Irregular Use and Conditional Counterclaims: The Munich Local Division on Medical Devices
The Munich Local Division clarifies when the irregular use of a medical device constitutes infringement. The panel also establishes strict cost consequences for counterclaims made conditional at the oral hearing.
The doctrinal boundary between the normal, non-infringing operation of a device and its irregular, infringing use requires careful navigation during enforcement proceedings. The Munich Local Division has now clarified this boundary for the medical field in UPC_CFI_125/2025, establishing that the mere possibility of an irregular use falling within the claims only constitutes infringement if it aligns with professional practice. Furthermore, the decision provides strict guidance on the cost consequences when a defendant makes a counterclaim for revocation conditional at a late stage of the proceedings.
How does the Munich Local Division assess the irregular use of medical devices?
A central dispute in the infringement action concerned whether the attacked embodiment, the FLOWer embolic protection device, could be operated in a manner that infringes the patent. The panel established a nuanced standard for such situations. The panel held that patent infringement is not excluded by the fact that a device is normally operated in a non-infringing manner and customers therefore do not regularly make use of the patented teaching. Infringement remains possible as long as the use of the patented teaching remains possible when using the device.
However, the panel introduced a specific limitation for the medical sector. In the case of a medical device, the possibility of an irregular use falling within the claims can only be considered as patent infringement if such use is in line with professional practice and the recognised rules of medical science. A theoretical possibility of infringement that contradicts accepted medical practice was therefore insufficient to establish liability.
How did the panel interpret the cylindrical outer structure of EP 2 129 425?
The claimant asserted that the attacked embodiment infringed EP 2 129 425, which claims an embolic protection device featuring an approximately cylindrical outer structure and a pull loop or other graspable structure. The defendant disputed the presence of these features.
Applying the claim construction principles from UPC_CoA_335/2023, the panel defined the person skilled in the art as a team comprising an engineer with a solid knowledge of mechanical engineering and a cardiovascular clinician. The claimant argued that the approximately cylindrical shape should be understood functionally, allowing the device to fit into the tapered aortic arch. The panel agreed that a precise geometrical cylinder is not required, noting that the patent uses the term "approximately" because blood vessels do not have a geometrically exact cylindrical shape. However, because the patent explicitly distinguishes between a cylindrical outer structure and a conical inner structure, the outer structure must be described as rather cylindrical than conical. Ultimately, the panel found the infringement action unfounded.
What are the cost consequences of a conditional counterclaim under Rule 263.3 RoP?
The procedural posture of the counterclaim for revocation shifted significantly during the oral hearing. The defendant had initially filed an unconditional counterclaim for revocation. At the hearing, the defendant made this request conditional on the patent being found infringed.
The panel held that this transition from an unconditional counterclaim to a conditional counterclaim constitutes a limitation of a claim. Specifically, the panel found that this transition means the counterclaim is limited in accordance with Rule 263.3 of the Rules of Procedure (RoP). Because the Court dismissed the infringement action, the intra-procedural condition set by the defendant did not occur. Consequently, no decision was made on the counterclaim. The panel ruled that if no decision is made on the counterclaim in accordance with the counterclaimant's request, the counterclaimant must bear the costs of the counterclaim.
What must litigators evaluate when making a counterclaim conditional at the oral hearing?
Defendants in infringement proceedings must carefully weigh the financial implications of amending their procedural requests late in the action. Transitioning an unconditional counterclaim for revocation into a conditional one at the oral hearing successfully avoids a substantive decision on validity if the infringement action fails. However, this strategic limitation under Rule 263.3 RoP carries a strict financial consequence: the defendant bears the costs of the undecided counterclaim.
For claimants enforcing medical device patents, the decision imposes a clear evidentiary burden. It is not enough to demonstrate that a medical device could theoretically be manipulated into an infringing configuration. Claimants must be prepared to prove that such irregular use complies with recognised medical science and professional practice.
Sources
Further Reading
Articles related to the topics covered above.
Conditional Counterclaims for Revocation: The Court of Appeal on Rule 263.3 RoP
The Court of Appeal has clarified the procedural mechanics for making a counterclaim for revocation conditional upon a finding of infringement. The order establishes a framework for conditional appeals to preserve validity attacks.
Retroactive Revocation and Penalty Refunds: The Court of Appeal on Enforcement Costs
The Court of Appeal clarifies that revoking an injunction of the Court of First Instance retroactively revokes associated penalty orders. Claimants enforcing pending appeal bear a significant cost risk if the merits decision is overturned.
Public Access and Redaction: The Düsseldorf Local Division on Rule 262 RoP
The Düsseldorf Local Division clarifies the mechanics of public access to the register after proceedings have concluded. The order establishes a staggered disclosure process to manage the administrative burden of redaction.