Abbott v. Canada/Minister of Health; appeal of a listing decision; 2008 FCA 354; Meridia (sibutramine); November 17, 2008

The Court of Appeal upheld the decision of the trial judge and dismissed Abbott's appeal. As a result, the patent at issue was not added to the Patent Register.

The Court set a new standard of review of the Minister's decisions in such cases. The Court held that in cases regarding use patents, the Minister should determine first what use is claimed by the patent; then determine what use is approved by issuance of a NOC; and finally, determine whether the claimed use is an approved use.

In construing the patent, the Minister's decision should be reviewed on the standard of correctness. However, when determining the use approved by the existing NOC, this is a question of fact to be reviewed on a standard of reasonableness, due to the particular expertise of the Minister. With respect to the third question, as it relates to an application of the law to the facts, the factual component must be reviewed on a standard of reasonableness. However, the legal component of the question which relates to the interpretation of the Regulations must be reviewed on the standard of correctness.

Furthermore, the Court of Appeal upheld the trial judge's decision with regard to the use of evidence at the application stage. The general rule in an application for judicial review is that the record before the Federal Court should not include any documentary evidence that was not before the maker of the decision being reviewed. However, when dealing with a point of patent construction, it could be helpful for the judge to have the benefit of a formal expert opinion on construction in the form of an affidavit. Thus, the trial judge should have the discretion to admit such an affidavit.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2008/2008fca354/2008fca354.html