UPC_CFI_8/2023 – Edwards v Meril

Expert Commentary

Settlement The Court The case was settled, and the parties asked the Court to confirm the settlement, enter the redacted version of the settlement agreement in the register, and reimburse 20% of the court fees. The Court granted the request. Comment 1. The fact that the redacted version of the agreement is placed in the Register means the public cannot challenge the confidentiality, as is possible under R. 262 RoP. This is in accordance with R. 365.2 RoP. 2. The Court specifically states that the agreement may be enforced as a final decision of the Court and orders the Registry to provide, upon request, the enforcing party with an authentic copy of the enforceable decision.

Full Decision Text

1 Nordic-Baltic - regional division UPC_CFI_8/2023 Decision of the Court of First Instance of the Unified Patent Court delivered on 18/07/2025 CLAIMANT 1) Edwards Lifesciences Corporation One Edwards Way - 92614 - Irvine, California – US Represented by Magnus Dahlman (Advokatbyrån Gulliksson AB), Siddharth Kusumakar & Bryce Matthewson (Powell Gilbert (Europe) LLP), Adam Rimmer (Powell Gilbert LLP), Dr. Jonas Weickert & Bernhard Thum (Thum & Partner) DEFENDANTS 1) Meril Lifesciences PVT Limited Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, - 396191 - Vapi, Gujarat – IN 2) Meril GmbH Bornheimer Strasse 135 – 137 - 53119 - Bonn - DE 3) Smis International OÜ Harju maakond, Kesklinna linnaosa, Kaarli pst 9-1a - 10119 - Tallinn - EE 4) Sormedica UAB V. Kuzmos str. 28 - 08431 - Vilnius - LT Represented by Andreas von Falck, Alexander Klicznik, Kerstin Jonen, Felipe Zilly Claude, Lukas Wollenschlaeger, Beatrice Wilden, assisted by Kyra Lueg Althoff (Hogan Lovells International LLP), co-represented by Karin Westerberg & Julia Ericsson (Sandart & Partners Advokatbyrå KB) 2 PATENT AT ISSUE Patent no. Proprietor/s EP2628464 Edwards Lifesciences Corporation COMPOSITION OF PANEL – FULL PANEL Presiding judge Stefan Johansson Judge-rapporteur Kai Härmand Legally qualified judge Rute Lopes Technically qualified judge Elisabetta Papa LANGUAGE OF PROCEEDINGS: English SUBJECT-MATTER OF THE PROCEEDINGS Infringement action and counterclaim for revocation STATEMENT OF THE FORMS OF ORDER SOUGHT BY THE PARTIES 1. Claimant requests the Court to confirm the settlement agreement by decision of the Court and reimbursement of 20% of the court fee. 2. Defendants confirm that the counterclaim for revocation filed under the reference numbers CC_587594/2023, CC_587616/2023, CC_587597/2023 and CC_587618/2023 shall also be settled by the Settlement Agreement and be confirmed by decision of the Court. Defendants request partial reimbursement of court fees in the amount of EUR 4,000.00. SUMMARY OF FACTS 3. On 1 June 2023, Edwards Lifesciences Corporation (Claimant) filed a claim with the Nordic-Baltic Regional Division of the Unified Patent Court against Meril Lifesciences PVT Limited, Meril GmbH, SMIS International OÜ and Sormedica UAB (Defendants) based on European Patent EP 2 628 464 B1 (EP 464 B1) concerning the transcatheter heart valve prosthesis Myval™ THV. 4. The Defendants filed a counterclaim for revocation on 16 November 2023. The proceedings, comprising the Infringement Action (ACT_459769/2023), the Counterclaim for Revocation (CC_587594/2023, CC_587597/2023, CC_587616/2023, CC_587618/2023) as well as all related proceedings, are registered under case no. UPC_CFI_8/2023. 5. Upon the request of parties, the Court stayed the proceedings until the final decision of the Technical Boards of Appeal of the EPO (TBA). On 3 June 2024 the TBA upheld EP 464 in amended form (EP 464 B2). 6. On 16 August 2024, the Court refreshed the case and granted the parties permission to amend their respective cases to take account of the amendments made by the TBA. Following the instructions given by the Court the Claimant amended its statement of claim on 30 August 2024 in view of EP 464 B2 and the Defendants filed amended counterclaims on 11 October 2024. On 8 October 2024 the Claimant sought to further amend and request for relief in respect of Romania, which was allowed by the Court on 27 June 2025. The oral hearing of the case was scheduled on 3 18 July 2025. The Claimant filed its R. 365 application on 11 July 2025 and Defendants filed their written comments on 17 July 2025. GROUNDS FOR THE ORDER Settlement and confidentiality 7. Pursuant to Art. 79 UPCA the parties may, at any time during proceedings, conclude their case by way of settlement and request the settlement to be confirmed by a decision of the Court. The provision limits the scope of the settlement and stipulates that a patent may not be revoked or limited by way of settlement. According to R. 365.1 and 365.2 RoP where the parties have concluded their action by way of settlement, they shall inform the judge-rapporteur. The Court shall confirm the settlement by decision of the Court, if requested by the parties, and the decision may be enforced as a final decision of the Court. At the request of the parties the Court may order that details of the settlement are confidential. R. 262.2 RoP stipulates that a party may request that certain information of written pleadings or evidence be kept confidential and provide specific reasons for such confidentiality. 8. The parties have settled the dispute and concluded a settlement agreement, which has been signed by all parties involved. The Claimant has requested that the court confirm the settlement in the infringement action (ACT_459769/2023). The Defendants have confirmed the settlement of the counterclaim for revocation filed under the reference numbers CC_587594/2023, CC_587616/2023, CC_587597/2023 and CC_587618/2023. The parties have agreed that certain terms of the agreement (pages 2, 3, 4, 7 and 8) are confidential, and that the settlement agreement will be entered in the register in redacted form only. The Court has granted the request to keep the details of the settlement agreement confidential. Therefore, the settlement shall be confirmed by the Court, the proceedings shall be declared closed, and the decision shall be entered into the register in redacted form. Costs 9. Pursuant to R. 370.9(c) (iii) if the parties have concluded their action by way of settlement the party liable for the Court fees will be reimbursed by 20 % if the action is settled before the closure of the oral procedure. According to R. 370.11 RoP, the party seeking reimbursement shall lodge a reasoned application for reimbursement to the Court. The Court shall deal with the application without delay and if satisfied that the reimbursement is appropriate shall direct the Registrar to make the payment as soon as practicable. 10. As the parties have agreed that the Court should not issue an order regarding their costs in these proceedings, the Court will refrain from doing so. In its statement of claim, the Claimant estimated the value of the dispute to be EUR 8,000,000 and therefore paid a total court fee of EUR 63,000. The Defendants estimated the value of the counterclaim to be EUR 8,000,000 and paid a total court fee of EUR 20,000. The Court confirmed the value of the proceedings in its order of 27 June 2025. 4 As the action was withdrawn before the oral hearing, the Claimant shall be reimbursed 20% of the court fee, i.e. EUR 12,600. The Defendants paid court fees totaling EUR 20,000 for the counterclaim for revocation and shall be reimbursed 20% of this amount, i.e. EUR 4,000. DECISION 1. Confirm the Settlement Agreement on 10 July 2025 between Edwards Lifesciences Corporation and Meril Lifesciences PVT Limited, Meril GmbH, SMIS International OÜ and Sormedica UAB regarding European Patent EP 2 628 464. 2. The Settlement Agreement is Annex 1 of this decision. 3. The Claimant shall be reimbursed 20 % of the court fees, amounting to EUR 12,600. 4. The Defendants shall be reimbursed 20 % of the court fees, amounting to EUR 4,000. 5. Declare that the p 2; 3; 4; 7 first sentence and 8 of the Settlement Agreement remain confidential. 6. The Parties agreed on costs and request no order as to costs. 7. The decision shall be entered on the register in redacted form. INFORMATION ABOUT APPEAL An appeal against the present Decision may be lodged at the Court of Appeal, by any party which has been unsuccessful, in whole or in part, in its submissions, within two months of the date of its notification (Art. 73(1) UPCA, R. 220.1(a), 224.1(a) RoP). INFORMATION ABOUT ENFORCEMENT (RULE 68(1) RGR) The decision may be enforced as a final decision of the Court Art. 82 UPCA, Art. Art. 37(2) UPCS, R. 118.8, 158.2, 354, 355.4 RoP. An authentic copy of the enforceable decision will be issued by the Deputy-Registrar upon request of the enforcing party, R. 69 RegR 5 ORDER DETAILS Order no. ORD_ 32871/2025 in ACTION NUMBER: ACT_459769/2023 CC_587594/2023; CC_587616/2023; CC_587597/2023; CC_587618/2023 UPC number: UPC_CFI_8/2023 Action type: Infringement Action and counterclaim for revocation Related proceeding no. Application No.: 32815/2025 and App_32835/2025 Application Type: APPLICATION_ROP_365 Stefan Johansson Presiding judge Kai Härmand Legally qualified judge and judge-rapporteur Rute Lopes Legally qualified judge Elisabetta Papa Technically qualified judge For the Deputy-Registrar Johanna Mikkola Jäghammar Clerk Exhibit EDW-APP-2 Final Settlement Agreement [Redacted] SETTLEMENT AGREEMENT between Edwards Lifesciences Corporation, incorporated under the laws of the State of Delaware, USA, and having its registered office at One Edwards Way, Irvine, California, 92614, USA, – referred to as "Edwards" – a n d Meril Lifesciences Pvt. Limited, incorporated under the laws of India and having its registered office at Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, 396191, Vapi, Gujarat, India, – referred to as "Meril India" – a n d Meril GmbH, incorporated under the laws of Germany and having its registered office at Bornheimer Strasse 135 - 137, 53119, Bonn, Germany, – referred to as "Meril GmbH" – a n d SMIS International OÜ, incorporated under the laws of Estonia and having its registered office at Harju maakond, Kesklinna linnaosa, Kaarli pst, 9-1a, 10119, Tallinn, Estonia, – referred to as "SMIS International" – a n d Sormedica, UAB, incorporated under the laws of Lithuania and having its registered office at Linkmen str. 28, LT-08217, Vilnius, Lithuania, – referred to as "Sormedica" – – together referred to as the "Parties" – - 2 - PREAMBLE 1. WHEREAS, on 1 June 2023, Edwards filed a claim with the Nordic Baltic Regional Division of the Unified Patent Court (hereinafter the "UPC") against Meril India, Meril GmbH, SMIS International and Sormedica (together, the “Defendants”) based on European Patent EP 2 628 464 B1 (hereinafter "EP 464 B1") concerning the transcatheter heart valve prosthesis Myval™ THV; 2. WHEREAS, the Defendants filed a Statement of Defence and a Counterclaim for Revocation on 16 November 2023. The proceedings, comprising the Infringement Action (ACT_459769/2023), the Counterclaim for Revocation (CC_587594/2023, CC_587597/2023, CC_587616/2023, CC_587618/2023) as well as all related proceedings, are registered under case no. UPC_CFI_8/2023 (hereinafter the "Proceedings"); 3. WHEREAS, on 3 June 2024, following an appeal by Meril GmbH of the decision of the Opposition Division of the EPO to uphold EP 464 B1, the Technical Board of Appeal of the EPO (hereinafter the "TBA") upheld EP 464 in amended form (EP 464 B2); 4. WHEREAS, on 16 August 2024, the Court issued Order no. ORD_44404/2024, inter alia, granting the parties permission to amend their respective cases to take account of the amendments made by the TBA; 5. WHEREAS, on 30 August 2024, Edwards amended its statement of claim in these Proceedings to include EP 464 B2; 6. WHEREAS, on 11 October 2024, the Defendants filed an Amended Statement of Defence as well as an Amended Counterclaim for Revocation; 7. WHEREAS, on 8 October 2024, Edwards sought to further amend its statement of claim in the Proceedings to include a request for relief in respect of Romania, which was allowed by the UPC with its Order no. ORD_598602/2023 dated 27 June 2025; 8. WHEREAS, on 4 April 2025, the Munich Local Division of the UPC issued a decision (ORD_598588/2023, ORD_69128/2024) in the infringement proceedings initiated by Edwards against Meril GmbH, Meril India, and Meril Italy S.r.l (together, “Meril”) (case no. UPC_CFI_501/2023, ACT_597277/2023) based on EP 3 669 828 B2 (“EP 828”), and in the revocation proceedings initiated by Meril (case no. UPC_CFI_501/2023, ACT_23112/2024), upholding EP 828 and concluding that the transcatheter heart valve prosthesis Myval™ THV and an assembly comprising the Myval™ THV and NavigatorTM infringes EP 828, and granting an injunction (hereinafter the “UPC 828 Decision”); - 3 - 9. WHEREAS Meril have not appealed the UPC 828 Decision which is accordingly now final; 10. WHEREAS an oral hearing is scheduled in the Proceedings to take place on 18 July 2025; 11. WHEREAS the Parties desire to settle the Proceedings amicably to avoid further costs and efforts by concluding this settlement agreement; NOW THEREFORE, without acknowledgement of any legal obligation to do so, without acknowledgement of any obligation to bear the costs of the Proceedings save as expressly agreed herein, and without acknowledgement of any rights of the other party, the Parties agree as set out in the following (hereinafter the "Agreement"): 1. The Defendants undertake to immediately cease and desist from offering, placing on the market, using, or importing or storing for these purposes in Austria, Belgium, Bulgaria, Estonia, Finland, Latvia, Lithuania, Luxembourg, the Netherlands, Portugal, Romania and Slovenia: an implantable prosthetic valve, comprising: a radially collapsible and expandable annular frame; a leaflet assembly positioned within the frame, the leaflet assembly comprising a plurality of leaflets that are connected to each other to form commissures of the leaflet assembly; wherein the frame comprises a pair of vertical struts adjacent each of the commissures, the vertical struts being arranged at an upper area between two frame sections and the struts of each pair being spaced apart from each other so as to define an opening therebetween; wherein at each commissure, two adjacent leaflets are positioned between an adjacent pair of vertical struts, with one of the leaflets wrapping around at least a portion of one of the vertical struts at a location outside of the frame and the other leaflet wrapping around at least a portion of the other vertical strut at a location outside of the frame; and wherein a cloth portion is positioned radially outward of the frame at each pair of vertical struts and positioned over portions of the leaflets that extend radially outside of the frame, the cloth portions being sutured to the leaflet portions that are radially outside of the frame, wherein the cloth portion of each commissure comprises a first cloth portion and each commissure further comprises second and third cloth portions, the second cloth portion wrapping around one of the vertical struts and the third cloth portion wrapping around the other vertical strut, each of the second and third cloth portions - 4 - being sutured to the first cloth portion and one of the leaflet portions that are radially outside of the frame, characterized in that the leaflet assembly is attached to the frame such that the leaflets are not directly sutured to the vertical struts. (independent claim 1 of EP 464 B2), especially when, in the valve of claim 1, each of the second and third cloth portions of each commissure comprises an attached portion that is attached to one of the leaflets and an excess cloth portion that extends inward into the frame and wraps back around one of the vertical struts, the first cloth portion being sutured to the attached portions and the excess cloth portions. (dependent claim 2 of EP 464 B2), especially when, in the valve of either claim 1 or claim 2, the vertical struts of each pair are connected to each other at their upper ends. (dependent claim 3 of EP 464 B2), especially when, in the valve of any of claims 1, 2 or 3, each pair of vertical struts are connected to adjacent pairs of vertical posts by a row of circumferentially extending angled struts. (dependent claim 4 of EP 464 B2), especially when the transcatheter heart valve prosthesis is designed as shown below: Docusign Envelope ID: BB1C05EA-D2C6-456A-816A-3FA7111CA3E6 - 5 - 2. 3. 4. ‘i/ Ne It. • V ••• ' 1G1 • er • and the leaflets are attached to the prosthetic aortic heart valve as schematically shown below, Leaflet Uppen tob of leaflet Th'ed suture Fdtn suture Inner surface of %vet itiV Lootet Upper tab of 'tett Second suture suture Strut Strut Loots, tots of leottot Coromrsouto — ottochrsent fabric Fa5t First suture suture Fig.. 24 L000r lob of leaflet Commissure support fabric - 6 - 5. Edwards undertakes not to rely on this Agreement as an admission of validity or infringement of EP 464 B2 by the Defendants. 6. Save for Sections 1 and 5 of the Agreement which shall not be confidential, the parties agree to keep the terms of this Agreement confidential and shall not disclose them to any third party, except for (a) the Parties’ auditors, insurers and (patent) attorneys, or (b) as required by law or order of a competent court or authority, or (c) unless necessary to implement and enforce any of the terms of the Agreement, or (d) with prior written consent of the other party; the Parties further agree to not issue any statements to the general public (whether press, social media or otherwise) in relation to the Proceedings and the conclusion of the Proceedings. 7. Notwithstanding the provisions of Section 6, the Parties shall seek an order pursuant to R. 365.2 RoP that the highlighted terms of this Agreement are confidential and that the Agreement is entered on the register in redacted form only (with the highlighted portions redacted). 8. On behalf of Meril Lifesciences Pvt. Limited Name: ktuanAS itS4, Position: ISAAM141.4" (Alpe- 6144 Date m4o %kis i Aie Signature: 4 4't- 162 1, On behalf of Meril GmbH Name: A1.4.01/4xCA4 Vt'. IAA Position: ,f -inwr - t ite 441- Ltotket4 Date: %•14(% Int Signature: On behalf of SMIS International 00 Name: 4tAitivtits Position: Date: Signature: %rittitri tirtorl-KJA LOINA(111-OLC On behalf of Sormedica, UAB Name: A il, CIA AS Vb.% ;li t Position: Rcv I tC6)(Scet.t. c1964-S-4 Date: 10 /4„CA et( Signature: Docusign Envelope ID: BB1C05EA-D2C6-456A-816A-3FA7111CA3E6 - 8 - On behalf of Edwards Lifesciences Corporation Name: Linda Park Position: Senior Vice President, Associate General Counsel, and Corporate Secretary Date: July 10, 2025 Signature: DocuSigned by: 61EE82C985C24C2

Key Holdings

• Settlement confirmed and redacted version entered in Register.
• 20% of court fees reimbursed.
• Settlement enforceable as final decision.

Tags

• Confidentiality
• Court Fees
• Enforcement
• Settlement

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