Sanofi-Aventis Canada Inc. v. Teva Canada Limited

Sanofi-Aventis Canada Inc. v. Teva Canada Limited

The court held that the Relevant Period cannot commence prior to the imposition of the statutory stay and on the facts here the appropriate commencement date is December 13, 2005 (expiry of the '457 Patent), with the Relevant Period December 13, 2005 to April 27, 2007; it is more likely than not that Apotex and an authorized generic would have entered on or about December 13, 2005 so the Generic Market would have comprised Teva, Apotex and an AG sharing the market equally (Teva one‑third); evidence and claims for 'lost business value' and 'duplicate ramp‑up' represent future losses outside s.8 and are excluded; other adjustments (pricing, trade spend, API cost, pre‑judgment interest from...

Citation
2012 FC 552
Parties
Plaintiff and Defendant by Counterclaim: Sanofi-Aventis Canada Inc.; Plaintiff and Defendant by Counterclaim: Schering Corporation; Plaintiff and Defendant by Counterclaim: Sanofi-Aventis Deutschland GmbH; Defendant and Plaintiff by Counterclaim: Teva Canada Limited
Court
Federal Court
Jurisdiction
Canada
Judgment Date
23 May 2012
Procedural Posture
Patent/regulatory Damages Action Under the Patented Medicines (notice of Compliance) Regulations S.8 / Trial — Reasons for Judgment (decision on Liability and Methodology; Quantum to Be Agreed or Submitted)
Outcome
Court decided legal and factual issues: Relevant Period is Dec 13, 2005–Apr 27, 2007; Generic Market likely comprised Teva, Apotex and an authorized generic entering Dec 13, 2005; Teva's share estimated at one‑third; excluded claims for lost business value and duplicate ramp‑up as unrecoverable under s.8; left final...
Legal Topics
Section 8 Pm(noc) Damages, Statutory Stay, Patent Hold Date, Authorized Generic, Market Erosion and Market Share, Causation and But‑for Analysis, Pre‑judgment Interest, HOPE Indications
Source Language
English
Patent Law Regulatory Law Administrative Law Pharmaceutical Regulation Civil Damages Section 8 Pm(noc) Damages Statutory Stay Patent Hold Date +5 more

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Parties

Sanofi-Aventis Canada Inc.

Plaintiff and Defendant by Counterclaim

Schering Corporation

Plaintiff and Defendant by Counterclaim

Sanofi-Aventis Deutschland GmbH

Plaintiff and Defendant by Counterclaim

Teva Canada Limited

Defendant and Plaintiff by Counterclaim

Procedural Posture

Patent/regulatory Damages Action Under the Patented Medicines (notice of Compliance) Regulations S.8 / Trial — Reasons for Judgment (decision on Liability and Methodology; Quantum to Be Agreed or Submitted)

Legal Issues

  1. 1 What is the Relevant Period for s.8 damages?
  2. 2 Whether Relevant Period can commence before statutory stay
  3. 3 Appropriate commencement date for Relevant Period on these facts

Ratio Decidendi

The court held that the Relevant Period cannot commence prior to the imposition of the statutory stay and on the facts here the appropriate commencement date is December 13, 2005 (expiry of the '457 Patent), with the Relevant Period December 13, 2005 to April 27, 2007; it is more likely than not that Apotex and an authorized generic would have entered on or about December 13, 2005 so the Generic Market would have comprised Teva, Apotex and an AG sharing the market equally (Teva one‑third); evidence and claims for 'lost business value' and 'duplicate ramp‑up' represent future losses outside s.8 and are excluded; other adjustments (pricing, trade spend, API cost, pre‑judgment interest from...

Court Disposition

Court decided legal and factual issues: Relevant Period is Dec 13, 2005–Apr 27, 2007; Generic Market likely comprised Teva, Apotex and an authorized generic entering Dec 13, 2005; Teva's share estimated at one‑third; excluded claims for lost business value and duplicate ramp‑up as unrecoverable under s.8; left final...

Orders

  • Relevant Period set as December 13, 2005 to April 27, 2007
  • Findings that likely generic entrants in but‑for world were Teva, Apotex and an authorized generic entering on or about December 13, 2005 and market share allocated equally