Publications

Biosimilar and Generic Drug Companies Benefit from Patent Related Amendments to the USMCA

January 22, 2020

It is very likely the U.S. President will soon sign the newly amended United States-Mexico-Canada Agreement (USMCA), which is intended to replace NAFTA. Mexico has already ratified the amended USMCA and Canada is expected to ratify soon. This trade agreement has important implications for intellectual property rights and the recent amendments will especially have an impact on the biopharma industries.

While biologics in the United States currently enjoy 12 years of marketing exclusivity protection, Canada provides for only eight years, and Mexico provides five years of exclusivity. Earlier drafts of the USMCA would have extended the exclusivity of biologics in Canada and Mexico to ten years. The new amendments to the USMCA will leave the individual country’s exclusivity terms unchanged. This allows Congress to further debate the exclusivities provided under current U.S. law without being constrained by a trade agreement, which is part of the larger debate in the United States on drug pricing.

The amendments also removed language requiring parties to confirm that their patents would be available for new uses of known products. The original provision helped to ensure patent evergreening strategies (drug companies patenting new uses for known products). The removal of this provision again allows Congress to make changes to U.S. law that it believes are necessary to address this issue.

Lastly, the original language of the USMCA provided for three extra years of exclusivity for clinical information submitted in connection with new uses of previously approved products. This provision would have further delayed generic access to the market. With its removal, that extra hurdle for generic competition has been eliminated.

  • share with
Name Title Direct Dial Vcard
Braginsky, Philip Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice 212.216.8065 VCard

Privacy Policy

We have updated our privacy policy. Click here to view.

I agree