The Federal Court of Appeal took the occasion of an appeal of the order of the Patented Medicines Prices Review Board (the “Board”) that required a patentee to share reports on medicines that were no longer under patent, to reaffirm the jurisdiction of the Board.
Courts have consistently held that the Board’s jurisdiction is limited to patented medicines and does not extend to medicines for which the patent has expired.[1]
The Board ordered Galderma Canada Inc. (“Galderma”) to provide reports on sales for six years after the patent had expired.
Galderma had provided the reports while the medicine was under patent. It refused to do so for years after the patent had expired.
The Federal Court of Appeal set out the Board’s jurisdiction:
The Constitution, the Patent Act and the jurisprudence under each is clear: the Board does not have any freestanding consumer protection or general price regulation mandate. … Absent an emergency, national concern, or some other specific source of federal power, none of which apply here, freestanding consumer protection and general price regulation are provincial responsibilities.[2]
The Federal Court of Appeal described the Board’s order forcefully as follows:
By making that order, the Board crashed through the constitutional, statutory and jurisprudential guardrails.[3]
The Attorney General sought to defend the Board’s decision by noting that the same active ingredient was in a use patent, also owned by Galderma, for another medicine, albeit in a different concentration. The Federal Court of Appeal noted that since the patent had expired, Galderma no longer had market power over the medicine at issue. One could not stretch the subsequent use patent to encompass the use of the medicine.
The Federal Court added some acknowledgement of the Board’s role:
The Board has an important mandate. Given the importance of that mandate, the Board is dedicated and enthusiastic about pursuing it. That’s worthy of praise. But the Board must temper its dedication and enthusiasm with a firm and unwavering obedience to legality and the rule of law. Like all administrative decision-makers, the Board must stay within the constraints imposed by the Constitution, its governing statute (the Patent Act, interpreted reasonably in the administrative law sense), and the jurisprudence under each.[4]
The conclusion was that the Board’s order was quashed.
The case reminds us that however important an administrative body might feel its work is, it can only act within its jurisdiction.
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[1] See Galderma Canada Inc. v. Canada (Attorney General), 2024 FCA 208 at para 5 citing Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2021 FCA 157, [2022] 1 F.C.R. 153; Merck Canada Inc. v. Canada (Attorney General), 2022 QCCA 240; Innovative Medicines Canada v. Canada (Attorney General), 2022 FCA 210 at para. 19; Canada (Attorney General) v. Sandoz Canada Inc., 2015 FCA 249, 390 D.L.R. (4th) 691 at para. 26; ICN Pharmaceuticals Inc. v. Patented Medicine Prices Review Board (1996), 66 C.P.R. (3d) 45, 108 F.T.R. 190, aff’d [1997] 1 F.C. 32, 119 F.T.R. 70 (C.A.); Manitoba Society of Seniors Inc. v. Canada (Attorney General) (1991), 77 D.L.R. (4th) 485, 70 Man. R. (2d) 141 (Q.B.).
[2] See Galderma Canada Inc. v. Canada (Attorney General), 2024 FCA 208 at para 7 citing Re: Anti-Inflation Act, [1976] 2 S.C.R. 373, 68 D.L.R. (3d) 452.
[3] See Galderma Canada Inc. v. Canada (Attorney General), 2024 FCA 208 at para 10.
[4] See Galderma Canada Inc. v. Canada (Attorney General), 2024 FCA 208 at para 19.
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