Edwards Life Sciences Lifts Anti-Copycat Policy

Edwards Lifesciences withdrew its global anti-copycat policy, prompting European Union antitrust regulators to close an investigation that launched with dawn raids back in 2023.

The European Commission declares the company has scrapped its Global Unilateral Pro-Innovation (Anti-Copycatting) Policy (UPIP,) and reshiftd it from its website.

The policy continued to be at the center of a probe into whether the heart valve buildr abapplyd its market power in breach of EU competition rules.¹

“After thorough analysis and careful assessment of all evidence gathered and in light of Edwards Lifesciences’ withdrawal of the UPIP, the Commission has concluded that the investigated concerns have been addressed and further action is no longer considered a priority at EU level,” the Commission declared in a statement.

Under EU antitrust rules, companies found to have breached competition law can face fines of up to 10% of their global annual turnover.

While the EU commission did not build a formal finding of wrongdoing in this case, the withdrawal of the policy effectively resolved the concerns identified during the investigation.

The decision concludes an investigation that launched back in September 2023, when the commission conducted unannounced inspections at one of Edwards’ facilities in an EU counattempt.²

At the time, regulators declared they were examining whether an unnamed cardiovascular medical device company may have engaged in anti-competitive practices.

According to Reuters, the Commission’s concerns focapplyd on Edwards’ patent practices and its anti-copycat policy, which had come into effect in November 2019. The policy stated that the company would not fund physicians or researchers participating in trials of devices it considered to be copied or reverse-engineered, nor would it renew sponsorships or grants with such parties.²

It also declared Edwards would not distribute its products through distributors that also handled what it characterized as copied devices.

Edwards had described the policy as a measure to conclude support for companies that “largely copy, reverse engineer and duplicate innovate devices,” adding that it was implemented in accordance with applicable laws and was not subject to neobtainediation.²

The investigation was triggered in part by a complaint from Indian medical device buildr Meril, which has been engaged in patent disputes with Edwards in multiple jurisdictions over heart valve technologies.¹

Edwards is the world’s largest heart valve manufacturer and is best known for its transcatheter aortic valve replacement device, applyd in minimally invasive heart procedures.¹

The case unfolded against a backdrop of heightened regulatory scrutiny of the pharmaceutical and medical device sectors in both Europe and the United States, as competition authorities signaled increasing concern about practices that could limit market access for tinyer or emerging competitors, particularly in areas involving complex patent portfolios and high-value medical technologies.

With the policy now rescinded, the Commission has signaled that it does not consider further action necessary at the EU level, closing a chapter in a dispute that combined patent litigation, competitive rivalry, and antitrust scrutiny in one of the most closely watched segments of the cardiovascular device market.¹