Edwards Lifesciences vs Meril Life Sciences

"Patent Protection vs Regulatory Approval: Edwards Lifesciences vs Meril Life Sciences Sets Precedent"

Short Description

Edwards Lifesciences, a medical device company, sued Meril Life Sciences for patent infringement over its transcatheter heart valve technology. The dispute centered on whether Meril's importation of heart valves for a medical conference fell within the safe harbor provision of 35 U.S.C. § 271(e)(1).

Facts

- Meril imported two transcatheter heart valves into the US for the Transcatheter Cardiovascular Therapeutics Conference in San Francisco to discuss potential clinical trials with researchers.

- The valves were not displayed or sold at the conference, and Meril claimed the importation was for FDA approval purposes.

- Edwards Lifesciences alleged patent infringement, while Meril argued its actions were exempt under the safe harbor provision .

Findings

- The US Court of Appeals for the Federal Circuit affirmed the district court's summary judgment in favor of Meril, finding that the importation of heart valves was "reasonably related" to the submission of information to the FDA.

- The court held that the safe harbor provision applies to acts with mixed purposes, as long as they bear a reasonable connection to FDA submission.

- The court also ruled that Meril's importation of valves was protected under the safe harbor provision, despite potential commercial benefits.

Judgment

- The US Court of Appeals for the Federal Circuit affirmed the district court's judgment of noninfringement.

- The Unified Patent Court's Local Division in Munich later granted Edwards Lifesciences a permanent injunction against Meril, prohibiting the sale of its heart valves in 16 UPC member

countries.

- Meril's appeal against the injunction was rejected by the UPC Court of Appeal, which found no manifest error in the lower court's decision.