Publication Title

New England Law Review

Keywords

stem cells

Document Type

Article

Abstract

This article will not address the science and ethics of stem cell research—at least as far as those topics are normally addressed in the existing literature. Instead, this article argues that an even more contentious battle is looming on the horizon, with dire practical consequences: Namely, who will own the revolutionary medical breakthroughs that are supposed to emerge from this research? Along the way, this article will assume that stem cell research will progress in some fashion and that at least some of the purported benefits will materialize.

But the central premise is that the pitch of the ownership battle will rise proportionally to the success rate of the research. Thus, the more we achieve the vaunted promises of stem cell research, the more a crisis will be precipitated over the ownership of its results. Further, because the research will most likely proceed under some combination of federal, state, local, non-profit and private for-profit funding sources, the ownership rights will be anything but clear. In this way, the ownership questions will mirror those currently faced every day by universities and their tech-transfer offices. Which funding sources were used in reaching certain patentable research inventions? Are there intellectual property (IP) ownership claims attached to these funding sources? If multiple claims exist, which one trumps the others?

Part I of this article begins by parsing the funding sources and environment for stem cell research. Part II then lays out the pros and cons of using federal funds for such research. Part III argues that stem cell research will be a victim of its own success because the more successful it is, the more contested the ownership rights to, and distribution mechanisms of resultant therapies will become. Part III also uses the examples of two recent similar controversies to speculate as to how the conflicts over ownership and use of stem cell therapies will play out.

Finally, Part IV offers perspectives on the hyperbole and rhetoric surrounding recent life sciences IP ownership debates, and asserts that pro-active, thoughtful allocation of IP rights in advance could do much to mitigate the coming crisis of ownership. Further, Part IV argues that even absent such effective planning, the government does have a few de facto compulsory license tools at its disposal that can be acted on, provided there is a public health solution that can be deemed to be of vital importance to the government.

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