Section 5(1.1) of the NOC Regulations does not apply to innovative drugs containing public domain medicines.
The appellant developed a cancer-fighting drug containing paclitaxel, a medicine in the public domain.
The respondent held patents for specific formulations and uses of paclitaxel.
The appellant applied for a Notice of Compliance (NOC) as a new drug, not relying on the respondent's data.
The Minister issued the NOC.
The respondent sought to quash the NOC, arguing that under s. 5(1.1) of the Patented Medicines (Notice of Compliance) Regulations, the mere presence of paclitaxel triggered a statutory freeze.
The Supreme Court of Canada held that s. 5(1.1) does not apply to innovative drugs but is confined to generic copies.
The Minister was entitled to issue the NOC without subjecting the appellant to the statutory freeze.
Bristol‑Myers Squibb Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533, 2005 SCC 26