Handling inventions based on second medical use (2)

In the following we will explain patent claims for medical inventions with a peculiar mode of administration and/or dosage regimen.

As for such inventions, even if a medical invention A (X + Y), that describes the application of a certain substance X to a patient Y, is common knowledge and the substance is applied to the same patient Y, some countries recognize novelty if the medical invention compromises a new prescription method Z. (medical invention A (X + Y + Z))

For such cases a patent is granted for a peculiar mode of administration and/or dosage regimen, that if applied to a certain disease, achieves effects that would exceed the exceptions of a specialist.     

For example there is a ramosetron hydrochloride (product name: Irribow) that demonstrated a curative effect for the Irritable Bowel Syndrome, if you reduce the prescribed dose from 0.1 mg  per day to 5 μｇ per day.

Claims are formulated like this : “Substance X for use in the treatment of disease Y, wherein the substance X is to be administered by(i) route/mode of administration Z/(ⅱ)by dosage regimen Z/（ⅲ）to patient group Z”.

By such claims the prescription interval and dosage are limited, but after all it is an “invention of a thing”.

Inventions that have a peculiar mode of administration and/or dosage regimen can be granted a patent in Japan, but in China and Korea such inventions are not accepted in general. However in China it might be possible to obtain a patent if changing the mode of administration and/or dosage regimen has a remarkable effect. In other cases it would be advisable to formulate a dependent claim for the administration and/or dosage regimen. In Korea the law does not clearly say that medical inventions with peculiar mode of administration and/or dosage regimen can be granted a patent however there have been successful cases in the past.