Abbott Laboratories v. Canada (Health)

Abbott Laboratories v. Canada (Health)

The Court found Sandoz's allegation of invalidity justified because US Patent No. 4,990,602 disclosed recrystallized crystalline clarithromycin (corresponding to Form I) and its oral therapeutic use, and that disclosure was enabling; therefore claim 5 was anticipated (and would be obvious in any event). The Court further found Abbott failed to prove Sandoz's non-infringement allegation: the likely manufacturing/drying conditions meant some batches would contain detectable Form I and thus fall within the properly construed scope of claim 5. Accordingly the prohibition sought was denied and the application dismissed with costs to Sandoz.

Citation
2008 FC 1359
Parties
Applicant/patentee: Abbott Laboratories; Applicant/regulatory NOC Holder: Abbott Laboratories Limited; Respondent/regulatory Authority: The Minister of Health; Respondent/second Person/generic Manufacturer: Sandoz Canada Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
11 December 2008
Procedural Posture
PMNOC Proceeding (section 6 Application Under the Patented Medicines (notice of Compliance) Regulations) / Hearing and Final Judgment
Outcome
Application dismissed. Allegation of invalidity justified; allegation of non-infringement not justified. No prohibition on issuance of Notice of Compliance.
Legal Topics
Anticipation, Obviousness, Infringement, Claim Construction, Notice of Compliance Regulations, Costs
Source Language
English
Patent Intellectual Property Administrative/regulatory Law Anticipation Obviousness Infringement Claim Construction Notice of Compliance Regulations +1 more

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Parties

Abbott Laboratories

Applicant/patentee

Abbott Laboratories Limited

Applicant/regulatory NOC Holder

The Minister of Health

Respondent/regulatory Authority

Sandoz Canada Inc.

Respondent/second Person/generic Manufacturer

Procedural Posture

PMNOC Proceeding (section 6 Application Under the Patented Medicines (notice of Compliance) Regulations) / Hearing and Final Judgment

Legal Issues

  1. 1 Construction of claim 5 of Canadian Letters Patent No. 2,386,527
  2. 2 Whether claim 5 is invalid for anticipation
  3. 3 Whether claim 5 is invalid for obviousness

Ratio Decidendi

The Court found Sandoz's allegation of invalidity justified because US Patent No. 4,990,602 disclosed recrystallized crystalline clarithromycin (corresponding to Form I) and its oral therapeutic use, and that disclosure was enabling; therefore claim 5 was anticipated (and would be obvious in any event). The Court further found Abbott failed to prove Sandoz's non-infringement allegation: the likely manufacturing/drying conditions meant some batches would contain detectable Form I and thus fall within the properly construed scope of claim 5. Accordingly the prohibition sought was denied and the application dismissed with costs to Sandoz.

Court Disposition

Application dismissed. Allegation of invalidity justified; allegation of non-infringement not justified. No prohibition on issuance of Notice of Compliance.

Orders

  • Application dismissed
  • No prohibition issued against the Minister of Health granting a Notice of Compliance to Sandoz Canada Inc.