CAJ | 학술논문

随着中药单方专利侵权案件的日益增多，如何认定一个新中药单方是否构成对现有中药单方专利的侵权，显得尤为重要。按照我国《专利法》的规定，必须经过“三性”认定，而新中药单方“三性”认定的关键在于其与现有的中药单方专利相比是否具有创造性。因此，尽快制定中药单方专利的创造性认定标准迫在眉睫。当新中药单方与现有的中药单方专利相比使用了不同的药用部分、不同的剂型导致给药途径改变、不同的炮制方法导致归经改变、不同生产方法、工艺及增加或使用不同的引药、改变现有中药单方专利的混合物组分或组成混合物组分的剂量等时，如果其能在作用同一病症的不同类型、减少毒副作用、显著提高疗效、适应新的病症、作用新的部位等任何一方面有所突破，就应当认定该新中药单方对中药领域的普通技术人员来说具有“非显而易见性”，有突出的实质性特点和显著的进步，具有创造性。
수착중약단방전리침권안건적일익증다，여하인정일개신중약단방시부구성대현유중약단방전리적침권，현득우위중요。안조아국《전리법》적규정，필수경과“삼성”인정，이신중약단방“삼성”인정적관건재우기여현유적중약단방전리상비시부구유창조성。인차，진쾌제정중약단방전리적창조성인정표준박재미첩。당신중약단방여현유적중약단방전리상비사용료불동적약용부분、불동적제형도치급약도경개변、불동적포제방법도치귀경개변、불동생산방법、공예급증가혹사용불동적인약、개변현유중약단방전리적혼합물조분혹조성혼합물조분적제량등시，여과기능재작용동일병증적불동류형、감소독부작용、현저제고료효、괄응신적병증、작용신적부위등임하일방면유소돌파，취응당인정해신중약단방대중약영역적보통기술인원래설구유“비현이역견성”，유돌출적실질성특점화현저적진보，구유창조성。
With the increase of the infringement cases of the traditional Chinese medicine unilateral patents, how to identify whether a new traditional Chinese medicine unilateralism infringes the existing traditional Chinese medicine unilateral patents ,which becomes particularly important. According to the requirements of our county＇ s Patent Law, it must go through the indenfication of creativeness , practicality and novelty, the key to the indenfication of creativeness , practicality and novelty of the new traditional Chinese medicine unilateralism lies in whether the new traditional Chinese medicine unilateralism possesses creativeness compared with the existing traditional Chinese medicine unilateral patents. Therefore , drawing up the recognized standard of the creativeness of the traditional Chinese medicine unilateral patents is urgent. When the new traditional Chinese medicine unilateralism compared to the existing traditional Chinese medicine unilateral patents uses different medical parts , different formulations leading to change of the way of taking medicine , different processing methods resulting in the change of tropism channel, different production methods, process and increases or uses different leading traditional Chinese medicine, changes the parts of components of the existing traditional Chinese medicine unilateral patents or the doses of consisting of conponents ,and so on ,if they have any one breakthrough in working different kinds of the same illness, cutting down the poisonous side effects, notably improving curative effects, adapting to the new illness, working new locations, and so on , so that we can say the new traditional Chinese medicine unilateralism possesses of ＂not noticeable＂ towards average technicians in traditional Chinese medicine field,have dramatically substantial characteristic and notable progress, own creativeness.