In an invalidation action of a patent term extension based on an approved drug, Galvus, for the first time, the Patent Court has ruled that the foreign clinical trial periods can be eligible for a patent term extension (Patent Court Decision 2019 Heo 3588 issued on October 29, 2020).
In Korea, the period required for conducting Korean clinical trials and reviewing approval-related documents for a concerned drug is regarded as the period during which the patented invention could not be practiced, and thus, is eligible for a patent term extension. Thus, if the clinical trial was conducted in a foreign country, a patent term extension was allowed only for the time spent to review the approval-related documents (generally, several months). However, this Patent Court decision is attracting the attention of the industry as it is contrary to the conventional practice in which the foreign clinical trial period was not eligible for a patent term extension in Korea.
Specifically, the Patent Court held that if a foreign clinical trial necessary for the domestic drug approval is conducted between the later of the domestic clinical trial start date or the patent registration date and the drug approval date, the foreign clinical trial periods should be included in the period during which the patented invention could not be practiced. Additionally, the Patent Court determined that Article 89 of the Patent Act and Article 34(4) of the Pharmaceutical Affairs Act regarding the patent term extension merely stipulate that a clinical trial refers to “a trial of the activity, safety, etc. required for a drug approval” and do not limit the clinical trial to a domestic clinical trial.
As the Patent Court decision above has not been appealed, the Supreme Court has not rendered a decision for the concerned issue. Furthermore, whether the foreign clinical trial periods are eligible for the patent term extension is not the critical issue of the case in the Patent Court decision. Thus, the Patent Court did not provide any specific standards for calculating a patent term extension for a foreign clinical trial. Therefore, it is unlikely that the Patent Court decision above will be immediately reflected in the Korean Intellectual Property Office (KIPO)’s examination practice.
However, the Patent Court decision above may impact the KIPO’s examination practice as it is the first time that the Patent Court indicated that the Patent Act and the Pharmaceutical Affairs Act do not explicitly exclude the foreign clinical trial periods.