The Implications Of USMCA For Biologic Innovation

Law360 (February 11, 2020, 3:04 PM EST) -- On Jan. 29, President Donald Trump signed the United States-Mexico-Canada Agreement into law, which superseded the North American Free Trade Agreement. The USMCA contains a number of key and last-minute revisions that implicate protections for biologic medicines and patent obligations.

The first of these revisions concerns market exclusivity for new biologic medicines. Canada provides eight years of exclusivity for biologic medicines, meaning a biosimilar version of an innovator biologic cannot be approved by the country’s governing regulatory agency for eight years following the approval of the innovative biologic medicine.

Mexico only provides five years of exclusivity for small-molecule drugs (i.e. new...

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