Patent Infringement after FDA Approval: Making Waves in the Safe Harbor

Two recent Federal Circuit decisions raise a simple question with no easy answer: Can the patent infringement safe harbor for FDA-related activities (35 U.S.C. 271(e)(1)) continue after a product has been approved by the FDA? While the current disputes focus on quality assurance/quality control procedures and clinical trial protocols, other types of patents may be affected as well. Resolution of the conflict will affect the value of these patents and their ability to effectively protect against generic, biosimilar, and even innovator competition. Join us to learn about the warring factions, the possible outcomes, and how to evaluate your IP – and your competitors’ IP – in the meantime.