Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd.

Background

Edwards Lifesciences Corporation and Edwards Lifesciences LLC sued Meril Life Sciences Pvt. Ltd. and Meril, Inc. The court referred to the two Edwards entities collectively as “Edwards” and to the two Meril entities collectively as “Defendants.” Edwards develops and supplies devices used to treat heart disease, including artificial heart valves.

The complaint alleged that Meril Life Sciences, described in the opinion as an Indian company, markets Myval-branded transcatheter aortic valves in India and Europe. Meril distributes those valves as part of the Myval System. The complaint also alleged that Meril did not have approval from the Food and Drug Administration (FDA) to market the Myval System in the United States and had not yet sought that approval. Meril, Inc. was described as Meril Life Sciences’ United States subsidiary.

In September 2019, officers of Meril and Meril, Inc. attended a cardiovascular conference in San Francisco. Meril exhibited the Myval System there and publicized the exhibition on LinkedIn. Edwards alleged that Meril infringed its patents under 35 U.S.C. §§ 271(a) and 271(g) by importing its patented invention and devices made using its patented process into the United States. Edwards also alleged trademark infringement and unfair competition.

Motion to dismiss

The defendants moved to dismiss Edwards’s patent-infringement claims under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint states a legally sufficient claim. They argued that the only infringement alleged in the complaint—the conference display—was protected by the safe harbor in 35 U.S.C. § 271(e)(1).

That safe harbor protects certain otherwise infringing activities involving a patented invention when they are carried out solely for uses reasonably related to developing and submitting information under federal law, including information needed for FDA approval. The defendants argued that they imported and displayed the devices to identify or recruit clinical investigators for studies required for FDA approval.

Edwards responded that the safe-harbor question was factual and could not properly be resolved at the motion-to-dismiss stage. The complaint alleged that the defendants imported the devices to promote commercial sales in Europe and had not sought FDA approval in the United States.

Court’s analysis

The court held that the cited conference-display cases did not create an automatic rule that such displays are always protected by the safe harbor. Those cases were decided on summary judgment, not on motions to dismiss, and involved situations in which the relevant purpose or facts were not disputed. The court also noted that the cases required evaluating the accused activities and their relationship to regulatory approval in context.

Accepting the complaint’s factual allegations as true and drawing reasonable inferences for Edwards, the court concluded that the defendants had not shown at this stage that the safe harbor applied. The complaint’s allegation of commercial promotion, together with the absence of facts establishing that the display recruited—or reasonably could have recruited—investigators for studies producing information that could be submitted to the FDA, prevented dismissal.

The defendants separately argued that the lawsuit was premature because the FDA had not approved the accused device and the device might change during the approval process. The court rejected that argument, explaining that even a single act of infringement could support a claim for damages and that the defendants’ cases concerning declaratory-judgment controversies did not apply because Edwards had standing.

Disposition

The court denied Defendants’ motion to dismiss. It set an initial case-management conference for February 25, 2020, and stated that the parties did not need to submit another joint case-management statement.

The opinion also states that the court denied Edwards’s request to file a sur-reply. Because the court had denied that request, it later granted Edwards’s administrative motion to file under seal. The opinion states that the court’s decision did not rely on the additional materials for which Edwards had sought judicial notice, so it denied the request for judicial notice as moot.