Lepu Medical's CE-Certified MemoCarna Occluders Blocked in Four European Countries Prior to Commercialization Amid UPC Patent Infringement Ruling

CE certified, but not actually sold

• From March to May 2025, Lepu Medical’s two MemoCarna devices—the atrial septal occluder and the ventricular septal occluder—successively obtained CE certification. Subsequently, Lepu Medical rapidly initiated pre-launch activities for the European market, including showcasing physical products at international exhibitions such as EuroPCR in Paris and sponsoring the CSI conference in Frankfurt.Reports indicate that the end-user prices listed in its price schedule are 20%-40% lower than those of comparable Occlutech products.

Occlutech Files Direct Lawsuit, Initiating UPC Legal Proceedings

Occlutech determined that once the product was launched, it would severely erode its market share, and thus initiated UPC legal proceedings:

• June 19, 2025:OcclutechFiling for an Injunction on Patent EP2387951 with the Hamburg Regional Division

  Hamburg Branch Ruling (October 21, 2025)：

  Full support for Occlutech's claims. The court held that CE marking is the sole statutory threshold for market access in the European Union; once a company obtains such certification and engages in extensive public promotion and physical product displays at offline exhibitions, it has effectively “paved the way for infringement,” allowing the risk of infringement to be established even in the absence of actual sales.Lepu Medical’s Defense That “No Actual Sales Constitutes No Infringement” Was Not Accepted, the court issued interim injunctions covering the entire territories of five countries—Germany, France, Italy, the Netherlands, and Ireland—prohibiting the importation, market launch, and promotion of the products involved in the case, with a maximum fine of €250,000 per violation.

July 8, 2025: Occlutech once again filed an application for a preliminary injunction based on patent EP1998686 with the Düsseldorf Regional Court.On October 31, 2025, the Düsseldorf branch court ruled in the first instance that Lepu Medical's products did not constitute infringement.Occlutech Continues to Appeal

May 11, 2026The UPC Court held an oral hearing. It is worth noting that,Lepu Medical Absent from Court Hearing, submit only written defense materials.

On June 18, the Court of Appeal issued a final ruling, overturning the first-instance judgment of non-infringement by the Düsseldorf court, and determined that both models of MemoCarna occluders fall within the scope of protection of Occlutech’s EP1998686 patent, constituting infringement.

The court explicitly stated in its judgment that the Düsseldorf branch’s first-instance technical interpretation of the patent claims was erroneous, and that the “partially functionally equivalent” substitute structures in Lepu Medical’s products still constitute infringement under the doctrine of equivalents in the sense of patent law.

The list of countries under sales ban has been reduced from five to four (Germany, France, Italy, and the Netherlands), with Ireland excluded.

This case has become one of the strictest precedents involving the determination of "equivalent infringement" and "imminent infringement" encountered by Chinese medical device companies in Europe since the establishment of the Unified Patent Court (UPC).。

• CE Certification Is No Longer a “Safety Net”

  Public promotion and exhibition displays following the acquisition of CE certification may serve as key evidence for courts to determine "imminent infringement." The legal significance of CE certification has been redefined by the Unified Patent Court (UPC)—transforming from a "proof of compliance" into a "signal of completed sales preparation." Every step of commercial预热 after obtaining the certificate requires scrutiny for patent compliance.

• The timing of patent layout needs to be significantly advanced.

  Although Lepu Medical holds 214 EU CE certifications, it failed to circumvent Occlutech’s core patent layout. Patent strategy should shift forward from the “pre-certification” stage to the “R&D” phase. It is particularly important to note that the Unified Patent Court (UPC) has ruled that “replacement structures with partially equivalent functions” still constitute infringement under the doctrine of equivalents; thus, mere structural modifications do not necessarily mitigate risk.

• Establish a full-chain patent compliance system covering “R&D – Registration – Certification – Pre-launch – Market Launch – After-sales”

  The risk exposure in this case spans the entire product lifecycle. The “vacuum period” between “regulatory approval,” “promotion,” and “market launch” is not a safe harbor—on the contrary, UPC considers this phase to be critical for “paving the way for infringement.” Every public action may serve as evidence for competitors to seek preliminary injunctions.