Guest Post by Edward Reines. Reines Co-Chairs the nationwide Patent Litigation practice at Weil Gotshal. He represents CareDx and Stanford in the pending patent lawsuits.
Professor Holman’s recent post on the Federal Circuit’s CareDx v. Natera opinion is a thoughtful addition to Professor Crouch’s review of that decision. Professor Holman concludes that the Stanford inventions were doomed from the start because they can be labelled as “molecular diagnostics methods” and are thus patent ineligible under Federal Circuit law. Professor Holman’s conclusion is troubling. It would limit the patentability of new inventions in an entire scientific discipline merely based on a label.
This labelling mode of analysis is fundamentally flawed because the Supreme Court’s Alice decision mandates a two-step test focused on the claimed advance of the patent, no matter the field of invention. The test is designed to “distinguish between patents” that would pre-empt a field by broadly claiming “[l]aws of nature, natural phenomena, and abstract ideas” and patents that do not pose this risk because they add to these concepts with “human ingenuity.” There is thus nothing inherent about molecular diagnostics that precludes their patentability and merely labelling a method as “molecular diagnostics” should not be a kiss of death.
Take the Stanford patents. Those patents document that the natural correlation between organ rejection and elevated levels of cell-free DNA of the organ donor was known for almost a decade before the inventions. The patents then explain that numerous scientists motivated to measure that increase in cell-free DNA failed to come up with the patented measurement methods. The patents cite an article published right before the Stanford patent filing that concluded that it was altogether “impractical” to measure cell-free DNA to monitor organ rejection.
The Stanford patents distinguish the failed prior art measurement efforts and describe new inventions on how to better measure cell-free DNA using advanced DNA analysis techniques. The claimed inventions are better measurement methods that previously eluded the field – not the discovery of the natural correlation itself. And there was no claim that they posed the pre-emption risk that animated Alice.
Federal Circuit law places at the heart of Alice step one whether the “claimed advance” is the natural law. In CareDx, as Magistrate Judge Burke had originally concluded, the claimed advance of the Stanford patents is an improved human-devised measurement method. The Federal Circuit’s opinion failed to properly focus on the “claimed advance” analysis and failed to squarely address that the patents describe numerous prior art failures. This prior art history is irreconcilable with the panel’s conclusion that the patented measurement methods are so conventional as applied to the natural correlation that they could not possibly qualify as patent-eligible human invention.
Instead, the Federal Circuit imported the “conventionality” analysis from step two into step one in lieu of a proper “claimed advance” analysis of Federal Circuit precedent. As originally contemplated in Mayo, the “conventionality” analysis was akin to determining if the claims included mere trivial additions on top of discovery of a natural law. Here, the conventionality analysis instead became a short-cut obviousness analysis. Yet, even that fails because the decade of prior failures at measuring the cell-free DNA for a good organ rejection test proves that it was not conventional to use the patented measurement methods for this purpose – otherwise the many groups working on the problem would have arrived at that solution ultimately invented by the Stanford team. And the supposed disclaimers in the patents never even suggest that applying the claimed measurement techniques to the tough context of cell-free DNA somehow was not an invention. Everything about the description of the inventions is inconsistent with that conclusion.
The Federal Circuit cannot blame the Supreme Court for this latest constriction of molecular diagnostic patenting even though many Federal Circuit judges have bemoaned the stinginess of the Supreme Court’s Alice test in this area. As explained long ago in Diamond v. Diehr, and as repeated in Bilski and Mayo, the Supreme Court recognizes that: “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Even if the Stanford measurement methods were known (and the prior art history calls that into serious doubt) their application to a natural law can certainly be patent eligible if it is the product of human innovation, as claimed by the patents.
Professor Holman’s conclusion that the Federal Circuit labelling method may have controlled the CareDx outcome should give real pause to the patent law community. Such labelling might be useful to describe the inventions at issue in prior decisions, but it is not a basis to proscribe whether an invention is eligible for patenting. The Stanford patents are plainly directed to a better measurement method that evaded many motivated prior artists. Such human innovation is the claimed advance and is patent eligible under Alice even if it can be labelled as a molecular diagnostic method.