Pfizer Canada Inc. v. Apotex Inc.

Pfizer Canada Inc. v. Apotex Inc.

Claims 8 and 9 properly construed to cover the novel crystalline Form I ODV succinate; Pfizer proved on a balance of probabilities that Apotex’s allegations of obviousness (including obvious-to-try), inutility, anticipation and double patenting and non-infringement were not justified; utility of claimed subject-matter demonstrated; therefore prohibition under s.6 of the NOC Regulations granted and Minister prohibited from issuing NOC to Apotex in respect of the challenged NOA until expiry of Canadian Patent No. 2,436,668.

Citation
2017 FC 774
Parties
Applicant: Pfizer Canada Inc.; Applicant: Wyeth LLC; Respondent: Apotex Inc.; Respondent: The Minister of Health
Court
Federal Court
Jurisdiction
Canada
Judgment Date
22 August 2017
Procedural Posture
NOC Regulations Proceeding (patented Medicines (notice of Compliance) Regulations) / Application for Prohibition Under S.6 of the NOC Regulations
Outcome
Application granted; Minister of Health prohibited from issuing NOC in respect of Apotex's NOA until expiry of Canadian Patent No. 2,436,668; costs awarded to Pfizer on agreed terms
Legal Topics
Obviousness, Obvious to Try, Utility/inutility, Anticipation, Double Patenting, Non Infringement, Claim Construction, S.27(3) Overpromising, NOC Prohibition
Source Language
English
Patent Law Pharmaceutical Regulation Intellectual Property Administrative Law Obviousness Obvious to Try Utility/inutility Anticipation +5 more

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Parties

Pfizer Canada Inc.

Applicant

Wyeth LLC

Applicant

Apotex Inc.

Respondent

The Minister of Health

Respondent

Procedural Posture

NOC Regulations Proceeding (patented Medicines (notice of Compliance) Regulations) / Application for Prohibition Under S.6 of the NOC Regulations

Legal Issues

  1. 1 construction of claims 8 and 9 (Form I ODV succinate)
  2. 2 obviousness and obvious-to-try
  3. 3 utility/inutility (AstraZeneca implications)

Ratio Decidendi

Claims 8 and 9 properly construed to cover the novel crystalline Form I ODV succinate; Pfizer proved on a balance of probabilities that Apotex’s allegations of obviousness (including obvious-to-try), inutility, anticipation and double patenting and non-infringement were not justified; utility of claimed subject-matter demonstrated; therefore prohibition under s.6 of the NOC Regulations granted and Minister prohibited from issuing NOC to Apotex in respect of the challenged NOA until expiry of Canadian Patent No. 2,436,668.

Court Disposition

Application granted; Minister of Health prohibited from issuing NOC in respect of Apotex's NOA until expiry of Canadian Patent No. 2,436,668; costs awarded to Pfizer on agreed terms

Orders

  • Minister of Health is prohibited from issuing a Notice of Compliance in respect of the Notice of Allegation dated January 21, 2016 by Apotex Inc. until expiry of Canadian Patent No. 2,436,668
  • Apotex Inc. shall pay Pfizer its costs of the application in accordance with the parties' agreed Schedule A (directions on assessment)