Examination Guidelines for Patent Applications Relating
to Pharmaceutical Inventions in the Japan Patent Office｜IP Laws & Practices

4. NoveltyGeneral
- Patent applications are examined as to whether the claimed medical uses of the active ingredients are patentable over the prior art.
Prior Art
- A mere speculation of a possible medical use is not considered as prior art.

NOTE: Claims are examined to determine if the claimed medical uses of the active ingredients (e.g. compounds, peptides, DNAs) are anticipated by prior art.
A mere prior art speculation of a possible medical use is not considered as a bar to novelty.

4-1. NoveltyClaims lack novelty when the claimed medical uses can be deduced from prior art based on a common mode of action.

Examples

NOTE: However, if the claimed medical uses could easily be deduced from prior art based on a common mode of action therebetween, the claims may be rejected as lacking novelty.

4-2. NoveltyClaims may lack novelty when the claimed medical uses can be ascribed to pharmacological effects closely related to those in prior art.

Examples

NOTE: The Japan Patent Office states that claims may lack novelty when the claimed medical uses can be ascribed to pharmacological effects closely related to those in prior art. However, the patent office also admits that there would be cases where this sort of assumption cannot always apply. For example, the teaching in the prior art that the claimed compound can be used as an anti-inflammatory drug may not destroy the novelty of the analgesic application if it is also suggested by the state of the art that some classes of anti-inflammatory drugs are known to be devoid of any analgesic effect.

4-3. NoveltyOthers - Genus medical use claims would lack novelty over known specific medical use/uses. e.g. Anti-lung Cancer v. Anti-cancer
- A mere discovery of the mode of action does not render the invention novel. e.g. Antibiotics v. a Bacterial cell wall synthesis inhibitor
- A mere discovery of a beneficial property of a component does not render the composition novel. e.g. A pharmaceutical composition comprising compound A in combination with compound B that improves the stability of compound A

NOTE:
1. Claims reciting the medical uses as generic concepts, e.g. anti-cancer would lack novelty when the claims encompass known specific medical use/uses, e.g. anti-lung cancer in the prior art. In contrast, generally, claims to a specific medical use would be novel over the prior art disclosing it as a generic concept unless the prior art clearly and specifically suggests the specific use.
2. A discovery of the mode of action would not make the invention patentable over the prior art insofar as the medical uses are still identical therebetween.
3. A discovery of a beneficial property of a component would not render the pharmaceutical composition novel insofar as the claim cannot be otherwise distinguished from the prior art.

5.Inventive StepGeneral
- An invention may not involve inventive step if the medical uses of the invention and the prior art can be correlated with each other in view of the mechanism of the biological effect.
- Use of veterinary drugs for the treatment of corresponding human diseases may not involve inventive step.

NOTE: The Japan Patent Office generally considers that an invention would not involve inventive step (obvious to try) if the prior art is considered to suggest the claimed medical uses in the light of the mechanism of the biological effect shared between them. The patent office also states that it would be obvious to try to use veterinary drugs for treating corresponding human diseases. In both cases, if unexpected advantageous effects can be recognized, the claims may involve inventive step.