Indirect comparisons to an innovative drug’s data can trigger data protection provisions

On July 24, the Federal Court of Canada released its decision in a judicial review of the Minister of Health’s refusal to accept Natco Pharma (Canada) Inc.’s (Natco) abbreviated new drug submission (ANDS) for a generic version of Gilead Sciences Canada Inc’s (Gilead) drug DESCOVY. The Court held that Natco’s ANDS could not be accepted for filing until the expiry of the “no-file” period of the data protection term for another drug of Gilead, GENVOYA, because Natco indirectly compared its drug to GENVOYA, which is protected by the data protection provisions of the Food and Drug Regulations (the Regulations).

What you need to know

• Natco’s ANDS identified Gilead’s drug DESCOVY, which contains two medicinal ingredients: tenofovir alafenamide hemifumarate (TAF) and emtricitabine, as the Canadian Reference Product. DESCOVY does not have data protection under the Regulations.
• TAF is a medicinal ingredient contained in Gilead’s previously approved drug GENVOYA, which is an innovative drug subject to data protection under the Regulations.
• The data protection provisions of the Regulations prevent a manufacturer from filing a submission for a notice of compliance for six years (“no-file” period) and prevent that submission from being approved for a total of eight years (“no-approval” period). The data protection provisions are triggered if the manufacturer seeks a notice of compliance “on the basis of a direct or indirect comparison between the new drug and an innovative drug” (emphasis added).
• The regulatory approval of DESCOVY was based in part on comparative bioavailability studies for DESCOVY compared to GENVOYA.
• The Minister’s decision to refuse Natco’s ANDS until the “no-file” period of data protection GENVOYA expires was reasonable: even though Natco made a direct comparison of its drug to DESCOVY, which has no data protection, it made an indirect comparison to GENVOYA, thereby triggering the data protection provisions for GENVOYA.
• A generic version of an innovative drug is not the only product that can trigger data protection. Any product that directly or indirectly compares itself to an innovative product can trigger the data protection provisions.
• In obiter, the Court noted that a generic submission relying on independent studies and not making a “direct or indirect comparison”—which the Federal Court equated with relying on the data in the innovative product’s submission—will not trigger the data protection provisions.
• Combination drug products, particularly those involved in product line extensions, may be the subject of indirect comparisons by generic manufacturers.

Background

Natco filed an ANDS for an anti-retroviral drug containing two medicinal ingredients: TAF and emtricitabine. Natco’s ANDS compared its drug to Gilead’s DESCOVY, containing the same two medicinal ingredients. DESCOVY is not subject to data protection under the Regulations. However, TAF is contained in Gilead’s earlier-approved drug GENVOYA (along with three other medicinal ingredients). GENVOYA is an “innovative drug” under the data protection provisions of the Regulations. In reviewing Natco’s ANDS, Health Canada searched the medicinal ingredients which were the subject of the ANDS to learn whether either ingredient appeared alone or in combination on the Register of Innovative Drugs. Learning that TAF appeared on the Register as an ingredient of GENVOYA, Health Canada refused to accept Natco’s ANDS for filing until the six year no-file data protection period for GENVOYA expires. Natco sought judicial review of the refusal, arguing that it did not make a comparison to an innovative drug, and therefore, the data protection provisions do not prevent it from filing its ANDS.

Analysis

On judicial review, Justice McHaffie of the Federal Court held that the Minister’s decision was reasonable because Natco’s ANDS indirectly compared its drug to the innovative drug GENVOYA via comparison to DESCOVY. The Court noted that the six year no-file period and the eight-year data protection period under the Regulations are each triggered if a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug. The data protection provisions also contain an express purpose clause that states that the purpose of the data protection provisions is to implement provisions in the North American Free Trade Agreement (NAFTA) and the Agreement on Trade-related Aspects of Intellectual Property (TRIPS) that encourage the development of new drugs by protecting undisclosed test or other data submitted for regulatory approval in respect of a new chemical entity from disclosure or unfair commercial use. These trade agreement obligations were implemented in the Regulations by the data protection provisions.

The Court emphasized that even though the mechanism used in the data protection provisions is based on the existence of an “innovative drug”, that does not mean that the only product that can trigger the data protection provisions is a generic version of the innovative drug. Other products, including combination products that contain a different number of medicinal ingredients compared to the innovative drug can also trigger the data protection provisions, provided that a direct or indirect comparison is made between the new drug that is the subject of the regulatory submission and the innovative drug.

Equally, the Court was quick to point out that the data protection scheme requires the reliance on data; the scheme isn’t triggered because the second drug contained the presence of the new chemical entity. The Court ruled that had the decision-maker based its conclusion solely on the fact that Natco’s ANDS compared to DESCOVY and DESCOVY contained TAF, the decision-maker’s decision would have been unreasonable.

The key determinant, which the decision-maker considered in this case, is whether a drug submission relied on the data for GENVOYA in the approval of DESCOVY: “An approach that assumes data protection applies on the presence of the new chemical entity alone does not reflect the statutory scheme.” The Court noted that an approval could be based on independently filed studies and not on comparisons to, or reliance on, the data that lies at the heart of the protection. The Court explained that statements in prior decisions to the extent that the Regulations “are to protect new chemical entities” must be read with caution and in context.

The Court also stressed that a product line extension or other drug containing the same new medicinal ingredient that was the basis for the “innovative drug” designation does not necessarily invoke data protection. The trigger of a direct or indirect comparison by the manufacturer to the data associated with the innovative drug must be met. The Court was satisfied that Health Canada had determined that Natco’s ANDS indirectly compared its drug to GENVOYA because the approval for DESCOVY relied on comparative bioavailability studies for DESCOVY compared to GENVOYA. Therefore, the Court determined that the Minister’s refusal to accept Natco’s ANDS for filing until the expiration of the six-year no-file data protection period was reasonable.

What’s next?

Natco may appeal this decision to the Federal Court of Appeal by September 30, 2020.

This decision furthers an interesting trend involving Health Canada decisions where the Federal Court looks to Canada’s international obligations and purpose and policy rationale for the implementation of Canadian legislation to meet these requirements¹. Pointing Health Canada to its obligations under trade agreements may be helpful when having discussions relating to drug or other health product submission, in order to assert that a manufacturer should be afforded intellectual property protections.

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¹ See our recent bulletins:

“Health Canada instructed to reconsider scope of CSP protection for drug containing multiple active ingredients”

“Federal Court instructs Health Canada to reconsider “medicinal ingredient” in the context of CSP”

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