by Dennis Crouch
Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc., No. 18-817 (Supreme Court 2019)
In this case, the Supreme Court has requested input from the U.S. Government — requesting the views of the U.S. Solicitor General (CVSG). The SG’s office will likely submit its brief in December 2019 — so we have a nice wait on this question presented:
The question presented is 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.
Although Hikma did not declare all method-of-treatment claims automatically patent eligible. It appears that the court has doubled-down in Natural Alternatives Int’l. Inc. v. Creative Compounds, LLC (Fed. Cir. 2019) (“These are treatment claims and as such they are patent eligible.”).
The court is also awaiting the views of the SG in HP v. Berkheimer on the question of the extent that eligibility is based upon a questions of fact. Berkheimer has become standard Federal Circuit law — as the court explained recently in Natural Alternatives: “Eligibility under § 101 is a question of law based on underlying facts.”