For Medical Devices, “Possible Use” Amounts To Infringement Only If The Use Is In Line With Medical Practice

Why It Matters

It raises the evidentiary bar for patent enforcement on medical devices, forcing patentees to tie claims to clinically accepted procedures and prompting manufacturers to design around professional standards.

Key Takeaways

• Infringement requires possible use aligned with medical standards
• Normal non‑infringing operation alone does not avoid liability
• Counterclaims may hinge on a finding of infringement
• Abandoned counterclaims force the claimant to pay costs
• Design must respect recognized professional medical practices

Pulse Analysis

The Munich Local Division’s January 2026 judgment in Emboline v. AorticLab adds a nuanced layer to European patent law for medical devices. While the court reaffirmed the long‑standing ‘possible use’ doctrine—allowing infringement when a patented function could be employed—it conditioned that possibility on ‘lege artis’ compliance. In practice, a device that could be removed with a hook only if a practitioner deliberately chose that method will not be deemed infringing unless such a hook‑removal is a recognized medical practice. This creates a two‑fold test: technical feasibility and professional acceptability.

For manufacturers, the ruling signals that product design must anticipate not just the literal claim language but also the standards of clinical use. Features that are technically possible but medically atypical may now be insulated from infringement claims, encouraging more flexible engineering. At the same time, patentees can tighten claim drafting to tie the invention to procedures that are entrenched in guidelines or consensus statements, thereby preserving enforceability. Litigators must also reassess counter‑claim strategies; linking revocation requests to an infringement finding, as seen here, can limit exposure but also shift cost burdens.

The decision is likely to ripple through the European Patent Convention landscape, influencing how courts evaluate medical‑device patents across jurisdictions. By embedding professional practice into the infringement analysis, the LD Munich aligns patent protection with patient safety considerations, reducing the risk of over‑broad enforcement that could hinder clinical innovation. Patent counsel should therefore conduct thorough prior‑art and practice reviews, documenting accepted procedural norms when filing or defending patents. As more cases adopt this approach, the industry can expect clearer boundaries between permissible design freedom and actionable infringement.