Edwards Lifesciences Faces European Scrutiny Over Patent Policies, Copycat Devices

U.S. medical devices manufacturer Edwards Lifesciences Corp EW is reportedly under the scrutiny of EU antitrust regulators for its patent practices and policies aimed at thwarting copycat devices that prompted a series of dawn raids by EU authorities last month.

The increased vigilance on both sides of the Atlantic reflects a broader effort to ensure that the pharmaceutical industry remains competitive for smaller, innovative companies and that drug and product prices stay affordable.

The primary concern of EU regulators centers on Edwards Lifesciences' patent practices, focusing on its activities related to the transcatheter aortic valve replacement (TAVR) device, which is widely used in heart surgery.

Edwards Lifesciences has asserted its patent rights in the U.S., taking legal action against those allegedly infringing on its valve replacement device patents, Reuters reported. The company has also faced lawsuits from competitors over various patents.

Another area of focus for EU regulators is Edwards Lifesciences' global unilateral pro-innovation (anti-copycat) policy, implemented in November 2019 and publicly available on the company's website. 

This policy seeks to terminate support for companies or entities that engage in substantial copying, reverse engineering, or duplication of innovative devices, per applicable laws.

As part of this policy, Edwards Lifesciences will not fund doctors or researchers involved in trials sponsored by copycat companies, nor will they renew sponsorship or grant agreements with such entities. 

The company will also avoid distributing its devices through distributors that handle copied devices.

Price Action: EW shares are down 1.02% at $70.55 on the last check Tuesday.

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