Both parties are involved in a worldwide commercial and legal battle over Transcatheter Aortic Valve Implantation (TAVI) devices, which are minimally invasive systems used to treat severe aortic stenosis by replacing the diseased aortic valve with an artificial valve via a catheter, typically through the femoral artery.  Edwards argued that Meril had unlawfully entered the market with copycat products that violated Edwards’ intellectual property.

The focus of the Commission’s competition law investigation was Edwards’ “Global Unilateral Pro-Innovation (Anti-Copycatting) Policy” (UPIP), according to which Edwards would withhold sponsorships, training opportunities, and grants from physicians who also chose to participate in clinical trials or research for devices that Edwards labeled as “copycats”.

While Edwards argued that the UPIP is a legitimate means to protect its innovations, the Commission was concerned that the UPIP was an abusive strategy to unlawfully prevent the entry of new competitors.  According to the Commission, UPIP limited the physicians’ freedom to participate in clinical trials and other scientific and educational activities in relation to TAVI technology sponsored or supported by Meril. This, in turn, allegedly made it more difficult for Meril to gain a foothold in the European Economic Area.

Ultimately, the Commission will not decide whether Edwards violated the competition laws, as Edwards has withdrawn the UPIP and the Commission has closed its investigation, without any finding of whether the UPIP complied with the competition rules.

While positive for Edwards, the Commission’s press release terminating the case leaves some important questions unanswered:

• Was Edwards legitimately defending its innovations against unlawful copying?  In the parallel IP litigation between the parties, Edwards secured a significant victory before the Court of Appeal of the Unified Patent Court (UPC) in late 2025.  In that judgment, the Court confirmed the validity of Edwards’  European patent EP 3 646 825 (relating to a system comprising a prosthetic heart valve and a delivery catheter) and maintained an injunction barring the sale of Meril’s competing product, which Edward’s public filings suggest have caused Meril to exit the market.   Against this backdrop, the question arises whether the UPIP was a valid expression of Edwards’ efforts to protect its intellectual property rights.
• Which elements of the UPIP might have been an abuse?  The Commission’s press release states that the UPIP has been withdrawn but does not provide details about what specific provisions raised concerns, meriting such a withdrawal.  Are some of the genuine limitations on the exercise of patent rights specific to the healthcare sector, such as the objective to safeguard patient-centered clinical trials (a concern that was mentioned in the Commission’s press release) or the goal to serve patients’ needs (as is evidenced by the decision of the UPC to create a carve-out from the sales ban imposed on Meril for a type of device not supplied by Edwards)?
• What did the Commission achieve?  Did the Commission’s intervention in this case actually make any practical difference?  The position of the parties in European markets was ultimately determined by the outcome of the patent litigation.  Further, while Edwards has withdrawn the UPIP, it has not provided any commitments concerning future activities.  By contrast, the press release which Edwards published in the wake of the Commission decision states that “Edwards continues to take IP and trade secret protections very seriously and will take all appropriate steps to ensure that trade secrets and other commercially sensitive information are not leaked to competitors.”

As the Commission has closed the investigation of Edwards without either an infringement decision (as happened in the Teva case – see, Van Bael & Bellis Life Sciences News & Insights of 31 October 2024) or a commitment decision (as used in the Vifor case (see, Van Bael & Bellis Life Sciences News & Insights of 22 July 2024), there will be no resolution of these open issues in the present case.