Traditionally the Boards have held that the "substance or composition" of Art. 54(4) and (5) must be an "active agent or ingredient", in the sense of a pharmaceutically active agent. Chemicals which merely acted physically, such as injected collagen agents, were considered more a "device" rather than a "substance or composition" (see, e.g., T 1758/15).
T 264/17 takes a different view on the issue.
