PhRMA | 26 November 2018
Comments on negotiating objectives for a US-Japan trade agreement
- Promote Adequate and Effective Protection of American Medical Innovation
As the Administration considers objectives for negotiations, ensuring that Japan continues to encourage and value innovation will significantly contribute to greater opportunities for trade and investment and improve U.S. biopharmaceutical competitiveness. Such commitments should appropriately recognize and reward the value of innovative medicines, provide due process, embrace science-based decision-making, reflect international best practices and norms, and uphold 21st century-level IP standards. These commitments are critical features of U.S. law. To this end, the innovative biopharmaceutical industry encourages the U.S. Government to pursue a trade agreement with Japan that meets the following robust negotiating objectives:
• Build on the Strong IP Standards in the USMCA: These trade negotiations between the United States and Japan – two of the most innovative countries in the world – offer a unique opportunity to establish ambitious IP provisions to protect and provide effective enforcement mechanisms for inventions from each country. The recently concluded negotiations with Canada and Mexico resulted in an agreement that includes high-standard IP protections that, if included and enhanced in a U.S.-Japan trade agreement, would address several of the deficiencies in Japan’s IP regime, including the lack of formal early and effective resolution mechanisms for patent disputes, the need to provide patent term adjustments in the event of patent office delays and the extension of the grace period in Japan from 6 to 12 months.
In addition, the negotiations with Japan offer an opportunity to ensure Japan protects regulatory test data against reliance and disclosure for a sufficient period of time. Regarding biologics, for example, Japan’s system of post-marketing surveillance currently has the effect of providing protection that is similar to 8 years of regulatory data protection (RDP). RDP complements patents on innovative medicines and provides critical incentives for investment in new treatments and cures. RDP is particularly critical for biologic medicines, which may not be adequately protected by patents alone. Because they are often made through the use of living organisms, biologics are so complex that it is possible for follow-on manufacturers to produce a version, “biosimilar,” of the original biologic that may not be covered within the scope of the innovator’s patent. For this reason and others, U.S. law provides 12 years of RDP for biologics. This was not an arbitrary number, but rather the result of careful consideration and considerable research on the incentives necessary to ensure biopharmaceutical innovators and the associated global scientific ecosystem are able to sustainably pursue groundbreaking biomedical research. Consistent with U.S. law and the negotiating objectives prescribed by the Bipartisan Congressional Trade Priorities Act of 2015 (TPA), the proposed trade agreement should require Japan to implement a RDP system that provides at least 12 years of RDP for biologics.
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