Data protection upheld for subsequently approved combination drugs containing new chemical entities: Federal Court finds Minister of Health’s decision to deny generic ANDS filing is reasonable

Summary

On July 24, 2020, the Federal Court dismissed an application for judicial review brought by Natco Pharma (Canada) Inc. (Natco) in respect of a July 26, 2019 decision (Decision) by the Minister of Health (Minister).  The Decision refused to accept Natco’s ANDS filing using Gilead Sciences Canada Inc.’s (Gilead) product DESCOVY as the Canadian Reference Product.  DESCOVY contains a combination of tenofovir alafenamide (TAF) hemifumarate and emtricitabine.  The Minister determined that TAF is a new chemical entity first approved in another Gilead drug product GENVOYA.  GENVOYA is a designated “innovative drug” in respect to TAF pursuant to the data protection provisions of the Food and Drug Regulations, CRC, c 870 (Data Protection Regulations).  Because DESCOVY contains TAF, it benefits from the same data protection term granted to GENVOYA.  The Natco ANDS, which was submitted for filing before the end of the six year “no file” period, was therefore properly refused by Health Canada.

Background

GENVOYA and DESCOVY are both fixed-dose combination drugs marketed by Gilead for the treatment of HIV.  GENVOYA contains a combination of four medicinal ingredients including TAF. Health Canada issued a Notice of Compliance (NOC) for GENVOYA on November 27, 2015 and added it to the Register of Innovative Drugs in respect to the medicinal ingredient TAF. The six year “no file” date expires on November 27, 2021 and data protection ends on May 27, 2024.

Health Canada issued an NOC for DESCOVY on April 29, 2016. DESCOVY also contains TAF and was included on the Register of Innovative Drugs listing for GENVOYA as a “drug containing the medicinal ingredient” TAF.  Accordingly, DESCOVY benefitted from the same data protection term as GENVOYA.

Minister of Health’s Decision

Before the Minister, Natco initially argued that TAF was not an eligible medicinal ingredient under the Data Protection Regulations, but subsequently switched its approach to argue that its ANDS filing was not barred because the Canadian Reference Product DESCOVY was not an “innovative drug” and thus not subject to any data protection.  The Minister rejected Natco’s submission finding that DESCOVY properly benefited from the data protection term for GENVOYA in order to protect the new chemical entity TAF.  Natco sought judicial review.

The Minister’s Decision is Reasonable

There was no dispute between the parties that GENVOYA was an “innovative drug”.  Mr. Justice McHaffie for the Federal Court held that Health Canada’s Decision that Natco’s comparison to DESCOVY triggered the data protection provisions was reasonable including: (i) its assessment of the relevant treaty obligations that the Data Protection Regulations are intended to implement, and (ii) its explanation on how Natco made a “direct or indirect comparison” that triggered the regime.  The application was therefore dismissed.

Norton Rose Fulbright Canada LLP represented Gilead Sciences Canada Inc. in this application.

Link to decision: Natco Pharma (Canada) Inc v Minister of Health and Attorney General of Canada and Gilead Sciences Canada Inc, 2020 FC 788