WASHINGTON—The Information Technology and Innovation Foundation (ITIF), North America’s top-ranked science- and tech-policy think tank, today released the following statement from Stephen J. Ezell, ITIF vice president for global innovation policy, on the Canadian Supreme Court’s June 30, 2017 ruling that the so-called Promise Doctrine is inconsistent with global intellectual property norms in assessing patent utility.
Since 2005, Canadian courts have applied an impractical evidentiary burden not used anywhere else in the world, the so-called Promise Doctrine, which effectively required pharmaceutical innovators to predict at the date of filing—in many cases before research and development (R&D) and clinical trials had even been completed—specifically how useful a patented drug would be in the future. Under the Promise Doctrine, if any one of the initial claims (i.e., “promises”) in the patent application went unrealized, patent applications could be revoked in their entirety. Canada’s discriminatory application of the Promise Doctrine has led to 29 court decisions which invalidated 26 patents on 22 medicines over the past decade, leading pharmaceutical companies to suffer well over $1.1 billion in lost sales.
In AstraZeneca Canada Inc. et al. v. Apotex Inc., Canada’s Supreme Court ruled 9-0 that the deprivation of patent protection because not every promised use was sufficiently demonstrated or soundly predicated at the date of filing is “antagonistic to the bargain on which patent law is based wherein we ask inventors to give fulsome disclosure in exchange for a limited monopoly.”
The Canadian Supreme Court’s decision to repudiate the Promise Doctrine is a victory for Canadian innovators, for Canada’s innovation system, and for all enterprises and individuals seeking to secure intellectual property rights in Canada in accordance with international norms of patentability. From 2009-2014, business R&D investment by domestic Canadian enterprises fell by 22 percent and by foreign enterprises by 29 percent (while R&D investments by pharmaceutical firms fell 34 percent), in part as innovators recognized the technologies and products leading from their R&D activities might not enjoy robust IP protections. The Supreme Court’s decision today represents an important step toward restoring Canada’s standing as a leading country where intellectual property is robustly protected and knowledge-led innovation can thrive.