Lee International

In 2021, a major controversy arose in Korea when it was discovered that a Korean pharmaceutical company (“D Company”) obtained an approval of the Ministry of Food and Drug Safety (MFDS) for a stomach medicine Albis D by submitting fabricated bioequivalence test data and obtained a related patent in order to prevent the competitors from entering the market.  Subsequently, D Company filed patent infringement lawsuits against the competitors based on this patent.  As a result, the Korea Fair Trade Commission (KFTC) determined that D Company’s actions constituted unfair trade practices and issued a corrective order and fines.  Furthermore, the MFDS revoked its approval for Albis D for violation of the duty to control drug production.

During investigation by the KFTC, it was also revealed that D Company had obtained the patent with a wider range of the particle sizes of the active ingredients by including false bioequivalence test data in the specification, even if D company has the actual bioequivalence test data for only one particle size of active ingredients. 

The Korean Intellectual Property Office (KIPO) ex-officio filed a patent invalidation trial for D company’s patent and requested the prosecutor to investigate D Company for fraudulent behavior under the Patent Act.  During the patent invalidation trial, the KIPO argued that some of the data included in the specification were fabricated and substantial effects of the inventions based on the fabricated data cannot be verified, as the grounds for invalidations.  However, D Company was able to maintain its patent right by deleting the false data from the specification and canceling the related claims, leaving only the valid data and its related claims. 

The current Korean Patent Act does not stipulate a separate ground for invalidating patents obtained through false or fraudulent acts.  Therefore, even in cases of fraud, patents can only be challenged in an invalidation trial based on the ground for insufficient description of the invention, as described above.  Moreover, there is no way to systematically prevent a patentee from retaining its patent right by deleting false data and the related claims.

To address this issue, an amendment to the Patent Act was proposed in February 2023.  This proposed amendment would allow examiners to request invalidation of the entire patent if the applicant obtained a patent through false or fraudulent conduct.  The proposed amendment would prohibit patentees from amending the specification and the claims for a patent obtained through false or fraudulent conduct.  It is expected that the fairness of the patent system will be further strengthened through such proposed amendment.