Infringement of medical device claims: the standard use threshold (UPC_CFI_628/2024; UPC_CFI_125/2025)

In this infringement action Emboline v AorticLab, the Munich Local Division had to decide whether the defendant’s medical device infringed a claim directed to an “embolic protection device that can be deployed in a patient’s blood vessel to protect the downstream organs from potential emboli” (r. 18). A central dispute was whether the accused product included “graspable structures into which a hook can engage as specified in the patent claim” (r. 51), i.e., structures that would enable removal of the device from the blood vessel (r. 24). 

The Court found that the attacked embodiment was “objectively neither intended nor suitable for removal from the blood vessel by means of a hook using the section referred to by the claimant as ‘V-shaped’” (r. 52). Instead, it was “normally removed from the blood vessel by pulling it out using the rod to which it is firmly attached” (r. 53).

The Court acknowledged the general principle that infringement is not excluded merely because a device is typically operated in a non-infringing way, even if the manufacturer specifies a different use, “as long as the use of the patented teaching remains possible” (r. 55). For medical devices, however, the Court added an important qualification: an unconventional, claim-compliant use is relevant only if it aligns with professional practice and recognised rules of medical science. In particular, the standard use in medicine requires that the procedure be performed “professionally, carefully and in accordance with current medical standards” (r. 56).

Here, using a hook to retrieve the device did “not constitute proper, professional and intended use”, even if technically possible, because it would damage the device and it was at most possible in the context of “unconventional methods in an emergency”, which “cannot play a role in the assessment of patent infringement” (r. 57). Accordingly, the Court concluded that the accused device did not infringe the patent.

The decision does not make clear whether, when assessing validity, this feature would also be construed as limited to being suitable for use only under standard medical practice. It will be interesting to see whether the UPC case law further develops in this direction:EPO case law does not expressly include this principle.

As an aside, the case also nicely illustrates a significant downside of making the revocation counterclaim dependent on a finding of infringement: if the counterclaimant establishes non-infringement they must then bear the costs for the revocation counterclaim.