Silimed Indústria de Implantes Ltda v. Polytech Health&Aesthetics GmbH, UPC Court of Appeal, 29 June 2026, Case no. UPC-CoA-066/2026
On 29 June 2026, the President of the UPC Court of Appeal issued an important decision on applications to remove an allegedly unauthorised opt-out under Rule 5A of the Rules of Procedure (RoP). The ruling will be of particular interest to parties involved in entitlement disputes and those seeking to challenge opt-outs filed by registered proprietors.
Background
The dispute concerned European patent EP 2 581 193, registered in the name of Polytech Health & Aesthetics GmbH. Polytech filed an opt-out application during the UPC’s sunrise period on 30 March 2023. Silimed, which had been pursuing long-running entitlement proceedings in Germany concerning the patent, subsequently applied to have the opt-out removed on the basis that Polytech was not entitled to have filed it.
Silimed’s application before the UPC Registrar sought removal of the opt-out as an “unauthorised application to opt out” under Rule 5A RoP. The Registrar rejected the application, and Silimed sought review by the President of the Court of Appeal.
The key issue
The central question was what an applicant must show in order to have an existing opt-out removed.
Silimed argued that because entitlement proceedings had established that Polytech was not the true owner of the patent, the opt-out had not been validly filed. The Court therefore had to consider the relationship between the UPC’s opt-out rules and national disputes concerning patent ownership.
The Court’s decision
The President dismissed the application and upheld the Registrar’s decision. In doing so, the Court set out a clear framework for Rule 5A applications.
The Court held that an application to remove an allegedly unauthorised opt-out must establish one of two things, being:
- the person who filed the opt-out was not the person shown in the relevant national patent registers as being entitled to be registered as proprietor of the validated European patent.
- even if the filer was the person shown in the relevant national registers, the applicant must demonstrate that, under the national law of each validated state, that registered person was not entitled to be registered as proprietor – and that the applicant itself was the party so entitled.
The Court made clear that the burden rests squarely with the applicant seeking removal. It is not enough merely to allege defects in title or to point to entitlement disputes in the abstract. The applicant must prove both that the registered proprietor lacked entitlement and that the applicant itself was entitled to be registered as proprietor.
A register-based approach
The opt-out procedure is designed to operate on the basis of objectively ascertainable information. Where an opt-out has been filed by the party appearing on the registers as proprietor, a party seeking to unwind it will face a substantial evidential burden.
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Why it matters
This is the first significant ruling on Rule 5A RoP and provides welcome certainty for proprietors who filed opt-outs on the basis of their registered status.
For challengers, the judgment confirms that Rule 5A is not a shortcut for relitigating entitlement disputes within the UPC framework. A successful application will require a carefully constructed case on ownership, supported by the relevant national laws governing entitlement in each validated state.
For patentees, the ruling reinforces the protective effect of the register and reduces the risk that opt-outs can be displaced on the basis of competing ownership allegations alone.
Comment
Although procedural in nature, the decision is likely to have wider significance. As disputes arising from assignments, corporate restructurings, insolvencies and historic ownership challenges continue to reach the UPC, the framework set out in this ruling will serve as an essential reference point for Rule 5A applications.
The Court of Appeal’s message is clear: the UPC will not lightly disturb an opt-out filed by the registered proprietor. A party seeking removal must prove not only that the filer lacked entitlement, but also that it was itself entitled to be registered as proprietor at the relevant time.
The decision can be read here.
