|Publication date||2020-01-31||Author||Fumi KATOH|
Dr. Katoh’s paper, titled “Studies on product-by-process claims in biotechnology field” , was published in “World of Intellectual Property Studies (知的財産学の世界)“ on January 31, 2020.
Two Japan Supreme Court decisions issued in 2015 (Heisei 24 (Ju) 1204 and Heisei 24 (Ju) 2658, Pravastatin Sodium Case) state that product-by-process (PbP) claims should be treated based on the product itself (i.e. not limited to the process) both in prosecution (patentability) and litigation (technical scope of protection), and that a PbP claim invention satisfies the clarity requirement only if it is not possible or not practical, at the time of filing, to identify the invention by its structure or characteristics. Trends in this area of law attract interest because they may affect the validity of registered patents. The Japan Supreme Court decisions have received critical and negative feedback, especially regarding the future applicability of PbP claim drafting. In this study we will review the history of the Pravastatin Sodium Case, and discuss future opportunities for the protection of inventions in biotechnology fields in prosecution and litigation. In biotechnology fields, PbP claim drafting seems to be only one strategy to protect the invention as a product, and may also expand the technical scope of protection.