The reproducibility challenge for advanced therapies (T 0827/23)

Reproducibility is an inherent challenge in advanced therapies. Therapeutic extracellular vesicles (EVs), the subject of the recent Board of Appeal case in T 0827/23, are particularly heterogeneous and hard to define products. Aside from the manufacturing and regulatory issues, the inherent heterogeneity of these products also presents a challenge for patentability in Europe. In the