What You Need To Know

• On August 21, the Federal Circuit denied en banc review of a precedential opinion it issued earlier this year in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., providing clarity about when acts of alleged patent infringement are protected by the safe harbor of 35 U.S.C. § 271(e)(1).

• The Court’s opinion reaffirms that the safe harbor is an objective standard that depends on whether an act of alleged patent infringement was solely for uses reasonably related to the development and submission of information to the U.S. Food and Drug Administration. An accused infringer’s subjective intent is not relevant.

• The opinion reaffirms a long line of Federal Circuit cases holding that demonstrating a product at a conference to recruit clinical trial investigators falls within the safe harbor.

District Court Proceedings

In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate victory. Meril had imported two demonstration samples of its Myval transcatheter heart valve (THV) system into the United States for the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, where Meril was recruiting clinical investigators for a clinical trial to support FDA approval. Edwards alleged that Meril’s importation of these two samples infringed Edwards’ patents.

Meril sought summary judgment from the district court, arguing that its importation of the two Myval THV devices was protected under the safe harbor of Section 271(e)(1), which provides a safe harbor to acts that would otherwise infringe a U.S. patent if those acts are “solely for uses reasonably related to the development and submission of information” to the FDA. The district court granted the motion because, at the time of the importation, Meril had taken significant steps towards obtaining FDA approval for the Myval system, Meril met with potential clinical investigators at the TCT conference, and there was no evidence of any sales or offers for sale of the Myval system at the conference.

Affirming and Clarifying Prior Safe Harbor Decisions

On appeal, the Federal Circuit affirmed summary judgment of non-infringement under the safe harbor. The panel majority—including Judges Kara F. Stoll and Tiffany P. Cunningham—concluded that “for each act of infringement[,] the safe harbor is available only [i.e., solely] for acts or uses that bear a reasonable relation to the development and submission of information to the FDA.” In other words, “[i]t is not that the use must only be reasonably related to the development and submission of information to the FDA” as Edwards had argued.

The panel majority also addressed and rejected the arguments raised by Edwards in the appeal. The majority rejected Edwards’ argument that a jury could have found that Meril imported the devices to support commercial sales, rather than to recruit clinical investigators, as it was undisputed that no sales or offers for sale occurred at the TCT conference. The majority also held that no actual “use” of a device is needed before an activity falls within the safe harbor. Instead, the statute protects activities including making, using, selling, offering for sale, and importing so long as those activities are reasonably related to obtaining FDA approval.

Judge Alan D. Lourie dissented. The dissent recognized that the district court followed the Federal Circuit’s safe harbor precedent. But the dissent wrote that the statute should apply “only for uses, sales, and importations that solely are for…development of information for the FDA,” and advocated for en banc review to revisit the statutory interpretation.

Edwards petitioned for rehearing en banc. Like the dissent, Edwards argued that the panel decision excuses commercial “alternative uses” and that the statute should protect only uses that are “solely for regulatory uses.” The Federal Circuit denied the petition on August 21, 2024, without any further opinion. The panel majority’s precedential opinion stands, and the safe harbor remains an objective test that looks to whether an alleged use is reasonably related to FDA approval without regard to subjective intent.

Key Takeaways

The Meril decision is the latest in a line of decisions interpreting the scope of the safe harbor and should inform a company’s strategy in bringing new products to market or building a patent enforcement strategy.

A company’s subjective intent or alleged alternative purposes are irrelevant when determining whether the safe harbor applies. What matters is whether the act was for a use “reasonably related” to the development or submission of information to the FDA.

A plaintiff may not avoid summary judgment on its patent infringement claim by alleging that the defendant was motivated by commercial purposes, so long as the use was reasonably related to seeking FDA approval under an objective standard.