Attorney General of Canada v. Alexion Pharmaceuticals Inc.

(Federal) (Civil) (By Leave)

(Certain information not available to the public)


Administrative law - Judicial review, Standard of review, Intellectual property - Administrative law — Judicial review — Standard of review — Intellectual property law — Patented Medicine — Pricing — Interpretation of statutes — Whether the proposed appeal raises issues of public importance concerning (1) the nature of the Patented Medicine Prices Review Board’s statutory mandate, (2) the proper approach to the international price analysis under s. 85(1)(c) of the Patent Act, and (3) the appropriate approach to review of administrative decisions for reasonableness — Patent Act, R.S.C. 1985, c. P 4, ss. 83, 85. .


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The respondent, Alexion Pharmaceuticals Inc. (“Alexion”), developed the patented medicine, Soliris. It now manufactures and markets it. Soliris is a breakthrough treatment for two rare and life threatening blood related disorders.

The Patented Medicine Prices Review Board (“Board”) held a hearing regarding the pricing of Soliris in Canada and found that Alexion priced Soliris excessively contrary to ss. 83 and 85 of the Patent Act, R.S.C. 1985, c. P 4. The Board ordered that excess revenues earned by Alexion be forfeited to the applicant.

The Federal Court dismissed Alexion’s application for judicial review, finding the Board’s decision was reasonable. The Federal Court of Appeal allowed Alexion’s appeal, set aside the judgment of the Federal Court and granted Alexion’s application for judicial review. It found that the Board’s decision was unreasonable, quashed that decision and remitted the matter to it for redetermination, with costs.