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Court Limits Sprycel PTE Against Generic
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May 15, 2025 — Sawai Pharmaceutical v. BMS
Tokyo District Court, 2023 (Wa) 70527 / 2024 (Wa) 70016
– A Formalistic Ruling That Undermines the Foundation of Japan’s Patent Term Extension System in the Sprycel® Generic Drug Litigation
Summary
In a patent infringement lawsuit concerning whether Sawai Pharmaceutical’s manufacture and sale of a generic version of Sprycel® (dasatinib), a drug marketed by Bristol-Myers Squibb (BMS), falls within the scope of a patent right extended under Japan’s Patent Term Extension (PTE) system, the Tokyo District Court ruled on May 15, 2025, that the extended patent right does not apply. The court found that Sawai’s generic product is not substantially identical to Sprycel® as a pharmaceutical product and therefore does not fall within the enforceable scope of the extended patent.
While the court nominally acknowledged the legal principle that an extended patent right may cover not only the specific drug product approved under the regulatory approval (i.e., the "designated product") but also other pharmaceuticals that are substantially the same, it applied this standard in an unduly narrow and formalistic manner. The judgment raises serious concerns by failing to engage in a substantive comparison, thus potentially weakening the very foundation of the PTE system in Japan.
See:
https://www.tokkyoteki.com/2025/06/2025-05-15-r5-wa-70527-r6-wa-70016.html
7月3日
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