While the nation debates the future of healthcare, one of the most promising hopes for curing diseases—personalized medicine—is at risk of ending before it really begins. A perfect storm is gathering force against personalized medicine. Measures in Congress affecting patent protection for personalized medicine and a number of court cases have arisen, and regulatory elements are looming on the horizon. This is particularly troubling for the biotechnology and pharmaceutical industries, which are uniquely dependent on patents. In fact, personalized medicine now faces challenges from all three branches of government, each of which could capsize and submerge this developing new area of science. In this paper we discuss these new developments in the courts, the Administration, and Congress.
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