Therapeutic or Pharmacological Use

Date Published

Note: The information in this part only applies to:

  • standard patent applications with an examination request filed on or after 15 April 2013.
  • innovation patents with an examination request filed on or after 15 April 2013.
  • innovation patents where the Commissioner had not decided before 15 April 2013 to examine the patent.  

For all other standard patent applications/innovation patents, see Useful (Utility).

Inventions asserted to be useful in the treatment of human or animal disorders are subject to the same legal requirements for usefulness as inventions in other technologies (see Assessing the Claims for Lack of Usefulness, Does the Invention Achieve the Promised Benefit? and Specific, Substantial and Credible Use).

The useful purpose of many inventions is self-evident, well-established in the art, or may be implied in the specification. If the skilled addressee, based on the disclosure of the specification in combination with the common general knowledge in the art, could appreciate without difficulty that the claimed invention is useful, the claim will satisfy the requirement for usefulness.

Where this is not the case, examiners should consider the statements in the specification, and any other evidence provided in support of an asserted therapeutic or pharmacological use, to determine if there is a reasonable correlation between the stated activity of a compound or composition and the use asserted in the specification.

An applicant can establish the existence of a reasonable correlation between an activity and the asserted use by relying on: data documenting the activity of the compound or composition; logical arguments or reasoning; documentary evidence; or any combination of these. Factors that may be considered to corroborate an asserted therapeutic or pharmacological activity include:

  • Evidence of structural similarity to a compound known to have a particular therapeutic or pharmacological use.
  • Data from in vitro or in vivo tests or in silico modelling that the person skilled in the art would accept as being reasonably predictive of an asserted use.
  • Human clinical data.

Note that a reasonable correlation between an activity and the asserted use is sufficient to establish usefulness. The applicant is not required to prove as a matter of statistical certainty that a correlation exists between a particular activity and an asserted therapeutic use, or to provide evidence of efficacy or success in treating particular animals/humans where such a use is asserted.

Claims directed to a method of treating or curing a disease for which there have been no previously successful treatments or cures may necessitate careful review for compliance with the usefulness requirements. The fact that there is no known cure for a disease does not necessarily lead to the conclusion that such an invention lacks usefulness. Examiners should determine if the asserted use for a claimed invention is credible based on the information disclosed in the specification. Where there is doubt that the evidence provided in the specification establishes a credible use, evidence from experts in the art indicating that there is a reasonable expectation of success, or submissions supported by sound reasoning, may be sufficient to establish that an asserted use is credible.

Any objection that the claimed invention is not useful should include a reasoned explanation of why the claimed invention does not have a specific, substantial and/or credible use and/or why it does not achieve the promised benefit.

Note: Where claims to methods of treatment do not meet the requirements for usefulness, examiners should also consider whether a lack of support objection applies (see Support Required for Pharmaceutical Inventions and Methods of Treatment).