Direct Or Indirect Comparison: Reliance On Innovative Drug Data Key To Engaging Data Protection

• Published date: 15 August 2020
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Privacy, Data Protection, Food and Drugs Law
• Law Firm: Gowling WLG
• Author: Mr Marc Richard and Cole Meagher

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....