ONCA Permits Pleading Amendments Asserting Validity Of Previously Invalidated Patent Following Nexium Decision

This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi's blockbuster ramipril drug.

Apotex's claims in this action are linked to the invalidity of Canadian Patent No. 1,341,206 (206 Patent). The 206 Patent had previously been invalidated based on the application of the "promise doctrine". In June 2017, the Supreme Court of Canada (SCC) held that the invocation of the "promise doctrine" was an error in law and abolished the doctrine once and for all in AstraZeneca Canada Inc. v. Apotex Inc. (Nexium). This decision of the ONCA reverses a lower court decision denying Sanofi's pleadings amendments, which asserted that the underlying decision invalidating the 206 Patent was based on wrong legal principles, and relied on the Nexium decision.

This is a significant development in this case which also highlights a growing tension between decisions of the Federal Court and the Ontario Superior Court in a novel legal proceeding.

Background

In this action Apotex claims damages pursuant to three statutes: An Act concerning Monopolies, and Dispensation with penal laws, etc., R.S.O. 1897, c. 323 (Ontario Statute of Monopolies); An Act concerning Monopolies and Dispensations with Penal Laws, and the Forfeitures thereof, 1624, 21 Jac. I, c. 3 (UK Statute of Monopolies, and collectively with the Ontario Statute of Monopolies, the Monopolies Acts); and the Trade-marks Act, R.S.C., 1985, c. T-13. While the Patented Medicines (Notice of Compliance) Regulations (the Regulations) provide a specific remedy for delayed generic market entry pursuant to section 8, and despite Apotex having already received $215 million in section 8 compensation, Apotex commenced this novel action in the Ontario Superior Court claiming additional sums under the Monopolies Act and Trade-Marks Act.

Following the SCC's rejection of the promise doctrine in Nexium, Schering and Sanofi-Aventis et al. (Defendants) sought to amend their pleadings, which Apotex opposed on the basis of issue estoppel. The motions judge denied the Defendants' amendments, as we previously reported.

The amendments assert the validity of the 206 Patent, which was previously held to lack utility in both PM(NOC) proceedings and in a subsequent infringement action. Both cases predated the abolition of the promise doctrine by the SCC in the Nexium decision, reported here. The ONCA found...