By Can Cui*

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I.  Introduction

The 1952 Patent Act sets forth four categories of subject matter that are patent-eligible: process, machine, manufacture, and composition of matter.[FN1] The Supreme Court has interpreted the subject-matter eligibility to be very broad[FN2]; instead of delineating what is patent-eligible, the Supreme Court has crafted a number of categories of “patent-ineligible” subject matter.[FN3] These judicially crafted categories, however, are not well defined.  The boundaries of these categories are also constantly challenged by the advancement of science and technology, particularly biotechnology.  While the Patent Act has remained largely unchanged since its codification in 1952, the discovery of the structure of deoxyribonucleic acid (“DNA”) in 1953 has revolutionized our lives in a great number of ways.  The complete mapping of the human genome has also changed our way of thinking about life and dealing with disease.  Discoverers of new genes, especially those associated with disease susceptibilities, rushed to the patent office to protect their discoveries.  Whether DNA molecules should be patented had been the topic of active policy debate for more than twenty years until the early 2000’s, when the question about their subject-matter eligibility was first seriously raised in the academy.[FN4]