How does the Vanda case relate to the treatment or prophylaxis consideration in Step 2A Prong Two?

The Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd. case is significant in the context of the treatment or prophylaxis consideration in Step 2A Prong Two. According to MPEP 2106.04(d)(2):

“Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The claims in Vanda recited a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the heart’s normal rhythm that can lead to serious health problems) in patients having a particular genotype associated with poor drug metabolism.”

The court held that Vanda’s claims were eligible at Step 2A because they were not “directed to” the recited judicial exception. The claims used the recited law of nature (the relationship between the patient’s genotype and the risk of QTc prolongation) to more safely treat patients with the drug, thereby reducing the patient’s risk of QTc prolongation.

This case demonstrates how a treatment method that applies a law of nature can be patent-eligible when it includes specific steps that go beyond merely applying the natural relationship.

To learn more:

• Vanda Case
• Treatment Consideration
• Patent Eligibility
• Step 2A Prong Two
• Law of Nature