Edwards Lifesciences Corp. v. Meril Life Scis. Priv. Ltd

Authored by: Jeremy J. Gustrowsky

A recent decision clarified how the “safe harbor” provision in U.S. patent law protects companies when they import medical devices for activities related to FDA approval. In this case, an India-based medical device company brought two sample heart valve systems into the United States to attend a medical conference. The devices were never displayed, sold, or offered for sale; instead, they stayed in a bag during the event and were later taken to Europe. The company’s goal was to identify potential clinical trial investigators and gather information needed for a future FDA submission.

The patent holder, a competitor, sued for patent infringement, arguing that the importation was for commercial purposes and not solely for FDA-related activities. However, the court found that the evidence showed the importation was reasonably related to preparing for FDA approval. The law, specifically 35 U.S.C. § 271(e)(1), provides a “safe harbor” that exempts certain otherwise infringing acts—like making, using, or importing a patented invention—from being considered infringement if they are done for uses reasonably related to developing and submitting information to the FDA.

The court emphasized that the safe harbor is broad and does not require the activity to be exclusively for FDA purposes, nor does it depend on the subjective intent of the party importing the device. As long as there is a reasonable basis to believe the activity is connected to FDA approval, the exemption applies—even if the information is never actually submitted to the FDA. The court also clarified that simply importing a device for potential use in clinical trials or investigator recruitment can fall within the safe harbor, even if the device is not actively used or demonstrated at the event.

A dissenting judge argued that the law’s use of the word “solely” should mean that only activities done exclusively for FDA approval qualify for the exemption, and that commercial motives should matter. However, the majority held that current precedent supports a broader interpretation, focusing on whether the act is reasonably related to FDA approval, not on the party’s intent or other potential uses. The decision affirms that companies can take preparatory steps toward FDA approval without risking patent infringement, as long as those steps are reasonably connected to the regulatory process.