Vol. LVI No. 4

Claiming a Cell Reset Button: Induced Pluripotent Stem Cells and Preparation Methods as Patentable Subject Matter

Abstract: In 2006, a team of scientists discovered a method to create pluripotent stem cells—cells that have the potential to become almost any other type of cell in the human body—by inserting specific genes into a skin cell. The resulting cells were called induced pluripotent stem cells (“iPS cells”). The ability to manufacture stem cells could eventually eliminate the need to harvest stem cells from embryos, thereby rendering the embryonic stem cell debate irrelevant. Should a patent claim directed toward an iPS cell-related technology be challenged in the future, the absence of a bright-line test for patentable subject matter could present challenges to the presiding court. This Note proposes two new standards by which courts should evaluate whether products of nature and processes in the life sciences are patentable subject matter and, applying those standards, concludes that sufficiently narrow claims directed to iPS cells and preparation methods would likely be upheld as patentable subject matter.

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