On 10 December 2019 the United States, Mexico and Canada signed amendments to the US-Mexico-Canada Agreement (USMCA).(1) The original USMCA was signed on 30 November 2018 (for further details please see "USMCA versus NAFTA: what's changed and what it means for intellectual property in Canada").

Only Mexico had thus far ratified the original USMCA. Regarding pharmaceuticals, the original USMCA required a data protection term (market exclusivity) for biologics of at least 10 years from the date of first marketing approval. The recent amendments removed this provision, such that Canada can maintain its current data protection laws which provide an eight-year data protection term, with a possible six-month paediatric extension, for all pharmaceutical products, including biologics.


(1) A summary of revised outcomes is available here.

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