A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

By way of the Patent Act of 1952, the United States Congress established four statutory categories defining limits on inventions eligible for patent protection that are still in use today: process, machine, manufacture, and composition of matter. On its face, this framework would appear to allow for the patenting of medical diagnostics, which often revolve around a process and/or machine (e.g., a diagnostic device). However, the current patent-eligibility environment in the United States surrounding medical diagnostics is unforgiving and those seeking to patent such inventions face significant challenges in trying to protect their innovations. This is largely due to courts having created, in their established role of interpreting and apply laws, judicially recognized exceptions to the four broad categories of patent-eligible subject matter that bar the patenting of abstract ideas, laws of nature, and natural phenomena.

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