Impact of U.S Supreme Court Patent Law on Canadian and Global Systems-Based Innovation Ecologies
Bouchard, Ron A., Health Law Journal
I say unto you: one must still have chaos in oneself to be able to give birth to a dancing star. I say unto you: you still have chaos in yourselves.
In the companion article, (1) the impact of the decision by the Supreme Court of the United States (SCOTUS) in KSR v. Teleflex (KSR) (2) on the Canadian intellectual property and regulatory (IPR) rights landscape was discussed in relation to the current medical research enterprise. (3) A number of claims were made as to why patent jurisprudence handed down by SCOTUS is important for scholars of Canadian health law and policy, including (1) economic and trade considerations for Canadian inventors and firms; (2) issues revolving around the importance of IPR rights to a system of state-sponsored public health, including determination of the availability, price, and safety and efficacy of medical products, as well as the distribution of the tangible and non-tangible benefits of commercializing medical research among various public and private actors responsible for generating, capitalizing and marketing the products of that research; and (3) the importance of institutional structures underpinning IPR rights afforded to medical inventions from a global perspective. This article discusses a fourth set of reasons, namely that decisions by a global patent court of prominence such as SCOTUS have the potential to significantly affect the rate and direction of innovative activity of Canadian inventors and firms through the continually evolving nature of the relationship between large-scale IPR rights, national science and technology (S&T) policies meant to stimulate innovation, and the inherently spontaneous emergent characteristics of innovation (4) and those responsible for it in IPR rights-intensive sectors.
Large scale S&T-based legal and regulatory regimes are crucial for inventors and firms working within innovation-intensive industries. (5) This is particularly true in relation to domestic policies having as their objective enhancement of national competitiveness and productivity via commercialization of publicly funded research, (6) which often single out biomedical and life sciences sectors as fertile policy targets. (7) Indeed, it has been suggested that commercialization-based S&T policies, legislation and initiatives provided both the foundation and fuel for the global biotechnology revolution. (8) Therefore, to the extent that Canadian domestic IPR rights are out of line with IPR rights on a more global scale, they have the potential to harm local inventors and corporations seeking to market innovative products globally. (9) As such, Canadian inventors do not operate within purely a local or narrow sphere, but rather are embedded within a complex global network of scientific, medical, legal, regulatory, economic, political and other social actors that--combined--act to produce, construct and use the products of scientific advances, (10) including those within the medical sciences rubric. (11) It is for this reason that creative acts underpinning innovation are increasingly being viewed as emanating from a complex "innovation ecology."
As discussed in more detail below, the conceptual framework of an innovation ecology is encompassed and informed by the broader systems theory framework. (12) Wulf recently defined an innovation ecology as the various "interrelated institutions, laws, regulations and policies" necessary to underwrite successful commercialization of publicly funded research through an "infrastructure that entails education, research, tax policy, and intellectual property protection, among others." (13) As such, IPR rights form the linchpin between innovative medical research and the marketing and consumption of approved medical products. Casting the innovation landscape as a complex organic ecology rather than the historical linear model of basic-to-applied research is wholly consistent with newer conceptual and analytical models such as complex adaptive systems, (14) network dynamics (15) and systems dynamics, (16) which view and model systems as a dynamic, adaptive and indeterminate network of nodes where the behavior of the system as a whole is governed by the ever-changing and non-linear nature of the connections between actors and institutions rather than as a predictable sum of a set of linear deterministic nodes. …