Edwards Lifesciences Corporation, et al. v. Meril Life Sciences Pvt. Ltd., et al.

This case presents an exceptionally important question regarding the proper scope of the Hatch-Waxman Act’s regulatory safe harbor. Under the Act, Congress declared that “[i]t 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 federal regulatory process. 35 U.S.C. 271(e)(1) (emphasis added). In a split decision, the Federal Circuit held that Section 271(e)(1)’s safe harbor applies by identifying any regulatory “use,” even if there are “additional” non-regulatory uses (including blatant commercial conduct) by the infringing party. The dissent disagreed: an infringing act with “alternative uses” is not “solely for [regulatory] uses” (35 U.S.C. 271(e)(1))—and the circuit’s contrary position “ignore[s]” the “word ‘solely’ in the statute,” invites “future mischief,” and cements an “unsupported expansion of the safe harbor.” This issue is significant. It frequently arises in disputes with massive stakes. It is the repeat subject of industry and expert analysis. It has split Federal Circuit panels, divided district courts, and prompted criticism from judges and academics. This Court has twice granted review to consider the scope of the same safe-harbor provision—underscoring its obvious importance. And it sets the proper boundary between innovation and competition in a trillion-dollar industry. The question presented is: Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely for uses reasonably related” to the federal regulatory process, when the infringing act is performed for both regulatory and non-regulatory uses. (I)