active inducement. Just to be clear, there is no such evidence, no evidence that Hikma somehow intended its archived prelaunch litigation-related press releases to induce infringement or its online product catalogue to induce infringement. Zero evidence. The dismissal below also was with prejudice, and it was with prejudice because Amarin conceded to that judgment. And so, if -- if the Court were to remand, it -- it -- the only thing left -- or, if the Court were to reverse and remand, the only thing left would be a Rule 60 motion, and Amarin could file that if -- if -- if they wish. I do want to address this argument that the conduct element turns on how a physician would understand vague and equivocal statements. That -- that is not the standard when there's an obvious alternative 1 explanation. Twombly and Iqbal make it very clear, if there's an obvious alternative explanation, a complaint doesn't survive the pleadings stage just because maybe some physician out there might possibly read an instruction to infringe into an equivocal or vague statement like generic version of Vascepa. And there are obvious alternative explanations for all the accused statements in this case. The -- the press releases that are accused were all archived as of the launch. They concern litigation victories. And -- and -- and they -- the only indication mentioned is Vascepa's non-infringing indication. At the time of launch -- and this is in the record -- the November 2020 press release, so this is when the product's first available, makes it clear the product is only accused -- the -- the product is only approved for the non-infringing indication and not approved for any other indication. And it has all the labeling information in the press release itself. That -- there's no way that induces infringement. 1 I do want to talk about the web page because I don't think my friend accurately characterized the web page. The web page refers to an AB rating for hypertriglyceridemia, which is a lot of jargon, but the jargon is conceded and explained in the complaint and in the decision below, and it means therapeutically equivalent only as labeled to reduce high triglycerides. That's what it means. The label is linked to the web page. So there is no plausible way to read that web page as somehow encouraging doctors to go off-label and -- and use the product for a patented method that has been carved out. That is not plausible. The obvious alternative explanation is the plain reading of -- of the -- of the web page. I see I'm out of time.
Thank you, counsel. The case is submitted. (Whereupon, at 1:24 p.m., the case was submitted.)
“This is a purely procedural closing statement marking the end of oral argument, with no emotional valence or substantive content whatsoever.”