Litigation Challenges in the Medtech Sector: Regulatory Entanglement, NPEs & Competitor Suits

This session provides a practical discussion on patent litigation trends and challenges in the MedTech sector, including NPE risk, competitor suits, and the litigation constraints created by regulatory frameworks. As devices increasingly integrate software, connectivity and AI, regulatory submissions, clinical data, and product approvals are becoming central to discovery, infringement theories, and evidentiary strategy in patent disputes. In this session, we will explore how these dynamics are shaping MedTech litigation strategy and what in-house counsel can do to prepare.

• Why NPEs are increasingly targeting MedTech companies, particularly
• Where devices incorporate software, connectivity, and third-party technologies.
• How regulatory evidence shapes litigation strategy, including the role of FDA submissions, clinical trial data, and regulatory timelines.
• The litigation challenges created by AI-enabled and software-driven devices, particularly around technical evidence, product functionality, and compliance with regulatory frameworks.