Issue: September / October 2024

This article explores the evolving patent landscape at the intersection of biotechnology, pharmaceuticals, and artificial intelligence (AI), focusing on the impacts of AI on patentability and enforcement within UK and European patent law. As AI becomes increasingly integrated into biotech and pharma innovations, it introduces new complexities that can affect patent grant rates and enforceability, potentially deterring ongoing investment. The article discusses key challenges, including subject matter exclusions, the rigorous examination process, and the implications for future innovation. It also highlights the importance of adapting patent strategies to secure the necessary protection for AI-driven advancements in these critical sectors.

The article focuses on the challenges of the pharmaceutical industry that are closely linked to the production process, covering engineering, scale-up, technology transfer and operations. It covers digital, modeling- and simulation-based approaches to overcome these hurdles. The use of digital platforms allows for the collection and harmonization of vast amounts of data from various sources and consistent data integration. Model-based technologies are key for simulations and many optimization measures. Using models for optimization (e.g.: Model predictive control (MPC)) are up-and-coming methods for improving biopharmaceutical manufacturing systems. It is investigated whether the bioprocess models generated in a QbD/DoE approach can also be used online for operational support.