KEI’s pre-hearing submission to the ITC on the USMCA

KEI has filed a pre-hearing statement for the International Trade Commission, “On the United States-Mexico-Canada Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors Investigation (No.TPA-105-003)”


The submission covers the following topoics:

  • Patentable subject matter for medical or surgical procedures, page 2
  • Exclusivity for biologics test data, including the application to certain cell and gene therapies, pages 2-4
  • The USMCA provisions on injunctions, page 4
  • The USMCA provisions on damages, pages 4-7
    • Even more problematic for copyright, pages 7-8
  • The USMCA agreement provisions on test data for biologic products, pages 8-9
    • Exceptions, pages 9-12
  • Copyright term, pages 12-14
  • Limits on source code disclosure requirements, pages 14-15