Overview
If you are planning to register a generic or biosimilar drug in Japan, it is essential to understand the country’s two-stage patent linkage system, that operates through Ministry of Health, Labor, and Welfare (MHLW) administrative notices rather than formal regulations.
Introduction
When planning to register a generic or biosimilar drug in Japan, it is essential to understand the country’s two-stage patent linkage system, that operates through Ministry of Health, Labor, and Welfare (MHLW) administrative notices rather than formal regulations. The First Stage ensures generic drugs do not infringe on brand patents during regulatory review. The Second Stage focuses on additional patent disputes before the drug enters the market. Unlike the U.S. Orange Book, Japan’s Pharma Patent Information Sheet is not publicly available, limiting transparency.
The First Stage occurs during the Review of the generic or biosimilar drug application
By the Pharmaceuticals and Medical Devices Agency (PMDA). It is governed by the “Joint Notice from Two Division Directors” (2009), which mandates a check for patent conflicts, primarily focusing on substance and use patents listed in the Pharma Patent Information Sheet (similar to the U.S. “Orange Book,” but not publicly accessible).
During the review process, PMDA ensures that the generic or biosimilar drug does not infringe on listed brand patents. However, other patents like formulation and manufacturing process patents are not considered at this stage.
If a patent invalidation trial is ongoing, approval of the generic or biosimilar drug is generally withheld until the case is finalized, potentially delaying market entry.
Second Stage
The Second Stage occurs during the Negotiation of the generic or biosimilar pricing before being listed on the NIH Drug Price Listing. This step occurs after marketing approval (MA) but before the generic or biosimilar drug is listed in the NHI Drug Price Standard, which is necessary for commercialization. This process is governed by the Medical Affairs and Economics Bulletin (2009), this stage primarily addresses disputes over patents not covered in the First Stage (e.g., formulation or manufacturing process patents).
The brand manufacturer may negotiate with the generic or biosimilar maker before the drug is priced in the NHI Drug Price Standard. Reporting to the MHLW is mandatory, but reaching an agreement is not. Patent litigation can still arise even after the drug price is listed, and in some cases, lawsuits may be filed to prevent price listing altogether.
If you are planning to register a generic or biosimilar in Japan, consult with GRP team of regulatory and patent expert to help.
Conclusion
To avoid major delays in your generic or biosimilar registration in Japan and navigate successfully the Japan’s regulatory and patent landscape, we recommend you to contact Global Regulatory Partners team legal and regulatory experts for guidance before starting the registration process of your generic or biosimilar in Japan.
GRP Japan
If you are interested in registering your products in Japan, GRP is ready to help. Our team of experts can simplify the process of registering products in Japan.
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Email: info@globalregulatorypartners.com
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References
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.