Is it necessary to specify dosage or method of use in a patent application?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

Generally, it is not necessary to specify the dosage or method of use in a patent application if:

• It is known to one skilled in the art that such information could be obtained without undue experimentation
• One skilled in the art, based on knowledge of compounds with similar physiological or biological activity, could discern an appropriate dosage or method of use without undue experimentation

The MPEP states: For example, it is not necessary to specify the dosage or method of use if it is known to one skilled in the art that such information could be obtained without undue experimentation. (MPEP 2164.01(c))

This guideline helps streamline patent applications while ensuring that the enablement requirement of 35 U.S.C. 112(a) is still satisfied.