By Jacquelyn Pariseau, Hadia S. Ahsan, Haley S. Ball, Shoshana Marvin and Gaby L. Longsworth

Patenting diagnostic methods poses a unique challenge to U.S. patent practitioners. “Section 101” of the Patent Act, 35 U.S.C. §101, defines four statutory categories of subject matters eligible for U.S. patents: “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”  While this paper focuses on diagnostic methods because the majority of 101 case law has developed around these technologies, we expect current and future 101 case law to affect the development of many other critical technologies, such as the development of sensor technology, artificial intelligence, and personalized medicine.

Section 101 is subject to “judicial exceptions,” which preclude certain subject matter from patent eligibility; abstract ideas, laws of nature, and natural phenomena are not patentable. Navigating where diagnostic methods fit within Section 101 and its judicial exceptions can be challenging for applicants and practitioners. Nonetheless, it is vitally important for innovators of diagnostic methods and techniques to protect their intellectual property. In the Unites States, the tension between Section 101 and the judicial exceptions has played out with a patchwork of case law outlining the limited avenues to patentability for diagnostic methods.

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