Injunction, Japan, Pharma

, , (Abe, Ikubo & Katayama)/

On November 28, 2023, the Tokyo District Court issued a preliminary injunction order against Sawai Pharmaceutical Co., Ltd. (“Sawai”) to suspend the manufacture and sale of Sawai’s pharmaceutical product (“Sawai’s Product”) developed and sold as a generic drug of Bristol-Myers Squibb (“BMS”)’s cancer drug “Sprycel®” (Case No. 2023 (Yo) 30214; AIK represented BMS in this…

Case Law, Japan, Pharma

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On January 26, 2023, Regeneron Pharmaceuticals, Inc., who sought to invalidate Amgen Inc.’s Japanese patent (JP5705288) covering an isolated monoclonal antibody used as cholesterol medication, won an appeal case in the IP High Court (Case No. 2021 (Gyo-ke) 10093). What was surprising in this case was that the IP High Court’s invalidity conclusion was the…

Case Law, Japan

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On July 20, 2022, the Japan Intellectual Property High Court (“IP High Court”) rendered the first-ever decision allowing enforcement of Japanese patent rights against infringing acts partially committed outside of Japan (Case No. 2018 (Ne) 10077). The plaintiff Dwango Co., Ltd. sued co-defendants FC2, Inc. (U.S. company) and Homepage System, Inc. (Japanese company), alleging that…

Japan, SEP

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On March 31, 2022, the Ministry of Economy, Trade and Industry (METI) publicized the “Good Faith Negotiation Guidelines for Standard Essential Patent Licenses” (hereinafter, the “METI Guidelines”). The METI Guidelines are not legally binding but were created as norms of good faith negotiations to be followed by SEP holders and implementers involved in SEP licensing…

Japan, Legislation

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On June 3, 2022, the Japanese government announced its Intellectual Property Strategic Program 2022. The Intellectual Property Strategic Program sets out the government’s policies and future actions for promoting the creation, protection and exploitation of intellectual property in a focused and systematic manner. It is discussed and decided every year by the Intellectual Property Strategy…

Case Law, Japan, Pharma

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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…

Case Law, Japan, Pharma

, (Abe, Ikubo & Katayama)/

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…

Case Law, Japan, Pharma

, (Abe, Ikubo & Katayama)/

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…

Japan, Legislation

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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…