By Vicki G. Norton and Michael A. Swit
FDA-regulated firms — drug, device, biologic or otherwise — on both sides of the patent aisle concerned with the bounds of the “Safe Harbor” exception to patent infringement under 35 U.S.C. § 271(e)(1) can learn several key lessons from the recent decision in Isis Pharmaceuticals, Inc. v Santaris Pharma A/S Corp. (hereafter: “Isis”), particularly how to properly prove the safe harbor defense once the litigation unfolds and also when the harbor provides shelter from post-approval patent storms.