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Federal Court of Appeal refuses to grant stay of Federal Court decision remanding Health Canada’s refusal of SHINGRIX CSP

The Federal Court of Appeal recently dismissed a motion brought by the Minister of Health (the Minister) for stay of a judgment of the Federal Court (see our article here) that held Health Canada’s refusal to issue a Certificate of Supplementary Protection (CSP) in respect of Canadian Patent No. 2,600,905 (905 patent) and SHINGRIX was unreasonable: Canada (Health) v GlaxoSmithKline Biologicals SA, 2020 FCA 135. A motion brought by GlaxoSmithKline Biologicals SA (GSK) for an expedited hearing was also granted.

Health Canada viewed the claims of the 905 patent as formulation claims because they included an adjuvant in addition to an antigen and therefore ineligible for a CSP. Its decision was held to be unreasonable for failing to take appropriate account of Canada’s commitments under the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) and the full scope and purposes of the applicable CETA provisions. The Federal Court did not order the issuance of the CSP but rather ordered the matter be redetermined by Health Canada. The Minister appealed the judgment and subsequently filed the motion at issue in this decision.

To stay the Federal Court’s judgment, the Minister was required to establish that (1) there was a serious issue to be tried, (2) there would be irreparable harm if the stay was not granted, and (3) the balance of convenience favoured granting the stay. The Notice of Appeal set out several grounds for appeal, including that the Federal Court improperly applied the reasonableness standard and erred by interpreting the relevant provisions of CETA de novo. GSK accepted that the issues raised in the appeal met the standard of a serious issue and the Federal Court of Appeal agreed. To establish irreparable harm, clear and non-speculative evidence must be adduced that irreparable harm will follow. The Minister argued: (i) if a CSP is issued, the appeal may be rendered moot, denying the opportunity to obtain guidance from the Court; (ii) if the Court declines to hear the appeal because it is moot, Canadians would be denied the opportunity to pay lower prices for biosimilar versions of SHINGRIX during the two-year term of the CSP; (iii) if the appeal was granted after a CSP issues, the revocation of a CSP issued in error would be difficult and uncertain; and (iv) there is a risk that contradictory decisions would compromise the public interest in the integrity of the Minister’s decision-making authority and the certainty and predictability of the CSP regime. The Federal Court of Appeal held that the Minister had provided no concrete evidence that any irreparable harm would be suffered: the evidence included hearsay evidence and was speculative. The third step of the test, the balance of convenience, therefore, did not need to be considered.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation group.

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