Hanol IP & Law

Precision medicine, also known as personalised medicine, is an emerging field in healthcare and seems to have a promising future as it accounts for 42% of new molecular entities which the Food and Drug Administration (FDA) approved in 2018. Since precision medicine aims to provide bespoke medical treatments based on individual patient's characteristics, it essentially incorporates diagnosis and treatment methods. Under Korean patent law and practice, treatment and diagnosis methods are not considered patent eligible subject matter. As such, it is necessary to circumvent restrictive eligibility requirements to obtain protection for precision medicines in Korea. In the past, although precision medicines can be pursued as a pharmaceutical/diagnostic composition claim, it was not easy to claim methodological aspects of precision medicines (e.g. dosage regimen) which were not considered as technical features constituting composition itself (Supreme Court decisions 2007Hu2926 and 2007Hu2933, rendered on May 28 2009).

In Korea, patent term extension (PTE) of a maximum of five years may be granted once for a patent covering a drug or agrochemical that has to obtain marketing approval after patent registration. According to Article 95 of the Korean Patent Act, however, the scope of protection during the extended period is limited only to the working of the patented invention in relation to products whose marketing approval was the basis for PTE.

Korea requires a number of drawings for design applications showing several views that usually comprise one perspective view and six principal views (e.g. front, rear, right, left, top and bottom view, etc.) such that the design for protection can be clearly identified.

To raise funds for research and development, start-ups sometimes have to announce the existence of licensing agreements, supply and distribution agreements etc. (i.e. a contract for a future sale of a product embodying an invention). In places like the US, if such agreements were made public more than one year prior to the effective filing date, even though the details of the invention are kept confidential, a statutory on-sale bar may be triggered, resulting in loss of patent protection for the invention in the US.

When inventions/designs are disclosed to the public by one of the inventors/designers or applicants, a one year grace period is available in Korea for patent, utility model, and design applications.

In 2015, the Korean Supreme Court cleared the patent eligibility hurdle for dosage regimen inventions, and announced that dosage regimens are patentable if they satisfy other patentability requirements including novelty and inventiveness (Supreme Court en banc decision 2014Hu768, May 21 2015). In the first case where the inventiveness of a dosage invention was at issue (Patent Court decision 2015Heo7889, February 3 2017), the Korean Patent Court denied inventiveness on the ground that optimising dosage regimens to achieve the reduction of toxicity or improvement of efficacy is considered routine experimentation or work of a person having ordinary skill in the art (PHOSITA). This shows that Korea has a strict standard for the inventiveness of dosage regimen patents.