“투여용량·투여용법(주기)에 특징이 있는 의약발명의 진보성 판단”에 대하여

A Case Study Regarding Patent Appeal Board Case No. 2019WHON2123

The appeals at the Korean Patent Appeal Board (KPAB) has a serious problem in determining nonobviousness(inventiveness) of pharmaceutical patents characterized in dose and dosage regimen. Nonobviousness is the most critical patentability criterion. Pharmaceutical patents covering dose and dosage regimen had been challenged for obviousness during prosecution and/or litigation. However, many foreign countries have recently been allowing patentability of dose and dosage regimen in the pharmaceutical invention and so has the Korean Supreme Court. The claimed invention relates to the new dosing regimen of opicapone but not the discovery of a therapeutic combination. However, in the subject decision of the KPAB, the Board analyzed the claimed invention of claim 1 into 3 elements only with mechanical or structural perspective. The Board should have applied the standard of nonobviousness to the claimed invention as a whole with functional perspective. The Board just states that the three elements are disclosed in the prior art reference, and concludes that the claimed invention is lack of inventive step over the reference. Moreover, the Board ignored the scientific evidence which verifies that the new dosing regimen of opicapone has an unexpected effect by providing a result of prolonged activity. The reasoning of the Board does not make any sense how a person skilled in the art can derive the dosing regimen of the subject invention and predict the effects, in situations where contradictory results of loss of effect are expected even if it is estimated by scientific methods. The counterpart applications were accepted for patent in Japan, Canada and EPO. However, the Board never discussed about the counterpart patents.