Gugatan sengketa paten luar negeri Sanuo Bio ditolak banding, produk terkait dikenai larangan sementara

Xinjingbao News (Reporter Liu Xu) 1 April, San Nuo Biotechnology Co., Ltd. (hereinafter referred to as “San Nuo Bio”) issued an announcement that on 30 March, the company received the appeal result regarding the European patent EP4344633 temporary injunction. It was learned that the Unified Patent Court (UPC) Court of Appeal in Europe rejected the appeal filed by the company and A Menarini Diagnostics S.r.l. (hereinafter “Menarini”) and upheld the temporary injunction ruling against the GlucoMen iCan CGM product issued by the Hague UPC division.

The product accused of infringement by San Nuo Bio is the GlucoMen iCan CGM, mainly used for blood glucose monitoring in diabetic patients. The involved patent is EP4344633, which discloses a sensor component with a specific structure and its matching device. On 4 July 2025, Abbott Diabetes Care Inc. (hereinafter “Abbott”) filed a temporary injunction application with the Hague UPC division against its patent EP4344633, targeting San Nuo Bio and Menarini. Abbott believes that the GlucoMen iCan CGM product produced by San Nuo Bio infringes its patent rights.

On 17 October 2025, the Hague UPC division made a preliminary judgment, approving Abbott’s temporary injunction application against EP4344633, and both parties could appeal the injunction decision within 15 days after the judgment takes effect. On 31 October 2025, San Nuo Bio filed an appeal, requesting the UPC Court of Appeal to dismiss Abbott’s temporary injunction application against EP4344633 and to revoke the first-instance judgment.

On 9 February 2026, the UPC Court of Appeal held a hearing on the appeal of the temporary injunction ruling for EP4344633. The Court of Appeal believed that there was a possibility of infringement by the involved product; at the same time, since the product had already entered some European markets, failing to take temporary measures could cause irreparable damage to Abbott. Therefore, it decided to maintain the temporary injunction. However, the Court of Appeal explicitly clarified that this temporary injunction does not apply to San Nuo Bio’s marketed product “Sinocare iCan i3.”

The UPC Court of Appeal issued a judgment on 30 March 2026 local time, rejecting the appeal of San Nuo Bio and Menarini, and upholding the first-instance court’s temporary injunction ruling, prohibiting San Nuo Bio and Menarini from manufacturing, selling, importing, or using the GlucoMen iCan CGM product within the jurisdiction of the UPC. Meanwhile, San Nuo Bio is required to bear the relevant costs of this appeal process and pay Abbott 200,000 euros in temporary costs within 14 days.

Menarini is an Italian company mainly engaged in the research, production, and sales of medical diagnostic products. In November 2024, San Nuo Bio signed a “Distribution Agreement” with Menarini, under which the two parties reached an exclusive cooperation to jointly distribute San Nuo Bio’s first- and second-generation continuous glucose monitoring systems (iCan CGM System) in over 20 European countries and regions under a joint brand.

Additionally, Abbott filed a complaint against EP4344633 at the Hague UPC division on 17 November 2025. As of now, the case has not yet gone to court.

San Nuo Bio stated that this judgment is a result of the temporary injunction review and not a final ruling on the case’s substantive issues. Since the main complaint has not yet been heard, the final outcome remains uncertain, and the specific impact on the company’s future profits is also uncertain. The involved product GlucoMen iCan CGM is still in the market development stage in Europe. In 2025, the sales revenue of this product within the UPC jurisdiction accounted for no more than 0.5% of the company’s total operating income. It is expected that from the time of this judgment to the main case ruling, the sales revenue affected in the UPC jurisdiction will not significantly impact the company’s production, operation, or overall product sales.

This is not the first patent dispute San Nuo Bio has encountered. On 4 June 2024, Roche Diabetes Care, Inc. (hereinafter “Roche”) filed a patent infringement lawsuit against San Nuo Bio’s subsidiary Trividia Health, Inc. (hereinafter “THI”) in the Federal District Court of Delaware, USA. Roche claimed that THI’s sales of TRUE METRIX and TRUE METRIX PRO test strips infringed its U.S. patents No. 7727467 and No. 7892849. THI denied any infringement and counterclaimed that Roche’s patents were invalid due to prior art, and that Roche infringed THI’s patent No. 8128981.

Considering costs and time, after friendly negotiations, THI signed a cross-licensing and settlement agreement with Roche on 2 October 2025 regarding BGM products. After the agreement took effect, THI obtained patent licenses from Roche (covering at least 39 U.S. patents and patent applications and corresponding foreign patents) for implementing THI products; meanwhile, Roche obtained patent licenses from THI (covering at least 2 U.S. patents and corresponding foreign patents). THI is required to pay Roche a net amount of 19 million USD according to the agreement. The lawsuit was terminated on 17 October 2025 with a “disfavor dismissal.” The above matters impacted San Nuo Bio’s net profit in the third quarter of 2025 by 136 million yuan.

In terms of performance, San Nuo Bio expects a net profit attributable to shareholders of the listed company of 85 million to 127.5 million yuan in 2025, a year-on-year decrease of 73.95% to 60.92%; net profit after deducting non-recurring gains and losses is estimated to be 45 million to 67.5 million yuan, down 84.73% to 77.09% year-on-year.

Regarding the significant decline in performance, San Nuo Bio explained that the full subsidiary PTS’s operating performance in 2025 did not meet expectations, and a portion of goodwill arising from the acquisition of PTS was impaired, with an estimated impairment total of 130 million to 170 million yuan. The patent settlement with Roche by its U.S. subsidiary THI involved a payment of 19 million USD, which is expected to impact the net profit attributable to shareholders of the listed company in 2025 by 74.63 million yuan. Due to increased investment in new products for CGM (continuous glucose monitoring) and BGM (point-of-care blood glucose testing), the overall gross profit margin of glucose monitoring products was affected. To enhance the recognition of new products and consolidate and expand the market, marketing expenses increased. Non-recurring gains and losses are expected to be 38 million to 42 million yuan, an increase compared to 2024.

Editor: Wang Lu

Proofreader: Mu Xiangtong