A treatment method is not patentable in Korea unless a human being is explicitly excluded from the subject to be treated. Since a dose and a dosage regimen are related to a treatment method, in the past these features alone were not considered in determining inventiveness of a medical use invention (Supreme Court decisions 2007Hu2926 and 2007Hu2933 rendered on May 28 2009).
The Supreme Court, however, overturned the previous position in its decision 2014Hu768 rendered on May 21 2015, ruling that a dose and a dosage regimen can be considered as technical features of a medical use invention, and thus, a dose and a dosage regimen may be patentable subject matter if they satisfy the patentability requirements such as novelty and inventiveness. The critical point in obtaining a patent for a dose or a dosage regimen in Korea is now how to demonstrate inventiveness of the specified dose or dosage regimen.
The Patent Court recently provided guidelines for determining the inventive step of a dose and a dosage regimen (Patent Court decisions 2015Heo7889, etc rendered on February 3 2017). Considering the common goal in the medical field that optimisation of a dose and a dosage regimen such as a dosing cycle is required to increase therapeutic effects and minimise toxicity or side effects, the Patent Court indicated that an optimised dose or dosage regimen of a known medical substance would be, in principle, easily conceivable from the prior art by a person skilled in the art.
Further, the Patent Court made it clear that, inasmuch as there are no special circumstances, when a specific dose or dosage regimen either shows advantageous effects which are unexpectedly remarkable over the prior art, or minimises toxicity or side effects while maintaining therapeutic effects, the dose or dosage regimen that is unexpectable from the prior art has an inventive step over the prior art.
According to this decision, the inventiveness of a dose or dosage regimen hinges on how to differentiate it from the prior art in terms of pharmacological effects or side effects, for which it is important how to draft a dose or dosage regimen claim. The answer can be found from previously granted patents featuring a dose and/or dosage regimen. A dose may be combined with a dosage regimen, such as an administration route, a dosing interval, and an administration frequency, in drafting a claim of a medical use invention so as to enhance therapeutic effects. In another way, a dose or dosage regimen may be combined with other features such as other components of the composition and a preparation process to secure a patent therefor. Developing a dose or dosage regimen would be one of the strategies for securing a secondary patent for an original drug in Korea.
|Patentable features||Example of claim drafting|
|Dose||A pharmaceutical composition for the treatment of … comprising a to b mg of X ….|
A pharmaceutical composition for the treatment of … comprising X … wherein the composition is administered at a dose of a to b mg per kg body weight.
|A pharmaceutical composition for the treatment of … comprising X … wherein X is administered at a dose of a to b mg per kg body weight by subcutaneous or intramuscular administration.|
|A pharmaceutical composition for the treatment of … comprising X … wherein X is administered in a dose of a to b mg per kg body weight at time intervals of one to two months.|
|A pharmaceutical composition for the treatment of … comprising X … wherein the composition is administered at an initial daily dosage of a mg for c days and then at the standard daily dosage of b mg after the initial daily dosage.|
|A pharmaceutical composition for the treatment of … comprising X and a pharmaceutically acceptable carrier, wherein the dose of X is a to b mg and the composition further comprises a surfactant selected from ….|
|A pharmaceutical composition for the treatment of … comprising (i) a to b mg of X, (ii) c to d mg of … carrier and/or diluent, and (iii) e to f mg of EDTA ….|
|A pharmaceutical composition for the treatment of … comprising X … wherein X is administered at a dose of a to b mg per kg body weight, and the composition is prepared/isolated by the process: ….|
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