Bayer Inc. v. Canada (Health)
The application judge correctly found from the patent disclosure that the '970 patent claimed a delivery system/packaging designed to inhibit precipitation and maintain stability of the drug, not a dosage form of estradiol; therefore the application judge did not err in dismissing the application for judicial review...
Source-derived case information.
- Citation
- 2009 FCA 133
- Parties
- Appellant: Bayer Inc.; Respondent: The Minister of Health; Respondent: The Attorney General of Canada
- Court
- Federal Court of Appeal
- Jurisdiction
- Canada
- Judgment Date
- 28 April 2009
- Procedural Posture
- Judicial Review Appeal / Appeal Heard and Judgment Delivered at Federal Court of Appeal
- Outcome
- Appeal dismissed with costs
- Legal Topics
- Patent Claim Construction, Dosage Form Vs Packaging, Notice of Compliance Linkage, Drug Stability/precipitation
- Source Language
- en
Source-derived case record
Summary, issues, holding and outcome
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Parties
Bayer Inc.
Appellant
The Minister of Health
Respondent
The Attorney General of Canada
Respondent
Procedural Posture
Judicial Review Appeal / Appeal Heard and Judgment Delivered at Federal Court of Appeal
Legal Issues
- 1 Whether the '970 patent claimed a dosage form of estradiol whose use had been approved by issuance of a notice of compliance
- 2 Whether the patent in fact claimed a delivery system/packaging that inhibits precipitation (a stability-maintaining means) rather than a dosage form
- 3 Whether the application judge erred in dismissing the judicial review application
Ratio Decidendi
The application judge correctly found from the patent disclosure that the '970 patent claimed a delivery system/packaging designed to inhibit precipitation and maintain stability of the drug, not a dosage form of estradiol; therefore the application judge did not err in dismissing the application for judicial review and the appeal is dismissed.
Court Disposition
Appeal dismissed with costs
Orders
- Appeal dismissed with costs.
Full Case Text
Judgment text and source record
1 paragraphs
Bayer Inc. v. Canada (Health) Court (s) Database Federal Court of Appeal Decisions Date 2009-04-28 Neutral citation 2009 FCA 133 File numbers A-450-08 Decision Content Date: 20090428 Docket: A-450-08 Citation: 2009 FCA 133 CORAM: NOËL J.A. PELLETIER J.A. RYER J.A. BETWEEN: BAYER INC. Appellant and THE MINISTER OF HEALTH and THE ATTORNEY GENERAL OF CANADA Respondents Heard at Ottawa, Ontario, on April 28, 2009. Judgment delivered from the Bench at Ottawa, Ontario, on April 28, 2009. REASONS FOR JUDGMENT OF THE COURT BY: PELLETIER J.A. Date: 20090428 Docket: A-450-08 Citation: 2009 FCA 133 CORAM: NOËL J.A. PELLETIER J.A. RYER J.A. BETWEEN: BAYER INC. Appellant and THE MINISTER OF HEALTH and THE ATTORNEY GENERAL OF CANADA Respondents REASONS FOR JUDGMENT OF THE COURT (Delivered from the Bench at Ottawa, Ontario, on April 28, 2009) PELLETIER J.A. [1] Notwithstanding Mr. Gaikis' able argument, we are not persuaded that the application judge erred in dismissing the application for judicial review. [2] The essential question before the application judge was whether the '970 patent claimed a dosage form of the drug estradiol whose use had been approved by the issuance of a notice of compliance. We are satisfied that the application judge concluded that the "delivery system" described in the claims of the patent was in fact a novel means of maintaining the stability of the drug to be administered by avoiding precipitation: see paras. 59 and 64 of his reasons. There is support for this view in the language of the patent disclosure which the application judge quoted at paragraph 57 of his reasons: "… Consequently certain transdermal delivery devices involving dissolved drugs have shown a tendency to exhibit precipitation of the drug during storage. This problem is at least in part attributable to formation hydrate forms of the drug. Accordingly this invention provides a method of inhibiting precipitation of a drug in the carrier of a transdermal drug delivery device… [emphasis in the reasons]. [3] In light of these findings we are of the view that the application judge correctly found that the '970 patent did not claim a dosage form but rather a form of a protective packaging: see para. 64 of his reasons. [4] In the result, the appeal will be dismissed with costs. "J.D. Denis Pelletier" J.A. FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-450-08 (APPEAL FROM AN ORDER OF THE HONOURABLE MR. JUSTICE RUSSELL, DATED JULY 10, 2008, DOCKET NO. T-1518-07) STYLE OF CAUSE: Bayer Inc. and The Minister of Health and The Attorney General of Canada PLACE OF HEARING: Ottawa, Ontario DATE OF HEARING: April 28, 2009 REASONS FOR JUDGMENT OF THE COURT BY: NOËL, PELLETIER, RYER, JJ.A. DELIVERED FROM THE BENCH BY: PELLETIER, J.A. APPEARANCES: Gunars A. Gaikis Nancy Pei FOR THE APPELLANT David Cowie FOR THE RESPONDENTS SOLICITORS OF RECORD: Smart & Biggar Toronto, Ontario FOR THE APPELLANT John. H. Sims, Q.C. Deputy Attorney General of Canada FOR THE RESPONDENTS