Edwards Lifesciences Corporation v. Meril Life Sciences Pvt Ltd. and Meril GmbH

This case before the Local Division Munich of the Unified Patent Court (Case No. UPC_CFI_15/2023) concerned European Patent EP 3 646 825 held by Edwards Lifesciences Corporation, a globally leading developer and manufacturer of artificial heart valves. Edwards' SAPIEN 3 transcatheter prosthetic heart valve is used in TAVI (Transcatheter Heart Valve Implantation) procedures to treat aortic valve stenosis, a life-threatening narrowing of the native aortic valve. The defendants, Meril GmbH (a German subsidiary based in Bonn) and Meril Life Sciences Pvt Ltd. (an India-based parent company), launched the competing Myval transcatheter heart valve along with the Navigator delivery system and the Val-de-Crimp crimper in Europe in 2019.

The court addressed several preliminary legal issues. First, it held that the Unified Patent Court has jurisdiction over acts of infringement committed before the entry into force of the UPCA Agreement on 1 June 2023, pursuant to Articles 3(c) and 32(1)(a) UPCA. Second, the claimant's choice among potentially competent German local divisions determines competence. Third, regarding bifurcation, the court held that following a central division ruling upholding the patent in amended form, a stay of the infringement action may be based exclusively on R. 295(c)(i) or (m) RoP, and that a decision on infringement is possible prior to the central division's resolution of the referred counterclaim. The court found only limited circumstances warranting deviation from proceeding with the infringement action after the central division's decision, namely where the aggrieved party demonstrates the central division's decision is manifestly and prima facie erroneous.

On the merits, the court found that Meril's Myval products infringed Edwards' patent. Regarding remedies under Article 34 UPCA, the court held that injunctive relief and corrective measures can extend to all contracting member states where the European Patent has effect, provided infringement is proven for at least one contracting member state. The court also addressed the interests of third parties and the public interest under Articles 63(1), 64(1), and 64(4) UPCA, noting that while the defendants might be regarded as unwilling licensees, the public interest must still be considered as members of the public may face serious consequences if access to the infringing embodiment were denied.

The operative orders included: (I) a finding of infringement; (II) prohibition of further infringing acts with a penalty of €10,000 per day of delay; (III) an order to provide information and accounting; (IV) recall of infringing products from distribution channels; (V) an order to take back products placed on the market since 17 March 2021; (VI) destruction of infringing products and materials; (VII) permission for Edwards to publish the decision in five public media; (VIII) an order for defendants to reimburse Edwards for damages; and (IX) an order for preliminary damages of €663,000 payable within three weeks. Importantly, orders V.2 and VI.2 excluded XL devices already scheduled for implantation in an individual patient by 15 November 2024. The court established a mechanism enabling individual members of the public to request a single-use licence to address public needs where the SAPIEN 3 valve is not clinically suitable. All other applications were rejected, and the decision was declared immediately and directly enforceable from the date of service in each Contracting Member State without security payment.