Posts Tagged: "diagnostic testing"

On May 6, 2016, the U.S. Patent and Trademark Office released new life science examples on subject matter eligibility (Examples 28-32, consecutively numbered after the previously released USPTO examples). Examples 28 and 30 illustrate the application of the “markedly different” and “significantly more” analysis to nature-based products. Examples 29 and 31 illustrate the USPTO approach to the eligibility analysis of diagnostic claims, which has been much anticipated. Finally, Examples 32 and 33 illustrate the use of a streamlined eligibility analysis. At first glance, the new life science examples, which identify most of the presented hypothetical claims as patent-eligible, provide several teaching points for achieving patent-eligibility in commonly encountered situations in the life sciences area.

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.

As the amici correctly argue, the panel’s decision striking down Sequenom’s noninvasive prenatal test strikes at the very heart of the patent system. Revolutionary diagnostic testing methods that cost tens of millions of dollars to produce should be the flagship of the modern patent system. But the panel’s misapplication of Mayo calls into doubt many meritorious inventions that benefit us all. Moreover, the panel’s reasoning simply cannot be squared with several innovations that the Supreme Court has historically upheld as proper statutory subject matter. Hopefully the entire Federal Circuit will agree to take up this important case so that vital innovations such as Sequenom’s patented method continue to be produced.