Patent law 101

New guidance may make it easier to patent diagnostics, biomarkers and natural products

The director of the U.S. Patent and Trademark Office, Andrei Iancu, said last week that a fundamental aspect of patent law that affects life science patents is completely screwed up, and because Congress can’t be counted on to address the problem he plans to release guidance that will fix it.

The problem involves Section 101 of the of the U.S. Patent Act, a single sentence written into law in 1952 that is intended to serve as a gateway to more complex analyses. “Whoever 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.”

A series of Supreme Court rulings interpreting Section 101 has narrowed the definition of “useful process, machine, manufacture, or composition of matter” by excluding a law of nature, a natural phenomenon, or

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