The new agreement between the US, Canada, and Mexico is to have several key impacts on intellectual property in the pharmaceuticals sector. The United States Mexico and Canada Agreement (USMCA) is the successor agreement to the North American Free Trade Agreement (NAFTA) which was agreed in 1994. It should be noted that while the deal has been struck, the agreement still needs to be ratified by all three governments.
As MAP suggested last month, the new agreement will mean that new biologics will have 10 years of patent protection in all three nations. This will not affect the US which already exceeds this threshold, but will mean the period is increased in Canada from eight years to ten and from five to ten in Mexico (Article 20.F.14, section 1).
In addition, the agreement also restricts the release of generics, and potentially biosimilars, by preventing use of a competitor’s data where it is released as part of a marketing approval submission for a period of five years. This suggests that the release of generic drugs is limited for this five year period in cases where the generics firm relies on any precedent, data, or the existence of a prior marketing authorisation to obtain it’s Market Authorisation (Article 20.F.13, section 1a).
The USMCA agreement confirms that it does not restrict the provisions of the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) regulations, so the deal does not impact matters handled under this, such as compulsory licensing.
The relevant section of the agreement is available here