Apotex Inc. v. Sanofi-Aventis

Apotex Inc. v. Sanofi-Aventis

The Court found the Partnership had standing and that Apotex committed infringing acts, but the '777 selection patent was invalid: the patent failed the sound‑prediction/utility requirement because the factual basis and, critically, the disclosure of the factual basis and line of reasoning were insufficient; in the alternative claims were obvious (obvious‑to‑try). Accordingly Apotex’ impeachment action was allowed and Sanofi’s infringement action dismissed.

Citation
2011 FC 1486
Parties
Plaintiff/defendant: Apotex Inc.; Defendant/plaintiff: Sanofi‑Aventis; Co‑plaintiff: Bristol‑Myers Squibb Sanofi Pharmaceuticals Holdings Partnership; Co‑defendant: Apotex Pharmachem Inc.; Co‑defendant: Signa SA de CV
Court
Federal Court
Jurisdiction
Canada
Judgment Date
6 December 2011
Procedural Posture
Patent Impeachment and Infringement (selection Patent Re: Clopidogrel) / Trial; Reasons for Judgment (judgment Issued)
Outcome
Apotex' impeachment action allowed; Sanofi's infringement action dismissed; '777 Patent declared invalid for lack of utility (unsound prediction) and, alternatively, obviousness
Legal Topics
Utility, Sound Prediction, Obviousness (obvious‑to‑try), Anticipation, Claim Construction, Standing, Infringement, Experimental Use Exemption, Limitation Period, Double Patenting, Selection Patents
Source Language
English
Patent Law Pharmaceutical Regulatory Law Intellectual Property Commercial Litigation Utility Sound Prediction Obviousness (obvious‑to‑try) Anticipation +7 more

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Parties

Apotex Inc.

Plaintiff/defendant

Sanofi‑Aventis

Defendant/plaintiff

Bristol‑Myers Squibb Sanofi Pharmaceuticals Holdings Partnership

Co‑plaintiff

Apotex Pharmachem Inc.

Co‑defendant

Signa SA de CV

Co‑defendant

Procedural Posture

Patent Impeachment and Infringement (selection Patent Re: Clopidogrel) / Trial; Reasons for Judgment (judgment Issued)

Legal Issues

  1. 1 Whether Sanofi/Partnership had standing
  2. 2 Whether Apotex infringed the '777 patent
  3. 3 Whether the '777 patent is valid (utility, sound prediction, obviousness, anticipation, double patenting)

Ratio Decidendi

The Court found the Partnership had standing and that Apotex committed infringing acts, but the '777 selection patent was invalid: the patent failed the sound‑prediction/utility requirement because the factual basis and, critically, the disclosure of the factual basis and line of reasoning were insufficient; in the alternative claims were obvious (obvious‑to‑try). Accordingly Apotex’ impeachment action was allowed and Sanofi’s infringement action dismissed.

Court Disposition

Apotex' impeachment action allowed; Sanofi's infringement action dismissed; '777 Patent declared invalid for lack of utility (unsound prediction) and, alternatively, obviousness

Orders

  • Declaration that Canadian Patent No. 1,336,777 is invalid
  • Sanofi’s action for infringement dismissed