IP Newsletter | Summer 2015
	PATENT
	Is a Dosage Regimen Patentable? Yes, Says the Korean Supreme Court
	Korean courts have long held that a known drug treating a known disease with a new dosage regimen is not patentable subject matter. In a significant en banc decision, the Korean Supreme Court reversed this entrenched precedent, and settled debate on an aspect of Korean patent law involving pharmaceutical inventions. Legal Precedent on Dosage Regimens and Court's Rationale The subject case arose out of a scope trial (for determining enforceable patent scope with respect to a generic product) involving a composition patent covering the top selling drug in Korea. The Supreme Court took up the case to determine the broader preliminary question of whether the dosage regimens of the claimed pharmaceutical composition — "once a day administration" and "0.5 to 1.0 mg" of the active ingredient — should be included in the patentability analysis as claim elements that by themselves may confer novelty or inventiveness. Until this case, Korean court precedents largely discounted dosage regimens from patentability analysis on the basis that the composition of a drug does not physically embody a dosage regimen, and that the use of the drug according to a particular dosage regimen does not qualify as patentable subject matter under Korean patent law. However, in establishing its new precedent, the Court reasoned that the dosage regimen of a drug is closely linked to improving the effectiveness of the drug — enhancing efficacy, safety or patient compliance — and therefore that denying patentability as to dosage regimen claims would be improper. Implications of the Case Ultimately, the Court determined that the scope of the subject patent did not cover the generic product because one skilled in the art would have expected the therapeutic effects of the claimed dosage regimen in view of the relevant prior art (and thus the generic belonged to the public domain). Thus, the final outcome of the ruling is that Korean courts should require a claimed new dosage regimen for a known drug to show unexpected results in order to be patentable. Notwithstanding the above negative outcome, this decision represents a major shift in Korean patent law as it relates to pharmaceuticals because it potentially recognizes the patentability of new dosage regimens in Korea, and thus is a welcome sign that Korean courts are beginning to recognize the need to protect all inventive features of pharmaceutical inventions. Kim & Chang represented the patentee in the case.
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