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ARTICLE · 07 AUGUST 2017

Pharma And Biologics Disputes In Canada—Big Changes For Big And Small Molecule Litigation

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The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines...

CanadaIntellectual Property

The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines (Notice of Compliance) Regulations, which govern patent infringement and invalidity disputes involving patented medicines between "first" and "second" persons (i.e., brand v. generic and biologic v. biosimilar). The resolution of these disputes determines the timing of market approval of generic and biosimilar products. The proposed regulations are subject to a brief public consultation period until the end of July. The amendments could affect new cases starting as early as September 21, 2017, when the Comprehensive Economic Trade Agreement (CETA) that inspired the changes will likely take effect.

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