Must the Factual Basis for Sound Prediction be Disclosed in the Patent?
The Canadian Intellectual Property Review (CIPR) is a double-blind peer reviewed journal. It is sent to over 1,800 IPIC members at no cost and can be purchased by non-members for a fee. If you would like to browse the articles included in the CIPR, please consult our database below.
Any author, member or non-member can submit an article for consideration in the CIPR. The CIPR Editorial Board welcomes both short pieces (2,000 to 5,000 words) that may be included in the Notes section of the issue or longer, more in-depth articles. The maximum length of articles, including references, is 20,000 words. Articles may be submitted in French or English. Each article should be accompanied by a 150-word abstract.
All submissions undergo a double-blind review process: the reviewers are not given the authors' identities and the identities of the reviewers are shielded from the authors. Additionally, articles submitted must be original and must not have been previously published elsewhere.
If you would like to submit an article for an upcoming issue of the CIPR please contact admin@ipic.ca.
Canadian Intellectual Property Review
Share
Must the Factual Basis for Sound Prediction be Disclosed in the Patent?
Issue: Volume 28 no 1
Author(s): Norman Siebrasse
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 U.S. nor European law has any such requirement. The raloxifene doctrine is unsound in principle, because 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 that threatens to undermine the crucial incentives to innovation in the pharmaceutical industry provided by the international patent system. It should be abandoned at the earliest possible opportunity.
