Under the Patented Medicines (Notice of Compliance) Regulations (the Regulations), the Minister of Health (the Minister) determines whether a generic manufacturer’s drug submission makes either a direct or indirect comparison to a Canadian reference product (a brand product). If the Minister finds that it does reference a brand product, the generic manufacturer will be required to address the patents listed on the Patent Register for the brand product before it can receive a Notice of Compliance (NOC), which is a regulatory requirement for market entry.

On October 12, 2016, the Federal Court of Appeal, in reversing the decision of the Federal Court, upheld two decisions of the Minister to issue NOCs to generic drug manufacturers without having to address the Patent Register based on the Minister’s finding that no comparison had been made.

The appeal decision clarifies that the Minister’s decision under the Regulations are to be reviewed on a standard of reasonableness, which is in contrast to earlier decisions of the Supreme Court of Canada that applied a standard of correctness. The Federal Court of Appeal (and the Federal Court) found that these earlier decisions were not binding since they were made prior to the presumption of reasonableness set out in more recent Supreme Court of Canada decisions.

The Federal Court of Appeal held that the presumption applies in situations where an administrative decision-maker is interpreting its home statute or those “closely connected to its function” and disagreed with the Federal Court that the presumption had been rebutted since:

  1. there was no evidence that it was Parliament’s intention that a less deferential standard of review should apply; and
  2. the role of the court in the Regulations was not inconsistent with a reasonableness review.

For an electronic version of the decision, see: http://tinyurl.com/z78jogv

Summary by: Thomas Wong  

E-TIPS® ISSUE

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