Supreme Court Declines to Hear Vanda’s Patent Obviousness Appeal

by Dennis Crouch

The Supreme Court has denied Vanda Pharmaceuticals’ petition for certiorari, leaving in place a Federal Circuit decision that invalidated Vanda’s patents on methods of using the sleep disorder drug Hetlioz (tasimelteon) as obvious.

Vanda had argued in its cert petition 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.”  Vanda contended this lower bar for obviousness threatens innovation, especially in the pharmaceutical field where extensive experimentation is often required with unpredictable outcomes.  However, the Supreme Court was  apparently unmoved by these arguments and, without comment, declined to take up the case. As I discussed in a previous post, Vanda had also unsuccessfully sought en banc Federal Circuit review of the panel decision, arguing it conflicted with precedent, including the reliance on an ongoing clinical trial to show a reasonable expectation of success.

While Vanda raised important legal questions about how the obviousness analysis should be conducted post-KSR, especially for method of treatment claims, the particular facts of this case were not ideal for making that stand. The claimed differences over the prior art, like administering without food or avoiding co-administration with certain drugs, seem relatively weak from an innovation perspective.  These are particular research questions that are  strongly suggested by the FDA and the potential results are fairly simple (either take with or without food).  The upshot is that the Federal Circuit’s obviousness analysis remains undisturbed for now.  More broadly, this case illustrates a continuing challenges of protecting follow-on pharmaceutical innovations.

The Obviousness Hurdle