Pfizer Canada Inc. v. Apotex Inc.

Pfizer Canada Inc. v. Apotex Inc.

On a balance of probabilities Pfizer met its legal burden: the disclaimers were validly filed; Apotex adduced evidence sufficient to put invalidity in play but failed to rebut the presumption of validity; the prior art did not make the claimed use of oral sildenafil for ED obvious or anticipated the claims as construed; the claims are properly construed as use claims within the Regulations; accordingly the prohibition order preventing the Minister from issuing an NOC to Apotex for sildenafil until expiry of Canadian Patent No. 2,163,446 must issue.

Citation
2007 FC 971
Parties
Applicant: Pfizer Canada Inc.; Applicant: Pfizer Ireland Pharmaceuticals; Respondent: Apotex Inc.; Respondent: Minister of Health
Court
Federal Court
Jurisdiction
Canada
Judgment Date
27 September 2007
Procedural Posture
Prohibition Application Under the Patented Medicines (notice of Compliance) Regulations / Final Judgment (reasons for Judgment)
Outcome
Application granted; prohibition order issued; respondent's motion to dismiss dismissed
Legal Topics
Obviousness, Anticipation, Claim Construction, Disclaimer Validity, Notice of Compliance / NOC, Burden of Proof, Patent Listing Eligibility
Source Language
English
Patent Law Pharmaceutical Regulation Intellectual Property Administrative Law Obviousness Anticipation Claim Construction Disclaimer Validity +3 more

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Parties

Pfizer Canada Inc.

Applicant

Pfizer Ireland Pharmaceuticals

Applicant

Apotex Inc.

Respondent

Minister of Health

Respondent

Procedural Posture

Prohibition Application Under the Patented Medicines (notice of Compliance) Regulations / Final Judgment (reasons for Judgment)

Legal Issues

  1. 1 burden of proof and presumption of validity
  2. 2 validity of disclaimers under s.48(1) Patent Act
  3. 3 obviousness of claimed use of sildenafil

Ratio Decidendi

On a balance of probabilities Pfizer met its legal burden: the disclaimers were validly filed; Apotex adduced evidence sufficient to put invalidity in play but failed to rebut the presumption of validity; the prior art did not make the claimed use of oral sildenafil for ED obvious or anticipated the claims as construed; the claims are properly construed as use claims within the Regulations; accordingly the prohibition order preventing the Minister from issuing an NOC to Apotex for sildenafil until expiry of Canadian Patent No. 2,163,446 must issue.

Court Disposition

Application granted; prohibition order issued; respondent's motion to dismiss dismissed

Orders

  • Respondent's motion to dismiss the application dated May 22, 2007 is dismissed with costs to the applicants
  • The Minister of Health is prohibited from issuing a Notice of Compliance to Apotex Inc. in accordance with s.6(1) of the Patented Medicines (Notice of Compliance) Regulations for sildenafil, sildenafil citrate, or any drug connected to sildenafil citrate as described in ss.5(1) or 5(1.1) until after expiry of...