Korean Supreme Court’s En Banc Decision on Patentability of Medicinal Invention in which Administration Method and Dosage are specified

1. Summary of the Decision

On May 2, 2015, the Korean Supreme Court held that a method of administration and dosage of a medicine for treating, alleviating, preventing or diagnosing a disease can be elements of a claimed invention, based upon the reasoning that they can be considered as limitations for assessing patentability of a claimed medicine (Korean Supreme Court Case No. 2014 Hu 768, En Banc Decision).  All the precedents that now have become contradictory to this decision have accordingly been overruled.

2. Details of this En Banc Decision

1) Precedents set by the Korean Supreme Court

The Korean Supreme Court established its precedents holding that an administration period and dosage of a medicine cannotbe elements of a claimed invention, for the reason that these are: (i) related to a medical behavior, or (ii) not related to a final product itself obtained from the claimed invention.

2) Reasoning of this Decision

Through this En Banc Decision, the Korean Supreme Court held that a method of administration and dosage of a medicine should be considered as elements for assessing patentability of the invention for a medicine, not as part of medical behavior.  The Court’s reasoning is that: a method of administration and dosage of a medicine share the essential feature with a second medicinal use invention in that they provide a new way in which a medicine is used from a finding of specific pharmaceutical effects of a medicine, and changes on a method of administration and dosage of a medicine may result in an unexpected effect on treatment or prevention of a disease. Since a patent right can be granted for a second medicinal use invention, a method of administration and dosage of a medicine should be considered as elements for assessing patentability of the invention for a medicine, not as part of medical behavior.  In other words, in this En Banc Decision, the Korean Supreme Court takes up the position that a patent right can be granted for an invention recited in claims directed to a known medicine if such claims are limited by a method of administration and dosage which confer novelty and inventive step.  Based upon the foregoing, all the precedents that now have become contradictory to this new decision have been overruled.

3. Significance of the New En Banc Decision by the Korean Supreme Court

According to the Korean patent practice, an invention related to a medical behavior such as treatment method on human being is unpatentable, and from the court precedents an administration method and dosage had been regarded as a medical behavior.  The Korean Supreme Court overruled the precedents and held that an administration method and dosage can be elements to a medicinal invention, thereby a medicinal invention characterized by a specific administration method and dosage can be granted for patent if it satisfies the requirements of novelty and inventive step.