Written Description Of Therapeutic Efficacy

Inventors are generally counseled to file a patent application as soon as they have a patentable invention to avoid potential forfeiture of important rights in today's first inventor-to-file system. However, inventors—particularly those in drug development—should be wary of potential risks associated with racing to the U.S. Patent and Trademark Office and filing too early. As one example of additional considerations to take into account prior to filing, we look at two recent cases in which the U.S. Court of Appeals for the Federal Circuit invoked the “written description requirement” of 35 U.S.C. § 112 to require evidentiary support for efficacy—a twist the U.S. Supreme Court was asked to consider but denied.