Confronting the Patentability Line in Biotechnological Innovation

Abstract

Twice in the last two years the Supreme Court of Canada, in the absence of legislative guidance from Parliament, has been called upon to resolve fundamental conflicts in applying the provisions of the Patent Act to unique characteristics of biotechnological innovations, particularly in relation to higher life forms. The result in each case has been a bare 5-4 majority. The lack of a strong majority on basic issues of patent law such as the statutory definitions of “composition of matter” and “use” is not surprising. The very nature of patentability as protection for innovation means that the interpretation of the Patent Act can never be finalized or definitive; protection of innovation requires an inherently indeterminate text in relation to key terms. This presumptively open-ended framework, however, is not particularly well-suited to the task of dealing with innovation involving life itself. Complex and controversial issues of innovation, knowledge management and ethics are being decided, with much uncertainty and unpredictability, by bare majorities. The time has long since come to recognize that the drafters of the Patent Act did not anticipate inventions that could reproduce themselves, and for Parliament to enact amendments accordingly.

Keywords: biotechnology, intellectual property, patent