David Gindler, Irell & Manella partner ()
David Gindler has more cutting edges in his practice these days than a knife drawer. The Irell & Manella partner has been litigating the subject matter eligibility of prenatal DNA testing before U.S. District Judge Susan Illston, the U.S. Court of Appeals for the Federal Circuit and the newly reconstituted Patent Trial and Appeal Board. Gindler represents Ariosa Diagnostics, maker of the Harmony prenatal test. Last month he persuaded the Federal Circuit that although a competitor made a significant discovery in the area, its test was not eligible to be patented under the Supreme Court’s recent rulings in Mayo Collaborative Services v. Prometheus Laboratories and Association of Molecular Pathologies v. Myriad Genetics. When he’s not litigating high stakes cases on parallel tracks, Gindler volunteers as board chairman of the Los Angeles Master Chorale and on the executive committee of the L.A. Philharmonic.
What was the key to winning this ground breaking decision? The key started with helping Judge Illston understand the following very important distinction: looking at what is patentable subject matter and determining what is new and inventive in a claim. If someone claimed I’m the first to have discovered X, and that’s what was found to be what was new and useful, then every patent claim which is directed to a natural phenomenon would become patentable.
What the Supreme Court has said in a series of decisions which have gotten clearer and clearer and clearer as time has passed, is you have to look at the natural phenomenon on one hand, and then look at on the other hand what else is there in the patent claim [that makes it inventive]. That’s where the teaching of the Supreme Court’s decision in Mayo and also the decision in Myriad became critical, because those decisions really fleshed out what that means in life sciences. Those cases said if what you have is a natural phenomenon, plus purely conventional, routine, well-understood activity at the time of the invention, then that’s not an inventive concept.
The law of subject matter eligibility has been evolving, to say the least. Did you have to do anything special with your case to stay out in front of the law as it evolved? I wouldn’t say so much that we were out in front of the law, as much as understanding exactly how the recent Supreme Court precedents impacted the evolution of the law. We had to see exactly how these decisions were going to impact a very important area that’s evolving in life sciences, which is diagnostics. Because diagnostics are going to make use of natural phenomena. And in fact many patents in the life sciences and elsewhere make use of natural phenomena or abstract ideas or natural laws, and that’s perfectly appropriate. But what’s not perfectly appropriate is getting a patent on a natural phenomenon without adding enough to the patent claim so that you actually are claiming something that is truly inventive.
Judge [Richard] Linn wrote a separate concurrence. He agreed that you were absolutely right on the law, but at the same time he encouraged the Supreme Court to reconsider it. What’s your response to the policy arguments Judge Linn made about patenting useful discoveries? Well, Judge Linn is a very powerful and thoughtful jurist. And there are clearly different views about where to draw the line on patentable subject matter. And to be fair, the Federal Circuit and the Supreme Court have had different views about how to draw that line. Even more importantly, there are vastly different views within the Federal Circuit itself.
There’s a very interesting passage in the Myriad decision that talks about the fact that it required a lot of work to actually isolate and characterize the BRCA-1 and BRCA-2 genes. And the Supreme Court said that if the scientists who did this work had relied upon new and inventive techniques to isolate the BRCA-1 and -2 genes, well that would be different. They might have a patent on that. But that’s not what happened.
The Supreme Court was making absolutely clear that, even in the context where you have the identification of a gene sequence not previously known and the knowledge of that gene sequence is going to be profoundly important, that if you just were to combine that with sort of conventional techniques to detect it, identify it, you don’t get a patent on that. Why? Because it’s just almost the same thing as having a patent on the natural phenomenon itself. And then you lock everybody else out.
Ariosa’s been litigating its IP rights in district courts, the Federal Circuit, and in numerous Patent Trial and Appeal Board actions. I’m curious how you keep track of all the pieces on the chess board. Yeah, me too. What you’ve described, though, is almost becoming the new model of patent litigation. And it’s amazing how quickly it has fallen into place. In so many patent cases that are filed today, IPRs become an inevitable adjunct to the patent litigation. The timing of the IPRs might vary from case to case, depending on a whole variety of strategic and other issues, but we are seeing that IPRs and patent litigation are going hand in hand.
Now you’ve got to keep track of the IPRs, the patent litigation, sometimes cases are stayed, sometimes they’re not, in which case you’re litigating in parallel. Sometimes you’re working with co-counsel who is working with you on the IPRs, sometimes you’re doing the whole thing.
When I was a kid I loved Star Trek. Star Trek had this fictional game, I think it actually became a reality, called three-dimensional chess. And you know, district court litigation was chess. Now we have three-dimensional chess.
You have an undergraduate degree in philosophy and economics, so how did you end up litigating cutting-edge life science patent law issues? I spent the first 10 years of my practice doing many different things. I did intellectual property work, I did employment litigation, I did securities litigation, I did entertainment litigation. And then starting about 20 years ago, I started to get more involved in patent litigation. But what really was my first foray into life sciences was the City of Hope v. Genentech case.
That’s a good one to start off with. It was. It’s a case that came to our firm because the general counsel at the time at the City of Hope was somebody I’d known for a very long time, went to law school with him and his wife. His father actually was a professor of mine at Pomona College and was also a rabbi and performed my wedding. And so it was that case that really started my trek down learning about life sciences. It was fascinating because that case was literally about the dawn of the biotechnology area. That case was about the founding of Genentech, the collaboration with City of Hope, to see if somebody could actually make biotechnology a reality.
How did you get involved with the L.A. Master Chorale? My wife and I share something in common, which is we are very passionate about the performing arts. Around 2008 I made a decision that I was going to act on that passion and start getting involved in the nonprofit performing arts world. Because if you’re passionate about something, it really makes a profound impact on your life.
I grew up in Los Angeles. I had my first subscription to the L.A. Philharmonic when I was 16 years old. I’ve been going to performances at the music center since I was a kid. My wife is as involved as I am. She is president of the board of directors of the Center Theater Group, one of largest non-profit theater groups in the country. So together she and I spend a lot of time enjoying but also working in the nonprofit performing arts world.
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