The “patent linkage system” is in general a system wherein market approval of generic drugs is linked with the status of the originator drug’s patents, for the purpose of early resolution of patent disputes and ensuring the stable and consistent supply of generic drugs. Japan has not statutorily adopted the patent linkage system, but the…

The hurdle for being a co-inventor in a medicine field in Japan might be a little higher than what is expected from precedents. The IP High Court affirmed, in its judgement of 17th March 2021 (2020 (ne) No. 10053), the first instance decision of 21st August 2020 (2017 (wa) No. 27378) which denied co-inventorship of…

In Japanese patent litigation, calling expert witnesses is very rare and the parties usually try to prove common technical knowledge (CGK) by submitting documentary evidence, such as publications available as of the priority date and written expert declarations. Thus, parties need to be aware that descriptions in the publications are crucial and cannot be supplemented…

On 14 September 2021, the Japan Patent Office (JPO) announced that most of the amendments to the Patent Act and other intellectual property laws, which were promulgated on 21 May 2021, will come into force on 1 April 2022.  The amendments cover various matters such as the introduction of online oral hearings at the trial…

In the pharma industry, constant battles have been taking place for many decades  between innovators and generics.  More recently, battles among innovators have also started to occur.  This post concerns a case which may have an impact on the development strategies of innovators, as well as licensing strategies of universities and public research institutions which…