In Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd., [2022-1877] (Fed. Cir. 2024), the Federal Circuit affirmed the district court’s summary judgment that Meril’s act of importation of the two transcatheter heart valve systems fell within the safe harbor provision of 35 U.S.C. § 271(e)(1).

The Federal Circuit concluded that the undisputed evidence showed Meril’s importation of the two transcatheter heart valve systems was reasonably related to submitting information to the United States Food and Drug Administration, and affirmed the district court’s
summary judgment of noninfringement.

Section 271(e)(1) sets forth:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .

This safe harbor “provides a wide berth for the use of patented [inventions] in activities related to the federal regulatory process.” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005). As the Supreme Court in Merck explained, “it [is] apparent from the statutory text that § 271(e)(1)’s exemption from infringement extends to all uses of patented
inventions that are reasonably related to the development and submission of any information under the Food, Drug, and Cosmetic Act].” Moreover, the § 271(e)(1) exemption is not limited temporally. Mooring in the safe harbor is available to defendants irrespective of
the stage of research and even if the information is never ultimately submitted to the FDA.