BIO Submits Comments on USTR's 2022 Special 301 Review
January 31, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing. We hope our contribution will assist the United States Trade Representative’s (USTR) efforts in strengthening President Biden’s Build Back Better agenda by preserving strong intellectual property (IP) protections for United States’ innovators, companies and workers internationally.
The annual Special 301 Review presents a key opportunity for the U.S.-based innovative biotechnology research community to share with USTR and the broader U.S. Government interagency stakeholders the main intellectual property (IP) challenges in trading partner countries abroad that harm the competitiveness of our member companies and their workers. The examples provided throughout this submission of the absence of adequate and effective protection of U.S. IP rights serve to illustrate how the ability of U.S.-based biotech enterprises, collectively employing over 1.87 million workers in the United States,1 that rely heavily on their IP rights to export and operate overseas is frustrated by certain policies put in place by key trading partners.
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on…
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how…
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The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing. We hope our contribution will assist the United States Trade Representative’s (USTR) efforts in strengthening President Biden’s Build Back Better agenda by preserving strong intellectual property (IP) protections for United States’ innovators, companies and workers internationally.
The annual Special 301 Review presents a key opportunity for the U.S.-based innovative biotechnology research community to share with USTR and the broader U.S. Government interagency stakeholders the main intellectual property (IP) challenges in trading partner countries abroad that harm the competitiveness of our member companies and their workers. The examples provided throughout this submission of the absence of adequate and effective protection of U.S. IP rights serve to illustrate how the ability of U.S.-based biotech enterprises, collectively employing over 1.87 million workers in the United States,1 that rely heavily on their IP rights to export and operate overseas is frustrated by certain policies put in place by key trading partners.