Decision Of Minister Of Health Rejecting ANDS Upheld (Intellectual Property Weekly Abstracts - Week Of February 20, 2017)

PATENT DECISIONS

Decision of Minister of Health Rejecting ANDS Upheld

Apotex Inc. v. Canada (Health), 2017 FC 127

Drug: protesterone

Apotex sought judicial review of a decision of the Minister of Health that had the effect of rejecting its Abbreviated New Drug Submission (ANDS) for progesterone capsules. Health Canada had issued a Notice of Non-compliance (NON) with respect to the ANDS. It then issued a NON-W. Apotex filed for reconsideration of the NON-W and asked that the matter be determined by an external panel. An internal panel was convened. The chair of the panel circulated notes for a decision to the panel members. The panel then held a meeting with representatives of Health Canada and Apotex. The panel issued a report rejecting the reconsideration and recommending that the NON-W be upheld.

Apotex made subsequent attempts to obtain a reconsideration. The Court held it was unreasonable in fact and an error of law for Apotex to think that a further reconsideration could be granted. It was unreasonable to confuse a polite negative response with a positive expectation of further reconsideration. However, the Court also held that Apotex was on the horns of a dilemma, as if a judicial review was filed, any reconsideration or hope thereof would end. Thus, the Court granted Apotex an extension of time to start the Judicial Review.

Apotex sought judicial review on grounds of procedural fairness. The Court held that the exercise engaged in by the panel was detailed, technical and based on expert knowledge. There is no hard and fast rule that an external panel is needed for a reconsideration. Furthermore, the Court held that it is one thing to make notes and sketch potential conclusions, as here, and another to arrive at a hearing with a draft decision ready to be signed.

In addition, the Court held that the panel was entitled to stay up to date on what was known in the art. Apotex could have done its own research with its consultants. Furthermore, Apotex did not request an extension of time to deal with what they now say is new evidence. Procedural unfairness must be raised with the first instance forum. Thus, the Court held that there was no breach of natural justice or procedural unfairness. Furthermore, the decision was reasonable. Thus, the judicial review was dismissed.

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