In a recent decision, the Federal Court upheld the decision of Health Canada in refusing to accept Natco Pharma’s abbreviated new drug submission (ANDS) for a generic version of DESCOVY, a drug marketed by Gilead Sciences Canada in the treatment of HIV/AIDS. In its ANDS, Natco compared its generic to DESCOVY, which comprises the same medicinal ingredients but is considered not an “innovative drug”, avoiding reference to Gilead’s innovative drug GENVOYA. Health Canada found that because GENVOYA also included these same ingredients, Natco’s reference to DESCOVY indirectly compared the generic to GENVOYA, thereby prohibiting Natco from obtaining its ANDS because of the data protection provisions of the Food and Drug Regulations (the “Regulations”).
This decision provides guidance as to the meaning of “on the basis of a direct or indirect comparison” under the data protection provisions of the Regulations.
The Regulations require a manufacturer obtain regulatory approval from Health Canada before marketing a drug product in Canada. The manufacturer submits either a New Drug Submission (NDS) or an ANDS. In an NDS, the submission must include drug efficacy and safety data, while in an ANDS, the submission may simply show that the drug is pharmaceutically equivalent to an approved drug for which this data has been previously provided.
To comply with Canada’s treaty obligations, the Regulations state that where a manufacturer makes a “direct or indirect comparison” between its generic and an innovative drug (i.e. referencing the innovative drug to rely on the data that supported its Notice of Compliance (“NOC”)), the manufacturer may not file an ANDS within six years from the innovator’s approval for the innovative drug, and the Health Minister shall not approve the ANDS and issue a NOC within eight years from approval for the innovative drug.
Data exclusivity only applies to an “innovative drug” as defined in the Regulations - a drug that contains a medicinal ingredient not previously approved in a drug, which is not a variation of a previously approved ingredient. Health Canada maintains a Register of Innovative Drugs listing drugs that are eligible for data protection pursuant to the Regulations.
Health Canada’s Decision
Gilead manufactures two approved drug products for the treatment of HIV/AIDS which are marketed in Canada: DESCOVY and GENVOYA. Although the medicinal ingredient TAF is listed in the Register of Innovative Drugs for the innovative drug GENVOYA, that entry also lists DESCOVY as another drug containing the medicinal ingredient. In fact, Gilead had applied for both drugs to be listed uncertain of which would be granted first. Gilead provided drug efficacy and safety data in its submission for approval for GENVOYA, and in its DESCOVY submission, included bioavailability studies for DESCOVY compared to GENVOYA.
Natco filed an ANDS seeking regulatory approval for a generic version of DESCOVY. Health Canada refused to accept Natco’s ANDS, concluding that it was prohibited under the data protection provisions of the Regulations because it indirectly compared to GENVOYA, the innovative drug. Natco responded that GENVOYA was not an innovative drug, and that even if it was, DESCOVY was not. It also argued that it was seeking approval on the basis of a direct comparison to DESCOVY, and made no comparison to GENVOYA as a reference product. Accordingly, Natco claimed the ANDS was not precluded by the data protection provisions.
In its final decision, Health’s Canada confirmed GENVOYA was an innovative drug properly granted data protection under the Regulations. In reply to Natco’s argument that no comparison was made in its ANDS to GENVOYA, Health Canada referred to the intent of the data protection provisions in the Regulations to implement treaty obligations under certain trade agreements. Specifically, it noted that a combination drug containing a medicinal ingredient that was the basis for a previous “innovative” drug designation, i.e. a new chemical entity, will also benefit from any term of the data protection for the innovative drug that is still in effect. Health Canada also noted that Gilead’s reliance on the data for GENVOYA in the approval for DESCOVY further supported DESCOVY’s protection under the same data protection terms. As a result, DESCOVY also benefitted from the same period of data protection.
The Federal Court Affirms Health Canada
The Federal Court considered Health’s Canada analysis, applying the reasonableness standard of review as required by Vavilov. The Court held that Health Canada’s assessment of the intent of the data protection in view of treaty obligations was reasonable, and observed that the “trigger” for an ANDS prohibition under the Regulations is a direct or indirect comparison to an innovative drug. The Court considered a theoretical situation in which DESCOVY had been approved based on independently filed studies, and not in comparison to, or reliance on, the data that underlay the GENVOYA approval. If that had been the case, GENVOYA’s innovative drug data protection terms would not have applied, and Natco’s ANDS would have been allowed.
The Court also observed that while the presumption of consistent expression usually results in the same language appearing in the same or related legislation having the same meaning, in this case the meaning of “direct or indirect comparison” varied as between the Regulations and the Patent Medicine (Notice of Compliance) Regulations as a result of their respective regulatory contexts.
The Court concluded that Natco’s ANDS submission comparing its drug to DESCOVY made an “indirect comparison” to GENVOYA, the innovative drug, rendering Health Canada’s decision to prohibit the ANDS reasonable.
This decision confirms that the phrase “direct or indirect comparison” to an innovative drug in the data protection provisions of the Regulations will likely mean a manufacturer’s comparison to a drug product that was previously compared to an innovator product for approval, will render the manufacturer’s ANDS submission prohibited. Innovative drug manufacturers may rest assured that data provided during the drug approval process in Canada is robustly protected.