[Article / Patents] Cases and challenges in patent protection for biopharmaceuticals (Biotechnology and Life Sciences Committee, Patent, December 2025)
Updated: 7 hours ago
Article information
Article type: Publication review
Categories: Patents / Other Japanese law
Main issues: Patent linkage / Pharmaceutical data protection
First published on this website: October 1, 2026
Display and classification checked: October 1, 2026 (not a revalidation of the legal analysis)
[Article / Patents] Cases and challenges in patent protection for biopharmaceuticals (Biotechnology and Life Sciences Committee, Patent, December 2025)
1. De facto patent linkage in Japan
Under the practice based on the Ministry of Health, Labour and Welfare's “two division directors' notification,” biosimilars (BS) are, in principle, not approved while patents exist on the originator product's active ingredient or use.
2. Re-examination period
Japan's distinctive re-examination system functions as a de facto regulatory data protection period (RDP), sometimes creating a barrier to entry even after patent expiry.
3. Considerations and future challenges
The high-cost medical expense benefit system makes it difficult for patients to perceive an advantage in choosing inexpensive BS. To reconcile sustainable healthcare finances with protection of innovation, a transparent system involving the judiciary and a market environment predictable for overseas companies will be essential.
Original article: https://lnkd.in/g3ksZg4N
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Updates and corrections
Substantive corrections and additions are recorded separately from classification, related links and display changes.
October 1, 2026: First publication of the author's original LinkedIn text on this website. Article type, categories, topic tags, sources and consultation navigation added.
2026-10-01 | Classification: updated issue tags and displayed issues to match the article; jurisdiction categories and original text retained.
2026-10-01 | Display maintenance: added case references stated in the original or language-alternate metadata; not a revalidation of legal analysis.
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