September 10, 2020
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In The Minister of Health v. GlaxoSmithKline Biologicals, 2020 FCA 135, the Federal Court of Appeal dismissed the Minister of Health’s motion for a stay of the judgment of the Federal Court (2020 FC 397) until the appeal of that decision is determined.
Background
GlaxoSmithKline, the owner of Canadian Letters Patent No. 2,600,905 (the “905 Patent”), sought a Certificate of Supplementary Protection (CSP") for its shingles vaccine SHINGRIX and the 905 Patent.
GlaxoSmithKline applied to the Minister of Health (the “Minister”) for a CSP to extend the expiration of the 905 Patent from March 1, 2026 to March 1, 2028. The Minister refused to issue the CSP, by way of letter dated August 3, 2018.
GlaxoSmithKline applied for judicial review of the Minister’s decision. The Federal Court allowed the respondent’s judicial review application and ordered that the matter be redetermined by the Minister on the merits in accordance with its reasons (2020 FC 397). (See our post regarding that decision here.)
The Minister appealed the decision of the Federal Court and also filed a motion for a stay of the judgment of the Federal Court until the appeal is determined, relying on paragraph 50(1)(b) of the Federal Courts Act.
Federal Court of Appeal's Analysis
The Minister was required to satisfy the tri-partite test outlined in RJR-MacDonald v Canada (Attorney General), [1994] 1 SCR 311.
The Federal Court of Appeal was satisfied that the Minister met the first threshold requirement, as the Notice of Appeal set out several grounds for the appeal.
To attempt to establish irreparable harm, the Minister tendered an affidavit from a Patent Officer employed in the Health Products and Food Branch of Health Canada.
The Minister advanced four arguments outlining why a failure to grant a stay would result in irreparable harm. The Minister argued that the appeal would be rendered moot by the issuance of the CSP, Canadians would be denied the opportunity to pay lower prices for competitors’ biosimilar versions of SHINGRIX during the two-year term of the CSP, the revocation of a CSP issued in error would be difficult and uncertain, and there would be a risk that contradictory decisions would compromise the public interest in the integrity of the Minister’s decision-making authority and in the certainty and predictability of the CSP regime.
The Federal Court of Appeal was unpersuaded and found that there was no irreparable harm. The Court held that the judgment of the Federal Court was not time-limited and did not order that the CSP be issued, and that, at best, the Minister’s evidence was hearsay and the arguments advanced in the Cann affidavit were “argumentative and speculative”.
The Federal Court of Appeal was also not persuaded that the public interest would be impacted.
As the Minister failed to demonstrate that it would suffer irreparable harm if the motion to stay were dismissed, the Federal Court of Appeal did not consider the third step of the RJR-MacDonald test, the balance of convenience. The Federal Court of Appeal granted the Minister’s motion for an expedited hearing.
Author: Jaclyn Tilak
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