Patent Protection for New Use of Known Pharmaceutical Drugs in Korea

The Korean Supreme Court decides that new medical use characterized by a dosage regimen or dose is patentable.

Given the ever-growing costs of developing new drugs, attention in the pharmaceutical industry is very often focused on finding new therapeutic uses for existing drugs or optimizing the administration regimen. And, indeed, many important pharmaceutical innovations resulted from this approach. While pharmaceutical companies attempt to patent such innovations, this practice is opposed by the generic pharmaceutical industry and other entities.

Patent Laws throughout the world differ, by legislation or court made law, in their approach to patenting such innovations, although the laws are often unclear. Accordingly, such matters occasionally reach the courts. One country where patentability of a dosage regimen or dose of pharmaceutical drug was challenged was Korea – one of the world’s leading economies with a thriving pharmaceutical industry.

In a 2009 decision, the Korean Supreme Court decided that inventions residing in dosage regimen or a dose is not a medical substance and, therefore, non-patentable. It was then concluded that such an invention constitutes a medical procedure and not a final product and consequently is not eligible for patent protection. This matter came up again before the Supreme Court which has now decided on this question en banc.

In an en banc decision of May 21, 2015 the Korean Supreme Court overturned its earlier decision and held that “a dosage regimen and a dose” can be considered as elements of an invention for determining patentability; and, hence, patent eligible. In reaching its decision that Court stated that
“[a] medical use is a feature of an invention that can give a product new significance by defining properties of a medicine as the product that produces efficacy, and not as a medical activity itself“.

This is important and welcome news for the many innovators seeking to patent such inventions in Korea, an important pharmaceutical market with a very strong and thriving pharmaceutical industry.