Peak Fiction: XRPD and the Illusion of Novelty

Abstract

This viewpoint addresses the growing use of X-ray powder diffraction (XRPD) data to support patent claims on crystalline forms of pharmaceutical compounds. XRPD patterns are inherent material properties, not inventions. We demonstrate that different sample preparations and holders impact the XRPD peaks returned for the same commercially available sample. Thus, treating XRPD peaks as stand-alone proof of novelty weakens patentability standards across the field of medicinal chemistry and pharmaceutical intellectual property.