by Dennis Crouch
Hikma Pharmaceuticals USA Inc., v. Vanda Pharmaceuticals Inc. (Supreme Court 2019)
I wrote earlier about the Federal Circuit’s decision on Vanda’s drug dosage claims that have two basic steps:
- Determining whether a patient is likely a poor metabolizer of the drug iloperidone based upon DNA analysis (i.e., if the patient has has the CYP2D6 genotype)
- Administering iloperidone at a lower dose to predicted poor metabolizers in order to reduce the risk of “QTc prolongation” for poor metabolizers.
In the case, iloperidone was already known as a drug treatment and that some folks were poor metabolizers in a way that created the risk. For poor metabolizers, the lower dose is still effective (since the drug stays in the body longer). A remaining problem though was how to predict who should get the low dosage. The core discovery here is that a genetic difference explains the risk, and the inventors made that discovery and then implemented it with its administration steps. The question then is whether this approach is patent eligible.
I previously explained my position in the case as follows:
(1) Vanda’s claims should be patent eligible [on policy grounds]; (2) but the claims are not patent eligible under Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) and Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014).
The Federal Circuit disagreed with my second conclusion and in a 2-1 decision held the claims eligible. Patent challenger Hikma (formerly West-Ward) has petitioned the Supreme Court review and that petition is supported by two strong amicus briefs:
- Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc.
- IP Law Professor Brief (with Engine Advocacy and R-Street Institute).
- Association for Accessible Medicines Brief (“AAM”) along with generic manufacturers Inventia and Mylan.
All three briefs say basically same thing — The Federal Circuit’s Vanda decision conflicts with Mayo and Flook. “The Federal Circuit’s decision effectively overturns this court’s precedents, thwarts the proper development of patent eligibility law, and will lead to countless improperly issued patents.”
The Law Professor Brief was filed by Stanford’s IP Clinic – although neither Mark Lemley nor Lisa Larrimore Ouellette signed-on. Professors Josh Sarnoff (DePaul) and Katherine Strandburg (NYU) substantially drafted the brief. Top pharma-patent litigator Douglass Hochstetler (KelleyDrye) filed the AAM brief.