Tuesday, July 21, 2026
Overview
On June 4, 2026, a unanimous Supreme Court reset the rules for one of the pharmaceutical industry’s most important tools for bringing generics to market: the “skinny label.” In this recorded conversation, the Goodwin Procter appellate and Hatch-Waxman team that followed Hikma v. Amarin from argument to decision breaks down what the Court held — and what it means for every brand, generic, and investor navigating method-of-use patents.
Instructor(s)
William Jay, Partner, Appellate & Supreme Court Litigation, Goodwin Procter
Jaime Santos, Partner, Co-Chair, Appellate & Supreme Court Litigation, Goodwin Procter
Daryl Wiesen, Partner, Goodwin Procter
Isabel Marin, Associate, Appellate & Supreme Court Litigation, Goodwin Procter
5 Key Questions Answered
1.What is a “skinny label,” and how does the Section viii carve-out let generics launch around a brand’s method-of-use patents?
A skinny label is a generic label that copies the brand’s label but omits — “carves out” — the specific uses the brand still holds under a method-of-use patent, using the statute’s Section viii (“little eight”) pathway. Because the generic seeks approval only for the drug’s unpatented uses, this route avoids the brand notice, the automatic 30-month stay, and the pre-launch litigation that other pathways trigger — and the panel notes it has become a heavily used way to market.
“The third option that comes up for generics … is when, for example, the drug itself is unpatented, but some of the uses are still patented. In that circumstance, the generic can file what’s called a Section Eight or ‘Little Eight’ carve out, and they can use a label that has some of the indications or some of the uses, but not all of them, and they can carve out or remove the ones that are patented. In that circumstance … there’s not the 30 month stay there is not the notice that’s provided to the brand, and there’s not necessarily the litigation before launch.” — Daryl Wiesen
2.What did the Supreme Court actually hold — and how does its “actively encouraged” standard differ from the Federal Circuit’s “could a physician read it that way” approach?
The Federal Circuit had treated inducement as a jury question about whether a doctor might read a label or press release as covering the patented use; the Supreme Court rejected that, holding the focus is on whether the statement itself actively encourages the patented use — the statement, not the listener. The Court stopped short of requiring express encouragement, allowing that a statement can be both active and implicit.
“Passive encouragement is not good enough, and so the court really disapproved quite firmly the idea that, well, all that matters is how doctors will hear a statement. As I said, that is where the federal circuit had gone in a previous case, and in this case as well, and they said basically … the focus should be on the statement, not on the listener. Does the statement actively encourage infringing uses?”— William Jay
3.Which routine generic communications are now safe — standard labeling, “generic equivalent” descriptions, A/B ratings, investor press releases — and where does litigation risk remain?
The panel reads the decision as protecting routine generic conduct: copying the brand label as the law requires, describing a product as a “generic version” of the brand, echoing the FDA’s Orange Book, and issuing ordinary press releases reporting brand sales. Risk remains where a communication crosses into affirmative direction — telling prescribers to use the generic “for everything the brand is used for.” The panel reads the Court as having rebuffed the argument that calling a product A/B rated was itself an implicit instruction to use if for all the brand’s uses.
“[Describing the product as] a generic version of Vascepa, or generic Vascepa, that’s just standard industry practice. Everyone in the generic industry understands that because … a generic is approved because it is the same as an existing approved brand drug. It’s very hard to describe what your product is without saying what brand product it was approved as an equivalent version of, so this is just a truthful description. The FDA itself makes the same point in the Orange Book, that the products are the same, and so that can’t be the basis for inducement.” — William Jay
4. What does the decision mean for brand patent strategy, generic launch planning, and drug pricing and access?
The speakers frame the case as a balance: without pre-launch certainty, generics facing lost-profits exposure many times their thin margins simply won’t launch — collapsing the skinny-label pathway that lowers prices — while blanket immunity would sap brands’ incentive to develop new patented uses. Going forward, brands may look to state-law fixes such as narrowing automatic-substitution laws to on-label indications, among other strategies.
“If there’s no ability to determine your … potential patent liability before you launch, generics just won’t launch, and then no one will use the skinny label pathway … and your lost profits damages can dwarf your actual profits by orders of magnitude, and so this would really just kind of destroy the skinny label pathway to launch, but then on the innovator side, I think there were really serious concerns that if there’s some type of magical immunity for using the skinny label pathway … then innovators will have no incentive to try to create new patented methods of use” — Jaime Santos
5. What comes next — for “implicit encouragement” theories, and for the legislative and regulatory action on the horizon?
On implicit encouragement, the panel expects future plaintiffs to need far more than anodyne conduct — real evidence of something everyone understands as “a wink and a nudge.” On the policy horizon, they flag the Skinny Labels Big Savings Act — the subject of a House Judiciary Committee hearing the day the decision issued — which would create a broader safe harbor and extend the same principle to biosimilars.
“I think plaintiffs are going to have to point to a lot more than conduct that seems anodyne, or that can kind of be taken either way, and I don’t think it’ll be impossible to win in other cases … but I think you’re going to have to come forward with some pretty strong evidence, and show that … even if the defendant didn’t expressly mention every claim element, they were doing something that everyone understands to be equivalent to a wink and a nudge.” — Jaime Santos
Keywords
skinny label • Section viii carve-out • Hatch-Waxman Act • induced infringement • active inducement • method-of-use patents • Orange Book • abbreviated new drug application (ANDA) • Twombly/Iqbal pleading standard • automatic substitution laws • biosimilars • Supreme Court skinny label ruling • induced infringement standard for generic drugs • generic-drug competition
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Transcript
In this transcript, appellate and pharmaceutical-patent litigators William Jay, Jaime Santos, Daryl Wiesen, and Isabel Marin from Goodwin Procter unpack what the Hikma v. Amarin ruling changes: how it reshapes induced-infringement risk, what it means for generic labeling strategy and launch timing, and what it may signal for future legislative and regulatory action.
Vincent Joralemon 00:30
Good morning, and welcome. I’m Vincent Joralemon, Director of the Life Sciences Law and Policy Center at Berkeley Law. Thank you for joining us for this conversation, produced by the Center for Law and Technology and hosted by Berkeley Law, on June 4, the Supreme Court handed down a unanimous decision in Hikma Pharmaceuticals v. Amarin, a case that sits right at the intersection of patent law, FDA [Food and Drug Administration] regulation, and the economics of generic drug competition. At its heart is the skinny label, the mechanism that lets a generic reach the market for a drug’s unpatented uses, while carving out the uses a brand still holds under patent. For years, a line of federal circuit cases have left, had left generic manufacturers unsure how much the carve out actually protected them. In Hikma, the court reset the standard and the implications for branded engineering companies, for patent strategy, and for life science investment are still coming into focus. I can’t think of a better team to unpack it. I’m joined by the Appellate and Hatch-Waxman litigators from Goodwin Procter, who followed the case from oral argument through decision. They’ll walk us through that court decision, why it decided it that way, and what it means going forward with that. I’ll turn it over to Jaime to take us through the decision.
Jaime Santos 01:49
Thank you so much, Vincent. We are absolutely delighted to be here. I will give a couple of disclaimers that our firm makes us give at any webinars. This is a general presentation about rapidly changing events. It should not be construed as legal advice, because we’re not considering the facts of your specific situation. But if you have a situation on which you need advice, please feel free to reach out to any of us, or if you’re simply interested in talking about these issues further, we are all nerds and would be delighted to chat with you. I’m going to just switch to the next slide, so you can see our contact info. My name is Jaime Santos. I’m the co-chair of Goodwin’s Appellate and Supreme Court practice. I work on a variety of appellate and civil matters, including patent cases and other IP litigation matters, and, as especially relevant here, I worked on one of the predecessor cases to Hikma v. Amarin, called GlaxoSmithKline [GSK] v. Teva, which we’ll talk about today, and I worked on that, along with my colleagues Daryl and Willie, who you will also be hearing from today. And Daryl, let me kick it to you to introduce yourself.
Daryl Wiesen 02:55
Great, thanks, Jaime. My name is Daryl Wiesen. I am a litigation partner in the Boston office of Goodwin, focusing for the last almost 30 years on life sciences litigation generally, and Hatch-Waxman litigation in particular, representing both generics and brand companies. As Jaime said, I worked extensively on the GSK v. Teva case, including being one of the lead trial counsel on that case. Let me turn it over to Willie.
William Jay 03:24
Hi, my name is Willie Jay. I am an appellate litigator at Goodwin. I focus my practice mainly on cases in the Supreme Court and appellate issues for life sciences companies like Daryl. I work for both brand and generic companies, and this case lands right at the intersection of those specialties, because it’s a key life sciences issue that went all the way to the Supreme Court, like Jaime. I worked on a similar skinny labeling case, the GSK case that Jaime alluded to, and I’ll hand it off to our colleague, Isabel.
Isabel Marin 04:01
Hi, everyone. I’m Isabel Marin, and I’m an associate in Goodwin’s Appellate and Supreme Court practice. I also focus on the life sciences and healthcare industries, and worked on an amicus brief in the Hikma case for the Association for Accessible Medicines.
Jaime Santos 04:20
So we have a jam-packed agenda for today. As you know, we’re going to be talking about the Supreme Court’s decision in Hikma v. Amarin. We’re going to start by giving you some background on the legal landscape, including a little primer on Hatch-Waxman litigation and some background on the relevant indirect infringement cases, and then we’re going to jump right into the Hikma v. Amarin case itself, and we’ll talk about what the Supreme Court decided, how it came to that decision, and then finally we’ll touch on what this case means for the future, both for pharma patent cases and also for other IP cases, and with that, I think Isabel is going to start us off.
Isabel Marin 05:01
Yes, we wanted to start with giving some background on the major players that define this legal landscape and what’s at stake for them. So, of course, the two main players are the brand manufacturers and generic manufacturers. Brands are protected by patents, and that patent law provides an exception to the general rule against monopolies and the right to a free and open market, and patents do so for a very important reason, which is to encourage innovation, so brands invest a lot of money into research and development, and the patents enable that innovation and investment, because the exclusivity period created by the patent enables brand drugs to recoup that investment and make a profit by charging higher margins on their products later on during that period. Now, of course, patent law is designed to allow that balance of encouraging innovation, but also allowing for the benefits of competition once the patent expires. So, at times, patent laws had to be adjusted to maintain the right balance between innovation and competition, we also want to note that brands receive certain regulatory exclusivities, in addition to the patent exclusivities, to supplement their incentives to innovate in order to come to market with a new drug, a brand has an expensive and arduous journey because it has to file a new drug application, an NDA, and be approved by the Food and Drug Administration. That new drug application must include a statement of the drug’s components and scientific data showing that the drug is safe and effective, as well as proposed labeling describing the uses for which the drug is allowed to be marketed, so that is an extensive application process with the FDA. When generics enter the market, the added competition lowers prices, meaning that generics have a very different market proposition. They make money by selling in bulk, but with very thin margins.
Now, at the heart of this case is a 1984 statute called the Hatch-Waxman Act, and it was important because it fundamentally changed the availability of generic drugs on it – on the pharmaceutical market.
So, before the Hatch-Waxman Act, generics also had to file the full-blown new drug application that a brand had to file, and that involved conducting their own clinical trials to establish the safety and effectiveness of the generic drugs, that meant that generics had to repeat clinical trials in a way that was expensive and unnecessarily time consuming, since the brand name drug that the generics are based off of and equivalent to were already determined to be safe and effective, in addition, generics generally had to wait until all patents expired on a brand drug before beginning to seek approval from the FDA because the very process of developing and testing the generic drug exposed generics to patent infringement lawsuits, so this long process that generics had to go through with the NDA in practice further expense extended a brand’s exclusivity period and monopoly power, and one more thing is that brands don’t have just one kind of patent for their drug, like it doesn’t – the patent does not only cover the active ingredient, there can also be patent protection for other aspects of the drug, including methods of treating particular conditions, and so those method of use patents and other kinds of patents can also extend a brand’s exclusivity period. So, in light of all that, Congress had to develop a new balance through the Hatch-Waxman Act. And with that, I’ll turn it over to Daryl.
Daryl Wiesen 09:36
Thanks, Isabel. As Isabel said, everything changed in the process we know now for what are called abbreviated new drug applications, or ANDAs, as we tend to call them, was adopted in 1984 in a statute that’s named after two of the leading proponents for it, the Hatch-Waxman Act, and that created a pathway for generics. Unlike as what was required before, they no longer needed to do all of the clinical trials. Instead, they could file the abbreviated application and just show their product was the same as the brand product. The FDA would still review it. The FDA would still determine that it was actually the same, and if so, the product could be launched as a generic without having to do all of the expensive clinical trials.
There were some other things that were adopted as part of the Hatch-Waxman Act. For example, as Isabel also mentioned previously, the development work was infringement of a patent, the Hatch-Waxman Act creates a safe harbor under 35 U.S.C. § 271(e) You’ll hear people talk about the safe harbor, and that allows the development of a generic. In addition, the Hatch-Waxman Act created what we call the Orange Book, which is where the brands would list all of the patents that they have that cover the product, and the generic would then have to deal with the patents that were listed in the Orange Book when they filed the abbreviated new drug application, when they filed the ANDA.
If we go to the next slide, there were a variety of different ways the generic can deal with those patents in the Orange Book. First thing you can do, you can wait for them to expire, pretty simple, pretty straightforward. Just you could file your ANDA, but tell the FDA we don’t want approval until the patents have expired. The second thing you can do as a generic, and it’s the more standard thing people do, is file what’s called a paragraph four certification. Where’s paragraph four come from? It’s the number in the statutory paragraph that drives this, and what happens at that point is the generic declares the patents are either invalid or won’t be infringed by the filing of the and/or the selling of the product, and if that happens, two things get well, then litigation can automatically begin. The act of submitting a paragraph four certification is technically an act of patent infringement under the Hatch-Waxman Act, and the brands can sue the generics immediately before the generic gets approval from the FDA. If the lawsuit is brought within 45 days of receiving the notice, there’s an automatic 30 month stay on FDA approval of the generic. The idea of that is it will let the litigation play out before the generic gets approval and gives you sort of an automatic injunction, but lets the lawsuit happen before the before the generic launches, and as Isabel says, starts competing, dropping the price and creating all of those implications, the third option that comes up for generics, and the one that we’re going to really focus on today, is when, for example, the drug itself is unpatented, but some of the uses are still patented. In that circumstance, the generic can file what’s called a section eight or little eight carve out, and they can use a label that has some of the indications or some of the uses, but not all of them, and they can carve out or remove the ones that are patented in that circumstance. There is not the automatic, there’s not the 30 month stay there is not the notice that’s provided to the brand, and there’s not necessarily the litigation before launch. Now, historically, this has turned out to be a very important option. It’s been used extensively.
Daryl Wiesen 13:55
Some studies have shown that a relatively high fraction of pat of generic approvals, maybe even 40% use this literally carve out strategy, and so that method is one that’s important to keep in mind, and is what leads to the skinny label that happens, but what’s also necessary to talk about is the fact that even if something’s not on the label, even if an indication has been carved out, sometimes the generic drug will still be used for that purpose.
The automatic substitution laws in states or pharmacies may end up substituting the generic drug for something that’s not on the label, and that’s the balance we get into as we start to talk about the skinny label situation that comes up in the Hikma v. Amarin case. Jaime, if you want to talk a little bit about inducement.
Jaime Santos 14:52
Sure. So this case, as you will talk about, is an inducement case. There’s different types of infringement. Liability that arise in patent cases, and one of them is induced infringement, and the standard for inducement played a really important role in the court’s decision, as you’ll see. So we wanted to give you a bit of a background as to what it means and where it came from. Inducement is one of the forms of indirect infringement that allow a patent owner the right to sue, and it’s created by statute in the Patent Act in 35 U.S.C. § 271(b) And interestingly, it is in the Patent Act, but it’s actually not in the Copyright Act. The copyright indirect infringement is generally brought kind of derived from principles of common law and the Patent Act Act’s provision is based on the common law, and so the Supreme Court has generally said that inducement works the same way in patent and copyright cases. So that’s part of the reason I’m about to talk about some copyright cases. So here’s the relevant language: whoever actively induces infringement of a patent shall be liable as an infringer, and I would say make a special note of the actively induces language, because it’ll become really important. It’s also sometimes referred to as affirmative encouragement, and so we will talk a little bit more about that. This is not all set forth in that very short provision that I just read, but induced infringement is understood to have three different elements derived from the common law. First, there has to be direct infringement by a third party. You can affirmatively encourage someone to infringe until the cows come home, but if no one actually directly infringes, you can’t be liable. So, in other words, there’s no such thing as attempted active inducement, and this comes from a case called Limelight Networks v. Akamai Technologies. Second, the inducer must know that the induced acts constitute patent infringement, and that’s from a case called Global-Tech Appliances v. SEB S.A., and that basically means that if you don’t know that the thing you’re encouraging infringes, then you can’t be held liable, and in the Hatch-Waxman context, this actually comes up less frequently, because the whole process that’s created that Isabel and Daryl talked about is really intended to ensure that everyone knows what indications are covered by patents and what aren’t, which indications aren’t, so they’re all published in the Orange Book, but this comes up a ton in patent cases in the tech context, and also in copyright cases. Then the third element, which is most relevant here, the inducer must take active steps to encourage direct infringement, and this is the affirmative encouragement, active inducement, that element that I mentioned before.
Now, there are two important copyright cases, or Supreme Court cases, both copyright from about the last 20 years or so, that help kind of illustrate how this third element operates in practice. The first one is Metro-Goldwyn-Mayer Studios v. Grokster, it’s often just referred to as the Grokster case, or MGM v. Grokster, and this case really gave us the modern standard for inducement liability. You all may know this case pretty well already, but the short version is that it involved a peer-to-peer file sharing network that let users share files directly with each other without having any server that exercised kind of centralized control over what is shared, and the overwhelming majority of what got shared through Grokster was copyrighted music and movies, and they were shared without permission from the license holder. What happened is that movie studios and record labels were really unhappy with the situation, and they sued the software distributors, not the individual end users, or at least not just the individual end users, and they argued that the distributor, so that Grokster should be liable for the infringement that they are software enabled. The lower courts ruled for Grokster, and the Supreme Court unanimously reversed, and what the court held is that if someone is distributing a device with the object of promoting its use to infringe, and that object is shown by what the court referred to as clear expression or other affirmative steps taken to foster infringement, then they can be liable for the resulting acts of direct infringement by third parties, and the decision drew really heavily from patent law.
Jaime Santos 19:28
The affirmative encouragement in that case included things like internal communications that were aiming at capturing former users of Napster, another file sharing network. The court also pointed to marketing that affirmatively touted access to copyright files for potential users. The fact that there was no effort to develop any filtering tools, and also that the business model for Grokster was built on ad revenue that was tied to high volume use, which meant that more infringement. Equaled more revenue, and I think of all of those, the marketing materials affirmatively touting access to copyrighted files were really the key piece of evidence that became relevant in later cases, though, as we’ll see in the Cox Communications v. Sony Music case, I’m about to talk about, you know, there were certainly discussions of the lack of filtering tools to discourage infringement that many people kind of latched on to in trying to, you know, get copyright liability in other contexts.
Okay, so the second case, which I just mentioned, is Cox Communications v. Sony Music Entertainment. That was a case from this most recent Supreme Court term. It came out just this year, and Cox, as you may know, is an ISP, an internet service provider. It has millions of subscribers, and many of its subscribers, though not a majority, they were using Cox’s services to illegally upload or download copyrighted songs. I feel like this occurs a little less now than that there are streaming services like Spotify and Amazon Music, but some people are still uploading or downloading copyrighted songs, and there’s no question in this case that Cox knew that its customers were doing this. It actually received specific notice of individual infringing uploads or downloads that traced those activities, the infringing activities, to specific IP addresses, so Cox knew it was happening and knew who was doing it, and Cox did actually send its customers warnings, and even suspended their service, and after 13 notices and warnings, it would, it could terminate the service of one of its customers, but over a multi year period it only actually suspended a handful of people, and Sony then sued Cox and said that Cox was contributing to its subscribers infringement. A jury ended up awarding Sony a billion dollars in damages, and the Supreme Court reversed and said that the there are only two pathways to contribute a contributory liability under the Copyright Act. You can have active inducement, like in the Grokster case, or you can provide a service that is essentially capable of only of infringing uses, or almost only of infringing uses, but if all you’re doing is providing a service that has infringing and non-infringing uses, and you have knowledge that some people are definitely infringing, and you have the ability to cut those people off. That is not enough. And I think here again the court leaned really heavily on inducement liability under the Patent Act to reach its decision. Okay, so now with the table all nicely set, Willie, do you want to talk about this case?
William Jay 22:43
Sounds great, thanks, Jaime. And starting on the next slide, we’re going to just go over the basic facts of the dispute about Vascepa and the generic version of it. So Amarin is the brand company, and it markets a drug called Vascepa that drug has two FDA-approved indications. One of them is for treatment of a disorder called severe hypertriglyceridemia, which I think is having way, way, way too many triglycerides in your blood, and the other one in red on this slide, is the patented one. There’s the one, the one that the patent that we’re going to talk about relates to, which is to reduce cardiovascular risk in patients having high triglycerides. So, Amarin cleverly calls that the CV indication for cardiovascular, and they have patents not on the molecule itself, and not on the use of the molecule to treat to improve health generally, but to specifically reduce cardiovascular risk, and it is, it is not correct that they have a patent on the entire indication, their patent is more specific than that, and includes in some instances administering the drug with a statin, or the patient has to have particular characteristics, could be it could be to reduce the risk of death, but the point is that treatment of severe hypertriglyceridemia is not patented, and the substance is not patented, and so under the background that we laid out earlier in this program, there should be a way to market a generic alternative with a skinny label, and that is exactly what Hikma sought to do. They went through one round of litigation with with Amarin, and then they got their product on the market after winning that round of litigation, and then they were sued again, and Hikma alleged that. Their skinny label and other materials were going to induce infringement of the patented indication, or I should say, of the patents on the CV indication.
So, let’s talk a little bit about what the allegations consisted of, because that went up becoming important in the Supreme Court, one of the allegations relied on the label itself and said essentially that the that wording in the label that remained after doing the carve out was enough to show that Hikma was trying to get users to practice the patented indication for CV patients, another, and I think here it might make sense to just click to the next slide, where we actually have the press release in question. There’s a, there was a Hikma press release that referred to Hikma’s product as a generic version of Vascepa, and that is exactly what lots of generics describe their products as, and that wound up being a significant question about how skinny labels ought to work, and whether describing your product, which has fewer indications, fewer approved indications than the brand as the equivalent, is basically a representation to the world that it can be used in all the same ways. Let’s click to the next slide as well. Their generics don’t do a lot of marketing, but they do have to make available to pharmacies and wholesalers a catalog or website versions of a catalog, saying what products they sell, and so you can see that on this Hikma website listing, sort of at the on the right, right, ish side, second line, it describes the therapeutic category that this belongs in as hypertriglyceridemia, and Amarin said, “Aha, the approved indication that is not patented is severe hypertriglyceridemia, and so you are saying that this belongs in this broader therapeutic category, which also would include the patented use, it includes a lot of other things as well, and then this is way too small to see, but under the picture of the two capsules there is actually a disclaimer that says Hikma’s generic version is indicated for I can’t even read it myself, for basically for fewer than all of the approved indication, so Hikma would say that anyone reviewing this website could see that its product was not being marketed as exactly the same for all indications as the Amarin product. Let’s click to the to the next slide. There, there were there was more to this, more to the case than this, but these were basically the key allegations in the case. So, Amarin brought this case in federal court in Delaware and accused Hikma of patent infringement, induced patent infringement.
William Jay 28:21
The district court threw the case out, but the federal circuit, which is the appeals court that hears all patent appeals, decided that Amarin had pleaded enough to get into court and ordered the case to go forward, and they, they emphasized each of the things that I’ve gone through in the last couple of minutes, and they didn’t buy the point about the disclaimer. They were not the first panel of the Federal Circuit to touch on this issue, as we alluded to earlier in this program. There was another case also involving a carve out called GSK v. Teva, which basically said that it’s a fact question to be proved to juries by lawyers whether a doctor would read, whether it’s a press release or marketing materials or any of these other statements, whether a doctor would interpret such a statement as a representation that the products are the same and can be used for all the same uses, including the patented one. So the generic filed a cert petition, a petition to the Supreme Court, asking it to hear the case, and before deciding whether to grant that petition, the Supreme Court sent it over to the Department of Justice through a procedure called calling for the views of the Solicitor General [SG]. The Solicitor General, the government’s top Supreme Court lawyer, and the Supreme Court, a dozen or more times a year, will ask about a pending cert petition and ask for the government’s views on. On whether that petition is a meritorious one, that both means whether the lower court decision is wrong and whether the case is important enough to deserve a place on the Supreme Court’s merits docket, and in this case the Solicitor General came back saying yes, it does deserve a place in the merits docket, and no, the Federal Circuit did not get it right. Its decision should be reviewed and reversed. So, the Supreme Court took the SG’s advice, granted the petition, had briefing throughout the early part of this year, and then heard argument in April. And next slide, please.
Bang, the decision came out quite quickly, as, as we see on this footage from Justice Jackson’s chambers, the author and Justice, Justice Ketanji Brown Jackson, got her opinion out just 36 days after oral argument. It helped that there were no concurrences or dissents, no separate writings. Next slide, please, by Kermit. The the court basically emphasized a couple of themes, one of them was the pleading standard, that this is just a settled application of the existing pleading standards, which were not up for debate, and so the court wound up coming back to its own prior decisions, looking at complaints and the rules, saying you can’t rely on speculation and you can’t rely on sort of threadbare allegations. Next slide, please.
Of course, the court also emphasized that, as Jaime explained at some length, the bar for active inducement is high. Passive encouragement is not good enough, and so the court really disapproved quite firmly the idea that, well, all that matters is how doctors will hear a statement. As I said, that’s that is where the federal circuit had gone in a previous case, and in this case as well, and they said basically it’s a, the focus should be on the statement, not on the listener. Does the statement actively encourage infringing uses? Now, Hikma, at one point during the proceedings, had said, well, that means that it has to be express encouragement. You must actually say use the product for the patented use. So, the Supreme Court said we’re not going that far. We are not saying that encouragement has to be expressed. It does have to be active, but something can be both active and implicit. A statement could be suggestive enough so that it is actively encouraging without actually using the words take for cardiovascular or something like that.
William Jay 32:49
Next slide, the skinny label is something thatAmarin had kind of run away from somewhat in the Supreme Court, that wasn’t a centerpiece of their merits arguments, but the what the Supreme Court emphasized is that carving out a label in accordance with the FDA is existing procedure is just complying with the law, the law doesn’t allow you to put in your label material that the brand has identified as patented, and so everything that the brand identifiedHikma carved out, and what remained is just following the law, because generics don’t get to write their own labels, they have to copy the brand label, except insofar as they are carving out patented portions of it, so the court basically said, don’t talk to me about the skinny label itself.
And next, this is a really important part of the decision for generics, saying that the product is a generic version of Vascepa, or generic Vascepa, that’s just standard industry practice. Everyone in the generic industry understands that because, asDaryl explained, a generic is approved because it is the same as an existing approved brand drug, that you, it’s very hard to describe what your product is without saying what brand product it was approved as an equivalent version of, so this is just a truthful description. The FDA itself makes the same point in the Orange Book, that the products are the same, and so that can’t be the basis for inducement.
And then next slide, you also can’t rely on vague, innocuous statements. Now, this, this is where the court went back to the pleading standards that apply in all civil cases, and say basically, vague statements are not enough. So, that point about hypertriglyceridemia is a broad therapeutic category that could include other stuff, the court said you’re kind of piling way too many inferences on top of each other, there’s nothing explicit in on this website that says infringe, and these vague statements are not enough, and then one more slide from me, Jaime pointed out, including in her discussion of the Cox case, that sometimes you know that infringement is happening, but you’re, and maybe you’re not doing anything to stop it. If you’re like an internet service provider in the copyright context, you might know that that infringement is happening, that’s not the same thing as encouraging it or taking active steps to promote it, and so a press release saying the total amount of sales for the brand is not a statement that doctors should regard the every one of those sales as a sale that ought to be be switched to the generic, because the generic could be used for all the same purposes. This is not enough subtle encouragement to actually be an active inducement, and recognizing that some infringement might occur is not the same thing as encouraging that inducement to occur. So, these press releases, which are, you know, again pretty standard practice in the industry, where you, you tell the market what you know, and what you know is how much the brand sold last year to give a rough idea of how big the market is. That’s not the same thing as saying that’s how much we’re going to capture with our skinny label generic product that’s labeled for one use.
Jaime Santos 36:39
Yeah, so now that we have all of that backdrop set and we was helpfully gone through the opinion, we wanted to discuss some of the kind of key pieces that were part of the opinion and that will be important going forward for pharmaceutical companies and also just for anyone involved in inducement or indirect infringement litigation, so as Willie mentioned, there are kind of three different ways of thinking about this case, or kind of three different axes that the court, you know, looked at. That number one, should the court either clarify or change or develop the law of inducement? Number two, should the court, you know, change or clarify Twombly, theTwombly/Iqbal pleading standard, or maybe just, you know, straight up apply it. And number three, what is this doing to that, to the entire Hatch-Waxman regime? One thing we didn’t talk about too much is that I think there were real serious policy concerns on both sides about the implications of allowing cases to kind of go through into discovery and into really expensive litigation for either manufacturers who are brand manufacturers or generics on the generic side, you know, they generic companies are often making, you know, pennies a pill, they get their margin, they get their profits based on kind of bulk small margin sales, not based on large margins between the cost of manufacturing and the amount that you make when you sell it, and so if there’s no ability to determine your patent potential patent liability before you launch, generics just won’t launch, and then no one will use the skinny label pathway, because there’s no way to get patent certainty before you launch, and your lost profits damages can dwarf your actual profits by orders of magnitude, and so this would really just kind of destroy the skinny label pathway to launch, but then on the innovator side, I think there were really serious concerns that if there’s some type of magical immunity for using the skinny label pathway, and we also know that there’s lots of infringement that occurs because pharmacies substitute generic for brand name drugs all the time without even knowing or looking at whether a particular prescription is for an infringing use or a non infringing use, then innovators will have no incentive to try to create new patented methods of use that might be, for example, pediatric uses or uses for a particular marginalized group that you know is very expensive to do, and if you can’t continue to sell at a high margin, why put the research and development in, or even just completely unrelated uses, on you know, for that might be groundbreaking, and you know, cure something that you didn’t think could be cured, or completely manage an ailment that was, you know, essentially a death sentence years ago, and so there are really serious policy concerns on each side about what would this do to the Hatch-Waxman regime. I actually kind of thought that the Supreme Court was just kind of going to stick to one area of focus, but it really touched on all three, and I think in doing so it made its opinion broadly applicable to all kinds of cases, despite I think intending to write a very cabined and fact-specific ruling, I. Okay, I think we’ll all be watching closely to see what happens with this opinion in the years to come, because I think the court thought it was just, you know, correcting error below, and I think we all probably think that it was doing much more. So, I’m going to start with the kind of Twombly/Iqbal piece, which seems like the most boring piece, but I promise you, we can find something interesting in it. So, as Willie mentioned, the court said that it was just applying well-established law, and Justice Jackson kind of started her opinion really by saying that the court wasn’t making any new law in this space, that the standards are well established, they’re undisputed. But I have to be honest, I’m kind of skeptical of that.
Jaime Santos 40:42
You can see here the language that’s on the screen, it talks about plaintiffs having to rule out obvious alternative explanations for the defendant’s conduct, and you might notice that the part of that sentence, there’s part of the sentence that’s in, you know, quoting something else, and part of it that’s not, the obvious alternative explanations point is something that was in theTwombly and Iqbal decisions, and the court had generally said, you know, if something has an obvious alternative explanation, it could either be legal or it could be totally innocuous, you know, that’s something, at least something for courts to consider, and there’d been a real division, certainly, between the plaintiffs bar in the defense bar in many civil cases, and even between courts of appeals below, about what, what that language meant. Do you have to affirmatively rule it out in, you know, pleading a complaint, or is it just, you know, something for the court to consider? And here the court expressly said, you, the plaintiffs have to rule out obvious alternative explanations, that’s not something the court had said before, and I think it’s something that certainly is has already been cited. I mean, I’ve already written motions citing that, and briefs citing that language, so I’m confident that others will as well.
Another important piece I think is that the court took actually a really hard look at all of the allegations, the categories that Willie went through in detail, and you know the way I view the court’s decision, it was really exercising its own independent judgment about whether these categories of allegations passed the smell test. You know, usually in civil cases under theTwombly and Iqbal pleading standard, you’re supposed to draw all reasonable inferences in favor of the plaintiff. Some courts do that with more vigor than others, and you know, when I read the opinion, it was, it was not doing a ton of drawing inferences in favor of the plaintiff in this case, which I found very interesting, and when I actually first saw the opinion, the first thing I did after skimming it, it wasn’t actually sending it to our patent litigators, I sent it to our consumer financial services litigators, our class action litigators, our illicit ERISA [Employee Retirement Income Security Act] litigators, who file motions to dismiss all the time, because I thought they would really look closely at this language.
The fact that the court took a hard look, and the fact that the court said, you know, standard industry practice doesn’t allow a plausible inference of some type of violation of the law that that’s all language that’s going to be used in a variety of civil cases and I think will be broadly relevant, but at the same time I think I really wonder from a pragmatic perspective how much this, you know, theoretical ratcheting up of the Twombly and Iqbal pleading standard will actually be applied in other cases, and how much does the Supreme Court intend for it to be applied in other cases? There were there was a case, actually just a few months ago, that came out called Burke v. Choi. It was a Justice Barrett opinion, and it really was very plaintiff favorable about how to plead viable claims in civil cases. It had language saying that a complaint satisfies the 12 Iqbal standard, if it’s, well pleaded, it can proceed even if it strikes a savvy judge that actual proof of the facts alleged is improbable.
Jaime Santos 43:52
It also said, our system of notice pleading, it makes it relatively easy for plaintiffs to subject defendants to discovery, even for claims that are likely to fail, which, which feels a bit different from theHikma decision, and so you know one thing I think about is that the court wasn’t just looking at allegations in the abstract, it was looking at allegations against a backdrop of a legal standard, inducement liability that sets a very high bar, you know, active inducement, it requires clear expression, it has to be active, it has to be affirmative, it can’t be passive, and so I do wonder when the substantive legal standard isn’t as strict, when you’re just talking about, you know, what what a reasonable doctor would do, or what a reasonable, prudent fiduciary would do, you know, it’s not as clear that the court will want district judges to be quite as discerning and to exercise quite as much independent judgment about the inferences it’s willing to draw from different types of allegations, I’m curious if any of you all have seen this arise already in non-inducement patent cases in. The opinion came out because I know my IP lit colleagues, they actually don’t write as many motions to dismiss as class action litigators, especially in the Hatch-Waxman context, where the whole point is to jump into litigation, get into discovery, and you know, go to trial kind of as quickly as you can make it through. Daryl, have you seen it?
Daryl Wiesen 45:20
Yeah, Jaime, thanks. I have seen it. I do think it’s, it’s interesting. As the person who spends more time, probably from this group in district court, I will say, before this case, to the point you just made, I don’t think the patent litigators tended to file a lot of Twombly/Iqbal, or as Justice Barrett called it, and I have adopted Twiqbal motions to dismiss the standard. Seemed pretty straightforward. There was sort of the rule eight example of patent complaints that just said here’s the patent, you infringe it, and people tended to rely on pretty bare bones complaints.
I do think that that explicitly applying this standard in patent cases by the Supreme Court is going to people are going to sit up and take notice, even in the patent cases, and I have seen even this week I was reading a reply brief in a case where someone had filed a motion to dismiss, and even though it’s not an inducement case, the question of whether the complaint alleged just the sort of final step, the final result, but it was a process patent, and the question of whether they followed the process or not. There were ways you could get there by infringing or not infringing, and suddenly Hikma gets cited for this exact proposition of whoop, there’s ways to infringe, there’s ways to not, that’s possible, not probable, and therefore dismissal is appropriate. And I think we’re going to see a lot more of that in patent cases, generally beyond just the inducement cases. We’ll have to see how it plays out in what the federal circuit has to say when people try and get those dismissals, but I do think we’re already seeing just less than a month after the decision this result.
Jaime Santos 47:12
And one thing I want to give Willie a shout out, because he, during one of our prior presentations on this case, even before the opinion came out, coined a new term, instead of Twiqbal, we now have to call it Hikball. So this will be new pleading standard. You know, one last thing I wanted to mention before passing it back to Willie is that the Supreme Court doesn’t usually take or keep a case where all they have to do is establish is apply an established legal standard to a set of facts. So I think there’s been a fair bit of wondering from members of the Supreme Court bar about why the court even take this case, and in fact, at the argument itself, a couple of the justices even pondered that out loud at the argument, like I think Justice Barrett said, “I don’t really know why we have this case, except that four of my colleagues voted to grant it, and I think your answer to that question is on this next slide, I think the court wanted to clearly and unequivocally repudiate the federal circuit’s very plaintiff-friendly approach in skinny label cases, and I think that is how Judge Prost’s many dissents in this space became completely vindicated. All right, so Willie, do you want to talk a bit more in depth about the inducement piece?
William Jay 48:21
Sure, speak because this is not just a skinny labeling case. It is a case about inducement that will be instructive, not just for, like, civil pleading for ERISA litigators, but for patent lawyers who are thinking about inducing infringement of us, whether it’s a software patent or, you know, patent, and in the industrial space, so the contrast the court drew, as I said before, it said that encouragement doesn’t have to be express, and Amarin tried to analogize to one of the court’s other recent decisions in the First Amendment context, which was sort of a nice restaurant you have here, be a shame if something happened to it type of scenario, in which a government regulator basically said we don’t send to the companies that she regulated, that she sort of strongly suggested that they take a look at not doing business with an organization who’s the state of New York did not like, and the court held that that was enough to state a claim in the First Amendment context, but it is not enough to state a claim here in the patent inducement context, like it’s got to be active inducement and not the kind of implication that the court is much more sensitive to where constitutional rights are at issue. Jaime already also alluded to the point that the Supreme Court really. Wanted to disapprove the idea that anything a listener might misinterpret as inducement is inducement, and that’s significant in these cases, because it means that you can’t just sort of get over both the pleading burden and the summary judgment hurdle by having an expert who’s willing to say yes, I could understand it this way, and I know I said I was wasn’t going to talk specifically about Hatch Waxman, but this is one one Hatch Waxman relevant point in the world of Hatch Waxman, showing even a little bit of inducement can be enough to block a generic from getting approved, so in other words, if you actually have a patent litigation about whether the generics product induces infringement, the label doesn’t have to induce every single person who reads it to infringe the patent, so there are patents that, for example, apply to only a small subset of those who use the product, and if, if you induce those people to infringe the patent, that can actually block the generic as a whole from getting approval, so this is not going to be as easy in light of the Hikma decision, because the focus is on the design of the statement and not on how the listener would hear, but I’m interested in what Daryl has to say about what this leaves open for brand manufacturers in this context, and actually the next slide is has hit several of the relevant things, but the product name that Jaime alluded to, like from from Grokster, is not something that we see as much in the brand generic context, right? Daryl?
Daryl Wiesen 51:51
Yeah, no,that’s right, Willie, and I thinkthe third sort of framing that we’ve talked about for the case was sort of how much is this going to be specific to the Hatch-Waxman context? The idea that there is a statute out there that encourages the development of generics, but that the way it was, this inducement law was playing out previously left a lot of uncertainty for the generic companies and created some concern that people wouldn’t use this pathway, balancing that again against what the brands are saying, which is we spent, as Isabel talked about, a lot of time, money, and effort to develop these new indications, and we should get something for that. You want, we want to encourage that innovation, and I, we do, I do think that the Supreme Court’s decision has some what I might call hatch waxman or generic specific logic to some of the things they talk about. For example, one of the things that they end up talking about as not being sufficient to show inducement is if the alternative explanation is simply complying with the law, and they do that in the particular context of the Hatch-Waxman case, where Hatch Waxman requires the generic, as we talked about, to copy the brand label, so some of the things thatHikma did were copying the brand label, and the Supreme Court said, well, we’re not going to hold that against Hikma. Outside of this context, those statements may have been enough to create at least a question of are you trying to encourage infringement, but in the context of a little eight carve out, where Hikma specifically said we’re trying to avoid infringement, but we have to leave this piece on our label. The Supreme Court said we’re going to say that’s okay, we’re not going to hold that against Hikma. It raises some interesting questions beyond the same fact pattern we have here. One example people may be familiar with was thisAstraZeneca v. Apotex case, where the patent claimed giving a drug once a day, and the brand label allowed it to be given twice a day or once a day, but also had language that said better to give it less frequently, so decrease as much as you possibly can to avoid the once a day patent, the generics carved that out. They said, “Nope, we’re going to only have the twice a day language on our label, but they were required to keep on the language, reduce as much as possible. In that scenario, the federal circuit found that was sufficient to induce infringement of the once a day patent. I think it’ll be an interesting question going forward. What happens now? The generic will say we have to keep that on to comply with the law. The brand will say, but that explicitly encourages you, the only. Thing that’s less than twice a day is once a day, and or less frequent than that, but once a day is the pretty obvious next step. So that’s what you’re encouraging, and I think there’s going to be an interesting question that comes up, whether you can rely on the label at all, or whether once the label is approved by the FDA as a skinny label, everything on the label is off the table for inducement. We see that similarly, as Willie talked about before, some of the standard things that that the generics do, calling the drug AB rated. Again, you might interpret that as encouraging for all the uses. I think Willie was talking about the not whether it needs to be express or implicit. The brands, I think, the innovators tried to argue that saying A/B rated was at least an implicit statement to use it for everything the brand is used for. I think the federal circuit or the Supreme Court has said not so fast, but when Willie talks about what might be an implicit instruction to infringe, I do think there’ll be some interesting questions if you said, for example, use the generic for everything the brand is used for, use it exactly the same way, if you’ve carved things out that might be an implicit but affirmative instruction that would would create liability, so I do think there are some very Hatch-Waxman generic specific contexts that are discussed here that are going to be interesting to see as everything plays out.
Isabel Marin 56:40
So one more really important sort of theme and aspect of this case involves another piece of sort of legal background that we haven’t touched on yet, but is really interesting, so all in order to try to reduce health care costs all 50 states and the District of Columbia require or permit pharmacies to substitute a prescription for a brand product with a generic product, unless, of course, the prescription says, you know, brand only, but most prescriptions don’t, and so, in effect, medical professionals also routinely prescribe, and pharmacists routinely dispense skinny label generics interchangeably with brand name drugs, including, you know, the brand name drug that has still has a patent and method of use, of course, because it’s a skinny label generic, so this, of course, raises one of the issues that Jaime touched upon, that a brand legitimately has a patent on a method of use, and yet its market share for that method of use is being eroded by this background, these background state laws and practices that exist, even if the generic does absolutely nothing, you know, they have no role in that, that’s just how the background landscape, legal landscape works, and so, as the court, you know, said in its decision, pointing this out, pharmacists and medical professionals, they, they interchange the generic with the brand with the blessing of their state’s generic substitution laws, so the court acknowledged that the automatic substitution laws are likely responsible for all or virtually all direct infringement.
Interestingly, the justices did not explain what role that aspect of the case played in their doctrinal analysis. The court mentions this in their background section, right before introducing the pleading standard for active inducement, and so I think that that that placement suggests that the background was important to the justices, it sets it sets the stage as to why pleading active inducement has to have an appropriately high standard, and that the court, it court needed to police that standard and not let it fall too low.
Okay, so we’re going to look ahead a little bit about how this opinion, it might change things going forward. So I wanted to start asking Daryl how he thinks brands might be able to protect their patented methods of use, given the court’s opinion here.
Daryl Wiesen 59:40
Yeah, thanks, Isabel. I do think this will be a little bit of a change, or even a big bit of a change, because there have been a lot of inducement cases focused on is the skinny label skinny enough, how much has been carved out, whether there is inducement, but there are a number of things. Brands can think about doing the first relates to the generics, the automatic substitution laws, which is to say you could consider doing some lobbying at the state level to change and amend the automatic substitution laws, so that automatic substitution is limited only to the indications that are on the label right now, the automatic substitution laws tend to focus just on the drug, so the Hikma drug would be automatically substituted for the Amarin drug, no matter what the indication or use was. You could consider trying to get those laws amended. It may not be easy to do. It will be counter to think some of the policy implications that people are focused on right now but it is one pathway
Jaime Santos 1:00:46
Can I ask one question about that? How would, aside from, you could change the automatic substitution piece to allow or require substitution only for the unpatented indications, but a lot of times the physicians don’t put the indications on the prescription pad, they just say dispense, Vascepa twice a day with water. So, how would it work in practice? You’d have to change kind of the fundamental prescription practices as well, right?
Daryl Wiesen 1:01:16
I think that’s right. I mean, I suppose you could change the default as well. In other words, you can only substitute if the carved out indication is on the prescription or vice versa, but I think the change you’re right, Jaime, would have to be a fairly broad amendment, and would have to change the way doctors and pharmacies currently fill out fill prescriptions, because most of the time, at least my prescriptions, they don’t say what, what the indication is, they just say you’re right, this drug this amount of times per day or per week or whatever it is, with no more detail than that.
William Jay 1:01:53
And in this case, for example, like even if it said on the label to reduce cardiovascular risk, that wouldn’t be enough to establish that it infringes, and pharmacists obviously are not patent lawyers, and there becomes a point at which administering the sort of infringing, not infringing question would be beyond pharmacists’ capability. So I think what you said, Daryl, is exactly right. Everything would turn on how you set the starting presumption, and what, whether the doctor would have to, like, negate the presumption in order to allow substitution, or whether it be like we have now, that substitution is required unless the doctor says don’t substitute,
Daryl Wiesen 1:02:42
I think another option for the brands is to focus detailing on these issues.
In other words, to when they go to market their product to doctors, to explain to them the generic does not have this indication on the label, you should write what’s called dispenses written require the brand product for these indications that are still patented related to that, and I think most innovators would not want to take this pathway. Historically, people have been, have not done it. Is technically the doctor is still inducing infringement of the patented indications, you could sue the doctors. Now, no one likes the idea of that. No one has that, I know of, has gone down that path. But actually, in the Hikma v. Amarin case, there was a second defendant, besides Hikma, which was the insurance company, and I think another thing people are going to think about is if the insurance company is willing to reimburse the generic for the patent infringement, are they inducing that that infringement? I think that becomes another question to sort of think about how to go about this, and then the last idea is just to think about what is your patent portfolio. Can you come up with any other IP as an innovator that you can use to try and keep the generics more generally off the market? Finally, I guess I said last, but one more thing is wait a little bit longer to file a lawsuit and see what the generics say if they end up doing more marketing, they may mess up, for lack of a better description, and say something you can use to prove the active affirmative inducement. Part of what happened here again was Amarin sued Hikma quite quickly after the launch. There was not a lot of public statements. Now, generics don’t do a lot of marketing, so there’s not going to be a lot out there, but watching carefully and seeing what you can find is another option for the brands and the innovators to try and continue to enforce these patents.
Jaime Santos 1:04:54
I mean, certainly in the product liability space, there have been lawsuits against the generics for off-label per. Motion, there are, investigators, experts who talk about, what someone, and I know that the Supreme Court doesn’t want speculation about what a particular doctor might have read into a particular statement, but I could see, some plaintiffs’ lawyers coming forward and filing a complaint with, more well-developed allegations that in this context, everyone knows this is a wink and a nod, everyone would understand it to mean this, or even kind of, filing something with an expert report, or with, further evidence about what the generic is doing, whether it’s off-label promotion or something else, but I do think it’s going to have to be way more than just, you know, you gave the total amount of revenue for last year.
Isabel Marin 1:05:47
Wow, that’s all very interesting. And speaking of potential state legislative action, I wonder, Willie, do are there – is there any federal legislative action on the horizon tackling this issue?
William Jay 1:06:00
Actually, like the day the decision came out, the House Judiciary Committee was having a hearing on the cleverly named Skinny Labels Big Savings Act, which is a piece of legislation that would overlap somewhat with what the Supreme Court has said. So, in other words, some things the Supreme Court has said are not actionable, the legislation would also say are not actionable, but the legislation is a broader safe harbor for skinny label generics, and it also would do another important thing, which is extend the same principle to biosimilars. Biosimilars are to oversimplify a bit, the generic version of biologic medicines. Biologic medicines are sort of big molecules where you know standard medicines are small molecules, they tend to be have a have a component that is made in or reminiscent of something made in like a biological system, like synthesized like a protein, and this decision by the Supreme Court refers several times to long-standing commercial practice, longstanding usage in the small molecule brand generic space. These are not as well established in the biosimilar space. Biosimilars are not chemically exactly the same as the product of the reference product that they, whose approval they piggyback off of, and they do more marketing, they some some biosimilars in some states get automatically substituted, but many do not, and so biosimilar companies often wind up doing more marketing of their product, and the exactly as Daryl was saying, there may be more opportunities to capture marketing that is gives at least a plausible basis for an induced infringement claim.
The legislation, I think, would say whatever that, whatever such a claim might be, it can’t just be based on saying I am a bio similar of or I am therapeutically equivalent to the reference product.
Isabel Marin 1:08:10
Really interesting. Last question for the team, Jaime, what should we read into the terms indirect infringement decisions outside of the skinny label contex?
Jaime Santos 1:08:22
So I think if you kind of take together Grokster, Cox, and nowHikma, I think the court is sending a pretty clear message that when we’re talking about products that have both infringing and non-infringing uses, that’s really been an important premise of all of these kind of high standard for inducement cases, the court does not want someone to be liable, or maybe even subject, subjected to expensive litigation, unless there are some pretty clear signs that they’re actually trying to get someone to infringe, and I think that’s especially true in the Hatch-Watch, the Hatch-Waxman context, where I think the court was very worried that the threat of litigation and the total inability to resolve the threat of litigation before launch would really just chill generics from using this pathway at all, which would undermine the whole purpose of the statute.
So, I think in future indirect infringement cases, whether patent or otherwise, I think plaintiffs are going to have to point to a lot more than conduct that seems anodyne, or that can kind of be taken either way, and I don’t think it’ll be impossible to win in other cases, or impossible to, you know, viably plead an inducement case entirely, but I think you’re going to have to come forward with some pretty strong evidence, and show that, you know, even if the defendant didn’t expressly mention every claim element, they were doing something that everyone understands to be equivalent to a wink and a nudge. I don’t know if others have used though on that.
Daryl Wiesen 1:09:51
I agree, not much of a view, I suppose.
Isabel Marin 1:09:57
Well, we have gotten a bit over time. And I just wanted to reiterate what Jaime said at the beginning, to please reach out to us if you have any questions or would like to speak further, and I’m going to turn it over to Vincent for the final goodbye.
Vincent Joralemon 1:10:14
I just want to say thank you so much to the amazing folks at Goodwin Procter for this fantastic presentation, and hope you all enjoyed. Thanks, everyone.
This transcript was created with an automated transcription service and reviewed by a human