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PhRMA Flags Patent Linkage Concerns
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From the May 3, 2025 blog post:
"[Breaking] PhRMA Raises Concerns over MHLW’s Proposed Patent Linkage System"
On May 2, 2025, the Pharmaceutical Research and Manufacturers of America (PhRMA) published a position paper on its Japanese-language website, addressed to the Pharmaceutical Evaluation Division of Japan’s Ministry of Health, Labour and Welfare (MHLW). The submission sets forth PhRMA’s preliminary views on the draft framework for a Japanese-style patent linkage system currently under deliberation by the Ministry.
In particular, PhRMA expresses significant concern over the Ministry’s proposed introduction of an “Expert Opinion System” (有識者意見照会制度), under which designated experts would be asked to provide advisory, non-binding opinions on potential patent infringement issues during the regulatory review process.
The timing and public disclosure of the submission—while the policy framework remains under internal development—strongly suggest that PhRMA regards the proposal as raising serious systemic and procedural concerns.
This article summarizes PhRMA’s key arguments and offers additional commentary from the perspective of Japanese pharmaceutical patent and regulatory practice.
For further details, see the full article:
"[Breaking] PhRMA Raises Concerns over MHLW’s Proposed Patent Linkage System" (May 3, 2025)
https://www.tokkyoteki.com/2025/05/phrma-opinion-patentlinkage.html
#Pharmaceuticals #Patents #IntellectualProperty #RegulatoryAffairs #PatentLinkage #JapanIP #LifeSciencesLaw
2025年5月5日
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