Potentially Lethal: New NAFTA IP chapter requires 10-year biologics monopolies (worst such rule in a U.S. FTA)

The renegotiated NAFTA intellectual property text is available here.


The rules go significantly beyond the original NAFTA text in their government-sponsored patent and exclusivity protections for corporate monopoly control over needed medicines.


Their purpose is to better insulate expensive new medicines from generic competition; helping pharmaceutical corporations keep the prices of at least some new medicines higher for longer.

Canada and Mexico should be embarrassed – perhaps even ashamed – for agreeing to such terms.  At least as regards their own peoples’ access to medicines and health, Mexico and Canada have failed to stand up to North America’s neighborhood bully.

This is especially sad given it has been just three years since eleven countries including Canada and Mexico rejected many of these same ideas in the Trans-Pacific Partnership negotiations. That was a significant victory for health; this is a somewhat less pronounced defeat.

The revised rules are worse than the original NAFTA in that they require, among other harmful measures:

  • A minimum ten years of government-granted marketing exclusivity – that is, monopoly – for biologics (which include many of the most important and expensive new medical technologies). This is the worst such rule yet negotiated in a U.S. trade agreement.
  • Special marketing exclusivity periods for either new uses and forms or new combinations of older medicines. 
  • The granting of patents for at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product.
  • Offering multi-year extensions on patent terms when reviews at the regulatory or patent office take longer than terms deemed “unreasonable.” (Note that the public gets no reduction in patent terms when these processes move quickly.)
  • Linking regulatory safety and efficacy reviews to patent disputes, which can mistakenly delay generic competition.

Contact us for more information: medsaccess@citizen.org