Since its inception, the Canadian patent linkage system structured by the Patented Medicines (Notice of Compliance) Regulations has been subject to much criticism by the innovative pharmaceutical industry, the generic manufacturing industry, Canadian courts and legal practitioners. Among other things, it has been described by courts as "a minefield for litigants and counsel" creating "litigation wars" between pharmaceutical innovators and generic drug manufacturers. Its statutory damages scheme has also been qualified as being inherently inconsistent.
Considering recent developments in regard to Canadian international obligations for the pharmaceutical industry, there is an opportunity to look more closely at Canada's regime and find solutions to the system's current flaws that only Parliament can address and rectify. A new balanced and efficient patent linkage system will ensure predictability and finality of outcomes for both the innovative pharmaceutical industry and generic drug manufacturers. At the very least, we hope that our proposal will invite further debate for crafting a better patent linkage system in Canada.
