Eli Lilly Canada Inc. v. Novopharm Limited

Eli Lilly Canada Inc. v. Novopharm Limited

The '113 selection patent is invalid because Lilly failed to establish, as of the 1991 filing date, any substantial and peculiar advantage of olanzapine over the '687 genus or provide the requisite factual basis and line of reasoning in the specification to support a sound prediction; disclosure was inadequate and therefore no new invention was disclosed beyond the genus, rendering the claims invalid.

Citation
2009 FC 1018
Parties
Plaintiff (defendant by Counterclaim): ELI LILLY CANADA INC.; Plaintiff (defendant by Counterclaim): ELI LILLY AND COMPANY; Plaintiff (defendant by Counterclaim): ELI LILLY AND COMPANY LIMITED; Plaintiff (defendant by Counterclaim): ELI LILLY SA; Defendant (plaintiff by Counterclaim): NOVOPHARM LIMITED
Court
Federal Court
Jurisdiction
Canada
Judgment Date
5 October 2009
Procedural Posture
Patent Infringement (selection Patent Validity) / Trial Judgment (federal Court, Decision Dated 2009 10 05)
Outcome
The claims of the '113 patent are invalid; Lilly's action for patent infringement dismissed.
Legal Topics
Selection Patent, Sound Prediction, Insufficiency of Disclosure, Obviousness, Anticipation, Double Patenting, Misrepresentation (s.53 Patent Act), Deemed Abandonment (s.73 Patent Act), Patented Medicines (notice of Compliance) Regulations
Source Language
English
Patent Law Intellectual Property Pharmaceutical Regulation Administrative Law Selection Patent Sound Prediction Insufficiency of Disclosure Obviousness +5 more

Case Brief

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Parties

ELI LILLY CANADA INC.

Plaintiff (defendant by Counterclaim)

ELI LILLY AND COMPANY

Plaintiff (defendant by Counterclaim)

ELI LILLY AND COMPANY LIMITED

Plaintiff (defendant by Counterclaim)

ELI LILLY SA

Plaintiff (defendant by Counterclaim)

NOVOPHARM LIMITED

Defendant (plaintiff by Counterclaim)

Procedural Posture

Patent Infringement (selection Patent Validity) / Trial Judgment (federal Court, Decision Dated 2009 10 05)

Legal Issues

  1. 1 Whether the '113 patent is a valid selection patent over the earlier '687 genus patent
  2. 2 Whether the patent disclosed a factual basis and line of reasoning sufficient for sound prediction
  3. 3 Whether alleged advantages (liver enzymes, CPK, EPS, cholesterol, efficacy, prolactin, white blood cell effects) were known or soundly predictable as of filing

Ratio Decidendi

The '113 selection patent is invalid because Lilly failed to establish, as of the 1991 filing date, any substantial and peculiar advantage of olanzapine over the '687 genus or provide the requisite factual basis and line of reasoning in the specification to support a sound prediction; disclosure was inadequate and therefore no new invention was disclosed beyond the genus, rendering the claims invalid.

Court Disposition

The claims of the '113 patent are invalid; Lilly's action for patent infringement dismissed.

Orders

  • The claims of the '113 patent in issue are declared invalid.
  • The plaintiffs' (Lilly's) action for patent infringement is dismissed.