Engelberg Center Live!

Section 112: Amgen v. Sanofi

Episode Summary

This episode is the discussion of the Amgen v Sanofi case currently before the US Supreme Court from the Engelberg Center's Disclosure Under Section 112 in Policy and Practice event. It was recorded on April 19, 2023.

Episode Notes

John Desmarais (Moderator), Desmarais LLP 

Judge Kathleen O'Malley, Irell and Manella LLP 

Lisa Pensabene, O'Melveny & Myers 

Jonathan E. Singer, Fish and Richardson

Episode Transcription

Michael Weinberg  0:00  

Welcome to Engelberg Center Live!, a collection of audio from events held by the Engelberg Center on Innovation Law and Policy at NYU Law. This episode is the discussion of the Amgen versus Sanofi case currently before the US Supreme Court, from the Engelberg Center's Disclosure Under Section 112 in Policy and Practice event. It was recorded on April 19 2023.


John M. Desmarais  0:27  

Hey, everybody, I'm John Desmarais. I'm a patent litigator at Desmarais LLP. I've been in patent litigation for over 30 years. In fact, this weekend is my 35th reunion here at NYU Law School. So very excited about that. And I do a lot of Life Sciences cases. So the Amgen case, is a keen interest in me and my practice, you know, when you think about the importance of the case, and what people are debating, as Bruce well outlined, and what the Supreme Court is considering right now, you know, with a stroke of a pen, they are destroying, you know, billions of dollars in these patent estates. I mean, it's literally billions of dollars, not just at one company, but at individual companies, their you know, the the ramifications of the outcome of this case is, is phenomenal, and will have I think lasting impact on innovation in the biotech area if, if not the tech area as well going forward. So this panel is a great panel to sort of kick off the issue. We're going to discuss the Amgen case and what really is going on. And what is it the supreme court's going to decide and we have a great panel for you. So let's start with Lisa pensive. Annie, who is partner at all, Melanie, like me, she's been doing patent litigation for Big Pharma for many, many years, not as many as me. I'm older than Lisa. She deals with 112 issues regularly, if not on a daily basis. And she'll give us insights to help Big Pharma thinks about these issues and about some of her cases. And then we've got Jonathan, he's a partner at fish out in the San Diego office, one of my favorite places. He as well has been litigating patent litigating pad cases for years. And deals with 112 pretty regularly. In fact, he represented Gilead and the big identical versus Gilead case where Gilead identical patent on 112. So Jonathan is a bad person. And hopefully, he at least, are on opposite sides, at least is going to be pro Big Pharma and, and Jonathan will tell her why she's wrong. And then to mediate those two, we have the talented judge O'Malley, who was on the district court for years in the Northern District of Ohio, that was elevated to the Federal Circuit, where she served for over 11 years. So hopefully before the end of the end of the panel, she will resolve all this for us. animate the dispute between Lisa's view and Jonathan's view and, and hopefully predict the outcome of the Supreme Court decision. So we're putting a lot of some of those introductions. Let's


Judge Kathleen O'Malley  3:16  

That's what we get for missing the prep panel.


John M. Desmarais  3:20  

Exactly. So with that background, let's jump right in. So the Supreme Court took the Amgen case on section 112, on specifically enablement. And let's have Jonathan give us a little background on what the Federal Circuit opinion what they said in their opinion that got the Supreme Court interested in the issue. And, you know, what exactly did the Federal Circuit hold? And why was that interesting to the Supreme Court. So with that, I'll turn it over to John.


Jonathan E. Singer  3:47  

Okay. Thanks, John. And full disclosure, you can't throw hard to tell which side John is on read. He's got I've got. I've got his amicus brief on behalf of the petitioners here and in the pending in the pending matter before the Supreme Court. The question John asked was, you know, what did the Federal Circuit hold that was so interesting with all they did really, I mean, in their defense was hold the same thing they've been holding for quite some time. Now. I mean, this is nothing, nothing new that the Federal Circuit did in the Amgen case, but apply, it's fairly long standing full scope of the claim, enablement test. And what is the full scope of the claim enablement test? It asks simply have you enabled? Have you taught the person of skill in the art to practice without undue experimentation? The full scope of the claim, not just an embodiment here and there, but the full scope of the claim? And of course, that question then becomes what the heck does that mean? And it's a it's a great question. And it's a question I think the Supreme Court for those of you who listen to the oral argument, but those of you who read the briefs are for those who know nothing about the case other than what I'm about to tell you, our will be able to appreciate and I think in good terms that Bruce laid out for us right at the beginning In it, because those are were excellent comments by Bruce that I think really will guide our discussion today. So what's the case about just a little bit on the facts? And then John, I'll I'll hand it back to you for questions about the case and all the other cases that that relate to it. Pretty simple in case in terms of trying to understand and I'm gonna keep the technology down at a level that I like to understand it. So the claim, so but let's step back to what was the invention, a very dangerous word it sounds like. But these were drugs that help people with lower cholesterol, essentially, just just that simple. As a lot of the people in the room know having high cholesterol is bad. And the drugs were about helping people lower cholesterol, so they reduce the risk of heart attacks and the like. Unlike the statins that many people are familiar with small molecules, these were antibody based drugs and the claim at issue, the claim not the invention, the claim that issue related to an antibody, that binded, one of 15 particular protein residues in a particular protein that destroys LDL receptors in your level, LDL being the bad cholesterol, that causes heart attacks, and those receptors stick out from your liver, there's a protein in your body that binds to those receptors, and gets drawn into the liver and actually destroys them so that they don't reemerge. When LDL binds those receptors, they go into your liver, your liver destroys the audio on those receptors come back. But this protein, it's P with P C S K nine, destroys the receptors, and the antibody competitively binds to that protein, and stops it from binding to the LDL receptor simply blocks the action of that protein. So that was the claim any antibody that bound to one of these 15 residues that would block binding to the LDL receptors in your liver,


John M. Desmarais  6:56  

could have used you at the Supreme Court.


Jonathan E. Singer  7:00  

But you know, therefore, you know, helping you reduce LDL cholesterol because those receptors still exist, right? They're no longer destroyed by this, this protein in your body, which we will discover in 10 years is probably the greatest protein in your body that does something else, but which today we know of as destroying LDL. So that's the claim that was issue. And there's a battle to Supreme Court now. Okay. Why did the Supreme Court take this case? I don't know that anyone will have a definitive answer. But this test that the Federal Circuit applied here, if we accept the claims, by Andrea, that they were the first right to identify an antibody that could do this, right, and identified this sweet spot, which is what they call it nice phrase, good phrase, good jury phrase in the protein where you needed to bind these antibodies, right that you had to bind this sweet spot in the protein. And if we accept that they identified that, and I think that's kind of the the battle here, then the question for the Supreme Court really boils down to is Well, shouldn't they haven't discovered that sweet spot, sweet spot? Why should they be eliminated limited to the particular embodiments that they isolated, if you will, the particular antibodies that they marketed that bind to that sweet spot, and prevent this whole process of destroying these receptors? Versus right, that's the Amgen point we why should we be limited at we discovered it, we taught everybody how to do this. Why shouldn't we be able to claim any antibody that binds versus the Sanofi side? You invented these one or two, or in the case 26 antibodies that bind this sweet spot? It's if you will, you put your metes and bounds your piece of real property, and you are over here in the top right corner of the property or the top third, however you want to describe it. You know, you're over here in this top third, you didn't explain what's in this other two thirds of the property. All you did was the 1/3 of the property. Why should you get a claim to the two thirds where we are? We're over here down in those bars. Se we're over here in San Diego. You know, we're here in New York, you invented the New York and the whole northeast corridor or whatever it is. We're we're over here in San Diego, why the heck should you be able to get to claim that? That's the fundamental question that's at issue in the Amgen case. And frankly, it's the issue in almost every validity case that the Supreme Court takes, right? Why does Supreme Court take these particular bloody cases? Bruce, I'm just I'm just stealing from good travelers. We're all good travelers, we just steal everything. All we do is steal from other people to steal from Bruce. Yeah, but that's what we do. And so this is the issue in almost every validity case before the Supreme Court is what is the appropriate breadth of the claim versus what somebody discovered 112 police's that disclosure aspect of that you disclosed, one to one police's public policy? Do we want people to claim particular things, period? Right period? Or do we want to just reserve those for the public? And then 102 And 103 relates to the prior art? Have you claimed something too broadly, to cover the priority? That's it. That's what the Supreme Court is interested in. And they haven't done a 112 case for ever, almost, it seems. And that's, I think, why fundamentally, they took the case they see case after case coming up to them that they've denied certain isn't well, you know, in my opinion, it's about time we took one of these whether this is a good vehicle or not, I think we're gonna argue about here on the panel. But that's, I think, why the ticket


John M. Desmarais  10:44  

date, Jonathan, that was that was great outline. And, as I said, for those of you who listen to the Supreme Court argument they could have used, Amgen could use Jonathan's explanation because they had trouble explaining the invention. But let me just add one thing, for those of you who not too facile with the science here, as Jonathan explained in this claim, or this invention, you know, the antibody that Amgen came up with bound to the right places to get the activity that Jonathan described. And for those of you who understand antibodies, the rest of the antibody is sort of irrelevant. So any scientist of ordinary skill could change the other aspects of the antibody, as long as they kept the parts that were binding to the right places. And so the Federal Circuit said, you know, because there are so many permutations of antibodies that will do this, and Jim's claim was just too broad under 112. But from a scientific point of view, that's sort of, it's hard to grapple with, because any scientist knows you can change all those other things, and they don't make a difference. So, so let me throw it over to judge O'Malley and say, you know, did the Federal Circuit get it right, and Amgen? Is that, did they? And


Judge Kathleen O'Malley  12:02  

well, the Federal Circuit certainly thinks that


John M. Desmarais  12:04  

you can say no, because we're not on.


Judge Kathleen O'Malley  12:07  

The Federal Circuit truly believes that it didn't do anything to change the law. Mm hm. And if anything, Alan Laurie's opinion, I guess, I'm not sure what to call it, because it's not precedential. It wasn't by the whole court. But he wrote an opinion. He wrote his own views, I guess, additional views, as Judge Rader used to say, about why it was okay to deny cert. And he I think he was responding a little bit to that article that Mark Lemley and and Dimitri Karstadt had written about is the genius claimed dead. And he wanted to say, no, no, no, no, this isn't anything new. This isn't anything different. It's just that, that you have to at some point, limit the number of exercises that you have to take to make these determinations. What was a little disconcerting to me is that, that I think that that am Jim's point, that the Federal Circuit seemed to just say it's cumulative effort was all you're saying was was was enough to make it bad, even though anyone could get there. That they were saying that's different than than the Federal Circuit had ever said before? Because it had to be cumulative plus undue experimentation. And, you know, there really wasn't any evidence that it would be undue experimentation to to accomplish this. There had been a couple of cases before that sort of procedure. This, I think, where it used to, it troubled me when I was there, because there were cases where they'd say, Well, you know, it doesn't matter how easy it is, if you have to do it a lot to make sure you've covered the whole gamut, then then just pure numbers alone is a problem. And that's where I think the Federal Circuit went off the rails not because I think that in this particular case, they might have not might not have been able to get to the right, the same result. But because in this case, there was really just no evidence that that the experimentation was necessarily undue.


John M. Desmarais  14:19  

I mean, there seems to be in the Federal Circuit, at least to my perception, a little bit of hostility towards biotech and the use of 112. To to knock down these biotech claims. Can you do you perceive that to and if so, why, or why is the Federal Circuit hostile? Yeah,


Judge Kathleen O'Malley  14:33  

I mean, I think there's a lot of people that think the Federal Circuit is somewhat hostile to biotech or somewhat hostile to patents if, you know, in terms of the majority of them, but but I don't think they think they're trying to get to a policy and I think that that what one of the things that I suspect, and this is not from, you know, inside baseball, information from other people telling me things. But I kind of suspect that some of these cases were an effort to avoid 101. In other words, they looked at the patent and said, you know, this may very well not be eligible. But we don't want to have yet another one or one data point where people can say, we're confusing the law. So if 112 can be a vehicle to get to the same place, and they're comfortable believing that you're getting there, then I think that's why we're seeing this expansion of 112. I'm not sure it's a conscious thing, as much as it's a conscious thing to avoid a one to one. And, and there are probably good 112 arguments with respect to a lot of these kinds of patents.


John M. Desmarais  15:42  

Thank you, Judge. So Lisa, let me ask you, based on what you've heard so far, and what you know, about what the Federal Circuit is doing on 112, in these biotech cases, are our genus claims or anybody claims data at the Federal Circuit going forward?


Lisa Pensabene  15:58  

Well, I think the first thing that we have to think about too, is that genius claims are important to all technologies, period. Right? It that's what an invention is, it's more than just or this would Bruce actually was talking about, is it just the one form that you made? Or is it something more? And that's something more is a genus, right? It's these couple of these different ways and how big that genus is, depends on kind of your invention, right? How many different ways can it be done? Range claims are geniuses to write it's many, many different, different parts. So these are important all over not just to form or to biotech, of course. And it seems like the real issue that's troubling, and I throw this to judge O'Malley, but there's trouble the Federal Circuit is a functional genius claims. It's not a structural genius, right? There's lots and lots of chemicals, right? Because we know we can see them, right and point to them and say, Well, I know there are a million, and I can point out each part of them. But it seems like these functional genius claims which have a more maybe amorphous edge. That is the real trouble here. And I think, as Judge O'Malley pointed out that in some ways, this is kind of dirtying up 112, when it's really a section one a one, it's really a patent eligibility question that is that is at heart, the problem. So are they dead? I sure hope not. Because I think Chad, his claims are really important. And they shouldn't be dead. Are they going to be limited? And what should we be doing in the future? I think is kind of a question. What about prosecution in the future on this? And you heard some of this in the arguments in the Amgen argument, should we be going to means plus function claims to deal with some of these questions? Should there just be some kind of common structural features like area of like, make sure you always have structure in the claims, as you're prosecuting? Maybe consider explaining why the invention works with reference to structure to protect yourself from 112.


John M. Desmarais  18:16  

What do you think she would think I'm throwing an unexpected question at you. So we'll see how your How do you think the patent office overall circuit would react if it was a an antibody that was a means for binding to the particular places?


Lisa Pensabene  18:29  

You know, I think that's interesting, because then if you think about we have a government what, what the government argued right in, in the argument in front of the Supreme Court was that the doctrine of equivalents, right, would fix this problem, right? Just use the doctrine of equivalents just claim your exact antibody, and you can get anybody else with the doctrine of a court because it's predictable, right? Because it's not. And but it means plus function claims, similarly, you're going to have to have equivalents. Right? So I think it would have changed the tenor, right? Of the argument, and maybe given less of a of a hook.


John M. Desmarais  19:08  

Why don't biotech companies use me as well? Because I've received


Lisa Pensabene  19:12  

no, you don't ever see them. But but also, but they're limited then to the equivalence of the structure that's in the in the specification. And there's a lot of uncertainty then write about, and you heard the you heard the arguments that were made that wait, if it's a different, if you have a different amino acid, are you going to wind up with an argument that is non equivalent? So so it's messy, and it seems like by putting this as 112 It's almost made messiness in these other aspects of the statute when the question is really almost more as I think going back to what Bruce was saying, a philosophical one,


John M. Desmarais  19:56  

and philosophical, the thing that I found really curious About Amgen is, Big Pharma us was totally split. So you had Amgen GSK, Bristol Myers Squibb all submit amicus briefs for Amgen, and others. But then on the other side, you had Johnson and Johnson, Janssen, Eli, Lilly, Merck, submitting amicus briefs. For the other side, why is Big Pharma split on this issue?


Lisa Pensabene  20:22  

I think that's kind of that that's probably doesn't have any easy answer, that there's a nuanced answer there. And part of it is perhaps different philosophical bases, right, that the kind of arguments that again, Bruce race, but also philosophies of patent prosecution, you know, each it philosophies and strategies that each company uses, and is aware of, and is looking down the pike and saying, Oh, this is this is not going to be good for us if it comes down this way. So I think that's part of it. And different perspectives really on encouraging either searches for new targets versus searches for other ways to hit the same target. Right. And so different philosophies on whether there is a danger in sort of controlling a particular target where some companies feel like that's what they invented, and others think, no, it's the way and I should be able to hit other people's targets. Yeah. And I think that's kind of a really fundamental,


Judge Kathleen O'Malley  21:25  

I think, part part of it is is that that this, this claim was really pure functionality. I mean, you're claiming the thing, based on what it does. And I think that that some of some of the pharma companies think that that's dangerous. And they think that if you can have purely functional claims, as opposed to more well defined functional claims, then then, you know, how do you know whether you're going to get hit with with some kind of an infringement challenge? And so, you know, I mean, I, I know that some think that that's short sighted, and because you're, you're, especially when you're talking about antibodies, because they are a different animal, and there was some discussion with the Supreme Court, maybe we should treat it as a different animal. But I think that that there, there was a lot of concern about how purely functional This claim was. Yeah,


Lisa Pensabene  22:18  

I think that the functionality was really the, you know, the big issue and what somewhat divided pharma and some people thinking about it just in terms of antibodies, right. And the particular you know, the name of the game is the claim that this particular issue that's in front of the Supreme Court and others thinking about it in a different sense. And I do think we have to think about not it's not just big pharma, right, that has different philosophies. Here. It's little biotech, too, right? Little biotechs out there getting enormously broad claims, because that's what brings in their IPO money, right? That they're covering a big swath of the area. So that may be part of what, you know, the established pharma companies are saying, I'm gonna get hit with these, like super broad claims that this little biotech has, right, almost like a, so that that's an issue too. And universities similarly are looking at these kind of broad, they wind up getting these very broad claims that say, like, our guy's been investigating this for 30 years, it's his life's work. And we're entitled to this broad claim around this whole technology. So there's a lot of I think, Nuance things at play here. Based also important on you know, kind of where the money's flowing.


John M. Desmarais  23:31  

Moving on to another interesting thing about the Amgen petition, so in addition to the fact that it's split Big Pharma. Amgen petitioned on two questions. First, the Federal Circuit held that enablement to question a law, which is sort of funny because of the second half of the same sentence written description they have is a question of fact. And so Amgen petitioned the Supreme Court for two questions One is, you know, the Federal Circuit is wrong, saying enablement is a question of law. And they've had, you know, they cited some early Supreme Court cases that came out the other way. And the second question is the one they took, which is whether the claim was valid under what 12. But I would have thought the Supreme Court would have been more well suited to answer that first question about law versus fact. And it was, in fact, contrary to prior Supreme Court questions or decision. Why didn't they certify on both?


Judge Kathleen O'Malley  24:23  

I think they didn't certify and both because they've been struggling with this law fact distinction in a lot of areas of law, not and, you know, putting patent law aside, and they haven't always been in agreement about how you handle it and how you define it. And I just think they didn't want to touch it for that broader purpose. That's my guess.


John M. Desmarais  24:45  

Well, Jonathan, I know you do you try a lot of these cases. Does it make a difference to you that it's a question of law or fact, however, the case is resolved in the real world.


Jonathan E. Singer  24:54  

It's funny, you know, when I read that part of the opinion, I was like, wow, it's an issue of law. I didn't know that because when we Try these cases they go to a jury. And then the judge, of course, will then do whatever the judge does after but I have yet to have a case where the issue wasn't sent to the jury. And they the issue of 112 going to a jury is a very serious one. And it's one why you why you see all these 112 cases is because it is the most when you when you we do a lot of of course, mock trials, when we are getting ready for these million dollar cases, as you might expect. And when you confront the ordinary citizen with the doctrines of enablement and written descriptions, description, it's hands up, right, they have no, and and I think it makes sense that they have hands up, they're being asked to take the patent document the disclosure, and compare it to the claims. These are fundamentally legal things that they're being asked to, to focus on. And so to have the Federal Circuit say that it's an issue of live, hopefully, we'll be able to use that when I'm on the defense in the future, to get these cases out from juries because they're exceedingly exceedingly difficult to win in front of a jury. Judge O'Malley I think I looked and And, John, I was wrong. You know, I had, I said, I hadn't heard of a case on 112 that a jury had found for a defendant. I bet I found one on the advi case, from 2014. The jury didn't rule for the defendant in that case, but every other case that you see is a jury verdict of, you know, something with a billion, starting with a billion and up, and then the Federal Circuit, or the judge comes in and says no, no, these patents are invalid under 112. And it's a real problem. You can you can go to juries with non infringement, anticipation, obviousness, these are concepts they get, because they're like, Well, are they practicing the invention? Or they're not practicing invention? Did somebody do this before these guys are idiots, or these guys really invent something new versus I have to look at this legal document written in language, I don't understand and compare it to this other set of legal stuff that claims that I also don't understand. Very, very challenging for jurors to do that.


Judge Kathleen O'Malley  27:17  

And they're going to have an expert who says, of course, it's enabled. I've got it, you know, the other side might not get it, but I get it. And and obviously, the inventor got it. Right. And so I think that's an easy way for juries to say, yeah, it must be an a,


Jonathan E. Singer  27:32  

an almost always right. If you're doing a 112 defense, you are presenting to a jury as an infringer. You're an infringer, that's why you're presenting a 112 defense, it's very hard to to somehow preserve a non infringement defense and try a 112 issue at the same time. They tend, they tend the two shall never meet. You can try but but it's very, very difficult to


John M. Desmarais  27:58  

do. exposing my bias. I know what's your bias, primarily a jury trial? Or why should we trust the jury when you have you have both sides have experts in both sides, experts give opinions on whether or not it's enabled or whether or not the written description is met? And the jury, in my experience are great. Juries are great at sussing out who's telling the truth and who's fibbing? Why shouldn't we let it rest on their determination of which expert is right because I watched the Supreme Court argument ambient? And I don't feel more comfortable with that. No, I just


Jonathan E. Singer  28:40  

I hear you know what to be fair, you know, my, it's funny. Half of my life, I work for big pharma, in, in hatch Waxman cases, small molecules and the other half of my life, I work for a biosimilar companies on the other side of the coin. So I do both of these. And so I depending on which hat I'm wearing, John, I get to go to a different panel. Next, I'm going to fail next week. I'm taking the opposite side. But But I believe in germs. I do. I think the jury system we have is terrific. I've I've observed trials abroad, where I'm sitting there watching, you know, to listening in, I was a Norwegian, Swedish court, watching listening in English of the thing was so painful to listen to. But it wasn't better. You know, it was just different. And it's not that we don't trust juries. John, it's that it's a big challenge. It's a much more difficult challenge for jurors to measure a disclosure compared to the claims than it is to suss out as you would say, who's telling the truth and whether there's an invention here or not, and who's telling the truth and why not there's infringement, they have alternative things to look at. So for infringement, they can look at emails that say, Oh, crap, we're right in the middle of these claims, which they're often yes or uninformed on invention emails, say, Wow, did you see the patent? Those guys got incredible. On 112? Ah, no, I haven't seen too many emails that, you know, in the cases that we've tried that talk about? Well, you know, this disclosure really does say what's in the claims, right? It just, it's just not the same. There aren't those real world things to compare? In your own experience to with this, this issue? That is an issue of fact, that is very challenging for people?


John M. Desmarais  30:26  

Well, let's stay on this theme of who should be deciding these issues. Because I had the pleasure of sitting in at the Amgen argument at the Supreme Court back on March 27. And for anyone who knows anything about patent law, or anyone who knows anything about antibodies, it was horrifying. There were three litigants, one for Amgen, one for Sanofi Regeneron and one for the government, the Solicitor General. And the three of them, not one of them knew anything about the science or or patent law. And in fact, could the amateurs lawyer when asked directly by Justice Thomas, what is the invention fumbled and couldn't get that out? You think he would have prepped on that? And then, and then Paul commit comment, gets a question from the same question from justice. Thomas says, I didn't get a clear answer the image informasjon tell me what the invention is, is it? And Justice Thomas tried to help them by saying, you know, you start out with this antigen, and then you generate all these, the computer generates all these antibodies, and then you get down to 30 or something. Is that right? And Paul comments, as I don't think this is almost a quote, I don't think is done by a computer. I think a human does it at the lab bench. But frankly, Your Honor, I just don't understand the details of the image. Like, have you had a Supreme Court argument? Where the only question is, what is the invention? How did these two guys how are they not able to do that? So really frustrating. And then when you watch the, the justices, the we're asking the most basic questions struggling to understand they were trying their best to understand the science and metes and bounds of the claim, and they were not getting it. And as a patent lawyer, like I want to raise my hand and say, I'll go to the podium. Let me straighten, you guys. So that leads me to my question to judge O'Malley haven't been on the Federal Circuit. How do you feel about the Supreme Court weighing in on these intensely detailed patent issue? So So Jonathan prefers the judges over the jury? After watching the argument? I'm not so sure I agree. But but as between the Federal Circuit and the Supreme Court, like, what do you think? And how should these things be resolved? Yeah,


Judge Kathleen O'Malley  32:38  

I can now say this, every time the Supreme Court touches a patent case, I cringe. Because it's not just sitting here. You know, it, even in times when I don't disagree with how they come out. They always mess it up. Because they don't really understand. And it's frustrating, frankly, because, you know, they dig into other areas of law, they dig into antitrust, they dig into other things. I don't know why they don't dig in more to patent law and try to understand it. And maybe it's because we're having generalists do the arguments at the Supreme Court. And so maybe they the generals are trying to avoid making them dig in, because they know how painful it is to take into patent law. But that was the first thing that I said when when the Supreme Court took this case is Oh, my God, you know, it's people are arguing enough about where 112 is and where it should be. And after the Supreme Court touches, it could be completely confused. I suspect that might not happen, because because they don't understand it. I think they're going to try to not touch it. But but I generally think that juries are better than the Supreme Court and patent cases.


John M. Desmarais  33:53  

So Lisa, Jonathan, do you have coming up with a Supreme Court should be weighing in on these technical patent cases?


Jonathan E. Singer  33:59  

I think they should. I don't, I don't even have the I get the heebie jeebies, just like anybody else. But you know, it's it's a very important part of our law, and the Supreme Court ought to weigh in on it. I mean, I don't really think it it's, it's a negative thing. Did they did they do their best? And, and we go forward with that, but I think it's a societal thing. It's it's a good thing. And as you know, I've been involved in Supreme Court cases. And yeah, you get up there and you listen to the questions that they ask, and you can, it's easy to poke fun in. And I have so you know, I'm not I'm not innocent here. But these are the same kind of things that that district court judges who don't regularly deal with patent law, they asked the same kind of questions, they get more time on the case, right. So they get a little better handle on it than the supreme court because they have to try the case. But um, I think it's, it's a difficult and challenging area, and I like your judgment. I just wish they would spend it. But from my perspective, you're right. They only do one or two cases a year, I wish they would dive in deeper. Right? And so then we'd get the more nuanced treatment, but they're busy court,


Judge Kathleen O'Malley  35:08  

maybe they should hire some former federal circuit. It might make a difference.


Jonathan E. Singer  35:12  

I'm sure Josh is gonna tell us all about it. Josh Rosencrantz over there. He's gonna tell us all about the Supreme Court and patent cases. And I'd be interested in what Josh has to say.


John M. Desmarais  35:22  

Or at least what do you think the Supreme Court should do in this case?


Lisa Pensabene  35:25  

Oh, well, I think first, we have to think about what what what could the court do? Right. And then what should they do sort of ripping off what what both of you said one of them? I think one of the most dangerous things that the Supreme Court could do here is to kind of wade into the policy and graft onto enablement, issues that really are issues of section 101, you know, obviousness or doctrine of equivalents, because at the argument, there was this wide ranging arguments of policy that didn't stay in the enablement lane at all. They were in whole other sections of the statute. So I think that that could be a dangerous and messy thing that would make a neighborhood confuse enablement law than for the, for the future, but it doesn't seem like they were inclined to do that. So I'm hopeful that that won't be the case. And the other extreme, I think what they could do is they could dig it, right, they could just dismiss as an improvidently. Granted, because there isn't a question a lot. Right? And they sort of alluded to that as well. Right? That that could be a potential outcome, and just


John M. Desmarais  36:35  

see if it was hoping for that.


Lisa Pensabene  36:36  

Yes, indeed, indeed. So it was to know. Exactly. And then the other thing they could do, which was another weird thing that kind of came out in the argument was kind of wade into the facts. Right, they spent, there was a lot of time spent on what are the what were the facts here, rather than really what the question of law was here. So they could wade into that and look at applying the, the facts. And that would be kind of messy and sort of procedurally problematic, right? And have some procedural ish impacts. And then I think, finally, and this where I think they should go is they could clarify the law. And I think here, and the question came up, you know, repeatedly is this idea of cumulative effort, and judge, Judge O'Malley, raise that just before and that's kind of been a weird thing grafted onto enablement of the full scope of the invention. And I say a weird thing grafted onto it. Because if you think about it, and this is really from the jury perspective, right, juries are good at logic, right? Is there anybody who wants to go in and make every single embodiment of a claim? Right, as a business matter, right, that that somebody actually logically wants to do? No, they don't, right? There's never ever a person who wants to do that, who wants to make the each embodiment of the so that you care about the cumulative effect of making every single embodiment of a claim? It's just not a real life scenario. So why is it part of our enablement? argument? And it really it's not in the statute, right. The statute doesn't say, make and use every single embodiment that anyone can think of. of the invention, right? The statute says making use the invention, right? You only want to make one, right? I want to make this one. Is it possible? Yeah, I know how to do it. Because I read the specification. That's the question. So I think the Supreme Court could do a great thing for patent law, if they came in and said, this cumulative effort thing doesn't make a lot of sense, right. It's not really part of the question here. The question is, can you do it? Right, the court let's go back to the statute, which says making use so for me, personally, I hope they go back to the statute. And tell us about because I don't think that's this cumulative effort is good for either side. You know, it's not good for invention. It's just another sort of tool of kind of attacking Pantone, we can use the there are good tools, the wands, factors or other you know, other tools to do it. So that's my, that's my vote.


John M. Desmarais  39:23  

Yeah. Federal Circuit seem to graft on to that making us with a little extra requirements. Do you think the Supreme Court is going to say, cut that out stick to the statutory language?


Lisa Pensabene  39:33  

I would lay? I don't know, because there was a there was debate on that. Right. And as you probably remember, in the argument, Amgen and Sanofi seemed to be an agreement that that wasn't a requirement and then seem to diverge a little bit towards the end of the argument with Sanofi saying that it still was an important consideration, you know, not required but an important consideration and So I think that is something that is a legal question that the Supreme Court could clarify and seems curious about.


Judge Kathleen O'Malley  40:07  

They were grappling to find a legal question because the parties pretty much agreed on a test. And it was the test that was used. And if you read judge Lori's additional opinion, he said, No, we didn't deviate from that test. So I think that that the Supreme Court essentially, wants to agree with the Federal Circuit. I mean, even so much to the extent that there was a discussion of whether there should be a dig. But and then justice Cavanaugh said, Well, wait, if we're going to agree with this Federal Circuit Judge, I think it's important that we say we agree with the Federal Circuit and come right out and write an opinion to say that, and so then you think, okay, but what are they going to write about? And whether they use the language of the statute to rein in this cumulative effort, approach or not? Is is still up in the air. But I still, at least my gut reaction is, like it or not, I think they're going to affirm in this case, or they could send it back theoretically, and say, rethink it. And my guess is, if it goes back, the result comes out the same way with this language, amended somewhat.


John M. Desmarais  41:20  

Yeah. Before the argument, I thought for sure, they would reverse and say that the Federal Circuit had gone beyond the statute like they've done in prior cases, because it seemed teed up for that. And that seemed to explain why they took it. But then listening to the argument, I agree with you like as they asked both sides, did the Federal Circuit get the law wrong? And both sides seem to agree that the Federal Circuit got the law? Right. And the justices kept asking each other well, what what are we doing then? Yeah, and so I think you might be right.


Judge Kathleen O'Malley  41:46  

But I think that that Amgen, then in fairness to the to the litigants, I thought that there were a lot of things they did do well. But that Amgen did argue it's not so much the test is wrong. It's the application of the test. And and so the question is, how do you get to the full scope of the claim? And is it really true that you have to identify every single antibody that could possibly perform this function? And that can't be right in the antibody world? I think it was. Justice Barrett, that said, Well, maybe we should just say that, that the test is the test is the test. And if it doesn't work in the antibody world, then you go to Congress, which of course, we know what that would do. But I mean, I think that that there, that there was at least some understanding that in the antibody context, things are a little different, and that you were sensually, it's hard to claim things that work this way without being able to have a genius claim. But they didn't know how to fix that.


John M. Desmarais  42:57  

But one thing is curious about the Supreme Court was the question about why they took MJ, right, so they had two other options. They had the Titan V Juno and they had the identity versus Gilead, which I know Jonathan's you are involved in. What was it about iGenex versus Gilead or the kite VG, you know, that weren't, you know, interesting enough to the Supreme Court. But the Amgen case was how do you rationalize the choice to take Amgen but not the other two? And I think people think it was kind of a unit where after they took Amgen, they read petition and said, Right, we're the same take us and they didn't do that. What what do you think that happened?


Jonathan E. Singer  43:33  

That's obviously the brilliant lawyering in both cases. We were involved in both with working with Josh over here was a great team now. But those I think those cases to me I putting aside on KP Juno, it was written description. And maybe they only wanted to tackle, you know, one thing at a time. But there I think of those as different cases. I didn't lose really a moment sleep thinking that the identical versus Gilead case would get taken at the Supreme Court. Fundamentally, what that case was about was about someone who, who didn't invent the solution to the problem. The problem at hand being to cure Hepatitis C


John M. Desmarais  44:10  

says the accused infringer, no.


Jonathan E. Singer  44:14  

At the end of the day, they didn't actually have anything in the specification that actually worked. Right that to treat the the treat the disease, they excluded from the disclosure in the specification, the thing that actually did work to treat the disease. So factually, it was a very poor vehicle. John, if the Supreme Court wanted to elucidate the enablement law, it would have had to wait in my view, they would have be like, Oh my gosh, we gotta affirm this case, and it just would have been a poor vehicle. Kate versus Jr. And it's a similar case. It's a breath case, identities first Gilead, but in the chemical arts, so a little simpler than the antibody arts came first. You know, I think that is a very different case. Even though the Feds search In its jurisprudence, I think has judge O'Malley merged a little bit the requirements for written description and enablement in these genus biotech cases that the requirements are starting to look pretty darn similar. But I think in that case very differently, I think of the kite versus Juno cases, the person, I'm gonna really dumb this down for my own understanding that that they invented the steering wheel, if you will, of the car and ultimately ended up with a claim because it was about car t. So that's why think cars, they ended up with a claim of the steering wheel in any car, right? They invented that steering wheel, in this case, the backbone of the car, right, and they got a claim to the steering wheel in the car, in that case, the backbone plus this antibody region, the binding region that would bind to a target. And so they were it really goes down to philosophies of claiming, and the fundamental question that we have a little what's the invention, right? And they actually defended that case, by saying, well, we didn't invent that antibody region, we defend, we invented the backbone. And so we ought to be able to claim the backbone with the antibody region, because that antibody region, right people know what that is. And they say, Well, no, you didn't describe it in your specification, you therefore you don't get it. That's what that case is about, I think the Amgen case, John as the car, you invent the car, right? And you want the claim to any four wheeled vehicle that can drive from New York, to San Diego? And that those are fundamentally very different issues, should I be able to attach my invention to another aspect of the technology? That's the case versus you know, case? Versus if I invent something? How broad? can I expand it into a patent claim? I think it's a very philosophically very different issues. And I think it would, once the Supreme Court used, it's very smart clerks, and they have great clerks there. I know quite a few of them. Once they've explained that times, Oh, these are very different cases, even though they kind of look superficially similar. So I, that's how I understand you know why they would take one and why they would deny the other, even though the legal standard start to look very similar when you start to boil it


John M. Desmarais  47:09  

down. Right. That was helpful, helpful discussion. Let's open it up for questions. Anyone have any questions for this fantastic group of lawyers here? Oh, there's one in the back. All right. What do you got?


Speaker 5  47:22  

Terrific panels. Beautiful, having a turn. One possible legal difference. It felt like sort of ships passing in the night a little bit at the oral argument was? What does it mean, to enable the full scope of the claims? And how do we come to know that? And it seemed like, Amgen was basically saying, Does the patent teach you how to achieve and incremental embodiment without knowing in advance which one it will be follow our method, you'll continue to generate more, you'll randomly walk across the terrain, and eventually you'll get them all. Whereas Clemente for sort of Santa Fe was pushing this idea of, is it possible using the patent to achieve any particular embodiment that you please? Right? Like it sort of magic? I want to? I want that one. I want the 15 binder, you haven't talked about the 15? Binder, right, a particular one, and the patent gives me no help in answering that question. And I'm just wondering, I mean, that's feels like a pretty fundamental kind of legal difference about how to figure out full scope. I didn't detect the justice is giving a moment to this. And I'm wondering, is one of these obviously correct? It seems like it could, it could be pretty important for just figuring out what do we mean, by the Federal Circuit's kind of full scope? Well,


Judge Kathleen O'Malley  48:45  

I mean, that was the point that I was making, where I said that the that the parties agreed on the legal standard, but how to apply the law to the facts of this case is where they seem to diverge. And there was a fair amount of discussion from the justices about the cumulative effort concept. And, and so I think that they were zeroing in on that. And what's the right result? I don't know. And that's the problem is that there was not enough factual development about the, the, the antibodies here and how they how they would work and whether you would you really would likely stumble across a lot. That don't work. And and there just was no discussion of that scientific principle in in the Supreme Court decision, or the Supreme Court argument.


John M. Desmarais  49:38  

Yeah, I thought I thought the point Clement was making that you pointed out, was very clever of him. You know, if I criticize him earlier, so let me give him a pat on the back on this part. I thought it was super clever to point out, you know, a failing of the teaching of the patent if you want to call it that, but but I think gets a game he was playing, because I think if you understand the antibody science, what he was saying doesn't actually make a lot of sense because you don't necessarily care what the sequence is on the parts of the antibody that are not doing anything. So to say that I want an antibody with a particular sequence of amino acids, and it is to is to say something that doesn't make a lot of sense, really, what you want is an antibody that binds to these two places. And the rest of the sequence is sort of irrelevant. And if you follow the Amgen pact specification, you will get an antibody that will get a lot of them that will bind to the particular place. So I think he was playing a game of of sorts, it was a very clever game. But you know, and it was, it's interesting that you picked up on it. I did, too. But But I don't think it's a fair assessment of what should be the requirement for an antibody claim that you you have to be able to get a particular sequence for the whole antibody. I don't know at least if you have any thoughts on that.


Lisa Pensabene  51:01  

I agree with you. And I think it does come back to the name of the game is the claim, right? Because what is what is that works right? Under this claim, right? We have to look at the claim the claim says binds, right. And so that's what works means not I want one that looks like x. Right. So I would agree with you on on that. And I thought it was it. But it was a clipper argument.


Judge Kathleen O'Malley  51:27  

There was a funny exchange with Paul where that justices said, you just really don't like functional claiming. And and he said, it's amazing how the truth comes out.


leaks out. Yeah, leaks out. That's right.


John M. Desmarais  51:40  

And any follow up on that? Does that answer your question?


Speaker 5  51:43  

Yeah, I think I think it mostly did. I mean, I heard Clement to be doing something a little bit tighter to the facts than what you just described it. That slightly different from like, like an antibody with the following sequence that I'd like an antibody that binds on 15 of the 16 spots where it could write, which would be a kind of Holy Grail. Yeah, cuz they only got the Northeast Corridor. And San Diego's where the action is, right? They only got nine or less, so maybe they get the numbers not exactly right, right. But in San Diego, we got 15. And the patent gives me no help in achieving what might be better. But again, it has this feature of being able to call your shots, which felt beyond what I had normally understood by enabling the full scope and struck me as clever but not well rooted in the jurisprudence. Thus far.


Jonathan E. Singer  52:38  

I think these these the antibody claims present real difficulties for try to understand the question you asked, which is a really I think it's a really good question. But I go back to the go back to the Denix case is another example where it's a little easier to answer your question. So in that case, the the, the working drug that actually cured hepatitis C had a fluorine substitution at the two prime position down, that's what the case talks about. And the specification taught you no way, how to get to that how to actually make that two prime down substitution. And in fact, the it was very, very difficult to do a very hard subject of its own patent, etc, is a very challenging thing. And the patent didn't teach that. And that was one of the reasons. It went down on on enablement. And that's where I think that the line should be drawn. And I don't pretend to understand and know the science in the Amgen case. I just No, no, what I read. And the to me, I would vote for well, they should just affirm because and trust the outcome that that we got in the case, whether through the jury or the appeal process, because the ones test, I think answers, it answers the question that you have, there is room to present evidence on the point that you raised in front of the jury in front of the court, I can roll in under the current test, and I can present a hey, wait a minute here. Here's my expert who says getting that 15 residue, Holy Grail is simply not possible. Here's why. Right from the disclosure that's here. It's not enabled, specifically, right, versus I think what we're arguing here is it's really theoretical. And here we have examples of particular residues that are bound in the specification. But are we really comfortable that they should get the entirety of any combination of the 15, including all 15, which when we do the math is a huge number. And I so I would vote okay, we should just affirm because our current test allows litigants to present evidence on the very point that you raised. And you know, we'll live with the result in this case, and we shouldn't, I think, in my view, distort the law any further to try to match antibody cases which present an enormous level of complexity that a lot of or cases don't have.


Judge Kathleen O'Malley  55:01  

Well, you're, you're saying maybe we should trust that the result the jury result, this is the epitome of that trusting the jury. So actually the the the case was, you said, but you said from the jury, I said, What I'm saying is this is this is the epitome of that trusting nature. There was not one trial, but two. And that's what Justice Jackson was trying to say is, wait a minute, you know, is is the that was it's so clearly wrong. Especially if everybody's saying the test is the test is the test. So, so that didn't get a lot of play. But but it's an issue that I that I think, you know, everybody should think about is that it'd be one thing if if the jury found the other way, and we were all comfortable with that result. But having the jury found not once but twice this way, it makes it a little more uncomfortable to to see that being overturned. Yet last time I was in this room. I was giving a lecture on the importance of the jury trial and how we shouldn't let complex cases like patent cases be an excuse to get rid of juries. But but so I think that's important. It was I had a second point.


John M. Desmarais  56:11  

But now I wonder if it was if it was a question of fact, whether the district judge would have flipped it. Would it be a gold standard? It would have been whether the jury substantial evidence. Yeah. So that curious, curious, I don't know the district court opinion well enough to know if he would have flipped it anyway. That's interesting. Do we have time for any more questions? Or are there any more questions of Judge Jen? Yep.


Judge Raymond Chen  56:35  

Yeah. All right. Great panel.


Great event for NYU, I'm really glad to see that there's a lot of students here today. I don't see a lot of 112 cases personally. But for me, sometimes when I look at these types of cases, these genius cases, whether it's written description, or enablement, it feels like a needle in a haystack, where you have a big haystack. And maybe someone has found a needle. And in this metaphor, the needle is a good thing. And now you've found a needle, or maybe you found a collection of needles, and now you want all the needles in the haystack. But upfront, maybe when the application is being filed, you have no idea how many needles there are. And you also don't know how big the haystack is, I mean, the haystack could be the size of an ocean. And so theoretically, you could, you know, plug and chug your way through that haystack, and test out every single piece of hay until you've exhausted the entire ocean. That is the haystack. So now you've located all the needles. But upfront, it's really hard to see and know. And sometimes you don't really understand what the scope of the claim is until a decade later, where competitors have found some of those needles. And those needles might be out in San Diego, so to speak, as opposed to the northeast corridor. And now with that information, ex post information, I'll say you have a better grip and appreciation of the wide wide scope of where all these needles are located. And in that respect, it becomes it puts a lot more pressure on the patent owner to defend the scope of that claim. Because maybe, upfront, it was reasonable to say I have a representative number of species that I've located, but now against the scope of this claim. But now 10 years later, through the advance of science, there's an appreciation that wow, this claim goes really, really far afield from the collection of structures of needles that were initially identified to justify the scope of the claim. But that


Judge Kathleen O'Malley  59:01  

almost feels like and this is I mean, I see this in the Federal Circuit jurisprudence, it feels like the Federal Circuit is sort of moving, Blaze Mark jurisprudence into the enablement constant. So that name only enablement category. And I'm not sure if that's a good thing or a bad thing. But I mean, my gut tells me it's a bad thing. But it because they're supposed to be two different tests, which is what this right, like I said an area that the fact that they keep bringing more and more together makes me wonder whether they are too different.


Judge Raymond Chen  59:31  

But it goes fundamentally to the question we keep saying over and over again is how do we understand what the inventors invention is, and then figure out what should be the reward for that inventor for having invented that thing. And then how, what's the way to right size, the scope of the claim? It's something that is just going to keep reoccurring, and we're we're going to keep talking about this. And Kate is right. Judge O'Malley has right The the formulations for enablement and written description might vary or migrate in ways. But whether it's written description enablement, one on one, something else, we're going to keep asking ourselves the same questions of what's the right scope of the reward for an inventors invention that he actually where she discloses in a patent?


John M. Desmarais  1:00:21  

I think one way to solve this problem, and I'm really surprised that hasn't happened yet is what Lisa and I were talking about earlier, what what patent applicants are doing, in my view wrong in this art is they are finding chemical molecules that have specific function in the body, for instance, like a small molecule where it has a couple of rings, and those rings do something, they fit into a pocket, or they do something else and a human and the rest of the molecules irrelevant. Or they find an antibody that has, you know, binds to particular receptors, and the rest of the antibodies irrelevant. And what the patent prosecutors are doing in those instances, is they're trying to dream up how to claim that in a broad way to collect all the needles, as you're suggesting. So in the chemical arts, they, they will draw the backbone structure. And then we'll say, these are all places you can replace, and you can replace with any one of these million things and winds up being a trillion molecules, because they're trying to think about who's going to design around this, it's the backbone that matters, and all the other stuff doesn't matter. So some clever next Congress is going to design around it and in the antibody space, if you get an antibody that binds these two things, the rest of isn't relevant. So the next summer is going to change that. And they're trying to claim this with words, when they should be using the other part of section 101 12, which is means plus function. And nobody does it in the chemical arts, they should, in the small molecule, say, I've got dispensing rain and this federal ring, and they do the following. And in between is a linker or in between as a means for linking or, you know, around the antibody, you know, what's a means for binding to this receptor or something like that. And then they would be then limited, they'd have a broader scope, because they get any means by any means, disclosed in the spec or equivalent there too. And then you do an equivalence test. And the equivalence tests would, would provide some metes and bounds because if it was undue experimentation or it didn't do it, same thing in the same way or it's it's you know, a significant difference and we'd have the battle there. And we wouldn't be having the battle over you know, the words of a claim and how many needles were in it so I don't know why no one patents things with me so as function in the biological arts, I don't know. Do


Michael Weinberg  1:02:43  

you have a question you have to read linger and please join me in thanking this fantastic panel.


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