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Japan: Guidelines on the ‘Fair Value Calculation of SEP for Multi-Component...
A Study Group appointed by the Japanese Ministry of Economy, Trade and Industry has recently published Guidelines on Fair Value Calculation of Standard Essential Patents for Multi-Component Products....
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Japan Compulsory License
Legal Basis The legal basis for compulsory licenses under Japanese Patent Law is Article 83 of the Japanese Patent Act (Patent Act), which stipulates that, “Where a patented invention is not...
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Japan: The IP High Court has clarified that the Japanese Bolar exemption...
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...
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A Japanese version Amicus Brief system will be introduced in spring 2022
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...
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Japan: MSD v Wyeth – The IP High Court upholds the validity of patent claims,...
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...
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The Japanese Government calls for views on SEP Licensing Negotiations
Back in 2021 the Competition Enhancement Office and the Intellectual Property Policy Office at the Japanese Ministry of Economy, Trade and Industry (METI) established the “Study Group on Licensing...
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Japan: PD-1/PD-L1 related patents: What are the co-inventorship requirements...
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...
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Japan: Problem of Japan’s patent linkage system comes to the surface by a set...
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...
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JPO publishes the Status Report 2022
Every year the Japan Patent Office (JPO) publishes a status report in spring, and this year’s report (the “Status Report 2022”) was published on March 30, 2022. The Status Report 2022 contains...
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Japan: The government of Japan announces the Intellectual Property Strategic...
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...
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Japan: Guidelines for a Transparent and Predictable SEP Licensing Negotiation
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...
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Japan IP High Court’s first-ever decision allowing patent enforcement against...
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...
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Amgen v. Sanofi and Regeneron: Japan IP High Court overrules its own decision...
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...
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Japan: Sawai’s Generic Drug is approved by the MHLW amid patent litigation...
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...
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