Nikhil Pradhan (Independent) has posted “Intellectual Property Strategies for AI-Enabled Drug Development” (Bringing Medicines to Life: How Intellectual Property Enables Innovation in the Life Sciences (eds. Jonathan M. Barnett and Bowman Heiden, Cambridge University Press, forthcoming 2026)) on SSRN. Here is the abstract:
Conventional biopharma IP strategy, focused on tangible drug assets, faces disruption on several fronts. AI-driven drug discovery technologies continue to improve and bring candidates into trials, if not yet to full FDA approval. Greater awareness of the high cost and failure rate of traditionally developed drugs is also highlighting the potential of AI technologies to bring drugs to market faster and with lower cost. The impending patent cliff for several blockbuster drugs will also lead firms to reevaluate efforts allocated to asset-focused patent protection. In addition, more stringent disclosure requirements for AI technologies used in drug development may shift the line on the tradeoff between patent and trade secret protection.
This chapter will outline these disruptions as well as the current AI drug development landscape, including identifying trends on how AI-focused firms are currently allocating resources to assets, specific targets or modalities, and/or underlying AI technologies. In view of this landscape and other disruptions in the biopharma market, the chapter will outline actionable IP strategies for players across the landscape including academic institutions, early-stage companies, and large pharmaceutical enterprises. Specific considerations for executing on IP strategies and other approaches for establishing exclusivity around new technologies and business models will be evaluated, including guidance on the patent vs. trade secret decision and tactics to strengthen patent applications for examination and litigation success, enabling stakeholders to adapt and thrive in this evolving landscape.
