Apotex Inc. v. Sanofi-Aventis et al., (2015) 470 N.R. 153 (SCC)
| Judge | McLachlin, C.J.C., Abella, Rothstein, Cromwell, Moldaver, Karakatsanis, Wagner, Gascon and Côté, JJ. |
| Court | Supreme Court (Canada) |
| Case Date | April 20, 2015 |
| Jurisdiction | Canada (Federal) |
| Citations | (2015), 470 N.R. 153 (SCC);2015 SCC 20;[2015] 2 SCR 136 |
Apotex Inc. v. Sanofi-Aventis (2015), 470 N.R. 153 (SCC)
MLB headnote and full text
[French language version follows English language version]
[La version française vient à la suite de la version anglaise]
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Temp. Cite: [2015] N.R. TBEd. AP.017
Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. (appellants) v. Apotex Inc. (respondent)
Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. (appellants) v. Apotex Inc. (respondent)
Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. (appellants) v. Apotex Inc. (respondent)
Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. (appellants) v. Apotex Inc. (respondent) and Canadian Generic Pharmaceutical Association and Canada's Research-Based Pharmaceutical Companies (interveners)
(35886; 2015 SCC 20; 2015 CSC 20)
Indexed As: Apotex Inc. v. Sanofi-Aventis et al.
Supreme Court of Canada
McLachlin, C.J.C., Abella, Rothstein, Cromwell, Moldaver, Karakatsanis, Wagner, Gascon and Côté, JJ.
April 20, 2015.
Summary:
Apotex Inc. sold a generic version of ramipril (Apo-ramipril), a drug used mainly to treat hypertension. Sanofi-Aventis held patent rights to a brand-name version of ramipril (ALTACE). In spite of the fact that Apotex received certain regulatory approvals from Health Canada in 2004, it was unable to commence sales of Apo-ramipril until December 12, 2006, when it received its Notice of Compliance (NOC) pursuant to the Patented Medicines (Notice of Compliance) Regulations. In whole or in part, the delay was caused by the actions of Sanofi, which exercised its rights under the Regulations to a statutory stay of the issuance of a NOC to Apotex. Apotex commenced an action against Sanofi, claiming damages pursuant to s. 8 of the Regulations, for the loss it suffered during the period from April 26, 2004 to May 2, 2008. Sanofi raised issues respecting the validity of s. 8 which were considered in separate proceedings.
The Federal Court, in a decision reported 410 F.T.R. 145; 2012 FC 551 (the validity judgment), rejected Sanofi's arguments respecting the validity of s. 8. Sanofi acknowledged that if s. 8 was valid, then Apotex was entitled to damages under s. 8, but disputed certain elements of Apotex's claim, including: (a) the relevant dates for computing the loss; and (b) the various assumptions and projections built into the assessment of damages.
The Federal Court, in a decision reported 410 F.T.R. 78 (liability judgment), dealt with the issues accordingly. The court, inter alia, held that the relevant period for the purpose of determining Apotex's net lost profits commenced on April 26, 2004 (the patent hold date) and ended on December 12, 2006. For purposes of calculating damages, the court determined the size of the ramipril market in a hypothetical world having regard to generic competition by an authorized generic and another competing generic, Teva. While the court was unable to finalize a quantum of damages, the court expressed the hope that Sanofi and Apotex could quickly agree on a final amount to be paid by Sanofi to Apotex based on the court's reasons for judgment. Apotex appealed the liability judgment (Docket A-191-12). Sanofi brought a separate appeal from the liability judgment (Docket A-193-12). Sanofi brought an additional appeal (Docket A-397-12) respecting a subsequent order and direction issued by the trial judge on June 22, 2012 (the "Subsequent Ramp-Ups Order") which allowed a motion for reconsideration submitted by Apotex and which resulted in an amendment to the liability judgment. Sanofi also brought a subsequent appeal (Docket A-474-12), from a subsequent judgment of the trial judge dated November 2, 2012 (the "Final Quantum Judgment") which ordered, further to the liability judgment, the precise amount to be paid by Sanofi to Apotex, together with post-judgment interest.
The Federal Court of Appeal, Mainville, J.A., dissenting, in a decision reported 456 N.R. 279, allowed the Apotex appeal in A-191-12. The trial judge erred in ruling that Teva would have entered the hypothetical market during the liability period. The court dismissed Sanofi's appeals in A-193-12 and A-397-12. The court allowed Sanofi's appeal in A-474-12, solely to facilitate the redetermination of the quantum of damages. Sanofi appealed.
The Supreme Court of Canada dismissed the appeal substantially for the reasons of the majority of the Court of Appeal.
Editor's Note: An appeal respecting the validity judgment was also dismissed - see 459 N.R. 179; 2014 FCA 69. This case contains no topics.
Counsel:
[None disclosed].
Solicitors of Record:
[None disclosed].
This appeal was heard on April 20, 2015, before McLachlin, C.J.C., Abella, Rothstein, Cromwell, Moldaver, Karakatsanis, Wagner, Gascon and Côté, JJ., of the Supreme Court of Canada. On that same date the following decision was delivered orally, in both official languages, by McLachlin, C.J.C., for the court.
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