As we reported, Federal Court jurisprudence is being continually reshaped by the Supreme Court’s decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (NEXIUM Decision). In Apotex v. Schering Corporation, 2018 ONSC 903, the Ontario Superior Court has now considered the impact of the NEXIUM Decision in the context of Apotex’s action for damages against Schering relating to ramipril.


This action arises from Apotex’s success both in litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations) and in a subsequent action to impeach Schering’s patent relating to ramipril (206 Patent). Both decisions were upheld on appeal. Apotex subsequently succeeded in a claim for damages under section 8 of the Regulations. It then brought the present action in the Ontario Superior Court for damages pursuant to the Trade-marks Act and Monopolies Acts, reported here.

Pleading amendments denied

Following the NEXIUM Decision, Schering brought a motion to amend its pleadings. The proposed amendments alleged that the prior decisions of the Federal Court concerning the validity of the 206 Patent would have been decided differently in light of the NEXIUM Decision (i.e., the 206 Patent would not have been invalidated on the basis of the promise doctrine). Accordingly, Apotex should not be permitted to rely on those decisions to support the present action.

The Ontario Superior Court denied the amendments, applying the doctrines of issue estoppel and collateral attack. It found that the Federal Court’s decision impeaching the 206 Patent was final. Permitting the proposed amendments would invite the parties to relitigate the patent’s validity in the present action.

The Court further found that sections 62 and 63 of the Patent Act supported the same result. Section 62 provided that a patent voided by a judgment is void ab initio against all persons and for all purposes unless reversed on appeal as provided by section 63. As the previous impeachment decision was affirmed on appeal, it had to be given effect.

No “special circumstances”

Schering and Sanofi argued that the change in the law brought about by the NEXIUM decision negated issue estoppel and collateral attack. Although the Court recognized the possibility of such a “special circumstances” exception, it characterized Nexium as a change in an aspect of the interpretation of a statutory provision rather than a change in the law. It distinguished this from prior cases which effected a change in law that was entirely common law based (for example, the law of trusts) or for which there was an intervening legislative change. Further, where the “special circumstances” pleaded to avoid issue estoppel would effectively require extensive relitigation, there are no special circumstances.


Apotex v. Schering Corporation, 2018 ONSC 903