Gene Patents: AMP v. Myriad Genetics

The Supreme Court today vacated the Federal Circuit’s decision in AMP v. Myriad Genetics and has ordered the appellate court to reconsider the case in light of the recent Supreme Court decision in Mayo v. Prometheus. To be clear, the Supreme Court’s move here is not a ruling on the merits but rather merely a recognition that the validity of Myriad’s human gene patents may be impacted by the Mayo decision.

I previously wrote that one reasoned result of the Mayo decision is that Myriad’s claims directed toward isolated human DNA are now invalid.

Following Mayo, the court could logically find that the information in the DNA represents a law of nature, that the DNA itself is a natural phenomenon, that the isolation of the DNA simply employs an isolation process already well known and expected at the time of the invention, and ultimately that the isolated DNA is unpatentable because it effectively claims a law of nature or natural phenomenon. One distinguishing point is that Prometheus claimed a process while Myriad claims a composition of matter. As we have seen in recent cases, the Federal Circuit already largely rejects formalistic distinctions between process and composition claims. Here, that distinction is further minimized by the reality that the claimed DNA is functionally characterized by the already well known process of isolating human DNA.