Must the Factual Basis for Sound Prediction Be Disclosed in the Patent?

Abstract

It has been accepted at least since the Supreme Court decision in Consolboard v. MacMillam Bloedel that the evidence supporting utility need not be disclosed in the patent itself. However, in its 2009 decision in Lilly/raloxifene, the Federal Court of Appeal held that when utility is based on sound prediction, the supporting evidence must be disclosed in the specification. Since that time, the raloxifene doctrine has been determinative of invalidity in three important pharmaceutical cases, including, most recently, the blockbuster blood-thinner, PLAVIX. This article argues that the raloxifene doctrine is unsound. There is no basis in the text of the Patent Act, in legal principle, or in practice, for a distinction between demonstrated utility and utility based on sound prediction. The raloxifene doctrine is not supported by the case law; there is no leading case affirming the validity of a patent on the basis of sound prediction in which the factual basis for the sound prediction was disclosed in the patent. Neither US nor European law has any such requirement. The raloxifene doctrine is unsound in principle, as neither the disclosure requirement, nor the utility requirement, purposively understood, mandates disclosure of the evidence supporting utility. Introducing such a requirement engenders technical attacks on patents for valuable inventions, without providing any offsetting benefit to the public. In short, the raloxifene doctrine is an ill-advised departure from well-established legal principles which threatens to undermine the crucial incentives to innovation in the pharmaceutical industry that are provided by the international patent system. It should be abandoned at the earliest possible opportunity.

Keywords: Patents, Utility