INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP
ers in the USA but provided to users based in Japan. Having set out a four-part test to assess the circumstances and co-defendants’ activities, the IP High Court held that the co-defendants’ acts could be regarded as having been “sub- stantially and wholly” conducted in Japan. Also in 2024, a long-running case in respect of a potential compulsory (non-exclusive) licence was settled. The JPO had established a special committee to assess whether such a licence should be granted on public policy grounds and substantial evidence and opinions had been submitted for consideration. No compulsory licence based on public policy has ever been granted in Japan; here, it appears that the com- mittee formed a tentative view that a narrow compulsory licence might be possible, which when shared with the parties was sufficient to encourage settlement. The details of the case and the committee’s deliberations are not pub- licly available and so a fresh case will be need- ed before the relevant criteria for a compulsory licence in Japan are properly understood. Other developments in 2024 include Japanese companies arguably continuing to become more assertive and initiating patent litigation, particularly in the technology field and including between domestic companies. More disputes may arise in this sector in the coming year or so, potentially in respect of 5G and other telecom- munications standards, the internet of things and connected devices, especially in respect of connectivity in the automotive sector. In the life sciences field, originator versus gener- ics cases continue. Interestingly, a number of generics companies continue to appear to ben- efit from Japan’s non-statutory “patent linkage” system and the regulator’s apparent readiness to grant a generic MA in certain cases (for instance,
where a patent has been held invalid by the JPO but not all avenues of appeal have yet been exhausted and the decision finalised), poten- tially conflicting with the regulator’s long-held position of seeking to ensure a stable supply of pharmaceutical products to the Japanese mar- ket. In particular, in 2023, the regulator approved generic versions of two or more drugs the active ingredients of which may still have been pro- tected by relevant patents or patent term exten- sions. In one case, a preliminary injunction order was granted promptly after the grant of such generic MAs; at least one other case is on-going. Once the cases are fully resolved, there may be important changes to the regulator’s practice in the future in favour of originators and patentees, as well as potentially in respect of the scope of patent term extensions in Japan. Finally, a number of biologics and biosimilar pat- ent cases continue to be the subject of dispute resolution in Japan, somewhat mirroring cases in the USA and Europe. It is still unclear whether the Japanese courts will take similar positions in respect of issues already litigated elsewhere. For instance, in respect of antibody patenting in Japan, the current approach appears to be more similar to that of Europe than that of the United States, in that the Japan Patent Office tends to focus on the new functions or properties of the claimed antibody in finding an inventive step or non-obviousness. Notably, expert evidence seems to have made a significant contribution in certain disputes. In any event, it is expected that the number of such biologics patent cases will increase, and it will be important to monitor Japan-specific developments in due course.
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