On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and Innovation Act (BPCIA) to ten years. According to The Wall Street Journal, the Trump administration is considering the change in order to persuade Democrats to support the U.S.-Mexico-Canada Agreement (USMCA), a replacement for the North American Free Trade Agreement (NAFTA), that the administration negotiated last year. The USMCA would establish at least a 10-year data exclusivity period for biologic drugs, which would double the exclusivity period in Mexico and increase the exclusivity period in Canada by two years.

As Patent Docs readers may recall, the data exclusivity period in the BPCIA (and prior biosimilars legislation packages) was a hotly contested topic of debate, with some supporting a 14-year period, the Obama administration preferring a 7-year period, and others calling for a 5-year period (see "Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term"; "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements"; "Senators Send Letter on Biosimilars to FDA"; "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not"; and "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements").