Section 271(e) Safe Harbor Extends to Clinical Trial Participants’ Continued Treatment After Trial

The court granted defendant's motion for summary judgment that it did not infringe plaintiff's chronic pain treatment patents because the post-trial use of the accused systems fell within the safe harbor provision of 35 U.S.C. § 271(e). "The use of the [two] systems in patients that have participated in the Accelerate trial fits within the safe harbor provision of 35 U.S.C. § 271(e), even after the patients have completed their participation in the trial. This use is 'reasonably related to the development and submission of information' to the FDA for device approval. The FDA specifically approved a trial plan that allowed participants to continue to receive treatment after results were collected. And international standards for medical research require trial sponsors allow participants to access studied treatments even after the trial's conclusion."

Nevro Corp. v. Boston Scientific Corporation et al, 3-16-cv-06830 (CAND July 24, 2018, Order) (Chhabria, USDJ)