On Monday, U.S. heart valve manufacturer Edwards Lifesciences Corporation (NYSE:EW) faced an EU antitrust complaint from Indian competitor Meril, alleging anti-competitive behavior, particularly concerning patents.

This could potentially intensify EU regulators' scrutiny of Edwards, Reuters reports.

Recent regulatory actions in the United States and Europe aim to promote fair competition and maintain drug and product affordability, especially for smaller innovative companies challenging larger incumbents.

Meril has formally complained to the European Commission, citing longstanding disputes over heart valve patents spanning various global jurisdictions.

Renowned for its transcatheter aortic valve replacement (TAVR) device, Edwards Lifesciences underwent an EU antitrust probe last year amid concerns about potential market dominance abuses.

The core of Meril's grievance centers on Edwards' global unilateral pro-innovation policy, which Meril claims obstructs engagement with entities labeled as patent copiers.

Additionally, Meril accuses Edwards of employing tactics such as evergreening and patent thickets, extending patent protections and creating barriers to entry for competitors.

Edwards denies Meril's accusations, citing successful injunctions against Meril's Myval system in seven countries and the Unified Patent Court.

The company asserts that Meril substantially copied its technology rather than engaging in fair competition.

In a regulatory filing from February, Edwards disclosed that the European Commission is investigating certain business practices, including its anti-copycat policy and patent strategies.

Meril alleges that Edwards has launched a disparagement campaign to undermine its intellectual property rights and is currently undergoing patent litigation.

Price Action: EW shares are up 1.24% at $85.75 at last check Tuesday.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Photo via Wikimedia Commons