JAPAN Trends and Developments Contributed by: Naoko Nakatsukasa, Katsuya Hongyo, Tatsunori Enomoto and Ronald Kaloostian, Chuo Sogo LPC
Intellectual Property High Court Grand Panel Decisions The rulings of the Intellectual Property High Court (the “IP High Court”) have a major impact on the interpretation of intellectual property rights in Japan. In cases involving particularly important legal issues and where decisions could signifi- cantly impact business activities and the indus- trial economy, the Grand Panel, which is made up of five judges of the IP High Court, is formed ad hoc to render its decisions. However, there is no pending case at the Grand Panel of the IP High Court at this moment (December 2024). Life sciences In 2024, several significant rulings by Japanese Courts, including the IP High Court, have been made in the field of life sciences. The first case below shows the criteria for determining the inventive step with regard to a patent relating to a vaccine adjuvant, which enhances a vac- cine’s effectiveness. The second case show- cases another interesting discussion regarding the patent linkage system in Japan. KM Biologics Co, Ltd. v Seqirus UK Limited, Case No 2023 (Gyo-Ke) 10056, Intellectual Prop- erty High Court (decision rendered on 25 March 2024) In a recent case concerning a patented invention titled “Hydrophilic Filtration During the Manufac- ture of Vaccine Adjuvants,” the IP High Court rescinded the decision of the Japan Patent Office (JPO) that the request for a trial for patent invalidation for the patent owned by the defend- ant (the “Invention”) is groundless, stating that, at the time of the priority date, a person skilled in the art could have easily conceived the structure of the Invention based on the cited invention and well-known techniques. Furthermore, the Court noted that the effects achieved by the Invention
were neither unpredictable by a person skilled in the art based on the structure of the Inven- tion nor demonstrated to exceed the scope of effects reasonably expected from the structure. As a result, the decision of the JPO to invalidate the patent was overturned. The Invention in question provided a method for manufacturing a squalene-containing oil-in- water emulsion, and this method comprised of: • a process to provide a first emulsion having a first average oil droplet size; • a process to microfluidize said first emulsion to form a second emulsion having a second average oil droplet size that is smaller than said first average oil droplet size; and • a process to filter said second emulsion using a hydrophilic double-layer polyethersulfone membrane comprised of a first layer having a pore size of 0.3 µm or greater and a second layer having a pore size of less than 0.3 µm, thereby providing a squalene-containing oil- in-water emulsion. In Japan, the concept of an inventive step is defined in Article 29(2) of the Patent Act. This article states that a patent cannot be granted for an invention if it could have been easily created, prior to the filing of the patent application, by someone with ordinary skill in the relevant field based on existing prior art. The patent examiner determines whether the claimed invention is novel by comparing it with the prior art cited to identify the differences between them. Where there is no difference, the claimed invention lacks novelty. If there is any difference, the examiner determines whether the claimed invention has an inventive step. If there is an invention-specific feature in the claimed invention that is not described in the prior cited
324 CHAMBERS.COM
Powered by FlippingBook