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Andrew Gesior and Elizabeth Weiswasser | Are genus claims really dead or can trial lawyers create a legitimate fact issue for the jury and survive appellate review
Juno IP is another in a long line of Federal Circuit cases flipping jury decisions on genus claims. What should prosecutors and trial attorneys be thinking about to survive both the jury and the Federal Circuit?
More on Andrew Gesior & Elizabeth Weiswasser.
SPEAKERS
Wayne Stacy, Andrew Gesior, Elizabeth Weiswasser
Wayne Stacy 0:00 Welcome, everyone to today's podcast for the Berkeley Center for Law and technology. This is Wayne Stacy, your host and the Executive Director for BCLT. And today we're going to talk about the Juno IP case and how a billion dollars disappears overnight. With me, we have two experts from Weill, Gotshal on this life sciences litigation and this particular case in the decades and making that it was we have Andrew Gesior, and Elizabeth Weiswasser, both from Weil, so thank you both for joining us. And I'm just gonna lead with I guess the basic question here for you is, why did the court flip this billion dollar verdict?
Elizabeth Weiswasser 0:48 Wayne, this is Liz. And I'm here with my colleague Andrew, thank you so much for having us. I'll start briefly I think with just framing the issue up and then I'm going to turn to my colleague, Andrew, to focus specifically on the Kite case. So I think it's important to understand the the framework on which the Kite case was decided. The case is really about 35 USC section 112. It's the part of the patent act that requires that claims meet the requirements of written description and enablement. The underpinning is you can't claim and own what you haven't invented what you haven't described, you haven't taught the public how to use. A number of decades ago, I would say, really, beginning in the early 90s. In fact, I was a law clerk with Judge Laurie, at the time, this doctrine really started to evolve in the biologic and pharmaceutical space of really looking hard at genus claims directed to biologic or chemical entities where the genus is not defined by the structure of what's claimed. It's defined instead by the function, trying to claim the molecules by what they do, rather than by what they are. And Judge Lurie, my former boss in particular was very focused on trying to discern what is permissible in terms of claiming by function and what is not permissible. And it's really beginning there, that we see the origins of this doctrine that has now really come into its own in a very fulsome way, with the Kite case. And so this has been developing over the 90s, 2000s, 2010s. And the Kite case is really just the latest, I would say, in a long series of cases that where the Federal Circuit has invalidated genus claims that again, are covering the genus of molecules defined by what they do, rather than by what they are. And what we have seen is that this has resulted in the Federal Circuit overturning a number of jury verdicts, Kite is not the first one the Federal Circuit in Kite did flip a jury verdict that was over a billion and the Idenix case the jury verdict was two and a half billion. And the Federal Circuit also set aside that verdict on the same grounds in the Amgen case, the Federal Circuit also set aside a jury verdict there in favor of Amgen. So I think it is important to have an understanding of the Kite case in this background. This is not an outlier. This is just the latest in the theory. This is a very important one. So with that, I'm going to turn this over to my colleague, Andrew to really take us through the case.
Wayne Stacy 3:56 Well, Andrew, I guess one of the first questions I would have is about how much we can learn from this case. I mean, at the end of the day, it's a question of fact. And the court was pretty clear that there just weren't enough facts in the record for the jury to decide this
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By Kelly TorresJuno IP is another in a long line of Federal Circuit cases flipping jury decisions on genus claims. What should prosecutors and trial attorneys be thinking about to survive both the jury and the Federal Circuit?
More on Andrew Gesior & Elizabeth Weiswasser.
SPEAKERS
Wayne Stacy, Andrew Gesior, Elizabeth Weiswasser
Wayne Stacy 0:00 Welcome, everyone to today's podcast for the Berkeley Center for Law and technology. This is Wayne Stacy, your host and the Executive Director for BCLT. And today we're going to talk about the Juno IP case and how a billion dollars disappears overnight. With me, we have two experts from Weill, Gotshal on this life sciences litigation and this particular case in the decades and making that it was we have Andrew Gesior, and Elizabeth Weiswasser, both from Weil, so thank you both for joining us. And I'm just gonna lead with I guess the basic question here for you is, why did the court flip this billion dollar verdict?
Elizabeth Weiswasser 0:48 Wayne, this is Liz. And I'm here with my colleague Andrew, thank you so much for having us. I'll start briefly I think with just framing the issue up and then I'm going to turn to my colleague, Andrew, to focus specifically on the Kite case. So I think it's important to understand the the framework on which the Kite case was decided. The case is really about 35 USC section 112. It's the part of the patent act that requires that claims meet the requirements of written description and enablement. The underpinning is you can't claim and own what you haven't invented what you haven't described, you haven't taught the public how to use. A number of decades ago, I would say, really, beginning in the early 90s. In fact, I was a law clerk with Judge Laurie, at the time, this doctrine really started to evolve in the biologic and pharmaceutical space of really looking hard at genus claims directed to biologic or chemical entities where the genus is not defined by the structure of what's claimed. It's defined instead by the function, trying to claim the molecules by what they do, rather than by what they are. And Judge Lurie, my former boss in particular was very focused on trying to discern what is permissible in terms of claiming by function and what is not permissible. And it's really beginning there, that we see the origins of this doctrine that has now really come into its own in a very fulsome way, with the Kite case. And so this has been developing over the 90s, 2000s, 2010s. And the Kite case is really just the latest, I would say, in a long series of cases that where the Federal Circuit has invalidated genus claims that again, are covering the genus of molecules defined by what they do, rather than by what they are. And what we have seen is that this has resulted in the Federal Circuit overturning a number of jury verdicts, Kite is not the first one the Federal Circuit in Kite did flip a jury verdict that was over a billion and the Idenix case the jury verdict was two and a half billion. And the Federal Circuit also set aside that verdict on the same grounds in the Amgen case, the Federal Circuit also set aside a jury verdict there in favor of Amgen. So I think it is important to have an understanding of the Kite case in this background. This is not an outlier. This is just the latest in the theory. This is a very important one. So with that, I'm going to turn this over to my colleague, Andrew to really take us through the case.
Wayne Stacy 3:56 Well, Andrew, I guess one of the first questions I would have is about how much we can learn from this case. I mean, at the end of the day, it's a question of fact. And the court was pretty clear that there just weren't enough facts in the record for the jury to decide this