Really Strict Description Requirement on Pharmacological Effect in Korea

In principle, the pharmacological effect should be described to such an extent that persons skilled in the art could clearly understand, recognize and reproduce the invention without any additional specific knowledge in the specification for a medicinal use invention at the filing stage. It is paramount to understand that under Korean patent practice the specification for pharmaceuticals or medicinal use inventions must quantitatively describe their pharmacological effects. The Korea Supreme Court specifically held that (1) if a pharmacological mechanism by which a certain pharmacological effect is provided has been clearly known, a simple description of the pharmacological effect would suffice; however, (2) in case such a pharmacological mechanism has not been known, the specification should include quantitative experimental data or the specific development of confirmation the pharmacological effect, i.e., when specific experiments were conducted, experimental methods, experimental results or the like, so that others could also confirm such a pharmacological effect.

For example, a new pharmaceutical composition with an enhanced anti-emetic effect in which the composition comprises two known anti-emetic agents, i.e., ondansetron and dexamethasone was claimed but the specification only described in connection with the pharmacological effect of the claimed composition that “the anti-emetic properties of one anti-emetic agent (i.e., ondansetron) are enhanced by administering with the second anti-emetic agent (i.e., dexamethasone).” No quantitative data supporting the enhanced effect was included in the original specification. The application was finally rejected on the ground that the specification violated the description requirement and that the claimed invention had not been completed.

Furthermore, it is not permitted to add quantitative pharmacological data to the specification through an amendment during prosecution. For example, there was a real case that an applicant submitted a declaration which was prepared before the application filing date, describing experimental data supporting the synergistic effect of the composition during the examination and trial proceedings. In that case, KIPO and the Patent Court did not allow the applicant to add data based on the ground that the addition of experimental data is new matter to the specification. Therefore, it is required to have such data or descriptions contained within the original specification at the filing stage.