by Dennis Crouch
Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc. (Supreme Court 2019)
Briefing is now complete in this important eligibility case pending before the Supreme Court. Hikma’s petition presents the following question:
Whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps
Hickma’s question clearly mischaracterizes the Federal Circuit opinion – a common approach these days. In its opposition brief, the patentee Vanda calls-out the intentional error:
Hikma’s Petition wrongly asserts that the Federal Circuit declared all method-of-treatment claims to be “automatically” patent-eligible under Section 101. . . [Hickma’s] Question is not presented by the decision
below or any other decision.
Although Hickma does a good job of nit-picking, the underlying reality is important — the Federal Circuit’s decision in Vanda is not easily reconciled with its Ariosa decision or the Supreme Court’s decision in Mayo v. Prometheus. And, the Federal Circuit and USPTO have effectively green-lighted patents on methods of treatment that would be ineligible if recharacterized as methods of diagnosis or creating a treatment plan.
- Petition for a writ of certiorari
- Brief amici curiae of Intellectual Property and Innovation Professors, Engine Advocacy, et al.
- Brief amici curiae of The Association for Accessible Medicines and Certain Individual Companies
- Brief of respondent Vanda Pharmaceuticals USA, Inc. in opposition
- Reply to Brief in Opposition of Hikma Pharmaceuticals USA Inc
The amicus briefs in this case all focus on the same issue — arguing that the Federal Circuit’s Vanda decision conflicts with Mayo and Flook. The Law Prof brief explains: “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.
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In a previous post, I explained that 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., determine 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 it was also known that some folks were poor metabolizers in a way that created the particular health risk and that a lower dosage is still effective for poor metabolizers (since the drug stays in the body longer). A remaining problem solved by the inventors was how to predict who should get the low dosage. The core discovery here is that a genetic difference substantially explains the risk. The inventors made that important discovery and then implemented it with straightforward administration steps. The question then is whether this approach is patent eligible.