Edwards Lifesciences Corporation v. Meril GmbH and Meril Life Sciences Pvt Ltd., Decision of the Court of First Instance of the UPC Local Division Munich concerning EP 3 646 825, 15 November 2024, Case no. ACT_459987/2023 UPC_CFI_15/2023
On 15 November 2024, Edwards successfully obtained an injunction in the Munich Local Division (LD) against Meril in 16 UPC member countries for infringing Edwards’ EP 3 646 825 (EP 825) patent with Meril’s transcatheter heart valves. Meril was ordered to cease and desist from further infringements, recall and destroy infringing goods pay a preliminary damages payment of €660K. The exception to the injunction are those “XL devices that have already been scheduled for implantation in an individual patient by 15 November 2024”.
Background
These proceedings form part of a long-standing dispute between the two companies.
EP 825 protects a “system comprising a prosthetic valve and a delivery catheter”. The dispute is focused on second generation transcatheter heart valves which Meril sells under the brand name Myval Octacor. The infringement action was brought in the Munich LD in August 2023. A standalone revocation action was brought by Meril Italy in the Paris CD whilst two counterclaims of revocation were brought by the other two Meril entities (named in the original infringement proceedings) in the Munich LD. These revocation actions were then consolidated after the Munich LD referred the counterclaims to the Paris CD by order of 28 March 2024 in accordance with Rule 302 RoP. The Paris CD upheld the patent in amended form in July 2024 (see analysis here).
Decision
On the facts, and having adopted the accepted approach to claim interpretation (which apply equally to the assessment of infringement and validity) set out in the Court of Appeal’s decision in 10x Genomics v NanoString (UPC_CoA_335/2023), the Munich LD found that Meril’s Myval Octacor infringed EP 825 on a literal basis.
This is a comprehensive decision which considers a number of important practice points.
1. Request for stay of proceedings with other parallel actions
Meril appealed the decision by the Paris CD in the revocation action, and argued that the Munich LD should stay the infringement case pending the appeal. However, the standard for deviating from the default next case management step (which in this case was the decision in the infringement action) is a manifestly and prima facie erroneous decision. The Munich LD set out in this decision that this standard hasn’t been reached as it believed the Paris CD decision to be correct, rejecting Meril’s request for a stay. In particular, Meril argued that the Paris CD had infringed Meril’s right to be heard as some of their main invalidity arguments were not mentioned in the written decision, with these arguments meaning that the patent will be revoked on appeal. The Munich LD disagreed – setting out that the arguments were discussed during the oral hearing, addressed and dismissed in the written decision and that they believed the arguments would be dismissed in the appeal hearing.
2. Amending pleadings to include member countries which have ratified the UPC after a case has commenced
Edwards had applied at the oral hearing to amend their requests to include Romania. Edwards argued that Romania had only joined the system on 1 September 2024 and so the amendment could not have been made with the statement of claim. However, given the hearing was on 24 September 2024, the court held that the request should have been made before the oral proceedings, and in any event, Edwards had also failed to prove that the renewal fee for Romania had been paid in time and that the patent is valid there (as the online register entries were silent on these points).
Therefore, for future parties looking to add jurisdictions to their requests in infringement/revocation proceedings, they should ensure that this is done as soon as possible (for example, if Ireland later ratifies the UPC, requesting Ireland to be added very shortly following ratification), with patentees also ensuring that the patent is shown as being valid on the relevant national online register as part of infringement proceedings.
3. Date on which acts of infringement began
Meril argued that the UPC does not have jurisdiction to decide on acts of infringement committed before the UPC starting date on 1 June 2023. However, the court rejected this argument, stating that the UPC has jurisdiction over acts of infringement before this date, which is in line with Article 3(c) and 32(1)(a) UPCA – with the court explaining that once the transitional period is over, if Meril’s argument were to be accepted, then neither the UPC nor national courts would have the authority to adjudicate claims for damages for infringements committed prior to 1 June 2023, which would not be viable.
4. Rejection of the proportionality defence to injunctive relief
Meril asserted that third parties’ interests and the public interest required a denial of injunctive relief, as “Meril’s product offered significant advantages over Edwards’ product and it was essential to practitioners that they have a range of options for treatment”. The Munich LD held that the only respect in which there can be a valid public-interest argument is for Meril’s XL product, as this is the best option available for patients with XL annuli. Having a variety of treatment methods at their disposal would not be sufficient for a public interest argument, rather “it is essential to demonstrate that this is the sole available treatment method or that it represents an improvement upon a known treatment method, resulting in a notable enhancement in patient care”, with Meril’s XL product meeting this criterion.
Clinicians who wanted to treat a patient with Meril’s XL product had to request a single-use license from Edwards through its Medical Request Portal and let Edwards’ physicians decide whether Meril’s XL product would be appropriate. The decision notes that given “the Medical Request Portal for the Myval valve prosthesis is functioning effectively, it is evident that no further arrangements or limitations with regard to injunctive relief are necessary”. The only exception made was in respect of Meril’s XL devices scheduled for implantation in a patient by 15 November 2024. These devices were excluded from the order for recall/destruction “to ensure that no patient is placed at risk during the interim period required to disseminate information regarding the applicability of the Medical Request Portal to XL-sized Myval Octacor devices.”
In the Headnotes, the Munich LD stated that when considering third party interests and the public interest, the court will consider whether the infringer is able to enter into a license agreement or initiating proceedings for a mandatory license and that the outcome of a compulsory-license case will be considered by the court.
The court considered that Meril had already sought a compulsory license from the Federal Patent Court of Germany. Meril was not awarded one because it was considered an “unwilling licensee” as it had not made sufficient efforts to obtain a license, such as not complying with Edwards’ reasonable request for access to samples and documentation. Additionally, during licensing negotiations, Meril had offered a payment of €100,000. The court considered this sum to be inadequate and unreasonable given that the infringement action’s value is estimated to be €8 million and the market value of one device is five digits. Hence, the Munich LD concurred with the stance adopted by the German court that Meril is an unwilling licensee and that a public interest is only to be recognized for valve prostheses with annuli exceeding 30 mm in diameter (Meril’s XL product).
As the Munich LD pointed out, whilst a party may be regarded as an unwilling licensee, patients are unable to influence that party’s behaviour and so the public interest must still be considered in these cases to ensure that patients don’t face serious consequences due to lack of access to a product.
5. Acts of infringement in UPC contracting member states
Meril had stated that one of the catheter embodiments was not for sale in Germany. Pointing to Article 34 of the UPCA, the Munich LD held that injunctive relief is available in all contracting member states as long as an actual or imminent infringement has been proven for at least one contracting member state.
6. Consideration of expert evidence
In previous UPC cases, UPC judges have provided their opinions on technical matters in judgments without referring to expert evidence which has been offered. Here, the court referred to expert evidence submitted in this case, various national proceedings and the revocation proceedings when forming their opinion on claim construction.
The decision can be read here.
