Canada:
Amendments To USMCA Remove 10-Year Data Protection Requirement For Biologics
26 December 2019
Smart & Biggar
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On December 10, 2019, the parties to the Canada-United
States-Mexico Agreement (commonly referred to as USMCA, or the new
NAFTA) signed amendments (see summary of revised outcomes) to the Agreement.
The original USMCA was signed November 30, 2018; for details, see
our previous article here. 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 ten 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.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
directly.
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