Direct or indirect comparison: Reliance on innovative drug data key to engaging data protection

13 August 2020

The Federal Court recently issued its decision in Natco v Canada (Minister of Health), 2020 FC 788, providing useful guidance on the circumstances under which data protection under the Food and Drugs Regulations ("FDR") may be engaged. In particular, the Court commented on when the data protection provisions may be engaged in relation to subsequent products entering the market that contain the same medicinal ingredient as an innovative drug currently benefitting from active data protection.



Data Protection under the Food and Drugs Regulations

A drug considered to be an "innovative drug" may be eligible for data protection under section C.08.004.1 of the FDR. An innovative drug is one that contains a medicinal ingredient not previously approved in Canada. 

Data protection provides innovator manufacturers a prescribed period of market exclusivity from the date of the product's approval. During this period of market exclusivity, generic manufacturers are prevented from filing an abbreviated new drug submission ("ANDS") that makes any indirect or direct comparison to the innovative drug for a period of six-years. Moreover, the generic product may not be approved for a period of eight-years. The eight-year period may also be further extended by an additional six-months where the innovator investigates the drug's use in pediatric populations (see our previous article on the requirements to receive the pediatric extension).

Gilead's GENVOYA and DESCOVY Products

In 2015, Gilead launched its product GENVOYA, containing the medicinal ingredients tenofovir alafenamide hemifumarate ("TAF"), emtricitabine, cobicistat and elvitegravir and used for the treatment of HIV. Under the FDR, GENVOYA was the first product approved in Canada containing TAF and as such was eligible for data protection.

Subsequent to GENVOYA's approval, in 2016, Gilead launched DESCOVY. Like GENVOYA, DESCOVY contains the medicinal ingredient TAF (along with emtricitabine) and is used for the treatment of HIV.

Health Canada's Decision

Prior to the expiry of GENVOYA's data protection, Natco submitted an ANDS seeking approval for a generic TAF and emtricitabine product using Gilead's DESCOVY as the reference product. Health Canada refused to accept Natco's ANDS, in essence, on the basis that an indirect comparison was being made to GENVOYA, thus contravening the data protection provisions in the FDR.

The thrust of Natco's position was that if GENVOYA was an innovative drug, DESCOVY was not, as GENVOYA contains TAF and was approved first. Thus, while a direct comparison to DESCOVY was made in its submission, Natco asserted that no comparison to GENVOYA was made.

In reaching its decision, Health Canada reviewed the purpose and intent of the data protection provisions of the FDR, including their purpose in implementing obligations under Article 39 of TRIPS and NAFTA's Article 1711. This is reflected in the stated purpose of the FDR s. C.08.004.1(2) and in the Regulatory Impact Analysis Statement which accompanied the current version of the FDR.

Specifically Health Canada determined that "consistent with the intent of section C.08.004.1 to protect new chemical entities, other drugs containing [TAF], such as DESCOVY, also benefit from the same period of data protection". Natco therefore engaged the data protection provisions in submitting its ANDS using DESCOVY as its reference product. Health Canada noted "further support" for this in light of the fact that Gilead included comparative bioavailability studies between GENVOYA and DESCOVY in its drug submission for DESCOVY, and that Natco relied on the same data in making its comparison to DESCOVY.  

Natco subsequently sought judicial review by the Federal Court on the basis that Health Canada erred in refusing its submission.

The Purpose and Intent of C.08.004.1

The issue before the Court was whether, on a reasonableness standard, Health Canada properly interpreted and applied the data protection provisions of the FDR in refusing to accept Natco's ANDS. Following Vavilov, the modern principles of statutory interpretation apply to an administrative tribunal in the sense that a reasonable interpretation is one consistent with the text, context and purpose of the relevant provisions.

The Federal Court found it reasonable for Health Canada to deduce the purpose and intent of the data protection provisions in the context of international agreements. However, the Court was somewhat critical of Health Canada's perceived assumption that, merely because drugs contain the same medicinal ingredient, they must benefit from the same period of data protection.

The Court held the key question in determining whether the data protection provisions are engaged depends on whether an indirect or direct comparison is made to the innovative drug. Health Canada's apparent assumption, that DESCOVY was entitled to data protection because GENVOYA was so entitled, did not fully answer this question. To this point, it was GENVOYA and the data underlying its approval that is protected by the Food and Drugs Regulations. The question therefore became whether Natco's ANDS in fact made a comparison (direct or indirect) to GENVOYA.

Indeed, the Court noted that had Health Canada rejected Natco's submission solely on the basis that DESCOVY contained TAF, without assessing whether Natco's submission directly or indirectly compared its drug to GENVOYA, the decision would not have been supportable.

However, since Health Canada noted in its decision that Gilead's submission for DESCOVY included comparative bioavailability studies with GENVOYA, providing "further support" for concluding that the data protection provisions applied, the Court found as a matter of fact that Natco's ANDS made an indirect comparison to GENVOYA. As such, the data protection for GENVOYA was triggered and Natco's submission was held to be properly rejected by Health Canada.

Natco's application was therefore dismissed.

Requirements for Subsequent Products to benefit from a Pre-Existing Data Protection Term

As of August 2020, of the 280 innovative drugs with active data protection, 22 are listed to have subsequent products benefiting from the pre-existing term.

When planning to introduce a subsequent product containing the same medicinal ingredient as an innovative drug, where available, innovative manufacturers should be aware of the requirements for the product to benefit from a pre-existing data protection term. For such products, there must be a relationship between it and the innovative drug beyond the common medicinal ingredient (i.e. an indirect/direct comparison to the data underlying the innovative drug's original submission). In the case of DESCOVY, the requisite relationship was established via the bioavailability studies comparing DESCOVY to GENVOYA in its submission.


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