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Abstract

Laura Pedraza-Fariña: I’m really excited to moderate this discussion, which is going to center mainly around Section 101 (35 U.S.C. § 101) kinds of legal issues, and if we have time we can branch out to talk about inter partes review. So, let me start by introducing the members of the panel, and I’ll give a few introductory comments to sort of frame the issues that we will talk about. Then we’ll turn it over to the panelists to give some more specific answers to the big issues that I’m going to frame.

My name is Laura Pedraza-Fariña, and I am an associate professor here at Northwestern where I specialize in patent law. I also teach the intellectual property survey course and seminars on innovation and technology. Let me introduce our speakers. We have Ann Marie Wahls, who is a partner in the litigation and trial department at Latham & Watkins. She has lots of trial experience, experience in complex litigation matters, and also experience in biotechnology, which is very relevant to this discussion that we’re going to be having here.

And then, let me introduce Hari Santhanam, who is a partner in the IP group of Kirkland & Ellis. Again, a trial lawyer with lots of experience, and experience in particular in the biotechnology area, which is so relevant for the conversation that we’re going to have today.

We have Rod Passman, who is actually an MD, so he’s going to give us a perspective on practicing physicians. He also has some experience in innovation and trying to figure out how patents impact his day-to-day activities.

And finally, we have Valerie Eaton, who works at Northwestern in the immunology department and is currently pursuing an MSL degree.

So let me just frame what we want to talk about today. We want to talk about Section 101 and the challenges that recent jurisprudence in Section 101 has caused for diagnostic methods and also, more broadly, methods of treatment. So a brief overview for those of you who may not know what Section 101 is about and how it is framed. In a series of decisions, and the most recent decision is most on point, the Supreme Court has reshaped a lot of patents based on the subject matter. In one particular decision made over Prometheus (Mayo Collaborative Servs. v. Prometheus Labs., Inc.), which is the one that is going to impact diagnostic technologies the most, the Supreme Court basically set out what’s called a two-step framework to figure out if a diagnostic method or a method of treatment is patentable.

The first step is to figure out if that treatment is directed to a law of nature. The way that Mayo set out that test, basically most diagnostics—although this would be something for the panel to talk about—end up being directed to a law of nature, because a lot of diagnostic technology is about finding a clinical relation between a particular marker and a disease.

Then step two is where the Court in Mayo introduced this idea of the inventive concept. If a method of treatment is directed to a law of nature, and if you have an inventive concept, then that method of treatment is still patentable. But, what constitutes an inventive concept is something that’s been kind of hard to pin down; there are a couple of recent decisions that suggest two different ways of looking at the concept. And so I’ll briefly summarize what those positions are, and then we’re going to turn it over to the panel with the questions of how the idea of the inventive concept evolved in diagnostic technologies, and is that something that you see in your practice a lot.

Let me set out two cases that seem to be somewhat irreconcilable. There’s one particular case that’s called Ariosa (Ariosa Diagnostics, Inc. v. Sequenom, Inc.) which had to do with fetal diagnostic technology. The court basically said, well, this is a law of nature, because all you’re finding is that there are some cells of the mother and there are some cells of the fetus that you can find in the mother as well. This was a huge discovery at the time, because it allows non-invasive testing of pregnant mothers. But that was a law of nature, because it existed before it was actually found.

And then the court says once you know that law of nature, then taking those cells out of the mother’s blood and testing them for abnormalities is a routine procedure. Those are methods that we know how to do. And so this routine procedure is not enough to make something an entirely inventive concept.

Then there’s this other case that’s called CellzDirect (Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc.) that seems to suggest the court taking a 16:1 (2018) Panel Discussion: Medical Technology different tack. In CellzDirect, it’s a method for basically preserving cells by freezing them twice, when people thought that it would only work by freezing them once. It turns out you can freeze them twice and the cells survive. So potentially that’s a law of nature: You find that the cells can survive two freezings. And here, the Federal Circuit said something quite interesting. The Federal Circuit says, yes, but freezing it twice is not a routine step, because people weren’t doing that in the real world before. So there’s a contrast between the two cases: When we talk about routine steps that are not part of any inventive concept, are those routine steps things that in fact were happening in the real world, or are they things that anybody would know how to do once you actually know the law of nature? So the CellzDirect case maybe provided hope for people who are doing diagnostics, but maybe that hope has been shattered by subsequent decisions. So that would be one question to the panel: There are these two cases that are similarly irreconcilable, but we have had later cases since then, so what do we think about that dynamic?

And then I’m going to ask some broader questions about whether the panelists think that the Supreme Court got it right. The broader question of whether patents promote innovation or access to diagnosis, and the even broader question of—and somebody who is involved in medicine might be able to contribute to this—do we even need patents in this technology? Are there other alternatives that will give us those diagnostics?

So did the Supreme Court get it right in basically eliminating a lot of diagnostics in method of treatment and patent protection? I will now open it up for a lively discussion.

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