Patenting the Use of Medical Devices (T 0941/24)

Key Takeaways

• Board allowed patent on surgical device use by limiting claim scope
• Implicit steps like bone attachment not deemed “encompassed” under Article 53(c)
• Description language proved crucial to exclude surgical steps from claim interpretation
• Decision clarifies drafting strategy for European medical‑device patents
• Highlights distinction between method‑of‑surgery and device‑use claims

Pulse Analysis

Patenting medical devices in Europe has long been hampered by two overlapping statutory bars: Article 53(c) EPC excludes methods of treatment by surgery, while Article 54(4) limits second‑medical‑use claims to substances or compositions. Consequently, companies often can only protect the physical device, leaving the innovative way the device is employed in the operating room unguarded. The recent Board of Appeal decision in T 0941/24, concerning BrainLab’s dual‑sensor tracking system, provides a rare illustration of how those exclusions can be navigated when the claim language and description are meticulously aligned.

The Board focused on the meaning of “encompass” from the earlier G1/07 precedent. It held that a claim does not automatically capture every conceivable implementation of a generic feature; only steps expressly or implicitly defined as essential are considered. By showing that the method claim neither required attachment of the sensor to bone nor any motion of an exposed bone, the Board concluded that the invention fell outside the surgical‑method exclusion. This nuanced interpretation underscores the importance of explicit disclaimer language in the specification and of limiting claim scope to technical steps that are clearly non‑surgical.

For MedTech innovators, the ruling offers a strategic template: use precise functional language, embed clear statements in the description that the invention does not involve surgical steps, and avoid embedding implicit surgical features in the claim hierarchy. Patent practitioners can now draft “use” claims for devices that focus on data acquisition, navigation or verification, expanding the protectable portfolio beyond the hardware itself. As the European patent landscape evolves, this decision is likely to be cited in future disputes, shaping how companies allocate R&D resources and negotiate licensing in a market where surgical innovation is a key competitive differentiator.