The infollution crisis: navigating the legal implications of fraudulent science in the US patent system

Abstract The integrity of the US patent system is predicated on the reliability of the scientific record. However, the explosive growth of fraudulent scientific literature, or ‘infollution’, driven by commercial paper mills, presents a critical and under-examined threat to patent validity and enforceability. This article analyses the legal implications of this crisis for patent stakeholders. It examines how reliance on fraudulent science creates profound risks across four key domains of US patent law: (1) the duty of candour and the potential for inequitable conduct findings under the Therasense framework; (2) substantive patentability requirements, where fraudulent data can create fatal deficiencies in written description and enablement under 35 USC § 112; (3) the distinct treatment of fraudulent prior art in anticipation versus obviousness analyses and (4) patent litigation, where reliance on such literature exposes expert testimony to Daubert challenges. The article concludes by arguing that patent practitioners must move beyond passive reliance on published science and adopt proactive screening and risk mitigation strategies to safeguard their intellectual property. It serves as a call to action for the IP community to confront the practical consequences of the infollution crisis.