Supreme Court Denies Vanda Pharmaceuticals’ Appeal in Patent Case

The Supreme Court has rejected Vanda Pharmaceuticals’ appeal to review the Federal Circuit’s decision invalidating patents related to the use of Hetlioz, a sleep disorder drug, according to an article by Dennis Crouch writing for PatentlyO. 

Crouch called the Court “unmoved” by Vanda’s argument that the Federal Circuit applied the wrong test for obviousness by looking for a “reasonable expectation of success” in combining prior art teachings, rather than requiring a showing of “predictable results.”

He also notes that in a previous post on this case “The Supreme Court has not addressed obviousness standards since its 2007 decision in KSR Int’l Co. v. Teleflex Inc. If the Court grants review, this (Vanda) case offers an opportunity to resolve both new and longstanding divergence in Federal Circuit obviousness decisions.” Vanda had previously sought en banc Federal Circuit review of the panel decision, claiming it was in conflict with precedent. That was denied.

Vanda argued that the lower “reasonable expectation of success” bar for obviousness is a threat to innovation. That is especially true in pharmaceuticals, where extensive experimentation is often required with unpredictable outcomes. The Supreme Court declined to take the case without comment.

According to Crouch, the specific details of this case weren’t the best for settling significant legal issues regarding how to conduct the obviousness analysis after KSR, particularly for claims related to treatment methods. Crouch believes that the differences between the prior art and Vanda’s method of administration without food or avoiding co-administration with certain drugs, appear relatively insignificant from an innovation perspective.

The Federal Circuit’s obviousness analysis remains undisturbed for now, but the case illustrates the continuing challenges of protecting follow-on pharmaceutical innovations.