1. This case presents important questions about the framework for determining patent eligibility. In particular, the case concerns whether compositions are patent-eligible when they contain a natural substance that has been isolated and incorporated into a dosage form, but have different characteristics than and can be used in a different manner than the substance as it appears in nature. This Court addressed a related, but distinct question in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and the Federal Circuit has applied Myriad inconsistently.

Whether a composition containing an isolated natural substance that exhibits markedly different characteristics from the substance as it appears in nature and possesses significant utility is patent-eligible subject matter under 35 U.S.C. § 101, or whether the act of isolation alone is insufficient to confer patent eligibility absent additional human intervention or transformation