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

7. Dosing Schedule/Dosage AmountGeneral
- Optimizing the dosing schedule/dosage amount to reduce toxicity and improve efficacy is normal and routine development.
- Accordingly, the invention does not involve inventive step unless an unexpected remarkable effect is attained by the invention.

NOTE: The patent office considers that optimizing the dosing schedule/dosage amount to reduce toxicity and improve efficacy is normal and routine development. Accordingly, the invention does not involve inventive step unless an unexpected remarkable effect is attained by the invention.

7-1.Dosing Schedule/Dosage AmountNovelty
- Claims to dosing schedule/dosage amount may be distinguished from the prior art by a recitation with regard to patients to be treated, dosage form or strength per dosage unit, or reciting them as a kit.
- Method of treating human diseases is not patentable subject matter in the Japan Patent Office.

NOTE: The Japan Patent Office states that claims to dosing schedule/dosage amount may be distinguished from the prior art by a recitation with regard to patients to be treated, dosage form or strength per dosage unit, or reciting them as a kit. This would also indicate that the patent office is very likely to reject the claims if they solely recite the dosing schedule/dosage amount and are not otherwise distinguishable. In this connection, a method of treating human diseases is not patentable subject matter in the patent office, even though the invention may adequately and properly be drafted as the method claim.

7-2.Example (Dosing Schedule/Dosage Amount)Novelty and Inventive Step: YES
[Claim]
A pharmaceutical composition for treating hepatitis C in a patient having α-type genotype, said composition comprising compound A as an active ingredient and being administered to said patient at an initial dose of 5.0 mg/kg to 10.0 mg/kg, followed by a dose of 0.3 mg/kg to 0.5 mg/kg on alternate days
[Prior Art]
Compound A was known to show severe side effects, and therefore its use was limited.
[Remarkable Effect]
It was discovered that the patients having α-type genotype can tolerate side effects of compound A.According to the claimed dosing schedule, the patients can be treated successfully.

NOTE: In this example case, the claim specifies the patients to be treated as "having alpha-type genotype" and this limitation renders the claimed invention novel. As to the inventive step, the patent office acknowledges the remarkable effect in that, according to the claimed dosing schedule, the patients can be treated successfully based on the discovery that the patients having alpha -type genotype can tolerate side effects of compound A.

7-3.Example (Dosing Schedule/Dosage Amount)Novelty and Inventive Step: YES
[Claims]
An oral composition for stimulating immune response in a patient comprising compound A or a pharmaceutically acceptable salt thereof in an amount of from 550 to 650 mg per unit.
[Prior Art]
An oral composition comprising from 10 to 30 mg per unit of compound A had been used for stimulating immune response.
[Remarkable Effect]
The specification demonstrates a remarkable bioavailability of compound A. The bioavailability of compound A is only improved when the compound is orally administered at the dosage amount of from 550 to 650 mg.

NOTE: In this example, the claimed composition is distinguished from the prior art composition in terms of the strength per dosage unit. The bioavailability of the compound is significantly improved only when orally administered at the dosage amount of from 550 to 650 mg. In summary, with regard to an invention concerning dosing schedule/dosage amount, it must attain an unexpected remarkable effect.
As explained, the remarkable effect should be demonstrated in the specification as filed by means of pharmacological test data, preferably in vivo test data. The patent office considers a difference in patients to be treated, dosage form and strength per dosage unit, as criteria for distinguishing the claims from the prior art. This would also indicate that merely reciting the dosing schedule/dosage amount in the claims would be insufficient for meaningfully distinguishing the claims.

Kawaguti & Partners