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 Federal Circuit decision has been widely criticized (see here and here, for example). Sequenom has asked for reconsideration en banc, with 12 separate amici filers in support of Sequenom’s petition for reconsideration en banc.
The original panel decision dealt with whether a non-invasive method for detecting paternally inherited cell-free fetal DNA (“cffDNA”) from a blood sample of a pregnant woman was patentable. 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 was uncomfortable with the decision, but wrote in a concurrence that he thought that the outcome was mandated by the “sweeping language of the test set out in Mayo.”
Sequenom has retained Tom Goldstein, co-founder of the SCOTUS blog, to handle the appeal. Goldstein has served as counsel in over 100 Supreme Court cases over the last 15 years. His presence sends a clear message that Sequenom is heading to the Supreme Court if they do not prevail in an en banc rehearing.
I spoke with Goldstein on August 31, 2015. What follows are the highlights of our conversation. For a complete transcript, please visit IPWatchdog.com.
Goldstein on the main arguments Sequenom has made to support its petition for rehearing en banc —
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.
Goldstein tells me that he expects that the Supreme Court will continue to refine patent eligibility law and that Myriad and Mayo are not the final word on the issue —
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.
Goldstein on the need for a course correction due to district courts and the Federal Circuit over-reading Supreme Court 101 cases —
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.
Goldstein on the need for patent protection in order to incentivize the investment necessary to create innovations like the one at issue in this case —
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.
On September 3, 2015, the Federal Circuit requested a response from Ariosa and Natera. Ariosa and Natera asked for a 30-day extension of time to respond, which means the due date for the response will be October 17, 2015. Stay tuned!
Tags: CAFC, Federal Circuit, patent, Patent eligibility, patentability, patentability requirements, patentable subject matter, patents, Tom Goldstein
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