Sanofi-Aventis v. Apotex Inc.
- Citation
- 2015 SCC 20
- Status
- Judgment
- Jurisdiction
- Canada
- Court
- Supreme Court of Canada
- Decision
- 21 April 2015
- Posture
- Appeal From Federal Court of Appeal (patent/pm(noc) Regulations) / Final Judgment on Appeal; Appeal Dismissed by Supreme Court of Canada
- Language
- English
More details
- Court
- Supreme Court of Canada
- Decision
- 21 April 2015
- Posture
- Appeal From Federal Court of Appeal (patent/pm(noc) Regulations) / Final Judgment on Appeal; Appeal Dismissed by Supreme Court of Canada
- Language
- English
On this page
Professional case brief
Research organized from the available case record
01
Holding and result
The appeal is dismissed: the Supreme Court upheld the Federal Court of Appeal majority that the trial judge did not err in fixing the liability period at 24 months, in finding that an authorized generic would have entered within three months and achieved approximately 30% market share during the liability period, and in awarding compensation for lost sales including those tied to unapproved indications under s.8 of the PM(NOC) Regulations.
Court disposition
Appeal dismissed
Orders
- Appeal dismissed with costs
02
Material facts
Parties
Sanofi-Aventis
Appellant Counsel: Andrew J. Reddon; Steven G. Mason; David Tait; Sanjaya MendisSanofi-Aventis Deutschland GmbH
Appellant Counsel: Andrew J. Reddon; Steven G. Mason; David Tait; Sanjaya MendisSanofi-Aventis Canada Inc.
Appellant Counsel: Andrew J. Reddon; Steven G. Mason; David Tait; Sanjaya MendisApotex Inc.
Respondent Counsel: Harry B. Radomski; Andrew Brodkin; David Scrimger; Benjamin HackettCanadian Generic Pharmaceutical Association
Intervener Counsel: Jonathan Stainsby; David W. Aitken; Devin DoyleCanada’s Research-Based Pharmaceutical Companies
Intervener Counsel: Allyson Whyte Nowak; Jason MarkwellAmounts and remedies
- Statutory Stay Months: 24
- Authorized Generic Entry Months: 3
- Authorized Generic Market Share Percent: 30
03
Procedural history
Posture
Appeal From Federal Court of Appeal (patent/pm(noc) Regulations) / Final Judgment on Appeal; Appeal Dismissed by Supreme Court of Canada
04
Questions and positions
Legal issues
- 01
Whether patentees' prohibition applications triggered the statutory 24-month stay under the Patented Medicines (Notice of Compliance) Regulations
- 02
Proper measure and period of liability under s.8 of the Regulations for delayed market entry
- 03
Whether an authorized generic would have entered the market within the liability period and obtained the estimated market share
- 04
Whether the generic manufacturer is entitled to compensation for lost sales associated with unapproved indications
- 05
Appropriate standard of appellate review of factual findings on hypothetical market outcomes
Party arguments
- Applicant
- Appellants contended the trial judge erred in (i) fixing the liability period at 24 months, (ii) finding the patentees' authorized generic would have entered the market within three months and achieved a 30% market share in the liability period, and (iii) awarding compensation for sales tied to unapproved indications; they sought reversal.
- Respondent
- Respondent argued the trial judge's factual findings and assessment of hypothetical market entry and market share were supported by evidence and properly assessed; the Federal Court of Appeal majority was correct to uphold those findings and the damages award.
05
Court’s reasoning
Legal principles
- 01
Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s.8
A prohibition application under the PM(NOC) Regulations triggers a statutory stay of 24 months that can give rise to liability under s.8 for delayed market entry.
- 02
Federal Court and Federal Court of Appeal precedent interpreting s.8 of the PM(NOC) Regulations
Damages for delayed market entry are assessed by a but-for analysis based on evidence of whether and when the generic (or an authorized generic) would have entered and the market share it would have captured.
- 03
Standard appellate review principles applied by the Federal Court of Appeal and Supreme Court of Canada
Findings of historical fact and commercial probability are reviewed on appellate courts on a reasonableness/deference basis; factual determinations supported by evidence should not be overturned lightly.
06
Ratio, limits and disposition
Ratio decidendi
The appeal is dismissed: the Supreme Court upheld the Federal Court of Appeal majority that the trial judge did not err in fixing the liability period at 24 months, in finding that an authorized generic would have entered within three months and achieved approximately 30% market share during the liability period, and in awarding compensation for lost sales including those tied to unapproved indications under s.8 of the PM(NOC) Regulations.
Court disposition
Appeal dismissed
- Appeal dismissed with costs
Source and reliance status
Supreme Court of Canada · 21 April 2015
This page organises the available record for research. Confirm quotations, current status, and subsequent treatment against the official source before relying on the case.
Judgment reading view
Judgment text
The complete available source text.
Supreme Court of Canada
Judgment· 21 April 2015
Sanofi-Aventis v. Apotex Inc. Collection Supreme Court Judgments Date 2015-04-21 Neutral citation 2015 SCC 20 Report [2015] 2 SCR 136 Case number 35886 Judges McLachlin, Beverley; Abella, Rosalie Silberman; Rothstein, Marshall; Cromwell, Thomas Albert; Moldaver, Michael J.; Karakatsanis, Andromache; Wagner, Richard; Gascon, Clément; Côté, Suzanne On appeal from Federal Court of Appeal Subjects Intellectual property Notes SCC Case Information: 35886 Decision Content
SUPREME COURT OF CANADA Citation: Sanofi-Aventis v. Apotex Inc., 2015 SCC 20, [2015] 2 S.C.R. 136 Date: 20150420 Docket: 35886 Between: Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellants and Apotex Inc. Respondent - and - Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellants and Apotex Inc. Respondent - and - Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellants and Apotex Inc. Respondent - and - Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellants and Apotex Inc. Respondent and Canadian Generic Pharmaceutical Association and Canada’s Research-Based Pharmaceutical Companies Interveners Coram: McLachlin C.J. and Abella, Rothstein, Cromwell, Moldaver, Karakatsanis, Wagner, Gascon and Côté JJ. Reasons for Judgment: (paras. 1 and 2) McLachlin C.J. (Abella, Rothstein, Cromwell, Moldaver, Karakatsanis, Wagner, Gascon and Côté JJ. concurring) Sanofi-Aventis v. Apotex Inc., 2015 SCC 20, [2015] 2 S.C.R. 136 Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellants v. Apotex Inc. Respondent - and - Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. Appellants v. Apotex Inc. Respondent - and - Sanofi-Aventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc.
Appellants v. Apotex Inc. Respondent - and - 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 Indexed as: Sanofi-Aventis v. Apotex Inc. 2015 SCC 20 File No.: 35886. 2015: April 20. Present: McLachlin C.J. and Abella, Rothstein, Cromwell, Moldaver, Karakatsanis, Wagner, Gascon and Côté JJ. on appeal from the federal court of appeal Intellectual property — Patents — Medicines — Manufacturer applied to market generic version of drug — Patentees of drug applied for prohibition orders that triggered statutory stay under Patented Medicines (Notice of Compliance) Regulations and prevented manufacturer from selling generic for 24 months — Action for damages brought under s. 8 of Regulations for delayed market entry — Court of Appeal holding that trial judge did not err in determining liability period of 24 months, in determining that patentees’ authorized generic version would have entered market within three months and achieved 30 percent share of hypothetical market within liability period, or in determining that manufacturer entitled to compensation for lost sales of its generic version associated with unapproved indications — Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. APPEAL from a
judgment of the Federal Court of Appeal (Sharlow, Pelletier and Mainville JJ.A.), 2014 FCA 68, 456 N.R. 279, 125 C.P.R. (4th) 403, [2014] F.C.J. No. 295 (QL), 2014 CarswellNat 700 (WL Can.), setting aside in part the judgment of Snider J., 2012 FC 553, 410 F.T.R. 78, [2012] F.C.J. No. 620 (QL), 2012 CarswellNat 1646 (WL Can.). Appeal dismissed. Andrew J. Reddon, Steven G. Mason, David Tait and Sanjaya Mendis, for the appellants. Harry B. Radomski, Andrew Brodkin, David Scrimger and Benjamin Hackett, for the respondent. Jonathan Stainsby, David W. Aitken and Devin Doyle, for the intervener the Canadian Generic Pharmaceutical Association. Allyson Whyte Nowak and Jason Markwell, for the intervener the Canada’s Research-Based Pharmaceutical Companies. The judgment of the Court was delivered orally by [1] The Chief Justice — We are all of the view to dismiss the appeal substantially for the reasons of the majority of the Court of Appeal. [2] The appeal is dismissed with costs. Judgment accordingly. Solicitors for the appellants: McCarthy Tétrault, Toronto. Solicitors for the respondent: Goodmans, Toronto. Solicitors for the intervener the Canadian Generic Pharmaceutical Association: Aitken Klee, Toronto and Ottawa. Solicitors for the intervener the Canada’s Research-Based Pharmaceutical Companies: Norton Rose Fulbright Canada, Toronto.
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