Reports Say Administration May Agree to Democrats' Demands on USMCA Biologic Patent Rules

Trade representatives for Canada and Mexico met last week over the ratification and implementation of the United States—Mexico–Canada Agreement (USMCA), and press reports say that the Trump administration is considering acceding to Democrats’ demands to reduce patent protections for reference biologics in order to get the pact through Congress.

The USMCA was signed by the 3 countries on November 30, 2018, ostensibly as a replacement for the original North American Free Trade Agreement (NAFTA), just weeks after Democrats took control of the House of Representatives.

The biosimilars industry has been working since earlier this year to convince legislators to join them in opposing a pharmaceutical intellectual property provision in the USMCA. Currently, the provision would give 10 years of marketing exclusivity for biologic drugs.

Under US law, the period of exclusivity is 12 years; Democratic leaders in the House of Representatives want the time reduced to fewer than 10 years, possibly to 8 years.

Canada’s current exclusivity period for biologics is 8 and Mexico’s is 5, meaning that US biosimilar exports would have to wait longer if the additional timeframe in the USMCA passes.

The Association for Accessible Medicines has said that the USCMA will hinder generic and biosimilar competition, particularly as the manufacturing process for biosimilars becomes more efficient.

Mexico’s trade negotiator, Jesús Seade, spoke optimistically about the possibility of a deal on Twitter after the meeting with Canada, and was also said to have met with the US trade representative.

In the United States, the regulatory exclusivity provisions of the Biologics Price Competition and Innovation Act (BPCIA) already provide for a longer exclusivity period than required by the USMCA; the BPCIA provides 4 years of data exclusivity and 12 years of marketing exclusivity for reference biologic products

Representative Jim Himes, D-Connecticut, told The Wall Street Journal this week that a deal before Christmas is possible. But Senator Chuck Grassley, R-Iowa, chairman of the Senate Finance Committee, said that if a deal is not reached this week, he does not see how a 2019 ratification is possible.

Innovator biotechnology firms and pharmaceutical industry groups, such as the Biotechnology Innovation Organization, known as BIO, and the Pharmaceutical Research and Manufacturers of America, known as PhRMA, approve of the intellectual property language currently in the agreement.