Apotex Inc., et al. v. Schering Corporation, et al.

(Ontario) (Civil) (By Leave)


Intellectual property — Patents — Medicines — Civil procedure — Pleadings — Amendments — Respondents seeking to amend pleadings after change in law allegedly affecting patent found to be invalid in previous proceedings — Under what circumstances may a change in law serve to excuse operation of res judicata, collateral attack and other preclusive doctrines? — Under what circumstances should a court infer prejudice so as to preclude availability of substantive amendments to pleadings which fundamentally alter course and progress of litigation?


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Apotex, a generic drug manufacturer, brought an action seeking treble damages pursuant to An Act concerning Monopolies, and Dispensation with penal laws, etc., R.S.O. 1897, c. 323; An Act concerning Monopolies and Dispensations with Penal Laws, and the Forfeitures thereof, 1624, 21 Jac. I, c. 3; and the Trade marks Act, R.S.C. 1985, c. T 13. Their action involved the 206 Patent for a drug called Ramipril that was held by Schering Corporation and licensed by the Sanofi respondents that had been declared invalid in a previous infringement action. The 206 Patent was declared invalid for lack of utility based upon the “promise doctrine”. Subsequently, the decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 was released in which the Court held that the promise doctrine was not the proper approach for the consideration of the utility of a patent. The basis of the decision in AstraZenca, the respondents moved to amend their statements of defence. The motion judge denied their motion. This decision was overturned on appeal and the amendments were allowed.

Lower Court Rulings

February 6, 2018
Ontario Superior Court of Justice

CV-11-429541, 2018 ONSC 903
Respondents’ motions to amend pleadings dismissed
November 8, 2018
Court of Appeal for Ontario

2018 ONCA 890, C65118, C65129
Respondents’ appeals allowed; Respondents entitled to amend statements of defence