03.04.2025 | Austrian competition authority
The Austrian competition authority, known as the Federal Competition Authority (BWB), raised concerns regarding the acquisition of JenaValve by Edwards, particularly focusing on potential market concentration in the aortic valve replacement sector. JenaValve is known for its transcatheter aortic valve replacement product, which is currently the only one approved in Europe for treating aortic regurgitation. Edwards, on the other hand, markets a product for aortic stenosis and has recently acquired rights to develop a similar product outside of China.
The BWB's investigation highlighted fears that the merger could significantly restrict competition by combining the only approved TAVR-AR valve in Europe with another existing alternative, albeit only approved in China. The authority also noted that the merger could further strengthen Edwards' already dominant market position, with high entry barriers due to existing intellectual property rights potentially hindering new competitors.
However, the Cartel Court dismissed the BWB's requests for a review, citing a lack of significant domestic activity from JenaValve. Both the BWB and the Federal Cartel Prosecutor appealed this decision to the Cartel High Court. The Cartel High Court clarified that the assessment of significant domestic activity should focus on the company's operations at the time of the merger, rather than any future plans. It concluded that JenaValve's domestic sales, which amounted to only eight products sold to a single customer in 2023 and 2024, did not meet the threshold for significant activity as defined by the law.
As a result, the Cartel High Court upheld the Cartel Court's decision, confirming that the merger did not require notification in Austria, thus concluding the merger review process without a substantive examination of the merger's implications.
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