Recently, the Korean Supreme Court rendered a remarkable ruling changing the former Supreme Court's precedents and admitting "a dosage regime, a mode or route of administration" as a constitutional element when determining novelty and/or an inventive step concerning a medical use invention (2014 hu 768 ruling sentenced on May 21, 2015).

 

Before the aforesaid new ruling, "a new dosage regime, a new mode or route of administration" was not considered as a novel constitutional element when determining novelty and/or an inventive step concerning a medical use invention. In this regard, a medical use invention characterized by a new dosage regime, a new mode or route of administration itself was not patentable according to the former Korean Supreme Court's precedents even though it has a remarkable effect derived from the dosage regime, the administration mode or route.

 

However, due to the new Supreme Court's ruling (2014 hu 768), a medical use invention characterized by a new dosage regime, a new mode or route of administration itself is patentable now if the medical use invention has an unexpected and remarkable pharmaceutical effect derived from the dosage regime, the administration mode or route when compared to the prior art.