How does the USPTO handle therapeutic or pharmacological utility claims?
The USPTO applies the same legal requirements for utility to therapeutic or pharmacological inventions as it does to inventions in other fields. According to MPEP 2107.01:
“Inventions asserted to have utility in the treatment of human or animal disorders are subject to the same legal requirements for utility as inventions in any other field of technology.”
The MPEP further clarifies that pharmacological or therapeutic inventions that provide any “immediate benefit to the public” satisfy 35 U.S.C. 101. Importantly, the USPTO does not require FDA approval or full clinical trials to demonstrate utility:
“FDA approval, however, is not a prerequisite for finding a compound useful within the meaning of the patent laws. […] Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development.” In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
This means that patent applicants do not need to prove that a drug is safe and effective for humans to satisfy the utility requirement, but they should provide credible evidence of pharmacological activity relevant to the claimed use.
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