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

INTRODUCTIONThe medical use of pluripotent stem cells was, for a time, one of the most contested bioethical issues in the United States.1 Pluripotent stem cells are naturally occurring cells that have the potential to differentiate into almost any type of cell in the body.2 Because of their unique differentiation capabilities, pluripotent stem cells have many different applications in medicine, including the treatment of various diseases through cell regeneration.3 Under the right conditions, pluripotent stem cells can develop into specialized cells that can ultimately replace diseased cells and tissues.4Prior to 2006, the only pluripotent stem cells in existence that could differentiate into nearly every type of bodily cell and that could be successfully maintained in a laboratory were embryonic stem cells ("ESCs").5 Such stem cells, however, could not be harvested without destroying a human embryo. 6 Opponents of stem cell research argue that unborn embryos should be protected and should not be sacrificed for medical purposes.7 Alternatively, proponents of stem cell research argue that the stem cell therapy should be explored and developed because stem cells have the potential to significantly improve the quality of life of many people with debilitating diseases.8 Because the harvesting and use of embryonic stem cells for medical research raises ethical questions, embryonic stem cell research has been the subject of intense political debate for nearly two decades.9Since 2006, however, the debate surrounding embryonic stem cell research has been on a steady decline.10 This decline has not been fueled by shifting ethical beliefs but has instead resulted from one of the most significant discoveries of the past century in the biological field.11 In 2006, Dr. Shinya Yamanaka of the University of Kyoto was credited with discovering induced pluripotent stem cells ("iPS cells").12 Dr. Yamanaka inserted four genes into a skin cell, which essentially "reprogrammed" the skin cell to become a cell resembling a pluripotent stem cell.13 Because of Dr. Yamanaka's discovery, there is a wide new range of scientific research on pluripotent stem cells that can now be carried out.14 Moreover, such research can be performed without confronting the major bioethical dilemma of destroying human embryos. 15 Since Dr. Yamanaka's discovery, the United States Patent and Trademark Office ("USPTO") has granted patents on iPS cell lines, iPS cell preparation methods, and nuclear reprogramming factors.16The U.S. Supreme Court has decided several patent cases in the past few decades relating to the patentability of life sciences inventions and methods.17 The Court has not, however, articulated a clear-cut standard as to what, in the context of life sciences products and methods, meets the patentable subject matter requirement. 18 Courts have routinely found that products of nature are not patentable subject matter under 35 U.S.C. § 101.19 Despite this, in 1980 in Diamond v. Chakrabarty, the U.S. Supreme Court held that a bacterium with an inserted foreign gene is patentable subject matter.20 An iPS cell is similar to the bacterium in Chakrabarty in the sense that both contain foreign genes. 21 Unlike the bacterium, however, an iPS cell is meant to resemble an unpatentable natural product.22 Should a patent claim directed toward an iPS cell-related technology be challenged in the future on patentable subject matter grounds, such a challenge would present a unique dilemma to the presiding court.23This Note proposes new standards that courts should employ when considering challenges to iPS cell line patents and iPS cell preparation method patents based on the § 101 patentable subject matter requirement.24 Part I provides an overview of the patentable subject matter requirement and the invention of iPS cells.25 Part II discusses the patentable subject matter requirement in the context of the life sciences.26 Part III discusses the problem of patent thickets in the life sciences and how courts have handled the issue. …