[Ip-health] US drug manufacturers want 12 years of data protection for biologics in US-Japan FTA

Nicolas Roux nicolas.bilaterals at gmail.com
Wed Dec 12 07:49:20 PST 2018


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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** 	*Nicolas Roux***
Skype: caveman3k



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