Natco Pharma (Canada) Inc. v. Canada (Health), 2020 FC 788 (Emtricitabine*)
Justice McHaffie - 2020-07-24
Read full decision. Automatically generated summary:
Health Canada refused to accept Natco Pharma (Canada) Inc’s abbreviated new drug submission (ANDS) for a drug that contains two medicinal ingredients, tenofovir alafenamide hemifumarate (TAF) and emtricitabine. Health Canada concluded that Natco’s ANDS was prohibited by the data protection provisions of the Food and Drug Regulations, CRC, c 870. Under those provisions, a manufacturer may not file an ANDS for a new drug “on the basis of a direct or indirect comparison between the new drug and an innovative drug” for a defined period. ... I conclude that Health Canada’s decision was reasonable. I agree with the Attorney General of Canada that Health Canada effectively concluded that Natco’s ANDS indirectly compared its drug to the innovative drug GENVOYA by comparing its drug to DESCOVY. Although it could have been expressed more clearly, a review of Health Canada’s decision as a whole makes clear that this is the nature of its conclusion. In my view, this conclusion is a reasonable, and indeed inevitable, one in the circumstances.
Decision relates to:
- T-1353-19 - NATCO PHARMA (CANADA) INC. v. MIN HEALTH & AGC & GILEAD SCIENCES CANADA INC.