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Market for aortic valve replacement products: Supreme Cartel Court decides on appeals lodged by official parties

The Austrian Federal Competition Authority (AFCA) and the Federal Cartel Prosecutor filed an application for an in-depth (Phase II) review of the planned merger of Edwards Lifesciences Corp. (“Edwards”) and JenaValve Technology, Inc. (“JenaValve”) notified in September 2024 (BWB/Z-6717). The Cartel Court rejected the application on the grounds that the merger had not been subject to notification requirements since the target company was not engaged in significant domestic activities. Both the AFCA and the Federal Cartel Prosecutor appealed against the Cartel Court’s decision. The Supreme Cartel Court dismissed the appeals, thereby confirming the Cartel Court’s rejection of the applications.

Background

The acquiring company Edwards intends to acquire all of the shares in and sole control of the target company JenaValve. The target company develops and sells a transcatheter aortic valve replacement product for the treatment of aortic regurgitation (TAVR-AR), the only product of its kind currently approved in Europe. The acquiring company sells a product for the treatment of aortic stenosis (TAVR-AS) and recently acquired a company that owns the rights to develop and market a TAVR-AR valve outside China.

AFCA competition concerns

The investigations conducted by the AFCA raised competition concerns, with regard to possible market concentration in particular. Bundling the only TAVR-AR valve approved in Europe with the only other currently existing alternative (even if only approved in China) could considerably restrict competition. There is also the risk that the already strong market position of Edwards would be further consolidated with the merger. High entry barriers, particularly in the form of IP rights, might additionally impede potential competitors’ market entry (see press release of 29 October 2024).

Cartel Court’s rejection of applications

The Cartel Court rejected the requests for examination since the target company JenaValve was not active in Austria to a significant extent. Both the AFCA and the Federal Cartel Prosecutor lodged an appeal with the Supreme Cartel Court against this decision.

Supreme Cartel Court ruling

In relation to the prerequisite of domestic activity “to a significant extent”, the Supreme Cartel Court has now stated that any assessment of the significance of a target company’s activity must be based on “the target company’s activity at the time of the (planned) implementation of the merger. [….] Possible or even planned future activities (in the following years) are not to be considered.”

At the time of the implementation of the merger, the target company had customer relationships in Austria and had been active here. However, the target company’s business in Austria extended to selling a total of eight products to one (sole) Austrian client in the calendar years 2023 and 2024, an activity that cannot be regarded as significant within the meaning of § 9 para. 4 no. 4 of the Federal Cartel Act (KartG).

The Supreme Cartel Court therefore dismissed the appeals, confirming the first-instance rejection of the applications submitted by the AFCA and the Federal Cartel Prosecutor (notification requirements not applying). In the absence of any notification requirement, the merger control procedure in Austria has therefore ended and the proposed transaction cannot be examined here.

The Supreme Cartel Court ruling (16 Ok 2/25t) can be downloaded here soon (German).