JAPAN Trends and Developments Contributed by: Naoko Nakatsukasa, Katsuya Hongyo, Tatsunori Enomoto and Ronald Kaloostian, Chuo Sogo LPC
invention, that feature will be recognised as a difference. If a person skilled in the art can easily think of that difference based on the state of the art at the time of filing, the claimed invention will be judged to lack an inventive step based on the cited invention. In its inventive step analysis, the Court first deter- mined that the technique related to the structure of filtration using a membrane of a commercially available product listed in a product catalogue was a well-known technique at the time of the priority date. This commercially available prod- uct had a hydrophilic heterogenous bilayer poly- ethersulfone membrane that combined a poly- ethersulfone prefiltration membrane with a pore size of 0.45 µm and a polyethersulfone final fil- tration membrane with a pore size of 0.2 µm, and the product catalogue state that the product was designed to filter a wide range of pharmaceutical products. Therefore, the Court noted that this product could naturally be applied to the manu- facturing of a vaccine adjuvant emulsion, and thus, the technical field to which the Invention and this product belong are the same. The Court reasoned that the difference between the filtra- tion process of the Invention and that in cited inventions could have easily been conceived by a person ordinarily skilled in the art by applying this well-known technique. Furthermore, regarding the effect of the Inven- tion, the Court referred to data from the descrip- tion in the specification and determined that, only based on such data, it is not proved that the significant recovery rate is achieved thanks to the effect of the hydrophilic double layer poly- ethersulfone membrane related to the Invention. The Court noted that according to the evidence, it is reasonable to find that a person ordinarily skilled in the art at the time of the priority date could have easily understood that if approxi-
mately 50 litres of emulsion is filtered using the commercially available product, the clogging degree of the membrane is reduced and a high recovery rate (as stated in the description of the specification) can be achieved. Based on its analysis, the Court denied the inventive step of the Invention and set aside the decision of the JPO that the invalidation trial was not successful. The Court concluded that a per- son ordinarily skilled in the art at the time of the priority date could have conceived of the con- figuration of Invention based on the cited inven- tion and well-known art above. Furthermore, the Court did not find that: • the effect of the Invention could not have been predicted by a person of ordinary skill in the art; or • the effect is significant beyond the scope that a person ordinarily skilled in the art could have predicted. A skilled individual in the field would have easily recognised the well-established filtration tech- nology using a membrane made from a commer- cially available product. Furthermore, based on the comparison presented in the specifications, the Invention did not produce any significant effect. The impact of the Invention was predict- able, considering the information contained in the catalogue listing the commercially available product. Samsung Bioepis Co., Ltd. v Bayer Healthcare LLC., Case No 2024 (Yo) 30029, Tokyo District Court (decision rendered on 28 October 2024) Patent linkage system in Japan The patent linkage system refers to a mecha- nism in which regulatory authorities consider the infringement of patent rights related to the
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