On July 24, 2020, Justice McHaffie of the Federal Court dismissed Natco’s application for judicial review, finding that Health Canada’s refusal to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir alafenamide hemifurate (TAF) / emtricitabine product in view of data protection was reasonable: Natco v Minister of Health and Gilead, 2020 FC 788. Specifically, the Federal Court found that it was reasonable for Health Canada to find that data protection precluded the filing of Natco’s ANDS for a drug making a comparison to Gilead’s drug (DESCOVY), which has a medicinal ingredient (TAF) in an innovative drug (GENVOYA), on the basis that Natco made an indirect comparison to GENVOYA.
GENVOYA and DESCOVY
Gilead markets GENVOYA, which contains 4 medicinal ingredients, including TAF and emtricitabine.
Health Canada considers GENVOYA to be an innovative drug under the Food and Drug Regulations (Regulations), as it was the first drug containing TAF approved by the Minister of Health.
Innovative drugs benefit from the following data protection provisions as regards to subsequent submissions making a direct or indirect comparison to the innovative drug:
- a “no file” period of six years (s. C.08.004.1(3)(a)); and
- a “data protection” or “market exclusivity” period of eight years (s. C.08.004.1(3)(b)), which is lengthened to eight years and six months if certain conditions are met regarding clinical trials involving pediatric populations (s. C.08.004.1(4)).
Gilead also markets a drug called DESCOVY, which contains only TAF and emtricitabine.
Natco filed an ANDS comparing its TAF / emtricitabine product to DESCOVY before the expiry of the six-year “no file” period for GENVOYA, November 2021.
The decision under review
Health Canada refused to accept Natco’s ANDS, on the basis that DESCOVY was protected under the data protection term for GENVOYA because it contains TAF. Specifically, Health Canada decided that a combination product containing a medicinal ingredient (or “new chemical entity”) that was the basis for an “innovative” drug designation will also benefit from the term of data protection for the innovative drug that is still in effect. The treaty obligations to protect data “necessarily extend to these additional products also containing the same new chemical entity during the data protection term for the original innovative drug”.
The Federal Court decision
The Federal Court found Health Canada’s decision was reasonable:
- Health Canada’s analysis considering the intent of the Regulations and obligations under trade agreements instituting the data protection provisions was entirely reasonable. The data protection provisions are not limited to a generic version of the innovative drug.
- While the intent of the regulations and context of trade agreements are relevant and important, they cannot override the text of the provisions. Health Canada had not first assessed whether the circumstances involved a “direct or indirect comparison” to an innovative drug, which was the critical triggering mechanism.
- Although Health Canada’s analysis “skips a step”, the Federal Court considered reasons given by Health Canada in “further support”, and found them to be “determinative”. Specifically, Health Canada stated that “the data to support DESCOVY were based on comparative bioavailability studies for DESCOVY compared to GENVOYA”, and that “the reliance on the data for GENVOYA in the approval of DESCOVY further supports the position that DESCOVY is properly protected under the same data protection term”.
The Court was satisfied that this passage can be fairly read as Health Canada making the determination that Natco’s ANDS indirectly compared its drug to GENVOYA.
The Court therefore dismissed the application for judicial review. Natco may appeal as of right.