On June 12, 2015, the United States Court of Appeals for the Federal Circuit issued a decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. The decision dealt with whether a non-invasive method for detecting paternally inherited cell-free fetal DNA (“cffDNA”) from a blood sample of the pregnant woman carrying a fetus. See U.S. Patent No. 6,258,540. The district court ruled that the method claims were patent ineligible and the Federal Circuit agreed. Judge Linn, who concurred, wrote that the innovation deserves patent protection, but also that the “sweeping language of the test set out in Mayo” requires a determination that the claims are patent ineligible.
The Federal Circuit decision has been widely criticized (see here and here, for example). Sequenom has asked for reconsideration en banc, and twelve amici groups have separately filed briefs in support of Sequenom’s petition for reconsideration en banc. On September 3, 2015, the Federal Circuit requested a response from Ariosa et al.
Sequenom is being represented by Tom Goldstein, co-founder of the SCOTUS blog. Goldstein has served as counsel in over 100 Supreme Court cases over the last 15 years. His presence in this petition for rehearing sends a clear message, namely that Sequenom plans to push this issue as far as they can, including petitioning the Supreme Court if necessary.
I had the opportunity to speak with Goldstein on the record for an interview on Monday, August 31, 2015. What follows is our discussion about the state of patent eligibility in the United States and the reasons why the Federal Circuit really should step in and rehear this case en banc.
Without further ado, here is my interview with Tom Goldstein.
QUINN: Thanks, Tom, for taking the time to chat with me today. I know last week there was some action in a case that you’re intimately involved in regarding patent eligibility, with about a dozen amicus briefs filed in support of your position. So I wanted to reach out to you and talk to you about the case. Can you tell us a little bit about the case and where we stand procedurally before we get into any substance?
GOLDSTEIN: Sure. This is a 101 eligibility case involving a biologic test, and it’s one of the cases in which the Federal Circuit has been trying to implement the Supreme Court’s 101 eligibility decisions. Cases like Mayo, Myriad and the like. And in this case we have the discovery of something incredibly new and important, which is that you can have cell free fetal DNA in the blood plasma of a mother, and you can distinguish it from the mother’s DNA by looking for the father’s sequences. What that means there’s a way of being able to identify hereditary traits, potential problems with fetuses that’s entirely not intrusive.
The invention claims not the cell free DNA but rather a method that involves amplifying the cell free DNA and applying various processes on it to use it as a diagnostic tool. It’s an incredibly significant discovery. Nobody disputes that. The Lancet article that describes the invention, it’s been cited a thousand times, as an illustration. And the Federal Circuit, a panel of three judges held that it was not patent eligible on the grounds that if you are dealing with a finding like this one, something as a law of nature, something that exists in the world then the discovery of that plus previously known techniques, like amplifying DNA, makes it not patent eligible.
One of the judges on the panel Judge Linn specially concurred to say this doesn’t make any sense, but he wrote that he thought he was required to reach this result by the Supreme Court’s decision in Mayo. So that’s where we are today.
This is a really important question both with respect to biologics and other interventions and also as the Federal Circuit does work with the Supreme Court’s body of precedents. We have basically two principle points. One is that in our view the Federal Circuit has to do a better job rationalizing and reconciling two different sets of precedent. One is the set of modern cases and the second is an older case that the modern cases embrace, Diamond vs. Diehr, which as we understand it adopts exactly the opposite rule from the Federal Circuit in this case, which is that the combination is what has to be new not the individual processes. And then second we believe that we have a case that fits squarely within what the Supreme Court intended to remain patent eligible after those more modern cases. So we filed an en banc petition and we thought that there would be amicus support for sure. But what we didn’t expect, to be honest, was the outpouring of interest and support that we received.
Virtually every interested party that we mentioned the case to was immediately interested in filing an amicus brief. There were many more than 12 amicus parties. They joined together in a bunch of briefs. We didn’t even know that some of the briefs were going to be filed. There were some that just came in on filing day and we were pleasantly surprised. We have still companies that are in a similar position, but also patent academics, leading people in the field saying this seems to go way too far with respect to 101 and the law is a real mess and en banc review is really a responsibility, to take the issue on in the interest of a rational patent system.
So the petition is in. The 12 amicus briefs that you mentioned are in. And now it’s in the hands of the Federal Circuit. We are waiting for the Federal Circuit to decide if it wants to request a response from the alleged infringer that succeeded in developing the patent. And if it does that and requests a response then there will be a vote in the Federal Circuit of whether or not to rehear the case en banc and if so then we’ll go through that whole process. If en banc is denied then we’ll proceed and try to persuade the Supreme Court. But the Federal Circuit needs to do the job of reconciling these precedents.
EDITORIAL NOTE: After this interview was completed, on September 3, 2015, the Federal Circuit requested a response from Ariosa and Natera. Ariosa and Natera have asked for a 30 day extension of time to respond, to which Sequenom has consented. If that extension is granted, which is anticipated, the due date for the response would be October 17, 2015.
QUINN: That was one question I wanted to ask you. With your name on the brief people who follow these issues would have to think that this is being set up for the next level.
GOLDSTEIN: Well, I think the client wanted that option for sure because once you lose in a court of appeals it’s very hard to get en banc review. We would much rather resolve it in the Federal Circuit. There’s no need to go to the Supreme Court, but not surprisingly any party has the right to take it up and I think the fact that they hired me does indicate their willingness to do so. We do think that this is something that the Federal Circuit can fix itself.
QUINN: I’m struck by all the problems that are being created by current 101 jurisprudence.
QUINN: In my mind it boils down to the unfortunate reality that the Supreme Court has not defined what it means to be an abstract idea. In reading your petition for rehearing en banc the one line that jumped out at me was where you talked about how on some level everything is an abstract idea.
GOLDSTEIN: Yes, and everything is an elaboration on what’s been discovered before. So I think that the Supreme Court is in the middle of a process. We can’t look at cases like Mayo and Myriad as the end of the discussion. The court is relatively new to returning to patent issues, relatively new to 101 eligibility, and I would be surprised if they didn’t take some more 101 cases over the years. I don’t know when they’ll take the next one but I think they will be conscious of the need to further refine it. That they couldn’t answer every question, get everything right in the first cases. So if we have to, hopefully we’ll be able to show them that if the Federal Circuit didn’t hear the case en banc it’s because they agree with Judge Linn that this is just at the footsteps of the Supreme Court.
QUINN: Now, playing devil’s advocate for a moment and giving the Supreme Court the benefit of the doubt for a moment, which is difficult to do I know because they don’t seem to understand patents, they overstate things, and there’s a lot of dicta in these cases. They really turn these cases into an exercise in reading tea leaves.
QUINN: But if you want to give the Supreme Court some benefit of the doubt here I think it has to be with respect to Mayo and Bilski, those two cases stand out because they took bad cases and they decided these very broad issues in a couple cases that should have been just thrown out on other issues. And that laid the foundation for a real mess I’m afraid.
GOLDSTEIN: Well, it is a great illustration of how important it is that the right case goes to the Supreme Court. Because the Supreme Court isn’t exposed to a lot of the cases and bad cases can make bad law. And you do have to think about cases like Bilski, about cases like Mayo as being ones that didn’t seem like good candidates to use to define 101 eligibility. And I think that the Court will take on some closer cases where we’re not gonna see 9-0 decisions, but we’re gonna see more debate inside the building over where exactly to draw the line. The message you should take away, I think, from the Supreme Court’s decisions should tell you there are too many patents, it’s inhibiting innovation, it’s getting in the way. The Supreme Court seems to think the Federal Circuit and the PTO are being too permissive and we need to take a step back. But you can’t parse words in these Supreme Court’s opinions yet, they’re too new to these questions.
QUINN: I think that’s exactly right. I guess that’s the real fear now because as you’re going through the judiciary you have these cases that have spoken in such broad language about claims that were so broadly written, in at least a couple cases. You’re seeing what in my words I will call “real technology” or “real innovation” being held up by these broad strokes. And I can’t—
GOLDSTEIN: I have another case just so you know. So that is anti-virus software. Right? So it is like solving a problem about a computer and the district court says nope, not patent eligible. Even though because it’s implemented on a machine even though it is but it seems to be exactly what the Supreme Court was talking about that the range of software patents that is available is the patents that actually are very computer directed, you know, dealing with a unique computer problem. But, nope. The overwhelming majority of 101 decisions now as you well know are ineligible, ineligible, ineligible, ineligible. I think that the lower courts have really over read the Supreme Court’s decisions which were intended to narrow 101. Everybody agrees with that. But they seem to have just run with it a little too fast, a little too far and there’s going need to be a bit of course direction.
QUINN: I agree. I just finished writing an article about wind energy and GE. I saw this commercial that sent me down this path. The commercial said the windmills of the future are going to follow the wind. And then if you look into what GE’s doing they have this elaborate software process that can allow for analysis of the data to predict how the windmill should be operating for its most optimal efficiency moving forward including figuring out whether operators need to be tilting the blades, when should we tilt the blades knowing that at certain times the wind is coming from various directions and all that sort of thing. And I think to myself is well, tilting the blades that’s just an idea, you know, the fact that nobody else has done this and that they can squeeze out an extra 5% from a wind farm doesn’t seem to be relevant in the 101 inquiry, which I think is a real problem. It would be relevant if we were talking about obviousness under 103. It would be a very relevant.
GOLDSTEIN: Yes it would be very relevant. And that’s probably what we should be talking about. I really agree with you. These are the kinds of innovations that we want and these are the kids of innovations that if companies start to believe they won’t get patent protection on they are not going to spend $20 million figuring out the solution, or if somebody does figure it out then they’re gonna keep it a secret.
GOLDSTEIN: The foundation, the very notion that there are too many patents accepts that there need to be patents. Our problem is that we are getting too close to the notion that a lot of innovations are going to be not patent eligible.
QUINN: Yes. I’m afraid that that’s unfortunately the consequence. We’re seeing it right before our eyes right now. I don’t know where it all ends, but I think what we should be doing is go back to having 101 be a very low threshold, a very low hurdle and using the other sections as they were designed to be used. Unfortunately, we’re stopping innovation from proceeding and that was the fundamental purpose of having a wider open 101 analysis.
GOLDSTEIN: Right. We have substituted patent eligibility for obviousness, which seems a much better fit. I did KSR, just seems a way better fit.
QUINN: Yes. Okay, well, that’s really all I have at this point. I appreciate you taking the time to speak with me today.
GOLDSTEIN: Okay, such a pleasure. Great to talk to you again and we’ll hope for the best.
QUINN: Good talking to you, too.