The use of Food and Drug Administration 510(k) notifications in patent litigation

The U.S. Food and Drug Administration (FDA) 510(k) approval process provides medical device companies with the ability to market a device after the company establishes that the device to the marketed is "substantially equivalent" to one or more predicate devices. Companies that submit 510(k) notifications should be aware, however, that a 510(k) notification is a public document that may later reappear as evidence in patent litigation. Courts have considered 510(k) notifications to be relevant evidence in determining direct and contributory infringement, patent invalidity, and patent unenforceability due to inequitable conduct before the U.S. Patent and Trademark Office (USPTO). In one case, the court held that a substantial equivalence determination by FDA constituted evidence that can be "construed as an admission of infringement." The court also has relied on a 510(k) notification to support a finding of personal liability for a corporate officer who signed the 510(k) notification to be evidence of willful and deliberate conduct, and have awarded treble damages and reasonable attorney's fees to the prevailing party. The potential for increased risk in patent litigation is important for practitioners in the medical device industry, because more than seventy-five percent of medical devices are approved for marketing through the 510(k) process. This article reviews a number of patent cases in which a court has admitted a 510(k) notification as relevant evidence, and proposes general strategies for avoiding these situations.