Heath Canada Reasonable In Finding Natco's Indirect Comparison To GENVOYA Triggered Data Protection

• Published date: 28 August 2020
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Privacy, Data Protection, Food and Drugs Law
• Law Firm: Smart & Biggar
• Author: Ms Katie Lee

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's product

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:

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